Return of individual research results and incidental findings in the clinical trials cooperative group setting

Michael Ferriere, Brian Van Ness

Research output: Contribution to journalArticlepeer-review

5 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)411-416
Number of pages6
JournalGenetics in Medicine
Volume14
Issue number4
DOIs
StatePublished - Apr 2012

Keywords

  • biobank
  • clinical cooperative group
  • human subjects research ethics
  • incidental findings
  • research results

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