To reach this result, Podlas argues that documentary films fail one or more of five tests necessary to trigger IRB jurisdiction:
First, the general type of undertaking must be one that is directly regulated by a federal agency. Second, the activity must be "human subjects research"; This requires the undertaking to conform to the regulatory definition of "research." Third, that research must collect information from or about living individuals. Fourth, that information must be either "data" or "private information." And finally, the "human subjects research" must be either biomedical or behavioral.
Let's take these in order.
1. Is documentary film the general type of undertaking that is directly regulated by a federal agency?
Podlas cites 45 C.F.R.§ 46.102 (e) to suggest that only if an agency is "statutorily charged" by Congress with regulating an activity can it do so. And since "there is no US Department of Film or Agency of Television News," no agency has the responsibility to regulate documentary film.
As a factual matter, this is doubtful. Common Rule signatories do sponsor documentary filmmaking. For example, the National Science Foundation has supported movie and television documentaries about Appalachia, the aftermath of Hurricane Katrina, and other topics about human events and society.
More importantly, neither 45 C.F.R.§ 46.102 (e) nor any other section of the Common Rule says that an agency must be statutorily charged with a responsibility in order to have that responsibility. To the contrary, 46.101 explains that "this policy applies to all research involving human subjects conducted, supported or otherwise subject to regulation by any federal department or agency which takes appropriate administrative action to make the policy applicable to such research" (emphasis added). So as far as the Common Rule is concerned, any Common Rule agency can decide for itself what types of research activities are covered.
2. Is documentary film "human subjects research"?
Here Podlas presents the familiar--and I think correct--view that activities like filmmaking are not intended to produce generalizable knowledge and are therefore not human subjects research under 46.102 (d).
She buttresses this argument by alluding to the Belmont Report's report definition of research: "an activity designed to test an hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalizable knowledge (expressed, for example, in theories, principles, and statements of relationships). Research is usually described in a formal protocol that sets forth an objective and a set of procedures designed to reach that objective." Since documentary filmmakers do not test hypotheses or write formal protocols, she reasons, they do not conduct human subjects research.
That's true enough, but there's one problem: the Belmont Report is not 45 CFR 46, and only the latter has legal force. The question, then, is to what degree the intent of the National Commission, as expressed in the Belmont Report, should inform a court's reading of the regulations' definition of research. For a work of legal scholarship, Podlas's essay is disappointingly silent on this issue.
3. Does documentary film collect information from or about living individuals?
Podlas does not dispute that it does, and I don't think anyone would.
4. Does documentary film collect data or private information?
Podlas argues that documentary film interviews do not collect "data": "when interviewing is used to collect data, it is not unstructured, common conversation, but standardized or somewhat regimented so that the researcher can elicit and obtain specific information." That's an intriguing idea, but I'd want to learn a lot more about regulatory and legal uses of the term "data" before agreeing.
Podlas then argues that "if an individual makes a disclosure about herself to another individual, even a reporter, the speech act is not behavior taking place in private. Obviously, when the individual speaks to a reporter or filmmaker, she knows she can be seen, heard, and recorded." Only if an interviewer misleads someone into thinking that her responses are private does the interviewer invade privacy. Here Podlas is on firmer legal ground, for she cites a good deal of case law.
5. Is documentary film behavioral research?
Podlas notes that the federal law governing IRBs, 42 U.S.C. § 289, covers only "biomedical or behavioral research involving human subjects." "Congress spoke, and spoke clearly," she writes. "It directed the President's Commission, HHS, and IRBs to regulate biomedical and behavioral human subjects research, and only biomedical and behavioral research." She then suggests that in order to trigger IRB review, "a film would not only need to meet the definition of research, but also its purpose and subject matter would have to be biomedical or behavioral investigation. It is difficult to imagine instances in which this would be so."
The question here is what did Congress, or anyone, mean by behavioral research? IRB proponents, such as Robert Amdur and Elizabeth Bankert, insist that there is no difference between "behavioral science" and "social science." (Institutional Review Board: Management and Function, 105.) I think they're wrong, but I would have liked more careful legal analysis of the point. Given Congress's failure to define behavioral research, how much leeway do agency heads have to define the term?
Podlas has posed important questions, but except for the section on private information, she does not explain how courts have interpreted the meanings of various terms used in federal laws and regulations, nor how much deference they would likely grant to OHRP's own interpretations. There is much work yet to be done along these lines.