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The Clinical Trials Directive (Officially Directive 2001/20/EC of 4 April 2001, of the European Parliament and of the Council on the approximation of the laws, regulations and administrative provisions of the Member States relating to implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use) is a European Union directive that aimed at ...
^1 Chapter 166 of the Texas Health & Safety Code ^2 Robert L. Fine, M.D.'s detailings of futile care statutes and processes from Baylor Health System ^3 White House Press Briefing 2005-03-21 ^4 As discussed in "Fine RL. Point: The Texas Advance Directives Act Effectively and Ethically Resolves Disputes About Medical Futility. Chest 2009 136(4 ...
European Union: In the EU, Good Clinical Practice is backed and regulated by formal legislation contained in the Clinical Trial Regulation (Officially Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC). [3] A ...
The ethics committee, according to Directive 2001/20/EC, is an independent body in a member state of the European Union, consisting of healthcare professionals and non-medical members, whose responsibility is to protect the rights, safety and well-being of human subjects involved in a clinical trial and to provide public assurance of that protection, by, among other things, expressing an ...
One of the earliest models for ethical human experimentation, preceding the Nuremberg Code, was established in 1931. [4] In the Weimar Republic of 20th century pre-Nazi Germany, the entity known as Reichsgesundheitsamt [5] (translating roughly to National Health Service), under the Ministry of the Interior [6] formulated a list of 14 points detailing these ethical principles.
The Texas Ethics Commission was established in 1991 to oversee and provide guidance on various public ethics laws within the state of Texas. The agency's main office is located on the 10th Floor of the Sam Houston State Office Building at 201 East 14th Street in Downtown Austin. [1] [2] Instituted through a state constitutional amendment, the ...
The Texas Administrative Code contains the compiled and indexed regulations of Texas state agencies and is published yearly by the Secretary of State. [8] The Texas Register contains proposed rules, notices, executive orders, and other information of general use to the public and is published weekly by the Secretary of State. [9]
Right to protection for patients involved in clinical trials: Clinical trials should comply with all the standards and protocols under the Directorate General of Health Services. Right to protection of participants involved in biomedical and health research: Studies involving patients should follow the National Ethical Guidelines for Biomedical ...