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. Copyright 2003 American Cancer Society.
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. Copyright 2003 American Cancer Society.
Authors: Sandeep Kadimpati; Jennifer B McCormick; Yichen Chiu; Ashley B Parker; Aliya Z Iftikhar; Randall P Flick; David O Warner Journal: AJOB Empir Bioeth Date: 2014-01-01
Authors: Ebony B Bookman; Aleisha A Langehorne; John H Eckfeldt; Kathleen C Glass; Gail P Jarvik; Michael Klag; Greg Koski; Arno Motulsky; Benjamin Wilfond; Teri A Manolio; Richard R Fabsitz; Russell V Luepker Journal: Am J Med Genet A Date: 2006-05-15 Impact factor: 2.802
Authors: Leslie G Biesecker; James C Mullikin; Flavia M Facio; Clesson Turner; Praveen F Cherukuri; Robert W Blakesley; Gerard G Bouffard; Peter S Chines; Pedro Cruz; Nancy F Hansen; Jamie K Teer; Baishali Maskeri; Alice C Young; Teri A Manolio; Alexander F Wilson; Toren Finkel; Paul Hwang; Andrew Arai; Alan T Remaley; Vandana Sachdev; Robert Shamburek; Richard O Cannon; Eric D Green Journal: Genome Res Date: 2009-07-14 Impact factor: 9.043