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Ministry of Health Research Proposal Guideline 1


Foreword

The well-known entity called R&D or Research and Development is a critical facet of any organizations

for its growth and continued relevance in the scientific world. Without research, there can be no

development. Without development, the organization remains static. And if an organization remains

static, it soon becomes irrelevant. Thus, research has to play a pivotal role for the future growth of the

any organisation.

With the dawn of the modern renaissance in Oman in 1970, great emphasis was placed in the domain

of Health and Education. They continue to be priority areas of the Government even to this date. In the

early decades of growth in Oman, health service was the main focus and it has paid rich dividends. By

all standards of measurement of health, Oman is now ranked along with the high income countries. A

clear understanding of the local situation, local needs and research priorities can be achieved only

through good quality focused research done within the country by the people that know it best. If the

health sector has to develop further and remain relevant to enhance the health and well-being of its

citizens, research has to be a priority.

Research within the health sector has been receiving increasing priority since the fifth 5-year plan.

Domains for research have been prioritized. Ways and means of encouraging, facilitating and

supporting research in health service and health system have been progressively increasing. The Health

Vision for 2050 has laid great emphasis on enhancing research within the health sector in Oman. But

health research does not happen just because of Governmental or Administrative initiatives. The

infrastructure and the human motivation have to enhance simultaneously. The Centre of Studies and

Research (CSR) and the Research and Ethics Review & Approval Committee (RERAC) have been

created exclusively to facilitate, encourage, support and monitor research within the Ministry of Health

in Oman. If these activities can be rendered using newer technologies that will improve efficiency, save

time and educe effort, it will prove to be beneficial in the long run.

I am glad that the Centre of Studies and Research has taken one more step in improving the situation

by initiating the process of online submission of research proposals on the MoH website. The website

was launched in December 2015 and now, all research proposals submitted for review by RERAC has

to be submitted online. Compared to the earlier system, this is more efficient in many aspects. The

research proposal forms have been upgraded and are now more comprehensive to cover different types

of research designs. This booklet is one more in a series of information that is designed to add some

more impetus to the system and process of administrative management of research activities within the

Ministry. It is designed to guide the researcher through the myriad of explanations and answers that are

required for compiling the research proposal form for submission to RERAC. Each form is designed in

a comprehensive and logical manner which will prompt the researcher to compile the form in a


methodical and systematic manner and submit it online which in turn will make it easier for the RERAC

Reviewers to evaluate and score the proposals as well as give constructive suggestions and feedback on

the proposal to the researcher. Through this process, the system of research proposal submission will

not only be made more efficient but also educational for the researcher and a gratifying experience.

No system should remain static. Continuous Quality Improvement (CQI) will be as much a need of this

enterprise as with any other health sector service. I am sure the team at CSR will strive towards CQI

and meet newer challenges as they emerge. This may be just another step in the right direction but I am

confident that all these endeavours that MoH is putting in place will collectively help to enrich research

in Oman.

Dr. Ahmed Mohamed Al-Qasmi

Director General of Planning & Studies

Chairman of Research and Ethical Review & Approval Committee


Task Force

Chairperson:

Dr Adhra Hilal Nasser Al-Mawali, Director, Centre of Studies and Research (Ministry of Health)

Ph.D. in Flow Cytometry and Molecular Genetics, University of Adelaide (Australia)

Members:

Dr John Idikula, Senior Specialist (Ministry of Health); MS; M.Med.Sci. in Epidemiology, University

of Newcastle (Australia)

Mr Avinash Daniel Pinto, Technical Manager of Health Information (Ministry of Health); M.Sc. in

Molecular Medicine, University of Sheffield (United Kingdom)

Mr Waleed Nasser Al-Shekaili, Head of Health Systems Research (Ministry of Health); M.Sc. in

Health Services and Public Health Research, University of Aberdeen (United Kingdom)

Ms Sultana Mohamed Saif Al-Sabahi, Head of the Department of Knowledge Translation and

Research Management (Ministry of Health); M.Sc. in Epidemiology and Medical Statistics, Sultan

Qaboos University (Oman)

Dr Brian Gunn, Senior Specialist Clinical Pharmacist & Section Head Research (Ministry of Health)

Ph.D., Heriot-Watt University (United Kingdom)

Prof. Gillian White, Advisor Directorate General of Education & Training (Ministry of Health)

Ph.D. in Community Health, University of Tasmania (Australia)

Acknowledgement

Members of the Research and Ethical Review & Approval Committee (RERAC)


Table of Contents Foreword ................................................................................................................................................ 2

Task Force ............................................................................................................................................. 4

Introduction ......................................................................................................................................... 10

Website of the Centre of Studies & Research ................................................................................... 13

Steps prior to Submission of a Research Proposal ........................................................................... 13

I. Ministry of Health (MoH) Staff as Principal Investigators ....................................................... 13

II. Non-Ministry of Health Persons as Principal Investigators ...................................................... 14

III. Non-Ministry of Health persons/institutions/organizations from outside Oman or non-

Omani researchers in Oman but not affiliated to any institution ...................................................... 16

Sensitive Data / Material .................................................................................................................... 19

Commensuration of Authorising Authority ..................................................................................... 20

Research carried out in Private Healthcare Establishments .......................................................... 21

Research Proposal Submission Process ............................................................................................ 22

Research Proposal System Timeline ................................................................................................. 24

Research Proposal Review Status/Decisions ..................................................................................... 25

RERAC Review Decision Appeals ..................................................................................................... 30

Common Section of all Forms ............................................................................................................ 32

1. Research Proposal Title ............................................................................................................ 33

2. Research Team Details.............................................................................................................. 33

3. Planned Contribution of Research Team Members .................................................................. 34

4. Research Proposal Summary .................................................................................................... 35

5. Background and Literature Review .......................................................................................... 36

6. What is the Reason for Conducting this Study?........................................................................ 37

7. Statements Related to the Problem ........................................................................................... 37

8. What Kind of Research Will be Conducted? ............................................................................ 39

Research Algorithm ............................................................................................................................ 40

Research Algorithm (Choosing the suitable Form to be filled) ........................................................ 41

Form A1: Clinical Trials .................................................................................................................... 42

9. Study Group Recruitment ......................................................................................................... 43

10. Sample Size Estimate of the Study / Experiment Group ...................................................... 44

11. Study / Experiment Group Allocation .................................................................................. 45

12. Control Group Recruitment .................................................................................................. 45

13. Sample Size Estimation of the Control / Comparison Group ............................................... 46

14. Control Group Allocation ..................................................................................................... 46

15. Baseline Characteristics Relevant to the Study ..................................................................... 47


16. Intervention ........................................................................................................................... 47

17. Informed Consent .................................................................................................................. 49

18. Blinding and Bias .................................................................................................................. 50

19. Co-intervention ..................................................................................................................... 51

20. Contamination ....................................................................................................................... 51

21. Confounders .......................................................................................................................... 51

22. Maintenance .......................................................................................................................... 52

23. Outcome ................................................................................................................................ 52

24. Outcome Measurement ......................................................................................................... 52

25. Data Synthesis and Management .......................................................................................... 53

26. Work Plan & Study Implications .......................................................................................... 54

27. Ethical considerations ........................................................................................................... 55

28. Additional Resource Utilisation ............................................................................................ 56

29. Pilot Study ............................................................................................................................. 56

30. Additional information .......................................................................................................... 56

31. Research Grant ...................................................................................................................... 56

32. Attachments .......................................................................................................................... 57

33. Declaration – To be signed by the Principal Investigator (P.I.) ............................................ 57

Form A2: Case-Control Studies......................................................................................................... 58

9. Study Group / Cases .................................................................................................................. 59

10. Target Population of Cases ................................................................................................... 59

11. Sample Selection of Cases .................................................................................................... 61

12. Sample Size Estimation of the Cases .................................................................................... 61

13. Study Group / Controls ......................................................................................................... 62

14. Selection of Controls ............................................................................................................. 62

15. Sample Selection of Controls ................................................................................................ 63

16. Sample Size Estimation of the Control ................................................................................. 63

17. Informed Consent ................................................................................................................. 65

18. Outcome Measuring Instrument ............................................................................................ 66

19. Exposure Factors ................................................................................................................... 66

20. Confounders .......................................................................................................................... 68

21. Exposure Measuring Instrument ........................................................................................... 68

22. Blinding................................................................................................................................. 68



25. Ethical Considerations .......................................................................................................... 71



27. Pilot Study ............................................................................................................................. 72

28. Additional Information ......................................................................................................... 72

29. Research Grant ...................................................................................................................... 72

30. Attachments .......................................................................................................................... 72

31. Declaration – To be Signed by the Principal Investigator (P.I.) ........................................... 73

Form A3: Cohort Studies ................................................................................................................... 74

9. Study Cohort ............................................................................................................................. 75

10. Target Population of Cohorts ................................................................................................ 75

11. Sample Size Estimation of the Cohort Group ....................................................................... 77

12. Enrolment of the Cohort Participants .................................................................................... 77

13. Control / Comparison Cohort ................................................................................................ 77

14. Sample Size Estimation of the Control / Comparison Group ............................................... 78

15. Control Group Allocation ..................................................................................................... 79

16. Matching ............................................................................................................................... 79

17. Informed Consent ................................................................................................................. 80

18. Exposure Measuring Instrument ........................................................................................... 81

19. Outcome Measuring Instrument ............................................................................................ 81

20. Confounders .......................................................................................................................... 82

21. Modification and Follow-Up ................................................................................................ 82

22. Outcome Measures ................................................................................................................ 83

23. Attrition ................................................................................................................................. 84

24. Blinding................................................................................................................................. 84



27. Ethical Considerations .......................................................................................................... 87


29. Pilot Study ............................................................................................................................. 88

30. Additional Information ......................................................................................................... 88

31. Research Grant ...................................................................................................................... 88

32. Attachments .......................................................................................................................... 88

33. Declaration – To be Signed by the Principal Investigator (P.I.) ........................................... 89

Form B: Qualitative Research ........................................................................................................... 90

Introduction ....................................................................................................................................... 91

9. Study Design ............................................................................................................................. 92

10. Research Strategy .................................................................................................................. 92


11. Data Collection Methods ...................................................................................................... 93

12. Sampling ............................................................................................................................... 93

13. Methodological considerations ............................................................................................. 93

14. Data Analysis ........................................................................................................................ 94

15. Pilot Study ............................................................................................................................. 94


17. Quality Control of Data......................................................................................................... 95

18. Ethical Considerations* ........................................................................................................ 95

19. Informed Consent .................................................................................................................. 97

20. Anticipated Results, Beneficiaries and Dissemination ......................................................... 98


22. Research Grant .................................................................................................................... 100

23. Attachments ........................................................................................................................ 101

24. Declaration – To be Signed by the Principal Investigator (P.I.) ......................................... 101

Form C: Non-Clinical Quantitative................................................................................................. 102

9. Study Group ............................................................................................................................ 103

10. Sample Size Estimation of the Study .................................................................................. 104

11. Study Group Allocation ...................................................................................................... 105

12. Control / Comparison Group............................................................................................... 105

13. Sample Size Estimation of the Control / Comparison Group ............................................. 106

14. Control Group Allocation ................................................................................................... 106

15. Measuring Instrument ......................................................................................................... 106

16. Pilot Study ........................................................................................................................... 107

17. Data Collectors Training ..................................................................................................... 107

18. Informed Consent ................................................................................................................ 108

19. Attrition and Non-Compliance ............................................................................................ 109

20. Data Synthesis and Management ........................................................................................ 110

21. Work Plan & Study Implications ........................................................................................ 110

22. Ethical Considerations ........................................................................................................ 112

23. Additional Resource Utilisation .......................................................................................... 112

24. Research Grant .................................................................................................................... 112

25. Attachments ........................................................................................................................ 113


Form D: Mixed/Other Research Designs ........................................................................................ 114

9. Research Design and Methodology ........................................................................................ 115

10. Study Population ................................................................................................................. 115


11. Sample Size Estimation ...................................................................................................... 116

12. Study Group Allocation ...................................................................................................... 117

13. Control / Comparison Group............................................................................................... 117

14. Measuring Instrument ......................................................................................................... 118

15. Gold Standard / Benchmark ................................................................................................ 119

16. Pilot Study ........................................................................................................................... 119

17. Data Collectors Training ..................................................................................................... 119

18. Informed Consent ................................................................................................................ 120

19. Attrition and Non-Compliance ............................................................................................ 121

20. Data Synthesis and Management ........................................................................................ 122

21. Work Plan & Study Implications ........................................................................................ 122

22. Ethical Considerations ........................................................................................................ 124

23. Additional Resource Utilisation .......................................................................................... 124

24. Additional Information ....................................................................................................... 124

25. Research Grant .................................................................................................................... 125

26. Attachments ........................................................................................................................ 125


Minimum required standards .......................................................................................................... 126

Glossary of Research Terms ........................................................................................................... 126


Introduction

Reviewing research proposals to evaluate them for ethical and research acceptability is an

important responsibility and function of the Review Board of every institution that supervises

research. The elaborate process of Ethical and Research Review begins with the submission

of the research proposal by the Principal Investigator who represents the research team and

takes the responsibility for making all the interactive dealings with the Committee from

proposal submission to final reporting of the completed research project.

