Author Affiliation: Boston University Schools of Law, Medicine, and Public Health, Boston, Mass.
Examination of the current system of protecting human subjects has highlighted
concerns about its overall effectiveness.1-4
It is infused with conflicts of interest, and research is increasingly financed
and promoted by for-profit entities.1,4
Institutional review boards (IRBs) review "too much, too quickly, and with
too little expertise," with many IRBs spending "only 1 or 2 minutes of review
per study."2,3 This inadequate
system of protection of the rights and welfare of human subjects in medical
research requires extensive reform. As part of the change process, efforts
should focus on taking the entire consent process seriously. In this issue
of THE JOURNAL, Beskow et al5 suggest elements
that may be helpful in preparing a consent form for population-based research
Annas GJ. Reforming Informed Consent to Genetic Research. JAMA. 2001;286(18):2326–2328. doi:10.1001/jama.286.18.2326
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