Changes to the human subjects system: a view from someone formerly on the inside

Philip Rubin*

The past years has been a time of concern and confusion for the behavioral sciences community on matters of federal policy and regulations related to human subjects. In particular, the recent announcement of delays in what appeared to be a pending update to the Common Rule has created a high degree of uncertainty related to the conduct of ongoing research and the submission of proposals for proposed work.

The Federal Policy for the Protection of Human Subjects was originally published in 1991 and consists of a set of related regulations spanning 16 federal departments and agencies. The regulations were last revised on January 15, 2009. Subpart A of the regulations is often referred to as “The Common Rule,” because this portion is shared in common by the participating federal agencies or departments. It is highly unusual for that many agencies to enter into a joint rule making process of this scale. Progress can be very slow. To assist with ongoing communication, the Office of Science and Technology Policy (OSTP) in the Executive Office of the President, created a subcommittee of the National Science and Technology Council (NSTC) in the 1990s called the Human Subjects Research Subcommittee (HSRS) that met regularly for many years to consider possible changes and/or improvements to the regulations. HSRS’s tenure ended during the Obama administration, although members of the group continued to meet informally.

In response to many concerns over the decades since the release of the regulations, the Department of Health and Human Services (HHS) and OSTP announced on July 22, 2011, via an Advance Notice of Proposed Rulemaking (ANPRM), that the federal government was considering regulatory changes focused on issues related to the ethics, safety, and oversight of human research, and intended to strengthen protections for human research subjects. After several years, there were reports that this modernization process had stalled. The complexity of the human subjects enterprise and the regulations, and the often conflicting interests of the many interested stakeholders, cannot be understated. Although considerable progress had been made on a number of issues, internal disagreements at HHS (CDC, FDA, NIH) had apparently brought things to a standstill, particularly around the issues of biospecimens and consent.

It appeared in 2014 that the process started in 2011 of modernizing the human subjects regulations might be abandoned. Concerns about the possible collapse of these efforts were raised in the press, by advocates, and within the government, by HHS, NIH, the Office of Management and Budget (OMB), OSTP, and others. President Obama tasked OSTP with helping to keep the effort going and moving it along as rapidly as possible, with the goal of releasing a final rule before the end of his administration, if feasible. At that time, I was the Principal Assistant Director for Science at OSTP. With the assistance of OSTP’s Assistant Director for Forensic Science, Tania Simoncelli (now at the Chan Zuckerberg Initiative), and with the encouragement of OMB/OIRA (Office of Information and Regulatory Affairs), a short-term interagency group, called The Common Rule Modernization Working Group (CRMWG), was created in February 2014. Membership in the CRMWG included representatives from the Common Rule agencies/departments. It was co-chaired by Dr. Jerry Menikoff, Director of the Office of Human Research Protections (OHRP) at HHS; Dr. Joanne S. Tornow, Deputy Assistant Director of the SBE Directorate at NSF (now Acting Assistant Director for Biological Sciences); and me. This was the first opportunity for interagency discussion beyond HHS addressing possible modernization of the regulations. For a number of reasons, the interagency review and approval process can often be difficult and move very slowly, however progress was made in this working group and the process of drafting a Notice of Proposed Rulemaking (NPRM) was started.

In addition to interagency conversations, individual agency/department review and approval was also required. Again, this can also be a difficult process, particularly if this activity is not a key priority for an agency. The working group also considered advice from a variety of outside stakeholders, including official comments and other reports and documents. For example, the National Academies Division of Behavioral and Social Sciences and Education (DBASSE) and its boards, including the Board on Behavioral, Cognitive and Social Sciences (BBCSS) created an ad hoc committee that produced a key report in 2014. This consensus report, entitled Proposed Revisions to the Common Rule for the Protection of Human Subjects in the Behavioral and Social Sciences “examine[d] how to update human subjects protections regulations so that they effectively respond to current research contexts and methods. With a specific focus on social and behavioral sciences, [it aimed] to address the dramatic alterations in the research landscapes that institutional review boards (IRBs) have come to inhabit during the past 40 years. The report [aimed] to balance respect for the individual persons whose consent to participate makes research possible and respect for the social benefits that productive research communities make possible.” Reports such as this one were taken very seriously by the CRMWG.

I left OSTP in February 2015, and Tania Simoncelli took over the lead for OSTP. Discussion, drafting, and agency review and approval continued throughout 2015, with constant attention from OIRA and OHRP. The NPRM was published in the Federal Register on September 8, 2015. Again, comments were sought from stakeholders “… on proposals to better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators.” The NPRM posed a number of questions to stakeholders and generated over 2,100 comments and raised considerable concerns. As a result of these comments, HHS and the other federal agencies made a number of significant changes from the proposed rule.

On January 19, 2017, the last day of the Obama Administration, the “Final Rule” was published in the Federal Register. Key elements included: improvements to the consent process; requirements, in many cases, to use a single institutional review board (IRB) for multi-institutional research studies; changes related to biospecimens and consent; establishment of new exempt categories of research based on the level of risk they pose to participants; and removal of the requirement to conduct continuing review of ongoing research studies in certain instances where such review does little to protect subjects. Although the Trump administration has appeared supportive, its general approach has been to carefully scrutinize regulations developed by the previous administration, particularly those released during its final year. In addition, many concerns have been raised by the research community, the public, advocacy groups, federal agencies, and other stakeholders, about the proposed, revised Common Rule, related to inconsistencies, complexity, and other issues.

