February 10, 2017: INVESTED Vanguard Year

February 10, 2017: INVESTED Vanguard Year

Slides: Slides


INVESTED Vanguard Year: What Did We Learn About SMART IRB?


Orly Vardeny, PharmD, MS, Associate Professor of Pharmacy and Medicine at the University of Wisconsin-Madison, and Principal Investigator for the INVESTED Trial

Nichelle Cobb, PhD, Director, Health Sciences IRB office at the University of Wisconsin-Madison

Adrian Hernandez, MD, MHS, Professor of Medicine at Duke University


Institutional review boards; IRB; INVESTED trial; NCT02787044; Influenza vaccine; Single IRB; Ceded review; Cardiovascular disease; National Heart, Lung, and Blood Institute; NHLBI; PCORnet

Key Points

  • The INVESTED trial is evaluating if preventing influenza, particularly by means of vaccination, can prevent influenza-triggered cardiovascular risk. The study, funded by the National Heart, Lung, and Blood Institute (NHLBI), began enrollment in September 2016 and currently has 39 sites enrolled, including sites in PCORnet.
  • INVESTED is also piloting a cost-efficient approach to research ethics reviews called SMART IRB, an initiative developed under an award from the National Center for Advancing Translational Sciences (NCATS) to support single IRB review to facilitate multisite human subjects research. SMART IRB is not an IRB, but is a Master Common Reciprocal IRB Authorization Agreement that permits participating institutions to cede review of human subjects research to other participating Institutions’ IRBs.
  • The INVESTED study team’s evaluation of SMART IRB will guide the continued implementation of the single IRB model within PCORnet. Three key domains are the focus of the evaluation: efficiency, resource use, and user perception.
  • Suggestions for advancing the success of the single IRB model include ensuring lead and ceding sites are clear on their own IRB’s requirements around single IRB; being clear on local requirements from the beginning; providing extra resources (education, funding) for the lead study team, especially if they are new to SMART IRB; and starting early to get sites on board.

Discussion Themes

Single IRB has a wide-ranging effect on institutions—this model has an impact on processes, communication, personnel, and other components. Institutions will need to rethink their processes and responsibilities around various legal/regulatory/policy issues.

Culture change takes time and perseverance. Adopting the single IRB model comes with both benefits and challenges, but the expectation is that comfort and trust will increase over time as more researchers and institutions gain experience with single IRB.

NIH’s policy on single IRB review for multisite research goes into effect on September 25, 2017.

For More Information

Learn more about the INVESTED trial www.investedtrial.org.

Learn more about SMART IRB at https://smartirb.org/.

@ncats_nih_gov, @PCTGrandRounds, @Collaboratory1, @PCORnetwork

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