As students, the process of submitting a dissertation or thesis proposal to the local Institutional Review Board, or IRB, is one in which we are often left to fend for ourselves with little to no guidance. This is an exciting milestone in your career, and submitting your first research protocol doesn’t need to be a daunting task.
There are four important considerations to keep in mind as you embark on your first submission: 1) be realistic about your timeline; 2) become knowledgeable about the IRB process 3) avoid some of the common pitfalls in your first submission; and 4) communicate early and often with both the IRB and your advisor.
Students often underestimate the length of time needed for the review process. Treat an IRB submission like a publication submission, with seriousness and patience. Students should allow for a minimum of two protocol revisions, which may take three or more months. It is important to remember that the IRB is not obligated to approve your protocol, just as an editor is not obligated to accept your article.
Regard your protocol as if it were a submission to a prestigious journal in your field of study rather than as a formality to mollify the IRB. Most researchers would not submit an article that does not follow the instructions to authors exactly. You should have the same concerns about the IRB submission. You should be knowledgeable about the IRB process and also develop a mentoring relationship with your advisor. You might want to request from your advisor or IRB a model protocol or template to use to draft your submission.
Graduate student researchers sometimes fear that if they identify any possible risks, the protocol will not be approved. On the contrary, by fully describing and justifying the risks involved in the study, you will be perceived as prepared and thorough, rather than ill-equipped and naïve. It is perfectly acceptable to have risk in your study as long as the benefits of the study outweigh the risks.
Students frequently are also unaware of the specificity required in the “Recruitment Procedures” section of the protocol. The possibility of coercion of participants is the number one bullet for shooting down your protocol. Try to reduce the risk of engaging in coercive practices by discussing recruitment procedures with the IRB and your advisor.
You should think of the reviewers as novice readers in your area of research. Often, protocols contain technical jargon that is not germane to the understanding of the protocol. Typically, graduate students have difficulty translating their immense and highly personal manifestos into a clear and concise description of the study. If a reviewer cannot decipher your language, he or she will not feel comfortable approving your protocol.
Communicate Early and Often
Successfully navigating the waters of your first review requires a great deal of communication among you, your advisor, and the IRB. You should try to include your professor in every step of the process, and ask your advisor to read your protocol as thoroughly as he or she would read your dissertation proposal. Also, most IRBs encourage students to run their research ideas by the IRB staff to ensure that any major issues are resolved before official submission. Think of the IRB as a source of invaluable information and take advantage of it.
Time is not on your side when submitting an IRB protocol. You should attempt to realistically estimate the timeline from preparation to acceptance, communicate efficiently with the IRB and your advisor, prepare your submission carefully, and consider your protocol as important as a manuscript submission to a prestigious journal. These precautions will reduce the amount of time from submission to approval and ensure an expedient and successful IRB review.