Avoiding Fatal Flaws
National Institute on Drug Abuse
Special Populations Research
Development Training Seminar
Avoiding Fatal Flaws
Margarita Alegria, Ph.D.
Center for Evaluation and Sociomedical Research
School of Public Health
University of Puerto Rico
Overview of the Presentation
- Research Grants: Review Criteria.
- Methodological Issues Posed by Reviewers of Researchers’ Proposals.
- Preparing an Applications.
- Most Common Reasons for Disapproval.
- Hints for a Successful Application.
Research Grants: Review Criteria
- Significance and originality from a scientific and technical standpoint.
- Adequacy of the methodology to carry out the research.
- Qualifications and experience of the principal investigator and staff.
- Reasonable availability of resources.
- Reasonableness of the proposed budget and duration.
- Other factors: Human Subjects, Animal Welfare, Biohazards, etc.
Methodological Issues Posed By Reviewers of Research Proposals
- Use of testable hypotheses.
- Preference for model building over data exploration.
- Proponent's prior experience with similar projects.
- Significance of the proposed research contribution.
- Specificity of the primary research objective.
- Exhaustive documentation of prior studies.
- Inclusion in reference list of "classic" studies.
- Thorough synthesis of the literature.
- Continuity of the proposed study with previous studies.
- Development of testable models.
- Precision in developing the research question.
- Availability of a solution to the proposed problem.
- Use of original methods for exploring previously studied phenomena.
Preparing an Application
- Read Instructions.
- Never assume that reviewers "will know what you mean".
- Refer to literature thoroughly and thoughtfully.
- Explicitly state the rationale of proposed investigation.
- Include well-designed tables and figures.
- Present an organized, lucid write-up.
- Keep in mind the standard deadlines for new NIH grant applications (February 1, June 1 and October 1). The deadlines for RFAs may differ.
- Read the program announcement or RFA in detail. Before you begin writing your grant application. Read the PHS 398 instructions carefully and become familiar with al the requirements and certifications necessary.
- Establish deadlines for the preparation of the grant proposal, particularly when collaborating investigations are involved.
- Reread your application. Have someone else read it. Proofread it.
- Clarify who has final editing responsibilities.
- Do not feel inhibited about requesting technical assistance from the funding agency or your institution.
- If possible, have objective experts (e.g., successful grantees, an institutional panel) review your proposal. Friends or close associates may not be as critical as the reviewers at NIH.
- Investigate funding priorities of funding agencies, and ascertain from the program person whether your project falls within the scope of set priorities.
- When submitting a revised application that originally responded to an RFA, remember that the application will need to provide all scientific rationale, importance, etc., because it will go to a different review group that is accustomed to looking at investigator-initiated research.
- ASK QUESTIONS!
Most Common Reasons for Disapproval
- Lack of new or original ideas.
- Diffuse, superficial, or unfocused research plan.
- Lack of knowledge of published relevant work.
- Lack of a good justification.
- Lack of experience in the essential methodology.
- Uncertainty concerning the future directions.
- Questionable reasoning in experimental approach.
- Absence of an acceptable scientific rationale.
- Unrealistically large amount of work.
- Lack of sufficient experimental detail.
- Uncritical approach.
Hints for a Successful Application
- Follow page limitations - Make use of appendices.
- Use as an example another successful proposal in the area of interest.
- Develop a team, if you do not have experts get consultants.
- Clear concise writing style (keep together related ideas, shorten long sentences, eliminate redundant ideas).
- Allow time for editing.
- Send your proposal to experts for comments.
- Include potential pitfalls and limitations.
- Contact Member of Program Review for advice.
- Contact researchers in the area.
- Get acquainted with literature review.
- Explain step by step the procedures.
- If design is complex, use visual figures describing it.
- Justify every single cent.
- Describe the function of each person in the proposal.
- Don't exceed 100% of the collective sum of percentages of time and effort for each individual.
- Justify increases in payment.
- Justify need for each consultant included. Itemize costs of consultant (role of compensation, per diem, travel, etc.)
- Read carefully federal regulations for exempt research of IRB.
- Ask other successful researchers for copies of their informed consent forms if using human subjects and adapt them to your study.
- Get Human Subjects Committee at the University to sign form.