The informed-consent policy of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use: knowledge is the best medicine.
نویسنده
چکیده
منابع مشابه
Protecting the rights of pediatric research subjects in the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.
This Comment argues that the parties to the International Conference on Harmonization of Technical Requirements for Regulation of Pharmaceutical Drugs (ITCH) should adopt more specific guidelines for pediatric research than those included in its Good Clinical Practice Guidelines (ICH GCP), and analyzes their attempt to do so in the Draft Guideline on Pediatric Trials. Part I of this Comment out...
متن کاملبررسی سیر تغییرات بیانیه‌ی هلسینکی و تفاوت‌های ویرایش سال 2008 نسبت به 2004
The Declaration of Helsinki, the most creditable ethical guideline for medical research on human subjects, has been updated 8 times since its establishment and the last revision was in 2008. Researchers, medical research subjects, authors, members of ethics committees, and editors of medical journals must be informed of the tenets of the Helsinki declaration in order to improve achievements of ...
متن کاملبیانیهی هلسینکی ویرایش 2008، ترجمه‌ی فارسی و چالش‌‌های آن
The Declaration of Helsinki, the most creditable ethical guideline for medical research on human subjects, has been updated 8 times since its establishment and the last revision was in 2008. Researchers, medical research subjects, authors, members of ethics committees, and editors of medical journals must be informed of the tenets of the Helsinki declaration in order to improve achievements of ...
متن کاملAn Assessment of National Maternal and Child Health Policy-Makers’ Knowledge and Capacity for Evidence-Informed Policy-Making in Nigeria
Background There is increasing interest globally in the use of more rigorous processes to ensure that maternal, newborn, and child health (MNCH) care recommendations are informed by the best available research evidence use. The purpose of this study was to engage Nigerian MNCH policy-makers and other stakeholders to consider issues around research to policy and practice interface and to assess ...
متن کاملLegal and ethical issues in research
Legal and ethical issues form an important component of modern research, related to the subject and researcher. This article seeks to briefly review the various international guidelines and regulations that exist on issues related to informed consent, confidentiality, providing incentives and various forms of research misconduct. Relevant original publications (The Declaration of Helsinki, Belm...
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ورودعنوان ژورنال:
- Cornell international law journal
دوره 30 1 شماره
صفحات -
تاریخ انتشار 1997