This Human Research Protection Program (HRPP) policy is provided in an effort to give comprehensive information about the organization and focus of the human research protection program to the members of the research community at Stanford University and affiliated organizations. Stanford University has had a program to protect human participants for many years. Prior to September 1, 2005, a large portion of the program was described in writing in the Institutional Review Board's (IRB's) standard operating procedures, the "Human Subjects Manual," the IRB's website, the official charge to IRB members upon their appointment, and other sections of this Research Policy Handbook. With the issuance of this HRPP policy, the program has been incorporated into one core document and reorganized around the principles and standards of the Association for the Accreditation of Human Research Protection Programs. It continues to require compliance with applicable laws such as the Common Rule (45 CRR Part 46) and FDA regulations relating to human subjects (21 CFR Parts 50 and 56) and includes ethical standards such as the Belmont Report. All members of the Stanford community who engage in research involving human subjects must be knowledgeable about the requirements of the HRPP.

The Vice Provost and Dean of Research (VP and Dean) has been given the authority and responsibility to establish, maintain, and oversee the HRPP by the President of Stanford University. The primary administrative responsibility for the day-to-day operation of the HRPP lies with the Research Compliance Office and the Administrative Panels on Human Subjects in Medical Research and the Administrative Panel on Human Subjects in Non-Medical Research (IRBs). The Research and Development Committee at the Veterans Affairs Palo Alto Health Care System (VAPAHCS) retains ultimate responsibility for the maintenance of its overall institutional system to protect human subjects.

The HRPP applies to the human subject research done at Stanford University and also at affiliate organizations for which it has an agreement to provide services related to the HRPP. The organizations covered by and participating in the HRPP are:

• Stanford University
• Stanford Hospital and Clinics
• Lucile Packard Children's Hospital
• Veterans Affairs Palo Alto Health Care System (VAPAHCS)
• Palo Alto Institute for Research and Education (PAIRE)

(This coverage includes any subsidiary entities listed in the Federalwide Assurance filed by these organizations.)

The VP and Dean or Associate Dean has approved the policies that constitute the HRPP. The VP and Dean may add or modify policies as necessary and appropriate to incorporate changes in the law and accreditation standards and to improve the effectiveness of protections for human subjects.

The IRBs acting on behalf of the five organizations covered by the HRPP will institute a continual process for reviewing and monitoring human subject research and its compliance with the HRPP.

The IRBs play a primary role in the HRPP through such activities as:

1. Prospective and continuing review of each research protocol involving human subjects, including an evaluation of its risks and benefits to the human subjects
2. Reviewing the adequacy of the informed consent document, particularly as to its description of the risks and benefits
3. Receiving, evaluating and conducting reviews concerning reports of unanticipated problems, possible non-compliance, and other information and incidents that might affect its approval of the protocol or the subjects' willingness to continue to participate

Stanford University and its affiliates train and require documentation of training for all investigators, research staff, students, IRB members and staff, and others engaged in human subject research about the requirements of the HRPP.

Anyone who knows that, or has reason to believe that human research is being conducted in a manner that is not in compliance with the HRPP must report the matter promptly to the Director of Research Compliance, or the VP and Dean. All reported matters will be reviewed in a timely manner and, when possible, will be handled confidentially. Where appropriate, sanctions will be considered and imposed. Any attempt to retaliate against a person for reporting possible non-compliance with the HRPP may itself be considered a violation of the HRPP.

Non-compliance, protocol deviations, and violations are addressed in the HRPP Non-adherence to Stanford policies and procedures, and applicable local, state and federal regulations concerning human subject research may, under certain circumstances, result in administrative, civil, or criminal penalties against individuals and the organizations participating in the HRPP. These penalties include action by the FDA to suspend or terminate an investigator or an organization's ability to participate in clinical trials for investigational drugs, devices, and biologics, and action by the US Department of Health and Human Services to suspend funding for human subject research. Employees, students, and contractors of the participating organizations who are not in compliance with the HRPP in the conduct of human subject research or related activities may be subject to disciplinary action up to and including termination of employment, contract, or other relationship with the participating organization.

If any member of the Stanford community has any questions about the HRPP or wishes to make a report related to human subjects in a research protocol, the protocol director of the relevant research protocol, the IRB, or the Research Compliance Office should be contacted. Contacting the IRB and Research Compliance Office, may be done anonymously.

Contact Information for IRB and Research Compliance Office

Telephone: 650-724-8943; email: anastasia.doherty@stanford.edu; US mail: 3000 El Camino Real 5 Palo Alto Square, 4th Floor, Palo Alto, CA 94306

Contact Information for Director of Research Compliance

Telephone: 650-723-4697; email: kathy.mcclelland@stanford.edu; US mail: 3000 El Camino Real 5 Palo Alto Square, 4th Floor, Palo Alto, CA 94306