Before I joined the IRB team (ahem, the “regulatorz”), I thought IRB reviewers were members of a secret society whose sole purpose was to strike down research. I believed my research would be put on the IRB butcher’s block, just like those before me, and be chopped into little bits.
I can’t stress the point enough—IRB reviewers are not the menacing force I had originally perceived. In fact, I’ve written about the inner workings of IRBs before in a previous blog post (“Don’t Fail to Try: An IRB Protocol Submission Experience”). I’m broaching this subject again because I recently met with a first year doctoral student. He came into my office asking about his first IRB submission. He started the conversation by saying, “I’ve heard IRBs can be really difficult.” He then proceeded to say, “I’m really worried about my research. I don’t think it is going to pass the review process.”
While I cannot speak for every IRB, I can say that our team of reviewers adheres to regulations and we work with researchers to see good research out in the field. Therefore, to lift the veil and uncover the great mystery, I shall write out a play-by-play of what our IRB reviewers consider during the review process. Please note, this list is by no means exhaustive, as every protocol requires a unique perspective, and reviewers prioritize guidelines above all else. But overall, reviewers consider:
- MINIMIZING RISK: Reviewers weight the risks of each protocol submission to ensure they are reasonable in relation to the benefits, if any.
- PARTICIPANT SELECTION AND WELL-BEING: Reviewers consider how researchers select participants and whether the selection of subjects is equitable. They discuss if the research involves vulnerable populations, (e.g., children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons). The reviewers also ensure researchers inform and protect participants throughout the research process.
- RESEARCH PURPOSE AND SETTING: The committee considers the purpose of the research and the research setting. The research setting may have important consequences that impact the research design and the type of data that can be collected, as well as how that data will be interpreted.
- INFORMED CONSENT: Often, the committee asks the following questions regarding the informed consent form (or parental permission, student assent, etc.):
- Is the informed consent clear for the intended audience?
- Is the time commitment on the informed consent consistent with the research design?
- How is confidentiality explained on the informed consent (e.g., protecting the privacy of subjects and maintaining the confidentiality of data)?
- Is there a chance for coercion or undue influence (e.g., remuneration)?
- Is it clear what the participant will be asked to do if they agree to participate in this study?
- What happens next if the participant wants to quit or shows signs of distress?
IRB reviewers help ensure safeguards are clearly included in the study to protect the rights and welfare of research participants. While these assurances may feel like a chopping block, they are designed to make research better. For more information on informed consents check out this write-up that presents the ethical responsibilities associated with research.