POLICY
It is the policy of UTHealth Houston that with the help of legal counsel, the UTHealth Houston Human Research Protection Program (HRPP) shall ensure that all research activities are compliant with applicable federal and state laws.
Key Terms:
Legally Authorized Representative of a patient means:
- a parent or legal guardian if the patient is a minor;
- a legal guardian if the patient has been adjudicated incompetent to manage the patient's personal affairs;
- an agent of the patient authorized under a durable power of attorney for health care;
- an attorney ad litem appointed for the patient;
- a guardian ad litem appointed for the patient;
- a personal representative or statutory beneficiary if the patient is deceased; or
- an attorney retained by the patient or by another person listed by this subdivision.
PROCEDURE
Mandatory Reporting
Child Abuse or Neglect - Professionals are required to report no later than the 48th hour after the professional has cause to believe the child has been or may be abused or is the victim of the offense of indecency with a child.
Abuse, Neglect or Exploitation of Elderly or Disabled Persons - A person having cause to believe that an elderly or disabled person is in the state of abuse, neglect, or exploitation shall report immediately to the Department of Protective and Regulatory Services.
Notifiable Condition - A physician, dentist, veterinarian, chiropractor, advanced practice nurse, physician assistant, or person permitted by law to attend a pregnant woman during gestation or at the delivery of an infant shall report, as required by these sections, each patient (person or animal) he or she shall examine and who has or is suspected of having any notifiable condition, and shall report any outbreak, exotic disease, or unusual group expression of illness of any kind whether or not the disease is known to be communicable or reportable.
Cancer - All laboratories, hospitals, facilities and practitioners are required to report to the Department of Health within 6 months of diagnosis any cancer in an individual if making the initial diagnosis. The report includes the diagnosis, occupation, family history and personal habits of the person diagnosed with cancer.
Review - IRB members are to be aware of the state law that may be relevant to the conduct of human subjects research and are to apply it to the consideration of whether research meets the criteria for approval, and to consider whether disclosure of the implications of the law is required for legally effective informed consent.
APPLICABLE REGULATIONS
- Texas Human Resources Code § 48. (n.d.). Investigations and protective services for elderly and disabled persons. Texas Legislature. https://statutes.capitol.texas.gov
- Texas Department of State Health Services. (2006). Cancer registry (25 Tex. Admin. Code § 91). https://www.sos.state.tx.us/tac
- Texas Administrative Code, 25 Tex. Admin. Code § 97. (n.d.). Control of communicable diseases. Texas Department of State Health Services. https://www.sos.state.tx.us/tac
- Texas Civil Practice and Remedies Code § 129. (n.d.). Age of majority. Texas Legislature. https://statutes.capitol.texas.gov
- Texas Education Code § 51.3525. (n.d.). Responsibility of governing boards regarding diversity, equity, and inclusion initiatives. Texas Legislature https://statutes.capitol.texas.gov
- Texas Family Code § 261. (n.d.). Investigation of report of child abuse or neglect. Texas Legislature. https://statutes.capitol.texas.gov
- Texas Family Code, Title 2, Chapter 32, Subchapter A. (n.d.). Consent to treatment of child by non-parent or child. Texas Legislature. https://statutes.capitol.texas.gov
- Texas Health and Safety Code § 313. (n.d.). Consent to medical treatment act. Texas Legislature. https://statutes.capitol.texas.gov
If you find errors in this document, contact [email protected]
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Document Number: |
101-A03 |
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Document Name: |
Texas State Laws - Human Subjects Research |
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Reviewed by: |
Associate Vice President, Research Compliance |
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Effective: |
1 Sep 2008 |
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Revised: |
1 Aug 2011, 1 June 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
