Proposed changes to HHS ‘Common Rule’ are of little benefit

Recently proposed changes to the “Common Rule” by the U.S. Department of Health and Human Services (HHS) and various other federal agencies, while aiming to enhance human subject protections for current and future research activities involving the ongoing storage and use of biospecimen materials, serve to de-incentivize the commitment to research by healthcare organizations.

{mosads}The recommendations seek to provide better protections for human research subjects and to provide guidance on the facilitation of future biospecimen-related research activities. HHS details several significant changes to the Common Rule, including a requirement for “informed consent for the use of stored biospecimens in secondary research (for example, part of a blood sample that is left over after being drawn for clinical purposes), even if the investigator is not being given information that would enable him or her to identify whose biospecimen it is.” The agency states that this will likely occur via a broad consent for future research, which it reports should represent an additional area of exempt research, thusly not requiring annual continuing review by an institutional review board (IRB).

With these identified changes, the proposal fails to address three key concerns when considering the use of biospecimen materials and associated health-related information for future unspecified research: (1) The increasing emergence of genomic-related research and precision medical advancements; (2) the core strengths of the IRB oversight mechanism in overseeing human subjects’ research and; (3) the impact of such recommendations on the operational models of healthcare organizations.

Precision and genomic medical advancements are inspiring in terms of their potential for better and safer treatments based upon the genetic underpinnings of an individual’s instance of disease, and, in fact, the potential for curative interventions secondary to such tests made possible by the emergence of genomic sequencing platforms and optimized bioinformatics models. The fuel for such advancements is data derived from the accession and processing of biological materials (e.g., tumor samples). This scenario positions patients and both objects of intervention and sources of information for the medical and biosciences community and must be considered by the federal regulatory oversight bodies in terms of risk and uncertainty associated with these rapidly evolving technologies.

IRBs are committees that provide ethical oversight of research activities involving human subjects. They are typically comprised of content experts, ancillary staff and unaffiliated community members. IRBs are complex socio-technical systems that derive power from regulatory oversight bodies such as the Food and Drug Administration and the National Institutes of Health’s Office for Human Research Protections (OHRP). IRBs assume and maintain their validity through in-depth reviews of proposed and ongoing research activities, robust group discussions and, oftentimes, a lack of consensus among committee members. IRBs operate independently and frequently maintain divergent thresholds for risk from one committee to another as it relates to investigational studies. The strength of the IRB process exists in the opportunity for democratic debate and consideration of the ethical implications of proposed research activities. By characterizing unspecified biospecimen-related research as an exempt category, HHS is, in effect, undercutting the core process upon which all human subjects’ research protections are built. There is inherent risk to privacy, as well as ethical challenges associated with genomic medical research, that are too significant to classify as exemptions with regard to primary ethical oversight mechanism.

In addition, by arbitrarily considering residual clinical biospecimens as potential unspecified research specimens, HHS is, in effect, creating a mandate for healthcare organizations to implement broad consent processes for all patients from whom clinical specimens may be collected. This creates fiscal and operational challenges for healthcare providers, regardless of whether they use electronic medical record systems or paper-based processes. For many hospital organizations, such a requirement will serve as a deterrent in their strategic prioritization of research activities.

In closing, while HHS seeks to provide a facilitative framework for biospecimen sciences and the potential breakthroughs associated with such activities, the actual recommendations provide little more than opportunity for negative ethical outcomes and operational roadblocks for healthcare providers.

Seabrooke is the director of research programs for Phoenix Children’s Hospital in Phoenix and a Ph.D. student in Human and Social Dimensions of Science and Technology at Arizona State University. He has a background in clinical and translational research, specializing in regulatory science and ethics. The opinions expressed are those of the author.