Approved: January 21, 2014
Next Scheduled Review: January 21, 2019
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’s procedures for safeguarding the rights of individuals shall be consistent regardless of sources of funding. Therefore, TTI has adopted guidelines and protocol procedures for the use of human subjects in research.
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, whether funded or unfunded, 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.
1.4 TTI shall develop written IRB procedures, including procedures relating to the review of human subject research protocols and reporting guidelines. A specific protocol must be developed for each TTI project that uses human subjects in research, whether funded or unfunded. This protocol must be approved by the Texas A&M IRB before the initiation of any project tasks involving human subjects.
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 IRB for review and approval.
2.2 PIs shall submit continuing reviews to the TAMU IRB as directed, but not less than annually.
2.3 For research projects involving more than one TAMUS component, all respective IRBs must approve the protocol, unless there is:
- a joint review arrangement;
- reliance upon the review of another qualified IRB; or
- similar arrangements for avoiding duplication of effort.
If the research involves federal funding and A, B or C above is utilized, the review process must be approved by OHRP or the funding agency.
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 Development Office