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. Over the next few weeks, we will be exploring the proposals put forward in the NPRM, including some of the questions that have already emerged about the potential impact of the proposed changes. In this post, we will provide background on the rationale for the proposed changes, and explore a new category of activities that would be excluded from oversight under the Common Rule.

Rationale for Proposed Changes
The over-arching goal of the NPRM is to ”modernize” the regulations. Specifically, the NPRM seeks to update the regulations given advances in research technologies and methodologies, such as genomics, the internet, “big data,” and mobile devices; the expansion of multi-site research and research being conducted in a wider range of settings (e.g., clinicians’ offices, outpatient clinics, community hospitals, virtually, etc.); and the greater diversity in the types of trials being conducted. The NPRM also acknowledges the recent emergence of a more “participatory” research model, in which the public actively expresses its views about the value and acceptability of research studies,  and subjects and communities are increasingly seen as active partners in research. Finally, the NPRM revisions are designed to respond to concerns that the current regulatory framework does not appropriately calibrate the level of review a study receives to the level of risk of harm it poses, which results in administrative burdens, but not necessarily enhanced subject protections.

To address these factors, the NPRM explicitly frames many of its proposed changes as an effort to strike the appropriate balance between the Belmont principles of autonomy (i.e., respecting persons) and beneficence (i.e., fostering socially valuable research). Indeed, many of the 88 questions embedded in the NPRM request public input on whether the proposals get that balance right. With this background and framework in mind, we begin our exploration of the NPRM by considering proposals related to what is referred to as “excluded activities.”

Overview of Excluded Research
The proposals in the NPRM that are aimed at “strengthen[ing] the effectiveness and efficiency of the oversight system by making the level of review more proportional to the seriousness of the harm or danger to be avoided” reflect a longstanding criticism of the Common Rule, namely, that the regulations are overly burdensome, especially with respect to low-risk activities (DHHS 201, 53936). A related criticism of the Common Rule has been that it is not always clear what types of activities fall under its purview.

The proposed addition of a new category of activities that would be entirely outside the scope of the regulation—known as “exclusions”—is part of DHHS’s attempt to address these concerns. Currently, activities that do not meet the definition of human subjects research  and activities that are “not described as research subject to regulation,”  do not have to meet the regulatory requirements at 45 CFR 46 (DHHS 2015, 53947). The addition of a list of explicitly excluded activities is intended to “eliminate uncertainty regarding some activities that are not research, and identify some activities that arguably might be judged to be research, but whose contributions to public welfare is so imperative that they should proceed without having to satisfy the regulatory  requirements.” (DHHS 2015, 53946)

The NPRM lists eleven types of exclusions, grouped into three categories: (1) activities deemed not to be research for the purposes of the policy; (2) activities that are inherently low risk; and (3) low risk activities where protections equivalent to those an IRB would require are separately mandated. Under the first category, certain activities related to program improvement; oral history, journalism, biography and historical scholarship; quality assurance or improvement; public health surveillance; and criminal justice and national defense would not be subject to the Common Rule. Under the second category, activities involving the collection or study of information that is publicly available, not identifiable, or already regulated by HIPAA would not be subject to the Common Rule. The second category also includes a provision that would make some activities involving the use of educational tests, survey procedures, interview procedures, or public behavior observation—a category of activity that was previously exempt—outside the scope of the regulations.

The final category—activities that are excluded because they are considered to be low-risk human subjects research activities that do not meaningfully diminish subject autonomy—focuses on the secondary research use of non-identified biospecimens that is designed only to generate information about an individual that is already known (e.g., the development and validation of certain tests and assays, quality assurance and control activities, and proficiency testing). This exclusion builds on other changes in the Common Rule that propose new consent requirements for research with biospecimens, which we will explore in greater detail in future posts. For more detailed information on the exclusions outlined in the NPRM, as well as specific language and related provisions, we encourage you to review PRIM&R’s chart comparing the current Common Rule with the proposed changes in the NPRM.

Questions Raised by the Proposed Changes
While some of the exclusions proposed in the NPRM will likely be widely welcomed, such as the explicit exclusion of journalism, oral history, biography, and historical scholarship activities, others are raising concern among the research oversight community. Specifically, there is some worry that the exclusion of certain activities involving the use of educational tests, survey procedures, interview procedures, or public behavior observation could lead to a weakening of subject protections. Under § __.101(b)(2)(i) of the proposed rule, research that involves the use of educational tests, survey procedures, interview procedures, or observation of public behavior would not be subject to the Common Rule if the information is not identifiable, or disclosure of the information would not reasonably put subjects at risk. The proposed rule does not, however, offer insight into how determinations about whether the disclosure of information would reasonably place subjects at risk will be made. Concerns about this lack of detail are made more acute by the fact that such determinations would likely be made by investigators or research staff with limited experience evaluating potential risks, and without any oversight by an ethics review body.

The exclusion of quality assurance or improvement activities involving the implementation of an accepted practice also raises questions. The challenge of distinguishing between quality improvement activities and research is a persistent and complex one, and there is a lack of consensus in the field about the appropriate oversight of activities that fall along the blurry boundary between the two. Under the proposed rule, whether a quality assurance or improvement activity is subject to regulation or not seems to hinge on whether the purpose of that activity is limited to “altering the utilization of [an] accepted practice and collecting data or biospecimens to evaluate the effects on the utilization of the practice” (DHHS 2015, 53948). If it is so limited, the activity is excluded. However, if the purpose is evaluation of the accepted practice itself, it is not excluded. Given the complexity of the debate in this area, it is not at all clear that this very brief and rather confusing explanation of the distinction between what counts as research and what doesn’t will alleviate the ongoing uncertainty in the research community around when quality improvement activities are subject to regulation.

In light of the proposed changes, members of the research community are also grappling with the question of whether the protections offered by HIPAA safeguards are an appropriate mechanism for protecting data and biospecimens in the research context.

To share your thoughts on these and other topics raised by the NPRM, members of the research ethics and oversight community are encouraged to submit 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.
• Menikoff, Jerry “Exclusions & Exemptions Under the NPRM.” US Department of Health and Human Services, 30 September 2015. Web.  4 October 2015.