Each Review Board would have its own format for the forms that need to be filled. Both the

form and the process of submission would change over time to meet the demand and the

evolving technology. From paper forms that needed to be manually filled and physically

submitted a few decades ago through to submission by e-mail, the Research and Ethics Review

& Approval Committee (RERAC) has now reached a stage where research proposals can be

submitted online on the dedicated website of the Centre of Studies and Research (CSR) to be

reviewed as well as followed up electronically by RERAC. The evolution to reach this stage

was as much due to the necessity of keeping abreast with advancing technology as the need to

be economically efficient, judicious in time management and transparent in the review process.

The CSR Team also had to take into consideration that researchers in the Ministry of Health

range from novice researchers who are planning to do research for the very first time to expert

researchers planning multi-centric international trials and even postgraduate students

proposing to do dissertations for MSc or theses for PhD programmes registered at international

universities. This meant that the proposal forms that need to be submitted have to be specific,

educational, and comprehensive as well as simple and user-friendly. The CSR Team took all

these factors into consideration in the process of creating the revised research proposal form.

The revisions were also reviewed for suitability by members of the RERAC and their opinion

and views were taken into consideration in the creation of the revised Research Proposal forms.

Another important consideration is the fact that there are different research designs, each of

them being specific to address a particular type of research concept. There are qualitative

research that makes detailed evaluation of a particular situation, quantitative studies that

analyses a problem to find an explanation or a solution and even clinical studies on patients

that determines the effect of an experiment or an intervention. The research method that needs

to be applied in each situation is distinct in many respects. Hence, the concept “one research


proposal form fits all” is not apt. Keeping the distinct nature of different research in

consideration, six different proposal forms were designed that are suitable for each of the most

common types of research. The forms are designed so that it is easy to fill even by a novice

researcher yet detailed and thorough enough for any type of study design to be filled adequately

by an experienced researcher.

The website went through several revisions and upgrading before it was considered ready and

was launched in December 2015. Like all interactive websites, when end users start using it,

some of the deficiencies and “bugs” in the programme will become apparent. Arrangements

have been made to meet with such contingencies - to resolve them and to keep improving the

usability of the web site and the research proposal forms. The website has several uses and

applications but the purpose of this document is to introduce the research proposal submission

forms and the process connected with it. The reader is encouraged to also read other

information available on the CSR website that connects this material to other similar materials

relevant to research in the Ministry of Health (For example, the latest booklet titled ‘The

Guidelines for Responsible Conduct of Clinical Studies & Trials’). There are also several

educational materials like PowerPoint® presentations of lectures on research methodology and

biostatistics, e-library resources, links to useful sites like Free Medical Journals, Sample Size

Calculators and several other useful resources for the researchers.

The research proposal form posted on the website of the Centre of Studies and Research

consists of 2 sections. The first section is common for all types of studies while the second

section is specific for each of the six different research types. At the end of the first section, the

researcher who is filling the proposal has to select the form that is best suited for the research

design of the proposed study. An algorithm to help in selecting the appropriate form to fill is

given at the end of the Common Section of the electronic form. This booklet will also help as

it gives a complete view of all the forms, giving the reader a chance to see all the forms and to

identify the most appropriate form that is suitable for the proposed study.

Each of the forms consists of items that have to be filled in by typing the matter or by copying

from another document, into boxes designed for each item. Instructions on what should be

written in each box are indicated above each box. Useful suggestions and helpful examples are

also given for most items. As mentioned earlier, this booklet contains the common section of

the form that has to be filled by all: as well as the six individual forms designed for each type

of study design, one of which has to be selected and filled to complete the proposal form. In


addition to the website form reprinted as it appears on the website, there are some notes to

provide additional information that are useful to the researcher filling out this form (these are

extracted from standard text books on research methodology and best practice, and are shown

in the coloured boxes in this booklet). To avoid replication, some of the notes are given only

in the first form, the one designed for clinical trial. This booklet is not intended to replace text

books or monograms on topics in research methodology but as a guide to fill this research

proposal form. The researcher must familiarize himself/herself with adequate knowledge on

research methodology, basic biostatistics and bioethics pertinent to the proposed research

before filling up this form so that all sections can be correctly, clearly and explicitly filled.

Once the proposal form is submitted, it will be screened to determine if it is complete with all

the required documents attached, and then it will be forwarded to the RERAC reviewers for

reviewing and scoring after which a final decision on approval will be taken by the RERAC.

The details of the review process and scoring are beyond the scope of this booklet and are given

in another document which is also found on the website of CSR. This booklet will fill the

existing gap on the contents of the electronic version of the research proposal submission forms

that are to be submitted online.


Website of the Centre of Studies & Research

You can visit www.mohcsr.gov.om to enter the online presence of the Centre of Studies &

Research, a dedicated website to stay up-to-date with the research activities of the Ministry of

Health as well as to get your research proposal submitted, reviewed, and approved by the

RERAC/Regional Research Committee. The website can also be accessed through a link from

the main Ministry of Health website (www.moh.gov.om). The fully responsive website can

seamlessly switch between English and Arabic. The website also has a mobile-friendly

interface which means visitors and researchers can browse the website on mobile, tablet and

PC. The website offers you search filtering options along with content-based features and

research databases. Promoting connectivity through the website offers you a one-stop-location

for research. All research conducted in Ministry of Health institutions should have prior

approval from RERAC/Regional Research Committee. If you are a researcher with a research

proposal to be submitted for approval to RERAC/Regional Research Committee, the steps

outlined in the sections below should guide you on how to proceed. For additional information

pertaining to research in the Ministry of Health, kindly refer to the publications which can be

found on our website homepage.

Steps prior to Submission of a Research Proposal

I. Ministry of Health (MoH) Staff as Principal Investigators

a) Register through a registration form (found on

www.mohcsr.gov.om by clicking on New User

on the homepage) directed through your

respective regional focal person

b) Mention your Name, Staff ID number and your

institution in the form.

c) Provide a copy of your Ministry of Health

Institutional ID card which mentions your 5-digit

staff number.

http://www.mohcsr.gov.om/

http://www.moh.gov.om/

http://www.mohcsr.gov.om/


d) After verification is complete, you shall receive your username and password through

the email you provided.

e) The username will be the MoH staff number of the Principal Investigator as this will

help in easy reference and identification for future correspondence/verification.

f) Researchers can login to the portal with the provided credentials to submit a research

proposal.

g) The submission must include letter(s) of provisional approval/authorization from the

institution(s) where the research will be carried out

II. Non-Ministry of Health Persons as Principal Investigators

Request for research to be carried out in any of the Ministry of Health institutions in Oman by

non-MoH persons would fall into one of the following categories:

a) Research carried out by students/staff of academic institutions in Oman

b) Research carried out by employees of a governmental or non-health private

organisation in Oman

c) Research carried out by Health professionals of non-MoH institutions in Oman (such

as private clinics, private hospitals etc.)

d) Research carried out by private citizens (Omani)

Such persons wanting to conduct research within MoH institutions have to contact

designated focal points within their particular region or the Centre of Studies & Research

at the MoH-Headquarters. The researcher should meet the criteria given below depending

on the nature of the study.

1) If the participants/subjects of the research/study include patients, clients or MoH staff

from MoH institutions and a competent MoH staff is included as a member of the

research team:

a. The username and password will be issued directly to the MoH staff for submission

of the research proposal

Note: MoH staff with Master’s/PhD research proposal submissions can request for

login credentials from their region or directly through ‘MoH Headquarters’.


b. The MoH staff member should ensure that the study is conducted as per the

approved protocol and health research guidelines of the Centre of Studies &

Research in the Ministry of Health

2) If the participants/subjects of the research/study include patients, clients or MoH staff

from MoH institutions and a competent MoH staff is not included as a member of the

research team:

a. The researcher will need to obtain a letter of provisional approval/authorization

from his/her parent institution as well as letter(s) of approval/authorization from the

institution(s) where the research will be carried out.

b. Username will be linked to the National ID card for submission of the research

proposal. Researchers will have to provide through email a scanned copy of their

national ID card along with their name, region, and institution (if applicable).

c. The proposal can then be submitted to obtain authorization from the respective

research committee (Regional or Central RERAC).

3) If the research/study does not involve using subjects such as patients, clients or MoH

staff, the research study will be assessed based on collection of any sensitive

data/material from MoH institutions*:

a. If it involves collection of sensitive data/material from MoH institutions*and a

competent MoH staff is included as a member of the research team:

i. The MoH staff can directly obtain credentials to submit the proposal online.

ii. The MoH staff member should ensure that the study is conducted as per the

approved protocol and health research guidelines of the Centre of Studies &

Research in the Ministry of Health.

b. If it involves collection of sensitive data/material from MoH institutions* and

the research team does not include an MoH staff:

i. The researcher will need to obtain a letter of recommendation/approval

/authorization from his/her parent institution as well as letter(s) of

provisional approval/authorization from the institution(s) where the

research will be carried out.

ii. The proposal can then be submitted to obtain authorization from the

respective regional research committee or central research committee.


iii. Username will be linked to the National ID card for submission of the

research proposal. Researchers will have to provide through email a scanned

copy of their national ID card along with their name, region, and institution

(if applicable).

c. If it does not involve collection of any sensitive data/material from MoH

institutions*:

i. The researcher will need to obtain a letter of recommendation/approval

/authorization from his/her parent institution

ii. The researcher can submit the proposal online to obtain authorization from

the respective regional research committee or central research committee.

iii. Username will be linked to the National ID card for submission of the

research proposal. Researchers will have to provide through email a scanned

copy of their national ID card along with their name, region and institution

(if applicable)

III. Non-Ministry of Health persons/institutions/organizations from outside Oman or

non-Omani researchers in Oman but not affiliated to any institution

For researchers outside of Oman (including non-Omani researchers residing in Oman but not

affiliated to any institution within Oman) wishing to do research within MoH institutions:

a) The researcher must get written permission from the Undersecretary for Planning

Affairs in the MoH

b) A competent MoH staff should mandatorily be included acting as a local supervisor/co-

ordinator of the research (who may be nominated by the approving authority in the

MoH)

c) The username and password will be issued directly to the MoH staff for submission of

the research proposal

*Sensitive data/material refers to information or material of any kind related to

patients/clients, confidential/personal information about staff, data or information

about health services or the health system of MoH and all such information that are not

in the public domain.


d) A letter of recommendation/authorization/approval should accompany the proposal

from the competent authority of the applicant’s parent institution abroad (where

applicable).

For quick reference, kindly refer the diagrammatic flowchart for the pathway for submitting

research proposals for non-MoH persons wanting to do research within MoH institutions.

Note: All approvals/authorizations from the institution(s) where the research will be

carried out are conditional subject to approval of the Central RERAC or Regional

Research Committee.


Flow Chart for Submitting Research Proposals by Non-MoH Persons Wanting to Do Research Within MoH Institutions

Academic research by a student/staff of an Academic

Institution in Oman #

Employee of a Governmental or

Private Organization in

Oman (#)

Contact Regional Focal Person or Administrator at CSR of MoH

Participants /subjects of the study includes patients/clients /MoH staff ?

Study involves collection of sensitive

data/material from MoH *

Obtain specific permission from a competent authority at the study

site/Directorate/MoH & applicants' parent institution

Username and password issued to the Applicant. Username linked to

National ID for submission of research proposal

A competent MoH staff is a Co-PI /

Local Supervisor for the research $

Non-MoH Health Professional in

Oman (#)

Private Citizen (Omani)

Non-Omani Person or

Institution/ Organization outside Oman

Approved by Competent Senior Authority in MoH

A competent MoH staff is a Local

Supervisor for the research $

Username and password issued to the MoH staff

connected with the study ($) for submission of Research Proposal & supervision

No

Yes

Yes

Yes

Yes

No

Yes

Yes

No

# Research Proposal should be accompanied by a letter of

recommendation/approval/authorisation from a competent

authority of the applicant’s parent institution.

* Sensitive data refers to information or any material related to

patient/clients, confidential/personal information about staff,

data or information about health service or the health system of

MoH and all such information that are not in the public domain.

$ The MoH staff should ensure that the study is conducted as

per the approved protocol using research guidelines of MoH.


Sensitive Data / Material

Sensitive data/material refers to information or material of any kind related to patients/clients,

confidential information about staff, data or information about health services or the health

system of MoH, and all such information that are not in the public domain.

Few examples of sensitive data / material are given below for clarification:

1. Examples of Sensitive Data (patient): Patient ID, Patient’s / clients personal profile, any

clinical data including diagnosis, results of investigations, treatment, clinical management

plan, case history, clinical findings, referral notes or any such information, including any

such information recorded in the case record of the patient. Any privileged communication

between patient and the managing health care provider – whether recorded or not; and

whether stored manually or electronically will all fall under the purview of sensitive data

for this purpose.

2. Examples of Sensitive Material (patient): Any blood, tissue or other biological samples

taken from the patient for testing including any left-over material, any biological material

that the hospital is entrusted by the patient for safe disposal such as expired blood from

blood bank, human placenta after delivery, expelled products of conception, amputated

body parts, medical waste that may contain body fluids or similar biological materials etc.

