New England Journal of Medicine
January 22, 2015 Vol. 372 No. 4
Foreseeable Risks? Informed Consent for Studies within the Standard of Care
Chana A. Sacks, M.D., and Celestine E. Warren, A.B.
N Engl J Med 2015; 372:306-307 January 22, 2015 DOI: 10.1056/NEJMp1415113
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?