IRB For Beginners: Staying SanePosted: Sat 08.06.2011
As an education PhD student,there was always a worry lurking in the back of my mind. I knew the day would come, but happily tooled along through coursework ignoring that nagging voice. I stayed in a blissful state of denial until this past Spring semester, when I began to undertake my qualifying project. This research project was the next step on my way to candidacy, and it was then that I realized that the fear was now a reality. I was faced writing my very first IRB proposal.
The IRB (Institutional Review Board) is essentially an ethics committee that reviews research proposals to determine that every step has been taken to ensure the safety, respect, and dignity of research participants. Looking back through the history of human subjects research, there are standout cases of abuse and mistreatment that has lead to the necessary review of all research that involve human beings. Having to prepare the application for IRB approval is an inevitable step for most of us in education. Whether it be psychometric testing, ethnographic research, or learning outcome assessment, your population of interest is learners, and those learners tend to be real, live humans. Hence, you need to apply for the ability to test on human subjects.
The IRB was a trying experience, but I feel that I was very lucky in one respect. My institution has a phenomenal staff that handles IRB processing and review, along with the faculty members who sit on the review board. Their guidance and feedback was both essential to the quality of my proposal and to my sanity. I feared that I would get rejected, and when I got a request for modification, I thought that surely they were unhappy with my proposal. Not just unhappy, but I believed they would forever see my proposal negatively. However, I was reassured that this was a normal step, especially for a first time applicant. A request for modification is more for clarification than a sure sign you are doomed. It means that you might not have given a complete answer, or a detailed enough process to how you are going to ensure safety. Without that help and encouragement that I was on the right track, I would have been a nervous wreck.
Every institution is a bit different and special in their own way. However, I have a few pieces of advice that will most likely benefit anyone trying to attain an IRB and can be generalized for those who are not specifically working in the realm of education.
- Spell it out. Make sure you are detailed in order to avoid having your application sent back to you for further clarification. If you are going to destroy the data, say that you are going to destroy the data and WHEN. Detail your process for recruitment. Ensure that you’ve looked at risks both mental and physical.
- There is always risk. It looks very suspicious when you affirm in your IRB application that you have no risks. If you are doing ethnographic research, is there a possibility of emotional distress? If you are working within a vulnerable population, how are you ensuring they are not being exploited or coerced? Think not only of the physical risks of your research, but the human risks that are less obvious.
- Educate yourself. The Office of Human Subjects Research at NIH has a comprehensive website that answers so many of your preliminary questions. If you have a staff at your institution dedicated to this process, do not be afraid to reach out with a question. The better educated on the process, the more complete your application will be, and the less likely you will be subject to modifications and delays.
- Give yourself time. Exempt? Expedited? Full? There are different types of review processes depending on the type of research proposal and the complicated nature of the research. Make sure that you give yourself ample time to allow for the possibility of a modification request, or a full review that would entail the panel gathering at a specific appointed time during the semester to review your application.
- Finally, don’t get discouraged. The committee may have an infrequent meeting schedule. They might ask for modifications. You might have to wait for a bit for a signature from your PI. There are a lot of seeming roadblocks to attaining that IRB. But, ultimately, if you have a strong design and a clear purpose (and an honest assessment of the risks and benefits of your research), you should be on your way testing your hypotheses!