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 12-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
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.
Under certain circumstances, HIPAA allows the IRB to waive the need for explicit authorization in order for patient-level data to be provided to the researcher in a manner that protects patient confidentiality.
PAMFRI information analysts create de-identified data sets that facilitate rapid execution of research projects while maintaining our patients’ privacy.
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The PAMF IRB panel includes a wide range of clinicians, researchers, an attorney and members of the community at-large. This 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, Francis A. Marzoni, M.D.
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Rita French, Ph.D., IRB Chair
Karen Butterfield, M.D.
Neil Ingels, Ph.D.
Dominick Frosch, Ph.D.
Janet Lederer, R.N., MSN
David Leibowitz, M.D.
Kathleen Orrico, Pharm.D.
Jane Risser, M.B.A
Ming Tai-Seale, Ph.D.
Douglas Tucker, M.D.
Peter Whitman, J.D.
Terrie Nghiem, PharmD
Rosendo So-Rosillo, M.D.
Mike Turbow, M.D.
Charles Weiss, M.D.
Peter Yu, M.D.
Diana Hill, RN, Clinical Research Manager
Jamie Hollibaugh, IRB Coordinator
Harold Luft, Ph.D., Director, Research Institute
Andrea Norcia, MA, IRB Coordinator
Nicole Ventre, MS, Research Associate
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The following list of documents are for professional use only and not meant for patients.
- 01 - PAMFRI Project Information Form for Assessing (PDF document)
- 02 - PAMFRI Financial Interest Screening Form (PDF document)
- 03 - PAMFRI Reporting on Holdings in Stock Portfolios (PDF document)
- 04 - PAMFRI Significant Financial Interest Disclosure Form
- Business Associate Agreement (Word document)
- Certificate of Confidentiality definition (Word document)
- Citi Sign-on Instructions (Word document)
- Conceptual Protocol request information (Word document)
- Conceptual Review definition (Word document)
- Conflict of Interest for PAMF PIs (Word document)
- Data Use Agreement (Word document)
- Flow chart for IRB Submissions (Word document)
- HIPAA Identifiers (PDF document)
- HIPAA Release (Word document)
- Information Statement (Word document)
- Informed Consent Cover sheet (Word document)
- Informed Consent (Word document)
- Inter-Institutional IRB Agreement (Word document)
- Memorandum of Understanding (Word document)
- Oral Consent (Word document)
- PAMF Assent (Word document)
- Short Form Consent Process (Word document)
- Social & Behavioral Bill of Rights (Word document)
- Social Behavioral Consent (Word document)
- Sutter FCOIP (Word document)
- What form do I Use (Word document)