Approved: January 21, 2014
Revised: April 19, 2019
Reviewed: October 4, 2023
Next Scheduled Review: October 4, 2028
The Texas A&M Transportation Institute (TTI) will comply with the applicable laws relating to human subject research.
Reason for Rule
This rule implements System Regulation 15.99.01, Use of Human Subjects in Research.
Procedures and Responsibilities
1. ADMINISTRATIVE REQUIREMENTS
1.1 TTI has adopted guidelines and protocol procedures for safeguarding the rights of individuals in research involving the use of human subjects.
1.2 TTI has entered into a Memorandum of Understanding with Texas A&M University (TAMU), which has a registered Institutional Review Board (IRB). All research involving human subjects, must be approved by the TAMU IRB before the initiation of any project tasks involving human subjects.
1.3 TTI shall obtain a Federalwide Assurance (FWA) from the Office for Human Research Protections (OHRP) of the U.S. Department of Health and Human Services.
2. GENERAL GUIDELINES
2.1 TTI’s Principal Investigators (PIs) and Division Heads are responsible for ensuring that all research involving human subjects (including protocols which may be exempt, as defined in the federal regulations) is submitted to the TAMU IRB for review and approval.
2.2 PIs shall submit continuing reviews and completion reports to the TAMU IRB as directed, but not less than annually.
Related Statutes, Policies, or Requirements
- Code of Federal Regulations, 45 CFR 46
- Code of Federal Regulations, 21 CFR Part 50 and Part 56
- United States Code, 5 USC Part 301
- United States Code, 42 USC 289
- Belmont Report, April 18, 1979
- Federal Policy for the Protection of Human Subjects (‘Common Rule’)
- Additional US Food and Drug Administration Regulations
- System Regulation 15.99.01, Use of Human Subjects in Research
IRB – Each Institutional Review Board (IRB) shall meet the requirements set out in the federal regulations and register with the Office for Human Research Protections (OHRP) of the U.S. Department of Health and Human Services. All research on human subjects, whether funded or unfunded, must be approved by the System member’s IRB before the initiation of the research project.
OHRP – The Office for Human Research Protections (OHRP) is a part of the U.S. Department of Health and Human Services.
FWA – The Federalwide Assurance of Protection for Human Subjects (FWA) form is submitted to OHRP. The requirements for the FWA and sample forms, as well as controlling documents (such as the Belmont Report, 45 CFR 46, etc.), may be obtained from the official website of OHRP.
TTI Research Compliance Office