Question: Is IRB review required for survey results that may be published?

Question:

I am working with a for-profit company to develop survey questions for patients who have a specific illness. Without IRB approval I may not be able to publish any results; but, getting IRB approval or a document showing exemption is too clunky and time consuming for this kind of work. Is it ok to simply wait to see if anything publishable comes of use of the survey instrument and then get retrospective approval?  I just don’t have time to submit an application to IRB for an activity that is only sometimes going to lead to publication.
- Professor at a medical school

Answer:

For the past decade, most IRBs - including yours - are working to facilitate research by offering guidance and tools to reduce the burden of unnecessary IRB review.  I strongly urge you to work with your IRB to help you decide if this activity meets the regulatory definition of humans subjects research, and if so, whether it meets the criteria for exemption from further IRB review.  It is important to remember that the criteria for whether IRB review is required is not based on whether the resulting data will be published; sometimes research that requires IRB review never gets published, and sometimes research that does not require IRB gets published.  The assessment may also depend on your role, and whether you are providing consultation only or whether you are considered engaged in the research.

As you noted, most journals require proof of IRB approval when manuscripts are submitted for publication.  Even if your project does not meet the definition of human research, many journals now require certification by the IRB or the institution that IRB review was not required so it is clear it was not just the researcher deciding their research did not need review. 

I looked at the publicly-available policies for your institution.  Your institution’s IRB, like many others, offers a checklist or tool to help guide the decision about whether the proposed project requires IRB review.  This completed tool may be used as documentation to show a sponsor, funding agency, or journal editor that IRB review is not required for the proposed activity, and that the determination was not made by the researcher alone.

Working collaboratively with the IRB to determine the need for IRB review may save you time in the long run if you seek to publish your work.

About the Author

Dr. Lindsay McNair, MD, MPH, MSB | Chief Medical Officer, WCG

Dr. Lindsay McNair has extensive experience in the pharmaceutical industry. Prior to joining WCG, she was a consultant to pharmaceutical and biotechnology companies, providing medical guidance on clinical development strategies and study designs for new drug studies, and medical oversight of all phases of clinical trials. Dr. McNair teaches graduate-level courses on the scientific design of clinical research studies. She has been actively involved in IRB work for 18 years, and has a Master’s of Science in Bioethics with a concentration in research ethics.

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