3. Examples of sensitive data (MoH staff): Staff profile, personal details and any

information stored in the personal record of any staff including but not limited to any

personal communication with the staff and any information or data that a staff may not wish

to disclose to an agent outside the MoH will all constitute as sensitive data for this purpose.

4. Examples of sensitive data (MoH Organization): Protected or secure information of any

of the organization or system within MoH including and not limited to official

communications, minutes of meetings and all other such administrative and policy matters

that are not in the public domain such as in the official MoH publication or MoH website

would be construed as sensitive material for this purpose.


Commensuration of Appropriate Authority

Letter of Recommendation from the parent institution of the researcher and the provisional

letter of acceptance at the study venue should be authorised by an appropriate functionary in

either organization and their designation should be commensurate with the nature and extent

of the study. For example, if a study is to be conducted at a Departmental or institutional level,

the corresponding Directors should be the recommending authority. If the study covers a

Governorate, the Director Generals should be the recommending authority. As described

earlier, the Principal Investigator should submit the research proposal to the appropriate

Research Committee along with the letters of recommendation or provisional acceptance of the

research for Approval by the respective Research Committee. The Committee may seek further

clarification, feasibility etc. from the concerned institutions as required before granting the

approval.


Research carried out in Private Healthcare Establishments

The scope of RERAC for research proposals coming out of private healthcare establishments

will fall under the following categories:

Clinical Trials/ Experimental Studies

Therapeutic Interventional Studies

Studies involving the use of therapeutic device or medication not currently approved

by MoH

Studies with international collaboration

Studies where tissue samples/fluids/other biological material is to be sent abroad

Any other situation that may arise on a case-by-case basis

Other research/audit being conducted in private healthcare establishments should get prior

approval from appropriate authority/Executive Director of the private hospital/institution.


Research Proposal Submission & Review Process

Using the login details (Username and Password), the researcher can log on to the website to

submit the research proposal. The unique username will help in locating the researcher for any

future reference and follow up. (The researcher may change the password but not the

Username).

Once logged in to the ‘Researcher Dashboard’, researchers can click on ‘Submit New Research

Proposal’ to begin a new submission. A common section of all forms has to be filled at the end

of which researchers will need to select the appropriate form to be filled specific to the study

design of the proposal. There is an algorithm provided which can be viewed to guide

researchers in choosing the right form. The PI should open the proposal form that is appropriate

to the type of study design and fill up the form completely. Each of these forms have been

tailored for even the novice researcher and in the process of filling up the form, the researcher

will be educated about the various facets and requirements of conducting a research using that

particular research method.

The spaces to be filled in each section of the form can be either typed in or copied from another

compatible electronic form (e.g. Word document). All relevant documents such as consent

form, participant information sheet, brief CV of researchers, signatures of researchers, approval

letter from parent institution, approval letter of supervisor if applicable etc. have to be attached

as electronic attachment in the prescribed format (e.g.: .jpg file for scanned images, or as PDF

file). When the proposal form has been completed and all enclosures have been attached, the

researcher should click “Submit” upon which the proposal will be delivered to the Technical

Focal Person (TFP). Once submitted, the research proposal will be locked from further editing.

The Technical Focal Person will screen the proposal to determine whether the proposal requires

to be forwarded to RERAC or can be approved by the Regional Research Committee based on

the guidelines for authorizing research. If the research fulfils criteria for approval by the

Regional Committee, the TFP will process the proposal through the Regional Committee

without submitting it to RERAC. If it is determined that, as per MoH guidelines, the proposal

needs to be reviewed by Central RERAC, the TFP will recommend and forward the proposal

to the RERAC electronically.


When the TFP has submitted the proposal to RERAC, the RERAC Administrator will be

alerted electronically. From then on, the RERAC Administrator will be able to communicate

with the PI directly. The research proposal will be screened to determine if it is complete with

all the required documents attached. If the submitted proposal is complete in all respects, the

RERAC Administrator will register the proposal. However, if the proposal is incomplete, the

Administrator will not register the proposal but will alert the PI about the deficiency and keep

the proposal submission process open till the deficiency is corrected and re-submitted. The PI

will be able to edit the submitted proposal during this phase.

The completed and registered proposals are forwarded electronically to the reviewers by the

RERAC Administrator. The reviewers will study the proposal in detail and make suggestions,

comments and remarks as needed and also give a score based on RERAC criteria. During this

stage, the PI will receive a notification/online alert that the proposal is under review. Once the

RERAC Administrator receives the reviewers’ remarks and recommendations, the same will

be sent anonymously to the PI for their perusal and feedback. The PI can now edit the proposal

if necessary and resubmit the proposal again which will be forwarded to the respective

reviewers for their perusal and final decision. Eventually, a final decision, based on the

reviewers’ feedback whether the proposal is Approved or not will be taken by RERAC by

voting for all members in a monthly meeting, and the PI will be informed accordingly.

The score given by the reviewers (at the first review of the proposal) will be collated and used

for approving research grants or research awards as per the criteria specified in the MoH

document “Health Research Funding Guideline”.


Research Proposal System Timeline

Task Step Duration Required (Days)

Screening proposals within 2 working days from date of proposal receipt

Registering proposals (if complete & correctly filled) within 2 working days from date of proposal receipt

Selecting & Sending to reviewers within 2 working days from date of registration

Reviewing period by reviewers ~22 calendar days

Preparing Agenda 5 working days before RERAC meeting

Committee Meeting 1 day (usually at the end of each month)

Sending feedback/update to researcher

(for ready proposals) 2 working days after the RERAC Meeting

Reviewers adding comments after meeting

(if required) 2 working days after the RERAC Meeting

Sending any pending feedback 1 working day of receiving additional comments by the

reviewers

Checking PI feedback of revised proposals with decision ‘Approval after

Minor Changes’ Maximum of 5 days from revised proposal receipt date

Checking PI feedback of revised proposals with decision ‘Approval after

Major Changes’ Maximum of 10 days from revised proposal receipt date


Research Proposal Review Status/Decisions

One of the important roles of the Centre of Studies & Research in the Directorate General of

Planning & Studies is to encourage, support, and facilitate research by health care professionals

in the Ministry of Health. RERAC is the central committee (under the Directorate General of

Planning & Studies) to review and approve research proposals. In as much as the Committee

critically reviews proposals, it would also offer suggestions to improve the quality of research

proposals so as to advance the quality of research overall in MoH. Members of the RERAC

have wide experience in research and can facilitate this role while reviewing and deciding on

the approvability of each research proposal.

The reviewers who review each research proposal will select a Review Status option which is

given in the Proposal Review form. Based on this selection of the Review Status by the

reviewers and the discussion among the Committee members at the monthly RERAC meeting,

a final decision on the approval status of the proposal will be finalised by the Committee. The

Status/Decision of the research proposal would be categorised to one of the following four

options:

1: Approved (as submitted)

2: Approval after MINOR changes

3: Approval after MAJOR changes

4: Disapproved


1: APPROVED (AS SUBMITTED)

The research proposal meets all the required standards in all aspects of the study. The

decision of the Committee will be intimated to the PI who can then proceed with the study

as per the approved protocol.

In some cases, there may be a few grammatical or spelling corrections or syntax changes that

may be required in the presentation. Also, the reviewers and the Committee in their wisdom

may offer some suggestions to further improve the study even though it can be approved

without incorporating those suggestions. In such situations also, the final decision can be that

of Approval. The PI can be informed of the Approved decision as well as the suggestions by

the reviewer(s) / Committee which may be incorporated during the course of the study.

Resubmission of the research proposal is not required in this case.

2: APPROVAL AFTER MINOR CHANGES.

The quality of the proposed study is deficient in certain aspects and requires modification

before it can be approved.

The deficiency is of a minor nature in the overall presentation and methodology. Criteria which

would lead to this decision include:

modification of inclusion/exclusion criteria

alteration of sample size calculation

minor errors in abstract and/or introduction sections

description of methodology that needs minor clarification and is clearly remediable

modification/addition/deletion of the allocation strategy of the samples

modification/addition/deletion of some of the dependent/independent variables

study implications and/or limitations are missing a point(s) which can be addressed

discrepancies within text, abstract, and other supporting information

minor listing/addition of references, especially an important article(s) that could impact

the proposal


references are not appropriately correlated to the text/subject of the proposal

references are in different citation styles making it difficult for the reviewer to follow

institutional pre-approval(s)/feasibility recommendations missing

other minor research points that could be addressed

The decision of the Committee will be sent to the PI along with the suggestions, comments

and clarifications required. The PI should revise the proposal in the light of the feedback from

the Committee and resubmit it to the satisfaction of the reviewer(s). The reviewer(s) may then

recommend that the study be approved (without bringing it again to the RERAC Committee)

and that decision can be conveyed to the PI who may commence the study as per the revised

protocol. However, if the reviewer(s) are not satisfied with the revision, the process may go

through another cycle till it meets the satisfaction of the reviewers.

3: APPROVAL AFTER MAJOR CHANGES

The quality of the proposed study is seriously deficient in certain aspects and requires

significant modification before it can be approved.

The deficiency is of a major nature in the overall presentation and methodology. Criteria which

would lead to this decision include:

hypothesis and objective not clearly worded/defined along with unclear methodology

incorrect sampling strategy

incorrect study design employed

description of methodology is unclear and needs major revision

several discrepancies within text, abstract, and other supporting information

lack of clarity, i.e. components are present but needs major rewriting to address it

incorporation of a pilot study needed to check validity/reliability of the instrument/tool

objectives and anticipated results are not matched but can be addressed by major

revision


significant number of objectives remained unanswered/unresearched

too many references are not appropriately correlated to the text/subject of the proposal

revision of any ethical issues that can be rectified

several points under minor changes occurring together in the opinion of the reviewer

The decision of the Committee will be intimated to the PI who should revise the proposal and

resubmit it. The reviewer(s) will then critically review the revised proposal and will take a

decision on the approvability of the revised proposal and that decision will be conveyed to the

PI. However, if the reviewer(s) is not satisfied with the revision, the process may go through

another cycle till it meets the satisfaction of the reviewers.

4: DISAPPROVED

This is a serious decision and will be taken only in extreme cases after due deliberation

by the Committee at the RERAC committee meeting. Few examples where such a decision

may be taken are listed below:

The quality of the proposed research is unlikely to reach the minimum required

standard even after major revision (e.g.: Master’s, PhD Thesis)

There are serious flaws in the research methodology and the research question

cannot be answered by the proposed research

The PI or members of the research team do not have the required professional

qualification or the technical competence to carry out their role in the study.

The health institution where the study is planned to be conducted lacks the

minimum infrastructure (including manpower, equipment, materials, finances or

any other) required for conducting the study and the items in the proposed budget

– even if approved for funding – will not make good the perceived deficiency. (non-

feasibility)

Unfixable flaws in data/research (number/selection of subjects; instruments/drugs

used)


Major discrepancies within text, abstract and other supporting information which

cannot be addressed by major revision

Serious Ethical issues

a. Any issues in the research that contravenes the law of the land or is in

conflict with accepted professional practice and professional ethics.

b. The research may create some sensitive/political issues

c. If the participants to the study are placed in any undue risk or if it

contravenes any of the International guidelines on human research.

d. The participants may be disadvantaged by the study (financially,

emotionally, physically or in any other way including an adverse labelling

effect) and is not adequately compensated or provided for within the scope

of the study.

e. Potential for misuse of any information or material (e.g.: biological samples)

collected as part of the study

If it is discovered that any of the research team members have undeclared and

serious conflict of interest or have been involved in conducting fraudulent research

in the past based on severity and circumstances

Any other issue that the Committee considers as a serious impediment to the proper

conduct of research as per the submitted proposal and which cannot be overcome

or circumvented even after suitable revision.

In this case, the PI will have to submit a new proposal which will be sent to reviewers, and

consequently be placed before the Committee to make a final decision on the approvability of

the proposal. However, if the Committee is still not satisfied with the proposal, the process may

go through another cycle till it meets a final review decision.


RERAC Review Decision Appeals

RERAC is committed to advancing high-quality research and ensuring that research activities

carried out as mentioned in research proposals meet minimum criteria for health, medical

ethics, rights, safety, and privacy of human participants and/or personal data. To ensure fairness

as part of this commitment, RERAC has established a procedure to allow appeals against

‘Disapproval’ decisions.

A researcher may not appeal against the decision of the Committee purely on the grounds that

he/she disagrees with the decision. The researcher may appeal the decision based on:

facts/circumstances which the Committee was not aware of and may have impacted on

the decision

demonstrable evidence of inadequate review

Appeal Process

A ‘Letter of Appeal’ should be addressed to the Chairman of the Research and Ethical Review

& Approval Committee within 10 days of being notified of the Committee’s decision. The

researcher must send the letter to [email protected] / [email protected] and notify the

rapporteur of the Committee by email or telephone on 22357274 / 22357280. Please write

‘Letter of Appeal’ in the subject line of the email.

