Revising the Common Rule: Ethics, Scientific Advancement, and Public Policy in Conflict

• Published in: The Journal of law, medicine & ethics Vol. 45; no. 3; pp. 452 - 459
• Main Author: Goldstein, Melissa M.
• Format: Journal Article
• Language: English
• Published: Los Angeles, CA SAGE Publications 01.09.2017; Cambridge University Press
• Subjects: Clinical trials; Consent; Departments; Ethics; Health education; Human subjects; Information dissemination; Management; Medical ethics; Mental health services; Observational studies; Precision medicine; Presidents; Privacy; Proposals; Public policy; Science and technology; Technology policy
• ISSN: 1073-1105; 1748-720X
• DOI: 10.1177/1073110517737546

In 2011, the Obama Administration formally began an odyssey with the goal of revising and updating the decades-old regulations that comprise the Federal Policy for the Protection of Human Subjects. The revision was undertaken in response to vast changes in the volume and landscape of human subjects research since the regulations were promulgated. Such developments include “an expansion in the number and types of clinical trials, as well as observational studies and cohort studies; a diversification of the types of social and behavioral research being used in human subjects research; increased use of sophisticated analytic techniques to study human biospecimens; and the growing use of electronic health data and other digital records to enable very large datasets to be rapidly analyzed and combined in novel ways.”1 In addition, commentators, including leaders of the federal research enterprise, have asserted that research has moved toward a more participa-tory model, where research subjects increasingly seek (and are asked) to be partners in research, as exemplified by such ventures as President Obama's Precision Medicine Initiative.2The regulations were first adopted by the Department of Health, Education, and Welfare in 1974 and revised by the Department of Health and Human Services (HHS) in the early 1980s. In 1991 a revised version of the regulations, known now as the “Common Rule,” was adopted by 15 U.S. federal departments and agencies in 1991. The regulations were last amended (with few substantive changes) in 2005.3The Obama Administration, led by the Office of the Secretary of HHS and the White House Office of Science and Technology Policy (OSTP), published an advance notice of proposed rulemaking (ANPRM) in July 2011 as a first step in its effort, requesting comment on how to better protect research subjects while facilitating valuable research and reducing burden, delay, and ambiguity for investigators.4 After considering more than 1100 public comments submitted in response to the ANPRM, HHS and 15 other federal departments and agencies published a Notice of Proposed Rulemaking (NPRM) on September 8, 2015.5While it is widely recognized that increasingly sophisticated information can be obtained from bio-specimens and that sharing of both information and biospecimens can accelerate discoveries, recent controversies surrounding the development of the immortalized cell line of Henrietta Lacks and the 2013 publication of the genome sequence of the HeLa cell line remind us of the need for greater involvement of and respect for research participants.6 Likewise, the experience of the Havasupai Indian Tribe has highlighted continued feelings of suspicion in or even betrayal by the research enterprise, especially among minority communities, emphasizing our societal need to reexamine core values including trust, transparency, and consent, particularly in the area of biospecimen research.7