Journal article
Unique challenges of obtaining regulatory approval for a multicenter protocol to study the genetics of RRP and suggested remedies
Otolaryngology--head and neck surgery, v 135(2), pp 189-196
2006
PMID: 16890066
Featured in Collection : UN Sustainable Development Goals @ Drexel
Abstract
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.
Sequential cohort of American children’s hospitals. A single protocol was submitted to each Institutional Review Board (IRB).
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.
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
Metrics
Details
- Title
- Unique challenges of obtaining regulatory approval for a multicenter protocol to study the genetics of RRP and suggested remedies
- Creators
- Mylaina L Sherwood - Allegheny General Hospital, Allegheny Singer Research Institute, Pittsburgh, PAFarrel J Buchinsky - Allegheny General Hospital, Allegheny Singer Research Institute, Pittsburgh, PAMatthew R Quigley - Allegheny General Hospital, Allegheny Singer Research Institute, Pittsburgh, PAJoseph Donfack - Allegheny General Hospital, Allegheny Singer Research Institute, Pittsburgh, PASukgi S Choi - Children’s National Medical Center, Washington, DCStephen F Conley - Children’s Hospital of Wisconsin, Milwaukee, WICraig S Derkay - Children’s Hospital of the King’s Daughters, Norfolk, VACharles M Myer - Cincinnati Children’s Hospital Medical Center, Cincinnati, OHGarth D Ehrlich - Allegheny General Hospital, Allegheny Singer Research Institute, Pittsburgh, PAJ. Christopher Post - Allegheny General Hospital, Allegheny Singer Research Institute, Pittsburgh, PA
- Publication Details
- Otolaryngology--head and neck surgery, v 135(2), pp 189-196
- Publisher
- Mosby, Inc
- Resource Type
- Journal article
- Language
- English
- Academic Unit
- Microbiology and Immunology; Otolaryngology (and Head and Neck Surgery); Surgery
- Web of Science ID
- WOS:000239795200003
- Scopus ID
- 2-s2.0-33746567337
- Other Identifier
- 991014878310104721
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InCites Highlights
Data related to this publication, from InCites Benchmarking & Analytics tool:
- Collaboration types
- Domestic collaboration
- Web of Science research areas
- Otorhinolaryngology
- Surgery