standardoperatingprocedures …

MTRH/MU- IREC of 48 | Version 9 | January 2021

Moi University College of Health SciencesP.O. Box 4606-30100Eldoret, Kenya.

Email: [email protected]

Moi Teaching and Referral HospitalP.O. Box 3-30100Eldoret, Kenya.

Email: [email protected]

STANDARD OPERATING PROCEDURESFOR

MOI TEACHING AND REFERRAL HOSPITAL / MOI UNIVERSITY COLLEGE OFHEALTH SCIENCES - INSTITUTIONAL RESEARCH

&ETHICS COMMITTEE

mailto:[email protected]


ForewordBiomedical research involving human beings has the potential for great good as well as great harm to

potential study participants who are at risk of physical and emotional exploitation. The lay public

holds health professionals and researchers in high esteem and trust. This relationship can easily be

abused. In addition, there are special groups including but not limited to minors, refugees and

mentally unsound who are even more prone to exploitation in research.

With increasing collaborative research involving external institutions/organizations of diverse societal

backgrounds, and different interpretations of ethical issues there is need to regulate research activities

and ensure protection of research participants. Through the Science, Technology and Innovation Act

No. 28 of 2013, the National Commission for Science Technology and Innovation (NACOSTI) was

establishment to regulate research in the country. To achieve this mandate NACOSTI facilitated the

establishment of Institutional Ethics Review Committees (IERCs), of which Moi Teaching and

Referral Hospital (MTRH) and Moi University College of Health Sciences (CHS) Institutional

Research and Ethics Committee (MTRH/ MU-IREC) is one.

The activities of MTRH/MU-IREC especially in review of research proposals may themselves be

prone to various forms of abuse that can inhibit rather than foster a vibrant research culture. It is

therefore important that systems and procedures for receiving, reviewing, approving research

proposals and post-approval compliance monitoring are put in place. These systems should be

standardized so as to allow expeditious, objective and reproducible review of proposals. The

development and dissemination of the Standard Operating Procedures (SOPs) of MTRH/MU-IREC

must therefore be viewed as an important step towards fostering an ethical and humane research

culture in our institutions. It is understood that, new ethical issues in health-related research will keep

emerging and hence there will be need for regular revisions of these SOPs to maintain their relevance

to contemporary trends.

Chief Executive Officer, Principal,Moi Teaching and Referral Hospital Moi University, College of Health Sciences


LIST OF ABBREVIATIONSAE – Adverse Event

ADR – Adverse Drug Reaction

AOB – Any other Business

CEO – Chief Executive Officer

CHS – College of Health Sciences

CITI – Collaborative Institutional Training Initiative

COBES – Community Based Education and Service

COI – Conflict of Interest

CV – Curriculum Vitae

DSMB – Data Safety Monitoring Board

HBM – Human Biological Material

HPA – Human Participant Administrator

IATA – International Air Transport Association

ICT – Information Communication Technology

IERCs – Institutional Ethics Review Committees (IERCs

IRB – Institutional Review Board

IREC – Institutional Research and Ethics Committee

LAR – Legally Authorized Representative

MUCHS – Moi University, College of Health Sciences

MURIO – Moi University Research Integrity Office

MTA _ Material Transfer Agreement

MTRH – Moi Teaching & Referral Hospital

NACOSTI – National Commission for Science, Technology and Innovation

PI – Principal Investigator

RCR – Responsible Conduct of Research

RM – Research Misconduct

SAE – Severe Adverse Event

SMS – Short Message Service

SUSAR – Suspected Unexpected Severe Adverse Reaction

SOPs – Standard Operating Procedures


TOR – Terms of Reference

UAR – Unexpected Adverse Reaction

USA – United States of America

WHO – World Health Organization


Table of Contents

Foreword............................................................................................................................................ 2LIST OF ABBREVIATIONS.............................................................................................................31.0 ROLE OF IREC......................................................................................................................72.0 TERMS OF REFERENCE........................................................................................................83.0 MEMBERSHIP....................................................................................................................... 93.1 Co-option.................................................................................................................................. 93.2 Appointments............................................................................................................................93.3 Training and Continuing Education...........................................................................................93.3 Tenure and conditions of appointment....................................................................................103.4 Resignation, disqualification, replacement of members............................................................ 103.5 Honoraria................................................................................................................................ 113.6 Review Fee.............................................................................................................................. 113.7 Contact Information for MTRH/MU- IREC.......................................................................... 11

4.0 FUNCTIONS AND RESPONSIBILITIES.......................................................................... 124.1 Chair:.......................................................................................................................................124.2 Deputy Chair........................................................................................................................... 124.3 Secretary.................................................................................................................................. 124.4 Deputy Secretary......................................................................................................................134.5 Human Participant Administrator............................................................................................134.6 Committee Members............................................................................................................... 14

5.0 REGULAR IREC MEETINGS.............................................................................................155.1 Frequency................................................................................................................................155.2 Quorum...................................................................................................................................15

6.0 CONFLICT OF INTEREST.....................................................................................................167.0 CONDUCT OF IREC MEETINGS..................................................................................... 187.1 IREC Meeting Schedule and Distribution of Agenda...............................................................187.2 Meeting Procedure...................................................................................................................187.3 Minutes of meetings................................................................................................................ 187.4 Special meetings.......................................................................................................................19

8.0 SUBMISSION OF A NEW RESEARCH PROPOSAL........................................................ 208.1: Application Procedure............................................................................................................ 21

9.0 TYPES OF REVIEW................................................................................................................ 249.1 Expedited Review....................................................................................................................249.2 Full Review..............................................................................................................................259.3 Exempt review.........................................................................................................................259.4 Continuing Review.................................................................................................................. 269.5 Review of Study Amendments.................................................................................................27

10.0 GUIDELINES FOR HANDLING, STORAGE AND TRANSPORTATION OF HUMANBIOLOGICAL SPECIMEN.............................................................................................................2910.1 Requirements.........................................................................................................................2910.2 Guidelines for collection of HBM..........................................................................................3110.3 Guidelines for transportation of HBM...................................................................................3110.4 Confidentiality and privacy should be maintained throughout the research............................ 31

11.0 ADVERSE EVENTS REPORTING........................................................................................33


11.1 Reporting procedure.............................................................................................................. 3411.2 Review and decisions on SAE reports...................................................................................34

12.0 COMMUNICATION OF REVIEW DECISIONS.................................................................. 3612.1 Communication/Reporting post meeting responsibilities and record keeping –Communicating the outcomes of the review..................................................................................3612.2 Dispatch of correspondence to a PI.......................................................................................3712.3 Handling a response from a PI or applicant........................................................................... 38

13. 0 FOLLOW UP...........................................................................................................................3913.1 Terms of reference of the monitoring and evaluation sub ccommittee...................................39

14.0 APPEAL AGAINST REVIEW OF COMMITTEE DECISION............................................. 4015.0 RESPONSIBILITY OF THE PRINCIPAL INVESTIGATOR IN THE REVIEW PROCESS..........................................................................................................................................................4116.0 HANDLING RESEARCH MISCONDUCT............................................................................4216.1 Approaches to Handling RM................................................................................................. 4216.2 Role of MTRH/ MU-IREC...................................................................................................42

17.0 COMPLETION OF STUDY..................................................................................................4418.0 DOCUMENTATION AND ARCHIVING............................................................................. 4519.0 FINANCES..............................................................................................................................4619.1 Sources of Funds................................................................................................................... 4619.2 Banking..................................................................................................................................4619.3 Expenditure........................................................................................................................... 4619.4 Accounting............................................................................................................................ 47

