In the context discussed here, the terms Research and Human Subjects are defined as follows:
Research is defined as a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research even if they are a component of a larger non-research activity (e.g., instruction, demonstration).
Federal regulations define a human subject as a living individual about whom an investigator, whether a professional or a student, conducting research obtains (1) data through intervention or interaction with the individual; or (2) identifiable private information. All human-subjects protocols are reviewed in accordance with the requirements set forth in the Code of Federal Regulations Title 21 Parts 50 & 56 and Title 45 Part 46, whether the project is sponsored by a government agency or a private funding source.
The University must ensure that research conducted under its jurisdiction does not expose human participants -- those participating as research subjects or respondents -- to unreasonable risks to their health, general well-being, or privacy. Specifically, the University is concerned that:
- The rights and welfare of the individuals involved are adequately protected;
- The subject's participation is freely given, through legally effective informed consent; and
- The risks to the subject are reasonable in relation to the sum of the benefit to the subject and the importance of the knowledge to be gained as to warrant a decision to allow the subject to accept these risks.
While primary responsibility for protecting the rights and welfare of research subjects rests with the principal investigator conducting the research, others engaged in the conduct of the research share in this responsibility. Teachers who assign or supervise research conducted by students have an obligation to consider carefully whether those students are qualified to adequately safeguard the rights and welfare of subjects.
To ensure the above considerations are met, the Office of the Vice President for Research and Economic Development established a centralized Human Subjects Office and corresponding Institutional Review Boards to review human subjects research conducted at the University or under its auspices.
The HSO provides administrative support to the Institutional Review Boards, assisting investigators and research staff who are preparing IRB applications and maintaining records of IRB reviews and approvals. The IRBs are charged with reviewing and approving any project involving human subjects before the research can begin. An IRB must review a project when:
- The research is sponsored by the institution;
- The research is conducted by or under the direction of any employee or agent of this institution, including a student, in connection with his or her institutional responsibilities;
- The research is conducted by or under the direction of any employee or agent of this institution, using any property or facility of this institution; and/or
- The research involves the use of this institution's non-public information to identify or contact human subjects. In addition, the IRB reviews the project information to determine whether subjects are informed about the nature of the study, the details of their participation, and the voluntary nature of their participation, and considers whether the risks and benefits of the research are evenly distributed among the possible subject populations.
The University has, in all, four IRBs:
- IRB-01 Biomedical;
- IRB-02 Behavioral/Social Science;
- IRB-03 VAMC and;
- IRB-04 Department of Defense projects
The Human Subjects Office staff and Institutional Review Board chairs are available to assist with any questions, encouraging investigators to visit the HSO in 105 Hardin Library for the Health Sciences (HLHS),
call 335-6564, and/or e-mail email@example.com. Additional information is also available on the HSO website.