Institutional Review Board

IRB approval of each referring physician site under the New IDEAS multisite protocol is required prior to full activation by the ACR®. Referring physician sites must use Advarra IRB as the IRB of record overseeing their research activity. Local IRBs are not permitted to serve as the IRB of record for the New IDEAS study.

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.

Please contact newideas-regulatory@acr.org or call Grace Dillon at 1-215-574-4177 with questions.

Initial Submission

Each site is responsible for obtaining IRB approval to participate in the New IDEAS study by submitting directly to Advarra IRB. The Advarra IRB protocol number for New IDEAS is Pro00046342. See instructions on how to submit to the Advarra IRB.

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 above.

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.

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 to the IRB. See instructions on how to submit to the Advarra IRB.

FAQ

No. All participating sites are required to use Advarra as the IRB of record for New IDEAS. The study has provided detailed instructions on how to use Advarra. Local IRB stamp of approval or acknowledgement is allowed, but oversight of study conduct must be given to Advarra.

Note: required institutional language can be included in the template ICF but must receive approval by the study and Advarra before use.

No. The PET scans are being done as a covered medical service to aid in the diagnostic evaluation of patients with mild cognitive impairment or dementia under a CMS Coverage with Evidence Development (CED) program. The scan could be obtained without participation in the New IDEAS study, but Medicare only covers the service for enrolled subjects.

We will do our best to make sure that the patient and management information obtained during the course of this research study is kept private. However, we cannot guarantee total privacy. Study information may be given out if required by law. If information from this study is published or presented at scientific meetings, participant name and other personal information will not be used.

The New IDEAS study database will contain only unique identifiers for patients to protect their identities. The study investigators will need to know patients’ identities in order to coordinate collection of Medicare claims data for the study. Protected health information (PHI) required for the study will be kept in a database dedicated to PHI, which will be housed separately from the primary database used for analysis purposes. Only the dementia specialist, the ACR data management center, the statistical team coordinating collection of claims data from CMS, and members of the IRB will have access to the records.

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