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The conduct of biomedical
research involving human participantsraises a host of ethical and legal
issues that have concernedlawyers, policy makers, scientists, and
cliniciansfor many years. Ethical concerns have been translated into a
complex regulatory framework, containing specific legal provisions
concerningsuch matters as participant safety, informed consent, and
confidentiality.
This timely new
program features a comprehensive introduction to the laws and
regulations governing human subject research conducted in
New York State.
The program is intended for
those individuals who are interested in learning about the fundamental
legal framework guiding human subject research, as well as those seeking
a refresher on the basics of human subject research law.
Reasons to
Attend
·Learn more about the
Protection of Human Subjects (45 CFR 46) and research conducted on
identifiable human tissue samples
·Understand the HIPAA Privacy Rule and Standards for Privacy of
Individually Identifiable Health Information (45 CFR Parts 160 and
164)
·Know the requirements for informed consent processes, IRB
review, participant safety, confidentiality and related
issues
·Become familiar with the controversy over the ethical and legal
need to obtain a tissue donor’s informed consent for the
collection, storage, and use of the donor’s biological specimen
for research purposes
Program
Contents
· Oversight Agencies and Applicable Law
·HIPAA and New York
State Law
· Genetic Testing and Research
· Panel Discussion with Representatives from Government and
Oversight Agencies
· Compliance with Medicare Billing Requirements for
Research
· Clinical Trial Agreements
Program
Speakers
Salvatore J. Russo, Esq. (Overall
Planning Co-Chair)
New York
CityHealth and Hospitals
Corporation
—New York
City
Roshni
D. Persaud, Esq. (Overall Planning
Co-Chair)
New York
CityHealth and Hospitals
Corporation
—New York
City
Mark Barnes,
Esq.
Executive Vice President and
Chief Administrative Officer
St. Jude
Children’s Research
Hospital
—Memphis,
Tennessee
Carl H. Coleman,
Esq.
Professor of Law, Director
Health Law and Policy Program
Seton
Hall Law School
—Newark,
New
Jersey
Nancy Dubler,
LL.B.
Director of the Center for Ethics
and Law in Medicine
Department of Family and Social Medicine
Montefiore
Medical Center
—Bronx
Leah B. Guidry,
Esq.
Manager, Huron Consulting
Group
—Washington, DC
Sara Krauss,
Esq.
Proskauer Rose LLP
—New York
City
Wayne A. McNulty,
Esq.
Associate Counsel
New York City Health and Hospitals Corporation
—New York
City
Anne H. Pearson,
Esq.
Section Chief
Civil Right Bureau
Office of the Attorney General
—New York
City
Vera Hassner
Sharav
Founding President of
the Alliance for
Human Research Protection
—New York
City
Marcia B. Smith,
Esq.
Iseman Cunningham Riester &
Hyde, LLP
—Albany
Elyse I. Summers,
Esq.
Public Health Analyst
Division of Education and Development
Office of Human Research Protections
U.S. Department of Health and Human Services
—Rockville, Maryland
Total
MCLE Credits......
6.5
Ethics
MCLE Credits.....
0.0
* Each additional person who uses the
tapes for MCLE credit must purchase a copy of the “MCLE
coursebook.”
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