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The Belmont Report summarizes ethical principles and guidelines for human subject research. Three core principles are identified: respect for persons, Beneficence, and Justice. The three primary areas of application were stated as informed consent, assessment of risks and benefits, and selection of human subjects in research.
For an individual to give valid informed consent, three components must be present: disclosure, capacity and voluntariness. [9] [10]Disclosure requires the researcher to supply each prospective subject with the information necessary to make an autonomous decision and also to ensure that the subject adequately understands the information provided.
Research ethics is a discipline within the study of applied ethics. Its scope ranges from general scientific integrity and misconduct to the treatment of human and animal subjects. The social responsibilities of scientists and researchers are not traditionally included and are less well defined.
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.
The study of health care organization and provision, which encompasses the evolving organizational structures of health care organizations and the social psychology of health and health care, is another important approach. These latter research cover topics including connections between doctors and patients, coping mechanisms, and social support.
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.
Beneficence is a concept in research ethics that states that researchers should have the welfare of the research participant as a goal of any clinical trial or other research study. The antonym of this term, maleficence , describes a practice that opposes the welfare of any research participant.
While little is known about the range and distribution of topics put forth for REC, such services may be particularly important and useful for studies of known regulatory and ethical uncertainty (e.g. assessment of minimal risk in pediatric studies) and frontier research for which there is little if any regulation or expert consensus. [4]