20.0 REFERENCES.........................................................................................................................48


1.0 ROLE OF IRECThe Moi Teaching & Referral Hospital / Moi University College of Health Sciences -Institutional

Research and Ethics Committee (MTRH/MU-IREC), was constituted jointly by Moi Teaching &

Referral Hospital (MTRH) and Moi University College of Health Sciences (MUCHS). The

MTRH/MU-IREC shall serve as the regulatory entity for research at the MTRH, MUCHS and

satellite areas in the Western half of Kenya. The MTRH/MU-IREC responsibilities shall include

review, evaluation and approval of proposed research involving humans, their tissue and related data

based on the scientific and ethical merits of research proposals and monitoring of the approved

studies with the aim of safeguarding the dignity, rights and welfare of the research participants - both

human and animal. The Committee governs health research as guided by applicable laws and

regulations of Kenya and other relevant international bodies. The Committee reviews and approves

research proposals for and on behalf of the National Commission for Science, Technology and

Innovation which is the legal entity authorized to review and approve research in Kenya under the

Science Technology and Innovation Act No. 28 of 2013. MTRH/MU-IREC work is legally

underpinned through a delegated mandate from National Commission for Science Technology and

innovation (NACOSTI) via accreditation.


2.0 TERMS OF REFERENCEMTRH/MU-IREC shall:

i. Provide independent ethics and scientific review of all proposed research involving humans,

their tissue and related data and provide approval prior to commencement of the research for

research undertaken within its specified jurisdiction.

ii. Not provide retrospective approval.

iii. Accept to review protocols submitted from outside its jurisdiction.

iv. Ensure the safety, dignity, rights and well- being of all human participants.

v. Conduct post approval compliance monitoring either through continuing review, for cause

audit and not for cause audit.

vi. Make an annual report to the National Commission for Science Technology and Innovation

copied to the institutional appointing authority.

vii. Keep abreast with international developments in relation to health research and associated

ethical issues and liaise with relevant local and international organizations.

viii. Work towards implementing the approved and most current version of the SOPs.


3.0 MEMBERSHIPThe Committee shall be composed of at most twenty- one (21) members, with 1/3 of the total being of

either gender, having core members from various disciplines including Biomedical, Clinical and Social

Sciences, Biostatistics, Law and two (2) lay persons. All appointments shall be made through a

participatory approach by both Appointing Authority.

3.1 Co-optionThe Committee may co-opt expertise external to the committee as and when required. The

Committee shall determine the duration of the co-option.

3.2 AppointmentsThe MTRH/MU-IREC members shall be appointed by the Appointing Authorities- (CEO-

MTRH and Principal –MUCHS). Appointments shall normally be completed within ninety

(90) calendar days following the request letter done by the chair to the appointing authority.

3.3 Training and Continuing Educationi. New members and secretariat are required to familiarize themselves with the SOPs,

and other relevant documents immediately after being appointed to MTRH/MU-

IREC.

ii. MTRH/MU- IREC shall facilitate opportunities for continuing education for all

members in keeping with current ethical and regulatory issues related to protection of

human participants.

iii. New MTRH/MU- IREC members and the Secretariat staff shall undergo CITI

training or any other relevant ethics training that deals with human participant

research and a copy of the certificate will be filed in the training files within the

Secretariat.

iv. Current MTRH/ MU- IREC members including the secretariat will be required to

undergo continuous personal development in ethics at least once a year.

v. The secretariat shall identify facilitators of training workshops and organize training.

vi. The secretariat shall continually provide information about relevant training courses,

workshops, conferences etc.

vii. Members may identify an appropriate course and inform the secretariat in writing for

any financial facilitation.

viii. The secretariat shall keep training records.


3.3 Tenure and conditions of appointment

i. MTRH/MU- IREC shall have a Chair, Deputy Chair, and Secretary, Deputy Secretary,

and members and will be assisted by a secretariat consisting of the Secretary, Deputy-

Secretary, Human Participant Administrator, Records Personnel, Office Administrative

Officer, Data Entry Personnel and Housekeeping Staff.

ii. Members shall be selected in their personal capacities, based on their interest, ethical

and/or scientific knowledge, and expertise, as well as on their commitment and

willingness to volunteer the necessary time and effort for the Committee’s work.

iii. Members shall be appointed initially for a period of three (3) years, renewable once.

iv. To maintain continuity in the operations of the Committee, at least a third of the

membership shall be retained.

v. The outgoing Chairperson shall be an ex-officio member in the incoming Committee for

one term.

At appointment;

i. Members shall sign a confidentiality agreement at the start of the term and abide by the

confidential agreement regarding meeting deliberations, applications, protocol submissions,

information on research participants and related matters; which they have had privilege to

as a result of being members of the Committee. The confidentiality agreement protects the

privacy and confidentiality of all parties whose information may be disclosed to the

Committee in the course of its work.

ii. Members shall provide their updated bio-sketches annually and be willing to publicize

their identity; name, profession and affiliation to the Committee

iii. Members are expected to disclose any Conflict of Interest whether - financial, personal,

professional or otherwise - in a project or proposal under consideration.

iv. Any member who has vested interest in a proposal submitted to the Committee- shall not

participate in the deliberations of the protocol (unless specifically requested by the Chair

for the purposes of clarifying issues on the protocol under consideration). Under no

circumstances may they vote on the decisions regarding the protocol.

3.4 Resignation, disqualification, replacement of membersi. Members may resign from their post by giving a letter of resignation, at least one month in

advance, to the Appointing Authorities through the Chairperson.

ii. Members may also be disqualified from continuance following advice from the committee.


iii. The Committee shall request for removal and replacement of any members under the

following circumstances: -

a. Following notification by the Chairperson in writing, persistent absenteeism of

three (3) or more consecutive meetings.

b. Voluntary withdrawal of a member.

c. Ethical/professional misconduct.

3.5 Honorariai. Honoraria determined by the Committee and approved by the Appointing Authority shall

be paid to the MTRH/MU-IREC members after every meeting.

ii. The community representative shall be paid transport allowance over and above the sitting

allowance.

iii. Any other temporarily co-opted non-institutional member shall be paid transport and

sitting allowance which shall be determined by the Committee from time to time.

3.6 Review FeeThe Committee shall charge a fee to cover administrative costs of research proposal review.

These fees shall vary from time to time as determined by the MTRH/ MU-IREC.

3.7 Contact Information for MTRH/MU-IRECPhysical address: - Moi Teaching and Referral Main Building, Second floor, Room 219.

Telephone contact: - +254787723677.website and e-mail addresses: - www.irec.or.ke and email [email protected]/

[email protected] The Human Participant Administrator shall be the contact person.

http://www.irec.or.ke




4.0 FUNCTIONS AND RESPONSIBILITIES

4.1 Chair:

The Chair shall:

i. Conduct meetings in accordance with the MTRH/ MU-IREC approved Standard

Operating Procedures.

ii. Facilitate induction and training of new Committee members.

iii. Facilitate continuing education for members.

iv. Oversee the functions and activities of the Secretariat.

v. Assign responsibilities and duties to any member of the Committee.

vi. Sign the minutes of the Committee meetings.

vii. Upon the recommendation of the Committee, sign approval letters for research

proposals.

viii. Facilitate logistical support for the Secretariat to ensure prompt execution of MTRH/

MU- IREC mandate.

ix. Liaise with the National Commission for Science, Technology and Innovation and

other IERCs to help foster an ethical and humane research culture in our country.

x. The Chairman shall be responsible for making communication on behalf of the

Committee to the Appointing Authority and other relevant bodies.

