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Editor's Note
September 2015

Informed Consent and Communicating Risk and Benefits of Research on Higher-Risk Medications

JAMA Intern Med. 2015;175(9):1568-1569. doi:10.1001/jamainternmed.2015.3555

The Belmont Report1 formally established ethical principles and guidelines in 1979 for the protection of human research subjects in the United States. Summarizing discussions among the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research from an initial 4-day meeting at the Smithsonian Institution’s Belmont Conference Center, as well as several years of subsequent deliberations, 3 core principles were identified in the Belmont Report: respect for persons, beneficence, and justice. While these principles frequently come into play in clinical research, the Belmont Report suggests that when designing a study, careful consideration should be given to informed consent, the assessment of risks and benefits, and selection of participants. To ensure that all conducted research involving human participants is aligned with these ethical principles and guidelines, institutional review boards (IRBs) have been formed across the country, both at academic medical centers and elsewhere. Considerable time and effort are invested by these IRBs, as well as by investigators and research staff, to ensure compliance with the aforementioned principles and guidelines. But how effective have we been? There are few simple ways to measure effectiveness in this area, but Bhattacharya et al2 suggest one in this issue of JAMA Internal Medicine: what proportion of applicable informed consent forms disclose black box warnings issued by the US Food and Drug Administration (FDA) for study medications?

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