The new Common Rule: Relief and unresolved questions

Research involving human subjects has changed dramatically over the last 25 years, so it makes sense that the regulations governing it would need to evolve with the times. On Jan.18, following five years of careful deliberation, the Department of Health and Human Services (HHS) brought these important regulations into the new millennium.

These changes apply to the set of human research subject protections known as the “Common Rule.” The purpose of this overhaul is to update the Common Rule to reflect the modern research environment and respond to challenges posed by technological advances that did not exist 25 years ago when the regulations were last revised.

The response of many in the research community to the new Common Rule has been jubilance — and relief.  That is because the changes go a long way toward streamlining the oversight process and expanding opportunities for investigation and collaboration.

For example, one major change involves what is known as an Institutional Review Board (IRB), which is the committee responsible for the initial approval and periodic monitoring of biomedical and behavioral research involving humans.

The new Common Rule mandates that a single IRB review the background, rationale, objectives, design, methodology, statistical considerations, and organization – commonly known as the “protocol” – of a study that will be conducted by multiple institutions. This is an improvement over the current practice requiring each institution’s IRB to separately review the protocol, which can create delay and result in conflicting decisions.

There are additional features of the new Common Rule that seek to expedite the research process in narrow areas that pose little or no additional risk to subjects. The new rules exempt more categories of research, provide for limited IRB review of research that poses minimal risk to research subjects, and eliminate ongoing IRB oversight of research that has advanced to the point where it involves only data access or analysis.

Arguably one of the most well-received changes is authorization for researchers to obtain “broad consent” from research subjects to store their data and biospecimens (e.g., blood and tissues) and later use it for different research purposes. Broad consent refers to the ability to obtain permission from study participants to use their data or biospecimens in an unspecified range of future research while they are consenting to a specific, present-day study.

HHS had earlier proposed that this mechanism be available only for research involving data that can be traced back to their human donors and not for identified biospecimens. My colleagues and I were among many who had criticized this distinction on logical, practical, and evidentiary grounds. This provision’s removal from the new rules will allow the efficient use of research materials regardless of their classification.

On the other hand, HHS declined to resolve several increasingly salient questions in research ethics. The new Common Rule maintains the previous regime’s fundamental distinction between the use of identified vs. non-identified materials from research subjects, where the former research is subject to regulatory oversight but the latter is excluded. However, it does not resolve whether genetic information, or data generated by certain analytic technologies, should be considered inherently identifiable.

The new regulations also do not recognize, much less attempt to accommodate, emerging “citizen science” models of research in which non-scientists collaborate with scientists on activities ranging from data analysis to the dissemination of results.

For these participatory research models, which are growing in popularity, it’s unclear whether their lay participants will be adequately protected by the new Common Rule—or conversely whether its measures will be overprotective.

Yet, it remains to be seen whether the regulatory changes will even go into effect.  The implementation date for most provisions is not until 2018, which leaves plenty of time for the new administration to chart a different path forward.

-By Christi Guerrini, J.D., assistant professor in the Center for Medical Ethics and Health Policy at Baylor College of Medicine

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