Unique challenges of obtaining regulatory approval for a multicenter protocol to study the genetics of RRP and suggested remedies.
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.


METHODS
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.


CONCLUSIONS
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.


METHODS
B-3b.
Sherwood
Mylaina L
ML
Center for Genomic Sciences at Allegheny Singer Research Institute, Allegheny General Hospital, 320 East North Avenue, Pittsburgh, PA 15212-4772, USA.
Buchinsky
Farrel J
FJ
Quigley
Matthew R
MR
Donfack
Joseph
J
Choi
Sukgi S
SS
Conley
Stephen F
SF
Derkay
Craig S
CS
Myer
Charles M
CM
Ehrlich
Garth D
GD
Post
J Christopher
JC
D002985:Clinical Protocols / Q000592:standards; D004282:Documentation; D028744:Ethics Committees, Research / Q000331:legislation & jurisprudence / Q000458:organization & administration; D006776:Hospitals, Pediatric; D006801:Humans; D015337:Multicenter Studies as Topic / Q000331:legislation & jurisprudence / Q000592:standards; D009364:Neoplasm Recurrence, Local; D010212:Papilloma; D012142:Respiratory Tract Neoplasms / Q000235:genetics; D014481:United States