2. Implementation of Credentialing, Liability, and Dietary Supplements Policies in Planning an Integrative Care Center. This research project has brought legal and regulatory expertise to a two-year planning process for the integrative clinical care center.

3. Emerging Credentialing Practices, Malpractice Liability Policies, and Guidelines Governing Dietary Supplements Recommendations: A Descriptive Study of 19 Integrative Health Care Centers in the U.S. This project analyzes credentialing practices, risk management policies, and guidelines for dietary supplement use (or avoidance) in 19 medical centers with integrative care centers. Our paper, submitted to the Archives of Internal Medicine, showcases the diversity of credentialing, liability, and dietary supplement policies and practices among leading hospitals, and makes recommendations to Congress and health care institutions to facilitate clinical research into CAM therapies.

4. Legal and Social Barriers to Alternative Therapies. This collaborative research with the Kennedy School, funded by the National Library of Medicine at the NIH, uses qualitative and ethnographic research to prepare a scholarly book that critically evaluates the integration of CAM therapies into conventional medical settings in the United States. To date, we have interviewed over 70 key personnel (medical directors, CAM providers, legal counsel, pharmacists, etc.) in 25 university-affiliated integrative care centers to understand what strategies they have used to pioneer and grow their centers. Our first article will be published shortly; two additional articles and a book are in draft form.

5. International Center for CAM Research. This NIH-funded planning grant focuses on the systematic evaluation of East Asian herbal products for potential therapeutic drugs. Legal Programs is developing the necessary legal infrastructure for this international collaboration with Beijing, Hong Kong, and Tokyo, and helping to negotiate intellectual property rights, royalty sharing, publication, and shared access to resources.

6. Parental Decision-Making Regarding CAM Therapies for Children. In this grant funded by a Canadian hospital, Legal Programs is collaborating with Canadian legal experts to create international guidelines for use of CAM therapies in pediatric care.

Educational Projects

Legal Programs pioneered an elective course, Complementary and Alternative Medicine: Health Law and Policy, at Harvard School of Public Health. Course faculty included representatives from Harvard’s Medical School, School of Public Health, Divinity School, and Kennedy School of Government. Students gave the course the highest overall rating. The course syllabus also served as a model for a parallel course at Georgetown Law School in Washington, D.C.

Legal Programs also offered several talks on legal and regulatory issues at the Division’s Continuing Medical Education courses; at programs and conferences across the U.S. sponsored by integrative care centers and other audiences;* at the Center for the Study of World Religions, Harvard Divinity School (where Michael Cohen served as a Fortieth Anniversary Senior Fellow); and at Harvard Law School’s Program on Negotiation.

Major Publications

Publications have included six articles in peer-reviewed medical journals:

• Ernst EE, Cohen MH. Informed consent in complementary and alternative medicine. Arch Intern Med 2001;161:19:2288-2292.
• Cohen MH, Eisenberg DM. Potential physician malpractice liability associated with complementary/integrative medical therapies. Ann Intern Med; 2002;136:596-603.
• Eisenberg DM, Cohen MH, Hrbek A, Grayzel J, van Rompay MI, Cooper, RA. Credentialing complementary and alternative medical providers. Ann Intern Med; 2002;137:965-973.
• Adams KE, Cohen MH, Jonsen AR, Eisenberg DM. Ethical considerations of complementary and alternative medical therapies in conventional medical settings. Ann Intern Med; 2002;137:660-664.
• Cohen, MH. Complementary and integrative medical therapies, the FDA, and the NIH: definitions and regulation. Derm Ther 2003;16:77-84.
• Cohen MH. Regulation, religious experience, and epilepsy: a lens on complementary therapies. Epilepsy Behav 2003;4:6:602-606.

Among these, the Malpractice article published in the Annals of Internal Medicine has garnered widespread attention as creating an authoritative framework for clinicians and hospitals integrating CAM therapies and developing risk management strategies to address clinical integration of evidence-based CAM therapies. The Ethics article is an original application of ethical standards to clinical decisions involving CAM therapies; and the Credentialing article has helped health care institutions across the U.S. wrestling with issues of licensure, scope of practice, and quality assurance, as they struggle with how to bring providers such as chiropractors, acupuncturists, massage therapists, and other CAM providers into mainstream clinical care.

Several additional medical publications are in progress. Publications also have included: two scholarly books;* seven book chapters (and several in progress, including one for the American Psychiatric Association on legal and regulatory issues in integrative mental health counseling, and others on cardiology and oncology); and four law review articles.

Public Policy Involvement

Legal Programs has contributed to several important public policy projects, including: Michael Cohen’s service as the Consultant to Institute of Medicine of the National Academy of Sciences, Committee on Study of Complementary and Alternative Medicine. In this capacity, the primary responsibility has been to advise the Committee on legal, regulatory, ethical, and public policy issues, and to participate in writing and commenting appropriate sections of the Committee’s draft report. Another significant policy project has involved assisting with the Federation of State Medical Boards of Model Guidelines for physician recommendations involving CAM therapies.

Planned Projects

These include: “Rethinking Intellectual Property Regulation of Dietary Supplements to Incentivize Private Funding of Clinical Effectiveness Research;” Development of “Educational Cases on Legal, Regulatory, and Policy Issues in Integrative Health Care;” and “Projects in Collaboration with the Program on Negotiation at Harvard Law School.”

Conclusion

Legal Programs offers the field of integrative medicine unique expertise in the legal, regulatory, and ethical issues common to integrative care centers in academic medical and other clinical environments. It aims to serve a broad audience, including conventional and CAM clinicians; hospitals and academic medical centers; legal scholars and others from various disciplines; and ultimately patients and their families.

Accomplishments to date highlight the opportunity to open potential legislative and other legal pathways, as well as scholarly venues, to help support the clinically responsible, ethically appropriate, and legally defensible emergence of sustainable models of integrative health care. Legal Programs is also multidisciplinary, and, with financial support, well-poised to continue developing projects in an academic medical center, in conjunction with law, business, public health, and other university faculties.