(DOWNLOAD) "Protecting Subjects Who Cannot Give Consent: Toward a Better Standard for "Minimal" Risks." by The Hastings Center Report " Book PDF Kindle ePub Free
eBook details
- Title: Protecting Subjects Who Cannot Give Consent: Toward a Better Standard for "Minimal" Risks.
- Author : The Hastings Center Report
- Release Date : January 01, 2005
- Genre: Life Sciences,Books,Science & Nature,
- Pages : * pages
- Size : 186 KB
Description
Most guidelines allow people to be enrolled in research that does not offer a prospect of direct personal benefit as long as they have the capacity to give informed consent. More controversial and difficult are research procedures and studies that propose to enroll subjects who cannot provide informed consent. Many clinical trials with children, for example, include blood draws or radiological scans that are important for research purposes but do not offer the children themselves any direct benefit. Similarly, early-phase pharmacokinetic studies of potential treatments for Alzheimer's disease may be targeted at adults who have lost the ability to consent, yet not offer them a potential for personal benefit. Commentators widely agree that subjects who cannot give consent may be enrolled in research that offers no prospect of direct benefit only when several additional requirements are met. (1) Perhaps the most important of these requirements is that the research presents risks that fall below some threshold--what is often called "minimal risk" research. (2) But then the question is what counts as "minimal" risk. Many guidelines, trying to give institutional review boards a workable standard, define risks as "minimal" when they are no greater than the risks individuals face in dally life. This constraint is known as the "risks of daily life" standard.
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