An interim final rule (IFR), titled Federal Policy for the Protection of Human Subjects: Delay of the Revisions to the Federal Policy for the Protection of Human Subjects, was released on January 17, 2018, that delays the effective date and general compliance date of the revised Common Rule for six months, with July 19, 2018 as the new effective date and general compliance date. All provisions are covered except the cooperative research (“single IRB”) provision, whose compliance date remains January 20, 2020. July 19, 2018 is the new effective date and general compliance date for the revised Common Rule. According to the IFR, “The federal departments and agencies listed in this document are in the process of developing a proposed rule to further delay implementation of the 2018 Requirements. The limited implementation delay accomplished by this interim final rule both provides additional time to regulated entities for the preparations necessary to implement the 2018 Requirements, and additional time for the departments and agencies listed in this document to seek input from interested stakeholders through a notice and comment rulemaking process that allows for public engagement on the proposal for a further implementation delay.”

So, where do things currently stand? Federal agencies are considering an additional delay until January 21, 2019. Because of the change of administration, it was not clear what would happen with the regulations. There appears to be interest in the agencies and OMB in moving ahead with an eventual rollout, but additional time might be needed to manage this complex process. In general, our community is supportive of the proposed changes that they have seen so far. For some, the possible additional delays are very frustrating. It is important that the agencies be given adequate time for implementation, should things move ahead. Critical to continued progress on these matters is community engagement and dialogue with the federal government. Leadership and vision in the academic community has come from many. I am encouraged to see the degree of engagement on the part of professional societies and other organizations that advocate for, or support, our communities. At the federal level, these issues continue to be of importance. Behind the scenes, many individuals at OHRP and OMB/OIRA have labored tirelessly to consider the broad policy impacts of regulatory change, the complexity of the details and their implementation, and the need to engage and balance the often competing interests of a broad array of stakeholders. Staff at many federal agencies, from NSF to the Department of Defense, have spent countless hours lending their expertise, reviewing documents, and working cooperatively.

For now, I counsel patience. The federal government represents a broad array of interests and stakeholders. Getting two agencies to work together can be extremely difficult. Herding sixteen of them can be extremely challenging, and can result in things moving very slowly. In addition, the implementation process at individual agencies or departments can be complex, including the development of agency-specific guidance and training. This sometimes requires multiple levels of internal scrutiny and approval. Things appear to be moving ahead, but additional delays may occur. As we wait, other steps can be taken or considered. I hope that at the federal level an interagency process be put back in place, if it has not already been done. As future changes happen related to human subjects and, possibly, problems emerge, this will help foster communication within government and make sure that the diversity of opinions and approaches reflected in the many agencies joined in the Common Rule and the communities that they serve are adequately represented. If there are additional delays in this process, use this as an opportunity to indicate your support for those aspects of the proposed regulations that are important to you and your colleagues, and encourage the government to make sure that these changes are eventually enacted. Also needed at some agencies is a better understanding and appreciation of the areas of mind, brain, and behavior and the methodologies used by these communities in basic research. If you have thoughts about these matters, I encourage you to make sure that your voice is heard, individually and/or collectively, through your organization, institution, professional societies, advocacy groups, etc. Stay engaged in the process, but also be patient, if possible. Working together is our best shot for increasing protections for research participants, making critical advances in research and education, and strengthening our nation.

Philip Rubin, Ph.D.
Chief Executive Officer Emeritus
Haskins Laboratories

P.S. I am sorry about all the acronyms — welcome to the government!

Philip Rubin, Ph.D. is the Chief Executive Officer emeritus and former Senior Scientist at Haskins Laboratories. He is also an adjunct professor in the Department of Surgery, Otolaryngology, at the Yale University School of Medicine, a Research Affiliate in the Department of Psychology at Yale, and a Fellow at Yale’s Trumbull College. From 2012 through February 2015, Rubin was the Principal Assistant Director for Science in the Office of Science and Technology Policy (OSTP) in the Executive Office of the President of the United States, where he also served as Assistant Director for Social, Behavioral, and Economic Sciences, led the White House neuroscience initiative, and was a senior advisor on national policy. During that period of time he was also a Senior Advisor in the Social, Behavioral and Economic Sciences directorate at the National Science Foundation (NSF). He is the former co-chair of the National Science and Technology Council (NSTC) Committee on Science, with the Directors of the NIH and NSF, and co-chair of the interagency Common Rule Modernization Working Group.

From 2006-2011, Rubin was the Chair of the National Academies Board on Behavioral, Cognitive, and Sensory Sciences. From 2009-2011, he was a member-at-large of the Board of the Federation of Associations in Behavioral & Brain Sciences. From 2000 through 2003, Dr. Rubin served as the Director of the Division of Behavioral and Cognitive Sciences at the NSF. While there he was the NSF ex officio representative to the National Human Research Protection Advisory Committee and the Secretary’s Advisory Committee on Human Research Protections, established to provide advice to the Secretary of Health and Human Services. He was also the co-chair of the interagency NSTC Committee on Science Human Subjects Research Subcommittee under the auspices of OSTP.

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