ISMMS Researchers Share Experience using the TIN sIRB

Jun 5, 2020 | Conduits News

The TIN (The Trial Innovation Network) is an innovative national collaboration between a network of CTSA hubs. The TIN addresses critical roadblocks in clinical research by accelerating the translation of novel interventions into life-saving therapies.

The ConduITS Institutes for Translational Sciences at Mount Sinai has established a local TIN Hub Liaison Team (THLT) to assist ISMMS investigators to better understand and utilize the TIN.

The (THLT) is part of The ConduITS Institutes for Translational Sciences at Mount Sinai, which is supported by The Clinical and Translational Science Awards (CTSA) grant UL1TR001433 from the National Center for Advancing Translational Sciences and offers guidance for multi-center studies like navigation of the single IRB process and input on protocol development. TIN offers additional services besides sIRB and the initial consultation.  Here is a full list. – Initial Consultation and Resources.

The ISMMS TIN Hub Liaison Team provides consultations for individuals requiring multi-site support to assist in determining if we have the resources internally or if investigators should use the TIN.

We recently had a chance to sit down with Karen O’Sullivan, Director of Regulatory and Administrative Affairs of the National Heart, Lung, and Blood Institute (NHLBI)-funded Cardiothoracic Surgical Trials Network (CTSN) Data and Clinical Coordinating Center to discuss her experience utilizing the TIN for one of the Multi-Site center studies funded by the NHLBI (Network for Cardiothoracic Surgical Investigations in Cardiovascular Medicine; 2U01HL088942-12) through the International Center for Health Outcomes and Innovative Research (InCHOIR) Data and Clinical Coordinating Center.

What was your overall experience with the TIN?

Our group is the data and clinical coordinating center for a large network. The requirements for multi-center Studies are now that they go through a single IRB process, our renewal for our funding cycle had come through, we were required to use single IRB, and so we reached out to our colleagues here. Our PI Dr. Annetine Gelijns, and I are on the ISMMS TIN HUB Liaison Team and we essentially heard about the opportunity to use TIN through one of our HLT meetings.

The initial process included Dr. Rosalind Wright, Horace W. Goldsmith Professor of Pediatrics and Preventive Medicine, Dean for Translational Biomedical Sciences and Director, Conduits (the Mount Sinai Health System CTSA Program) who is also the program PI of the CTSA grant, reviewing our proposal to determine if we should leverage local resources or submit it to TIN. Once it was determined that we would utilize the TIN Dr. Wright wrote us a letter in support of the project and we submitted a brief online proposal/application requesting sIRB services. The turnaround time was quick. We were then connected with the single IRB at Vanderbilt University Medical Center. TIN facilitated a conference call for us in the 4th quarter of 2018, with the Vanderbilt IRB and Mount Sinai received lead site IRB approval in August 2019. Since then, we have successfully received single IRB approval for 15 clinical centers, and we have another group of 6 in review with them currently”.

How many sites are you hoping to approve?

We are hoping to be open over 50 US sites, with a 3-year recruitment phase and a 6-month follow-up.  We just started enrollment in December. The study is supported by a network grant; it is a U01, so it is a collaborative process, and the NIH program officers are very involved in protocol development as well.

Did you find that the process was accelerated with the support that you were getting from TIN?

Yes, it has been a very collegial experience, so I think that having that introduction and having that team spirit has helped, and if we had to do this on our own, it would have been a much steeper learning curve.

What are some examples of how TIN was instrumental in guidance through this process and start-up?

Sure, first, this being a completely new paradigm for us, just understanding that there was potential for this collaboration was a big boost for us.  We were initially unsure of where we should turn and to whom we should ask for assistance.  There are stand-alone IRBs, but the expense may be prohibitive.  It is a seemingly overwhelming task when you take a first look at the process. TIN provided us with the option to work with them, and their putting us in touch with the right people at Vanderbilt was truly helpful to us in getting this all started.

Did the Duke-Vanderbilt group help guide your other sites through the process as well?

Yes, the Duke-Vanderbilt TIN Group was very much involved in training the sites and explaining to them the SMART IRB agreement and process.  For many of our site s, this was very new to them as well. The Duke-Vanderbilt TIN Group educated our sites on the reliance agreements and the pre-submission work that needs to be done via group webinars and conference calls and even via one-on-one discussions with some of our sites’ IRB administrators. They have been very available and helpful to us in that way.  They walked our group at the DCC through the process as the lead site. It is a new frontier for us, and now that we have been sitting with the process for several months, it makes a lot of sense.   It’s not very difficult, but when we were first faced with taking on a single IRB, it was not clear.   I feel like when you are new to this, you need a bit of handholding.

Developing a multi-site study? Learn more about the CTSA  resources that are available.

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