We’ve noticed that a lot of student research projects involve surveys, interviews, and/or focus groups. (Actually, a lot of faculty projects involve the same activities, but a wave of these kinds of student projects has arrived at the IRB in recent weeks.) Many of these proposals include full-blown draft consent forms that subjects are expected to sign and return, and occasionally full HIPAA authorization forms.
Drafting a full consent or HIPAA form may not be necessary, and it kind of pains us to have to tell a student that, hey, you didn’t need to go to all this trouble. If you, or one of the students you’re advising, is putting together a study that involves a survey, interviews, or focus groups, please get familiar with the categories of research deemed “exempt” by the federal regulations, as reflected in IRB Policy 7.3. Exempt category 2 (research involving the use of educational tests, survey procedures, interview procedures, or observation of public behavior, assuming certain conditions are met) applies to many of these studies.
Studies that qualify for exempt status are not required to have a full-blown consent form that the subject signs and returns. In fact, the consent form may be the most confusing part of the research for a subject, given the long and often rather technical nature of these forms, and may be the only place a subject’s name is ever recorded. Instead, in most cases, the IRB will ask you to draft a short (one page or less is ideal) summary of the project. When drafting this sheet, keep one question in mind — If you were the subject, what would you want to know about the study? Usually, that’s limited to a statement that this is research, what the research is about, what my participation would entail, how my information will be protected, would anything that the research team keeps for the study would allow others to identify me, and whom should I contact with questions? Subjects can keep this sheet; it does not have to be signed and returned. And the shorter it is, the better. We’ve seen students take what appears to be the consent form from a full-blown clinical trial and adapt it to their interview research. Such a consent form usually contains far more information than a subject needs to be told, and much of it does not apply to exempt status research.
We’ve also noticed that it’s pretty rare for a study that meets exempt status review criteria to need a full-blown HIPAA authorization form. If you’re only collecting names and contact information, you’re not collecting PHI because you’re not collecting any health information, and you therefore don’t need a HIPAA authorization form. If you’re collecting data about participants’ individual health, but not collecting any information that would allow you to link that data to an individual (e.g., your study involves an anonymous survey that includes a question about respondents’ health history), you’re still not collecting PHI because you have no identifiers linking those data to individuals. So you don’t need a HIPAA authorization in that case either.