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Foreseeable Risks? Informed Consent for Studies within the Standard of Care

By Chana A. Sacks and Celestine E. Warren
New England Journal of Medicine
2015

The Office for Human Research Protections has drafted guidelines on disclosing reasonably foreseeable risks in trials involving interventions that are within the standard of care. But what risks, aside from those already seen in clinical care, are reasonably foreseeable?

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