What do IRB members need to know about study design?
The Journal of Medical Ethics blog has a recent entry addressing findings of a study that examined the extent to which IRB members were familiar with some basic study design concepts. (In summary: not very familiar.) The blog entry author writes that she would expect IRB members to know enough about research design to be able to identify ethical issues that arise due to study methodology, and to ensure that poorly designed studies do not get approval.
You can read the entire blog entry here. Note that it includes a link to the full paper describing this project. If you have trouble accessing the full paper, please email Edith at firstname.lastname@example.org and she can email you a PDF of it.
After reading the entire paper, the IRB Members Blog editorial board got together (all one of her) to discuss some thoughts about it. First, she, I mean, the board, does not fully agree with the paper authors’ description of their survey questions as “easy and straightforward ones which no knowledgeable IRB member should have difficulties answering.” First, our editorial board wonders how many of the incorrect answers stemmed from vocabulary issues. When reading a protocol, it’s not really necessary to know that a particular study design is called “a cohort study” to be able to recognize the study design and consider whether it is ethical. Secondly, and most significantly, in the editorial board’s view, the IRB is required by regulation to have members with varying backgrounds. A board whose members all have enough epidemiological background to identify and name different kinds of study design may not meet that “varying background” requirement. In addition, the regs require at least one IRB member’s primary concern to be a nonscientific area. Again, that person may not know what a specific study design is called, but can still assess the design’s ethics and ability to return a worthwhile result.