4.2 Deputy Chair

The Deputy Chair shall:

xi. Perform all the functions and duties of the chair whenever the chair is absent.

xii. Perform any other duties as assigned by the Chairman.

4.3 Secretary

The Secretary shall:

i. Be responsible for the safety and maintenance of Committee documents, website and

records.

ii. Call meetings in consultation with the Chair.

iii. Liaise with the Chairman to grant administrative approval pending ratification by the

committee of proposals on exempt review and some on expedited review especially


undergraduate student proposals (bachelors, high diploma &diploma).

iv. Perform a pre-review of the submitted proposals assessing the completeness of the

submission and depending on risk status, categorize them into types namely, exempt,

expedited and full committee review.

v. Identify suitable reviewers and ensure assigned protocols are dispatched to reviewers.

vi. Receive reviewed proposals and monitor the review process of proposals to secure

comments from reviewers within the stipulated period.

vii. Prepare proposal review documents for discussion at regular Committee meetings.

viii. Design and disseminate templates for Committee submission documents, including

research protocols, informed consent materials, agreements and periodic and final

reports.

ix. Oversee the functions and activities of the Secretariat.

x. Record, process and circulate the minutes of the MTRH/MU- IREC meetings.

xi. Disseminate SOPs and MTRH/ MU- IREC guidelines.

xii. Receive final reports from the PI (s) of approved proposals.

xiii. Secretary will perform his/her functions working with the Secretariat and led by the HPA.

xiv. Perform any other duties as assigned by the Committee or the Chair.

4.4 Deputy Secretary

The deputy secretary shall:

i. Deputize the Secretary.

ii. Perform any other duties assigned by the Secretary.

4.5 Human Participant Administrator

The Human Participant Administrator shall:

i. Perform day to day running of the MTRH/MU- IREC secretariat including financial

management with approval of the Committee.

ii. Assist the Secretary in the performance of a pre-review of the submitted proposals and

depending on the risk involved categorize them into types namely, exempt, expedited

and full committee review.

iii. Liaise with the Chairman/Secretary/Deputy Secretary to grant administrative approval

of some proposals (minimal risk studies; studies which the grant date is imminent)


pending ratification by the committee

iv. Manage and maintain copies of all correspondences.

v. Organize meetings in consultation with the Secretary /Deputy Secretary.

vi. Assist the Secretary in drawing the agenda.

vii. Circulate research proposals and minutes to Committee members.

viii. Assist the Secretary to record Minutes of MTRH/MU- IREC meetings and ensure

accurate recording of decisions, including any amendments requested by the

committee.

ix. Record and correct any amendments to previousminutes submitted for approval.

x. Assist in preparation and submission of the budget and Procurement Plan in

consultation with the Chair.

xi. Design and maintain a system for collecting and filing all Committee documents,

including meeting minutes, member qualifications, protocol submission versions,

deviations from approved protocols, and periodic and final reports.

xii. Maintain inventory of all office equipment.

xiii. Undertake all other administrative duties as assigned by the Secretary.

Note: The Secretariat shall consist of the Secretary, Deputy Secretary, Human Participant

Administrator, Records Officer, ICT Officer, Office Administrator and Office Assistant.

4.6 Committee Members

The Committee members shall:

i. Review, discuss and consider all documents submitted for review.

ii. Consider decisions taken by the Chair on behalf of the Committee for ratification.

iii. Maintain confidentiality of documents and deliberations of the Committee meetings.

iv. Declare conflict of interest whenever applicable.

v. Participate in continuing education activities in biomedical ethics and research.

vi. Attend Committee meetings regularly and contribute constructively to the

deliberations.

vii. Provide technical support to uphold the integrity of MTRH/MU- IREC.

viii. Perform any other duties assigned by the chair.


5.0 REGULAR IREC MEETINGS5.1 Frequency

The Committee shall convene a meeting twice a month, every 2nd and last Thursday of the

month from 9.00 am to end at 3.00 pm latest.

A special meeting may be called when need arises.

5.2 QuorumQuorum shall be more than half of MTRH/MU- IREC membership including apologies and

more than one third of the members in attendance. A lay person shall be in attendance for all

meetings.


6.0CONFLICTOFINTEREST

i. Members shall be responsible for self-identifying and disclosing the conflict of interest during

review and also during MTRH/ MU- IREC meetings.

ii. A standing item will be included in the meeting agenda regarding conflict of interests.

iii. Members shall disclose any relationship, interest or other circumstances, which could

reasonably be perceived as creating conflict of interest-including the following:

a. Professional relationship: If the research proposal has been submitted by a

colleague with whom the member has COI (dispute, bias, any benefits etc.)

b. Personal relationship: If the MTRH/MU-IREC member (his/her spouse or

immediate family member) is the principal investigator or co-investigator or

coordinator / manager of the research protocol under review.

c. Business relationship or affiliation: If the MTRH/MU-IREC member his/her

immediate family serves as a trustee, director, manager, scientific advisor,

owner or partner of an entity that could be affected by the outcome of the

research under review by MTRH/MU-IREC.

d. Financial interest: If the MTRH/MU-IREC member has a financial interest

that could be affected by the outcome of the research protocol under review.

Included in the definition of financial interest are equity interests e.g. stock,

stock options or other ownership interests, payment or expectation of payment

derived from intellectual property rights (e.g. patent royalties) and payments

received from an entity for consulting or other services.

iv. Upon disclosure the Chairperson and the Committee shall determine whether a conflict exists.

v. The final outcome of such a determination shall be reflected in the minutes and captured in

the Conflict of Interest register.

vi. Where the Chairperson finds himself/herself in a situation of potential conflict of interest,

the Deputy Chairperson or in the absence of the Deputy Chairperson another member shall

act as Chairperson. The acting Chairperson will conduct the meeting for the remainder of the

discussion on the item in question.

vii. Members who have a conflict of interest related to any research protocol that the

MTRH/MU-IREC is about to consider will not participate in any discussion or decision


making of the protocol or related matters, except where it is necessary to provide information

requested by the Committee.

viii. The member with a conflict of interest will leave the meeting during the discussion and

voting process. The outcome of the committee decision in the absence of the recused member

will NOT be discussed upon return of the member concerned but may be conveyed after

closure of the meeting.

ix. All MTRH/ MU- REC reviewers assigned to review a protocol or related matter shall notify

the Secretariat so that the protocol can be re-assigned, should a conflict of interest be

identified.


7.0 CONDUCTOFIRECMEETINGS7.1 MTRH/ MU- REC Meeting Schedule and Distribution of Agenda

i. The Secretary shall notify and circulate the agenda, the minutes and inform members

of the time, venue, and date at least one week in advance.

ii. The Secretary shall notify all Committee members of any changes of the meeting time,

venue, date or agenda within 24 hours.

