6,510: Policy on the Use of Human Subjects in Research, Development and Related Activities
Last Revised: June 2010
All members of an academic community engaged in research, development, and related activities involving the use of human subjects have obligations to their subjects and to the University. This policy is intended to give broad guidelines for conducting such activities.
University policy requires that researchers respect and protect the rights and welfare of individuals recruited for, or participating in, research conducted by or under the auspices of the University of Nevada, Reno (UNR), including the University of Nevada School of Medicine (UNSOM). In the review and conduct of research, actions by the University and UNSOM are guided by the principles (i.e., respect for persons, beneficence, and justice) set forth in the Ethical Principles and Guidelines for the Protection of Human Subjects of Research (often referred to as the "Belmont Report") and are performed in accordance with the Department of Health and Human Services (DHHS) policy, Title 45 Code of Federal Regulations (CFR), Part 46 (also known as the "Common Rule") and with the Food and Drug Administration (FDA) policy, Title 21 CFR Part 50 and Title 21 CFR Part 56. In addition, the actions of the University shall also conform to all other applicable federal, State, and local laws and regulations.
To conduct this responsibility effectively, the President of the University has appointed the Vice President for Research as the Institutional Official to ensure that the university's human research protection program is appropriately supported and its federal-wide assurance filed with the Department of Health and Human Services is executed. The Institutional Official has the authority to act for the institution and to assume on behalf of the institution the obligations imposed by the federal regulations pertaining to human research protection; however, the Institutional Official or other organizational officials may not approve research that has not been previously approved by one of the Institutional Review Boards (IRBs).
The human research protection program maintains federally sanctioned IRBs. The primary functions of the IRBs are administrative, educational, and consultative. Their purpose is to facilitate ethical research and optimum protection of human subjects while also insuring the academic freedom of researchers and instructors.
The IRBs review and have authority to approve, require modifications in (to secure approval), or disapprove all human research activities overseen and conducted by the University and its affiliates for which the IRB(s) serve as the "IRB of Record"; to suspend or terminate approval of research that is not conducted in accordance with the IRB's requirements or that has been associated with unexpected serious harm to subjects; to require that information given to the subjects as a part of informed consent is done in accordance with the federal regulations and university policy, including observing or having a third party observe the consent process of the conduct of research.
The IRBs are not concerned with the quality, direction, or scope of activities being proposed, except when such consideration is required as part of the actual protection of human research subjects. Accordingly, the IRBs must decide whether a proposed research, development, or related activity places human subjects at risk.
The expression "subject at risk" means any person(s) who may be exposed to the possibility of any type of personal harm as a consequence of participation as a research subject. Members of the IRBs reviewing activities involving the use of human subjects have obligations to ensure that the following principles are applied in their deliberations:
- The rights and welfare of human subjects are adequately protected;
- The risks to the subject(s), in the judgment of the review committee, are outweighed by the potential benefits, either to the subject directly or to advancing scientific understanding in general,
- The confidentiality of the subject is maintained; and
- The informed consent of all subjects is obtained through methods that are both adequate and proper. Such consent is voluntary and subjects are free to withdraw and discontinue participation in a specific research project at any time.
The UNR Policies and Procedures for Human Research Protection details the policies and regulations governing research with human subjects and the requirements for submitting research proposals for review by the UNR IRBs. These policies and procedures, administered by the UNR Office of Human Research Protection, apply to all research involving human subjects, regardless of sponsorship and performance site, if UNR or UNSOM faculty, staff, students, or facilities are involved. In accordance with these policies and procedures, it is the responsibility of the administrative heads of these units or the academic deans to which these units report to assist in a continuing review of all activities involving the use of human subjects.
Departments, research institutes, and public service branches of UNR may conduct research, development, and related activities for which the support is obtained from appropriated and federal pass-through monies or from endowments and gifts to the university. It is the responsibility of the UNR faculty and students planning to submit proposals involving the use of human subjects to any sponsor to have their proposals and protocols submitted to the appropriate UNR IRB in accordance with sponsor guidelines and university policy. Financial support for any research activity involving the use of human subjects may not be released until the researcher has satisfied all requirements for human research protection.
University contributions to the training of students or to the resolution of questions concerning the human condition may involve the participation of humans in teaching and research experiences, in studies on human behavior, or on the influence of man-made or natural environmental factors on human welfare. The responsibilities of the teacher or researcher and the rights of the students or subjects researched are properly defined through a policy relating to each cooperator:
- The multiple values of human participation in research are recognized. Thus, students in a given class may be invited to serve as human subjects in research when such participation meets the pedagogical purposes of the course. Students are advised that they may complete an alternative assignment requiring an equivalent effort on their part if they are unable or unwilling to participate as a subject.
- As members of the academic community, students directing research, development, or related activities also have obligations to their subjects and to the University. The immediate supervisor or faculty advisor must inform students involved in the above activities of the university policy and of the procedures for obtaining approval from one of the IRBs.
- Although answering to the administrative units, faculty and students involved in the use of human subjects are the responsible parties for the development of research procedures and for submitting protocols of these activities for approval.
UNR is committed to ensuring that initial and continuing educational opportunities related to ethical concerns and regulatory and institutional requirements for the protection of human subjects are provided to researchers, IRB members, and staff of the UNR Office of Human Research Protection. All investigators and study personnel conducting research involving human subjects, or data or biological specimens derived from such research, must maintain certification of human research protection training.