Academic journal article The Hastings Center Report

Unrest about Research

Academic journal article The Hastings Center Report

Unrest about Research

Article excerpt

An ongoing series of articles and essays in the Report have noted that human subjects research ethics, a sometimes intricate and arcane set of discussions that are virtually a discrete subfield within bioethics, is the site of growing and multiplying controversies. Some of the questions at the core of these debates: Does the protection of research subjects from the harms of research need to be relaxed to promote quick and fair access to the benefits? (See the May-June 2001 Report.) Has the protection of research subjects been undermined by pharmaceutical firms' interest in promoting their own benefit? (See September-October 2004.) What kind of benefits must be provided when the research is conducted in developing countries--must subjects be able to get access to the drug under investigation, or, if the drug is not likely to be available to them, might some other benefit be acceptable instead? (See May-June 2004.) Should human subjects research be seen as a purely scientific enterprise--in which case subjects might consent to be deprived of a known benefit--or is it a special version of the doctor-patient relationship--so that researchers should stop a trial early, for example, if early results show that the trial drug will be efficacious? (The lead article in this issue takes this one up.) Is human subjects research ethics only about what happens to individuals--what harms they will bear and what they consent to--or, when a population is under study, is it also about harms to and consent of communities? (The second article takes this one up.)

These questions go to the very core of research ethics. They are about how we evaluate research, whose opinion counts, how ethics is done, and what the core principles of research ethics are.

Some questions that have generated intense public discussion recently are touched on in this issue by Greg Koski, former head of the Office of Human Research Protections. …

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