OBJECTIVE: Investigations that seek to generalize findings or to understand uncommon diseases must be conducted at multiple centers. This study describes the process of obtaining regulatory approval for a minimal risk genetic study in a multi-center setting as undertaken by the Recurrent Respiratory Papillomatosis (RRP) Task Force. STUDY DESIGN AND SETTING: Sequential cohort of American children's hospitals. A single protocol was submitted to each Institutional Review Board (IRB). RESULTS: Documentation was prepared for 14 IRBs over 2.5 years. The median time between enlistment and approval at the first 8 sites was 15 months. Institutions varied considerably in their requirements and in the issues that were raised. Protocols were submitted sequentially and accumulated experience was used in the preparation of applications to subsequent IRBs. Nevertheless, there was no correlation between the accumulated experience and the number of issues that were raised. CONCLUSION: Despite uniform federal standards, all local IRBs required unique and individualized submissions. For multicenter studies, investigators should seriously consider the establishment of cooperative authorization agreements. On a simpler level, a standardized format for applications needs to be adopted nationwide. EBM RATING: B-3b.
OBJECTIVE: Investigations that seek to generalize findings or to understand uncommon diseases must be conducted at multiple centers. This study describes the process of obtaining regulatory approval for a minimal risk genetic study in a multi-center setting as undertaken by the Recurrent Respiratory Papillomatosis (RRP) Task Force. STUDY DESIGN AND SETTING: Sequential cohort of American children's hospitals. A single protocol was submitted to each Institutional Review Board (IRB). RESULTS: Documentation was prepared for 14 IRBs over 2.5 years. The median time between enlistment and approval at the first 8 sites was 15 months. Institutions varied considerably in their requirements and in the issues that were raised. Protocols were submitted sequentially and accumulated experience was used in the preparation of applications to subsequent IRBs. Nevertheless, there was no correlation between the accumulated experience and the number of issues that were raised. CONCLUSION: Despite uniform federal standards, all local IRBs required unique and individualized submissions. For multicenter studies, investigators should seriously consider the establishment of cooperative authorization agreements. On a simpler level, a standardized format for applications needs to be adopted nationwide. EBM RATING: B-3b.
Authors: K L Edwards; A A Lemke; S B Trinidad; S M Lewis; H Starks; M T Quinn Griffin; G L Wiesner Journal: Public Health Genomics Date: 2011-04-11 Impact factor: 2.000
Authors: Amy A Lemke; Susan B Trinidad; Karen L Edwards; Helene Starks; Georgia L Wiesner Journal: J Empir Res Hum Res Ethics Date: 2010-03 Impact factor: 1.742
Authors: Stephanie M Zielinski; Helena Viveiros; Martin J Heetveld; Marc F Swiontkowski; Mohit Bhandari; Peter Patka; Esther M M Van Lieshout Journal: Trials Date: 2012-01-08 Impact factor: 2.279
Authors: Rahul Mhaskar; Elizabeth Barnett Pathak; Sarah Wieten; Thomas M Guterbock; Ambuj Kumar; Benjamin Djulbegovic Journal: Acta Inform Med Date: 2015-07-30
Authors: Ascanio Tridente; Paul A H Holloway; Paula Hutton; Anthony C Gordon; Gary H Mills; Geraldine M Clarke; Jean-Daniel Chiche; Frank Stuber; Christopher Garrard; Charles Hinds; Julian Bion Journal: BMC Med Ethics Date: 2019-05-07 Impact factor: 2.652
Authors: Farrel J Buchinsky; Joseph Donfack; Craig S Derkay; Sukgi S Choi; Stephen F Conley; Charles M Myer; John E McClay; Paolo Campisi; Brian J Wiatrak; Steven E Sobol; John M Schweinfurth; Domingos H Tsuji; Fen Z Hu; Howard E Rockette; Garth D Ehrlich; J Christopher Post Journal: PLoS One Date: 2008-05-28 Impact factor: 3.240