Institution Policies
- Committee on Research Involving Human Subjects – UTDPP1035
- Policy on Payment of Research Subjects – UTDBP3036
- Information Security and Acceptable Use -UTDBP3096
Office of Human Subjects Protections Policies and Procedures
OHSP Policy and Procedure Library
1. Authority & Institutional Commitment
2. Conducting Research
- 2.1 Research Involving Performance Sites
- 2.2 Offsite Research, Cooperative Research, and Unaffiliated Research
- 2.3 Biospecimens and Data
- 2.4 Human Subject Research Determination
- 2.5 Subject Privacy and Confidentiality
- 2.6 International Research
- 2.7 Internet Research
- 2.8 DoD Funded Studies
- 2.9 Data and Safety Monitoring
3. Records and Documentation
4. Committee Roles & Responsibilities
6. Researcher Responsibilities
8. Vulnerable Participants
10. Education & Training
Texas State Laws
Researchers must ensure all research activities are compliant with applicable state laws including reporting requirements below
What to Report?
Child Abuse or Neglect
Any person who suspects that a child (a person under 18 years of age) has been abused or neglected is required to report it immediately. This includes researchers, even if the information is obtained during study procedures.
Texas Code – Texas Family Code Chapter 261, Investigation of Report of Child Abuse or Neglect.
Abuse, Neglect or Exploitation of Elderly or Disabled Persons
Any person who suspects that elderly (a person above 60 years of age) or a disabled person has been abused, neglected, or exploited is required to report it immediately. This includes researchers, even if the information is obtained during the study
How to Report?
Failure to report suspected abuse is considered a criminal offense in Texas. Reporting to the Texas Department of Family and Protective Services (DFPS) or any local/state law enforcement agency through the Texas Abuse Hotline at 1-800-252-5400 or online at Texas Abuse Hotline Website.
Federal Regulations
The list below represents a few of the federal agencies from which UTD receives support for human subjects research. The links below reference federal websites or documents that contain policies, explain specific provisions, and provide links to resources for that agency.
U.S. Department of Health and Human Services (HHS)
- Protection of Human Subjects (45 CFR Part 46)
- The Common Rule
- 2018 Common Rule Update
- Information about regulatory changes effective January 21, 2019 guidance on implementation at UTD
Food and Drug Administration (FDA) Regulations
- Protection of Human Subjects (21 CFR Part 50)
- Institutional Review Boards (21 CFR Part 56)
- Investigational Device Exemption (21 CFR Part 812)
- Electronic Records, Electronic Signatures (21 CFR Part 11)
Department of Defense
- Protection of Human Subjects (32 CFR Part 219)
- Limitations on the Use of Humans as Experimental Subjects (10 USC 980)
- Protection of Human Subjects and Adherence to Ethical Standards in DoD-Supported Research (DoD Instruction 3216.02)
Data Protection Policies
FERPA (Family Education Rights and Privacy Act)
Protects the privacy of student education records and establishes guidelines for accessing records
GDRP (General Data Protection Regulation)
Mandates standards for handling certain personal data of residents of the European Union (EU) and non-EU citizens located in the EU.
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.