michelle groman, "hot topics at the presidential commission for the study of bioethical...

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Presidential Commission for the Study of Bioethical Issues Hot Topics at the Presidential Commission for the Study of Bioethical Issues Michelle Groman, J.D. Associate Director Harvard Law School Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics April 11, 2014

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Outline

• U.S. Bioethics Commissions – A Brief History

• The Presidential Commission for the Study of Bioethical Issues

• The Bioethics Commission and Research Ethics

• Bioethics Commission Impact • Questions and Discussion

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U.S. Bioethics Commissions National Commission for the

Protection of Human Subjects of Biomedical and Behavioral

Research (1974-1978)

President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research

(1978-1983)

Biomedical Ethical Advisory Committee (1988-1990)

Advisory Committee on Human Radiation

Experiments (1994-1995)

National Bioethics Advisory Commission (1996-2001)

President's Council on Bioethics

(2001-2009)

Presidential Commission for the Study of Bioethical Issues

(2010-Present)

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Creation of the Bioethics Commission

“As our nation invests in science and innovation and pursues

advances in biomedical research and health care, it’s imperative that we do so in a responsible

manner.”

- President Barack Obama

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The Bioethics Commission

AMY GUTMANN, PhD, Chair

JAMES W. WAGNER, PhD, Vice Chair

ANITA L. ALLEN, JD, PhD

JOHN D. ARRAS, PhD

BARBARA F. ATKINSON, MD

NITA A. FARAHANY, JD, PhD

CHRISTINE GRADY, RN, PhD

STEPHEN L. HAUSER, MD

RAJU S. KUCHERLAPATI, PhD

NELSON L. MICHAEL, MD, PhD

DANIEL P. SULMASY, MD, PhD

YOLANDA ALI, MBA*

ALEXANDER G. GARZA, MD, MPH*

*Former members

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Bioethics Commission Staff

• 15-20 full-time staff support all aspects of Bioethics Commission work – Senior staff; research staff;

communications staff; administrative staff

• Interdisciplinary: Expertise in science, law, philosophy, public health, education

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Bioethics Commission Reports

Current Topic: Neuroscience and Ethics

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Inputs to Bioethics Commission Reports

• Expert presentations, discussion, and deliberation at public meetings

• Subcommittee recommendations or preparatory work

• Federal Register requests for public comment

• Targeted requests to federal departments and agencies

• Review of relevant literature

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Bioethics Commission Educational Materials

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Ethical and Regulatory Framework for Human Subject Protections

• Respect for Persons • Beneficence • Justice

• Informed consent • Independent review • Minimize risk

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Federal Protections

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Research Ethics – Past Reports

• “[O]versee a thorough fact-finding investigation into the specifics” of the U.S. Public Health Service research in Guatemala from 1946-1948

“Ethically Impossible” • “[D]etermine if Federal regulations

and international standards adequately guard the health and well-being of participants in scientific studies supported by the Federal Government”

Moral Science

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Research Ethics – Subcommittee Report

• “[E]xamine: a. The dominant norms, and competing

alternatives, driving the ethics of medical research in different global regions outside of the United States;

b. The conflicts, if any, between U.S. norms and international standards;

c. The challenges facing researchers conducting U.S.-funded research in global settings; and

d. Possible strategies to address differences in regional norms for medical research”

Research Across Borders

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• “[C]onduct a thorough review of the ethical considerations of conducting clinical trials of

medical countermeasures in children” Safeguarding Children

• “[R]econciling the enormous public benefits anticipated from whole genome sequencing research with the potential risks to privacy of individuals”

Privacy and Progress

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• “The diversity of the research enterprise presents a challenge when establishing best practices for managing incidental and secondary findings.…Despite this diversity, researchers and institutions need clear, consistent, and practical guidance about the ethical duties owed to research participants with respect to incidental and secondary findings”

Anticipate and Communicate

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Research Ethics – Neuroscience and Ethics

• “[I]dentify proactively a set of core ethical standards—both to guide neuroscience research and to address some of the ethical dilemmas that may be raised by the application of neuroscience research findings”

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Research Ethics – Educational Materials

• Topic-based modules – Informed consent; community engagement – “Ethically Impossible,” Moral Science, Privacy and

Progress, Anticipate and Communicate – More under development

• A Study Guide to “Ethically Impossible” • Research resources

– Human Subjects Research Landscape Project – Analysis Dataset (Moral Science)

– Guatemala Subject Data Spreadsheet (“Ethically Impossible”)

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Research Ethics – Common Themes

• Informed consent • Community engagement • Compensation or treatment for research-

related injury • Transparency and accountability • Vulnerable populations • Equitable selection of research populations

and sites • Emerging science and technologies • Education and training

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Compensation or Treatment for Research-Related Injury

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Transparency and Accountability

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Education and Training

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Outline





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Bioethics Commission’s Potential Impact

• Direct implementation of recommendations • Consideration of recommendations, even if

not implemented • Heightened visibility of bioethics generally

and of specific issues – Public visibility – Outreach to stakeholder groups – Foundation for future research and

scholarship

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Compensation for Research-Related Injury: Four Decades of Recommendations

1973 Department of Health, Education, and Welfare (HEW) Tuskegee Syphilis Study Ad Hoc Advisory Panel

1973 HEW Medical Malpractice Commission 1977 HEW Secretary’s Task Force on the Compensation of

Injured Research Subjects 1982 President’s Commission for the Study of Ethical Problems

in Medicine and Biomedical and Behavioral Research 1995 Advisory Committee on Human Radiation Experiments 2001 National Bioethics Advisory Commission 2011, 2013 Presidential Commission for the Study of Bioethical Issues

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Transparency and Accountability: Early Uptake

• Some agencies already make data publicly available, e.g., DOE Human Subjects Research Database

• Others are taking steps toward accomplishing Bioethics Commission’s recommendation – DOD developing web-based system to track human

subjects research projects • Bioethics Commission made available collection of

project-level data of federally supported human subjects research – Supports transparency and future research and

scholarship

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Education and Training: Bioethics Commission Implementation

• Develop educational materials – Support ethics education – Facilitate integration of bioethical analysis into

existing curricula – Target audiences in traditional, non-traditional, and

professional settings • Conduct training at conferences and universities • Support scholarship in bioethics education

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@Bioethicsgov

Bioethicsgov

[email protected]

Thank you!

Bioethics.gov

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