The appeal request must include:

Title of the research proposal & Proposal ID

The reason for appeal

Any documentary evidence to support the appeal

The Committee will deal with appeal requests with reasonable expedition. The Committee will

appoint experts if deemed necessary. Following this, the Chairman will make an eventual

decision which will be final and binding. There is no further scope of appeal against this final

decision. However, the researcher may submit a new proposal avoiding the issues that were the

reason for disapproval.

mailto:[email protected]

mailto:[email protected]


Regional Technical Focal Person To Create Username & Password

Submit Proposal Online by PI & checked by Regional Focal Person

Researcher (PI) ready with Research Proposal

Focal Person Screens Proposal

& Forwards

To Regional Research Committee

Authorizes and forwards to RERAC the Proposal & all attachments

RERAC Administrator Checks Proposal

Incomplete

Incorrect

Return to PI Alert PI by e-mail

Updates / Appends / Modifies As necessary and Resubmits

Meets RERAC Submission Criteria

Meets Regional

Criteria

Complete and Correct

Register and Forward to selected

Reviewers in RERAC Committee

Reviewers Return to Admin with Score, Comments & Decision on the Proposal

Decision of Reviewer / Final Committee Decision (RERAC)

Needs Change

Minor or Major Admin Forwards comments to PI

PI makes needed modification to the proposal

Edited Version ready for submission

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Common Section of all

Forms

The first section in the research proposal form is a common section and all

researchers have to fill it regardless of the type of research. After that, based

on the research methodology and study type the researcher has to select one

of the study types and the system will direct the researcher to the appropriate

research form that has to be filled.

There are many parts in this section which will be listed along with some

guidelines and instructions.


1. Research Proposal Title

Research title (English):

Research title (Arabic):

2. Research Team Details

Role Name Qualifications Job Title Telephone Email

Principal Investigator

(PI)

Co-Principal Investigator

(Co-PI)

Add More

The title summarizes the main idea(s) of your study.

A good title contains the fewest possible words needed to adequately

describe the contents and/or purpose of your research.

Keep the title brief and clear. Use active verbs instead of complex noun-based

phrases, and avoid unnecessary details.

Good research titles (typically 10–12 words long) use descriptive terms and phrases

that accurately highlight the core content of the.

The title should not have abbreviations and jargon.

A catchy title posing a question or including an apparent contradiction may be

more easily remembered by a reviewer.

The title should address: what, why, who, how, when and where of the research.

It should catch the reader’s attention.

It should describe the contents accurately.

It should describe the subject specifically.

It should be easy to understand.

It should be suitable for indexing.


Name of the Affiliated Institution:

Institution address:

Governorate/Region:

Telephone number:

Fax:

E-mail:

Duration of study in months:

Proposed start date:

Study Area: {dropdown menu}

Specify the Hospital/Health Centre/Wilayats as applicable:

3. Planned Contribution of Research Team Members

z

Affidavit: It is the responsibility of the Principal Investigator to ensure that by signing/initialling for

the individuals listed above, the individuals have consented to be involved in this research.

S. No. Name of

Researcher Affiliation

Contribution of

Researcher Signature/Initials

Add more Remove Last

This is to indicate the planned contribution by each member in the research

team. A multidisciplinary team with relevant scientific expertise is often

required for most studies and should be listed here. It should be reported again

after completion of the study in the final report before dissemination by

indicating the factual contribution and time devoted by each of the team

members. The PI should be aware of the type of contribution and suitability

with each investigator’s qualifications and position.

[e.g. Conception of idea, Research design, Data collection/field work, Data

management, Analysis, Report writing, Interpretation of results, Critical

reviewing with intellectual input]


If the study is supervised or a Bachelor’s/Master’s/PhD (or other academic programme):

Supervisor’s name:

Position:

Institution:

Country:

Phone number:

Email address:

Declaration of supervisor:

I take responsibility for supervision and related aspects pertaining to this study.

Supervisor’s letter / signature: {Attach}

4. Research Proposal Summary

(Not more than 500 words in a structured format)

Please fill in this part only after completing your detailed proposal.

It must include the statement and importance of the research problem,

aims and objective(s), population under study, sample, sampling method,

sample size, data collection tool(s) and technique(s), data analysis methods,

expected results and implications for practice.

It should be a concise summary of the WHOLE project.

Use the abstract to identify the need for the research, state what

you intend to do, and how you intend to do it.

It should not include unnecessary detail.

It should contain key words for indexing.

It should stand on its own.

It should not contain references, abbreviations, citations, tables or

figures

It should avoid unsubstantiated conclusions


Research Summary / Abstract in English:

Research Summary / Abstract in Arabic:

5. Background and Literature Review

(Not more than 1500 words, please restrict to information directly pertaining to the research)

Literature Review:

Keywords:

References:

Background information [A brief description of the country/region,

socioeconomic, cultural characteristics, health status and health care system

with few illustrative statistics that are relevant to the research problem]. It

then includes the selection and analysis of the research problem, direct

determinants and the contributing factors. Please review critically the

already available information from relevant studies in Oman, from similar

countries and international studies. You must furnish references for all

quoted statements you make in the proposal.

Ten Simple Rules for Writing a Literature Review:

1. Define a topic and audience

2. Search and re-search the literature

3. Take notes while reading

4. Choose the type of review you wish to write

5. Keep the review focused, but make it of broad interest

6. Be critical and consistent

7. Find a logical structure

8. Make use of feedback

9. Include your own relevant research, but be objective

10. Be up-to-date, but do not forget older studies


Citation Search Strategy

6. What is the Reason for Conducting this Study?

o Partial fulfilment of PhD / Masters / other academic programme*

o Component of research methodology or other formal training programme

o Collaborating as part of a multicentre study or international study.

o Scientific curiosity / problem solving interest, etc.

o Professional (personal) advancement.

*Please specify the academic programme (Bachelor’s, Master’s, PhD)

7. Statements Related to the Problem

7.1 Statement of the problem that prompted the need to conduct this study (In 2-3 sentences):

How did you search for the background and foreground information on your research topic?

State the search terms/MeSH headings/Keywords and the internet search engines used to

acquire the reference material. (E.g.: PubMed, Google Scholar, MedlinePlus, UpToDate,

Embase, Cochrane Collaboration etc.)

Do not list individual web address from where references are cited.

The researcher should justify his selection of the research problem to convince

others about the importance of the problem or why the situation needs to be

investigated. For example, you may have observed that childhood diarrhea is

more common among children in one geographic area within the catchment area

covered by the health facility you are working in.


7.2 What is the primary research question?

7.2 State the scientific hypothesis.

7.3 What is the specific aim of this study? (State in one or two sentences)

7.4 What are the specific objectives of the study that will help to achieve the stated aim? (1 to

3 listing)

Research questions are posed when one wants to estimate a phenomenon in a

population, to compare a phenomenon in several populations, to evaluate the

effect of an intervention, to assess the expected relationships between two or more

variables or to determine risk factors for an outcome/disease. The research

question should be answerable by the planned research. It should be specific,

measurable, achievable, relevant and time bound (SMART).

Hypothesis is a statement about expected/conceptual relationships between two or

more independent variables and one dependent variable e.g. higher levels of field

health worker performance (independent variable) will lead to higher rates of

contraceptive acceptance among eligible couples (dependent variable)

Aim of a study is a general statement of what the study hopes to achieve within the

scope of the actual research. The aim should be clear and concise. For example in

the problem regarding childhood diarrhoea (mentioned earlier) the aim would be to

identify the common and preventable risk factors for the increased incidence of

childhood diarrhoea in that specific area. The specific objectives are the specific steps

taken to achieve the aim of the study.


7.5 Are there any secondary questions / hypotheses / aims that this research will attempt to

answer? If yes, list them out accordingly.

7.6 Are there any similar published studies locally, nationally, or internationally? If yes, justify

the need to replicate this study.

8. What Kind of Research Will be Conducted?

(The Applicant is advised to fill up the appropriate form. Click here (Algorithm is in the next

page) to view the algorithm to help guide you in the choosing the right form. If still in doubt,

the applicant is encouraged to preview each of the forms so that the most appropriate form that

will elicit suitable responses from the study to most of the items in the form can be used.)

8.0 What is the specific category to which the proposed Clinical Study can be classified?

(Check the most appropriate box.) {Logic based selection}

o A- Clinical Research

o B - Qualitative Research

o C - Non - Clinical Quantitative

o D - Mixed/Other Research Designs

8.1 Will the study group be subjected to an intervention as part of the research?

Yes (A1) No

e.g.: any therapy including medication, surgery, training, instruction etc. as part of the research

intervention?

8.2 Is your study a Case-control study or a Cohort Study?

Case-control (A2) Cohort (A3)

Case-control (retrospective observational) or Cohort study (prospective observational)?


Research Algorithm

The Applicant will have to choose the form most applicable to the design of

the proposed research study. This algorithm is a short guide to aid the

researcher in selecting the right form to be filled. It lists the most common

types of research and categorises it according to the main study designs.


Research Algorithm (Choosing the suitable Form to be filled)

Quantitative Qualitative/Quantitative

Qualitative

Interventional Observational

Clinical Trials

Form A1

Case-

Control

Studies

Form A2

Cohort

Studies

Form

A3

Non-Clinical Quantitative

Form C

Mixed / Other Research Designs

Form D

Pure qualitative design

Form B

Clinical trials of

investigational

medicinal

products

Clinical

investigations

or other studies

of medical

devices

Clinical trial of

a drug/device

combination

Other clinical

trials or clinical

investigations

Basic science

study involving

procedures with

human

participants

Studies to

determine aetiology

or causation of

diseases

Studies to

determine

prognosis after an

intervention or

exposure to an

agent or a factor

Study administering

questionnaires/interviews, KAP

studies for qualitative or

quantitative analysis

Exploratory Observational study –

involving patients /clients of health

service

Covert or overt observational

research/surrogate research with

analysis

Surveys and observations on

Clients, health professionals,

members of public or other persons

of interest

Clinical audit, audit of any service

through anonymous aggregate data

Observation or assessment of

health systems

Review and Analysis of stored

clinical data in Health records

without directly evaluating patients

(Use Form A-2 if clinical record

review is by Case-control or Form

A-3 if Cohort Study design)

Study incorporating aspects of

qualitative and quantitative

research, either simultaneously

or sequentially

Study limited to working with

human tissue samples and/or

analysis of data on them

Research confined to material in

blood or other tissue bank

Research or case records

database

Evaluation of a diagnostic test

Other research (not involving

direct human intervention)

Research using surplus or

existing samples unidentifiable

by the researcher

Economic Analysis

Decision Analysis

Study involving

qualitative methods

only:

Phenomenology

Ethnography

Grounded

Theory

Historical

Research

Critical Inquiry

Discourse

Analysis


Form A1: Clinical

Trials

This section is to be used if any intervention or experiments are to be

carried out on human participants as part of the research.

Note: Please refer to the ‘Guidelines for Responsible Conduct of Clinical

Studies & Trials’ booklet on the website homepage.


9. Study Group Recruitment

9.1 What is the source / reference / target Population for the purpose of this study?

9.2 Who are the accessible participants (to be drawn from the source / reference / target

population) who are under consideration for the study?

9.3: How will the potential study participants be accessed / invited to participate in the study

from the accessible population?

9.4: Specify the inclusion criteria.

9.5: Specify the exclusion criteria.

Target / Reference population: The group of people to whom we want our research

results to apply to

Study population: The people who meet our operational definition of the target

population

Research sample: The members of the study population from whom we collect our

data

Inclusion criteria: attributes of subjects that are essential for their selection to

participate. It should be broad enough to closely represent the target/reference

population. E.g. All persons living in a geographic area, all patients with a certain

disease or risk factor, all persons in a defined age group or gender or any such

specific attribute that are unique to the study

Exclusion criteria: attributes of subjects that warrants their non-inclusion in the

study. Such exclusion should not affect the generalisability of the study. Attributes

that can have a confounding effect on the study variables may be excluded. E.g.

extremes of age, presence of certain risk factors or disease or a physiologic state like

pregnant women, etc.


9.6 After applying the inclusion / exclusion criteria, does the selected study population closely

represent the source / reference / target population such that the study findings and conclusions

will apply to this population? (External validity). Briefly explain.

10. Sample Size Estimate of the Study / Experiment Group

10.1 What is the proposed sample size of the Study / Experimental group?

10.2 What is the basis for sample size calculation and how was it calculated? Indicate the

anticipated variability, margin of error, confidence level, effect size or other measures to justify

sample size.

10.3 Describe in detail the sampling process for the selection of Study / Experimental group

participants?

The extent to which a study's results (regardless of whether the study is descriptive or

experimental) can be generalized/applied to other people or settings reflects its external

validity. Typically, group research employing randomization will initially possess higher

external validity than will studies (e.g., case studies and single-subject experimental

research) that do not use random selection/assignment.


11. Study / Experiment Group Allocation

11.1 How will the eligible STUDY participants be enrolled / allocated to the study?

Random allocation Systematic

allocation

Convenient

allocation

All eligible

11.2 Describe briefly the allocation / randomization technique including any sub-categories

(block / strata etc.).

12. Control Group Recruitment

12.1 Will there be a Control or Comparison group?

12.2 What is the source / reference / target Population of Control or Comparison group?


population) who are under consideration for Control or Comparison group?

12.4 How will the potential Control or Comparison participants be accessed / invited to

participate in the study from the accessible population?

