POLICY
UTHealth Houston is committed to protecting the rights and welfare of individuals who participate in human subject research conducted under its authority.
Ethical Requirements:
All such research must be carried out in accordance with the ethical principles set forth in the Belmont Report. Published in 1979 by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, the Belmont Report serves as the ethical foundation for federal regulations governing human subject research. All individuals involved in the conduct, review, or oversight of human subject research under the jurisdiction of the UTHealth Houston Institutional Review Board (IRB) are required to comply with these fundamental ethical principles.
Respect for Persons - Individuals involved in research must be treated as autonomous agents who are capable of making informed decisions regarding participation. Persons with diminished autonomy, including children, prisoners, and individuals with cognitive impairments, are entitled to additional safeguards. This principle is applied through the informed consent process, which ensures that participation is voluntary and free from coercion or undue influence. Informed consent must be obtained from the participant or a legally authorized representative unless a waiver or alteration of consent is permitted under applicable federal regulations and approved by the UTHealth Houston IRB.
Beneficence - Research must be designed and conducted in a manner that maximizes potential benefits and minimizes potential risks to participants. This requires a thorough assessment of the risks and anticipated benefits of the research to ensure that risks are reasonable in relation to the expected benefits to participants or to society. Risk evaluation includes consideration of both the probability and magnitude of harm, including physical, psychological, social, legal, and economic risks.
Justice - The selection of research participants must be equitable, ensuring that the benefits and burdens of research are fairly distributed. Application of this principle requires careful review of recruitment and enrollment procedures to prevent the inappropriate inclusion of individuals or groups based solely on ease of access, compromised position, or vulnerability. Special consideration must be given to protecting populations that may be at increased risk of coercion or undue influence.
Regulatory Requirements
The UTHealth Houston IRB and the research community are responsible for ensuring that all human subject research complies with applicable regulations and policies, including:
- Federal Policy for the Protection of Human Subjects (Common Rule): All research conducted under the UTHealth Houston IRB must adhere to the Federal Policy for the Protection of Human Subjects (45 CFR Part 46, Subpart A, also known as the “Common Rule”) as well as any additional subparts outlined in 45 CFR Part 46. The same policies and procedures are used for all human subject research reviewed by the IRB.
- FDA-Regulated Research - Research involving test articles regulated by the Food and Drug Administration (FDA) must comply with FDA regulations governing the protection of human subjects (21 CFR Part 50) and Institutional Review Boards (21 CFR Part 56).
- Human Subjects Research Supported by Other Federal Agencies - Human subject research funded or overseen by other federal agencies must follow the applicable regulatory requirements and guidance specific to those agencies.
- Other Applicable Laws and Regulations - When relevant, research must also comply with additional federal, state, and local laws and regulations concerning human subjects.
IRB staff review each research study to determine which regulations apply. IRB staff regularly consult current guidance and resources from OHRP and the FDA, as well as other relevant interpretive materials, policies, and guidance documents, to inform determinations regarding the rights and welfare of human subjects participating in research studies. The IRB staff will work with the Office of Legal Affairs to resolve conflicts between federal or national law and other applicable laws.
Federalwide Assurance
UTHealth Houston has signed a federalwide Assurance (FWA #00000667) which defines the obligation of the UTHealth Houston to ensure the rights and welfare of human subjects of research are protected. Under the FWA, the UTHealth Houston Institutional Review Board (IRB), also known as Committee for Protection of Human Subjects (CPHS), must review all proposed research involving human subjects to determine if adequate measures are in place to protect participants.
UTHealth Houston is committed to upholding its FWA. The Vice-President of the Human Research Protection Program (VP HRPP) is the signatory on the federalwide assurance and is the designated Institutional Official (IO). It is the IO’s responsibility to exercise appropriate administrative oversight to assure that UTHealth Houston’s policies and procedures for protecting the rights and welfare of human participants are applied in compliance with its Assurance.
The IO or designee will update the UTHealth Houston FWA within 90 days after changes occur regarding the legal name of the institution, the Human Protections Administrator, or the Signatory Official. The FWA is effective for 5 years and must be renewed every 5 years, even if no changes have occurred, in order to maintain an active FWA.
IRB Registration:
The IO or designee is responsible for maintaining the IRB registration and 3-year renewals. The IRB office will maintain an IRB roster that lists all the IRB members identified by name; earned degrees; representative capacity indications of experience such as board certifications, licenses, etc. The IO or designee will submit a revised IRB roster annually at the start of each new term in September, if there are changes to IRB membership.
The IO or designee will register any new IRB panel before it begins to review research. The IO or designee will revise the registration information:
- Within 90 days, when the IRB's contact or chairperson information changes.
- Within 30 days, when the IRB's decision to review new types of FDA-regulated products (such as a decision to review studies pertaining to food additives whereas the IRB previously reviewed studies pertaining to drug products), or to discontinue reviewing clinical investigations regulated by FDA.
- Within 30 days, when an IRB disbands.
- All other information changes will be reported at the time of renewal of registration.
director or delegate office leadership will maintain a copy of the FWA and IRB registration within the IRB office.
REFERENCES
- 45 CFR 46 Protection of Human Subjects
- 21 CFR 56 Institutional Review Board
- OHRP FAQ – IRB Registration Process
- OHRP FAQ Assurance Process
- FDA FAQ - IRB Registration
If you find errors in this document, contact [email protected]
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Document Number: |
101-A01 |
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Document Name: |
Federalwide Assurance and IRB Registration |
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Reviewed by: |
Associate Vice President, Research Compliance |
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Effective: |
1 Aug 2008 |
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Revision History: |
1 Aug 2011, 1 Jun 2016, 21 Jan 2019, 1 Jun 2021, 1 Jun 2026 |
Please contact the IRB office for answers to questions, express concerns, and convey suggestions regarding human subjects protections.
IRB Office House: Thursdays, 1–4pm via Teams Room
Email: [email protected]
IRB Helpline: 713-500-7943 (please leave a message and we will get back to you as soon as possible)
iRIS Helpline: 713-500-7960
IRB Review Feedback: IRB Survey
Houston, Texas 77030
Phone: 713-500-7943
Email: [email protected]
Committee for the Protection of Human Subjects
IRIS Support: 713-500-7960
