Use of Advarra IRB at the NIH Tiffany

Use of Advarra IRB at the NIH Tiffany Gommel Director, OHSRP/IRBO Lipsett Amphitheatre July 30, 2019

We are pleased to introduce Advarra IRB • Kathleen Rankin: Business Point of Contact • Betsy Casillo: Client Engagement Partner • Jessica Reis (Bolte): Operational Point of Contact for all things study-specific

Topics to be presented by NIH • Under what circumstances can a NIH Investigator request to use the Advarra IRB • OHSRP/IRBO requirements before submitting to the Advarra IRB • Investigator Responsibilities • Institutional and Study-specific local context • I’m IRB approved, what’s next?

When can a NIH Investigator request to use the Advarra IRB There is a program-wide reliance agreement with Advarra Two options: • An external Sponsor has identified the Advarra IRB and the NIH investigator wishes to join a new/existing multi-site study; OR • An NIH investigator-initiates a multi-site study, and the NIH IRB cannot serve as the single IRB. • In addition, you will need: • Concurrence from the OHSRP/IRBO to use Advarra IRB; AND • To have addressed how IRB fees will be covered

Before submitting to Advarra IRB: IRBO Pre-Review Requirements

Before Submitting to the Advarra IRB • Arrange for an in-person consult with a member of IRBO staff, primarily – Shirley Rojas. • Complete & submit a reliance application, found on the IRBO website, for IRBO tracking purposes. • Submit a study application, protocol & consent documents in NIH i. RIS for pre-review by IRBO staff. • However, before submitting to the IRBO in i. RIS and while developing the protocol, you should review the Reviewing IRB’s policies & make sure to address them in the protocol & consent, as applicable. • In addition, complete any ancillary committee reviews that are required for your study (e. g. Scientific Review, RSC, DEC, IBC)

Before Submitting to Advarra IRB • The IRBO will conduct a pre-review of the i. RIS submission to ensure all NIH Institutional requirements have been met. • This is NOT an official IRB review. • The i. RIS submission should include the following: • The draft/approved protocol including a description of NIH’s role • All master and/or NIH site-specific consent documents, including assent(s) • All required Ancillary approvals (e. g. Scientific Review, DEC, RSC, etc. ) • Any other supporting documents

Before Submitting to Advarra IRB • • • During the pre-review, the IRBO staff will: • Confirm all NIH specific requirements are met (e. g. , NIH Investigator training, compensation, etc. ) • Review the consent document(s) to ensure all NIH required language is included. You might also be asked to: • Revise submission documents such as the informed consent or protocol • Obtain Ancillary Review approval(s) As a reminder, you are still required to comply with certain NIH policies when relying on another IRB, regardless of whether is it a commercial IRB. For example, OHSRP Policy 801 Reporting Research Events & Policy 802: Noncompliance in Human Subjects Research

Before Submitting to the Advarra IRB • Once all Institutional requirements have been met, an “Institutional Review Memo” will be issued from IRBO to the NIH PI indicating that you can submit to the IRB. • The Institutional Review Memo should be included in the submission to Advarra by the NIH PI. • Advarra will not review the study without the Institutional Review Memo from the IRBO.

Investigator Responsibilities when Submitting to the IRB

Investigator Responsibilities • After the IRBO has conducted its Institutional Review of the i. RIS submission, you will then need to submit the study documents to the Advarra IRB via their electronic system (CIRBI). • If the NIH PI is initiating the multi-site study and thus acting as the Sponsor/CRO, the following need to be submitted, as applicable to the study design: • Model protocol, model consent document(s), model recruitment material(s), NIH Conflict of Interest certification, study measures AND the IRBO Institutional Review Memo • Additional sites will be added to the study via Amendment/ Modification once the model protocol and consent document(s) are approved by the IRB

Investigator Responsibilities • After the IRBO has conducted its Institutional Review of the i. RIS submission, you will then need to submit the study documents to the Advarra IRB via their electronic system (CIRBI). • When the NIH PI is acting as only a Participating Site in an industry sponsored, industry-initiated (external sponsor) multi-site study, the NIH will be added to the study via an Amendment/Modification. • The following items need to be submitted, as applicable to the study design: • NIH site-specific protocol addendum and consent document(s) with NIH site-specific language incorporated, AND the IRBO Institutional Review Memo

Investigator Responsibilities • You will be responsible for drafting the consent document(s) and the consent template language will depend on the role of NIH: • If the NIH PI is initiating the research and acting as the Sponsor/CRO, then a “model” consent document will need to be developed and approved by the Advarra IRB first. • If the NIH is a Participating Site and enrolling subjects, an NIH site-specific consent has to be developed based on the Sponsor’s model consent template and the NIH investigator is responsible for inserting the NIH required language into the Sponsor’s model consent.

Institutional and Study-Specific Local Context

Institutional and Study-Specific Local Context • The Advarra IRB needs to understand the NIH’s specific policies, as well as local norms, special requirements, culture, etc. in order to conduct its review. This is called “Local Context”. • Local Context is comprised of information specific to the NIH AND study-specific information. • NIH Institutional local context will be provided to the IRB via the Institutional Review Memo • Study-specific local context is provided by the NIH PI to the IRB

Institutional and Study-Specific Local Context • Examples of NIH Institutional local context include: • NIH is a Federal Preserve – State laws do not apply • NIH is subject to the Privacy Act of 1974, not HIPAA • Examples of Study-specific local context might include: • Specific population being enrolling (adults lacking capacity to give informed consent, NIH employees) • Local expertise or equipment • Expertise, special equipment, assays, etc. at the NIH

I’m IRB approved, what’s next? The NIH Post-Review and on-going requirements

I’m Approved! Now what? • After you receive your IRB approval from Advarra you will need to submit the following items to the IRBO via i. RIS: • IRB approval letter • IRB approved protocol • IRB approved consent(s)/assent(s) • Investigators must continue to comply with NIH policies, for example: • Ensure that IRB approved consents are posted by OPS • Comply with pharmacy and medical records requirements, etc.

I’m Approved! Now what? • NIH is only ceding IRB review, this means that other NIH requirements still apply to your research. • You are required to inform the IRBO if there is any change in the PI, change in the protocol status, (e. g. if the IRB suspends or terminates the research), or the protocol closes.

I’m Approved! Now what? • If you have any questions, contact Advarra’s Points of Contact for: • Clarification on Advarra’s policies and procedures • Help with individual submissions • Questions about an IRB determination • Contact IRBO for any questions or concerns in regard to local context issues.

Reminders & Avoiding Pitfalls • NIH PI is Responsible for: • Confirming budget or payment for IRB services • Following applicable NIH institutional policies and becoming familiar with Advarra’s policies • Using the appropriate consent template • Appointing a study staff member to be the Point of Contact for Advarra • Providing Local Context - Institutional and study-specific

Reminders & Avoiding Pitfalls • NIH PI must always comply with NIH Conflict of Interest requirements, specifically: • Covered protocols must be submitted for DEC clearance • The Documentation of NIH Completion of Conflict of Interest Requirements certification must be provided to the Advarra IRB, not the Personal Financial Holdings (PFH) form. • When completing the Advarra study application via their electronic system (CIRBI), answer “No” to conflict of interest questions.

We are happy to answer your questions but please hold off until after the IRB presentation.