12.5 Specify the inclusion criteria.

12.6 Specify the exclusion criteria.


12.7 After applying the inclusion / exclusion criteria, does the selected Control or Comparison

group closely represent the source / reference / target population such that the study findings

and conclusions will apply to this population? (External validity). Briefly explain.

13. Sample Size Estimation of the Control / Comparison Group

13.1 What is the proposed sample size of the Control / Comparison group?

13.2 What is the basis for sample size calculation and how was it calculated? Will the number

be the same as in the Study / experiment group (1:1 ratio) or different? Explain / justify.

13.3 Describe in detail the sampling process for the selection of Control / Comparison group?

14. Control Group Allocation

14.1 How will the accessible control participants be enrolled / allocated to the study?

Random allocation Systematic

allocation

Convenient

allocation

All eligible

14.2 Describe briefly the allocation technique including any sub-categories (block/ strata etc.).


15. Baseline Characteristics Relevant to the Study

15.1 What are the baseline study factors (characteristics / parameters / variables) relevant to

the study that will be measured at the beginning of the study?

15.2 Should the study group and control group be similar at the beginning of the study? If yes,

what are the relevant measures of similarity (e.g.: age group, gender, severity of disease,

ethnicity, socio-economic status, BMI etc.)? Measure only those that can have a confounding

effect on the outcome factors.

15.3 Will there be more than one study group in this research? Describe in sufficient detail the

intervention in each study group that is planned to be carried out in this research.

16. Intervention

16.1 Is the intervention (medication, surgical procedure, training etc.) already in accepted

practice in the research location and / or approved as standard practice in the concerned

organization (e.g.: MoH)

Yes No

16.2 If No, justify its use. Include permission/approval from appropriate authority (including

ethical aspects for its use).

16.3 Describe in detail, the planned intervention in the experimental / study group.


16.4 Describe the intervention, if any, in the control group (e.g.: placebo, current therapy, other

intervention etc.).

16.5 Give the justification for the intervention, if any, in the control group.

16.6 What is the timeline / time gap / delay between randomization / allocation and starting of

intervention for each participant?

16.7 Is the intervention in the study group or control group likely to pose a potential risk to the

participant to any one of the following degree: - whether physical, psychological, spiritual,

social or economic?

Harm (including side effects or complication due to any intervention)

Discomfort (e.g.: pain, anxiety etc. from any intervention)

Inconvenience (including time, effort, finance etc. – either direct or indirect)

If yes, describe in detail the nature of the risk and how it will be taken care of in the study.


17. Informed Consent

17.1 Explain briefly how, when and by whom informed consent will be taken? How will it be

ensured that the consenter / participant has fully understood all the rights, duties and privileges

of consenting including the right to withdraw at any time and other inalienable rights that has

to be granted on account of the nature and process of the study?

17.2 Is there likely to be any perceived coercion / undue pressure (direct or indirect) or

incentive (material or otherwise) that may influence the participation in the study? Will there

be reimbursement for out of pocket expenses incurred by the participant? Will there be

compensation for any complication arising due to the participation in the study? Briefly explain

how these issues are addressed.

Informed consent is more than a form, it is also a process. Information must be

presented to enable persons to voluntarily decide whether or not to participate as

a research subject. Informed consent process must be a dialogue of the study’s

purpose, duration, experimental procedures, alternatives, risks, and benefits. The

process of consenting is ongoing and must be made clear to the subject that it is

his or her right to “withdraw” or “opt out” of the study or procedure at any time,

not just at the initial signing of paperwork. The location where the consent is

being discussed, the subject’s physical, emotional and psychological capability

must be taken into consideration when consenting a human subject. The

informed consent process should ultimately assure that the subject understands

and really “gets” what they are signing up for.


Note: Please attach a copy of the consent form and patient information sheet (in

‘Attachments’ section)

18. Blinding and Bias

18.1 Blinding and Masking: Will either the participant or the investigator know the

allocation? If blinding and masking are applied, describe briefly how it will be achieved. Who

and how will the allocation code be kept confidential?

18.2 Who will carry out the intervention? Will there be an intervention bias and how will it be

addressed?

A bias is a systematic error or deviation from the truth in results or inferences. Biases can

operate in either direction: different biases can lead to underestimation or overestimation

of the true intervention effect. Biases can vary in magnitude: some are small (and trivial

compared with the observed effect) and some are substantial (so that an apparent finding

may be entirely due to bias). Even a particular source of bias may vary in direction: bias

due to a particular design flaw (e.g. lack of allocation concealment) may lead to

underestimation of an effect in one study but overestimation in another study. It is usually

impossible to know to what extent biases have affected the results of a particular study

although there is good empirical evidence that particular flaws in the design, conduct and

analysis of randomized clinical trials lead to bias. Because the results of a study may in

fact be unbiased despite a methodological flaw, it is more appropriate to consider risk of

bias.


19. Co-intervention

Will there be any additional or associated intervention / therapy other than the principal

intervention in either the study group or control group (e.g.: other medication or any therapy

used concurrently for same or other clinical condition) that could influence the expected

outcome? If yes, how will it be monitored or its influence on the outcome be accounted for?

20. Contamination

Is the control participant likely to take a therapy intended for use by the study participant (e.g.:

self-medication, therapy from another practitioner etc.) or vice-versa? How will this be

monitored / controlled?

21. Confounders

Are there other known factors that could affect the outcome factors either directly or indirectly?

If yes, how will they be accounted or adjusted for?

Confounding: A situation in which the effect or association between an exposure and

outcome is distorted by the presence of another variable. Positive confounding (when

the observed association is biased away from the null) and negative confounding

(when the observed association is biased toward the null) both occur.

This can lead to erroneous conclusions about the relationship between the independent

and dependent variables. You deal with confounding variables by controlling them;

by matching; by randomizing; or by statistical methods.


22. Maintenance

What is the duration the participant will be followed up from intervention to outcome? What

is the follow up process? When will the participant be released from the study? Are there any

special adaptations in the study like cross-over design? Explain in detail.

23. Outcome

What are the main outcome factors that will be studied (as per the stated research question and

hypothesis)?

24. Outcome Measurement

24.1 Who will measure the outcome factors? Will the assessor be blind to the intervention

administered previously? How will potential measurement bias be managed?

24.2 Measuring instrument (Instrument used for outcome measurement): Describe how the

outcome of interest in the study will be gathered. Specify how the instrument will be evaluated

for Validity and Reliability.

24.3 Will there be an interim analysis? If yes, when and how will it become operational and

how will the result influence the further progress of the study?


24.4 Are all relevant clinical outcome being measured? Are any proxy measures used in place

of a clinical outcome? (e.g.: Reduction of serum lipid as a proxy for reduction in MI, smoking

cessation as a proxy for reduction of COPD or Lung cancer, compliance to taking medication

as a proxy for control of a chronic disease etc.) If yes, is that proxy measure a reasonable and

reliable measure of the true outcome? Explain.

24.5 Attrition: Indicate the measures to reduce attrition (drop outs / loss to or

incomplete follow up / failure to comply etc.) that may happen after

allocation or randomization to the study . How will these cases be

analyzed (e.g.: Intention-to-treat analysis, per protocol analysis, best

scenario response, worst scenario response, exclude from analysis etc.)

25. Data Synthesis and Management

Note: Please include a copy of the Data collection pro forma along with this proposal ( in


25.1 Indicate the computer program that will be used for data entry and data analysis.

Attrition of the original sample represents a potential threat of bias if those who drop out

of the study are systematically different from those who remain in the study. The result is

that the remaining sample becomes different from the original sample, resulting in what is

known as attrition bias. However, if sample attrition over time is not systematic, meaning

that there are no unique characteristics among those who drop out, then there is no attrition

bias, even though the sample has decreased in size between waves of data collection. It is

important, then, for researchers who collect multiple waves of data to check for attrition

bias.


25.2 Indicate the likely statistical tests that will be performed in analysing the data (descriptive

and analytical tests as appropriate to the study and the nature of the collected data).

25.3 Quality Control Of Data: What steps will be taken to ensure quality control of the data

(data is properly collected, data entry is accurate, transcribed and decoded correctly, managed

appropriately etc.)?

25.4: How will the data analyst be blinded to the treatment allocation (triple blinding)?

26. Work Plan & Study Implications

26.1 Please describe your work plan / timetable / Gantt chart. (Alternatively, it can be attached

in ‘Attachments’ section)

26.2 What is the anticipated conclusion that may result from the study and how can it be used

to improve / enhance scientific knowledge, patient management, professional or administrative

practice or influence policy making? (Please note that conclusions from a study should be

entirely and exclusively based on the observed findings and results of the conducted study.

Conclusions should not extend into making recommendations that are subjective assumptions

that are not proven by the concluded study.)


26.3 Beneficiaries of the research: Who will be the potential beneficiaries of the study and its

application?

26.4 How will the conclusion drawn from the study be disseminated for use by the scientific /

professional / administrative community?

26.5 What are the potential shortcomings / limitations of the study?

26.6 Indicate the Priority and Importance of the study / research topic.

26.7 Is your chosen research topic part of the ‘Health Research Priorities’ as listed in the

booklet by the Ministry of Health? (Refer the booklet on the Home Page)

Yes No

If Yes, kindly mention to which priority topic your research is related to.

27. Ethical considerations

Highlight the ethical issues in the study and how they have been addressed. (Refer the ‘Ethical

Checklist’ for relevant particulars)


28. Additional Resource Utilisation

Will the research take up any additional resources of the department / hospital / health facility,

including but not limited to human resources, time, equipment, consumables, reagents,

investigations, bed occupancy, finances etc. If yes, list them. Has due permission been obtained

from the appropriate authority? (Please include letter of approval(s) in ‘Attachments’ section)

29. Pilot Study

29.1 Will a pilot study or pre-test be carried out prior to the main study? If yes, describe the

pilot study in sufficient detail and how it will help in the main study. If no pilot study is planned,

explain why a pilot study is not required / necessary.

30. Additional information

30.1. Any other additional information (if applicable)?

31. Research Grant

Are you planning to apply for a research grant through the Centre of Studies & Research of the

Ministry of Health?

Yes No

If Yes, please submit / attach the Budget Form. (For more details about research grants, refer

to the Health Research Funding Guideline on the homepage)


32. Attachments

Kindly attach all additional documents in this section (for multiple files in one section, kindly

zip the files and attach):

1. List of Abbreviations (if applicable)

2. Curriculum Vitae of the P.I.

3. Curriculum Vitae of the Co-P.I./s

4. Participation Information Sheet

5. Informed Consent for Research Participants

6. Letter of Endorsement for the Study / Institutional Approval

7. Letter from Supervisor (for supervised studies)

8. Letter from Sponsor (for sponsored studies)

9. Data Collection Tools / Instruments / Questionnaires

10. Sample Spreadsheet for data entry

11. Work plan / Timetable / Gantt chart

12. Other Information relating to the study

33. Declaration – To be signed by the Principal Investigator (P.I.)

If the research proposal is approved, I (we) declare that I (we) shall be actively engaged in,

control the project and agree to provide progress reports and the final report to the committee

for revision before final dissemination of it.

I (we) confirm that the details of this research proposal are a true representation of the research

to be undertaken. I (we) will ensure that the research does not deviate from the protocol

described. If significant protocol amendments are required as the research progresses, I (we)

shall submit these to the Research and Ethical Review & Approval Committee for final

approval.

I (we) shall ensure that only the analysis specified in the protocol will be performed on the

samples. If I (we) send patients’ blood, body fluids or tissues outside the country for analysis,

official permissions to do so will be obtained. Any unused or remaining samples will be

disposed as per laboratory guidelines for specimen disposal.

Signature: Date:


Form A2: Case-

Control Studies

Use this section if the research is a retrospective analytical study involving clinical

cases (e.g. patients) and controls. Case-control studies are usually employed to

estimate the strength of association between a clinical condition or an outcome of

interest with the prior exposure to a potential causal / risk factor.

If any of the items are not applicable to your study, please mention “NA” to indicate

Not Applicable in the corresponding response box. You should also add any

additional information that is pertinent or specific to your study in the section

provided for it.


9. Study Group / Cases

9.1 Specify the criteria used to define a CASE as a case in the study (e.g. clinical diagnosis, disease

specific characteristic, outcome of interest, etc.).

10. Target Population of Cases

10.1 What are the Source / Reference / Target population of CASES for the purpose of the study?

10.2 Who are the accessible participants (to be drawn from the source / reference population) who

are under consideration for the study?

10.3 How will the potential study participants (CASES) be accessed / invited to participate in the

study from the accessible population?

Target / Reference population: The group of people to whom we want our research results

to apply to

Study population: The people who meet our operational definition of the target population

Research sample: The members of the study population from whom we collect our data




10.6 After applying the inclusion / exclusion criteria, does the selected study population of CASES

closely represent the source / reference /target population such that the study findings and

conclusions will apply to the reference population? (External validity). Briefly explain.




disease or risk factor, all persons in a defined age group or gender or any such specific

attribute that are unique to the study

Exclusion criteria: attributes of subjects that warrants their non-inclusion in the study.

Such exclusion should not affect the generalisability of the study. Attributes that can

have a confounding effect on the study variables may be excluded. E.g. extremes of

age, presence of certain risk factors or disease or a physiologic state like pregnant

women, etc.




external validity than will studies (e.g., case studies and single-subject experimental research)

that do not use random selection/assignment.


