Continuing IRB Review

Ongoing research studies must be reviewed by the Institutional Review Board (IRB) at least annually. This review must take place prior to the approval expiration date noted on the original approval letter. Otherwise, patient enrollment must be suspended.

Schulman-approved sites will need to submit a continuing review study status report. Beginning 8 weeks before study expiration, Schulman will contact the Principal Investigator by e-mail at 2 week intervals to remind him/her that continuing review is due. If assistance is needed with the submission, please contact the Schulman Ongoing Review Team at ongoingreview@sairb.com or call 513-761-4100.

Local IRB-approved sites should follow specific local IRB guidance. The IDEAS Study Practice Administrator will need to upload the IRB approval letter and informed consent.

For assistance, please contact IDEAS-Regulatory@acr.org.


Each referring physician who meets the criteria must apply and be approved by ACR. It is expected that a practice administrator or coordinator will register the site and include each physician who wishes to participate in the IDEAS Study. The practice will need to determine who will serve as site Principal Investigator, with the usual responsibilities, prior to submitting to the Institutional Review Board (IRB). Although each individual physician must be approved by ACR, physicians located within the same practice only need to obtain IRB approval once on behalf of the practice.

Central IRB – Schulman Associates Institutional Review Board

Schulman Associates is the designated central IRB for the IDEAS Study with costs absorbed by the study budget. Once your site has been approved by the Schulman, you will receive an alert via email prompting you to access the consents and approval documentation on their website. You should navigate to the “Schulman eTools” section of the Schulman website and use the email and password you registered with Schulman in order to access the consents and approval documents. The link below contains document access instructions.

 

Local Institutional Review Boards

Local IRB approval is also acceptable, but any fees would not be covered by the study. For purposes of this study, the referring physicians are considered subjects of research as well as investigators. A consent template provided for submission to the local IRB. The protocol and all supporting materials are listed below.

PLEASE NOTE: If your site is using a local IRB, you must upload the IRB approval letter and the approved consent forms before your site will be allowed to enroll subjects.

Responses to questions often asked by local IRBs can be found on the IDEAS FAQ page here .