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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 ...
Human subject research is systematic, scientific investigation that can be either interventional (a "trial") or observational (no "test article") and involves human beings as research subjects, commonly known as test subjects. Human subject research can be either medical (clinical) research or non-medical (e.g., social science) research. [1]
The Office for Human Research Protections (OHRP) is a small office within the United States Department of Health and Human Services (DHHS), specifically the Office of the Assistant Secretary for Health in the Office of the Secretary of DHHS, that deals with ethical oversights in clinical research conducted by the department, mostly through the National Institutes of Health (NIH).
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.
Directive 93/41/EEC, establishes the European Agency for the Evaluation of Medicinal Products; Directive 2001/20/EC, defines rules for the conduct of clinical trials; Directive 2001/83/EC; Directive 2005/28/EC, defines Good Clinical Practice for design and conduct of clinical trials