RCSEd +University of Bath; MSc Healthcare Informatics Unit 2 (July 2004) Assignment 2: Project Planning

PROJECT PROPOSAL APPRAISAL AND COMPARISON

1. Introduction

The task of an evaluator for a funding body is rather unenviable. He/she has to be fair in evaluating a research proposal; every new researcher deserves a break. [1] He/she also has to strictly ensure that the proposal meets all the rigorous research criteria. [2] Striking a balance between the two extremes is not easy.

Selecting a ‘model’ to evaluate research proposals poses its own problems. There are innumerable exemplar schemes to choose from. [3] No single ‘model’ is comprehensive enough to accommodate all proposals. Moreover, the two proposals under consideration are highly divergent conceptually; one is a quantitative study and the other is qualitative.

2. The model

After a search for numerous schemes for evaluating proposals, [3] a guide for writing research proposals from National Cancer Institute, USA has been chosen as a model [4] for evaluating the two proposals (Appendix-1). Originally designed for cancer research, it also included some generic information.

3. Discussion

In our discussion the Orthopaedic benchmarking proposal will be referred as OB and Healthcare and equity as HCE. Each will be analysed vis-à-vis the criteria set forth in the model (hereinafter called Model), and also compared with each other. The following reciprocal points will be established:

1. Approximation of the two proposals to the Model criteria 2. Comprehensiveness and relevance of the Model in analyzing a research proposal

3.1 Format of proposals

OB and HCE were presented by their respective authors under the headings outlined in Boxes-1,2.

Box-1: Orthopaedic benchmarking research proposal headings

2 Scientific part

2.1 Summary of the research proposal

2.2 Research proposal

2.2.1 State of research in the field

2.2.2 Own research

2.2.3 Detailed research plan

2.2.3.1 Objectives - Establishing benchmarks

2.2.3.2 Study design, data collection and data analysis

2.2.3.3 Data analysis

2.2.3.4 Confidentiality

2.2.4 Time frame

2.2.5 Relevance of the project

2.2.6 References

 

 

 

      Box-2: Healthcare and equity research proposal headings

1. Introduction and rationale

2. Defining Human Rights

3. Defining Equity

4. Research Questions:

1. What are people concerns …? 2. What does the government as health care provider think …? 3. How much health services does the government have to provide? 4. How to monitor that the government is doing its job?

5. Objectives

General objective

To identify Thai values and principles ….

Specific objectives

1. Brief examination of the concept of a right to health and its relation to equity:

- within Western political/philosophical tradition,

- in health economics literature,

- in relationship to Asian values,

2. To identify an institutional framework …,

3. To develop an appropriate approach for an equitable health system in Thailand.

6. Methodology

6.1 Literature review …,

6.2 Study a research program …,

6.3 Interviews and focus group …,

6.4 Synthesis of the results of 5.1, 5.2 and 5.3 …

6.5 Use the proposed institutional framework…

7. Conceptual Framework

8. Time frame

7. Expected outputs

7.1 The concept of rights to health and health care….

7.2 The relation of Equity and Rights …

7.3 The expected institutional framework…

8. References

Repeat numberings

Repeat numberings

 

OB was logically and sequentially formatted in the classical fashion, clearly indicating the headings and sub-headings, making it quite convenient to follow the article. The need for indentations for new paragraphs was obviated by the clearly numbered headings. Type-size, font, margin restriction and pagination were adequate. However, under section 2.2.3.2, there should have been paragraph breaks separating pilot study from selection of final study participants and the methods for ensuring confidentiality.

Formatting of HCE left much to be desired. Numbering of headings and sub-headings was defective (Box-2). Using ActiveX controls [5] for the principle heading, ‘Conceptual Framework’ and ‘Time frame’, ostensibly to make them appear glamorous was actually distracting, confusing and uninformative. It was a superfluous appendage to the proposal.

3.2 Study design

Box-3 gives the study design Model criteria, hyperlinked to corresponding rows in Table-1. It gives a comparison of OB and HCE with respect to each other and also relates to each of the points mentioned in the Model.

