PURPOSE: The offer to return a summary of results to participants after the conclusion of clinical research has many potential benefits. The authors determined current practice and attitudes and needs of researchers in establishing programs to return results to research participants. METHODS: An Internet survey of all 236 principal investigators (PIs) of the Children's Oncology Group in May 2002 recorded PI and institutional demographics, current practice, and perceived barriers to and needs of PIs for the creation of research results programs. RESULTS: One hundred fifty (63.8%) PIs responded. Few institutions (n = 5) had established, comprehensive programs to offer the return of results. PIs indicated that major impediments to the implementation of such programs are the preparation of lay summaries, time constraints, the task of contacting participants, and potential distress for the participants. PIs identified the following facilitators to the establishment of a program in their own institution: lay summaries, web site, preparation of an oncologist's summary, and financial credits. There was no clear consensus as to when the results should be shared: 30% indicated after the study was closed and 24% indicated at the time of publication of results. A substantial proportion of respondents opposed or strongly opposed the implementation of a universal offering of results to research participants. CONCLUSIONS: Few Children's Oncology Group institutions have programs that offer the return of results to research participants. Significant barriers and facilitators to this process have been identified.
PURPOSE: The offer to return a summary of results to participants after the conclusion of clinical research has many potential benefits. The authors determined current practice and attitudes and needs of researchers in establishing programs to return results to research participants. METHODS: An Internet survey of all 236 principal investigators (PIs) of the Children's Oncology Group in May 2002 recorded PI and institutional demographics, current practice, and perceived barriers to and needs of PIs for the creation of research results programs. RESULTS: One hundred fifty (63.8%) PIs responded. Few institutions (n = 5) had established, comprehensive programs to offer the return of results. PIs indicated that major impediments to the implementation of such programs are the preparation of lay summaries, time constraints, the task of contacting participants, and potential distress for the participants. PIs identified the following facilitators to the establishment of a program in their own institution: lay summaries, web site, preparation of an oncologist's summary, and financial credits. There was no clear consensus as to when the results should be shared: 30% indicated after the study was closed and 24% indicated at the time of publication of results. A substantial proportion of respondents opposed or strongly opposed the implementation of a universal offering of results to research participants. CONCLUSIONS: Few Children's Oncology Group institutions have programs that offer the return of results to research participants. Significant barriers and facilitators to this process have been identified.
Authors: Grégoire Moutel; Nathalie Duchange; François Raffi; Lama I Sharara; Ioannis Théodorou; Violaine Noël; Sandrine de Montgolfier; Ingrid Callies; François Bricaire; Christian Hervé; Catherine Leport Journal: Eur J Hum Genet Date: 2005-09 Impact factor: 4.246
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: Christopher R Long; M Kathryn Stewart; Thomas V Cunningham; T Scott Warmack; Pearl A McElfish Journal: Clin Trials Date: 2016-08-24 Impact factor: 2.486
Authors: J Mancini; D Genre; F Dalenc; J-M Ferrero; P Kerbrat; A-L Martin; H Roché; F Maylevin; C Tarpin; P Viens; J Genève; C Julian-Reynier Journal: Br J Cancer Date: 2010-03-02 Impact factor: 7.640