Opportunities and Challenges for Ethical and Regulatory Oversight

Description

Efforts to place the patient at the center of medical research, spurred by the Affordable Care Act’s founding of the Patient Centered Outcomes Research Institute, have begun to change the way clinical research is conceptualized and conducted. Such efforts hold great promise, but also raise potential challenges for ethical oversight. How should oversight bodies approach the presence of patients in potentially unfamiliar research roles, such as investigator? What forms of patient involvement in research, if any, warrant increased scrutiny from oversight bodies? How do we keep the patient voice from being ‘captured’ by special interest groups? This symposium brought together a diverse group of patients and community members, policymakers, bioethicists, and regulatory officials to address these and other issues.

This event was free and open to the public.

Agenda

10:00am – 10:45am, Registration

10:45 – 11:00am, Opening Remarks: Introduction to PCOROS—Motivation and Findings

11:00 – 11:45am, PCOROS: Data Gathering

11:45am – 12:45pm, Focus Topic 1: Patients in Non-Traditional Research Roles: Implications for Oversight

Challenge and Recommendations

​Response Panel

12:45 – 1:45pm, Lunch

1:45 – 2:45pm, Focus Topic 2: Patients in Simultaneous Roles?

Challenge and Recommendations

Response Panel

2:45 – 3:45pm, Focus Topic 3: Patients and Conflict of Interest: How Can We Keep the Patient’s Voice from Being ‘Captured’?

Challenge and Recommendations

​Response Panel

3:45 – 4:00pm, Closing Remarks: Where do we go from here?

4:00 – 4:30pm, Networking Reception

Part of the Patient-Centered Outcomes Research Oversight Study (PCOROS).

 

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Slide Presentations

• Jean-Christophe Belisle Pipon, “Patients in Multiple Roles: Does it Lead to Engagement?”
• Eric G. Campbell, “IRB Oversight of PCOR: A National Survey of IRB Chairs”
• Martie Carnie, “Putting Patients at the Center of Research”
• I. Glenn Cohen, “Patients and Conflicts of Interest: How can we keep patient’s voice from being captured?”
• Luke Gelinas, “Recommendations for PCOR Oversight: Seeking Consensus”
• Luke Gelinas, “Patients in simultaneous and multiple roles?”
• Emily Largent, “PCOROS: Qualitative Research Results”
• Holly Fernandez Lynch, “Patients in non-traditional Research Roles: Implications for Oversight”
• Megan Morash, “Patients in Nontraditional Research Roles: Implications for Oversight”
• Jane Perlmutter, “Patients in Non-Traditional Research Roles: Implications for Oversight”