Charge to the Administrative Panel on Human Subjects in Medical Research

The Administrative Panel on Human Subjects in Medical Research is responsible for review and approval of all University medical research and teaching activities involving human subjects, except those reviewed by the Administrative Panel on Human Subjects in Non-medical Research. The objective of these reviews is to ensure that the rights and welfare of the subjects are adequately protected and that all activities involving human subjects are in compliance with applicable University policies and external regulations.

The Panel is responsible for reviewing all projects involving human subjects (as defined below) that are conducted at Stanford facilities or by Stanford faculty, staff, students and/or visiting scientists. In addition, the Panel may be asked by the University administration to review research protocols on behalf of other institutions with which Stanford has formal affiliation agreements. At the present time, such institutions include UCSF Stanford Health Care, Veterans Affairs Palo Alto Health Care System, and Palo Alto Institute for Research and Education

All projects that involve human subjects shall be reviewed at intervals appropriate to the degree of risk, but not less than once per year, regardless of the source of funding. The Panel may approve research protocols with or without modifications, or may withhold approval of all or any portion of a protocol.

The Panel shall assess suspected or alleged protocol violations, subject complaints, or violations of external regulations or University policies. Activities in which serious or continuing violations occur may be suspended by the Panel. In such cases, the Panel will immediately notify the affected investigator(s), the relevant school dean, and the Vice Provost and Dean of Research and Graduate Policy, and others as required by University policies and external regulations, e.g., Food and Drug Administration.

Upon request, the Panel shall review and comment on proposed external regulations dealing with human subjects in medical research. When appropriate, the Panel will formulate draft policies and procedures for approval by the appropriate University bodies and promulgation by the Vice Provost and Dean of Research and Graduate Policy.

A living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information. "Intervention" includes both physical procedures by which data are gathered and manipulations of the subject or the subject's environment that are performed for research purposes.

Systematic investigation designed to develop or contribute to generalizable knowledge.

The following guidelines have been established to aid the Panel in the exercise of its responsibilities:

1. Research projects shall be reviewed in such a manner as to provide for the protection of the subject against undue or unnecessary invasion of privacy, disrespect for human dignity, and physical, psychological or social harm. In most cases, this will involve approval of a clearly-worded consent form to assure that the subject is fully informed of the risks inherent in participation and of the benefits which might be reasonably expected.

2. (a)   Conflict of Interest – Human subjects research protocols shall be reviewed for potential conflicts of interest involving possible financial gain from research results versus obligations to human subjects. The Panel shall notify the protocol director and request that she/he contact the Department Chair when it determines that a potential conflict of interest may actually or appear to exist. The Department Chair is required to review the matter with the relevant school dean. The dean shall notify the Panel Chair what action was taken to respond to the Panel’s concerns.

2. (b)   In accordance with the Code of Federal Regulations under "Protection of Human Subjects," 45 CFR 46.107(e): "No IRB may have a member participate in the IRB's initial or continuing review of any project in which the member has a conflicting interest except to provide information requested by the IRB."

3. All research protocols involving the use of human subjects shall be available for review by any member of the Panel, and any member of the Panel may, upon request, obtain full Panel review of such protocols. Approval of a protocol may be granted for no more than one year, appropriate to the degree of risk. Except for life-threatening emergencies, all protocols will be approved at a convened meeting of a quorum of the Panel (i.e., a majority of the voting members, including at least one member whose primary concerns are in non-scientific areas as required by 21 CFR 56.108 (b) ) with the affirmative vote of a majority of those present.
4. The Panel shall maintain, for at least three years, records of research protocol reviews and minutes of meetings, including records of attendance and Panel deliberations.
5. The activities of this Panel are subject to the Guidelines on Confidentiality of Administrative Panel Proceedings (copy attached).

In cases of dispute with respect to procedures or decisions of the Panel, appeals may be made to the Vice Provost and Dean of Research and Graduate Policy for mediation with the understanding that the University may not approve an activity if it has not been approved by the Panel, nor apply undue pressure on the Panel to reverse a decision.

The Panel is appointed by the Vice Provost and Dean of Research and Graduate Policy and shall be made up of at least ten members including: faculty and staff, one student nominated by the ASSU Committee on Nominations who is either an upperclassman or preferably a graduate student with previous human subjects research or medical experience, a member of the local community not otherwise affiliated with the University, and any others who may be invited to serve when their expertise is required.

Nonvoting ex officio members shall include representatives of the: Office of Vice Provost and Dean of Research and Graduate Policy, Office of General Counsel, Stanford Hospital and Clinics, Department of Environmental Health & Safety (Biosafety Officer), and Office of the Dean of School of Medicine.

The term of membership on the Panel is a 12-month renewable period beginning October 1 through September 30.

The Panel reports to the Vice Provost and Dean of Research and Graduate Policy, who is the institutional official responsible for assuring compliance with University policies and external regulations on the use of human subjects in medical research.

The Panel shall meet as necessary to conduct its business but not less than bi-monthly. The Chair shall submit an annual report of Panel activities and deliberations to the Office of the President by October 1st of the following year.

The Office of the Vice Provost and Dean of Research and Graduate Policy shall provide the necessary staffing and administrative assistance, and on behalf of the University, shall certify to external funding agencies the review and approval of projects involving human subjects.