title: "Special scrutiny": a targeted form of research protocol review.
abstract: Research participants require ongoing protection of the kind already established in law and regulation. However, "special scrutiny" for certain types of research is also needed. Three criteria for special scrutiny are 1) research that involves initial experiences of translating new scientific advances into humans, especially when the intervention is novel, irreversible, or both; 2) research with a known or credible risk for significant harm (death or serious disability are the clearest examples) to research participants as a consequence of the experimental intervention and with no potential for offsetting direct medical benefit; or 3) research with a protocol that raises ethical questions about research design or implementation for which there is no consensus. Special scrutiny recognizes that not all research protocols are equally ethically challenging and aims to provide appropriate protection for all research participants.
authors.affiliation: United Hospital Fund, New York, New York, USA.
authors.forename: Carol
authors.initials: C
authors.lastname: Levine
authors.forename: Ruth
authors.initials: R
authors.lastname: Faden
authors.forename: Christine
authors.initials: C
authors.lastname: Grady
authors.forename: Dale
authors.initials: D
authors.lastname: Hammerschmidt
authors.forename: Lisa
authors.initials: L
authors.lastname: Eckenwiler
authors.forename: Jeremy
authors.initials: J
authors.lastname: Sugarman
mesh_terms: D026724:Ethical Review; D028744:Ethics Committees, Research; D006805:Human Experimentation / Q000941:ethics*; D006801:Humans; D012107:Research Design; D012307:Risk Factors; D014481:United States