 

Box-3: Study design criteria in Model

1. Study design overview 2. Detailed description – specific methods to accomplish specific aims 3. Detailed discussion – results collection, analysis, interpretation 4. Projected timetable (work plan) 5. Description – new methodology 6. Potential difficulties; how these will be overcome 7. Expected results, alternative approaches for unexpected results 8. Precautions …to personnel/human subjects 9. Excessive experimental detail avoided 10. One method will be used in preference to others 11. If employing complex technology for first time 12. Proposed collaborations

Table-1: Comparison of study designs (vis-à-vis Model)

OB HCE

1 -Present (“cross sectional study, stratified on age, gender…”) -No overview

2 -Present in section 2.2.3.2 (“sample population…; …pilot study etc”)

-‘Methodology’ details woefully inadequate.

3 -Result collection, analysis (“mailed questionnaire; variance estimates; sample size calculations; stratified random sample; internal validity; calculation of averages; confidence intervals, percentiles; test-retest reliability; Kappa coefficients”)

-No details; simply, “Synthesis of the results of 5.1, 5.2 and 5.3 …”

4 -Present (similar to Gantt chart) [6]

- Five activities spread over 2 years

- Six activities over 3 years divided into 12 quarters; reminiscent of Gantt chart

5 -No new methodology -None

6 -Adequately described (non-compliance with mailed questionnaire; ensuring 60-70% compliance rate)

-None

7 -Mentioned (what constitutes a healthy population, for benchmarking purposes);

-No provisions for unexpected findings

-Mentioned (Expected outputs-7.1,7.2,7.3)

-No alternative approaches

8 -No precautions described -None

9 -Experimental detail just sufficient -Insufficient details

10 -No preferential method -None

11 -No complex technology -Not relevant

12 -Collaboration with insurance company, to ensure study participants’ confidentiality

-None

3.2.1 Analysis of study designs

OB is a quantitative research proposal. [7] It fulfills all criteria except #5 (new methodology), #8 (precautions), #10 (preferential method) and #11(complex technology). These deficiencies do not detract from the good quality of study design. In keeping with quantitative studies, sufficient statistical details are incorporated (criterion #3) to validate the design, though it is insufficient to state “data analysis using standard statistical software”. The statistical software should be specified. [8]

However, there is an oversight in the time-line (criterion #4); the period specified does not match the dates. “24 months beginning in October 1, 2001 and ending October 31, 2003” is actually 25 months.

Shortcomings notwithstanding, using the Model as basis of reference, OB is sufficiently well-designed to validly answer the focused research question, “What constitutes Orthopaedically healthy population?”

HCE is a qualitative research proposal. [7,9,10] It falls short in almost all criteria. There is no ‘Design overview’ (criterion #1); only a 5-point ‘Methodology’. There are no detailed descriptions of specific methods to accomplish specific aims (criterion #2). There is a cryptic mention of studying an obscure research program, and there are no details about literature review, interviews and focus groups, which are essential constituents of qualitative studies. [9] Scrolling text in time-line (criterion #4) is confusing. Criterion #7 (expected results) is only partially fulfilled.

As per the Model criteria, there is hardly any substance in the HCE study design to answer the four research questions that have been posed.

3.3 Thoroughness of research

Box-4 outlines the Model specifications of thoroughness of research. Table-2 utilises these criteria as basis for comparison.

  Box-4: Research plan details specified in Model (evidence of thoroughness of research)

1. Internal consistency of research proposal sections

2. Specific aims

Broad, long-term goals Numbered list of the aims (preferably 2-4) Hypothesis/hypotheses to be tested Specific time-phased research objectives

3. Background and significance

3.1 Rationale for proposed project

3.2 State of existing knowledge; literature citations

3.3 Gaps the project intends to fill; how can results be applied to further research in this field

4. Preliminary results / progress report

4.1 Applicant’s recent studies ( most important ), older published studies

4.2 Applicant’s previous studies not directly relevant to proposed project

 Table-2: Comparison of research thoroughness (vis-à-vis Model)

OB HCE

1 Research sections consistent No consistency

2 -Principal aim “…assess the subjective perception of…”

-Primary objective “…establish benchmarks to measure the efficiency of…”

-Time line: Five items

-General objective and three specific objectives provided;

-Time-frame: Six items

3.1 -Rationale: -“Introduction and rationale” excerpts from Universal Declaration of Human Rights (UDHR), World Health

“In the past treatments were compared with each other …".

“Only by comparison against a … “healthy” population one can make an objective assessment …”

Organisation (WHO), Royal Thai Constitution

3.2 -Fifteen literature citations in text; nineteen references: (Bellamy, 1986; Dutton 1982 etc).”

