Institutional Review Board Approval and Informed Consent Process

Central IRB Overview

All participating sites must use Advarra IRB as the IRB of record. Local IRBs are not permitted to serve as the IRB of record for ALZ-NET, however it is understood that local IRBs may need to review and acknowledge, per local policy, before a site is fully active to enroll.

Each practice will need to select a Principal Investigator, with the usual responsibilities, prior to submitting to the IRB. Although the ACR must approve each individual physician profile, physicians located within the same practice only need to obtain IRB approval once on behalf of the practice.

All sites must follow and refer to the Advarra IRB Handbook when conducting research. The revised Handbook is available in the Reference Materials section of the Advarra CIRBI Platform (login required). Clients are encouraged to check CIRBI for the latest version of the Handbook and applicable summary of changes

Please contact alznet-regulatory@acr.org or call Grace Koehler at 1-215-574-3177 with questions.

IRB Agreement with Advarra

Sites without a local IRB

If your site does not have a local IRB, you can submit directly to Advarra IRB without a legal agreement between Advarra and your site. Follow the submission instructions in the link below.

Sites with a local IRB

Each site must rely on Advarra IRB as the IRB of Record for this multisite protocol. This section will help guide you on how to set up your site’s reliance on the Advarra IRB. To decide which agreement fits your institution's needs, please read through the guidance below. Choose the appropriate contract, complete the attached form and submit it to institutions@advarra.com.

External Reliance Agreement
This non-exclusive agreement outlines the roles and responsibilities of both organizations and provides all deferral and organizational numbers for any trial the institutional site wishes to submit.

SMART IRB Ceding Letter
Any SMART IRB member institutional site can use this document to indicate that your institution will cede to Advarra using Smart IRB. Because Advarra is also a member, the site can use this agreement for the deferral and org numbers.

• Check to see if your institution is participating in the SMART IRB agreement by searching the SMART IRB website.
• Two options for ceding to Advarra using Smart IRB.

Institutional Authorization Agreement
Provides the deferral and org numbers for a specific study.

Advarra Statement of IRB Oversight Waiver
Can also be used to cede oversight to Advarra (for a non-federally funded study)

Once an agreement between your institution and Advarra is complete, you can submit for initial approval. See instructions on how to submit to the Advarra IRB.

If you have questions regarding how to enter into an agreement with Advarra IRB, please reach out to the IRB Help Desk:

Hours of Operation: 8:30 AM – 8 PM EST
Phone: 1-886-992-4724
Email: institutions@advarra.com AND cirbi@advarra.com

Creating a CIRBI Account

Each site’s PI must have a CIRBI account in order to complete the initial submission. We also recommend that site research coordinators have an account.

Please refer to the account creation instructions.

Initial Submission

Each site is responsible for obtaining IRB approval to participate in the ALZ-NET study by submitting directly to Advarra IRB.

The Advarra IRB protocol number for ALZ-NET is Pro00064645.

To complete the initial submission, follow these step-by-step instructions.

• IRB approval of each site and their Informed Consent Form (ICF) is required prior to full activation by the ACR
• Each site is responsible for notifying the ACR and the central IRB (Advarra) if any revisions are made to their ICF during their participation in ALZ-NET.