The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School

The Future of Human Subjects Research Regulation

May 2012

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.

Introduction

 
  I. Glenn Cohen  
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Morning Plenary

  
  Greg Koski Getting Past Protectionism:  Is it time to take off the training wheels?
  Plenary Q&A  
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Panel One: Risk
Moderator

Nir Eyal

    Presentation Videos

 

 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

 

 Panel One Q&A  
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Panel Two: Vulnerable Populations
Moderator
 I. Glenn Cohen
    Presentation Videos
  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

 

 Panel Two Q&A  
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Dean's Welcome


Martha Minow Welcoming Remarks
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Plenary Address
  Amy Davis & PRIM&R’s Response to the Proposed Changes
to the Common Rule: An overview


Elisa Hurley
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Panel Three: Tissues, Specimens, Data and Privacy
Moderator

Jeff Skopek
    Presentation Videos
  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
  Panel Three Q&A  

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Panel Four: Research-Participant Relationship
Moderator

Steve Joffe
    Presentation Videos
  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
  Panel Four Q&A  

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Panel Five: Governance
Moderator

Patrick Taylor
    Presentation Videos
  Holly Fernandez Lynch Human Research Subjects as Human Research Workers
  Melissa Frumin Questions and Challenges for a Central IRB
  Laura Stark Discretion and its Discontents: IRBs' "Local Precedents" and the Future of Multisite Research
  Heidi Li Feldman What's Right About the Medical Model
  Panel Five Q&A  

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Panel Six: Mapping the Outer Boundaries of Human Subjects Research
Moderator

Dan Wikler
    Presentation Videos
  Zachary Schrag What is This Thing Called Research?
  Barbara Evans In Search of Sound Policy on Nonconsensual Uses of Identifiable Health Data

 

 Panel Six Q&A  

 

  

 

 

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