| Human Subject Research & Medical Care: Balancing the Risks & Benefits
Cosponsored with the Boston Bar Association, Public Responsibility in Medicine and Research & the Massachusetts Hospital Association
Please Note: This course has already
been held.
Date: Friday, November 08, 2002
Location: Suffolk University Law School, 120 Tremont St., Boston, MA
Time: 09:00 AM - 04:00 PM
Schedule/Agenda
Registration Information
Unable to attend but are interested in the course materials?
Purchase Here! |
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As a result of the growth in medical research and the biomedical industry, the existing structure for review and approval of human subject research is under stress and increasing scrutiny. At the same time, public awareness of possible new cures for debilitating disease has put pressure upon government regulators and health care providers to rush marginally tested therapies into practice without the level of scrutiny that has previously been applied.
Serious questions have been raised concerning the effectiveness of present regulatory mechanisms on human subject research and the procedures for approving such experimentation. The traditional model of local Institutional Review Boards (IRBs) charged with applying federal and local law is under increasing criticism and scrutiny. Similarly, the rush from experimentation to application of new discoveries has placed hospital ethics boards in difficult roles of determining the medical efficacy - and possible harm - attendant to the use of the 'New Medicine".
Congress and state legislatures are deeply involved in hearings and drafting new legislation regarding human subject experimentation and standards for application of new therapies arising from genomic and stem cell research. The results of this debate will have significant impact upon the biomedical industry, medical providers, insurers, clinical researchers, health advocates and individual patients who seek to benefit from the remarkable progress of science and medicine.
Who Should Attend:
Hospital and health care lawyers, IRB members, Hospital ethicists, Counsel for hospital and health care regulators, Counsel for biomedical, pharmaceutical and device manufacturers, Hospital board members, Health care payers and academics.
Attend and Learn:
- About the various regulatory systems that apply to the research of human subjects
- From a window into the operation of IRBs and be able to identify the strengths and weaknesses of the current structure
- How ethical concerns are integrated into the balancing of risks and benefits of proposed therapies
- How recognition of the research - medical care continuum has been incorporated into Medicare reimbursement
| S C H E D U L E / A G E N D A |
| 9:00 |
Welcome & Introduction |
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| 9:10 |
State of the Law on Human Experimentation |
- Is there a crisis in protecting human subjects in research?
- What is the role of each branch of government?
- How is the federal government coordinating regulatory oversight?
- How the Office for Human Research Protections fits into the regulatory scheme
- What constitutes informed consent?
- What is the scope of authority of the FDA?
Professor Wendy K. Mariner, Director, Patient Rights Program, Boston University School of Public Health, MA
David C. Bowen, Ph.D., Deputy Staff Director for Health Senate Committee on Health, Education, Labor & Pensions
Elizabeth Goss, Esq., Ropes & Gray, Washington, DC
Greg Koski, Ph.D., M.D., Director, Office for Human Research Protections, Dept. of Health & Human Services, Rockville, MD
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| 10:45 |
Making a Proposal to an IRB |
- How to avoid financial conflicts of interest
- How to negotiate limits to liability
- Which party has the right to control publication results and findings?
M.C. Sullivan, Esq., RN, MTS, Managing Director, LifeSciences Advisory Group, LLC, Wellesley, MA
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| 11:15 |
IRB Issues and the Decision-Making Process |
- To what extent are members of IRBs potentially liable?
- How should IRBs follow-up and manage protocols?
- How to avoid conflicts of interest
- How to address ethical issues in research protocols
- What chilling effect might IRBs have on research?
- What is informed consent?
Susan T. Nicholson, Esq., Moderator, Ropes & Gray, Boston, MA
Patricia A. Bass, Esq., Boston Medical Center, MA
Nancy Dubler, Professor of Bioethics, Albert Einstein College of Medicine, Director, Division of Bioethics, Montefiore Medical Center, Bronx, NY
Laura Glynn, IRB Community Board Member, Spaulding Rehabilitation Hospital, Boston, MA
Leonard F.M. Scinto, Ph.D., Co-Director, Laboratory of Higher Cortical Functions
Brigham & Women’s Hospital, Boston, MA
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| 12:45 |
Lunch (on your own) |
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| 1:45 |
The Continuum of Research, Clinical Practice and Treatment: Do existing mechanisms insure safe and effective health care? |
Professor Michael A. Grodin, M.D., Boston University School of Public Health, MA
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| 2:45 |
Concurrent Workshops |
~ Workshop A ~ Drawing the Line Between Experimentation & Practice
- Distinctions between therapy & experimental procedures
- The risks of new therapies
- What are the mechanisms for introduction, oversight and monitoring of new therapies?
- What standards should apply to new therapies?
Professors Barry Brown & Renee Landers, Co-Chairs, Suffolk University Law School, Boston, MA
M. Judah Folkman, M.D. (Invited), Julia Dyckman Andrus Professor of Pediatric Surgery, Children’s Hospital, Boston, MA
Professor Michael A. Grodin, M.D., Boston University School of Public Health, MA
Robert S. Sinsheimer, Esq., Sinsheimer & Associates, Boston, MA
~ Workshop B ~ Medicare Reimbursement for Clinical Trials
- What changes have been made in the reimbursement regulations for clinical trials?
- When will and how does Medicare pay for clinical trials?
- From a policy perspective, should Medicare pay for clinical trials?
Thomas R. Barker, Esq., Moderator, Senior Outreach and Policy Advisor to the Administrator, Center for Medicare and Medical Services, U.S. Dept. of Health and Human Services, Washington, D.C.
Linda D. Bentley, Esq., Mintz Levin Cohen Ferris Glovsky & Popeo, P.C., Boston, MA
Jeffrey Kang, M.D., CIGNA Health Care, Hartford, CT, Former Chief Medical Officer, Center for Medicare & Medicaid Services, U.S. Dept. of Health and Human Services, Washington, D.C.
Diane Bissonnette Moes, Esq., Foley Hoag, LLP, Boston, MA
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| Date: |
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Friday, November 08, 2002 |
| Tuition: |
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Tuition is $199; $159 for BBA members and attorneys admitted since 1999. Tuition includes course book & refreshments. A limited number of scholarships are available. Please submit a written request. $75 for course book only (available after 11/8)
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| Walk-Ins: |
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Space is limited. Registrations at the door are welcome, but please register in advance to reserve a seat and your written course materials or call to confirm space availability.
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| Refunds: |
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Written requests for cancellations received via fax or email 24 hours prior to the program will be granted a refund, minus a $15.00 charge. If you cannot attend, you can send a substitute, otherwise you will receive the written course materials.
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| Location: |
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Suffolk University Law School, 120 Tremont St., Boston, MA
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| Credit: |
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Approved for CLE Credit in RI, NH, VT, ME & NY. If we are not an approved provider in your jurisdiction, we will assist you.
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Special
Needs: |
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If you have special needs addressed by the Americans with Disabilities Act, please notify us as soon as possible.
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Directions to the Law School.
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Unable to attend but are interested in the course materials?
Purchase Here! |
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|
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