Institutional Review Board
All clinical trials at PAMF must be reviewed by an Institutional Review Board (IRB) to ensure they comply with regulations protecting the rights and welfare of human subjects. The 12-member panel evaluates whether studies meet federal regulations and ethical principles. It exemplifies PAMF's institutional commitment to offer clinical trials of the highest quality.
Among other factors, the IRB considers whether the study shows respect for participants, strives to maximize benefits and minimize risks of research, and selects subjects fairly. The panel meets monthly and generally reviews nine or 10 studies per meeting, approving about 90 percent. Occasionally, the IRB will ask researchers to provide additional information, and may reconsider the study at a later meeting.
In keeping with federal standards, IRB members have diverse backgrounds, ensuring that studies are evaluated from multiple angles. The panel includes a clinical psychologist, physicians and scientists, a pharmacist, legal representatives and members of the community, all of whom serve on a volunteer basis. New members are solicited by current members or recommended by outside peers, and officially invited, jointly, by the chair of the IRB and director of the Research Institute.
Institutional Review Board for Human Subjects
Voting Members
Alternate Members
Oncology Subcommittee
Non-Voting Attendees
Patient Privacy
Patient privacy is also protected through compliance with recent changes in federal regulations known as HIPAA (Health Insurance Portability and Accountability Act of 1996). Patient authorization for the use and disclosure of their protected health information (medical records) for research is required. Specific rights and protections are discussed with patients prior to their participation in any research study.
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 regarding a research study and continues through study closure.
Last Reviewed: November 2007