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European Forum for Good Clinical Practice; European Medicines Agency – Agency of the European Union; Institutional review board – Type of committee that applies research ethics; Inverse benefit law – Drug benefit-harm ratio falls with marketing; Medical ethics – System of moral principles of the practice of medicine
Medical ethics is an applied branch of ethics which analyzes the practice of clinical medicine and related scientific research. [1] Medical ethics is based on a set of values that professionals can refer to in the case of any confusion or conflict. These values include the respect for autonomy, non-maleficence, beneficence, and justice. [2]
The Good Clinical Practice Directive (Directive 2005/28/EC of 8 April 2005 of the European Parliament and of the Council) lays down principles and detailed guidelines for good clinical practice as regards conducting clinical trials of medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products.
The Hippocratic Oath has been eclipsed as a document of professional ethics by more extensive, regularly updated ethical codes issued by national medical associations, such as the American Medical Association's Code of Medical Ethics (first adopted in 1847), and the British General Medical Council's Good Medical Practice. These documents ...
The Principles of Good Laboratory Practice (GLP) establish rules and criteria for a quality system that oversees the organizational processes and conditions in which non-clinical health and environmental safety studies are planned, conducted, monitored, recorded, reported, and archived.
The Declaration developed the ten principles first stated in the Nuremberg Code, and tied them to the Declaration of Geneva (1948), a statement of physicians' ethical duties. The Declaration more specifically addressed clinical research, reflecting changes in medical practice from the term 'Human Experimentation' used in the Nuremberg Code. A ...
The main guidance that the GMC provides for doctors is called Good Medical Practice. [21] This outlines the standard of professional conduct that the public expects from its doctors and provides principles that underpin the GMC's fitness-to-practise decisions.
[1] [39] In 2005, Eddy offered an umbrella definition for the two branches of EBM: "Evidence-based medicine is a set of principles and methods intended to ensure that to the greatest extent possible, medical decisions, guidelines, and other types of policies are based on and consistent with good evidence of effectiveness and benefit."