UNIVERSITY OF SOUTH FLORIDA SYSTEM
Policies and Procedures Manual

	Subject of Policy Statement	Effective Date	Policy Number
	Use Of Human Subjects In Research	Rev. 02/02/06	0-305

I. INTRODUCTION (Purpose and Intent)

The University of South Florida System (University/USF System) requires from faculty, staff, and students the responsible conduct of research and the ethical treatment of human subjects in research. The University has a systematic and comprehensive Human Research Protection Program (HRPP) that is designed to protect the rights, dignity, and welfare of human subjects who participate in the research programs of the University and its affiliated institutions. The program is based on the ethical principles outlined in the Nuremberg Code, the Declaration of Helsinki, and the Belmont Report.

II. STATEMENT OF POLICY

The HHRP includes the USF System Institutional Review Boards (IRB) and other duly constituted relied upon IRBs as set forth in the USF System Federalwide Assurance. All research involving human subjects must receive IRB review and approval prior to initiation and be conducted in accordance with the policies and procedures of the USF System, the Code of Federal Regulations governing the use of humans in research, and the applicable regulations set forth by the International Harmonisation Council. Related policies and procedures are available on the Division of Research Compliance website: www.research.usf.edu/cs/hsp.htm.

The President has delegated authority and responsibility of the HRPP to the Vice President for Research. The Vice President serves as the Institutional Official for the USF System Federalwide Assurance and is responsible for the oversight and compliant operation of the HRPP.

The IRBs are granted authority through federal regulations to review research proposals and take any of the following actions:

· Approve;

· Require modification to secure approval;

· Disapprove;

· Suspend or terminate approval;

· Observe or have a third party observe consent processes or the conduct of research; and

· Conduct Quality Assurance evaluations and for-cause audits of on-going and closed research studies involving human subjects.

No official of the USF System or its Affiliates can (1) approve human subject research that does not have approval from a designated IRB or (2) overturn a decision of the USF System IRBs.

III. RESPONSIBILITIES

A. The USF System Vice President for Research:

· Serves as Institutional Official and is ultimately responsible for the oversight and compliant operations of the HRPP.

· Maintains open and direct channels of communication with IRB members and staff, investigators and research staff, and administration to address questions, concerns or suggestions regarding the HRPP.

· Provides the IRB with sufficient meeting space, staff, and budgetary resources to support review and record keeping responsibilities. A program report drafted by the Director of Research Compliance is reviewed annually to ensure adequate resources are available to support required activities.

· Notifies the Office for Human Research Protections (OHRP), the Food and Drug Administration (FDA), and the Office of Research Oversight (ORO, for VA-regulated research) of incidents of serious or continuing noncompliance with IRB policies or regulations and suspensions or terminations of IRB approval.

· Protects IRBs from undue influence or threat of retaliatory actions so that IRBs can function independently, basing decisions on ethical principles, regulations, and institutional policies. IRB members and staff shall report any instances of undue influence to the Director of Research Compliance. The Director will investigate the matter and report the findings and recommendations for resolution to the Vice President for Research.

· Approves recommendations and appoints IRB members, alternates, ex-officios, and consultants.

· Evaluates all IRB members, Chairs, staff, board composition and number, annually to ensure adequate resources, program continuity, scientific, and professional expertise of members relevant to the business conducted. The Director of Research Compliance will prepare the annual report to present to the Vice President for Research.

B. The USF System Director of Research Compliance:

· Serves as the overall administrator for the HRPP and is responsible for ensuring that the IRBs function and operate in compliance with all federal, state, and local laws and regulations that govern the protection of human subjects in the conduct of research.

· Is responsible for notifying the Vice President for Research and, as applicable, other administrative and affiliated officials of any injury, breach of trust, unanticipated problems involving risks to subjects or others, serious or continuing non-compliance with requirements by research investigators, or suspension of IRB approval.

· Is responsible for investigating all issues of undue influence or threats of retaliation directed to the IRB members and staff and to provide recommendations for resolution to the Vice President for Research.

· Is responsible for presenting an annual report to the Vice President regarding the status of the HRPP programs that includes review of resources, continuity of IRB operations, and adequacy of scientific and professional expertise available to carry out requirements of the HRPP.

· May delegate operational authority to the USF System HRPP Administrator as appropriate.

Robert Chang

Vice President for Research

Judy Genshaft

President