19.052:  Research Projects Involving Human Subjects

The purposes of this policy are twofold:

1. To protect the rights and personal privacy of individuals; to assure a favorable climate for the conduct of scientific inquiry; and to protect the interests of Ohio University.

2. To ensure that research involving human subjects at Ohio University complies with federal, state, and local laws and regulations. These include the requirements set forth in the Health Research Extension Act of 1985 (P.L. 99 - 158); the regulations on public welfare set forth in Part 46 of Title 45 of the Code of Federal Regulations (45 CFR 46); Food and Drug Administration (FDA) Regulation on Human Subjects Protections, Parts 50 and 56 of Title 21 of the Code of Federal Regulations (21 CFR 50 and 21 CFR 56); principles set forth in "The Belmont Report"; and the university's assurance with the Office for Human Research Protections (OHRP).

I.   General Statement

All research activity involving human subjects must be submitted to the Office of Research Compliance ("ORC") and receive written, unconditional approval before commencing. This applies to all research activities, regardless of discipline, funding status, or the level of risk foreseen. Based on federally defined criteria, some research is exempt from review by the Institutional Review Board for Review of Research Involving Human Subjects ("IRB"). This determination must be made by the ORC or its designate and must be documented in writing prior to commencing the research. Non-exempt research must be reviewed by the IRB. In collaborative research, review may occur by multiple IRBs. Approval of research by another IRB does not negate the need for IRB review at Ohio University.

Any employee reporting concerns about human subject research to external agencies is encouraged also to report those concerns to a university Institutional Official (defined below) prior to or at the same time as reporting to an external agency. This will assist the university in taking the appropriate action to correct any concerns, and will assist the university in complying with Federal, State, and Local laws and regulations.

II.   Definitions

A.   Research (as defined by 45 CFR 46)

A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

B.   Human Subject (as defined by 45 CFR 46)

A living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.

C.   Institutional Official

The individual at a research facility who is authorized to legally commit on behalf of the research facility that the requirements of regulatory agencies will be met. Contact the Institutional Official through the office of the Vice President for Research.

The IRB shall be constituted in compliance with the regulatory codes set forth in item two in the Purpose section, above. Members will be appointed by the Institutional Official, with the advice and counsel of the sitting committee and practicing scientists, who will hold a voting majority on the committee. Members will serve three-year terms. The IRB will report to the Institutional Official, as designated in the Federal Wide Assurance with the Office of Human Research Protections.

I.  General Principles Guiding Project Review

The review shall determine that the following requirements (45 CFR 46.111) will be satisfied:

1. Risks to subjects are minimized by using procedures that are consistent with sound research design and that do not unnecessarily expose subjects to risk.

2. Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result.

3. Selection of subjects is equitable.

4. Informed consent will be sought from each prospective subject or the subject's legally authorized representative.

5. Informed consent will be appropriately documented.

6. Where appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.

7. Adequate provision is made to protect the privacy of subjects and to maintain the confidentiality of data. Where some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as persons with acute or severe physical or mental illness, or persons who are economically or educationally disadvantaged, appropriate additional safeguards must be included in the study to protect the rights and welfare of these subjects.

II.  Additional Review Levels

This policy does not limit the right of an academic or administrative unit from establishing its own review procedures for research conducted under its auspicies. Such review may supplement but may not be a substitute for review by the IRB. If the IRB has denied approval of a research project, the decision of the IRB may not be overturned at other review levels.

1. President

2. Executive Vice President and Provost

3. Executive Staff

4. Vice President for Research

5. Faculty Senate

6. Institutional Official

7. Institutional Review Board

8. General Counsel

9. Policy and Procedure Review Committee

1. The IRB Project Outline Form and instructional guidelines are available from the Office of Research Compliance, or online from http://www.ohio.edu/research/compliance/IRB-Forms.cfm.

2. The IRB Periodic Review Form and instructional guidelines are available from the Office of Research Compliance, or online from http://www.ohio.edu/research/compliance/IRB-Forms.cfm.