Minimal-risk waiver of informed consent and exception from informed consent (Final Rule) studies at institutional review boards nationwide

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. Objectives: 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.