UHD / Office of the Provost / Office of Research and Sponsored Programs / Committee for the Protection of Human Subjects / Human Subjects Research
Human Subjects Research
The University of Houston-Downtown (UHD) is committed to protecting the rights, safety, privacy, and well-being of individuals who participate in research. Research involving human participants or identifiable private information is subject to review and oversight by the Institutional Review Board (IRB).
The IRB ensures that human subjects research is conducted ethically and in accordance with applicable federal regulations, institutional policies, and the ethical principles outlined in the Belmont Report.
When is IRB Review Required?
Researchers must determine whether their project meets the definition of human subjects research and whether IRB review or an exemption determination is required before recruiting participants, collecting data, or beginning research procedures.
Key regulations may include:
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- 45 CFR 46 (Common Rule) – protections for human research participants.
- 21 CFR 50 and 56 – FDA requirements for informed consent and IRB oversight.
- 21 CFR 312 and 812 – requirements applicable to research involving drugs and medical devices.
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UHD may apply these protections to research regardless of funding source. Researchers should consult UHD ORSP/Research Compliance when they are unsure whether a project requires review.
IRB Submission
IRB applications are submitted to humansubjects@uhd.edu. Before beginning an application, researchers should:
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- Determine whether IRB review is required.
- Complete required human subjects research training through CITI Training.
- Principal Investigators require SBR Investigators (ID 62478) training.
- Complete the appropriate CPHS Application: New Research, Non-Human Subjects, Renewal/Revision.
- Prepare supporting documents, including consent forms, recruitment materials, surveys, interview questions, data collection tools, and other applicable materials.
- Submit a complete application and allow sufficient time for IRB review and requested revisions.
Incomplete submissions may be returned to the researcher for additional information before formal review begins.
IRB Review Catagories
Based on the nature and risk of the research, a project may qualify for:
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- Exempt determination
- Expedited review
- Full/Convened Board review
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The IRB or designated IRB staff will determine the appropriate review pathway based on applicable regulations and the information provided in the submission.
After IRB Approval
IRB approval must be obtained before beginning human subjects research activities. Researchers are responsible for conducting the study as approved and submitting required changes to the IRB before implementing modifications.
Researchers should also:
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- Keep the approved protocol and study documents current.
- Submit modifications before making changes to approved research, when required.
- Report unanticipated problems, noncompliance, or other reportable events as required.
- Maintain appropriate research records and participant protections.
- Complete continuing review or other required submissions when applicable.
- Ensure that research activities described in a grant or funding proposal are consistent with the IRB-approved protocol.
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IRB and Sponsored Research
For externally or internally funded research involving human subjects, ORSP Research Compliance may coordinate with the IRB to confirm that the research activities described in the funding proposal are consistent with the approved protocol. Researchers should ensure that any human subjects procedures included in a proposal are appropriately reflected in the IRB submission.
Questions and Resources
For questions about whether a project requires IRB review, submission requirements, training, or research changes, contact ORSP Research Compliance or visit CPHS.