title: Return of individual research results and incidental findings in the clinical trials cooperative group setting.
abstract: The National Cancer Institute (NCI)-funded cooperative group cancer clinical trial system develops experimental therapies and often collects samples from patients for correlative research. The cooperative group bank (CGB) system maintains biobanks with a current policy not to return research results to individuals. An online survey was created, and 10 directors of CGBs completed the surveys asking about understanding and attitudes in changing policies to consider return of incidental findings (IFs) and individual research results (IRRs) of health significance. The potential impact of the 10 consensus recommendations of Wolf et al. presented in this issue are examined. Reidentification of samples is often not problematic; however, changes to the current banking and clinical trial systems would require significant effort to fulfill an obligation of recontact of subjects. Additional resources, as well as a national advisory board would be required to standardize implementation.
authors.affiliation: Eastern Cooperative Oncology Group Coordinating Center, Boston, Massachusetts, USA.
authors.forename: Michael
authors.initials: M
authors.lastname: Ferriere
authors.forename: Brian
authors.initials: B
authors.lastname: Van Ness
mesh_terms: D002986:Clinical Trials as Topic / Q000941:ethics* / Q000331:legislation & jurisprudence; D005826:Genetics, Medical / Q000941:ethics / Q000331:legislation & jurisprudence / Q000592:standards; D006801:Humans; D033162:Incidental Findings; D054547:National Cancer Institute (U.S.); D035842:Research Subjects; D011795:Surveys and Questionnaires; D014342:Truth Disclosure / Q000941:ethics; D014481:United States