IRB Tip: Deferral avoidance for recruitment

Deferred is a categorization which an IRB gives a study after it has been reviewed by the Board and found to have significantly unclear or missing study procedures and/or goals. Most deferrals, believe it or not, are avoidable. Unfortunately, few on the research-side know how to accomplish this.

From time to time I think (mistakenly) that I could make a lot of money by helping biopharma or some for-profit consulting group manipulate the IRB review system such that as an IRB consultant I could prevent all studies I touched avoid deferral. Such an attitude is really quite silly. Like individuals, IRBs develop tendencies--personalities if you will--which cannot be predicted with 100% accuracy.

But I do believe I think I know my IRB pretty well and with that, another IRB tip.

When describing how you will recruit subjects for your study, it should almost never be just one sentence.

You would be surprised how many studies come across my desk with just this weakness.

You need not describe every second of the recruitment process, but you should describe it such that a reader who is unfamiliar with your project could envision when and how you identify, approach, screen, and enlist a prospective subject up to her signing the consent form.

There are some areas of an IRB application that you could be lazy and get away with it. However, recruitment procedures are not one of them. It's okay to use bullets, paragraphs, or even comic strip depictions--but clearly describe recruitment.

Suppose you are recruiting subjects directly in the context of clinical (non-research) procedures This is pretty common in medical research: You'd like to enroll your own patients in your study. Coercion, however, is a real concern. In other words, are your patients feeling pressure (real or imagined) to participate in a study for which you are both treating health care provider and researcher?

I recommend the following when recruiting subjects who are also patients: (1) Provide a study flyer, (2) recommend your patient review the flyer at home and talk to family members and/or friends about participating, (3) call the study team at the number on the flyer if interested in the study.

In this way, a prospective subject's real or perceived pressure to join your study is minimized. Of course, some patients will want to participate in your study straight away. And that is okay. Simply describe in the IRB application that if a patient asks to join the study during her clinical appointment, this will be clearly documented in her medical record.

Last but not least, include the following language (or something similar) on the first page of your consent form:

Disclosure Statement
Your health care provider may be an investigator of this research protocol, and as an investigator, is interested in both your clinical welfare and in the conduct of this study. Before entering this study or at any time during the research, you may ask for a second opinion about your care from another doctor who is in no way associated with this project. You are not under any obligation to participate in any research project offered by your physician.