The Journal of Clinical Research Best Practices (“Happy Trials to You” is its motto) recently published a list of items to be aware of when reviewing research. The authors, Dennis J. Mazur and Norman M. Goldfarb, call them “red flags” that should be addressed before an IRB begins its in-depth review of the project. The list is summarized below; see the very end for some UAMS-specific disclaimers.
Will the study’s findings matter? (Note: Here at UAMS, we sometimes see research that may not matter much to the world at large, but it matters a lot to the person trying to complete a degree.)
1. If the study is completed, will it create generalizable knowledge of any significance?
2. Have other studies addressed essentially the same hypothesis?
3. Is the study designed in such a way (an appropriate population and adequate statistical power) that the findings will be useful?
4. How likely is it that the study will have a material impact on medical practice, or create knowledge to support future research that could evenutally have a material impact on medical practice, or on whatever else it may impact?
5. Would negative results be useful?
Do the benefits outweigh the risks?
6. Are the risks clearly much larger than can be justified by the potential benefits?
7. Are the risks too uncertain to even assess?
Is this the right team for the study?
8. Is the protocol so poorly written that proper conduct of the study is questionable?
10. Does the investigator have the necessary qualifications, experience, and time to carry out the study? How about the rest of the research team? Are any other resources that will be necessary available and adequate?
11. Is the study team capable of handling any problems that come up, such as an adverse event, or someone from the study team leaving the project?
12. How is the situation likely to change over the course of the study?
13. Can any weaknesses be addressed with supervision or assistance from more qualified people?
A few things to keep in mind when looking at this list: Our prereview process handles some of these types of items before sending a study on to reviewers, and these red flags seem a bit slanted toward biomedical research. Also, we’re guessing these authors don’t see a lot of student research, where the primary intent is to meet a graduation requirement, and not to find some medical breakthrough. However, these are still worthwhile to keep in mind when reviewing research. This list is adapted from the list published by the journal. For more information about the journal, and to subscribe for free, see www.firstclinical.com.