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Research with Incapacitated Adults: Regulatory Challenges and Perspectives from New York State and Federal Policymakers

Date: May 20, 2010 to May 20, 2010
Time: 4:30 PM - 8:00 PM

Speaker(s): Introductions and Moderator: Alan Fleischman, MD - Senior Vice President and Medical Director, March of Dimes Jerry A. Menikoff, MD, JD - Director of the Office for Human Research Protections, U.S. Department of Health and Human Services David H. Strauss, MD - Director, Office of Human Subjects Research, Department of Psychiatry, College of Physicians and Surgeons, Columbia University Beth E. Roxland, JD, M.Bioethics - Executive Director , New York State Task Force on Life and the Law

Sponsored by: NYAM and The Metropolitan Ethics Network

Location: The New York Academy of Medicine 1216 Fifth Avenue at 103rd Street, New York, NY 10029

Individuals with impaired decision-making capacity cannot consent to participate in research studies using the traditional framework governing informed consent. A lack of specific regulatory guidelines governing research with this population leaves healthcare institutions, researchers, and IRBs in New York in a difficult position. Federal and state regulators are working on creating a more inclusive policy, and will discuss recent efforts in this area.

Speakers
Jerry A. Menikoff, MD, JD: "How Can We Treat Incapacitated Adults Justly?"

David H. Strauss, MD: "Secretary's Advisory Committee on Human Research Protections (SACHRP): Recommendations from the Subcommittee for the Inclusion of Individuals with Impaired Decision-making in Research (SIIIDR)."

Beth E. Roxland, JD, M.Bioethics: "Research Involving Adults Who Lack Full Consent Capacity: The New York Perspective."

Schedule of Events:

For more information please contact ethicsnetwork@nyam.org

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