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保护人类受试者委员会

德克萨斯州法律

POLICY

It is the policy of UTHealth that with the help of legal counsel, UTHealth Human Research Protection Program shall ensure that all research activities are compliant with applicable federal and state laws.

关键术语:

Legally Authorized Representative of a patient means:

  • 如果患者是未成年人,则是父母或法定监护人;
  • 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;
  • 为患者任命的监护人诉讼;
  • a personal representative or statutory beneficiary if the patient is deceased; or
  • 由患者保留的律师或该细分列出的其他人。

PROCEDURE

强制性报告

虐待或忽视儿童- Professionals are required to report not 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 and the professional has cause to believe the child has been abused.

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.

通知条件- 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.

癌症- 所有实验室,医院,设施和从业人员都必须在诊断后的6个月内向卫生部报告,如果进行初步诊断,则任何癌症。该报告包括被诊断出患有癌症的人的诊断,职业,家族史和个人习惯。

审查 -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

  1. 德克萨斯州民事实践与补救码第129章多数年龄
  2. 德州法规健康与安全法规第313章。同意医疗法案
  3. Texas Statutes Family Code Title 2. Chapter 32 Subchapter A. Consent to Treatment of Child by Non-Parent or Child
  4. 德克萨斯家庭法规第261章,Investigation Of Report Of Child Abuse Or Neglect
  5. 德克萨斯行政法典,第97章,Control Of Communicable Diseases
  6. 德克萨斯行政法典第25章,卫生服务第1部分,国家卫生服务部第91章,癌症亚第章,癌症注册表生效日期:2006年7月9日
  7. 人力资源法第48章。针对老年人和残疾人的调查和保护服务

引用其他SOP

If you find errors in this document, contactclinicals@uth.tmc.edu

Document Number:

101-A03

文档名称:

State Laws

Reviewed by:

Executive Director, Research Compliance

Effective:

1 Sep 2008

Revised:

2011年8月1日,2016年6月1日,2019年1月21日,2021年6月1日




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保护人类受试者委员会
6410 Fannin, Suite 1100
德克萨斯州休斯顿77030

Phone 713-500-7943
Fax 713-500-7951
Emailcphs@uth.tmc.edu

IRIS Support713-500-7960

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CLINICAL TRIALS RESOURCE CENTEROFFICE OF RESEARCHENVIRONMENTAL HEALTH & SAFETY

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