Research Projects Involving Human Subjects
SUPERCEDED on May 21, 2009
Procedure No.: 19.052
Page No.: 1 and 2 of 2
Date Issued: 01/30/86
Issued By: Ronald Barr
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- This policy applies to research investigations involving human subjects conducted by faculty, staff or students at, or under the auspices or financial support of Ohio University.
- A. 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.
B. To bring Ohio University policy on biomedical and behavioral research involving human subjects into compliance with the requirements set forth in the National Research Act (P.L. 93-348) and the regulations on public welfare set forth in Part 46 of Title 45 of the Code of Federal Regulations (45 CFR 46).
All research activity involving human subjects at Ohio University must be approved by the Institutional Review Board for Review of Research Involving Human Subjects (IRB) or a determination made by the IRB that the research is exempt from review. The review shall determine whether these subjects will be placed at risk, and when risk is involved, all of the following requirements will be satisfied:
- Risks to subjects are minimized by using procedures which are consistent with sound research design but which do not unnecessarily expose subjects to risk.
- 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.
- Selection of subjects is equitable.
- Informed consent will be sought from each prospective subject or the subject's legally authorized representative.
- Informed consent will be appropriately documented.
- Where appropriate the research plan makes adequate provision for monitoring the data collected to insure the safety of subjects.
- 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.
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B. Implementation Procedures
Implementation procedures shall rest upon the establishment of the Institutional Review Board, a recognized function of which shall be to provide advice and guidance to investigators regarding the protection of the rights and welfare of human subjects. Ultimate responsibility for the rights and welfare of human subjects, however, remains with the investigator; review and approval of a project do not relieve the investigators of that responsibility.
The Institutional Review Board shall be constituted in compliance with the Code of Federal Regulations, Title 45, Part 46.
C. General Principles Guiding Project Review
- Ohio University and the individual members of its faculty, staff and student body engaged in investigations and educational projects have a responsibility for protection of the rights and welfare of human subjects.
- Appropriate professional attention and facilities shall be provided to ensure the safety and well-being of human subjects. No subject in an investigation shall be exposed to unreasonable risk to his physical or psychological health.
- Before a subject participates in an investigation involving any physical or psychological risk or substantial stress or discomfort, such risks shall be carefully explained to the subject, and the invesitgator shall be satisfied that the explanation has been understood by the subject. The subject's written consent which contains a summary of the explanation and advice regarding risks, benefits, and compensation and medical treatment, if any, for physical injury resulting from the investigation, shall be obtained and kept as a matter of record of at least four years.
- A request by any subject for withdrawal from an investigation shall be honored promptly without penalty.
- Any investigation which undergoes substantial modification of design so as to change the effect on the rights or welfare of the human subjects involved must be resubmitted to the Institutional Review Board for re-evaluation. It shall be the responsibility of the project director to request such review prior to initiation of the modification.
D. 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.
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Dick Piccard revised this file (http://www.ohio.edu/policy/s19-052.html) on June 1, 2009.
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