THE REVISED COMMON RULE SINGLE IRB REQUIREMENT Hannah Helmstetter, Reliance Specialist August 7, 2019

OBJECTIVES Single IRB Requirement for Federal Studies How to Handle a Federal Grant Proposal How to Handle the Budget Miscellaneous Issues Q/A Session

What is Single IRB? Definition: The use of one single IRB where multiple institutions are engaged in the same protocol CONCURRENT IRB REVIEW: SINGLE IRB REVIEW: One study, multiple sites, IRB review at each. One study, multiple sites, one IRB reviews for all.

WHAT DO THE REGS SAY? OHRP: “Cooperative research projects are those projects…which involve more than one institution. …[An] institution participating in a cooperative project may enter into a joint review arrangement, rely upon the review of another qualified IRB, or make similar arrangements for avoiding duplication of effort.” 45 CFR 46.114 FDA: “…institutions involved in multi-institutional studies may use joint review, reliance upon the review of another qualified IRB, or similar arrangements aimed at avoidance of duplication of effort.” 21 CFR 56.114

THE CURRENT REGULATORY LANDSCAPE NIH SINGLE IRB MANDATE: As of January 2018, all multi-site NIH grant proposals required the submission of a Single IRB Plan naming which institution would serve as the IRB for all participating sites. Some exceptions apply: - K, T, and F awards - International, Native American, and VA sites - Other case-by-case exceptions may be given SINGLE IRB COMMON RULE REQUIREMENT: As of January 21, 2019, the New Common Rule is in place. All federally-funded multi-site studies which 1) receive IRB approval after that date or 2) transition to the Revised Common Rule are required to use a single IRB by January 2020. OHRP to release further guidance on exceptions hopefully at the beginning of September. When a federally-funded multi-site grant proposal comes across your desk, you should NOT submit it without following Emory IRB’s single IRB process…

Preparing a grant proposal when Emory is lead site/prime awardee… The Emory study team must submit a Single IRB Intake Form to the IRB Reliance Listserv (IRB-RELIANCE@LISTSERV.CC.EMORY.EDU) as soon as possible so that Emory can determine whether the study can be reviewed in-house, whether it can be reviewed by another institution’s IRB, or whether it has to go to WIRB. The Emory study team must prepare a Single IRB Plan and Communication Plan to submit with the grant proposal (for NIH and CDC applications, this is Question 3.2). Things to know: It is presumed that the lead site/prime awardee will either act as single IRB or choose another single IRB, but each participating site still has to agree to rely on the single IRB. Templates for the Single IRB Plan and Communication Plan are on our website. A fully executed reliance agreement is NOT required to be in place prior to receiving funding. The reliance agreement is negotiated later in the process. If it is taking longer to choose a single IRB, there is boilerplate language in the Single IRB Plan template to reflect that. If your study falls under an exception to the Single IRB requirement, you should state “N/A” in lieu of providing a Single IRB Plan and Communication Plan.

Handling the grant proposal when Emory is just a participating site… Although the lead site/prime awardee is responsible for preparing the grant proposal, the Emory study team must still submit a Single IRB Intake Form to the IRB Reliance Listserv (IRB-RELIANCE@LISTSERV.CC.EMORY.EDU) as soon as possible so that Emory can determine if we’re willing to rely on the single IRB chosen by the lead site/prime awardee. The lead site/prime awardee may ask the Emory study team to provide a Letter of Support stating Emory is willing to rely on the chosen single IRB. That Letter of Support must be issued by Emory IRB, not by the Emory study team or another Emory office. Only Emory IRB has the authority to agree to rely on an external IRB. The lead site/prime awardee will likely provide the study team with a Letter of Support template, so they can just forward that to the IRB Reliance Listserv. If not, there is a template on our website.

What to put in the budget… When Emory is the lead site/prime awardee: Single IRB costs need to be accounted for in the budget. When Emory is acting as the single IRB, there is no charge. When another institution is acting as the single IRB, the study team must get a quote from the chosen single IRB. When WIRB is acting as the single IRB, the study team must get a quote from WIRB by submitting the Single IRB Quote Request Form to Bob Tammaro per the instructions on the website. When Emory is a participating site: Single IRB costs must be budgeted by the lead site/prime awardee. When Emory is relying on another institution, there is no charge for processing the reliance here. The lead site/prime awardee must speak with the chosen single IRB to see if they charge for single IRB processing. When Emory is relying on a commercial IRB, there is no charge from the IRB for processing the reliance here but other regular fees still apply (such as the School of Medicine fee). The lead site/prime awardee should get a quote from the commercial IRB for single IRB processing. Most commercial IRBs have a quote form or a fee schedule they can provide.