-Twenty-two references; no highlights of relevant data

3.3 -Gaps aimed to fill:

“With a standardized benchmark … possible to compare the state of a patient…”

“….necessity to establish benchmarks … and validate them for several demographic groups.”

-Partially fulfilled:

“Use …institutional framework to assess the adequacy of … health services in Thailand”

“… to provide … health care to Thai people.”

4.1 -Applicant’s prior work:

“…twenty year’s history of a scientific registry …”

“…recently developed a standard evaluation system for quality assessment …”

“The clinical part … developed by Maurice E. Mueller.”

None

4.2 None None

3.3.1 Analysis of research thoroughness

OB has precise aims and objectives, backed by numerous relevant literature citations, and founded on concrete previous work done by applicant. Except the last criterion (applicant’s previous studies not directly relevant to proposed project), all criteria have been fulfilled. Criteria 3.1-4.1 (rationale, existing knowledge, citations, gaps to be filled, and applicant’s prior work) are particularly relevant in demonstrating thoroughness of research of this proposal.

For a qualitative research, the aim of HCE proposal is too ambiguous. The three ‘specific objectives’ are too convoluted and only vaguely relate to the four ‘Research questions’. Quoting excerpts from UDHR, WHO etc as a substitute for rationale smacks of escapism. There is insufficient material under ‘Methodology’ to substantiate the ‘Expected outputs’, while ‘Conceptual framework’, with its ubiquitous scrolling text, is too confusing to merit description. Apart from a brief mention of another research program that ‘will run parallel’ with the proposed project; there are no recent or older published studies on the subject by the applicant. This research is likely to blunder into oblivion.

3.4 Ethical matters

Both proposals did not comply with the clause B 5 of World Medical Association Declaration of Helsinki; [11] “The research protocol should always contain a statement of the ethical considerations involved and should indicate that there is compliance with the principles enunciated in this Declaration.”

Neither did the Model address this issue.

Issues of confidentiality [12,13] had been addressed in considerable detail in OB; (a) personal data to remain with insurance company; (b) questionnaires to contain only a reference number to insurance records. But situations requiring breaking of study have not been mentioned. As a courtesy, participants should be formally asked whether they wish to participate rather than assuming that return of the questionnaire implies consent.

HCE pertains to ethical issues in health care (‘Health Policy, Ethics and Human Rights’). Ironically, however, there was no concrete mention of how ethical issues [8,11,12,13,14] would be addressed while conducting the research itself. Consent to participate and guarantee of anonymity (to enhance responses) are important in these types of studies.

3.4.1 Recommendations

Research governance is the process of ensuring high scientific and ethical standards in research. Both proposals would have attained considerable distinction in this regard if they had included the following issues; misuse of statistics (not relevant to HCE), critical appraisal of previous studies (HCE), informed consent, data protection, research incentives/inducements, reporting results, and issues of potential harm to participants (researcher-participant inequality and unanticipated consequences). [8,13]

The Model also did not address these issues.

3.5 Other key issues

Issues pertaining to bias, [15] and measures to reduce it [16] had been partly considered in OB.

The Model however did not address these issues.

Bias: “The primary focus … was to… reduce bias...”. However, it may be argued that using a single insurance company to manipulate data could lead to bias.

Stratification: “stratified on age, gender, physical activity…” Randomisation: “Participants … are selected randomly within the mentioned strata…” Inclusion criteria: “…inhabitant of Switzerland, older than 20 years, no history of

traumatic ….”

Issues of bias [15] and Hawthorne effect, [9,10] arguably a source of potential bias, had not been addressed in HCE proposal. These issues are particularly relevant in this qualitative study.

3.6 Insufficient documentary information (vis-à-vis Model)

3.6.1 Abstract

An abstract is like an executive summary that should establish the framework so that the rest of the proposal has a frame of reference. [17] A formal ‘Abstract’ was missing in OB, though there were ‘Keywords’ and ‘Summary of research proposal’, which included part of the items that are normally required to be mentioned in the Abstract. [4]

A formal Abstract was not included in HCE either; however it may be said to its credit that the title could have served as ‘mini abstract’ [17] but for the irrelevant scroll.

3.6.2 Budget

Reviewers partly judge the researcher’s competence by how well the funding request matches the scope of the project. [1] Both proposals had no budget-timeline or justification. The requirements for the proposed period of study should have been listed item wise, broken down to months and years. [4,17]

The Model contained ‘Budget and justification’ but did not include a time-frame.

