title: Variations in institutional review board reviews of a multi-center, Emergency Department (ED)-based genetic research protocol.
abstract: BACKGROUND
  In the United States, institutional review boards (IRBs) oversee the scientific, ethical, and regulatory aspects of research conducted on human subjects. Institutional variations in the interpretation and application of federal and local regulations concerning genetic testing can have significant impact on the implementation of such studies.
  
  
  OBJECTIVE
  We assessed variability in IRB review of a multi-center Emergency Department-based study examining genotypic and phenotypic predictors of pain and psychological outcomes after minor motor vehicle collision (Project CRASH). This is one of the first multi-center genetic research protocols based solely in the Emergency Department (ED).
  
  
  METHODS
  We performed an observational study of sites participating in Project CRASH. We collected IRB information and correspondence from each site. We collected data that included information regarding institution demographics, original IRB application characteristics, subsequent IRB correspondence, and time interval between submission and approval. Descriptive statistics were used in analysis.
  
  
  RESULTS
  All sites that initially agreed to participate in Project CRASH also participated in this study (n = 7). The time interval in receiving IRB approval varied between 20-760 days (median 105, IQR 21-225). One site appeared to be an outlier (760 days). The most commonly requested changes were changes to the consent form.
  
  
  CONCLUSIONS
  Institutional interpretation of regulations regarding our ED-based genetic study was highly variable. Although the majority of our results are consistent with other similar published studies, the mean time interval for approval for this genetic study is far greater than other reported studies.
authors.affiliation: Department of Emergency Medicine, North Shore University Hospital, Manhasset, NY 11030, USA. dlee@nshs.edu
authors.forename: David C
authors.initials: DC
authors.lastname: Lee
authors.forename: David A
authors.initials: DA
authors.lastname: Peak
authors.forename: Jeffrey S
authors.initials: JS
authors.lastname: Jones
authors.forename: Robert M
authors.initials: RM
authors.lastname: Domeier
authors.forename: Phyllis L
authors.initials: PL
authors.lastname: Hendry
authors.forename: Niels K
authors.initials: NK
authors.lastname: Rathlev
authors.forename: Robert A
authors.initials: RA
authors.lastname: Swor
authors.forename: Samuel A
authors.initials: SA
authors.lastname: McLean
mesh_terms: D000063:Accidents, Traffic / Q000523:psychology; D032962:Consent Forms / Q000941:ethics / Q000592:standards; D004636:Emergency Service, Hospital; D028744:Ethics Committees, Research / Q000592:standards / Q000706:statistics & numerical data*; D056726:Genetic Association Studies / Q000941:ethics / Q000592:standards; D036281:Genetic Research / Q000941:ethics*; D006801:Humans; D015337:Multicenter Studies as Topic; D013997:Time Factors; D014481:United States; D014947:Wounds and Injuries / Q000235:genetics / Q000523:psychology