FAQs re. Legal Scholarship and IRBs

Composed by Mark A. Hall and Ronald F. Wright (Wake Forest University).

Q: Why should I care or worry about IRBs?
There is a large regulatory apparatus that governs faculty or students who engage in "human subjects research." That doesn’t include most legal scholarship, but it includes some, as explained below. Nobody will go to jail for noncompliance, but noncompliance can result in various institutional penalties and can harm individual reputation and eligibility for future grant funding. Noncompliance at the law school can create resentment elsewhere in the university community. Also, it’s good professional practice to comply with research ethics rules.
Doesn’t the IRB govern only federally or externally-funded grant research?
No. Most universities require IRB review of any type of human subjects research, whether funded or not, and whether done by faculty, students, or staff. They do so to remain eligible for federal funding.
Fortunately, I usually don’t do “human subjects research,” so I rarely need to worry about this do I?
Federal regulations define “human subjects research” broadly to include potentially any information gathered from or about living humans who are identifiable to the researcher. (It doesn’t necessarily matter that you protect their identity; what counts is if you know or record their identity.) Human subjects research could include non-quantitative research, and research solely with existing records or data sources about identifiable living people.

There are relevant exemptions, but they aren’t always clearly defined. University IRB committees normally have an expansive view of the activities that fall within their jurisdiction. Your institution probably expects you to apply for and receive verification that an exemption applies, especially in debatable situations.

Q. What are some examples from typical legal scholarship?

A. An informal poll of lawyers, or conceivably even a single communication that is reported in a footnote, might be viewed as human subjects research. So too if you dig up information about a living person by doing research on the internet or reviewing unpublished documents.

Q. What are the exemptions most relevant to legal scholarship?

See also http://obssr.od.nih.gov/IRB/isyour.htm

Q. What’s the difference between “exempt” research and an activity that isn’t subject to these rules in the first place?

A. Good question. Confusion arises because several exemptions simply articulate when one aspect of the basic definition of “human subjects research” is absent. For instance, inability to identify research subjects might be used to argue that an activity is not subject to these rules at all, or instead that the research merits an exemption even though it technically falls within the rules. The same is true for previously-recorded information that is not “private.” In these situations, it is not clear whether it is necessary to apply to your university IRB committee for an exemption, or instead whether it is permissible to carry on without getting anyone’s permission first.

Q. This is absurd. It’s maddening. It’s moronic. This is an outrageous infringement of academic freedom. Can’t something be done about this out-of-control regulatory regime?

A. Welcome to the world that social and behavioral scientists and others have inhabited for a generation.

Q. Seriously, what should a typical law professor do?

A. Someone from your law school should reach a general understanding with your university’s IRB about what is expected of you, especially when you think your research is probably not covered or is exempt. Some of the key terms are not well defined and so are subject to local administrative interpretation. For instance, when is an investigation not sufficiently “systematic” to count as research? What types of information available on the internet or through litigation documents, for instance, are “public,” and which types are “private”? Perhaps you can get a blanket exemption for certain research activities. Or, perhaps you can ask for ongoing permission under a broad, generic protocol that doesn’t require specific permission for each discrete activity (e.g., “interviewing lawyers from time to time about their professional views and activities . . . “).

Q. If I have to submit to the IRB, then what is required?

A. It depends. If all you need is verification that human subjects research isn’t involved, a simple e-mail to the IRB chair or administrator confirming this might suffice. At the next level, if you’re seeking an exemption, or no real risks are involved, then the review is usually “expedited,” but that still means you have to fill out the forms that describe what you’re doing and why it deserves exemption or expedition - which is annoying to say the least. If this happens very often, you could train a permanent employee to help with these tasks.

Q. How bad can it get?

A. An IRB might decide the research does not fit an exemption and poses more than minimal risk, which would then require full review and might also require written informed consent from participants. Now you’re looking at major headaches and potential delays.

Q. Where do I go for more information?

A: Try http://obssr.od.nih.gov/IRB/protect.htm Also, your University probably has an IRB webpage that links to all the relevant federal rules and definitions, as well as your institution’s own policies.

Q: I’m an analytically-minded literal-interpretation lawyer, so what is the text and cite for the actual rules?

A: Here are some relevant excerpts from 45 C.F.R. 46.101 et seq.:

Research means a systematic investigation . . . designed to develop or contribute to generalizable knowledge.

Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) Data through intervention or interaction with the individual, or (2) Identifiable private information.

Private information includes information . . . which the individual can reasonably expect will not be made public (for example, a medical record).

Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or

Research activities in which the only involvement of human subjects will be in one or more of the following categories are exempt from this policy:

Research involving the use of . . . survey procedures, interview procedures or observation of public behavior, unless:
information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and
any disclosure of the human subjects' responses outside the research could . . . be damaging to the subjects' financial standing, employability, or reputation.
Research involving the use of . . . survey procedures, interview procedures, or observation of public behavior . . . if:
(i) the human subjects are elected or appointed public officials or candidates for public office. . . .
Research involving the collection or study of existing data, documents, [or] records . . . if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.