Exploring the Ethical and Practical Considerations of Psychedelics Research

Session I: Ethics and Law

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Speakers

Moderator: Holly Fernandez Lynch, J.D., M.Be.
Assistant Professor of Medical Ethics and Law, University of Pennsylvania

Holly Fernandez Lynch, J.D., MBE

Holly Fernandez Lynch, J.D., M.Be., is Assistant Professor of Medical Ethics and Law at the University of Pennsylvania. She pursues conceptual and empirical scholarship regarding clinical research ethics and regulation, access to investigational medicines outside clinical trials, and FDA pharmaceutical policy. She is founder and co-chair of the Consortium to Advance Effective Research Ethics Oversight (www.AEREO.org), board member of Public Responsibility in Medicine & Research (PRIM&R) and the American Society for Law, Medicine, and Ethics, an elected fellow of the Hastings Center, and a National Academy of Medicine Emerging Leader in Health and Medicine. She served as a member of the Secretary’s Advisory Committee on Human Research Protection (SACHRP) from 2014-2019. Professor Fernandez Lynch has previously worked as an attorney in private practice, bioethicist serving NIH’s Division of AIDS, analyst with President Obama's Commission for the Study of Bioethical Issues, and executive director of Harvard Law School's bioethics and health law research program.

Psychedelics in therapeutic research: Expanding the scope of healing

What is the psychedelic experience and how is it uniquely different from the effects of other drugs in the treatment of mental disorders? Psychedelics can induce a manifold of anomalous and occasionally disturbing experiences, some of which mimic psychosis. One such experience that poses distinctive challenges to psychiatry, is that of the “mystical-type,” which is often claimed to be the main driver of therapeutic benefit in psychedelic-assisted psychotherapy (PAP). It has unique facets and offers risks and alleged benefits that are not attributed to anxiolytics, antipsychotics, or antidepressants. The experience challenges biological psychiatry to reckon with questions of meaning-making and spirituality, broadly defined. This shift is notable in palliative care psychiatry, where spiritual/existential suffering is a growing concern. Ethical questions about inducing psychedelic experiences via PAP arise from their benefits as well as their risks. I focus on their benefits, and the implications they have for psychiatric research and care.

Duff Waring, LL.B., Ph.D.
Professor, Department of Philosophy, York University

Duff Waring, LL.B., Ph.D.

Duff R. Waring is a philosopher/lawyer who has specialized in mental health law, psychiatric patient advocacy, bioethics, and philosophy of psychiatry. His research has focused on the ethics and praxis of psychotherapy. He is a member of the Law Society of Ontario and is currently a Full Professor in the Department of Philosophy at York University.

Research, referendum, litigation, and legislation: Picking the locks on the doors of perception

The “Psychedelic Renaissance” is taking place in the context of federal and state criminal prohibition that did not exist in the earlier era of widespread research. Federally-authorized clinical research has resumed as a result of decades of obscure advocacy by proponents of research within the psychedelic community. Other members of the community have attempted to evade criminal prohibition through illegal underground therapy and offshore healing retreat centers. Others have litigated for protections of sacramental use and for access under right to try laws, organized local and state decriminalization ballot initiatives, and lobbied state elected officials in support of reform bills—including legislation that supports clinical research. Legislative support for research and expanded access has emerged even at the federal level. This presentation will consider the relationship between IRB-approved research and the changes in the media image and political profile of psychedelics.

Noah Potter, J.D.
Legal Market Strategies

Noah Potter, J.D.

Noah Potter is a New York City-based attorney and psychedelic sector consultant. In the early 1990s, as an undergraduate political science student, he became an ibogaine legalization advocate and in that context analyzed the relationship between substance abuse prevention and treatment in federal policy priorities. He is chair emeritus of the New York City Bar Association’s Committee on Drugs and the Law. In 2010 he articulated the concept of psychedelic law when he created the New Amsterdam Psychedelic Blog. In 2018 he guided the Decriminalize Denver campaign in obtaining board of elections approval of that city's psilocybin decriminalization ballot initiative, which in 2019 launched a wave of state and local psychedelic law reform around the United States. In 2020 he began briefing New York State and New York City elected officials on psychedelic policy reforms options. His twenty-two years as a commercial litigator inform his perspective on psychedelic markets.

Beyond compliance: Building a comprehensive ethics infrastructure in psychedelics research with human participants

Psychedelics exist against the backdrop of cultural and religious tradition, biomedical research, the criminal justice system, and underground subcultures.  The unique position of psychedelics in society is characterized by conflicting value sets that impact psychedelic research involving human subjects. Given this ethically complex position, what resources might bioethics have to offer this new field of mental healthcare? How should the principles of the Belmont Report inform a more comprehensive ethical framework for psychedelics research that goes beyond compliance? How might the principles of fairness, equity, public trust, reciprocity, and transparency buttress this ethical framework?

Dominic Sisti, Ph.D.
Associate Professor of Medical Ethics & Health Policy, Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania

Dominic Sisti, Ph.D.

Dominic Sisti, Ph.D., is an associate professor in the Department of Medical Ethics & Health Policy at the University of Pennsylvania. He directs the Scattergood Program for Applied Ethics in Behavioral Health Care and holds secondary appointments in the Department of Psychiatry and the Department of Philosophy. Sisti's research includes the examination of ethical and policy challenges in mental healthcare, medical ethics in correctional healthcare, and ethical issues in psychedelic research and treatment.  Dr. Sisti was recently elected a fellow of the Hastings Center.

What are the ethical challenges with obtaining informed consent for participation in psychedelics research?

Psychedelic substances can cause substantive and irreversible changes to one’s beliefs, insights, and one’s sense of self. How should researchers disclose and explain this unique aspect of the psychedelic experience to prospective research participants? Is it possible to conduct a meaningful consent process for those with no prior experience with these substances? How can we respect autonomy, including requests to withdraw consent, in participants under the influence of psychedelic substances? For those with prior experience with these substances, could the chance to access psychedelics through trial participation constitute a form of undue influence?

Andrew Peterson, Ph.D.
Assistant Professor, Department of Philosophy, Institute for Philosophy and Public Policy, George Mason University

Andrew Peterson, Ph.D.

Andrew Peterson is an Assistant Professor in the Department of Philosophy and Institute for Philosophy and Public Policy at George Mason University. He is also an Affiliate Researcher at the University of Pennsylvania Memory Center. Previously, he was a Greenwall Faculty Scholar, and a Vanier Canada Graduate Scholar. His research centers on bioethics and the philosophy of neuroscience, with specialization in ethical issues related to neurology and human consciousness. He is a recipient of the 2021 Rising Star Outstanding Faculty Award from the State Council of Higher Education for Virginia.

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