3.6.3 Assurances

Age discrimination had been discussed in OB; “…older than 20 years…” Since HCE dealt with human rights, interviews and focus group, and OB included

questionnaires etc, assurances regarding handling of human subjects should have been included. [4,11,12,13,14]

Other items of assurance (inventions and patents, debarment and suspension, drug-free workplace, lobbying, delinquent Federal debt [as applicable to Switzerland (for OB) or Thailand (for HCE)], misconduct in science, civil rights, sex discrimination) had not been dealt in either proposal.

All these issues have been addressed in the Model, however. [4]

3.7 Miscellaneous issues

3.7.1 The following shortcomings were identified in OB:

Grammatical errors

Some paragraph breaks would have been ideal (described under Format), while there were a couple of grammatical errors (“…letters will be send”, “Questionnaires will be … digitalized”).

Abbreviation problems [1,4,17]

Expansion of abbreviations were not given (OMR Reader, SF, DAS, WOMAC) Full form did not match abbreviation [Swiss Federal Statistical Office (BFS)] Abbreviations and corresponding expansions were not linked appropriately during first

usage (MEM not linked to M. E. Muller; Continuing Education and Documentation not linked to CED)

Inconsistent referencing style

Harvard style [18] (used in the proposal), does not allow comma between author and year (viz. Ware, 1994; Müller, 1987).

Year was not mentioned in one instance [viz. Constant (no year)]. In Harvard-style reference list, the year should be in parentheses after authors’ names [18].

In OB reference list the year was often mentioned at the end, sometimes without parentheses.

3.7.2 The following deficiencies were noted in HCE:

Fancy style, verbosity

These should be avoided. [17] Scrolling text in main heading made it difficult to visualize. They were confusing in ‘Conceptual framework’ and inappropriate in ‘Time frame’. There is a risk of virus transmission through ‘persistent data’ in ActiveX controls. [5] ‘Introduction and rationale’, ‘Defining human rights’ and ‘Defining equity’ were irrelevantly verbose.

Grammatical, spelling errors

There is zero tolerance for such errors. [1,4,17] There were innumerable grammatical and spelling errors (Box-5).

 

Box-5: Examples of poor English usage

…whether it as a health care provider has took the concept… …helping each other when they get sick is merit in Thai culture… Allocation health resource throughout the country determine appropriated ways… While people has rights to access health care… There are several research projects have studied… Test the purposed criteria persuit, conflics, Litterature, Plublication, Dicisions

The Model addressed all except referencing issues.

3.8 Document rating

Three parameters (technical accuracy, quality, readability) are considered while rating a scientific document (Box-6). [19]

The Model did not specify any criteria for rating documents.

 

Box-6: Document rating [19]   The document rating scale uses the following parameters: Technical accuracy Quality (well written or otherwise) Readability (easy to follow or not)

Using these criteria, a document is scored and rated as:

Score Rating Explanation

1. Very low :Not technically correct, not well written, not easy to follow 2. Below average :Technically correct, not well written, not easy to follow 3. Average :Technically accurate, writing good, not easy to follow 4. Above average :Technically good, well written, easy to follow 5. Very high :Technically excellent, very well written, very easy to follow

 

Using these criteria, OB would be rated as 4 (above average) and HCE as 2 (below average).

4. Discussion on Model

4.1 Comprehensiveness

The Model, selected from numerous schemes for evaluating such proposals, provided a good framework for assessing the ‘Study design’ and ‘Thoroughness of research’ (Boxes-3,4 and Tables-1,2). It also provided a reasonable framework for assessing ‘Sufficiency of information’ and ‘Miscellaneous issues’ in each research proposal.

4.2 Deficiencies

The Model was deficient in the following areas:

Study subjects, variable types, sample size, statistical analyses [8] [Boxes-7,8] Resources: Budget-justifying timeframe in months/years [17] Ethical issues: Detailed in sections 3.4/3.4.1 [8,11,12,13,14] Evaluation plan: A concern for formative evaluation/process evaluation and summative

evaluation/product evaluation [17] Appendix: Dissemination plan, letters of support, cooperating agency descriptions,

evaluation instrument [17]

 

Box-7: ‘Ideal’ model for assessing ‘study subjects’ and ‘types of variables’ in research proposal [8]

Study subjects

described where they come from? explained why they are an appropriate group? described how the study subjects will be selected? specified inclusion / exclusion criteria? specified proposed sample size taking into account refusals/drop-outs?

