Unique challenges of obtaining regulatory approval for a multicenter protocol to study the genetics of RRP and suggested remedies. Otolaryngol Head Neck Surg 2006 Aug;135(2):189-96
Date
08/08/2006Pubmed ID
16890066DOI
10.1016/j.otohns.2006.03.028Scopus ID
2-s2.0-33746567337 (requires institutional sign-in at Scopus site) 18 CitationsAbstract
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.
Author List
Sherwood ML, Buchinsky FJ, Quigley MR, Donfack J, Choi SS, Conley SF, Derkay CS, Myer CM 3rd, Ehrlich GD, Post JCMESH terms used to index this publication - Major topics in bold
Clinical ProtocolsDocumentation
Ethics Committees, Research
Hospitals, Pediatric
Humans
Multicenter Studies as Topic
Neoplasm Recurrence, Local
Papilloma
Respiratory Tract Neoplasms
United States