Study Team follows up with Emory IRB once they’ve secured funding Reliance Agreement Negotiation and Execution Step 2 Step 1 XIRB Local Submission And Site Requirements Completed Step 3 EMORY RELYING….. Step 4 Local Context and Institutional Signoff Step 6 Emory study team supply of approval letter and approved site-specific documents to Emory IRB and other necessary ORA offices (RAS, etc.) Emory study team supply of Local Context Worksheet(s) and Site-Specific Forms to Lead Study Team for their submission Step 5

Why do we need a local XIRB submission? When Emory cedes IRB review, all other parts of the research administration still have to happen at Emory. Study staff training OSP routing PRA analysis with OCR Ancillary Reviews We also need a record of the study here to maintain institutional accreditation. Study Initiation Conflict of Interest Contract and Budget Data Transfer Agreement Biosafety Review Institutional Review Board Office of Quality Department Review REMS Review Radiation Safety Review

ALERT: There is a huge misconception that reliance is done once the Reliance Request Form is approved for Emory to rely on an external IRB. What to tell study teams: There has to be a reliance agreement in place. A reliance agreement is a contract which requires a back-and-forth negotiation between the institutions. That reliance agreement can take many different forms (see later slide: What is “evidence” of the reliance relationship?). IRB review is the only thing that has been ceded to the other institution. When Emory relies on another institution for IRB review, we are still responsible for all other parts of the research administration here. Emory cannot be approved as a site by the external IRB until all other parts of the research administration are complete here and institutional signoff has been given. The initial approval will not automatically apply to Emory. There has to be an amendment/modification to the external IRB’s submission to add Emory as a site, add Emory study staff members to the staff listing, and to approve any Emory-specific consent and HIPAA documents and other documents (recruitment materials, brochures, etc.). Emory will not be considered “Approved” and ready for study start-up until that amendment/modification approval letter specific to Emory has been provided to our Emory offices.

How will OSP and RAS know that Emory is approved and ready for site start-up? You should ask the study team for the following documents: There will be an initial approval letter. That approval letter applies to the studywide materials and the lead site only. There will be the follow-up letter from the single IRB specifically to add Emory as a site. It may be in the form of an amendment/modification approval letter, or it may be called a “site approval letter.” Be prepared to accept letters that look vastly different from one another. There will be some type of evidence of the reliance relationship. You should review the XIRB submission to see if funds can be released: Once the reliance agreement document has been executed and Emory has been approved as a site, the state of the XIRB submission will be changed to Approved.

What is “evidence” of the reliance relationship? Study-specific reliance agreement document for one study Umbrella reliance agreement document with several protocols listed Network reliance agreement document with a “scope” that references an entire network or consortium Memorandum of Understanding that details which IRB will be responsible for a study for long- term reliance with partner institutions SMART IRB Letter of Acknowledgement SMART IRB Online Reliance System or IRB Reliance Exchange System Note: Our network reliance agreements and Memorandums of Understanding are listed in a table on the website.

What is SMART IRB? Disclaimer: It’s not an IRB! It’s a master agreement! Emory is signed onto the SMART IRB Master Agreement, along with over 600 others (called “Participating Institutions”). Anytime we need to enter into a reliance agreement with another institution who is signed onto SMART IRB, we can simply execute a SMART IRB Letter of Acknowledgement or enter reliance via one of the online systems instead. 1. It means that we don’t have to negotiate a new agreement from scratch. 2. It is assurance that the other institution’s IRB is accredited or meets a certain standard and is covered by insurance.

WHERE TO FIND INFO ON THE WEBSITE… Visit the Collaborative Research webpage at: http://www.irb.emory.edu/forms/external- irbs/index.html For information about the Single IRB Requirement as well as any templates and forms mentioned, the “NIH and Federal Single IRB Requirements” tab. For the table of umbrella agreements and MOUs, the “Umbrella Agreements/MOUs” tab. For information about the SMART IRB agreement, the “What is SMART IRB?” tab. Plus any and all other information about reliance. There are specific pages for WIRB, NCI CIRB, and Advarra IRB. For questions that cannot be answered on the website, contact: Hannah Helmstetter, Reliance Specialist Hannah.helmstetter@emory.edu 404-727-8485 IRB-RELIANCE@LISTSERV.CC.EMORY.EDU

Questions?