5200 - Human Subject Research

CONTENTS:

A. General Policy, Legal Authority and Ethical Principles
B. Covered Activities
C. Scope of Responsibility and Authority
D. Institutional Review Board
E. Organization and Membership of the IRB
F. IRB Standard Operating Procedures
G. Contact Information

A. GENERAL POLICY, LEGAL AUTHORITY AND ETHICAL PRINCIPLES

A-1. GENERAL POLICY. The University of Idaho, in the course of carrying out its teaching, research, and service missions, engages in human subject or participant research across a wide array of academic disciplines. Recognizing that engaging in research involving human subjects imposes responsibility for safeguarding the rights and welfare of these persons, the University of Idaho ("University") is committed to the protection of human research subjects through compliance with applicable federal and state regulations and observance of ethical principles for the conduct of human research. This policy governs all human subject research performed under the auspices of the University. 

A-2. LEGAL AUTHORITY. All research subject to this policy shall be conducted in accordance with federal, state, and local law.

In fulfilling its commitment to protect the rights and welfare of human research subjects, the University applies the regulations promulgated by the United States Department of Health and Human Services (HHS) for Protection of Human Subjects to all federally funded research. Under the approved federal-wide assurance provided by the University to HHS, all federally funded human subject research, and the oversight of such research shall be performed in a manner that complies with the applicable federal regulations. The University also complies with human subject research regulations established by the Food and Drug Administration for clinical investigations involving drugs, biologics, medical devices, and other test articles. 

By this policy, the University also requires that all non-federally funded and unfunded research comply with these regulations, unless otherwise specified by University policy, including but not limited to University of Idaho IRB Standard Operating Procedures (see Section F, below). The University acts in conformance with other federal laws and regulations germane to human subject research and with applicable state and local law. 

A-3. ETHICAL PRINCIPLES. Consistent with its federal-wide assurance and this policy, the University shall be guided by the ethical principles governing the evaluation and conduct of research involving human subjects, whether or not such research is subject to federal regulation, set forth in The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research on the HHS website or contact Office of Research Assurances (see G below). While the principles announced in The Belmont Report serve to guide human subject research at the University, these principles are never held to or construed so as to supersede any local, state, or federal law or to supersede any regulations or policies promulgated by federal agencies. 

B. COVERED ACTIVITIES.

B-1. HUMAN SUBJECT RESEARCH ACTIVITIES. All activities that meet the criteria for: (i) “research” involving “human subjects,” as defined in HHS regulations or (ii) a “clinical investigation” involving “human subjects” or “subjects,” as defined in FDA regulations, shall be subject to this policy. 

B-2. EXEMPT HUMAN SUBJECT RESEARCH. Activities that meet the criteria for “human subject research” described in the HHS and FDA regulation may nevertheless be exempted from compliance with federal human subject regulations, if the only involvement of human subjects will be in one or more prescribed categories. The IRB, or designee of the IRB, shall make the determination as to whether a particular research activity involving human subjects is exempt. Even when research is determined by the IRB to be exempt, the ethical principles of The Belmont Report shall be applied by the investigator to the research activities. 

C. SCOPE OF AUTHORITY AND RESPONSIBILITY.

C-1. INSTITUTIONAL REVIEW BOARD (IRB) (see FSH 1640.54).

a. The IRB is the principle mechanism by which the University ensures that all human subject research activity is planned and conducted in a manner consistent with applicable law and policy and that the rights and welfare of human research subjects are adequately protected.

b. The responsibilities of the IRB include but are not limited to:

(1) reviewing, approving, requesting modifications, as well as disapproving human subject/participant research; 

(i) research that has been approved by the IRB may be subject to further review and approval or disapproval by University officials. University officials may not approve research that has not been approved by the IRB; 

(2) conducting continuing review of research approved by the IRB, according to federal regulations and at intervals appropriate to the degree of risk, including as necessary observing, or having a third party observe, the consent process and research activity; or requesting and inspecting information related to human subject research activity; 

(3) investigating instances of non-compliance, whether discovered during monitoring by the IRB or reported to the IRB, including unanticipated problems involving risks to research subjects or others and serious or continuing noncompliance with this policy or the requirements or determinations of the IRB; 

(4) suspending or terminating approval of research activity that is not being conducted in accordance with the requirements established by the IRB for a particular research activity or has been associated with serious harm to research subjects or that is not otherwise in accordance with federal human subject research regulations or University policy; 

(5) reporting to appropriate University and, for federally funded research, federal government officials: 

(i) unanticipated problems involving risks to research subjects or others and serious or continuing noncompliance; and 

(ii) suspension or termination of IRB Approval; 

(6) developing and implementing administrative policies and procedures to implement this policy.

C-2. SIGNATORY OFFICIAL. The Signatory Official is the Vice President of Research and Economic Development or designee. This individual cannot be a voting member of the IRB and shall have the legal authority to represent the University in providing assurance to the federal government that the University will comply with federal human subject research regulations and shall be responsible for ensuring that all regulatory and programmatic requirements for the conduct of human subject research at the University are met. 

C-3. OFFICE OF RESEARCH ASSURANCES. The Office of Research Assurances shall provide administrative support necessary for the IRB to fulfill its duties. 

C-4. UNIVERSITY INVESTIGATORS (FACULTY, STUDENTS, AND STAFF). Any person who engages in human subject research (See B. Covered Activities, above) under the auspices of the University (including faculty, students, and staff) shall comply with applicable federal, state, and local law, with University policy, and with the requirements of the IRB. 

D. ORGANIZATION AND MEMBERSHIP OF THE IRB. The IRB shall be organized and its membership determined in accordance with federal regulations and University policy (FSH 1640.54).

E. REVIEW OF HUMAN SUBJECT RESEARCH. 

E-1. The IRB shall conduct initial and continuing review of human subject research activity, following established procedures appropriate to the degree of risk involved in the research. IRB review of research shall be prospective, and no human subject research activity may be carried out by an investigator without prior approval from the IRB. The IRB shall not provide retrospective approval of human subject research. 

E-2. The IRB, or its designee, shall review all research that meets the regulatory definition for human subject research but may be eligible for exemption from further review and oversight (see B. Covered Activities above). The IRB, or its designee, shall make the final determination as to whether a particular research activity involving human subjects is exempt. For activities determined to be exempt, the IRB shall provide the investigator with a certification of exemption from continuing IRB oversight. 

E-3. The IRB, or its designee, shall provide guidance to investigators as to what activities do not constitute human subject research and, therefore, do not require IRB oversight. The IRB shall provide, as necessary, certification to investigators that research activity is not human subject research.

F. UNIVERSITY OF IDAHO IRB STANDARD OPERATING PROCEDURES. The administrative policies, guidelines, and procedures developed to implement this policy shall be set forth in the University of Idaho IRB Standard Operating Procedures, which shall be maintained and made available to investigators by the Office of Research Assurances. The University of Idaho IRB Standard Operating Procedures shall be reviewed and approved by the Signatory Official or designee in consultation with the IRB.

G. CONTACT INFORMATION. For further information regarding implementation of this policy, you may visit the IRB website or contact the Office of Research Assurances at 208-885-6340 or ored-ora@uidaho.edu 

Version History

Amended 2022. Editorial changes.

Amended 2018. Changes made to bring this policy into compliance with new federal regulations.

Amended February 2010. Substantially revised in accordance with federal law and university polices.

Amended 2009. Renamed Human Assurances Committee to the Institutional Review Board.

Amended July 2003. Revised to reflect changes in applicable federal law.

Amended July 1995. Revised to reflect changes in applicable federal law.

Adopted 1979.