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IRB Procedures

 

Human Subjects Protection

Supplements System Policy 15.99

  1. Texas A&M University-Texarkana 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, 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 Vice President of Academic Affairs, to staggered three-year terms. 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.The IRB will meet a minimum of once a semester, with additional meeting called as needed.
     

  4. Each program that conducts research using human subjects shall as a committee review research proposals and then forward them to the college Dean.  The Dean will either approve the proposal as ready for review by the IRB or require that the proposal be modified and resubmitted to the program by the principal investigator.  All proposals submitted to the program must include the IRB submission form and the complete protocol, including the consent form.
     

  5. Each program may designate one or more faculty members to review proposals for review of the Dean.
     

  6. All documentation associated with IRB reviews will be maintained by the Chair of the IRB.
     

  7. The IRB shall review and have the authority to approve, tentatively approve pending receipt of additional information, or disapprove the proposed research. All researchers must complete training for ethical conduct of research with human participants. The training is online at IRB Required Researcher Computer-Based TrainingThe completion certificate must be turned in to the IRB chair before the application can be reviewed.
     

  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. The Chair will perform an expedited review and determine the need for any additional review, 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.

 

Adapted with permission from Texas A & M –Commerce IRB Policy, 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, and Texas A & M Policy.

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 CONTACT FOR INTERPRETATION:  Chair Institutional Review Board  / Dr. Tommie Hughes