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February 18, 2004
Today's Reading - Scientists and Subjects
Pedroni, Julia A. & Pimple, Kenneth D. (2001). A Brief Introduction to Informed Consent in Research with Human Subjects. Poynter Center for the Study of Ethics and American Institutions [On-line].
Notes from a close reading: The article introduces the history of informed consent codes tying existing rules to the Nuremberg Code, through the Declaration of Helsinki, and the International Ethical Guidelines adopted by the Council for International Organizations of Medical Sciences (CIOMS). This short history grounds the article and allows the reader to understand from whence informed consent rules have come.
Consequentialist and nonconsequentialist reasons can be used to justify the status of informed consent as a fundamental principle of ethical research with human subjects. The consequentialist reason asserts that one should adopt as doing so would have the best expected results compared with alternatives. The authors present the following contentions to support this reason:
|1) Obtaining subjects' informed consent to participation tends to increase their adherence to the protocol, and hence the quality of the research.|
|2) Since investigators are not always able to identify the risks their research may pose to subjects, a process of informed consent provides the benefits of an additional layer of risk review tailored o the interests of the individual subject.|
|3) Affirming a principle of informed consent is likely to foster public trust of the research community; without such trust the research enterprise could not flourish. (p. 3)|
One can also apply consequentialist reasoning to the position against informed consent. These arguments would include: the process is expensive, time consuming, and can create a self-selection bias. Additionally the reasons for support listed above can be invalidated.
Nonconsequentialist reasons for adopting a principle of informed consent rest on the intrinsic qualities of persons or actions. This can provide a more robust foundation then the consequentialist perspective since it requires researchers acquire informed consent regardless of the expected consequences of doing so. The Belmont Report utilizes a nonconsequentialist rationale in its principle of informed consent.
Two notions of informed consent are drawn from Faden and Beauchamp (1986) The first meaning is a moral sense that defines consent as the "autonomous authorization" of an individual's involvement in research (Faden et al., 1986, p. 276). The second meaning is a socio-legal definition which establishes "legally or institutionally effective authorization (Faden et al., 1986, p. 281).
The authors present four elements of informed consent including providing information in one of three standards (professional practice, reasonable person, or subjected), subjects must substantially understanding the information, authorization must be freely given, and subjects must have the capacity to make the decision on their own. There are a limited number of reasons why informed consent would not be required.
Two circumstances where informed consent is undesirable are noted: a) when a signed form may pose a risk to the subject, and b) when obtaining informed consent may diminish the scientific merit of the research. In the first case the issue is the form of the consent, in that the existence of a signed form may pose a risk. In these cases informed consent is still required but the paperwork should either protected with a Certificate of Confidentiality or the paperwork process could be waived by the IRB.
In the second case the subject's knowledge that they are participating in a study could substantially change their acts and therefore alter the outcome of the research. In these cases IRBs may waive the paperwork process though post-hoc paperwork should be obtained if possible.
Faden, Ruth R. and Beauchamp, Tom L. (1986). A History and Theory of Informed Consent. New York: Oxford University Press.
Posted by prolurkr at February 18, 2004 10:04 AM
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