The Future of Human Subjects Research Regulation

May 6, 2012

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Conference Description

The U.S. Department of Health and Human Services recently released an Advanced Notice of Proposed Rulemaking (ANPRM), titled "Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators" which proposes to substantially amend the Common Rule for the first time in twenty years. This development, as well as attention by the Presidential Commission for the Study of Bioethical Issues, suggests we are at a moment when the regulation of human subjects research is ripe for re-thinking. The annual conference of the Petrie-Flom Center gathered leading experts from the U.S. and across the globe to assist in that endeavor.

Over the course of a day and a half of panels, plenaries, and extensive Q&A, conference attendees heard from a wide range of presenters, from the former director of the Office for Human Research Protections, Greg Koski, to social science researchers, lawyers, clinicians, and federal employees. Although the ANPRM served as a jumping off point, presentations and discussions were not so limited. A driving theme, however, was the tension between whether to accept the ANPRM's approach of tweaking the current system but keeping its primary elements in tact, or simply starting from scratch.

Conference Agenda:

Note: All keynote, plenary, and panel sessions included time for Q & A.

Introduction: I. Glenn Cohen

Morning Plenary: Greg Koski, Getting Past Protectionism: Is it time to take off the training wheels?

Panel One: Risk

  • Annette Rid, "Risk Based" Systems of Research Oversight: International Perspectives

  • Rosamond Rhodes, De Minimis Risk: A Proposal for a New Category of Research Risk

  • Ana Iltis, Risk Level, Research Oversight, and Decrements in Participant Protections

  • Michael McDonald

  • Susan Cox

  • Anne Townsend, Towards Human Research Protection that is Evidence-Based and Participant-Centered

  • Michelle Meyer, Risk-Proportionate Regulation and the Challenge from Participant Heterogeneity

  • Moderator: Nir Eyal

Panel Two: Vulnerable Populations

  • Osagie Obasogie, Human Subjects Research with Prisoners: Rethinking Contemporary Proposals to Loosen Regulatory Protection

  • Adam Braddock, Children as Research Partners in Community Pediatrics

  • Efthimios Parasidis, Military Research, National Security, and the Interests of Humanity

  • Moderator: I. Glenn Cohen​

​Dean's Welcome: Martha Minow

Plenary Address: Amy Davis & Elisa Hurley, PRIM&R's Response to the Proposed Changes
to the Common Rule: An overview

Panel Three: Tissues, Specimens, Data and Privacy

  • Ellen Wright Clayton, Do We Really Want Biospecimin Exceptionalism?

  • Leslie Wolf, The ANPRM and Biobanking: Two Steps Forward and One Step Back?

  • Carol Weil, The Impact of Mandatory General Consent for Use of Biospecimens in Research as Proposed in the ANPRM

  • Gail Javitt, Take Another Little Piece of My Heart: Regulating the Research Use of Human Biospecimens

  • Suzanne Rivera, Privacy Protections in the Age of Self-Disclosure

  • Moderator: Jeff Skopek​

Panel Four: Research-Participant Relationship

  • Seema Shah, Incorporating Investigator and Sponsor Obligations into the Common Rule

  • Alexander Capron, Subjects, Participants and Partners: What are the Implications for Informed Consent as the Role of the Person Being Studied Evolves?

  • Govind Persad, Democratic Deliberation and the Ethical Review of Human Subjects Research

  • Moderator: Steve Joffe

Panel Five: Governance

Panel Six: Mapping the Outer Boundaries of Human Subjects Research

Videos

VIDEO: Morning Plenary: Greg Koski & Panel 1: "Risk"

VIDEO: Panel 2: "Vulnerable Populations"

VIDEO: Plenary: PRIM&R's Response & Panel 3: "Tissues, Specimens, Data and Privacy"

VIDEO: Panel 4: Research-Participant Relationship"

VIDEO: Panel 5: Governance

VIDEO: Panel 6: Mapping the Outer Boundaries of Human Subjects Research

Tags

bioethics   health law policy   human rights   human subjects research   human tissue   regulation