Traditional vs. Aggressive Therapy for Multiple Sclerosis TREATMS Mo Monthly W thly Webinar ebinar Se Serie ries s March 1-2, 2018
To Today’s Agenda • Welcome 11:00-11:05 • Scheduling poll for future webinars 11:05-11:10 • JHM single IRB review process: TREAT-MS 11:10-11:50 • TREAT-MS site reliance status 11:50-11:55 • Closing remarks 11:55-12:00
• Select the Weekday(s) during which you would be available to attend an hour-long webinar between 9AM-12PM (Select ALL that apply) Monday AM Tuesday AM Wednesday AM Thursday AM Friday AM • Select the Weekday(s) during which you would be available to attend an hour-long webinar between 1PM-5PM FUTURE FU (Select ALL that apply) WEBINA WEBINAR R Monday PM Tuesday PM SCHEDULI SC EDULING Wednesday PM Thursday PM PO POLL LL Friday PM • Which of the following best describes your role at your site? PI Site Coordinator Contracts Point of Contact (POC) IRB Point of Contact (POC) Other (MS Specialist, etc.)
Today’s Feature Presentation To JHM Single IRB Review Process: TREAT-MS Megan Kasimatis Singleton, JD, MBE, CIP Assistant Dean for Human Research Protections Johns Hopkins University School of Medicine IRB Cindy MacInnis, MBA, CCRP Research Services Navigator
JHM Single IRB Review Process: TrEAT-MS What do Relying Sites Need to Know? Megan Kasimatis Singleton, JD, MBE, CIP Assistant Dean for Human Research Protections Johns Hopkins University School of Medicine IRB Cindy MacInnis, MBA, CCRP Research Services Navigator 5
Agenda • What are the steps for sIRB review? – Step 1: Onboarding to the necessary agreements • SMART IRB Agreement • Indemnification Addendum • SMART IRB Exchange Portal Access Agreement – Step 2: Completion of Local Context Review – Step 3: Site onboarding 6
JHU-Tufts TIC Research Services Navigator Resources Cindy MacInnis, MBA, • Single IRB: CCRP – Provide IRB reliance agreements to participating sites – Facilitate agreement execution: provide additional Research Services Navigator cindy@jhmi.edu information, aides further discussion with study site IRBs 667-208-7370 and legal departments – Ensure site managers have approved study documents for distribution Ryan Majkowski – Create study profile in SMART Exchange Portal and Research Assistant facilitate training rmajkow1@jhmi.edu 443-287-0119 • Agreements: – Facilitates sub agreement drafting with study PI’s institution – Distributes agreements to sites and facilitates negotiation when applicable
STEP 1: ONBOARDING TO THE AGREEMENTS & CEDING REVIEW 8
SMART IRB Reliance Agreement • In anticipation of the release of the NIH Key Facts: policy, the National Center for • Eliminates the need for study- Advancing Translational Sciences specific reliance agreement [NCATS] funded a multi-institutional negotiations collaborative initiative to develop a • Institutions may have “addendums” national IRB reliance agreement to cover items not specified in the [SMART IRB] agreement such as indemnification – As of September 2016, this agreement [JHM IRB does require an is now available: https://smartirb.org/ indemnification addendum] – FWA-holding Institutions sign on to use • Institutions must have an FWA the agreement through a joinder [FederalWide Assurance] to sign on process. – Once you are a signatory to SMART, 388 you may use SMART as your reliance agreement for any specific study that signatories also involves institutions that are 64 SMART signatories CTSA Hubs
How do relying sites cede review? • Sign onto the SMART IRB agreement via the joinder process – See www.smartirb.org for joinder resources • Execute the Letter of Indemnification with JHU [Will be provided by email] • Execute the SMART IRB Portal Access Agreement – 19 TrEAT-MS sites have signed all 3 agreements! – 10 TrEAT-MS sites have signed 2 of the agreements! – 7 TrEAT-MS sites have signed 1 of the agreements – 9 TrEAT-MS sites have signed no agreements to date
System Overview —Relying Site HRPPs—
Imp mpleme menting a National Single IRB Policy IT solutions are needed to support single The Reliance Agreeme ment IRB documentation and communication is a 1st s is a 1s t step. ep. across institutions. A national policy and reliance agreeme ment are necessary, but no but not t suf suffic ficie ient, t, to suppo support rt sI sIRB revie view w
Using the IR Using the IRB Ex Exchang hange e A web-based portal that helps facilitate the implementation of a single IRB from initiating the reliance process thru study close.