7.2 Meeting Procedurei. The meeting will start with the Chairperson opening the meeting and ensuring there is

quorum.

ii. The Human Participant Administrator will record those present as well as apologies.

iii. The Secretary shall read out the agenda to precede its adoption by the Chair and the rest

of the Committee members.

iv. Previous minutes will be confirmed followed by matters arising, considerations by

Chairperson on behalf of the Committee and consideration of new proposals.

v. The Chairperson will facilitate the discussions and summarize the various viewpoints of

the members.

x. The Standard agenda shall be as follows;

a. Prayers

b. Apologies

c. Communication from the chair

d. Declaration of Conflict of Interests

e. Receive and Consider New Research Proposals

f. Consideration of actions taken by the Chair on behalf of the Committee

g. Receive and Adopt Reports

h. Confirmation of minutes

i. Matters arising

j. Any Other Business (A.O.B)

xi. Decision making of the Committee shall be by consensus.

7.3 Minutes of meetingsi. The Chair shall review the minutes for accuracy and completeness then sign/approve

for circulation.


ii. The minutes of each meeting shall be distributed to members within a period of not

more than one week after every meeting.

iii. The minutes shall be confirmed at the next meeting.

iv. The confirmed minutes shall be distributed to, the CEO, MTRH and the Principal

CHS seven (7) calendar days after confirmation.

7.4 Special meetings

i. Special meetings shall be called as deemed necessary.

ii. Quorum will be adopted as for the general meeting and the lay person MUST be present.

iii. Specific agenda shall be circulated in the meeting notice (only specified agenda items shall be

discussed).

iv. MTRH/ MU-IREC may where necessary invite the Principal Investigator to the meeting to

clarify certain issues relating to their proposal.

v. There shall be no A.O.B.


8.0 SUBMISSION OF A NEW RESEARCH PROPOSALThe requirements for submission of a proposal are clearly described in the application procedures

available on the MTRH/MU-IREC web page www.irec.or.ke or can be obtained from the Secretariat

Office.

Review Procedure flow chart

http://www.irec.or.ke


A valid application is one that at the time of submission, is complete, with all the necessary

documents attached and is signed and dated.

The application should include the following information and materials:

i. The protocol in the required format (see annex 1) and other accompanying/supporting

materials sent to [email protected]/[email protected] or via the MTRH/MU- IREC

submission portal. Only E-Copies are allowed.

ii. The accompanying/supporting material shall include: -

a. Covering letter to the MTRH/MU-IREC Chairperson

b. Reviewer guideline form

c. Abstract form

d. Vulnerable population form if the research involves a vulnerable population.

e. Consent forms

f. Data collection instruments

g. Recruitment materials (e.g. fliers)

h. Detailed CV/Bio-sketch

i. Scanned copy of the Trans National Bank receipt produced on submission (externally

funded studies will be invoiced) payments expected once funds are availed

j. For studies dealing with HBM a copy of the MTA shall be required

8.1: Application Procedure

i. The Secretary/Deputy -Secretary /Human Participant Administrator shall conduct

administrative screening of the application package against the MTRH/MU-IREC

checklist within 24 hrs.ii. The Secretariat shallwrite an acknowledgement email of receipt of the proposal and

accompanying documents and inform Principal investigator(s) if the application is complete

or incomplete by SMS or E-mail after administrative screening.

iii. If application package is incomplete, the Principal investigator is required to provide the

missing documents/information within five (5) -calendar days after notification of theincompleteness of the package. If the missing information is not provided within the

stipulated five calendar days, the application package automatically gets rejected.

iv. The applicant, however, has the liberty to make a fresh submission of the package

v. On acceptance of the complete package, the secretariat will assign a reference number to



the proposal and informs the principal investigator that protocol has been accepted for

review.

vi. The Secretary/Deputy-Secretary /Human Participant Administrator shall perform a pre-

screening of the submitted proposals and depending on the risk involved categorize them into

types namely, exempt, expedited and full committee review.

vii. The Secretary/Deputy-Secretary /Human Participant Administrator assigns the

reviewer(s) of the protocol based on expertise in the subject area of the study and based onthe type of review that will be conducted.

viii. Secretariat will confirm availability of the reviewers either by E-mail, SMS or via a phone call.

ix. Secretariat will send via email or through the portal the proposal and accompanying

documentation to reviewer(s) whose feedback is expected within fourteen (14)- calendardays.

x. The Secretariat shall send reminders to the reviewers after seven to ten (7-10) -calendardays. In case the reviewer needs more time to review a seven (7)-calendar day extension canbe provided.

xi. The consolidated comments from both reviewers are forwarded to the PI for attention within48 hours.

xii. No revisions may be made, prior to the MTRH/MU -IREC review (Committee meeting), to

an application that has been accepted for review and assigned a reference number. Where an

applicant considers it necessary to revise the protocol or supporting documents prior to

review, the application should be withdrawn.

xiii. The Secretary in liaison with the Chairperson may grant administrative approval pending

ratification by the committee of proposals on exempt review and some on expedited review

especially undergraduate student proposals (bachelors, high diploma &diploma).

xiv. Once the reviewers are satisfied with the response from the PI, the proposal is consolidatedfor tabling in the meeting.

xv. The Principal Investigator shall be informed by email and SMS about the presentation date

and time.

xvi. The decisions made on the proposal will be communicated in writing and sent to the Principal

Investigator via email within two (2)- calendar days.


xvii. Research proposals that are approved are permitted to start the work while those that are

approved with suggestions/ comments will need to be revised and resubmitted.

xviii. Proposals that are rejected will have reasons explaining the rejection.

xix. Approval is given for one year, investigators wishing to continue research beyond their one-year approval time period must submit a continuing review request. The Principal Investigator

should submit a report on the progress of the study.

xx. IREC must approve any changes or amendments to an approved study before the researcher

implements such changes except in rare situations where delay may jeopardize the safety of

the participants.


9.0 TYPES OF REVIEWThere shall be five (5) types of review, namely;

1. Expedited Review

2. Full Review

3. Exempt Review

4. Continuing Review

5. Review of Amendments to a previously approved Proposal

9.1 Expedited Review

Expedited review refers to the review of a limited class of research outside of a convened IRB

meeting.

i. MTRH/MU- IREC Secretary, Deputy Secretary or Human Participant Administrator shall

carry out administrative review to determine if the research falls in expedited category.

ii. Expedited review will be carried out by a designated member of the MTRH/MU-IREC or a

designated expert other than a committee member.

iii. Once a reviewer determines that an application does not qualify for an expedited review,

they shall notify the administrator or secretariat who will table in the next meeting for

discussion.

iv. If the reviewer determines that the criteria for approval has been met, they may recommend

approval pending ratification by the committee in next meeting.

v. Expedited approvals shall be recommended by the Secretary in consultation with the

Chairperson but pending ratification by the Committee.

The following categories of research proposal may qualify for an expedited review and approval:

a. Research investigations that present no more than minimal risk to the study

participants at initial review or continuing review.

b. Minor amendment in previously approved research during the period for which

approval was granted.

Definitions of “minimal risk” and “minor amendment” means that the probability and magnitude

of harm or discomfort anticipated in the research are not greater in and of themselves than those


ordinarily encountered in daily life.

.

9.2 Full ReviewAll other research proposals submitted for review and which do not meet the criteria for

expedited and exempt review shall undergo full review process. These proposals have more

than minimal risk to participants and involve contact with vulnerable populations, may involve

data that could be traced or linked to individual participants’ and could also involve direct

interventions to participants that may have physical or psychological harm.

9.3 Exempt reviewi. Research protocols that are exempt from review are those that do not require formal

approval from the full ethical committee prior to their conduct. These are studies where

there is ‘minimal risk’.

ii. *Minimal risk is defined by the federal regulations as the probability and magnitude of

physical or psychological harm that is normally encountered in the daily lives, or in the

routine medical, dental, or psychological examination of healthy persons.

iii. Research studies involving vulnerable groups do not qualify to be exempt from review.

