Context Sequencing of the human genome provides an immense resource for studies
correlating DNA variation and epidemiology. However, appropriately powered
genetic epidemiology studies often require recruitment from multiple sites.
Objectives To document the burden imposed by review of multicenter studies and
to determine the variability among local institutional review boards (IRBs)
in the approval of a multicenter genetic epidemiology study.
Design A PubMed search was performed to determine the frequency of citations
of multicenter studies by 5-year intervals from 1974 through 2002. A 7-question
survey was sent to all participating study centers to obtain information on
frequency of IRB meetings, dates for submission and approval, use/nonuse of
a specific consent form, type of review performed, types of consent forms
required, preparation time, and number of changes requested by the IRB at
each center. Centers also provided a copy of all consent forms they generated
and IRB correspondence regarding the study.
Setting and Participants Thirty-one of 42 cystic fibrosis care centers in this single US multicenter
genetic epidemiology study of cystic fibrosis replied, yielding a 74% response
Main Outcome Measures Frequency of published research studies and consistency among IRBs.
Results The number of all published single-center studies has increased 1.3-fold
since 1985, while the number of published epidemiology and genetic epidemiology
multicenter studies increased by 8- and 9-fold, respectively, during this
same period. Evaluation of the risk of the same genetic epidemiology study
by 31 IRBs ranged from minimal to high, resulting in 7 expedited reviews (23%)
and 24 full reviews (77%). The number of consents required by the IRBs ranged
from 1 to 4; 15 IRBs (48%) required 2 or more consents, while 10 (32%) did
not require assent for children. The most common concern (52%) of IRBs pertained
to the genetic aspects of the study.
Conclusions Review of a protocol for a multicenter genetic epidemiology study by
local IRBs was highly variable. Lack of uniformity in the review process creates
uneven human subjects protection and incurs considerable inefficiency. The
need for reform, such as the proposed centralized review, is underscored by
the ever increasing rate of genetic discoveries facilitated by the Human Genome
Project and the unprecedented opportunity to assess the relevance of genetic
variation to public health.