Concurrent Session #1 (9:45 am – 11:00 am)

New Rule Exemptions – Exemptions
Ada Sue Selwitz of the University of Kentucky

One of the most significant changes in the new Federal Policy on Human Research Protection (i.e. the Common Rule) is the new exemption categories. Many studies that in the past were approved using expedited or even convened IRB review procedures will now be eligible for exemption. Also, the new rules introduces a new type of review (i.e. limited IRB) that applies to select exemptions. This session will discuss the eight new categories, outline the conditions for limited IRB review, and provide the participants with the opportunity to apply the categories to mini cases.

Experiences in Implementing Single IRB Review: Developing Policies and Practices
Presented by Joseph Datko & Evelyne Bital from the University of Miami 

In late 2015 the University of Miami Human Subject Research Office began laying the groundwork for its Central Institutional Review Board (UM CIRB), motivated both by the anticipated change in NIH award policy for multi-site research and by investigators at UM interested in using a single IRB. Since that time our project has expanded to oversee over 50 relying study sites with an anticipated demand of several hundred more from our partner research consortia.

Our session discusses the approach we took to program development for a single IRB at an academic medical center, including policy decisions made to fit that setting, feedback and adaptations made, and preliminary recommendations for similar institutions looking to set up their own single IRB. Our hope is to exchange developing best practices in the pursuit of increasing nationwide harmonization.

Through the course of the program we have established a dedicated committee of faculty and non-affiliated reviewers, expanded our regulatory support staff from two to four full-time positions, and implemented a customization to the software for UM’s electronic protocol management system to facilitate multi-site review.

Highlights of the program as implemented include:

  • Adaptation of AAHRPP accredited-policies and procedures
  • Communication model employing partnership with coordinating centers for research networks
  • Support from in-house Quality Assurance team
  • Embrace of SMART IRB reliance agreement

Ongoing challenges facing the program include:

  • Updating written procedures to match adaptations in practice
  • Limitations in software platform and upgrade timeline
  • Hesitation by institutions unfamiliar with external reliance practices
Human Subjects Protections–As the Regulations Intended 
Presented by: Norm Braaten from Grinnell College

Empirical data (Braaten, 2014) may suggest that individuals and institutions that review minimal risk research are not taking advantage of all the regulations have to offer in determining an activity to be exempt. Why is this the case? In this interactive session, participants will be encouraged to re-examine the ethical principles and federal regulations along with their policies, procedures, and practices guiding human research protections. Participants may be asked to participate in making a human subjects research determination. The presentation is not for the fainthearted, as participants may be taken out of their comfort zone or may become upset, and completely disagree with the evidence presented. That is perfectly acceptable.

HOWEVER: One “wise sage” once wrote: “We could spend hours reviewing a low-risk study, but that creates an inappropriate burden for researchers and IRBs and does little to improve protections” (AAHRPP, 2009). And another “wise sage” once said, “I’ve gone to IRBs all over the country. They are thoughtful, sincere, really intelligent groups. To have all this brainpower sucked into the vortex of minimal risk research is not efficient” (person to be named later, 2008). With those two quotes in mind, let’s get to work.