Types of variables

described all outcome and explanatory variables in terms of scale of measurement and data type?

described how the data will be collected? questionnaire or a non-standard measurement; provided information on its reliability and

validity?

Box-8: Comprehensive framework for assessing ‘sample size’ and ‘statistical analysis’ in proposal [8]

Sample size

provided a sample size calculation? defined the outcome variable(s) used in the sample size calculation?

defined the effect size which would be of clinical importance? described the significance level and power of the sample size calculation? sample size made allowance for expected response rates and other sample attrition? sample size consistent with the study aims? sample size consistent with the proposed analysis of the study? description of the sample size calculation adequate?

Statistical analysis

described the proposed statistical methods using appropriate terminology? proposed methods appropriate for the types of data generated by your study? Will the assumptions made by the proposed methods hold? Do the proposed methods take account of the structure of the data set? Have important confounding factors been listed and methods of adjusting for them

presented? Will the proposed methods take account of multiple testing where appropriate? Have biases due to measurement error been considered e.g. regression towards the mean? Have details on the calculation of confidence intervals been provided?

4.3 Relevance/applicability to each paper

The Model contained information and suggestions especially pertinent to cancer control research, along with more generic information. It had been modified to meet the needs of investigators preparing applications for laboratory-based research projects. [4] It was not adequate to comprehensively assess both research papers simultaneously, in their entirety. The matter was further complicated by the fact that one was a statistics-based study while the other one was a purely qualitative proposal.

Considering the twelve headings included in the Model (Appendix-1) and the eight deficiencies mentioned above, it was 60% adequate.

4.4 Generic model?

It is logically impossible to have a generic model that could serve as a comprehensive framework to evaluate all the different types of research proposals in healthcare. Some models are statistically-oriented, [8] some are inclined towards qualitative research, [17], others are directed towards novice applicants, [1] while yet others are for specific clinical conditions but with some generic information, as in this Model. [4] The National Institutes of Health grant application guidelines is quite comprehensive for health research. [2]

5. Conclusion

The Model is not perfect; no model can be, for the reasons mentioned earlier. Rather it serves a quick framework of reference on which to base the evaluation of a research proposal. Appendices-2,3,3 give some alternative models.

The Orthopaedic benchmark study was a well-researched quantitative proposal and merits approval; health care and equity study requires re-writing after adequate background research and revision of the qualitative study design to validly answer the concrete research proposals.

Reference

1. RESEARCH FUNDING: Tips for New NIH Grant Applicants. National Institute of General Medical Sciences. Last reviewed 18 March 2004. http://www.nigms.nih.gov/funding/tips.html (Accessed 10 September 2004). Back

2. National Institutes of Health grants. Latest revision 9 September 2003. http://grants.nih.gov/grants/funding/phs398/phs398.html#forms (Accessed 10 September 2004).

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3. Research at Carolina – Grant Source Library. University of North Carolina. Updated 16 July 2004. http://research.unc.edu/grantsource/grantwriting.html (Accessed 10 September 2004). Back

4. Quick Guide for Grant Applications. National Cancer Institute. Updated 2004. http://deainfo.nci.nih.gov/extra/extdocs/gntapp.htm (Accessed 10 September 2004).

5. Microsoft Corporation. Copyright © 1983-2003. http://r.office.microsoft.com/ (Accessed 10 September 2004). Back

6. Gantt chart. Techtarget. Updated 30April 2003. http://whatis.techtarget.com/definition/0,,sid9_gci331397,00.html (Accessed 10 September 2004).

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7. The Qualitative versus Quantitative Debate. Colorado State University. Copyright © 1997–2004. http://writing.colostate.edu/references/research/gentrans/pop2f.cfm (Accessed 10 September 2004).

8. Bland JM, Butland BK, Peacock JL, Poloniecki J, Reid F, Sedgwick P. Statistics Guide for Research Grant Applicants. St. George’s Hospital Medical School. Updated 6 July 2004. http://www.sghms.ac.uk/depts/phs/guide/guide.htm (Accessed 10 September 2004).