11. Sample Selection of Cases

11.1 How will the required sample be selected from eligible CASES?

Random sample Systematic sample Convenient sample All eligible cases

11.2 Describe briefly the sampling technique including any sub-categories.

12. Sample Size Estimation of the Cases

12.1 What is the proposed sample size?



sample size.

12.3 What are the baseline study factors (characteristics / parameters / variables) relevant to the

study that will be measured at the beginning of the study?


13. Study Group / Controls

Specify the criteria used to define a Control as a control in the study. (e.g. healthy individuals,

relatives of patients, persons/patients with different outcome or health conditions, etc.)

14. Selection of Controls

14.1 What is the Source / Reference / Target population of Controls for the purpose of the study?

14.2 Who are the accessible control participants (to be drawn from the source / reference

population) who are under consideration for the study?

14.3 How will the potential study participants (Controls) be accessed / invited to participate in the

study from the accessible population?




14.6 After applying the inclusion / exclusion criteria, does the selected study population of Controls

closely represent the source / reference /target population such that the study findings and

conclusions will apply to the reference population? (External validity). Briefly explain.

15. Sample Selection of Controls

15.1 How will the required sample be selected from eligible Controls?

Random sample Systematic sample Convenient sample All eligible controls

15.2 Describe briefly the sampling technique including any sub-categories.

16. Sample Size Estimation of the Control

16.1 What is the proposed sample size of the Control?



sample size.


16.3 What are the baseline study factors (characteristics / parameters / variables) relevant to the

study that will be measured at the beginning of the study?

16.4 How many controls will be selected for each case (e.g.: 1 Case to 4 Controls, 1: 1 etc.).

Indicate the justification and feasibility.

16.5 Is the study group and control group similar except for the outcome factor (e.g.: disease)?

What are the relevant measures of similarity that are to be matched between Cases and Controls

(e.g.: age group, gender, severity of disease, ethnicity, socio-economic status, BMI etc.)? Measure

only those that can have a confounding effect on the association between the study factors.




ensured that the consenter / participant has fully understood all the rights, duties and privileges of

consenting including the right to withdraw at any time and other inalienable rights that have to be

granted due to the nature of the study?

Note: Please attach a copy of the consent form (in ‘Attachments’ section)

17.2 Is there likely to be any perceived coercion / undue pressure (direct or indirect) or incentive

(material or otherwise) that may influence the participation in the study? Briefly explain how this

issue is addressed.


presented to enable persons to voluntarily decide whether or not to participate as a

research subject. Informed consent process must be a dialogue of the study’s


process of consenting is ongoing and must be made clear to the subject that it is his

or her right to “withdraw” or “opt out” of the study or procedure at any time, not just

at the initial signing of paperwork. The location where the consent is being

discussed, the subject’s physical, emotional and psychological capability must be

taken into consideration when consenting a human subject. The informed consent

process should ultimately assure that the subject understands and really “gets” what

they are signing up for.


18. Outcome Measuring Instrument

Measuring instrument (Instrument used for determining OUTCOME [e.g.: disease] measurement):

Describe how the outcome of interest in the study will be gathered. Specify how the instrument

will be evaluated for Validity and Reliability.

19. Exposure Factors

19.1 What are the EXPOSURE factors that are to be studied (as specified in the hypothesis /

research question)?

19.2 What is the time period between exposure and outcome? Is it biologically reasonable?

19.3 Who will assess/evaluate exposure factors? How will exposure factors be estimated?


19.4 What are the potential biases in the estimation of the exposure? How will bias such as Recall

Bias be reduced?


operate in either direction: different biases can lead to underestimation or overestimation of

the true intervention effect. Biases can vary in magnitude: some are small (and trivial

compared with the observed effect) and some are substantial (so that an apparent finding

may be entirely due to bias). Even a particular source of bias may vary in direction: bias

due to a particular design flaw (e.g. lack of allocation concealment) may lead to

underestimation of an effect in one study but overestimation in another study. It is usually

impossible to know to what extent biases have affected the results of a particular study

although there is good empirical evidence that particular flaws in the design, conduct and

analysis of randomized clinical trials lead to bias. Because the results of a study may in fact

be unbiased despite a methodological flaw, it is more appropriate to consider risk of bias.


20. Confounders

Are there other known risk factors that could affect the outcome factors either directly or

indirectly? If yes, how will they be accounted for?

21. Exposure Measuring Instrument

Measuring instrument (Instrument used for detrmining / estimating EXPOSURE [Risk factor]

measurement): Describe how the exposure/risk factors in the study will be gathered. Specify how

the instrument will be evaluated for Validity and Reliability.

22. Blinding

Will the person evaluating the Exposure be aware of the outcome status of the participant? How

will blinding of the Exposure evaluator to the outcome be achieved?


outcome is distorted by the presence of another variable. Positive confounding (when the

observed association is biased away from the null) and negative confounding (when the

observed association is biased toward the null) both occur.


and dependent variables. You deal with confounding variables by controlling them; by

matching; by randomizing; or by statistical methods.



Note: Please include a copy of the Data collection pro forma along with this proposal (in


23.1 What are the important variables that will be collected & what are the nature/characteristics

of the variables (ordinal, nominal, continuous, categorical etc.)?


23.3 Indicate the likely statistical tests that will be performed in analysing the data (Odds Ratio,

multivariate analysis, confidence levels, level of significance etc. to be used in analysing the data).

23.4 Quality Control of Data: What steps will be taken to ensure quality control of the data (data

is properly collected, data entry is accurate, transcribed and decoded correctly, managed




24.1 Please describe your work plan / timetable / Gantt chart. (Alternatively, it can be attached in


24.2 What is the anticipated conclusion that may result from the study and how can it be used to

improve / enhance scientific knowledge, patient management, professional or administrative

practice or influence policy making? (Please note that conclusions from a study should be entirely

and exclusively based on the observed findings and results of the conducted study. Conclusions

should not extend into making recommendations that are subjective assumptions that are not

proven by the concluded study.)


application?

24.4 How will the conclusions of the study be disseminated for use by the scientific / professional

/ administrative community?

24.5 What are the potential shortcomings/limitations of the study?



24.7 Is your chosen research topic part of the ‘Health Research Priorities’ as listed in the booklet

by the Ministry of Health?

Yes No


25. Ethical Considerations

25.1 Highlight the ethical issues in the study and how they have been addressed. (Refer the ‘Ethical




including but not limited to human resource, time, equipment, consumables, reagents,

investigations, bed occupancy, finances etc. If yes, list them. Will the research adversely affect

any of the normal services of the health facility? Has due permission been obtained from the

appropriate authority to use the resources of the health facility? (Please include letter of

approval(s) in ‘Attachments’ section)


27. Pilot Study

27.1 Pilot Study / Pre-test: Will there be a Pilot Study or a Pre-test of the questionnaire (data

gathering instrument) that will be used in this study. If yes, how, when, where and by whom it will

be done and how it may help the study. If no, justify why it is not required / necessary.

28. Additional Information

28.1 Any other additional information (if applicable)?

29. Research Grant


Ministry of Health?

Yes No

If Yes, please submit / attach the Budget Form. (For more details about research grants, refer to

the Health Research Funding Guideline)

30. Attachments

Kindly attach all additional documents in this section (for multiple files in one section, kindly zip

the files and attach):










9. Data Collection Tools / Instruments




31. Declaration – To be Signed by the Principal Investigator (P.I.)

If the research proposal is approved, I (we) declare that I (we) shall be actively engaged in, control

the project and agree to provide progress reports and the final report to the committee for revision

before final dissemination of it.

I (we) confirm that the details of this research proposal are a true representation of the research to

be undertaken. I (we) will ensure that the research does not deviate from the protocol described. If

significant protocol amendments are required as the research progresses, I (we) shall submit these

to the Research and Ethical Review Committee for final approval.

I (we) shall ensure that only the analysis specified in the protocol will be performed on the samples.

If I (we) send patients’ blood, body fluids or tissues outside the country for analysis, official

permissions to do so will be obtained. Any unused or remaining samples will be disposed as per

laboratory guidelines for specimen disposal.

Signature: Date:


Form A3: Cohort

Studies

Use this section if the research is a prospective study involving participants who already

have an exposure of interest (risk factor) and who are to be followed up for a specified

period of time to determine if they manifest the anticipated outcome (e.g.: disease). Ideally,

a comparison cohort (control cohort) which does not have the exposure factor is also

followed up for the same period. Cohort studies are usually employed to estimate the

strength of association between an exposure / risk factor and the outcome.

If any of the items are not applicable to your study, please mention “NA” to indicate Not

Applicable in the corresponding response box. You should also add any additional

information that is pertinent or specific to your study in the section provided for it.


9. Study Cohort

Specify the criteria used to define the exposure or risk factor of the study cohort.

10. Target Population of Cohorts

10.1 What are the Source / Reference / Target population of cohorts for the purpose of the study?

(e.g. exposed people in a community/locality/region)


population) who are under consideration for the study? (e.g. people from the source population

attending an institution/service)

10.3: How will the potential study participants (cohort) be accessed / invited to participate in the

study from the accessible population of participants having the exposure / risk factor?


to apply to




10.4: Specify the inclusion criteria.

10.5: Specify the exclusion criteria.

10.6: After applying the inclusion / exclusion criteria, does the selected study population closely

represent the source / reference population such that the study findings and conclusions will apply

to the reference population? (External validity). Briefly explain.



population. E.g. All persons living in a geographic area, all patients with a certain disease

or risk factor, all persons in a defined age group or gender or any such specific attribute

that are unique to the study



have a confounding effect on the study variables may be excluded. E.g. extremes of age,

presence of certain risk factors or disease or a physiologic state like pregnant women,

etc.




external validity than will studies (e.g., case studies and single-subject experimental research)

that do not use random selection/assignment.


11. Sample Size Estimation of the Cohort Group

11.1: What is the proposed sample size of the COHORT group?



sample size.

12. Enrolment of the Cohort Participants

12.1 How will the cohort of eligible participants be enrolled / allocated to the study?

Random sample Systematic sample Convenient sample All eligible

12.2 Describe briefly the sampling technique of the study cohort (if applicable).

13. Control / Comparison Cohort

13.1 Will the study include a CONTROL / COMPARISON group of participants who do not have

the EXPOSURE factor under study?


13.2 What is the source / reference / target Population for the purpose of Control or Comparison

group?


population) who are under consideration for Control or Comparison group?

13.4 How will the potential Control or Comparison participants be accessed / invited to participate

in the study from the accessible population?



13.7: After applying the inclusion / exclusion criteria, does the selected Control or Comparison

group closely represent the source / reference / target population such that the study findings and

conclusions will apply to this population? (External validity). Briefly explain.




14.2 What is the basis for sample size calculation and how was it calculated? Will the number be

the same as in the cohort group (1:1 ratio) or different? Explain / justify.

14.3 Describe in detail the sampling process for the selection of Control / Comparison group?


15.1 How will the accessible control participants be enrolled / allocated to the study?

Random allocation Systematic allocation Convenient allocation All eligible

15.2 Describe briefly the allocation technique including any sub-categories (block/ strata etc.).

16. Matching

Is the study cohort and control cohort similar except for the exposure / risk factor? What are the

relevant measures of similarity that are to be matched between study cohort and control cohort

(e.g.: age group, gender, severity of exposure, ethnicity, socio-economic status, BMI etc.)?

Measure / match only those that can have a significant confounding effect on the association

between exposure and outcome factors.





consenting including the right to withdraw at any time and other inalienable rights that has to be

granted on account of the nature and process of the study?



(material or otherwise) that may influence the participation including retention in the study?

Briefly explain how this issue is addressed.













18. Exposure Measuring Instrument

18.1 (Instrument used for EXPOSURE / RISK measurement): Describe how the exposure factor

of interest in the study will be gathered. Specify how the instrument will be evaluated for Validity

and Reliability.

18.2 What are the outcome factors / disease that are to be studied?

19. Outcome Measuring Instrument

(Instrument used for OUTCOME / DISEASE): Describe how the disease / outcome of interest in

the study will be gathered. Specify how the instrument will be evaluated for Validity and

Reliability.


20. Confounders

Are there other known risk factors that could affect the outcome factors either directly or

indirectly? If yes, how will they be accounted for?

21. Modification and Follow-Up

21.1 Exposure Modification: If the risk / exposure being studied is on-going through the study

period, can a change in the magnitude or nature of the exposure / risk after recruitment and group

allocation, result in effect modification? How will this be taken care of in assessing the association

between exposure and disease? (e.g. smoking and lung disease, diet and ischaemic heart disease

etc.)

21.2 Effect Modifier: During the period of follow up / observation, could there be any intervention

/ therapy in either the study group or control group (e.g.: medication or any therapy used

concurrently for any clinical condition) that could influence the expected outcome? If yes, how

will it be monitored or its influence on the outcome be accounted for?


outcome is distorted by the presence of another variable. Positive confounding (when the

observed association is biased away from the null) and negative confounding (when the

observed association is biased toward the null) both occur.


and dependent variables. You deal with confounding variables by controlling them; by

matching; by randomizing; or by statistical methods.


