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Regulations & Policies

Academic Affairs

I. OBJECTIVE AND PURPOSE OF POLICY

The ¾ÅÉ«ÊÓƵ (¾ÅÉ«ÊÓƵ) is committed to safeguarding the rights and welfare of all human subjects in research. ¾ÅÉ«ÊÓƵ accordingly accepts the principles set forth by the national Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in its report, Ethical Principles and Guidelines for the Protection of Human Subjects of Research (commonly known as the Belmont Report, April 18, 1979). Through this policy, ¾ÅÉ«ÊÓƵ also acknowledges its responsibility to conform and comply with all applicable federal, state, and other regulations, and with the terms of ¾ÅÉ«ÊÓƵ's Federalwide Assurance (FWA) on file with the U.S. Department of Health and Human Services (DHHS), Office for Human Research Protections (OHRP). This policy covers all human subject research, regardless of the source of sponsorship or funding, or if the research is unsponsored or unfunded.

II. DEFINITIONS

Human Subject: ¾ÅÉ«ÊÓƵ adheres to the definitions of "human subject" as provided by DHHS under 45 CFR 46.102(e) and the Food and Drug Administration (FDA) under 21 CFR 503.(g).

Research: ¾ÅÉ«ÊÓƵ adheres to the definitions of "research" as provided by DHHS under 45 CFR 46.102(l) and FDA under 21 CRF 50.3(c).

¾ÅÉ«ÊÓƵ Researcher: This includes any person who is engaged in human subjects research that is sponsored by ¾ÅÉ«ÊÓƵ; is directed or performed by ¾ÅÉ«ÊÓƵ faculty, staff, students, volunteers, or other agents with institutional responsibilities; occurs on ¾ÅÉ«ÊÓƵ property or in ¾ÅÉ«ÊÓƵ facilities; uses non-public ¾ÅÉ«ÊÓƵ information to identify or contact human research subjects; and/or is otherwise sponsored by or occurring under the auspices of ¾ÅÉ«ÊÓƵ. A ¾ÅÉ«ÊÓƵ employee involved in a research project in which the researcher is a consultant is still considered a ¾ÅÉ«ÊÓƵ researcher unless

1. the employee is hired on his/her own time;
2. the employee holds no rights in the work; and
3. neither the researcher nor ¾ÅÉ«ÊÓƵ retains any data.

Institutional Official: Under the direction of the President and such other ¾ÅÉ«ÊÓƵ officials as designated by the President, the Institutional Official (IO), as named in the University's FWA shall ensure compliance with this policy. The IO is authorized to act for ¾ÅÉ«ÊÓƵ, to assume on behalf of ¾ÅÉ«ÊÓƵ the obligations imposed by the pertinent federal regulations, and to execute ¾ÅÉ«ÊÓƵ's FWAs. The primary responsibility for enforcing this policy shall vest in the Institutional Official (IO).

III. STATEMENT OF POLICY

All research involving human subjects conducted by any ¾ÅÉ«ÊÓƵ researcher as defined above must undergo review and approval by the ¾ÅÉ«ÊÓƵ's Institutional Review Board for the Protection of Human Subjects (IRB) prior to commencement of the project. No research may commence until all required institutional approvals are obtained.

In accordance with federal regulations, the IRB is an administrative body established to protect the rights and welfare of human subjects involved in research activities conducted by ¾ÅÉ«ÊÓƵ researchers. The IRB has full authority to approve, require modifications to, or disapprove all research activities that fall within its jurisdiction and to conduct continuing reviews of the research activities at intervals appropriate to the degree of risk and as guided by federal regulations. If IRB approval lapses, all research activity, including data analysis, must stop unless the termination of study procedures creates a safety concern or ethical issue.

The ¾ÅÉ«ÊÓƵ Institutional Official may, under exceptional circumstances, independently review any research protocol and, if deemed necessary because of previously unforeseen risks to subjects or noncompliance with applicable regulations, has the authority to disapprove the implementation of a research protocol even if it has been approved by the IRB. However, no ¾ÅÉ«ÊÓƵ official(s) may approve the implementation of any research protocol in lieu of IRB approval, nor may they override IRB decisions disapproving a research protocol.

Infractions of federal regulations or ¾ÅÉ«ÊÓƵ policies and procedures for human subjects research by ¾ÅÉ«ÊÓƵ researchers may result in suspension or termination of the research. The IRB will investigate and determine the necessary corrective action with regard to any infraction of which it has notice, either through third-party allegation or self-disclosure. Sponsors of the human subjects research will be notified as required by regulation, statute, or contract. The IRB may recommend additional investigation and/or administrative action under other applicable ¾ÅÉ«ÊÓƵ assurances, policies, and procedures.

To implement this policy, the IRB shall adopt Standard Operating Procedures that detail its responsibilities and actions, and that are consistent with federal, state, and local regulations and statutes. These shall serve as the governing procedures for the conduct and review of all human research conducted under this policy. Adoption and modification of the Standard Operating Procedures require approval by the IRB, the Institutional Official, and any other ¾ÅÉ«ÊÓƵ officials as designated by the ¾ÅÉ«ÊÓƵ President.

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