9. Pope Catherine, Mays Nick. Reaching the parts other methods cannot reach: an introduction to qualitative methods in health and health services research. BMJ July 1995; 311:42-45.

10. Friedman Charles P, Wyatt Jeremy C. Chapter 1: Challenges of Evaluation in Medical Informatics. In: Evaluation in Medical Informatics. London: 1997. p3–11.

11. Policy: WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI – Ethical Principles for Medical Research Involving Human Subjects. World Medical Association. Updated 06.10.2002 09h00. http://www.wma.net/e/policy/b3.htm (Accessed 10 September 2004). Back

12. Research Involving Human Participants in Developing Societies – Ethical Guidelines for MRC-sponsored Studies. Medical Research Council. May 2004. http://www.mrc.ac.uk/pdf-devsoc./pdf (Accessed 10 September 2004). Back

13. National Health and Medical Research Council. ‘Ethical aspects of qualitative methods in health research'. NHMRC 1995, reprint 1997. Back

14. THE NUREMBERG CODE. University of Michigan. 2004. http://www.med.umich.edu/irbmed/ethics/Nuremberg/NurembergCode.html (Accessed 10 September 2004). Back

15. Hammersley M, Gomm, R. Bias in Social Research. Sociological Research Online. Copyright Sociological Research Online 1997. http://www.socresonline.org.uk/2/1/2.html (Accessed 10 September 2004). Back

16. ISSUES REGARDING BLINDED, RANDOMIZED STUDIES IN THE NIH INTRAMURAL RESEARCH PROGRAM. Office of Human Subject Research, National Institutes of Health. http://ohsr.od.nih.gov/info/sheet13.html (Accessed 20 September 2004). Back

17. Levine Joseph S. GUIDE FOR WRITING A FUNDING PROPOSAL. Learner Associates. Last updated 5 July 2004 17:14:07. http://www.learnerassociates.net/proposal/ (Accessed 10 September 2004).

18. Monash University. 2004. http://www.lib.monash.edu.au/vl/cite/citecon.htm (Accessed 10 September 2004). Back

19. Symantec Corporation. 2004. http://www.symantec.com (Accessed 10 September 2004). Back

Appendix-1: Model framework for evaluating research proposals

Abstract

Brief project background Specific aims/hypotheses Unique features of project Methodology (action steps) to be used Expected results Evaluation methods How results will affect other research areas Significance of proposed research

Research plan overview (What Why How Who When Where)

What is intended to be done? Why is this worth doing? How is it innovative? What has already been done in general, and what have other researchers done in this field?

(appropriate references). What will this new work add to the field of knowledge? What has been done to establish the feasibility of what is being proposed? How will the research be accomplished? Are Sections A to D (vide infra) internally consistent?

Research plan details

1. Specific aims (What) 2. Broad, long-term goals 3. Numbered list of the aims (preferably 2-4) 4. Hypothesis/hypotheses to be tested 5. Specific time-phased research objectives

2. Background and significance (Why) Rationale for proposed project State of existing knowledge, including literature citations and highlights of relevant data Gaps that the project is intended to fill (i.e., how can the results be applied to further

research in this field or related areas)

 

3. Preliminary results/progress report (How and Why) Description of recent studies (most important) by applicant – to establish the feasibility and

importance of the proposed project Brief description of older published studies by applicant – to provide important background

information relevant to the proposed project Results of previous studies by the applicant not directly relevant to the proposed project – to

establish applicant's competence and experience with experimental techniques to be used in the proposed project

4. Research design and methods (How) Overview of study design Detailed description of specific methods to be employed to accomplish the specific aims Detailed discussion of the way in which results will be collected, analyzed, and interpreted Projected sequence or timetable (work plan)

Description of any new methodology used and why it represents an improvement over existing ones

Discussion of potential difficulties and limitations and how these will be overcome or mitigated

Expected results, and alternative approaches that will be used if unexpected results are found Precautions to be exercised with respect to any procedures, situations, or materials that may

be hazardous to personnel or human subjects.

Budget and justification

Personnel Consultants Equipment Supplies Travel Miscellaneous expenses

Assurances

Human subjects Vertebrate animals Inventions and patents Debarment and suspension Drug-free workplace Lobbying Delinquent Federal debt Misconduct in science Civil rights Handicapped individuals Sex discrimination Age discrimination

Human subjects

Complete description of the proposed involvement of human subjects as it relates to the work outlined in the Research Plan section

All research applications involving human subjects must address the issue of inclusion of women and minorities in the subject population

Vertebrate animals

Complete description of the proposed use of vertebrate animals as it relates to the work outlined in the Research Plan section

Number of animals proposed should be realistic. All animal expenses should be justified

Resources and environment

The purpose of this section is to describe the resources, facilities, and support available to the researcher. All requirements of proposed research plan should be addressed in this section.