Even if research is classified as exempt from review, its conduct must still be in line with

all relevant national and institutional standards of ethics and codes of professional conduct

unless otherwise defined by the Committee and other relevant regulations.

iv. To qualify for review at the exempt level, the research must not be greater than minimal

risk* and must fall into one or more of the exempt categories described below

a. Education researchb. Surveys, interviews, educational tests, public observations (that do

not involve children)c. Benign behavioral interventions

d. Analysis of previously-collected, unidentifiable info/specimens.

e. National research/demonstration projectsf. Taste and food evaluation studies

v. The Secretary, Deputy Secretary or Human Participant Administrator will carry out

administrative review to determine whether the protocols will be categorized under this or

any other review category.

vi. Exempt review will be conducted by at least one reviewer.


vii. Exempt approvals could be given by the Secretary in consultation with the Chairperson

but pending ratification by the Committee.

viii. The Reviewer or Committee may recommend the proposed research to be re-categorized

to undergo full review.

9.4 Continuing Review

i. All studies approved byMTRH/ MU-IREC will require to seek continuing review uponexpiry of their approval if they intend to continue study related activities beyond the one-year

approval.

ii. A comprehensive progress report shall be required upon request for study continuation

together with a duly filledMTRH/ MU-IREC Continuing review form.iii. All studies that have completed study related activities shall be required to provide a final

study report and a duly filledMTRH/ MU-IREC study close-out form.iv. Continuing review submissions must include all current IREC approved study documents,

even if they have not changed since the last review.

v. MTRH/ MU-IREC maywithdraw approval of a protocol previously approved.

vi. The responsibility for the application for Continuing Approval lies with the researcher.

vii. The Principal Investigator should submit the application at least 60 calendar days beforeexpiry of the approval period. No study should continue without seeking re-approval.

viii. All continuing review applications shall be reviewed by the Monitoring and Evaluation Sub-

Committee and the decisions of the Sub-Committee ratified at the full board meeting.

ix. The review will occur annually, unless the level of risk requires more frequent review, in which

case the Principal Investigator shall be so advised.

x. The decision could be as follows;

a. Continue as originally approved

b. Have some modifications

c. Request a site visit by the safety monitoring committee

d. Be suspended

e. Be terminated

xi. The secretariat shall inform the Principal Investigator the outcome of the application and

reasons for the decision. All conditions set by the Committee shall be met before

consideration for re-approval.


The application for review of continuation of study should include the followinginformation and materials that should be availed in e-copies only:

a. Continuing Review form, accompanied by a progress report.

b. Consent/assent forms

c. Recruitment materials

d. Data collection instruments (surveys, interview questions, stimuli, etc.)

e. Other forms or documents utilized with human participants

f. DSMB Report (if applicable) please refer to reviewer guideline form.

g. Research personnel list for Continuing Review

h. If there is failure to seek Continuing Approval the study will be terminated.

9.5 Review of Study AmendmentsAmendments are defined as any changes to an approved research protocol. All amendments

to the study proposal shall be communicated to MTRH/MU-IREC.i. Minor amendment -does not change the risk benefit profile of the study including change of

title, administrative changes, adding an investigator, changes that do not affect study design

and outcomes, small changes to letter of information and consent such as editorial changes.

ii. Major amendment-does change the risk benefit profile of the study e.g. change in study aims

and objectives, alterations to study procedure, changing inclusion criteria, substantive changes

to the letter of information and consent.

The application for review of amendment should include the following informationand materials which should be availed in e-copies only:

a. Cover letter detailing the amendments

b. Amendment form with clear justification for the major amendments

c. Newly developed documents that support the proposed research modification

d. Proof of payment receipt for the requested modification

Procedure for handling amendments

i. The Secretary / Deputy Secretary will decide If the amendment has minor or major

implications for the study and its participants.


ii. If the change is minor it shall undergo expedited review and included as an agenda item at the

full board meeting.

iii. If the changes are major the proposed amendments are sent to the initial reviewer(s) and if

acceptable upon review included as an agenda item at a full Committee meeting.


10.0 GUIDELINES FOR HANDLING, STORAGE AND TRANSPORTATION OF HUMANBIOLOGICALSPECIMENHuman biological material(s) (HBM) of human origin means any material that comes from a person.

These include, but are not limited to, blood, urine, saliva or other bodily fluids; tissues; RNA, DNA,

hair or nails; placenta, umbilical cord & cord blood; sperms, oocytes, left over frozen embryos

following IVF & other products of conception; excess pathology tissues, and waste surgical tissues.

AMaterial Transfer Agreement (MTA) is a contract that governs the transfer of tangibleresearchmaterials between two organizations, when the recipient intends to use it for his or her ownresearch purposes. The MTA defines the rights of the provider and the recipient with respect to

the materials and any derivatives.

10.1 Requirements

i. The Institution exporting HBM shall be transparent about the purpose for which they wish to

export HBM and demonstrate that the purpose they are exporting for cannot be achieved

within the country and will significantly contribute to value addition in the field of science.

ii. All HBM must be accompanied by the informed consent form of the person whom the

tissue(s) belong to or his/her legally authorized representative (LAR).

iii. The informed consent should include details of the owner’s agreement that his/her sample be

sent abroad (including the country to which it is being exported).

iv. In circumstances where signed consent forms is not possible (e.g. in cases where researcher

has anonymized the samples to be exported) the principal Investigator should provide a copy

of the information sheet.

v. The information sheet will only be acceptable if the researcher is able to provide assurance

that the consent was in place.

vi. The MTRH/MU-IREC may also grant a waiver to consent participants under the following

circumstances when it is not practically possible to obtain the consent:-

a. The proposed research is going to contribute significantly to the understanding of

some local health problem and that the overall benefit to research is real and

substantial.

b. Potential risk to the privacy or well-being of the participants is minimal e.g. use of

unidentified archival specimen.


c. The nature of any existing consent relating to collection and storage and use of

material.

d. Whether the research proposal is an extension of, or closely related to a

previously approved research project.

e. The justification presented for seeking waiver of consent, including the extent to

which it is impossible, difficult or intrusive to obtain consent.

vii. A Material transfer agreement (MTA) shall be signed by the institutions of both importing and

exporting countries whenever they wish to transport the HBM.

viii. The PI should present the MTA for each batch of sample to be exported to MTRH/MU

IREC for scrutiny and approval.

ix. The MTA should define the rights, obligations and restrictions for both the importer and

exporter with respect to the materials and any derivatives, and any confidential information

exchanged with the material.

x. The MTA shall also encompass intellectual property rights (actual or potential) of the material

and any derived products, permitted use of material or information exchanged, liabilities of

both parties (including storage, distribution and disposal of HBM), arrangements for

confidentiality maintenance of provider information, rights to publication of recipient research

results and any other associated legal issues that the provider and recipient may wish to specify

in the transaction.

xi. After approval by MTRH/MU-IREC, the PI shall apply to the National Commission for

Science, Technology and Innovation that will verify and satisfy itself that the shipment is

justified and does not infringe on the rights of individuals, communities and the country.

xii. The National Commission for Science, Technology and Innovation will register the

application and issue a no objection letter and where appropriately requested, authority to

carry out research.

xiii. The PI shall then submit the application to the Ministry responsible for health for a

shipment permit.


