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2. Informed consent - Wikipedia

   en.wikipedia.org/wiki/Informed_consent

   Informed consent is documented by means of a written, signed, and dated informed consent form. [37] In medical research , the Nuremberg Code set a base international standard in 1947, in response to the ethical violation in the Holocaust .

3. Nuremberg Code - Wikipedia

   en.wikipedia.org/wiki/Nuremberg_Code

   [10] The idea of free or informed consent also served as the basis for International Ethical Guidelines for Biomedical Research Involving Human Subjects proposed by the World Health Organization. [ 10 ] [ failed verification ] Another notable symposium review was published by the Medical University of Vienna in 2017: "Medical Ethics in the 70 ...

4. Office for Human Research Protections - Wikipedia

   en.wikipedia.org/wiki/Office_for_Human_Research...

   However, Subpart D of 45 CFR 46 marks several distinctions about obtaining consent/assent and the nature of the research involving children. According to the actual rules of informed consent given by the IRB for the research in question, child assent and parental consent may both be required to conduct research on minors.

5. Informed assent - Wikipedia

   en.wikipedia.org/wiki/Informed_assent

   In adult medical research, the term informed consent is used to describe a state whereby a competent individual, having been fully informed about the nature, benefits and risks of a clinical trial, agrees to their own participation. National authorities define certain populations as vulnerable and therefore unable to provide informed consent ...

6. Clinical research coordinator - Wikipedia

   en.wikipedia.org/wiki/Clinical_research_coordinator

   The sponsor sets informed consent requirements, as does the IRB. Each local IRB must review and approve the informed consent, but the CRC is responsible for communication between the IRB and the sponsor. §46.116 of the Code of Federal Regulations outlines the basic elements of informed consent as a: [5]

7. Declaration of Helsinki - Wikipedia

   en.wikipedia.org/wiki/Declaration_of_Helsinki

   Informed consent was developed further, made more prescriptive and partly moved from 'Medical Research Combined with Professional Care' into the first section (Basic Principles), with the burden of proof for not requiring consent being placed on the investigator to justify to the committee. 'Legal guardian' was replaced with 'responsible relative'.

8. Glossary of clinical research - Wikipedia

   en.wikipedia.org/wiki/Glossary_of_clinical_research

   Informed consent is documented by means of a written, signed, and dated informed consent form. (ICH E6) Informed consent document A document that describes the rights of the study participants, and includes details about the study, such as its purpose, duration, required procedures, and key contacts. Risks and potential benefits are explained ...

9. Institutional review board - Wikipedia

   en.wikipedia.org/wiki/Institutional_review_board

   Broad complaints range from the legitimacy of IRB review, the applicability of the concepts of risk as it pertains to social science (e.g., possibly unneeded, over-burdensome requirements), [18] and the requirements for the documentation of participants' informed consent (i.e., consent forms). [19]