By Elisa A. Hurley, PhD, and Avery Avrakotos

On September 8, the Department of Health and Human Services (DHHS) issued a Notice of Proposed Rulemaking (NPRM) for revisions to the Federal Policy for the Protection of Human Subjects, or “Common Rule.” If adopted, the proposals in the NPRM will result in the most substantive revisions to the core regulation governing federally funded human subjects research in the United States since 1981.

In an earlier post, we explored the rationale for the proposed changes, as well as a new category of activities that would be excluded from oversight should the proposals in the NPRM be adopted. In this week’s post, we examine proposed changes to the category of exempt research.

Overview of Exempt Research
As previously discussed, one of the goals of the NPRM is to respond to concerns that the current regulatory framework does not appropriately calibrate the level of review a study receives to the risk of harm it poses. Specifically, the NPRM cites concerns about the overregulation of social and behavioral research and notes that IRB review of some survey and interview-based research may “distract attention from identification of social and behavioral research studies that do pose ethical challenges and thus merit significant oversight” (DHHS 2015, 53954). To address these, as well as related concerns, the NPRM proposes to expand the existing category of exempt research.

In contrast to excluded activities, which are not subject to specific requirements, activities that fall into an exemption category would be required to meet certain regulatory and documentation requirements, as they are under the current rule. The NPRM lists eight exemptions, organized into three categories: (1) low-risk interventions that do not require application of standards for information and biospecimen protection; (2) research that may involve sensitive information (but not biospecimens) that requires application of certain privacy standards to protect information outlined in the NPRM; and (3) secondary research involving biospecimens and identifiable private information that requires application of the privacy safeguards, broad consent, and limited IRB review, all of which are described in the NPRM and which we will discuss in more detail in future posts.

The first exemption category includes certain research involving normal educational practices; research and demonstration projects conducted or supported by a Federal department or agency; and taste and food quality evaluation and consumer acceptance studies. It also includes a provision that would exempt research involving “benign interventions,” a new concept in the Common Rule. In the NPRM, benign interventions are defined as those that are “brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and [for which] the investigator has no reason to think the subjects will find the interventions offensive or embarrassing,” such as activities where subjects are asked to read, review pictures, or play online games (DHHS 2015, 54048).

The second category exempts research involving the use of educational tests, survey procedures, interview procedures, or observation of public behavior when the information is identifiable, and secondary research with identifiable private information under certain conditions. Under the final category, secondary research with, and including storage or maintenance of, biospecimens or identifiable private information would be exempt as long as certain conditions are met. For more detailed information on the exemptions outlined in the NPRM, as well as specific language and related provisions, we encourage you to review PRIM&R’s descriptive chart of the NPRM.

Questions Raised by the Proposed Changes
One area of considerable discussion related to exempt research has been a proposal that would allow investigators, or other knowledgeable individuals, to utilize a decision tool (or, potentially, tools) created by Federal departments or agencies to make a determination about whether a given study is exempt. The tool, which is intended to ease the administrative burden associated with IRBs making exemption determinations, would require an individual to answer a number of questions about a proposed study and, based on that information, would provide a verdict about whether the activity is exempt, not exempt, or in need of further review by an experienced reviewer (Menikoff 2015). As noted in the NPRM, “so long as the information that was provided to the tool was accurate, result of the application of the tool will be presumed by the federal departments or agencies to be an appropriate determination of exempt status” (DHHS 2015, 53956).

However, of concern here is that no further details about what the decision tool looks like have been provided. It is thus impossible to evaluate how well the tool meets the NPRM’s stated goal of reducing burden without undermining subject protections. Some in the community have also expressed concern about whether it will even be possible to create a decision tool that accomplishes this task, given that no such tool has been successfully generated in the decades since the regulations were first promulgated.

A second issue with respect to the decision tool is whether researchers should be the individuals charged with making exempt determinations. In a recent blog post, Celia B. Fisher, PhD, director of the Center for Ethics Education and the Fordham HIV Prevention Research Ethics Training Institute at Fordham University, raised concerns about having such an important, and, at times, difficult, task completed by individuals with minimal research ethics training. She argues:

Regulations that rely solely on investigator judgment to ensure research participant protections should not go into effect without requirements that institutions increase research ethics training within their academic programs as well as for their research faculty and staff. Otherwise, the burden unfairly falls upon prospective participants who will serve as guinea pigs for a rush to modernization (Fisher 2015).

Indeed, the use of a decision tool for exemption determinations, like many of the proposals in the NPRM, signal a more decentralized approach to research protections, with fewer decisions and responsibilities resting with an IRB. The question that remains is whether and how this will enhance subject protections.

Members of the research ethics and oversight community are encouraged to share their thoughts on these topics, as well as other issues raised by the NPRM, by submitting formal comments to DHHS. Comments are being accepted on the proposed rule through January 6, 2016 at 5:00 PM ET.

References

• Department of Health and Human Services (DHHS). 2015. Notice of Proposed Rulemaking: Federal Policy for the Protection of Human Subjects. Federal Register 80 (173): 53931-54061.
• Fisher, Celia B. “Minimal Risk and Minimal Experience: Can Researchers Competently Navigate OHRP’s New Risk Categories?” Ampersand, 22 September 2015. Web. 4 October 2015.
• Menikoff, Jerry “Exclusions & Exemptions Under the NPRM.” US Department of Health and Human Services, 30 September 2015. Web. 4 October 2015.