The Institutional Review Board (IRB)

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Tips on Getting Your Research Off the Ground

Undertaking a brand new research project can be a daunting task. Part of this process may involve submitting a proposal to your local Institutional Review Board (IRB) for approval to perform human-subject research. While this is only a small portion of the entire process, it can often be a source of frustration as you receive multiple comments, requests for revision, or a rejection notice. There are a few proofreading steps you can take to help avoid the headache of IRB revisions.

One of the best steps to start with is to have someone who is familiar with research protocol design review your proposal. More experienced researchers have frequent interactions with IRB staff. They appreciate the intricacies of writing a proposal and may be able to identify areas of your protocol that require revision prior to submission.

Make sure there are no glaring errors that would cause a patient-safety issue or loss of patient confidentiality. If you are performing a prospective trial involving humans, there needs to be a clear safety plan for any anticipated and unanticipated side effects or adverse reactions to the therapy being studied.

If you submit a protocol with obvious safety errors or situations in which loss of confidentiality is an issue, the IRB will more highly scrutinize the rest of your protocol because it would be seen as a careless error.

During your proofreading, when you are reexamining all of your comments and wording, verify that every plan is 100% clear. Statements, such as “data will be recorded in a form,” need to be clarified. For example, you can have a written or electronic data form. The type of form, information on the form, location of the form, format, where it will be stored, and what security measures are protecting it all need to be addressed in addition to a sample of the actual form you plan to use.

That leads into the next point – ensuring that all required documents are included with your application. All e-mails, recruitment material, flyers, data-collection sheets, medical record forms, surveys, and other documents are required with your application. Ensuring these are available in the beginning of the application will prevent it being returned to you for revisions.

Attending an open IRB meeting, and listening to the comments made, is one of the best opportunities to learn how it scrutinizes and evaluates each proposal. I attended two of the sessions at my institution, and I left with a greater understanding of what they require from applications and why they need it. The IRB must independently evaluate every study proposal, and it is their responsibility to ensure that all aspects are accounted for. They will scrutinize each proposal literally, word for word. Attending the sessions was a great learning opportunity for me, and I would strongly encourage anyone interested in performing research to attend one.

Lastly, nothing should be left open to interpretation or assumption. A statement like “participants will be monitored in a controlled setting” is leaving the “controlled setting” open to interpretation. As long as everything in your IRB application is clearly specified, you should have no trouble with approval.

The process of submitting your proposal through the IRB can be daunting and is often fraught with frustration. These few simple tips may save you some headache to help you push through the IRB so you can get back to what fuels your research interests.

Joshua Bucher, MD

Joshua Bucher, MD

Resident Physician, Rutgers-RWJMS Emergency Medicine, New Brunswick, NJ
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