Carl Coleman

Carl Coleman

Associate Dean for Graduate Programs and Professor of Law

  • Degrees:

  • J.D., Harvard University | A.M., Harvard University | B.S.F.S., Georgetown University
  • Contact:

  • [email protected]
  • Tel: 201-688-7575
  • SSRN Site link
  • Curriculum Vitae
  • Courses:

  • Health Law; Public Health Law; Bioethics and the Law; European Union Law; Torts I; Food Law & Policy; Legal & Ethical Issues in Medicine; Public Health Law

Professor Carl Coleman specializes in the legal, ethical, and public policy implications of medical treatment, research, and public health. He currently serves as Associate Dean for Graduate Programs.

During the 2006-2007 academic year, Professor Coleman served as Bioethics and Law Adviser at the World Health Organization (WHO) in Geneva, Switzerland. Since then, he has continued to work closely with WHO’s Global Health Ethics team on a broad range of ethical issues in global public health. He has served as the lead author of numerous WHO guidance documents on topics such as ethical issues in infectious disease outbreaks, tuberculosis care and control, and clinical trials oversight.

From 2010-2013, Professor Coleman was a member of the Secretary's Advisory Committee on Human Research Protections (SACHRP), which is charged with providing expert advice to the Office for Human Research Protections of the U.S. Department of Health and Human Services. He has also served as a member of the institutional review boards at Seton Hall University and the University of Medicine and Dentistry of New Jersey, as a member of the New York State Attorney General’s Commission on Quality of Care at the End of Life, and as co-chair of the Committee on Ethical Issues in the Provision of Health Care of the New York State Bar Association.

Following graduation from the Harvard Law School, Professor Coleman served as law clerk to Chief Judge James L. Oakes of the U.S. Court of Appeals for the Second Circuit. He then worked as a litigation associate at Leventhal Slade & Krantz in New York City. In 1993, he was appointed Counsel to the New York State Task Force on Life and the Law, a nationally recognized interdisciplinary commission with a mandate to recommend public policy on bioethical issues. He was made Executive Director of the Task Force in 1995.

He came to Seton Hall in 2000 and was awarded the Andrea Catania Fellowship for Excellence in Teaching in 2007.

SELECTED PUBLICATIONS

LAW REVIEW ARTICLES

Cost-Effectiveness Comes to America: The Promise and Perils of Cost-Effectiveness Analysis in Medication Coverage Decisions, 38 Ga. St. U.L. Rev.811 (2022)

Physicians Who Disseminate Medical Misinformation: Testing the Constitutional Limits of Professional Disciplinary Action, 20 First Amend. L. Rev. 113 (2022)

Regulating Physician Speech, 97 N.C L. Rev. 843 (2019)

Rethinking the Regulatory Triggers for Prospective Ethics Review, 47 Journal of Law, Medicine & Ethics 247 (2019)

Control Groups on Trial: The Ethics of Testing Experimental Ebola Treatments, 7 J. Biosecurity, Biosafety & Biodefense L. (2016)

Toward Evidence-Based Conflict of Interest Compliance Training for Physician Investigators, 40 J.L. Med. & Ethics 500 (2012) (with Kate Greenwood & Kathleen Boozang)

An Argument against Embedding Conflicts of Interest Disclosures in Informed Consent, J. Health & Life Sciences L., 230-267 (June 2011) (with Kathleen M. Boozang and Kate Greenwood)

Allocating Vaccines and Antiviral Medications During an Influenza Pandemic, 39 Seton Hall L. Rev. 1111 (2009)

Vulnerability as a Regulatory Category in Human Subject Research, 37 J.L. Med. & Ethics 12 (2009)

Beyond the Call of Duty: Compelling Health Care Professionals to Work During an Influenza Pandemic, 94 Iowa L. Rev. 1 (2008)

Research with Decisionally Incapacitated Human Subjects: An Argument for a Systematic Approach to Risk-Benefit Assessment, 83 Ind. L. J. 743 (2008)

Duties to Subjects in Clinical Research, 58 Vand. L. Rev. 387 (2005)

Why Have IRBs at All? A Reply to Noah, 25 J. Leg. Med. 295 (2005) (response to article by Lars Noah)

Rationalizing Risk Assessment in Human Subject Research, 46 Ariz. L. Rev. 1 (2004)

Assisted Reproductive Technologies, International Encyclopedia of Marriage and Family 2d Ed. (2002)

Assisted Reproductive Technologies and the Constitution, 30 Ford. Urb. L.J. 57 (2002) (paper delivered at symposium at Fordham Law School, "Religious Values and Legal Dilemmas in Bioethics")

Conceiving Harm: Disability Discrimination in Assisted Reproductive Technologies, 50 Ucla L. Rev. 17 (2002)

