15.99.01.R0.01 Human Subjects Protection
Effective September 1, 2000
Supplements System Policy 15.99
Reviewed by Graduate Council FY03

1. Texas A&M University-Commerce recognizes the need for investigation in which human beings may serve as research subjects. The University acknowledges and accepts its responsibilities for ensuring that the privacy, safety, health, and welfare of such subjects are adequately protected. All research, which involves any form of participation of human subjects, qualifies as human subject research. This includes certain survey research, research by students as well as by faculty and staff and both internally and externally funded research.

2. Following Federal guidelines (CFR US Part 46), a five or more member Institutional Review Board (IRB) will be appointed by the President of the University, in consultation with the Dean of Graduate Studies and Research, to staggered three-year terms. The Chair will be granted a one-course released time from his/her assigned teaching responsibilities for the term of the appointment. The Board will review research proposals in regard to the protection of human subjects in research. Additionally, the Chair and/or others the Chair deems appropriate will be responsible for training faculty, students, staff and new appointees to the IRB regarding the procedures and requirements for the protection of human subjects in research.

3. The IRB will function according to applicable federal rules and regulations and follow the procedures described in the University IRB Procedures and Guidelines Manual.

4. Each department that conducts research using human subjects shall appoint a Department Human Subjects Committee (DHSC) to review research proposals. The DHSC will either approve the proposal as ready for review by the IRB or require that the proposal be modified and resubmitted to the DHSC. All proposals submitted to the DHSC must include the IRB submission form and the complete protocol, including the consent form.

5. For all funded research involving human subjects, the Office of Graduate Studies and Research, will be responsible for coordinating the submission of required documentation to the DHSC and the IRB for review.

6. All documentation associated with DHSC and IRB reviews will be maintained within the Graduate School. The Office of Graduate Studies and Research will provide staff support to the IRB in all phases of its work, help track and monitor submissions, and maintain records related to all research involving human subjects. The Office of Graduate Studies and Research will be responsible for determining that all theses and dissertations have received approval by the DHSC and IRB.

7. The IRB shall review and have the authority to approve, tentatively approve pending receipt of additional information or disapprove the proposed research.

8. Continuing review of research must be conducted at intervals appropriate to the degree of risk, but not less than once per year. The IRB cannot approve a research project for more than 12 months. All reviews for continuation will be conducted by expedited review, if no changes have been made to the research protocol and no adverse or unexpected reactions or side effects have occurred or are expected. If the investigator, during the course of conducting the research, revises the research protocol (e.g., makes changes to the informed consent form, survey instruments used or number and nature of subjects), the principal investigator must notify the IRB Chair immediately and in the case of funded research, the Office of Graduate Studies and Research. The Chair will determine the need for additional review, the type of review, full or expedited, and notify the IRB members.

9. In general, a human subjects research proposal should provide that: risks are minimized through procedures consistent with sound research design (reasonable risks beyond those incurred in daily life may be out-weighed by benefits to the subjects), selection of subjects is equitable and the setting appropriate, informed consent is adequate, consent is documented, continued monitoring takes place to ensure the safety of the subjects and privacy and confidentiality are maintained.

10. Participation of a human subject in any study must be voluntary and the information provided to gain subject consent must be adequate and appropriate. The IRB may choose to waive the requirement for informed consent in some cases; however, such action must be based on clearly defensible grounds.

References: References: Prior ETSU Policy B-104
Code Of Federal Regulations, Title 45 Public Welfare, Department Of Health And Human Services, National Institutes Of Health, Office For Protection From Research Risks, Part 46, Protection Of Human Subjects, Revised June 18, 1991, Effective August 19, 1991, September 1, 2000; Procedure A15.02

***************

CONTACT FOR INTERPRETATION: Dean for Graduate Studies and Research