Informed Consent Some Questions知情同意的几个问题.pptVIP

Informed Consent:Seven Questions for the IC fans Angus Dawson Keele University The IC Model Central to research ethics – guidelines and practice 2 Key Claims: Must gain informed consent Supported by appeal to autonomy Can ask some questions about this 1. What is the requirement? Provision or comprehension? ‘Before requesting an individual’s consent to participate in research, the investigator must provide the following information, in language or another form of communication that the individual can understand… an explanation of features of the research design (e.g., randomization, double-blinding)…’. (CIOMS, Guideline 5) (my italics) ‘must be adequately informed of the aims, methods, sources of funding, any possible conflicts of interest, institutional affiliations of the researcher, the anticipated benefits and potential risks of the study and the discomfort it may entail…..After ensuring that the subject has understood the information, the physician should then obtain the subject’s freely-given informed consent, preferably in writing’. (Helsinki, paragraph.22) (my italics) 2. What justified IC? Usual answer – autonomy (note – “Millian” nor Kantian) Other less common answer – welfare (note – this allows, even requires, commensurability) 3. What is the moral status of IC? An absolute claim? First amongst equals? Prima facie? 4. What is the purpose of IC? Normally seen as a kind of permission-giving (e.g. putting self at increased risk of harm) Another way to see it is as one form of legitimacy (and others may be just as important) 5. How does IC fit with other morally important factors? Harm/benefit. Role of REC. Protection. Paternalism. Methodological benefits of not obtaining IC (e.g. certain CRTs; cost of seeking retrospective IC – financial or harm etc) 6. Does the IC model assume a plausible view of agency? Perfect rational assessor and deliberator But: Therapeutic misconception Framing effects The ‘must try harder’ response 7. Do patients even want I