Any reliance on resources external to the research should be justified All subcontractors and consortium members should have the capability to perform the tasks

assigned to them. Resources and budget requests should be consistent.

General considerations

Application guidelines should be strictly observed. Basic English should be used; jargon avoided. All acronyms should be spelled out when used initially. Single-space typing, restriction to margin limits, type size and page limitations strictly

observed Photo reductions on a copy machine, particularly gels, etc. to be avoided Graphs, diagrams, charts, and tables to be drawn in black ink and labelled carefully Only those graphs, tables, etc. that are essential to the narrative should be included; these

should complement the text and be appropriately inserted. All citations (six pages maximum) to be listed at the end of the research plan; they should be

complete: title, authors, book or journal, volume number, inclusive pages, year of publication.

Careful proofreading is essential; zero tolerance of typographical errors Consistency with terms, references and form writing style Text material should be supplemented by including additional information in the

appendices; essential data should be included within the body of the application. A table of contents of appendices should be provided.

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Appendix-2: Research Project Evaluation Criteria (adapted from NIH website: http://grants.nih.gov/grants/funding/phs398/phs398.html#forms)

Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? 

Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? 

Innovation: Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? 

Investigator: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)?

Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support?

While these review criteria are intended for use primarily with unsolicited research project applications (e.g., R01, R29, P01), to the extent reasonable, they will also form the basis of the review of solicited applications and non-research activities. However, for some activities (e.g., construction grants), use of these criteria as stated may not be feasible. 

Human Subjects/Vertebrate Animals: In conducting peer review for scientific and technical merit, SRGs will also evaluate the involvement of human/animal subjects and proposed protections from research risk relating to their participation in the proposed research plan according to the following four review criteria: (1) Risk to Subjects, (2) Adequacy of protection against risks (3) Potential benefits of the proposed research to the subjects and others and (4) Importance of the knowledge to be gained.

When human subjects are involved in the proposed clinical research, the SRG will also evaluate the proposed plans for inclusion of minorities and members of both sexes/genders, as part of the scientific assessment of Approach criterion. The evaluation will be factored into the overall score for scientific and technical merit of the application.

Appendix-3: Checklist for a research proposal (compiled) 1. Primary purpose of study Basic research, applied research, summative evaluation, formative evaluation, action research. 2. Focus of the study Breadth versus depth trade-offs. 3. Units of analysis Individuals, groups, program components, whole programs, organisations, communities, critical incidents, time periods and so on. 4. Sampling strategy/strategies Purposeful sampling, probability sampling, variations in sample size from a single case study to a generalisable sample 5. Types of data that will be collected Qualitative, quantitative or both

6. Controls that will be exercised Naturalistic inquiry, experimental design, quasi-experimental options

7. Analytical approach(es) that will be used Inductive, deductive, content analysis, statistical analysis, combinations 8. Validity of, and confidence in, the findings Triangulation options, multiple data sources, multiple methods, multiple perspectives and multiple investigators. 9. Time issues: When will be the study? How will the study be sequenced/phased? Long term fieldwork, rapid reconnaissance, exploratory phase to confirmatory phase, fixed times versus open time lines 10. Logistics, practicalities to be handled Gaining entry to the setting, access to people and records, contracts, training, endurance and so on 11. Ethical issues, confidentiality matters to be handled Informed consent, protection of human subjects, reactions, presentation of self, and so on 12. Resources available Personnel, supplies, data collection, materials, analysis time and costs, reporting/publication costs

Appendix-4: Research proposal evaluation form for qualitative methodology (adapted from Cobb A, Hagemaster J. Journal of Nursing Education, Vo1 26;138-43)

1. Expertise 2. Problem and/or Research Question(s) 3. Purpose 4. Literature Review 5. Context 6. Sample 7. Data Collection 8. Data Processing 9. Plans for Analysis 10. Human Subjects

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Unit Tutor: Alice Breton Personal Tutor: Michelle Ibison; Student: Sanjoy Sanyal 1