The “Disparate Impact” Argument Reconsidered: Making Room for Justice in the Assisted Suicide Debate, 30 J.L. Med. & Ethics 17 (2002) (commentary on article by Ronald Lindsay)

Procreative Liberty and Contemporaneous Choice: An Inalienable Rights Approach to Frozen Embryo Disputes, 84 Minn. L. Rev. 55 (1999)

Guidelines for Physician-Assisted Suicide: Can the Challenge Be Met?, 24 J.L. Med. & Ethics 217 (1996) (with Alan R. Fleischman)

Stemming the Tide: Assisted Suicide and the Constitution, 23 J.L. Med. & Ethics 389 (1995) (with Tracy E. Miller); reprinted in Physician-Assisted Suicide (Greenhaven Press, 1997)

Developments in the Law — Sexual Orientation and the Law, 102 Harv. L. Rev. 1508, 1554-84 (1989) (primary author of section on employment law); reprinted in Sexual Orientation And The Law (Harvard University Press, 1990)

BOOK CHAPTERS

Risk-Benefit Analysis, in Graeme Laurie & Nayha Sethi Eds., Cambridge Handbook of Health Research Regulation (2021)

Research with Human Participants, in David Orentlicher & Tamara Hervey Eds., Oxford Handbook on Comparative Health Law (with David Townend, David Shaw & John Harrington) (2020)

The Right to Refuse Treatment for Infectious Disease, in Zeb Jamrozik & Michael Selgelid Eds., Ethics and Antimicrobial Resistance: Collective Responsibility for Global Public Health (2020)

Biobanks, in David Orentlicher & Tamara Hervey Eds., Oxford Handbook on Comparative Health Law (with Graeme Laurie) (2019)

Informed Consent; Collection of Data and Biological Specimens, in Ethics in Research, Surveillance, and Patient Care in Epidemics, Emergencies, and Disasters, World Health Organization (2015)

The Common Rule: US Regulatory Protections for Human Research Participants, in International Encyclopedia of Social & Behavioral Sciences, 2d Ed. (2015)

International Issues, in Fundamentals of Life Sciences Law: Drugs, Devices, and Biotech, American Health Lawyers Association, 2nd Ed. (2014) (with Simone Handler-Hutchinson)

End-of-Life Treatment Decisions in United States Law, in Stefania Negri Ed., Self-Determination, Dignity and End-of-Life Care: Regulating Advance Directives in International and Comparative Perspecitve (2012)

Decision Making for Residents Without Surrogates, in Mathy D. Mezey & Nancy Neveloff Dubler Eds., Voices of Decision in Nursing Homes: Respecting Residents’ Preferences for End-of-Life Care 65 (2001) (with Michele Petruzzelli)

OTHER JOURNAL ARTICLES

Protecting the Legitimacy of Medical Expertise, 388 New Eng. J. Med. 676 (2023) (with Richard J. Baron)

License Revocation as a Response to Physician Misinformation: Proceed with Caution, Health Affairs Forefront (Jan. 5, 2022)

Vulnerability and Detention in the Time of COVID: An American Failure, 1 Revue Confluence 91 (2022) (with Bryan Pilkington, Ana Campoverde, and D. Brian Nichols)

Steps toward a System of IRB Precedent: Piloting Approaches to Summarizing IRB Decisions for Future Use, Ethics & Human Research (Oct 2021) (with Andrea Seykora, Stephen J. Rosenfeld, Barbara E. Bierer, and Holly Fernandez-Lynch)

Equitably Sharing the Benefits and Burdens of Research: COVID-19 Raises the Stakes, 42 Ethics & Human Research 38 (2020) (Sept.)

Reining in IRB Review in the Revised Common Rule, 39 IRB: Ethics & Human Research 2 (2017) (Nov.-Dec.)

Selling Pharmaceuticals Ethically in Resource-Limited Settings: The Case of Sofosbuvir, Asian Bioethics Rev. 1 (2017) (with Calvin Wai Loon Ho)

What Makes IRBs Tick? An Empirical Analysis of IRBs and Their Relationship to Researchers, IRB: Ethics & Human Research, at 19 (September/October 2016) (review of Robert Klitzman, The Ethics Police?)

