Clinical Research: A Legal Overview
Friday | June 3, 2005 | 9:00 a.m. – 12:00 p.m.
Boston Bar Association
Conference Center
16 Beacon Street
Boston, MA 02108
Sponsor:
Health Law Section
Learn the ins and outs of dealing with the issues facing sponsors, institutions and investigators in setting up clinical trials, through completion and publication. This program will cover clinical trials agreements, human subject protection, conflicts of interest in clinical research and the industry sponsor perspective.
Specific topics include:
- disclosing and resolving conflicts of interest in human subject research
- overview of the law and policies in human subject protection including subject consent, sponsor and investigator disclosure, compensation for subject injury, uses and disclosure of subject protected health information (PHI)
- discussion of the Common Rule, OHRP/FDA, shut down of research, e.g., Johns Hopkins, U Penn; the role of Data Safety Monitoring Plans in subject protection
- the Institution Review Board’s (IRB) oversight over human subject research
- overview of a clinical trial agreement with a focus on several key provisions: publication, subject injury, inventions, indemnification, insurance, confidentiality from the perspective of the sponsor, institution and investigator.
Panel:
Maria D. Buckley, Esq.
Program Chair
Of Counsel
Nutter McClennen & Fish LLP
Gretchen A. Brodnicki, Esq.
Director of Research Compliance
Beth Israel Deaconess Medical Center
Dennis J. LaCroix, Esq.
Senior Director and Senior Counsel
Genzyme Corporation
Patrick L. Taylor, Esq.
Deputy General Counsel and Chief Counsel for Research Affairs
Children’s Hospital Boston
Program Prices
$115 - BBA Member
$145 - Non-Member
$80 - BBA Member - New Lawyer (admitted after 6/2003)
$60 - BBA Member - Legal Services/Government Lawyer
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