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

Conferences

Friday, May 18

8:00 am to 8:15 am

Continental Breakfast and Opening Remarks

8:15 am to 8:45 am

Plenary Address
Greg Koski

8:45 am to 8:55 am

Break

8:55 am to 11:00 am

Panel Discussion: 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

11:00 am to 11:10 am

Break

11:10 am to 12:30 pm

Panel Discussion:Vulnerable Populations

Osagie Obasogie
Human Subjects Research with Prisoners: Rethinking Contemporary Proposals to Loosen Regulatory Protections

Adam Braddock
Children as Research Partners in Community Pediatrics

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

12:30 pm to 1:25 pm

Lunch and Plenary Address                        
Amy Davis
Elisa Hurley

1:25 pm to 3:25 pm

Panel Discussion:  Tissues, Specimens, Data and Privacy

Ellen Wright Clayton                                                       
Do We Really Want Biospecimen Exceptionalism? 

Gail Javitt
A History of the Debate on the Use of Biospecimens in Research

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

Suzanne Rivera
Privacy Protections in the Age of Self-disclosure

3:25 pm to 3:35 pm

Break

3:35 pm to 4:55 pm

Panel Discussion: 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
A Deliberative Democratic Approach to Human Subjects Research

5:00 pm

Close of Day 1

7:00 pm  

Dinner for panelists

 

Saturday, May 19

8:45 am to 9:15 am

Continental Breakfast

9:15 am to 10:55 am

Panel Discussion:  Governance

Holly Fernandez Lynch
Human Research Subjects as Human Research Workers

Laura Stark
IRBs and the Problem of Local Precedents

Heidi Li Feldman
What's Right About the Medical Model

Melissa Frumin
Questions and Challenges for a Central IRB

10:55 am to 11:10 am

Break

11:10 am to 12:10 pm

Panel Discussion: Mapping the Outer Boundaries of Human Subjects Research

Zachary Schrag
What is This Thing Called Research?

Barbara Evans
In Search of Sound Policy on Nonconsensual Uses of Identifiable Health Data

12:10 pm to 1:30 pm

Conference close
Boxed lunches provided