title: Core safeguards for clinical research with adults who are unable to consent.
abstract: The National Bioethics Advisory Commission has proposed new safeguards for clinical research with adults who are unable to consent. Three other major U.S. groups have also proposed additional safeguards for this population, and existing Canadian and European guidelines already include such safeguards. While these six guidelines agree on some safeguards, they disagree on others. To allow important research to proceed while protecting adults who are unable to consent, it will be crucial to resolve these differences. This paper uses a side-by-side comparison of these six guidelines to highlight their major points of consensus, analyze their significant differences, and distill six core safeguards.
authors.affiliation: Department of Clinical Bioethics, National Institutes of Health, Room 1C118, Building 10, National Institutes of Health, Bethesda, MD 20892, USA.
authors.forename: D
authors.initials: D
authors.lastname: Wendler
authors.forename: K
authors.initials: K
authors.lastname: Prasad
mesh_terms: D000328:Adult; D001675:Bioethics; D002170:Canada; D002648:Child; D002986:Clinical Trials as Topic / Q000592:standards*; D003657:Decision Making; D005060:Europe; D006291:Health Policy; D006801:Humans; D007258:Informed Consent; D038622:Internationality; D016743:Mental Competency; D010361:Patients / Q000523:psychology; D017410:Practice Guidelines as Topic / Q000592:standards*; D011367:Professional Staff Committees; D018570:Risk Assessment; D014481:United States