10.2 Guidelines for collection of HBM.

i. At the time of collection of HBM individuals have the right to know for what purpose this

material will be used, the nature of research risk, where will it be stored, and for how long is it

going to be stored.

ii. If HBM was taken for clinical purpose and research on these samples is planned then consent

for the samples taken for the diagnostic and treatment purposes must be sought from the

patients using a separate consent for the use of remaining samples in research.

iii. A clear explanation should be given to the potential research participants. In cases in which

stored biological samples are to be used when no consent was obtained for research, or the

samples are not individually identifiable, and there is no potential harm to persons from whom

the samples were obtained, it is still required that MTRH/ MU-IREC approval be sought

prior to initiating research.

iv. Consent form must be explicit and separate from that used for routine surgery/procedure; it

must clearly mention the use of HBM in research.

v. Blanket/generic consent for future research in which purpose of the research and other

important information is unknown is not recommended.vi. For research on HBM samples that had been previously collected for routine treatment or

diagnostic procedure, it is suggested that consent should be taken from these patients.

10.3 Guidelines for transportation of HBM.

i. For labeling, packaging and handling, World Health Organization (WHO) guidance on

regulations for the Transport of Infectious Substances must be followed.

ii. Appropriate modes of transport, suitable routes and arrangements with people involved must

be planned and arranged in advance in accordance with recommended international standards.

iii. Professional courier services must be used whenever possible and should be IATA compliant.

10.4 Confidentiality and privacy should be maintained throughout the research

HBM custodian is responsible to protect and standardize the usage, storage, access, export, & disposal

of the tissue.

i. If samples are sent to third party, all parties must abide by privacy and confidentiality terms.


ii. Confidentiality must be ensured by implementing appropriate security measures to prevent

unauthorized access and restrict data.

iii. Prior to sending the HBM to third party identifiable information must be coded .

iv. The level of anonymization and process should be approved by the MTRH/MU-IREC.

v. Privacy should also be maintained at the time of reporting the results. In case of genetic

research it must be considered that any group or community will not be stigmatized by the

research outcome.


11.0ADVERSEEVENTSREPORTINGAll adverse events (AE), Serious Adverse Events (SAE), Adverse Drug Reactions (ADR), Serious

Adverse Drug Reactions (Serious ADR) and Suspected Unexpected Serious Adverse Reactions

(SUSARS) must be reported to the MTRH/MU- IREC for review.

It is the responsibility of the Principal Investigator on site as well as off site for multicentre studies to

report the occurrence of the all the aforementioned to MTRH/MU-IREC, Data Safety Monitoring

Board, and sponsor.

i. Adverse Event is defined as ‘any untoward medical occurrence in a participant in a researchinvestigation or clinical investigation participant administered a pharmaceutical product and

that does not necessarily have a causal relationship with this treatment. An AE can therefore

be any unfavorable and unintended sign (including an abnormal laboratory finding) symptom

or disease temporarily associated with the use of a medicinal /investigational) product,

whether or not related to the medicinal (investigational) product.

ii. Serious Adverse Event is defined as ‘any untoward medical occurrence that at any doseresults in death, is life threatening, requires hospitalization or prolongation of existing

hospitalization, results in persistent or significant disability /incapacity, or is a congenital

anomaly/birth defect.

iii. Adverse drug reaction (ADR) is defined as any noxious and unintended response associatedwith the use of a drug in human or animals.

iv. Serious adverse event (AE) or Serious Adverse Drug Reaction (serious ADR) is an AEor ADR that is associated with death, hospitalization, prolongation of hospitalization,

persistent or significant disability or incapacity, or a congenital anomaly or birth defect or is

otherwise life threatening.

v. Suspected Unexpected Serious Adverse Reactions(SUSARS): An unexpected adverse

reaction UAR is an adverse reaction that is not consistent with the product information in

summary of product characteristics, A Suspected Unexpected Serious Adverse Reactions

(SUSAR) is any UAR that at any dose results in death is life threatening (I.e. the participant

was at risk of death at the time of the event; it does not refer to an event which hypothetically

might have caused death if it were more severe); requires hospitalization or prolongation of

existing hospitalization, results in persistent or significant disability or incapacity, is a

congenital anomaly or birth defect.


11.1 Reporting procedure

i. All AEs must be reported to MTRH/ MU-IREC via the prompt reporting form and a cover

letter by the Principal Investigator via email within a maximum of 72 hours.

ii. If the AE is considered by the PI to have implications to other research participants and upon

assessment suggests further risk or possible adverse events the PI is required to report the AE

and its potential implications to MTRH/ MU-IREC immediately followed by the formal

completion and submission of the prompt report form within 72 hours of occurrence.

iii. All SAEs and Serious ADRs must be reported to MTRH/ MU-IREC immediately by the PI

followed by the formal completion and submission of the prompt report form within 72

hours of occurrence.

iv. All ADRs and SUSARS must be reported to MTRH/MU-IREC immediately by the PI

followed by the formal completion and submission of the prompt report form within 72

hours of occurrence.

11.2 Review and decisions on SAE reports

i. The Secretariat will receive the documentation within the specified timeframe

ii. The secretariat will verify that the report is complete and has been received within the

specified time frame. If the time frame is surpassed it shall be considered a deviation.

iii. The Secretariat will forward the report to the Secretary within 2 calendar daysiv. The Secretary will review the SAE and in liaison with the Human Participant Administrator

the report will be included into the agenda of the Monitoring and Evaluation Sub-Committee.

v. The reports will be reviewed by the Monitoring and Evaluation Sub-Committee during the

monthly meeting M&E Sub-Committee meeting with special focus on relatedness on the

clinical trial, medical management and financial compensation to be given to research

participants.

vi. The Monitoring and Evaluation Sub-Committee will refer the issue to the full board during

the monthly meetings, for further action or for ratification of the decision taken by the Sub-

Committee.

vii. Upon receiving the report from the Monitoring and Evaluation Sub-Committee the Full

Board Committee during the meeting shall determine and recommend appropriate

intervention(s) which may include review of the research protocol in light of the event, call for


further investigation, suspend the study till review is complete, suspend the study till changes

requested are completed, suspend enrolment of new participants, terminate the study or

recommend any other appropriate action.

viii. The decision of the Full Board Committee will be communicated to the PI within 2 calendardays.

ix. The PI will be requested to respond if there are further clarifications needed within 7calendar days.


12.0 COMMUNICATION OF REVIEW DECISIONS12.1 Communication/Reporting post meeting responsibilities and record keeping –Communicating the outcomes of the review.i. All decisions will be recorded in the MTRH/ MU-IREC minutes with each principal

investigator receiving the outcome of their application in a written communication via email

or SMS.

ii. The Chairperson shall inform the PI, in writing, the outcome of proposal review within

fourteen (14) calendar days of the meeting at which the decision was made.iii. The letter sent to the PI or applicant should explain the reasons for the decision and point out

the required information.

iv. If the requested information for new applications is not received by the MTRH/ MU-IREC

within sixty (60) calendar days, the research proposal will be removed from the agenda and

the principal investigator will be required to submit the proposal as a new application for

review. The PI or applicant shall be informed, in writing, of the decision.

v. The MTRH/ MU-IREC and the Secretariat shall encourage open communication with the

principal investigators to resolve outstanding requests for information, modification, and

clarifications of issues raised on a particular proposal or application.

vi. Any appeals against the MTRH/MU-IREC decision of disapproval or denial of ethical

clearance to a proposed research study shall be handled as laid down in section 13.0 of the

SOP – Appeal against Committee Decisions.

