Policies and Guidance

Institution Policies

Federal Regulations

CFR 45 Part 46, Protection of Human Subjects (revised January 15, 2018, effective July 15, 2018)
- Subpart A, The Common Rule
- Subpart B: Protections for Pregnant Women
- Subpart C: Protections for Prisoners
- Subpart D: Protections for Children
21 CFR 50 — FDA regulations
21 CFR 56 — FDA regulations

General Guidance and Helpful Information

Belmont Report

The Belmont Report sets forth basic ethical principles for the conduct of research involving human subjects. Those principles, respect for persons, beneficence, and justice, have been formally adopted by UTD through its Federalwide Assurance, for all research at UTD involving human subjects. Belmont is the foundation of the U.S. human subjects regulatory system.

Certificates of Confidentiality

Certificates of Confidentiality are issued by the National Institutes of Health (NIH) to protect identifiable research information from forced disclosure. The certificates may be granted for studies collecting information that, if disclosed, could have adverse consequences for subjects or damage their financial standing, employability, insurability, or reputation. A Certificate of Confidentiality will allow the researcher and others who have access to research records to refuse to disclose identifying information on individual research participants in civil, criminal, administrative, legislative, or other proceedings, whether at the federal, state, or local level.

Certificates of Confidentiality may be secured for any sensitive research, regardless of the funding source, so long as the research is relevant to the mission of the NIH/DHHS. In fact, the research does not have to be funded.