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November 14, 2001

Reforming Informed Consent to Genetic Research

Author Affiliations

Author Affiliation: Boston University Schools of Law, Medicine, and Public Health, Boston, Mass.

JAMA. 2001;286(18):2326-2328. doi:10.1001/jama.286.18.2326

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 involving genetics.