- Committee on Research Involving Human Subjects – UTDPP1035
- Policy on Payment of Research Subjects – UTDBP3036
- Information Security and Acceptable Use -UTDBP3096
- CFR 45 Part 46, Protection of Human Subjects (revised January 15, 2018, effective July 15, 2018)
- 21 CFR 50 — FDA regulations
- 21 CFR 56 — FDA regulations
General Guidance and Helpful Information
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.
- Office for Human Research Protections (OHRP)
- Office for Human Research Protections (OHRP) Educational Videos
- Investigator Responsibilities FAQs (OHRP)
- Research with Children FAQs (OHRP)
- Prisoner Research FAQs (OHRP)
- International Compilation of Human Research Standards
- Compilation of European GDPR Guidance
- IRB Guidebook (OHRP)