21.3 What is the duration of follow-up of each study participant? Is it a biologically reasonable

time period for the exposure or risk factor to cause the disease or the outcome under consideration?

22. Outcome Measures

22.1 Will the beneficial final outcome measure be substituted by a proxy measure (e.g. reduction

of serum lipid as a proxy for reduction in MI, smoking cessation as a proxy for reduction of COPD

or lung cancer, compliance to taking medication as a proxy for cure from a chronic disease etc.).

If yes, is that proxy measure a reasonable and reliable measure of the outcome? Explain.

22.2 When, How and by whom will the outcome factors be estimated?




compared with the observed effect) and some are substantial (so that an apparent finding may

be entirely due to bias). Even a particular source of bias may vary in direction: bias due to a

particular design flaw (e.g. lack of allocation concealment) may lead to underestimation of an

effect in one study but overestimation in another study. It is usually impossible to know to

what extent biases have affected the results of a particular study although there is good

empirical evidence that particular flaws in the design, conduct and analysis of randomized

clinical trials lead to bias. Because the results of a study may in fact be unbiased despite a

methodological flaw, it is more appropriate to consider risk of bias.


22.3 What are the potential biases in the estimation of the outcome? How will measurement bias

be reduced?

23. Attrition

Indicate the measures to reduce attrition (drop outs / loss to or incomplete follow up) that may

happen after allocation to the study. How will these cases be analysed?

24. Blinding

Will the person evaluating the outcome be aware of the exposure status of the subject? How will

blinding of the outcome evaluator to the exposure be achieved?

Attrition of the original sample represents a potential threat of bias if those who drop out of

the study are systematically different from those who remain in the study. The result is that the

remaining sample becomes different from the original sample, resulting in what is known as

attrition bias. However, if sample attrition over time is not systematic, meaning that there are

no unique characteristics among those who drop out, then there is no attrition bias, even though

the sample has decreased in size between waves of data collection. It is important, then, for

researchers who collect multiple waves of data to check for attrition bias.



Note: Please include a copy of the Data collection pro forma along with this application (in



25.2 Indicate the likely statistical tests that will be performed in analysing the data (Relative Risk,

multivariate analysis, confidence levels, level of significance etc.) to be used in analysing the data.

25.3 Quality Control of Data: What steps will be taken to ensure quality control of the data (data



25.4 When analysing the potential association between exposure and outcome, how will the data

analyst be blinded to the exposure status (Study cohort or control cohort)?





26.2: What is the anticipated conclusion that may result from the study and how can it be used to

improve / enhance scientific knowledge, patient management, professional or administrative

practice or influence policy making? (Please note that conclusions from a study should be entirely

and exclusively based on the observed findings and results of the conducted study. Conclusions

should not extend into making recommendations that are subjective assumptions that are not

proven by the concluded study.)


application?

26.4 Dissemination of the study findings and recommendations: How will the outcome of the

study be disseminated for use by the scientific and professional communities?



26.6 Indicate the Priority and importance of the study / research topic.


by the Ministry of Health? (Refer to the booklet in the Home Page)

Yes No



Highlight the ethical issues in the study and how they have been addressed. (Refer the ‘Ethical










29. Pilot Study

29.1 Pilot Study / Pre-test: Will there be a Pilot Study or a Pre-test of the questionnaire (data

gathering instrument) that will be used in this study. If yes, how, when, where and by whom it will

be done and how it may help the study. If no, justify why it is not required/necessary.



31. Research Grant

31.1 Are you planning to apply for a research grant through the Centre of Studies & Research of

the Ministry of Health?

Yes No



32. Attachments























to the Research and Ethical Review & Approval Committee for final approval.





Signature: Date:


Form B: Qualitative

Research

Use this form if the proposed research is a purely QUALITATIVE study. Observation

methods could be qualitative but the results can also be analysed statistically.

Please fill in all the responses that are applicable to your specific study. If any of the

items are not applicable to your study, please mention “NA” to indicate Not

Applicable in the corresponding response box. You should also add any additional

information that is pertinent or specific to your study in the section provided for it.


Introduction

A summary of the major qualitative philosophies, methodologies and approaches

Philosophy Methodologies Methods of Data Collection

Interpretivism

(Seeks to

understand)

Phenomenology

(Seeks to understand people’s

individual experiences and

interpretations of their world)

Interviews

Focus Group Discussions (FGDs)

Ethnography

(Seeks to understand the social

meaning of activities, rituals and

events in a culture)

Participant Observations

Interviews

Grounded Theory

(Seeks to develop theory based on

both an inductive [creative] and a

deductive [logical or empirical]

approach. Data is collected and

analysed, and then a theory is

developed that is grounded in the

data)

Participants Observations

Interviews

Historical Research

(Seeks not only to discover the events

of the past but to relate these past

happenings to the present and to the

future. Historical studies concern the

identification, location, evaluation,

and synthesis of data from the past.

Historical research Primary sources

should be used in historical research

when possible. There are many

examples of primary sources: oral

histories, written records, diaries,

eyewitnesses, pictorial sources, and

physical evidence)

Private letters

Personal and professional journals

Books, magazines, newspapers


Critical

Inquiry

(Seeks to

change)

Action Research

(Seeks action to improve practice and

study the effects of the action that

was taken. The purpose action

research is to identify facilitators and

barriers)

Participative group work

Interviews

Reflective Journals

(Quantitative methods may be

added)

Feminist Research

(Seeks to create social change

specifically to benefit women from a

feminist perspective)

In-depth interviews

Focus groups

(Quantitative methods may be

added)

Discourse Analysis

(Assumes that language constructs

what we think about ourselves, our

experiences, our world, and how we

relate to each other)

Study of written text and

communications such as policies

9. Study Design

Describe the research design that is specific to this study. Provide details about the research

approach that will be employed and list the procedural steps which will be used in the study.

Strengths and weaknesses of the design should also be discussed in this section.

10. Research Strategy

Specify the research strategy which will be used in the study. Provide details about the

characteristics and the selection of participants, how access to the participants will be done and

describe the setting in detail, and how the data will be collected (including need for training of data

collectors).


11. Data Collection Methods

Provide a description of any interview schedules, observation check lists, focus group discussions

(FGDs), or documentation to be collected along with examples attached. Intention to tape

record/videotape or use photographs must be stated.

Note: Please include a copy of the Data collection pro forma / Instrument along with this

proposal (in ‘Attachments’ section)

12. Sampling

What is the sampling technique used? (e.g: Snow ball; Homogenous; extreme deviant; maximum

variation; intensity or criterion (standard))

13. Methodological considerations

Indicate aspects of trustworthiness in qualitative research methods which are essential (such as

Credibility, Transferability. Dependability and Conformability).


14. Data Analysis

Specify how qualitative content analyses will be applied.

15. Pilot Study

Will there be a Pre-test / Pilot study? If yes, describe how it will be done (giving type and

number of participants, the data collection tool, the setting, what will be done with the results, and

whether it will be included or not in the main study).


16.1 Provide explanations about tape recording/videotaping management including the

management of written transcripts, photographs, or field notes which will be done in the study.

The secure handling of multiple documents including use of computer software packages (if used

such as Nvivo) to manage the data for transcription and coding should be described. The plan for

destroying the data (hard and soft copies) should be given.

16.2 Based on the available data if any descriptive and/or analytical tests can be done as

appropriate for the purpose of the study, kindly indicate in the box below. (N/A if not applicable)


17. Quality Control of Data

In addition to trustworthiness, what steps will be taken to ensure the quality of the data including

transcription of tape/video recordings? Statements of how the accuracy of the transcripts will be

checked, how the data will be verified, analysed, synthesized, interpreted, and how the

interpretations will be validated should be mentioned.

18. Ethical Considerations*

18.1 In this section, ethical issues must be critically considered including confidentiality and

anonymity, informed consent, the researcher – participant relationship (power, exploitation and

coercion), sensitive issues including support put in place if the participants are disturbed the

nature of the research. Please refer to the guidelines below.

Topic Guiding questions Yes No

Phenomenon

of interest

1. Is the research study relevant, important and

best studied using a qualitative method?

2. Is there any aspect of the research that could

be misleading?

3. Are there benefits in doing this research?

Review of the

literature

1. Has all the available literature been

reviewed?

2. Are all citations accurate in terms of quoting

and referencing?

3. Has the reason for including the article been

made explicit?

Participants 1. Is the well-being of the participants protected

(physically and psychologically)?


2. Is there evidence that informed consent has

been obtained and freely given?

3. If the participants are vulnerable is there

adequate explanation of how they were

recruited and protected?

Sampling

1. Will the confidentiality of the participants be

assured?

2. Is there evidence of coercion or deception?

3. Is there any payment or compensation being

paid to participants?

Data

generation

1. Will all the data collectors be trained and

prepared?

2. Is the credibility of the data assured?

3. Is there any evidence of bias in data

collection?

4. Is any data being collected covertly i.e. not

openly shown or hidden?

5. Is there evidence that the participants will be

clear about what the data will be used for?

6. Is there a clear mechanism for ensuring

authenticity and trustworthiness of the data?

Data

Analysis

1. Will data analysis be undertaken by more

than one person?

2. Is there evidence to ensure there will be no

data manipulation?

Conclusions

1. Is there a clear process describing how the

findings (interpretations) will be validated?

2. Is there a clear process to ensure that

confidentiality will be maintained when the

findings are presented?


*You should use the guideline for assistance however you must ensure you have

explained all the above further either in your full proposal or below in this section

18.2 Highlight the ethical issues in the study and how they have been addressed. (Refer the

‘Ethical Checklist’ for relevant particulars)


Explain briefly how, when and by whom informed consent will be taken? How will it be

ensured that the consenter / participant has fully understood all the rights, duties and privileges

of consenting including the right to withdraw at any time and other inalienable rights that have

to be granted due to the nature of the study?













20. Anticipated Results, Beneficiaries and Dissemination

20.1 What are the anticipated results that may result from the study? The relevance of the research

findings to action in practice or policy change should also be mentioned. (Anticipated results

means what the end point of the research will be, for example – themes related to the phenomenon

will be presented; an exhaustive description will be presented; theory will be developed;

description of a culture will emerge, etc.)

20.2 Beneficiaries of the Research Results: Who will be the potential beneficiaries of the study

and its application?

20.3 Dissemination of findings, conclusions and recommendations: How will the outcome of the

study be disseminated for the benefit of the scientific and professional community? (For example

– a report, a conference presentation (national/international), a workshop, peer reviewed

publication. Mention should also be made about managing dissemination of the findings to the

participants)



21.1 Please describe your work plan / timetable / Gantt chart. (Alternatively, it can be attached

in ‘Attachments’ section)

21.2 How will the administration and monitoring of research activities be carried out? (The

names of the administering, monitoring and supervising agencies/people should be given, for

example, University, College, School, Ministry, Hospital, mentors, advisors and/or supervisors.)

21.3 What are the potential shortcomings / limitations / constraints of the study?

21.4 Indicate the Priority and Importance of the study/research topic.


21.5 Is your chosen research topic part of the ‘Health Research Priorities’ as listed in booklet by

the Ministry of Health? (Refer the booklet on the Home Page)

Yes No


21.6 Will the research take up any additional resources of the department / hospital / health facility,







22. Research Grant


Ministry of Health?

Yes No


the ‘Health Research Funding Guideline’)


23. Attachments












10. Sample spreadsheet for the Data entry










to the Research and Ethical Review Committee for final approval.

Signature: Date:


Form C: Non-Clinical

Quantitative

Please fill in all the responses that are applicable to your specific study. If

any of the items are not applicable to your study, please mention “NA” to

indicate Not Applicable in the corresponding response box. You should also

add any additional information that is pertinent or specific to your study in

the section provided for it.


9. Study Group

9.1 Define and briefly describe the population you plan to study (the source population who have

the characteristic of interest that is to be studied and not the general / national population).

9.2 Who are the accessible participants (to be drawn from the source / reference / target population)

who are under consideration for the study?

9.3 How will the potential study participants be accessed / invited to participate in the study from

the accessible population? (e.g.: Outpatient visits, home visits, telephone / letter /e-mail invitation,

website announcement etc.)


to apply to






10. Sample Size Estimation of the Study




sample size.




disease or risk factor, all persons in a defined age group or gender or any such specific

attribute that are unique to the study



have a confounding effect on the study variables may be excluded. E.g. extremes of age,

presence of certain risk factors or disease or a physiologic state like pregnant women,

etc.


10.3 Describe in detail the sampling process (e.g.: sampling method, sample cluster, sample frame,

sampling unit etc. as applicable).

11. Study Group Allocation

11.1 How will the eligible participants be enrolled / allocated to the study?


11.2 Describe briefly the sampling technique.

12. Control / Comparison Group

12.1 Will there be a control / comparison group? If yes, how will they be selected?

12.2 How will the potential control / comparison participants be selected from the accessible

population?

12.3 Specify the inclusion criteria for controls.

12.4 Specify the exclusion criteria for controls.




13.2 What is the basis for sample size calculation and how was it calculated? Will the number be

the same as in the Study / experiment group (1:1 ratio) or different? Explain / justify.

13.3 Describe in detail the sampling process for the selection of Study group participants?


How will the accessible control / comparison participants be enrolled / allocated to the study?


