期刊
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION
卷 290, 期 3, 页码 360-366出版社
AMER MEDICAL ASSOC
DOI: 10.1001/jama.290.3.360
关键词
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资金
- NHLBI NIH HHS [HL68927] Funding Source: Medline
- NIDDK NIH HHS [R01 DK44003] Funding Source: Medline
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 rate. 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 multi center 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.
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