I.03

State Laws Relevant to Human Sujects Research

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PURPOSE

1. The purpose of this policy and procedure is to describe the areas where the federal and state law differ and provide guidance about regulatory compliance.

SCOPE

2. This policy and procedure is applicable to investigators, CPHS members and ORSC Staff.

DEFINTIONS

3. Legally Authorized Representative of a patient means:

1. a parent or legal guardian if the patient is a minor;
   
2. a legal guardian if the patient has been adjudicated incompetent to manage the patient's personal affairs;
   
3. an agent of the patient authorized under a durable power of attorney for health care;
   
4. an attorney ad litem appointed for the patient;
   
5. a guardian ad litem appointed for the patient;
   
6. a personal representative or statutory beneficiary if the patient is deceased; or
   
7. an attorney retained by the patient or by another person listed by this subdivision.

POLICY

4. With the help of legal counsel, UTHealth Human Research Protection Program shall ensure that all research activities are compliance with applicable federal and state laws.

5. Mandatory Reporting

5.1. Child Abuse or Neglect - Professionals a are required to report not later than the 48th hour after the hours 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 and the professional has cause to believe the child has been abused.

5.2. 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.

5.3. 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.

5.4. 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.

RESPONSIBILITY

6. IRB members are to be aware of the state law that may be relevant to the conduct of human subject research and to apply to the consideration of whether research meets the criteria for approval. IRB members are to be aware of the state law that may be relevant to the conduct of human subjects research and to consider whether disclosure of the implications of the law is required for legally effective informed consent .

Applicable Regulations and Guidelines

1. Texas Civil Practice & Remedies Code Chapter 129 Age of Majority
   
2. Texas Statutes Health & Safety Code Chapter 313. Consent to Medical Treatment Act
   
3. Texas Statutes Family Code Title 2. Chapter 32 Subchapter A. Consent to Treatment of Child by Non-Parent or Child
   
4. Texas Family Code Chapter 261, Investigation Of Report Of Child Abuse Or Neglect
   
5. Texas Administrative Code, Chapter 97, Control Of Communicable Diseases
   
6. Texas Administrative Code Title 25, Health Services Part 1, Department of State Health Services Chapter 91, Cancer Subchapter A, Cancer Registry Effective Date: July 9, 2006
   
7. Human Resources Code Chapter 48. Investigations And Protective Services For Elderly And Disabled Persons

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