The IRB Exchange: By The Numb mbers >150 partner institutions >600 users: including HRPP/IRB, Coordinating Center, and Study Team staff >80% 50 Studies in progress CTSA sites 29 Trial Innovation Network (TIN) studies signed on 21 Non-TIN studies
Who Who uses the IRB Ex uses the IRB Exchang change? e? Access is granted after Institutional Official executes the IRB Exchange Portal Access Form • Initial Access provided HRPP/IRB Personnel Study Teams Coordinating Centers • Access provided on a • Access provided on a to 1-2 “Liaisons” study-by-study basis study-by-study basis • Liaisons manage who by site’s HRPP/IRB by site’s HRPP/IRB has access to users users Exchange for their • Can add other study institution team members to • Add other HRPP or Exchange for their IRB staff/members site to Exchange • Remove HRPP or IRB staff/members from Exchange
Docume ment and track IRB reliance relationships HRPPs track all reliance relationships
Email notification to to your HRPP that your site is participating in study How should I respond to this email? 1. HRPP can open the attachment to view their local PI, and then notify the PI regarding the steps required to initiate reliance. 2. HRPP can login to Exchange and complete local context if they have the submission from their local study team 3. HRPP can ignore the email and wait until their PI submits
Indicating Reliance Step 1: Confirm m Site Engageme ment If multiple FWAs are engaged for a single study team, let the Reviewing IRB know the other engaged FWAs. The Exchange will capture the cede decision from each FWA. Soon: Relying Site HRPPs will correct/ add FWAs themselves.
AUTOMATIC EMAIL: Relying site study team m emailed about access to Exchange
Indicating Reliance Step 3: Comp mpleting the In Instit itution ional Pr al Profile (IP) ofile (IP) • If your IP is already complete, you can edit the information OR confirm it is up to date. • If you’ve never completed the IP, you will have to complete it to continue.
In Indic icatin ing R g Relian eliance S ce Step ep 4: Accep 4: Accept t the S e Study-S -Specific ecific Re Reliance Plan
AUTOMATIC EMAIL: CIRB and Relying HRPP emailed confirmation of reliance
AUTOMATIC EMAIL: Relying HRPP and study team emailed notification of approval by CIRB
Relying site approval docume ments are available in Ex Exchang hange Sites can download all docs in single file
Ne Next S Step eps • Start working on your Institutional Profile • Consider who within your HRPP needs access at your site • Watch the videos on the Resource page • Save the Reviewing and Relying Site Quick Guides • Begin considering your local requirements when relying on another IRB • What do you need submitted to your IRB before your PI can rely on another IRB? • What do you need submitted to your IRB at Continuing Review? • What do you need submitted to your IRB for study-wide amendments? • What study-related events do you want reported to your IRB? Resources: https://starbrite.vanderbilt.edu/rocket/index.php?wg=ws5493
STEP 2: LOCAL CONTEXT REVIEW 26
Single IRB Review ≠ Single Institutional Review Responsibilities given to an sIRB IRB Review Grants and Contracts Each Participating Site’s Institution retains responsibility for Review of Institutional ancillary and investigator Resources institutional reviews training and Review and verifications. expertise Ancillary Monitoring Reviews compliance (Safety, with local, Scientific, state laws; COI) HIPAA
What is a Relying Organization’s Responsibility? Each Relying Institution will … Communicate to the Reviewing IRB the requirements of any applicable state or local laws, regulations, institutional policies, standards, or other local factors, including local ancillary reviews, relevant to the Research (“Local Considerations”) that would affect the conduct or approval of the Research at the Relying Institution. Such communication may be made through the Reviewing IRB’s designee, as determined by the Participating Institutions in connection with the specific Research . [SMART IRB Agreement]
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