Institutional Review Board
All research involving PAMF patients or undertaken by PAMF Research Institute investigators must be reviewed by the Institutional Review Board (IRB) to ensure the research complies with regulations protecting the rights and welfare of human research subjects.
The 14-member IRB panel evaluates whether studies meet federal regulations and ethical principles. This careful review exemplifies our institutional commitment to only offer clinical trials of the highest quality.
The IRB also reviews proposed research that involves collecting data through new surveys or existing patient records to make sure patient privacy is protected at all times.
The IRB considers whether the study:
- Shows respect for participants
- Strives to maximize benefits and minimize research risks
- Selects subjects fairly
Privacy
Patient privacy is protected under federal regulations known as the Health Insurance Portability and Accountability Act of 1996 (HIPAA). HIPAA requires that patients must authorize the use and disclosure of their protected health information (medical records) for research.
Patients are given opportunities to have the research study discussed in detail and to have their questions answered. Such discussions include the purpose of the research study as well as benefits and risks of participation in the study. Consenting to participate in a research study is an ongoing process. It begins when a patient first inquires about a research study and continues through the end of the study.
The IRB panel meets monthly and generally reviews 15 to 20 studies per meeting. Researchers are occasionally asked to attend the IRB's full committee meeting to address members' questions.
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IRB Methodology
The PAMF IRB panel includes a clinical psychologist, physicians, scientists, pharmacists, an attorney and members of the community at large. These diverse backgrounds ensure that studies are evaluated based on multiple perspectives and a broad range of experiences.
All of the IRB members serve on a volunteer basis. New members are recommended by PAMF's current IRB members and are officially invited to join its membership by the chair of the IRB and PAMF's Institutional Official, David Druker, M.D.
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Voting Members
Rita French, Ph.D., IRB Chair
Karen Butterfield, M.D.
Neil Ingels, Ph.D.
Janet Lederer, R.N., MSN
David Leibowitz, M.D.
Kathleen Orrico, Pharm.D.
Virginia Pollard
Bernadine Scoles
Douglas Tucker, M.D.
Peter Whitman, J.D.
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Alternate Members
Joyce Lin, Pharm.D (alternate)
Charles Weiss, M.D. (alternate)
Mike Turbow, M.D.
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Oncology Subcommittee
David Leibowitz, M.D.
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Non-Voting Attendees
Barbara Anderson, R.N., Manager, Clinical Research
Arthur Bobrove, M.D., Interim Director, Clinical Research
Andrea Norcia, M.A., Research Support Manager, IRB Coordinator. She can be reached at 650-330-5963 or at norciaa@pamfri.org.
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