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  2. Site management organization - Wikipedia

    en.wikipedia.org/wiki/Site_management_organization

    Patient counseling; Patient recruitment; Patient follow-up; Informed consent form (ICF) translation into vernacular languages [dubious – discuss]. In Europe, this is often done by the Sponsor or CRO; Site initiation and trial close-out operations; Trial-related documents archival and maintenance

  3. Ethical guidelines for treating trauma survivors - Wikipedia

    en.wikipedia.org/wiki/Ethical_Guidelines_For...

    The APA ethics code [4] outlines many professional guidelines for clinicians including the maintenance of confidentiality, minimizing intrusions to privacy, and obtaining informed consent. Informed consent ensures the client has an adequate understanding of the techniques and procedures that will be used during therapy, expected timeline for ...

  4. Informed Consent in Medical Research - Wikipedia

    en.wikipedia.org/wiki/Informed_Consent_in...

    Informed Consent in Medical Research is a medical textbook on medical ethics, authored by Jeffrey S. Tobias and Len Doyal, and published by Wiley in 2001. It was produced in response to the debates between the authors in 1997, following the response to the 1990's British Medical Journal publications of studies in which consent was not obtained by participants.

  5. Informed consent - Wikipedia

    en.wikipedia.org/wiki/Informed_consent

    Informed consent is documented by means of a written, signed, and dated informed consent form. [36] In medical research, the Nuremberg Code set a base international standard in 1947, in response to the ethical violation in the Holocaust. Standards continued to develop.

  6. Belmont Report - Wikipedia

    en.wikipedia.org/wiki/Belmont_Report

    The Belmont Report is a 1978 report created by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.Its full title is the Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research, Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.

  7. 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 ...

  8. APA Ethics Code - Wikipedia

    en.wikipedia.org/wiki/APA_Ethics_Code

    The American Psychological Association (APA) Ethical Principles of Psychologists and Code of Conduct (for short, the Ethics Code, as referred to by the APA) includes an introduction, preamble, a list of five aspirational principles and a list of ten enforceable standards that psychologists use to guide ethical decisions in practice, research, and education.

  9. 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 ...