The atrocities committed by Nazi physicians on Jewish prisoners during World War II prompted an international tribunal, convened in the city of Nuremberg, Germany to elaborate principles, called the Nuremberg Code, by which research involving human subjects should be governed.
Since Nuremburg, a multitude of regulations and policy statements have been developed by domestic and international bodies. These regulatory guidance documents, share a common purpose: to protect the autonomy, safety, privacy, and welfare of human research subjects. Within institutions where clinical research is conducted, responsibility for the interpretation and application of these ethical principles and regulations rests with committees comprised of scientist and …show more content…
Implicitly, full autonomy requires that an individual be able to understand what they are being asked to do, make a reasoned judgment about the effect participation will have on them, and make a choice to participate free from coercive influence. The cornerstone of protecting autonomy is the informed consent process, whereby an investigator provides a potential research participant with full disclosure about the nature of the study, the risks, benefits and alternatives, and an extended opportunity to ask questions before deciding whether or not to participate.
• Populations presumed to have diminished autonomy, by virtue of impaired cognition like, children, cognitively-impaired elderly, or mentally ill subjects or have circumstances as prisoners or seriously ill people are considered to be vulnerable populations and special safeguards are put in place to protect their autonomy. An example of where autonomy is not protected will be where individuals with impaired cognitive are asked to participate in a study as in patients that are mentally retarded knowing fully well that they may not be able to understand the magnitude of the
Since Nuremburg, a multitude of regulations and policy statements have been developed by domestic and international bodies. These regulatory guidance documents, share a common purpose: to protect the autonomy, safety, privacy, and welfare of human research subjects. Within institutions where clinical research is conducted, responsibility for the interpretation and application of these ethical principles and regulations rests with committees comprised of scientist and …show more content…
Implicitly, full autonomy requires that an individual be able to understand what they are being asked to do, make a reasoned judgment about the effect participation will have on them, and make a choice to participate free from coercive influence. The cornerstone of protecting autonomy is the informed consent process, whereby an investigator provides a potential research participant with full disclosure about the nature of the study, the risks, benefits and alternatives, and an extended opportunity to ask questions before deciding whether or not to participate.
• Populations presumed to have diminished autonomy, by virtue of impaired cognition like, children, cognitively-impaired elderly, or mentally ill subjects or have circumstances as prisoners or seriously ill people are considered to be vulnerable populations and special safeguards are put in place to protect their autonomy. An example of where autonomy is not protected will be where individuals with impaired cognitive are asked to participate in a study as in patients that are mentally retarded knowing fully well that they may not be able to understand the magnitude of the