Scientific Review Criteria
Part A – Background and Significance
- Is the research innovative?
- Does this study address a problem of scientific and/or practical importance?
- Does the protocol define the underlying basic research?
- Does the protocol explain how the project will be a significant addition to the body of knowledge?
- Is there a clearly stated hypothesis? If not, what is the rationale for the research?
- Is the primary objective of the research clearly stated? If yes, summarize it here (or indicate location in the protocol)?
- Are the number of objectives reasonable such that the scope of research is appropriate?
Part B – Rationale/Approach & Design
- Are the research procedures adequately defined and are they valid?
- Does the strength of the scientific design and methodology support the research?
- Do the endpoints (i.e. methods, data collection) match the objectives?
- Are adequate measures described in the protocol to minimize investigator bias?
- Are there appropriate references or SOPs to ensure that research assays will generate valid data?
- Is the investigator’s evaluation of the relevant literature or discussion of previous studies (if available) thorough and accurate?
- Are the proposed methods and assays appropriate for the research? What are they (or indicate location in the protocol)?
- Is a statistical/data analysis plan included in the protocol or appendices? Summarize it here or indicate its location in protocol)?
- Is the statistical/data analysis plan reasonable and detailed (when appropriate)?
- Does the statistical/data analysis plan include appropriate statistical tests?
- Are the conceptual framework, design, methods and analyses adequately developed, well-integrated and appropriate to the aims for the study?
- Does the investigator acknowledge potential problem areas and consider alternative tactics?
- Is the statistical/data analysis plan consistent with the study objectives?
- What is the rationale for the proposed number of subjects (or indicate location in protocol)?
- Where appropriate, are there details to explain how missing data will be addressed?
- Will medical trainees (medical students, residents, fellows, PAs) be conducting the research?
- If yes, is there a mentorship plan?
- Is the mentorship plan adequate?
Part C – Investigator
- Is the investigator appropriately trained to conduct this study?
- Is the work proposed appropriate to the experience level of the principal investigator and associates?
Part D – Environnent
- Does the scientific environment in which the study will be done contribute to the probability of success?
- Does the proposed study take advantage of the unique features of the scientific environment or employ useful collaborative arrangements?
- Are the facilities appropriate?