15. Measuring Instrument

Note: Please include a copy of the Data collection pro forma/ Instrument along with this


15.1 How will the required data / information be collected with details? (e.g.: Interviewer

administered, self-administered, case records, other documents etc.)


15.2 Give details on who will collect the data / information?

15.3 Where (setting / location) and when (time-period) will the data be collected?

Where and when will the data be collected

15.4 Specify how the instrument will be evaluated for Validity and Reliability?

16. Pilot Study

Will there be a Pilot Study or Pre-test of the instrument? If yes, describe how it will be done (please

include target, number, purpose, what will be done with the results, and whether it will be included

or not in main study).

17. Data Collectors Training

Will the data collectors be trained on data collection? If yes, explain the process.













research subject. Informed consent process must be a dialogue of the study’s purpose,

duration, experimental procedures, alternatives, risks, and benefits. The process of

consenting is ongoing and must be made clear to the subject that it is his or her right

to “withdraw” or “opt out” of the study or procedure at any time, not just at the initial

signing of paperwork. The location where the consent is being discussed, the

subject’s physical, emotional and psychological capability must be taken into

consideration when consenting a human subject. The informed consent process

should ultimately assure that the subject understands and really “gets” what they are

signing up for.


19. Attrition and Non-Compliance

19.1 Indicate the measures to reduce attrition / non-participation (drop outs / loss to

or incomplete data procured) or non-compliance or non-response that may

happen after allocation of the participant to the study. How will these instances be dealt with?






particular design flaw (e.g. lack of allocation concealment) may lead to underestimation of an

effect in one study but overestimation in another study. It is usually impossible to know to

what extent biases have affected the results of a particular study although there is good












19.2 Adjustment for potential bias: Identify potential bias (if any) that could affect the study.

How will they be avoided or reduced at the various stages in the study? (e.g.: Selection bias,

Measurement bias, Recall bias, etc.).



20.2 Indicate the likely statistical tests that will be performed (descriptive and analytical tests as

appropriate to the study and the nature of the collected data).

20.3 Quality Control Of Data: What steps will be taken to ensure quality control of the data (data








improve / enhance scientific knowledge, professional or administrative practice or influence policy

making?


application?


21.5 Dissemination of the study findings and recommendations: How will the outcome of the study

be disseminated for the benefit of the scientific and professional communities?



by the Ministry of Health? ( Refer the booklet on the Home Page)

Yes No




22.1 Highlight the ethical issues in the study and how they have been addressed. (Refer the ‘Ethical



23.1 Will the research take up any additional resources of the department / hospital / health facility,

including but not limited to human resource, time, equipments, consumables, reagents,



23.2. Any other additional information (if applicable)?

24. Research Grant


Ministry of Health?

Yes No




25. Attachments












10. Sample Spreadsheet of Data entry















Signature: Date:


Form D: Mixed/Other

Research Designs

Use this section if the research is a mixed research incorporating aspects of qualitative and

quantitative research, either simultaneously or sequentially in the proposal. This form can

also be used if the study is proposed to be done in sequential phases. Studies of Diagnostic

tests, Economic analyses, Decision analyses etc. may also be used in this form; but if there are

any components that are specific to the study which are not covered in this form, it can be

brought out separately in the space provided.

Please note that if the study is done in phases and if any phase involves an intervention on

human participants, Form A1 should be used instead of this Form D.

Please fill in all the responses that are applicable to your specific study. If any of the items are

not applicable to your study, please mention “NA” to indicate Not Applicable in the

corresponding response box. You should also add any additional information that is pertinent

or specific to your study in the section provided for it.


9. Research Design and Methodology

Specify the research strategy (research design and methodology) that is unique / specific to this

study.

10. Study Population

10.1 Define and briefly describe the Population you plan to study (the source population who

have the characteristic of interest that is to be studied and not the general / national population)

10.2 Who are the accessible participants / study items to be drawn from the Source / Reference

/ Target population) who are under consideration for the study (e.g.: case records, disease registers,

telephone directory, tissue samples etc.)?

10.3 How will the potential study participants/items be accessed / invited to participate in the study

from the accessible population? (e.g.: Outpatient visits, home visits, telephone / letter / e-mail

invitation, website notification, case records, registers etc.)


to apply to






11. Sample Size Estimation




sample size.

11.3 Describe in detail the sampling process (e.g.: sampling method, sample cluster, sample frame,

sampling unit etc. as applicable)


participate. It should be broad enough to closely represent the target/reference population.

E.g. All persons living in a geographic area, all patients with a certain disease or risk

factor, all persons in a defined age group or gender or any such specific attribute that are

unique to the study


Such exclusion should not affect the generalisability of the study. Attributes that can have

a confounding effect on the study variables may be excluded. E.g. extremes of age,

presence of certain risk factors or disease or a physiologic state like pregnant women, etc.


12. Study Group Allocation

12.1 How will the eligible participants/study items be enrolled / allocated to the study?


12.2 Describe briefly the allocation / randomization technique.

13. Control / Comparison Group

13.1 Will there be a Control / comparison group? If yes, how will they be selected?

13.2 How will the potential control / comparison participants be selected from the accessible

population?

13.3 Specify the inclusion criteria for controls.

13.4 Specify the exclusion criteria for controls.

13.5 How will the accessible control / comparison participants be enrolled / allocated to the study



14. Measuring Instrument

14.1 How will the required data / information be collected with details? (e.g.: Interviewer

administered, self-administered, case records, laboratory tests, clinical images, financial records

etc.)

14.2 How and by whom will the data / information be collected?

14.3 Where (setting / location) and when (time-period) will the data be collected?

14.4 Specify how the instrument that will be used for data collection will be evaluated for Validity,

Reliability and Applicability.


15. Gold Standard / Benchmark

15.1 Will there be a comparison with a known standard or gold standard or benchmark? If yes,

describe.

16. Pilot Study

16.1 Will there be a Pilot Study or Pre-test of the instrument? If yes, describe how it will be done

(please include target, number, purpose, what will be done with the results, and whether it will be

included or not in main study).

17. Data Collectors Training

17.1 Will the data collectors be trained on data collection? If yes, explain the process.

Note: Please include a copy of the Data collection pro forma/ Instrument along with this








Note: Please attach a copy of the consent form (in ‘Attachments’ section).
















19. Attrition and Non-Compliance

19.1 Indicate the measures to reduce attrition (drop outs / loss to or incomplete

response) or non-compliance or non-response that may happen after allocation

of the participant to the study. How will these instances be dealt with?






particular design flaw (e.g. lack of allocation concealment) may lead to underestimation of

an effect in one study but overestimation in another study. It is usually impossible to know

to what extent biases have affected the results of a particular study although there is good












19.2 Adjustment for potential bias: Identify potential bias that could affect the study. How will

they be avoided or reduced at the various stages in the study (e.g.: Selection bias, Measurement

bias, Recall bias, etc.)?



20.2 Indicate the likely statistical tests that will be performed (descriptive and analytical tests as

appropriate to the study and the nature of the collected data).

20.3 Quality Control Of Data: What steps will be taken to ensure quality control of the data (data








improve / enhance scientific knowledge, professional or administrative practice or influence policy

making? (Please note that conclusions from a study should be entirely and exclusively based on

the observed findings and results of the conducted study. Conclusions should not extend into

making recommendations that are subjective assumptions that are not proven by the concluded

study.)


application?

21.4 Dissemination of the study findings, and recommendations: How will the outcome of the

study be disseminated for the benefit of the scientific and professional communities?





by the Minstry of Health? (Refer to the bboklet in the Home Page)

Yes No



Highlight the ethical issues in the study and how they have been addressed. (Refer to the ‘Ethical








Are there any specific processes in this study that need further elaboration in terms of the research

methodology or any other additional information? If yes, please highlight them in the following

box.


25. Research Grant


Ministry of Health?

Yes No



26. Attachments












10. Sample Spreadsheet of Data entry
















Signature: Date:


Minimum required

standards

This section provides a reference for the minimum required standards in a research

proposal.


MINIMUM REQUIRED STANDARDS

- The proposal is clear and coherent

- All aspects and components of the proposal are adequate and consistent with international best

practices and good research methodology

- The literature review is concise, comprehensive and up-to-date

- The yield of the proposed research will generate useful information / outcome at both the national

and scientific level to improve the efficiency of the health system, raise the level of health services

or improve the knowledge and health behaviour at the level of the community and the individual

- The research topic is preferably within the list of research priorities of the Ministry of Health

- The research plan is feasible with sufficient time to complete the proposed research and with

sufficient resources (human, material and monetary).

- The research team is capable & professionally competent for project implementation (skills,

scientific qualification & experience)

- Potential Ethical issues are addressed in the proposal

- Procedures for informed consent are provided (if required)

- Adequate measures are taken to ensure confidentiality, privacy, participant safety, data protection

and other factors that are consistent with Good Research Practice.

- The researchers have obtained due pre-approval (feasibility/administrative approval) or has

evidence of “No objection” from the appropriate authorities or supervisors to facilitate the study

if approval is granted by the respective research committee.


Glossary

of Research Terms

This glossary provides definitions of common research terms used and is intended as

a guide in understanding the terms and concepts within the context of health

research.


GLOSSARY

Aim(s): It is a general statement(s) of what the study hopes to achieve within the scope of the

actual research.

Attrition rate: The rate of drop-out (loss to or incomplete follow up / failure to comply etc.)

among participants/subjects in a research study.

Attrition The ‘wearing away’ or progressive loss of data/participants in research. Attrition occurs

when cases are lost from a sample over time or over a series of sequential processes.

Bias: It is a systematic error or deviation from the truth in results or inferences.

Blinding: It refers to the concealment of group allocation from one or more individuals involved

in a clinical research study to prevent bias. Blinding can be single-blinded, double-blinded, or

triple-blinded.

Case-control Study: It is a type of research design usually employed to estimate the strength of

association between a clinical condition or an outcome of interest with the prior exposure to a

potential causal / risk factor.

Clinical Trial: Any research study that prospectively assigns human subjects to one or more

health-related interventions to evaluate the effects on health outcomes.

Cohort Study: A research study (usually prospective) involving participants who already have an

exposure of interest (risk factor) and who are to be followed up for a specified period of time to

determine if they manifest the anticipated outcome (e.g.: disease).

Confidence interval: A whole interval of acceptable values for the parameter instead of a single

value.

Confidence level: The likelihood that the value for a parameter will be within the confidence

interval.


Confounding: A situation in which the effect or association between an exposure and outcome is

distorted by the presence of another variable.

Control/Comparison group: It is a group of subjects which closely resemble the

treatment/population-of-interest group in many demographic variables but do not get the

treatment/procedure being studied in the study. It will be used as a baseline and

allows researchers to eliminate and isolate confounding variables and bias.

Convenient allocation: It is the process whereby sample participants are allocated into groups

based on the investigator's convenience or primarily because they were available at a convenient

time or place.

Exclusion criteria: Attributes of subjects that warrants their non-inclusion in the study. Such

exclusion should not affect the generalisability of the study.

External Validity: The extent to which a study's results (regardless of whether the study is

descriptive or experimental) can be generalized/applied to other people or settings.

Hypothesis: Hypothesis is a statement about expected/conceptual relationships between two or

more independent variables and one dependent variable.

Inclusion criteria: Attributes of subjects that are essential for their selection to participate. It

should be broad enough to closely represent the target/reference population.

Informed Consent: A process whereby the subject voluntarily agrees to participate in the research

after provision of sufficiently detailed information on the research (including potential risks and

benefits).

Intervention: A systematic change in conditions or an action that produces an effect or is intended

to alter the course of a pathologic process.

Margin of error: It expresses the maximum expected difference between the true population

parameter and a sample estimate of that parameter.


Matching: The deliberate process of making a study group and a comparison group comparable

with respect to factors that are extraneous to the purpose of the investigation but which might

interfere with the interpretation of the study's findings.

Mixed Research: A research study type incorporating aspects of qualitative and quantitative

research, either simultaneously or sequentially in the proposal.

Objectives: The specific steps/measures taken to achieve the aim(s) of the study.

Qualitative Research: A research study which is primarily exploratory and involves data

collection methods such as interviews, focus group discussions. It is used to further understand

underlying reasons, opinions, and motivations.

Random allocation: It is a process in which identified sample participants are randomly assigned

to a treatment/procedure/group and each participant has the same probability of being assigned to

any particular treatment/procedure.

Random selection: It is the process of drawing a sample from a population where the sample

participants are not known in advance.

Research sample: The members of the study population from whom we collect our data.

Sample size: The number of subjects included in a sample.

Sampling: It is the process of selecting a number of study units from a defined study population

of interest.

Sensitive Data/Material: It refers to information or material of any kind related to patients/clients,

confidential/personal information about staff, data or information about health services or the

health system (of the Ministry of Health) and all such information that are not in the public domain.

Stratified allocation: It is the process in which identified sample participants are assigned to a

particular group based on baseline variables (potential confounding factors) thought to be

associated with the outcome.

Study population: The people who meet our operational definition of the target population.


Systematic allocation: It is the process in which identified sample participants are assigned to a

particular group based on a specific system (alternately, based on time, date of birth etc.).

Target / Reference population: The group of people to whom we want our research results to

apply to.

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