The letters for notification of approval shall include the following information:-a. The MTRH/MU-IREC number.

b. The name of the principal investigator and institutional affiliation.

c. The exact title of the research proposal or application.

d. The date and the MTRH/MU-IREC meeting at which the research proposal or

application was discussed.

e. The date approval was granted.

f. The duration of the approval.

g. The requirement that the research proposal or application must be carried out as

stipulated in the proposal or application.

h. The requirement that any changes to the research study or its conduct be reported to

MTRH/ MU-IREC prior to initiation.


i. The requirement that any unanticipated adverse events that might affect continued

approval of the study or if the study is terminated for any reason it should be reported to

MTRH/ MU-IREC.

j. The requirement for the PI or applicant to apply for new review and approval for

substantially modified or revised research protocols.

k. The requirement for the submission of an annual study report and a final report at the

completion of a study.

l. Requirement that NACOSTI approval must be sought before initiation of the study.

The letters for notification of disapprovals shall include the following information:-a. The MTRH/ MU-IREC number.

b. The name of the principal investigator and institutional affiliation.

c. The exact title of the research proposal or application.

d. The date and MTRH/ MU-IREC meeting at which the research proposal or application

was discussed.

e. A description to the PI or applicant providing the basis for the disapproval and any

modification to the research proposal or application that would be required for IREC to

re-consider its views on the proposed study.

f. An explanation to the PI or applicant that he or she may request MTRH/ MU-IREC to

consider a new application if additional information becomes available or if changes are

made to the proposed study that would address the MTRH/ MU-IREC’s initial concerns.

12.2 Dispatch of correspondence to a PIa. The letters shall be signed by the Chairperson of MTRH/ MU-IREC. However, the

Deputy-Chair may be authorized to sign letters on behalf of the Chair.

b. Two (2) copies of each letter shall be produced. One (1) of the letters shall be given to

the PI and one (1) letter shall be filed in the appropriate research study file.

c. The letter shall request a response from the PI or applicant within ten (10) calendardays from the date of the letter. Two reminders (initial and final) shall be sent to the PI,

after which a notice of removal of the item from the IREC agenda shall be sent to the PI,

who will be required to resubmit a new application.


d. The letter shall request that the PI or applicant directs his or her responses to the

Chairperson, MTRH/ MU-IREC.

e. The PI or applicant will be requested to resubmit one copy of the revised proposal with

all the relevant changes made highlighted in the document. In addition, the re-submission

should be accompanied by a cover letter.

12.3 Handling a response from a PI or applicanta. A response from a PI shall include a duly signed explanatory cover letter, the revised

research proposal highlighting the revisions made or any additional information, if

applicable.

b. Upon receipt of a response from the PI, the Secretary shall review the response to

determine if all revised or new documents have been received and each question raised

by the MTRH/ MU-IREC has been adequately addressed.

c. If the PI or applicant disagrees with MTRH/ MU-IREC interpretation or request, then

he/she should explain his/her reasons in writing. The response will be reviewed by the

secretariat and if necessary, the response will be included in the next available MTRH/

MU-IREC meeting agenda for further review.

d. Where outstanding issues have been resolved or adequately addressed, the MTRH/ MU-

IREC Secretariat shall proceed to issue an administrative approval pending ratification by

the Committee. As agreed upon earlier by the convened IREC committee meeting. The

approval shall be reported at the next convened IREC meeting as action taken by the

Chair.

e. If a research proposal or application require re-review, the response will be submitted to

the initial reviewers for further review. Once the reviewer is ok with the re-review, the

proposal shall be included in the next MTRH/ MU-IREC agenda, otherwise further

comments shall be collated and dispatched to the PI for response.


13. 0 FOLLOW UPi. The MTRH/ MU-IREC shall constitute a standing monitoring and evaluation sub Committee

to monitor post approval compliance and progress of approved research.

ii. The Monitoring and Evaluation Sub-Committee shall have seven (7) members with the

Secretary to the Committee and Human Participant Administrator being standing members of

the Committee.

iii. Chairmanship of the Sub-Committee will be agreed upon by the members of the Sub-

Committee.

iv. There will be sitting allowance similar to sitting allowances of the regular committee.

v. The Sub Committee will be tasked to hold a meeting once a month.

vi. The Sub-Committee will be answerable to the full Committee.

13.1 Terms of reference of the Monitoring and Evaluation Sub Committee

i. The monitoring and evaluation Sub Committee may follow up studies seeking amendments

and continuing approval that are likely to affect the rights, safety, and or well-being of the

participants.

ii. The Sub Committee shall be expected to provide reports to the Full Board Committee on

reported serious and unexpected adverse events related to the conduct of the study.

iii. The Sub Committee shall be further expected to conduct on site for cause or not for cause

follow up of any event or new information that may affect the benefit/risk-ratio of the study.


14.0 APPEAL AGAINST REVIEW OF COMMITTEE DECISIONAn investigator who feels dissatisfied with a review decision has a right of appeal.

i. The aggrieved investigator shall be expected to lodge their appeal with IREC Chair within 14

calendar days of receiving the review decision.

ii. The Chairperson shall then constitute an Appeals Sub-Committee of five, consisting of the

Secretary, the Human Subjects Administrator, a member of MTRH/ MU-IREC with expertise

in the subject matter or is content expert in the area of the research proposal under review and

two non– MTRH/ MU-IREC content experts and one non- MTRH/ MU-IREC ethics expert

in the subject matter of the proposal under review but who MUST not have reviewed the

proposal before the appeal.

iii. The Secretary shall be the convener and the chair of the Appeals Sub-Committee shall be the

non- MTRH/ MU-IREC member.

iv. The MTRH/ MU-IREC members will participate in the discussion BUT will not take part in

the decision making.

v. The MTRH/ MU-IREC Chair shall ensure the Appeals Sub-Committee has access to the

proposal in dispute and request them to meet once to consider the appeals merits and present

their report at the next regular MTRH/ MU-IREC meeting usually within one month of the

appeal being lodged with the chairperson of the Committee.

vi. The Committee shall consider the recommendations of the Appeals Sub-Committee and

MTRH/ MU-IREC decision at this point shall be final.

vii. If the appellant is dissatisfied with the decision of Committee, they have a right to appeal to

NACOSTI.

viii. The Secretariat shall communicate to NACOSTI within two weeks of the potential appeal.


15.0 RESPONSIBILITY OF THE PRINCIPAL INVESTIGATOR IN THE REVIEWPROCESSi. The Principal Investigator shall be responsible for prompt response to reviewers’ comments,

usually within one month of receiving the comments.

ii. The administrator shall remind the PI to respond to the reviewer comments after the month

grace period elapses.

iii. If after being reminded, the PI does not respond to the reviewer comments within a further

period of one month, the review shall be considered to have lapsed and the PI shall be

required to make a fresh submission for MTRH/ MU-IREC review.

iv. The Principal Investigator shall submit a final report resulting from the study.


16.0 HANDLING RESEARCHMISCONDUCTResearch Misconduct (RM) is deliberate fabrication (making up fake data), falsification

(misrepresenting data) and plagiarism (using other people’s ideas and words without due

acknowledgement of the source) in proposing, performing, reporting and or reviewing research. More

broadly, RM includes other questionable research practices such as deliberate protocol violation,

misappropriation of research funds and selective interpretation or publication of research data among

others. For the purposes of this SOP, RM refers to Fabrication, Falsification and Plagiarism.

