In the short time since our first Client Advisory on the recently issued Notice of Proposed Rulemaking (“NPRM”) for the Federal Policy for the Protection of Human Subjects (“Common Rule”) (80 Fed. Reg. 53933 (Sep. 8, 2015)), we have been working, along with many of our clients, to map out the “big picture” in terms of the proposed regulations’ broader scope of covered research, the expanded definition of what constitutes a human subject, the new category of excluded activities, and the modified exemptions and implications of being exempt.
To accomplish this, we created several decision charts that walk through the following issues:
- the scope of covered human subject research and clinical trials,
- the key definitions of “human subject” and “research,”
- the exclusions (and conditions for exclusion) from the proposed regulations, and
- the exemptions (and associated requirements) from the proposed regulations.
The number of changes and additions to these fundamental concepts from the current regulations can seem daunting, and on first (or second, or third!) read, the landscape of regulated activities and carve-outs seems muddied from what we have come to know.
For instance, the terms “excluded” and “exempt” are actually misnomers when one considers what these terms cover and what requirements still apply. The new excluded category includes both activities that are by definition outside the reach of the regulations—in other words, that are deemed not to be research at all (and thus currently would simply not trigger the regulations and not need to be explicitly excluded)—and activities that are “research” but are declared to be low-risk or already subject to sufficient protections such that subjecting them to the regulations is deemed unnecessary. Some of the exclusions have a number of conditions that must be met in order for the exclusion to apply. In addition, the commentary to the NPRM indicates that the U.S. Department of Health and Human Services and the other joining agencies “expect” investigators to conduct all excluded work in a manner that is consistent with the ethical principles outlined in the Belmont Report, including informing individuals of the purpose of data collection and, “where appropriate,” informing them that participation in the activity is voluntary, “although investigators are not explicitly required to do so.” 80 Fed. Reg. 53933, 53950 (Sep. 8, 2015).
With respect to the new roster of exemptions, each one is actually associated with one or more substantive requirements, which in some cases include new privacy safeguards for information and biospecimens, broad written consent, and limited IRB review. This is in contrast to the way the current regulations conceive of exemptions, for which no regulatory requirements apply. Further, the commentary to the NPRM indicates, in connection with one of the exempt categories (the exemption for use of educational tests, surveys, interviews, or observations of public behavior), that investigators “should provide prospective subjects with sufficient information to make an informed decision about participation,” an expectation not referenced in the actual proposed regulations. 80 Fed. Reg. 53933, 53962 (Sep. 8, 2015).
Indeed, the NPRM proposes to change the landscape significantly and deliberately, to bring all of the riskiest interventional research under protection without regard to funding source, to increase protections for biospecimens and particularly for the associated genetic information, and to reduce burdens for non-interventional and other lower-risk research. There is a logic to the substance of the proposed changes, even if it may not be immediately apparent when sorting through the weeds. Interestingly, many of the proposals may reflect what institutions are already doing in areas where the current regulations have been unclear, silent, or generally permissive (such as obtaining broad consent to the storage, maintenance, and use of biospecimens).
In subsequent analyses of particular topics under the NPRM, we plan to describe, compare, and contrast how specific types of research (e.g., biospecimen research, medical records research) are covered and regulated under the current regulations with the extent to which they would be covered and regulated under the proposed regulations.
We hope the decision charts, which were inspired by the Office for Human Research Protection’s existing decision charts under the current regulations, provide a structure, in an accessible visual format, to help institutions, IRBs, and others analyze step-by-step whether a particular activity or project would be subject to the proposed regulations. By necessity, the decision charts condense and summarize the provisions of the proposed regulatory text relevant to these questions. The decision charts are only a tool and not a substitute for reviewing the full text of the NPRM or for consulting with your own advisors regarding the application of the proposed regulations to particular situations.