Risk and Compliance: Human Subjects in Research

AboutResponsible for providing training and support to faculty and staff engaged in scientific research involving human subjects. Specific areas include, but are not limited to IRB application support and guidance using iRIS, approval process assistance, and continuing review of IRB protocols.

 

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Approval Process | Statement on Human Subjects Research
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All individuals engaged in human subjects research that is sponsored by Texas A&M AgriLife; conducted by or under the direction of any faculty, staff, or agent of Texas A&M AgriLife in connection with his or her institutional responsibilities; conducted by or under the direction of any employee or agent of Texas A&M AgriLife using any property or facility of Texas A&M AgriLife; or involved in the use of Texas A&M AgriLife’s non-public information to identify or contact human research participants or prospective participants, must submit an application to the IRB prior to commencement of any research activities.

 

 

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Texas A&M AgriLife is committed to the protection and safety of human subjects involved in research. As such we take very seriously the need for compliance with applicable state and federal laws and regulations for human subjects research, and the need for compliance with the terms of the Federal Wide Assurance for Protection of Human Subjects (as approved by the U.S. Department of Health and Human Services, Office of Human Research Protections), which provides authority to carry out such research and receive federal funding for its support. AgriLife is equally committed to the continued enhancement of our Human Subjects Protection Program (HSPP) in a manner that promotes compliance without compromising the conduct of outstanding research.

Investigators are responsible for reporting non-compliance to the Institutional Review Board (IRB) using the standard reporting form. Any change, divergence, or departure from the study design or procedures of a research protocol that affects the subject’s rights, safety, or well being and/or the completeness, accuracy, and reliability of the study data constitutes non-compliance. Changes or alterations in the conduct of the trial which do not have a major impact on the subject’s rights, safety, or well-being, or on the completeness, accuracy, and reliability of the study data also represent non-compliance. For example, enrollment of more subjects than the number approved by the IRB is non-compliance and must be reported promptly.

 

 

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 Texas A&M AgriLife Risk and Compliance / 979-845-7879

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