Office of Responsible Research Practices
The Ohio State University

News Archive for December, 2016

Ohio State joins SMART IRB!

Tue, 13th December, 2016

Supporting single IRB review on a national scale, advancing collaborative research

For investigators pursuing National Institutes of Health (NIH) funded clinical research involving multiple sites, coordination of Institutional Review Board (IRB) reviews can be challenging. Streamlining this process has been a major concern for NIH.

Ohio State is one of almost 60 institutions that have joined SMART IRB, a platform designed to ease common challenges and burdens associated with initiating multi-site research. Smart IRB will allow institutions to minimize duplicative IRB reviews while maintaining appropriate oversight. It is also designed to provide a roadmap to implement the National Institutes of Health (NIH) Policy on the Use of Single Institutional Review Board for Multi-Site Research.

SMART IRB will help Ohio State researchers involved in multi-site, NIH-funded research streamline human subjects research, while ensuring robust protections for study participants. The platform can be used for a range from large, complex clinical trials to two-site collaborations. Clinical investigators will be able to obtain trial results faster and, ultimately, speed development of new diagnostics, treatments and preventative measures for patients.

The project is led by three members of the national Clinical and Translational Science Award (CTSA) consortium: Harvard Catalyst, Dartmouth Synergy and the University of Wisconsin-Madison. It is funded by the NIH CTSA program. SMART IRB will support and encourage nation-wide collaboration through a flexible master IRB reliance agreement, standard operating procedures and complementary tools and resources.

Enabling Single IRB Review

As part of SMART IRB, institutions may choose to rely on another IRB to review, approve and oversee a research study.

  • The Reviewing IRB takes on oversight responsibilities associated with that study for its duration
  • Relying institutions provide local information about state law, study team member training and qualifications and conflicts of interest
  • Investigators and institutions retain their responsibilities for the protection of human subjects, compliance with applicable laws, regulations, ethical standards and the terms of the institution’s Federal Wide Assurance (FWA)

How it works

The Overall Principal Investigator (PI) of a multi-site study works with the Points of Contact (listed on the SMART IRB website) for each participating institution to determine an appropriate reliance arrangement. Together they will identify a Reviewing IRB and determine which institutions will rely upon that IRB for the review and oversight of the research.

Additional details are available in the SMART IRB Standard Operating Procedures on “Establishing Reviewing IRBs and Relying Institutions” and “Initial Review Submission and Review Process.” See the Resources page.

Click on the link to SMART IRB for more information. Contact Ohio State’s SMART IRB point of contact at IRBAgreements@osu.edu.

Category : IRB / ORRP

Update on NIH Policy on the Use of a Single IRB for Multi-Site Research

Thu, 8th December, 2016

Update – 12/16/2016: The NIH has delayed the effective date of the single IRB mandate from May to September 25, 2017.

The Office of Responsible Research Practices (ORRP) is in the process of identifying and implementing changes in local policies and workflow in order to be compliant with the NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research.  Progress thus far includes:

  • Ohio State joined the national SMART IRB reliance platform. Fifty institutions across the country have already joined.
  • ORRP is updating local policies and submission/review guidelines for requests to cede IRB review and to manage responsibilities if Ohio State is designated as the IRB of record
  • Additional ORRP staff and IRB reviewers are being trained to manage the anticipated increase in institutional agreements
  • Planned January build-out of Buck-IRB capacity to manage all multi-site IRB tasks for institutional agreements.

The current procedures to submit requests to cede review are as follows:

  • Begin a new application in Buck- Select “Create a New Study” and complete the application as requested.
  • Select “other external IRB” as the review board. Provide the name of the principal investigator and IRB contact information for the IRB of record for the external institution that will provide review.
  • Upload a copy of the IRB approval and/or IRB application form from the external institution as well as the protocol and any other relevant documents.
  • If the external IRB has already agreed to be the IRB of record and has provided an authorization agreement, upload it to Buck-IRB under “other files.”

For questions about institutional agreements, please contact Jessica Evans at Evans.309@osu.edu or 614-292-9832.

Category : IRB / ORRP