Autonomy and Informed Consent: Medical Research Ethics<br />Medical Ethics-Online<br />Summer 2011<br />Eli Weber-Instructor<br />
Lecture Goals<br />Specify the conditions for informed consent<br />Discuss vulnerable populations<br />Jehovah’s Witness-type cases/Applicability to research contexts<br />
Why Think Informed Consent Protects Autonomy?<br />-Autonomy-self determination; the right that persons have to be the authors of their own lives<br />Requiring that research participants give informed consent prior to participation in research is a way to ensure that patients make free, uncoerced, fully informed choices about their lives. <br />
Conditions for Informed Consent<br />Understanding-patients must understand :<br />potential risks <br />possible benefits<br />specific details of the treatment or procedure <br />Alternatives (including doing nothing)<br />Any other relevant considerations (i.e. recovery time, financial consequences) <br />
Conditions for Informed Consent<br />Competence<br />Psychologically stable<br />Emotionally stable<br />Of a proper age<br />Adequately aware of reality<br />
Conditions for Informed Consent<br />Absence of Coercion<br />No undue benefits/inappropriate compensation<br />Lack of personal connection between patient and obtainer of consent<br />No threat of punishment/harm to patient or loved ones<br />
The Jehovah’s Witness-Blood Transfusion Case<br />“Typical” analysis is that a patient’s right to autonomy requires that we allow the JW to refuse a blood transfusion. The disagreement with the JW’s decision is based on a difference of values.<br />Savalescu and Momeyer suggest that respect for autonomy requires rational beliefs, and the JW belief regarding blood transfusion isn’t theoretically rational. <br />While physicians should stop short of overriding the JW’s decision, they can try to engage the JW in rational deliberation about the JW’s choice, in order to encourage more rational decision-making. <br />
Implications of the JW Case for Research Ethics<br />Perhaps when individuals refuse to participate in research for irrational reasons, researchers should challenge their decision, out of respect for their autonomy.<br />The burden on researchers seeking to obtain informed consent is much greater than previously thought.<br />While some beliefs are clearly rational, some are irrational, and still others are indicators of incompetence. But how do we sort between these?<br />
The Bottom Line<br />Informed consent to participate in research requires understanding, competence, and freedom from coercion.<br />It is an open question how we should deal with members of vulnerable populations. <br />Depending on how we understand the requirements for informed consent, the burden it places on researchers ranges from fairly reasonable to nearly impossible to meet.<br />
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