Avoiding Unintentional Whistleblower Retaliation: Lessons from Halliburton v. Administrative Review Board, Revue internationale de la Compliance et de L'ethique Des Affaires, at 35 (2015)

Improving the Quality of Host Country Ethical Oversight of International Research: The Use of a Collaborative ‘Pre-Review’ Mechanism for a Study of Fexinidazole for Human African Trypanosomiasis, Developing World Bioethics (2014) (on behalf of the International Ethics Review Working Group)

Attorneys as False Claims Act Whistleblowers: The Second Circuit Weighs In, Revue internationale de la Compliance et de L'ethique Des Affaires, at 26 (2013)

The Role of Informed Consent in Turberculosis Testing and Screening, 39 European Respiratory J. 1057-59 (2012) (with Michael Selgelid, Andreas Reis, Lee Reichman, and Ernesto Jaramillo)

Do Physicians' Legal Duties Conflict with Public Health Values? The Case of Antibiotic Overprescription, 6 J. Bioethical Inquiry 181 (2009)

How Do We Know that Research Ethics Committees Are Really Working? The Neglected Role of Outcomes Assessment in Research Ethics Review, 9 BMC Medical Ethics 6 (2008) (with Marie-Charlotte Bouësseau)

Potential Penalties for Health Care Professionals Who Refuse to Work During a Pandemic, 299 Jama 1471 (2008) (with Andreas Reis)

The Contribution of Ethics to Public Health, 86 Bulletin of the World Health Org. 578 (2008) (with Marie-Charlotte Bouësseau and Andreas Reis)

HIV, ARTs, and the ADA, 3(1) Am. J. Bioethics 43 (2003) (commentary on article by Mark Sauer)

Closing the Gaps in Genetics Legislation and Policy: A Report by the New York State Task Force on Life and the Law, 5 Genetic Testing 275 (2001) (with Ann M. Carroll)

Is There a Constitutional Right to Preconception Sex Selection?, 1(1) Am. J. Bioethics 27 (2001) (commentary on article by John Robertson)

Developing Public Policy on Assisted Reproductive Technologies: Reflections on the Work of the New York State Task Force on Life and the Law, 73 Fertility & Sterility 21 (2000) (with Barbara A. DeBuono)

Treatment Decisions for Patients Without Surrogates: Rethinking Policies for a Vulnerable Population, 45 J. Am. Geriatrics Soc'y 369 (1997) (with Tracy E. Miller & Anna Maria Cugliari)

CENTER PUBLICATIONS

Ethical Considerations in Selling Pharmaceuticals in Emerging Economies, (2017) (A White Paper by the Center for Health & Pharmaceutical Law & Policy)

The Limits of Disclosure as a Response to Financial Conflicts of Interest in Clinical Research, (2010) (A White Paper by the Center for Health & Pharmaceutical Law & Policy) (collaborator)

Conflicts of Interest in Clinical Trial Recruitment & Enrollment: A Call for Increased Oversight, (2009) (A White Paper by the Center for Health & Pharmaceutical Law & Policy) (collaborator)

OTHER PUBLICATIONS

Genetic Testing and Screening in the Age of Genomic Medicine, New York State Task Force on Life and the Law (2000) (editor)

Assisted Reproductive Technologies: Analysis and Recommendations for Public Policy, New York State Task Force on Life and the Law (1998) (editor of entire volume; primary author of selected chapters)

When Death Is Sought: Assisted Suicide and Euthanasia in the Medical Context, Supplement to Report, New York State Task Force on Life and the Law (1997) (primary author); excerpts reprinted in <span style="font-variant:small-caps">John D. Arras and Bonnie Steinbock eds., ethical Issues in Modern Medicine, 5th Ed. </span>(Mayfield Press, 1998)

When Death Is Sought: Assisted Suicide and Euthanasia in the Medical Context, New York State Task Force on Life and the Law (1994) (primary author of chapter on legal issues)

CASE BOOKS

The Ethics and Regulation of Research with Human Subjects,, Lexis 2d ed. (2015) (with Jerry A. Menikoff, Jesse A. Goldner, and Efthimios Parasidis)

ONLINE COMMENTARIES

End-of-Life Decision-Making and the Politics of the Fetus, Bioethics Forum (July 26, 2006)

Strengthening Local Review of Research in Africa: Is The IRB Model Relevant?, Bioethics Forum (December 22, 2006) (with Marie-Charlotte Bouësseau)

PRESENTATIONS

Full list of presentations available in Curriculum Vitae

Beyond Research with Human Participants: Rethinking the Regulatory Triggers for Prospective Ethics Review, Unesco 13th World Congress on Bioethics, Medical Ethics & Health Law, Jerusalem, Israel (November 2018)

Reining in IRB Review in the Revised Common Rule, American Society of Law, Medicine & Ethics Health Law Professors Conference, Cleveland, Ohio (June 2018)

Ethical Considerations in Selling Pharmaceuticals in Emerging Economies, American Society of Law, Medicine & Ethics Health Law Professors Conference, Atlanta, Georgia (June 2017)

The Role and Limits of Ethics Codes for the Pharmaceutical Industry, University of Toronto Conference on Governance and Corruption in the Pharmaceutical Sector: Causes and Consequences (September 2017)

Managing Ethical Issues in Epidemic Outbreaks, 13th World Congress of Bioethics, Edinburgh, Scotland (June 2016)