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Description:
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Currently , research with human subjects is going through a period of tremendous upheavals . In many cases these upheavals have created a variety of unmet expectations and have given rise to the perception that trust in the research enterprise is eroding . Trust is vital to the responsible conduct of research and without it many believe that the entire system of research with humans will inevitably fail . Inherent in the practice of research with humans is a diverse set of physical , social , and psychological risks , the disclosure of which affects a subjects understanding and voluntary agreement to participate . Generally , trust asserts that research personnel can be relied upon to act with integrity , discretion , and competence in their relationships with subjects and the public . Trust in the research process is generated through the subject -investigator relationship and is warranted when role -specific obligations such as respecting the rights and welfare of participants are met . Crucial among these obligations is the ethical requirement to respect the autonomy of individual subjects through an ethically competent informed consent process . Using the Jesse Gelsinger case as an illustration , I will argue that when the doctrine of informed consent is inadequately applied not only can research volunteers be unjustly harmed but the foundation of trust is also betrayed . |