Research Integrity refers to the faithful, honest, transparent and trustworthy implementation of

approved research protocol, management of the data and preservation of the integrity of the research

record during and after study completion and documentation by the principal investigator.

Responsible conduct of research is an umbrella term that includes notions like authorship, plagiarism,

research misconduct, whistle-blowing, research ethics guidelines, codes of conduct, conflict of interest,

research ethics and other training.

16.1 Approaches to Handling RM

i. Prevention of research misconduct is achieved through promotion of research integrity by training

on responsible conduct of research. However, infrequently, investigators still commit acts of

research misconduct including fabrication, falsification and or plagiarism. In these circumstances

where misconduct is alleged to have occurred, sanctions shall be preferred against proven

perpetrators.

ii. Within Moi University, a special office of Research Integrity Oversight (MURIO) has been

formed under the Directorate of Research Moi University. MURIO will handle all allegations of

research misconduct involving staffers from Moi University. The MURIO is embedded within the

MU administrative structure and reports to the DVC academics, research and extension who in

turn reports to office of the Vice Chancellor, Moi University and eventually to the Commission of

University Education and NACOSTI. The MURIO has developed a Research Misconduct Policy

with a related SOP.

16.2 Role of MTRH/ MU-IREC

i. Collaborate with the MURIO to organize and facilitate trainings on RCR for all stakeholders

to promote a culture of Research Integrity.


ii. Place a complaints / whistle blowing box outside its office to receive any allegations of

research misconduct.

iii. MTRH/ MU-IREC may also whistle blow to MURIO on its own right when it becomes

aware of proposals which appear to have instances of RM during its review process.

iv. Where MTRH/ MU-IREC becomes aware of misconduct by investigators who fall outside

the jurisdiction of MU, MTRH/ MU-IREC shall make a report of the alleged RM to both the

alleged perpetrators institution as well as to NACOSTI concurrently for action per their

institutional policies.

v. Similarly open a web page at its website to facilitate online whistle blowing on RM.

vi. Regularly open the portals or whistle blowing, sort out the whistle blower reports and forward

them to the MURIO for further processing per the MURIO policy and SOPs.

vii. Receive RM reports from MURIO to include as addenda to the annual reports to NACOSTI

viii. Inform respective journal editors where publications involving proven research misconduct

may have happened to initiate retraction as part of efforts to cleanse the literature.


17.0COMPLETIONOFSTUDYA study is considered active or on going until all data is collected, follow up at all research sites is

complete and participant participation is no longer needed and evidence of dissemination provided.

The principal investigator/researcher must submit a closeout form and a cover letter to the MTRH/

MU-IREC Secretariat informing them that the study is completed along with the final study report or

a copy of the study abstract (in the case of student research).

If a study is not closed but is allowed to expire (a lapse in approval) a written reminder will be

forwarded by the Secretariat to the PI. Upon closure the secretariat shall issue an acknowledgement to

the principal investigator.


18.0 DOCUMENTATION AND ARCHIVINGMTRH/ MU-IREC shall document and archive the following documents:

Administrative:-

a.MTRH/ MU-IREC standard operating procedures

b.Duly signed confidentiality agreement forms

c.Bio-sketch/Curriculum vitae of members

d.Evidence of Research Ethics training such as CITI certificate

e.A list of MTRH/ MU-IREC members

f. Records of income and expenditure

g.Agenda of meetings

h.Minutes of MTRH/ MU-IREC meetings

i. Internal and External communication.

Protocol Related Documents: -

j. One copy of all materials submitted by applicants

k.Correspondence by MTRH/ MU-IREC members within reviewers and investigators in regard

to application decisions and follow up

l. All correspondence and other materials received during follow-up

m. Notification of completion, suspension or premature termination of a study

n. Final report of a study and study abstracts

Protocol related documents will be archived for a minimum of 5 years before disposal through an

innovative process or destruction.

Documents which require some exceptions can be stored longer than 5 years depending on

suggestions from the various stakeholders.

The soft copies of the documents shall continue to be archived.


19.0FINANCES19.1 Sources of FundsMTRH/ MU-IREC receives revenue from the following main sources:

i. Review levies

ii. MTRH

iii. Moi University

iv. Additional potential sources of revenue include grants.

19.2 Bankingi. The MTRH/ MU-IREC bank account shall be in Transnational Bank Account number

0063561011.

ii. The signatories to the account shall include high level representative of MTRH, Moi

University College of Health Sciences and RSPO accounts department as mandated by the

appointing authority but excluding the MTRH/ MU-IREC Chairperson.

19.3 Expenditurei. The MTRH/ MU-IREC account is run through a highly digital AMPATH Transformation

Program that is a customization of the ERP software.

ii. All expenditures from the MTRH/ MU-IREC bank account are identified and presented for

ratification by the committee.

iii. The Human Participant’s Administrator (HPA) develops a budgeted annual procurement plan

in consultation and subsequent approval by the committee.

iv. The Annual Budget and Procurement Plan is forwarded by the MTRH/ MU-IREC chair to

the appointing authority for review and approval.

v. Once approved, the HPA or designee make specific expenditure requests of the Procurement

plan and obtains the chairs approval.

vi. Subsequently the expenditure request is routed through the ATP system with the accounting

checks at every step eventually leading to either completion of purchases or disbursement of

cash for specified activities.

vii. The HPA then receives the items purchased, inventories it and dispatches for use or

dispatches the cash to the end-user.


19.4 Accountingi. To complete the accounting cycle for the cash disbursement or travel expenditure, the end-

user provides the HPA or designee with required accounting supporting documents which

may include receipts, boarding passes etc.

ii. The ATP process demands that the accounting for a preceding purchase be completed.

iii. There shall be regular inventory check as per the institutional procurement procedures.


20.0 REFERENCESi. International Ethical Guidelines for Biomedical Research involving Human subjects. Council of

International Organization of Medical Sciences (CIOMS), 1993.

ii. Guidelines for Collection, Usage, Storage and Export of Human Biological Specimen. National

Bioethics Committee Pakistan 2016

iii. Standard Operating Procedures. Navrongo Health Research Center Institutional Review Board,

2001.

iv. (Rossouw et al 2014, Responsible conduct of research: global trends, local opportunities; South

African Journal of Science, 2014

v. Standard Operating Procedures. Durban University of Technology Institutional Research Ethics

Committee, 2018.

vi. Standard Operating Procedures. Father Muller Medical College Institutional Ethics

Committee .2017

vii. NACOSTI Guideline for the transfer of Biological Materials for Research 2019

viii. Operational Guidelines for Ethics Committees That Review Biomedical Research. (WHO), 2000.

ix. The ENGAGE Guidelines for Good Clinical Practice Compliance and Quality Systems Auditing

in Conforming to the Note for Guidance on Good Clinical Practice.

x. World Medical Association Declaration of Helsinki. Ethical Principles for Medical Research

Involving Human Subjects. World Medical Association, Inc., 2000.

xi. Code of Federal Regulations (Title 45, part 46). Department of Health and Human Services,

National Institutes of Health, Office for Protection from Research Risks, 2001.

xii. The Republic of Kenya, National Council for science and Technology, 2004. Guidelines for

ethical conduct of Biomedical Research involving Human Subjects in Kenya. NCST NO. 45