title: Minimal-risk waiver of informed consent and exception from informed consent (Final Rule) studies at institutional review boards nationwide.
abstract: BACKGROUND
  Federal regulations allow waiver of informed consent for minimal-risk research (waiver). More than minimal-risk emergency research is allowed with an exception from informed consent (EFIC) under specific guidelines called the Final Rule. Performance of research without consent is controversial; however, chances for public health improvements are significant.
  
  
  OBJECTIVE
  1) To describe the number and demographics of academic medical institutions that have reviewed and approved minimal-risk waiver and EFIC studies; 2) to describe associations between National Institutes of Health (NIH) funding percentile and whether an academic medical institution reviews EFIC studies; and 3) to describe associations between geographic region and review of EFIC studies, and the interaction of region and NIH funding percentile with review of EFIC studies. The hypothesis was that schools with a higher NIH funding percentile (more funding) reviewed more EFIC studies research, and that this effect did not vary based on region.
  
  
  METHODS
  This was an e-mail and telephone survey of all 122 MD-degree-granting medical schools in the continental United States. Descriptive data were collected on the number of schools reviewing and approving EFIC research. Sites were split into those that have reviewed EFIC studies and those that have not. A multivariable logistic regression examined the effects of 1) funding percentile and 2) region (Northeast, North Central, Southeast, and West) on the likelihood of EFIC study reviews at the sites. Odds ratios (ORs) and 95% confidence intervals (95% CIs) were determined.
  
  
  RESULTS
  Ninety-eight of 118 eligible institutional review boards (IRBs) (83%) responded. Ninety-nine percent (97/98) approved waiver studies; 51% (50/98) had reviewed and approved EFIC studies. Academic medical institutions with higher funding percentile were significantly more likely to have reviewed/approved EFIC studies (interaction p = 0.01) in all regions except the Northeast, where higher funding percentile was associated with IRBs significantly less likely to have reviewed/approved EFIC studies (OR 0.25; 95% CI = 0.08 to 0.81).
  
  
  CONCLUSIONS
  Almost all medical school IRBs review minimal-risk waiver studies. About half of IRBs at medical schools have reviewed and approved an EFIC study. The higher the NIH funding percentile (more NIH funding), the more likely a site has reviewed EFIC studies, except in the Northeast region.
authors.affiliation: Department of Emergency Medicine, University of New Mexico, Albuquerque, NM 87131-0001, USA. aernst56@aol.com
authors.forename: Amy A
authors.initials: AA
authors.lastname: Ernst
authors.forename: Steven J
authors.initials: SJ
authors.lastname: Weiss
authors.forename: Todd G
authors.initials: TG
authors.lastname: Nick
authors.forename: Kenneth
authors.initials: K
authors.lastname: Iserson
authors.forename: Michelle H
authors.initials: MH
authors.lastname: Biros
mesh_terms: D000046:Academic Medical Centers / Q000706:statistics & numerical data; D028744:Ethics Committees, Research / Q000706:statistics & numerical data*; D005260:Female; D005843:Geography; D019983:Guideline Adherence / Q000592:standards* / Q000706:statistics & numerical data*; D017408:Guidelines as Topic; D019538:Health Care Surveys; D006801:Humans; D007258:Informed Consent / Q000592:standards* / Q000706:statistics & numerical data*; D016015:Logistic Models; D008297:Male; D009316:National Institutes of Health (U.S.); D016017:Odds Ratio; D012106:Research / Q000145:classification / Q000191:economics; D018570:Risk Assessment; D014481:United States