Location:  The Academy
Speakers: 
Jeffrey Botkin, MD, MPH, Professor of Pediatrics and Medical Ethics and Associate Vice President for Research Integrity, University of Utah
Nancy Neveloff Dubler, LLB, Director of Bioethics, Montefiore Medical Center
Joseph J. Fins, MD, FACP, Director of Medical Ethics, Weill Medical College of Cornell University
Alan R. Fleischman, MD, Senior Advisor, The New York Academy of Medicine
Ruth Macklin, PhD, Professor of Bioethics, Albert Einstein College of Medicine
Tia Powell, MD, Executive Director, New York State Task Force on Life and the Law
Bernard A. Schwetz, DVM, PhD, Director, Office for Human Research Protections, United States Department of Health and Human Services
David H. Strauss, MD, Chair, Institutional Review Board, New York State Psychiatric Institute, Columbia University

This event sponsored by:  Metropolitan New York Ethics Network and The New York Academy of Medicine

Accreditation

This activity has been planned and implemented in accordance with the Essential Areas and Policies of the Accreditation Council for Continuing Medical Education (ACCME). The New York Academy of Medicine is accredited by the ACCME to provide continuing medical education for physicians.

The New York Academy of Medicine designates this educational activity for a maximum of 3.5 Category 1 credits toward the Physician’s Recognition Award. Each physician should claim only those credits that he/she actually spent in the activity.

Disclosure Policy

The New York Academy of Medicine relies upon invited faculty participants to provide educational information that is objective and as free from bias as possible. In this spirit and in accordance with the guidelines of the session sponsor, faculty participants are required to indicate any commercial relationship that might be perceived as a real or apparent conflict of interest. Persons who have not completed a conflict of interest disclosure form will not participate as faculty. At this time, the panelists have no relationships to disclose.

Any presenter with disclosed relationships that prove to create a conflict of interest with regard to their contribution to the activity will not be permitted to present. The Academy also requires that faculty participating in any CME activity disclose when discussing any unlabeled or investigational use of any commercial product or device not yet approved for use in the United States.

Learner Outcomes

Upon completion of this activity participants will have a better understanding and familiarization with the current medical, legal and ethical implications of the use and protection of human subjects in research.

Keynote Address
Bernard Schwetz, DVM, PhD
Participants will obtain:

• knowledge of “big picture” issues of human subject protection.
• knowledge of priorities of the Office for Human Research Protections
• knowledge of the risks to human subjects of research

Genetics Research and Tissue Banking
Jeffrey Botkin, MD, MPH
Participants will:

• understand contemporary concerns about threats to privacy and confidentiality in the conduct of genetic research
• learn about regulatory guidance governing human subjects’ research with tissue specimens
• learn of proposals to manage psychosocial risks in the conduct of genetic research with tissues

Challenges in the Oversight of Research with Adult Subjects Who Have Impairments in their Ability to Provide Consent
David H. Strauss, MD
Learners will understand:

• the complex nature of decisional impairment in the research context
• the ethical and regulatory framework which governs the inclusion in research of subjects with impaired or absent decision-making abilities
• that gaps in regulatory coverage create barriers to progress and subject protection where pressing research questions for the most vulnerable subjects are at issue

Stem Cells and Embryos—Human Subjects?
Nancy N. Dubler, LLB
Participants will:

• understand the scientific controversy and how to design a prudent, ethical and controlled approach to scientific exploration
• appreciate the moral issues
• understand the recommendations and guidelines developed by the National Research Council and Institute of Medicine for human embryonic stem cell research and its implications for institutional commitments