title: Disclosure of the right of research participants to receive research results: an analysis of consent forms in the Children's Oncology Group.
abstract: BACKGROUND
  The offer of return of research results to study participants has many potential benefits. The current study examined the offer of return of research results by analyzing consent forms from 2 acute lymphoblastic leukemia studies of the 235 institutional members of the Children's Oncology Group.
  
  
  METHODS
  Institutional review board (IRB)-approved consent forms from 2 standard-risk acute lymphoblastic leukemia studies (Children's Cancer Group [CCG] 1991 and Pediatric Oncology Group [POG] 9407) were analyzed independently by 2 reviewers.
  
  
  RESULTS
  The authors received replies from 202 of the 235 institutions that were contacted (85%). One hundred eighty-one institutions had CCG 1991 (n = 96) or POG 9905 (n = 85) protocols that were approved by an IRB. Most institutions provided contact information for the principal investigator (n = 175; 97%) and a member of the institution's research services office (n = 154; 85%). Only 5 (2.8%) institutions provided an indication of a participant's right to receive a summary of research results; most of these institutions provided details on how (n = 5) or when (n = 5) this was to occur. All of these institutions (n = 162; 89.5%) provided a specific statement offering new information that might affect a participant's decision to continue to participate in a study. Only 2 institutional consent forms offered participants the option to receive research results, and only 10 (5.5%) consent forms contained an unambiguous, specific statement offering to provide new information after the study was closed.
  
  
  CONCLUSIONS
  Few institutional review board-approved consent forms explicitly indicate the right of research recipients to receive a summary of the results of the research in which they have participated.
authors.affiliation: Department of Pediatrics, IWK Health Centre, Dalhousie University, Halifax, Nova Scotia, Canada. conrad.fernandez@iwk.nshealth.ca
authors.forename: Conrad V
authors.initials: CV
authors.lastname: Fernandez
authors.forename: Eric
authors.initials: E
authors.lastname: Kodish
authors.forename: Shaureen
authors.initials: S
authors.lastname: Taweel
authors.forename: Susan
authors.initials: S
authors.lastname: Shurin
authors.forename: Charles
authors.initials: C
authors.lastname: Weijer
mesh_terms: D002648:Child; D002986:Clinical Trials as Topic; D032962:Consent Forms; D030881:Disclosure / Q000331:legislation & jurisprudence*; D032984:Ethics, Research; D006801:Humans; D028701:Patient Rights / Q000331:legislation & jurisprudence*; D054198:Precursor Cell Lymphoblastic Leukemia-Lymphoma