News & Announcements
October 11, 2022
Magnetic Resonance Research Center Protocol Committee Review (MRRC PRC) ancillary review process
Beginning October 11, 2022, the process will be changing for obtaining MRRC approval for research using the MRRC facility. Investigators will no longer request review of their research by directly contacting the MRRC via email. Instead, the HRPP Institutional Review Team (HRPP-IRT) will submit the request to the MRRC on behalf of the Investigators. This will occur when there is a new protocol that makes use of the MRRC or when there is a protocol modification that involves the MRRC.
What this Means to You
Investigators should visit the MRRC website for information on what the MRRC PRC will be looking for in the consent forms and protocol.
Investigators will still be required to fill out the Proposal for use of MRRC Resources form found on both the MRRC website and in the IRES IRB library. This form is to be uploaded into IRES IRB under Local Site Documents/Other Attachments as part of your submission to the IRB.
The HRPP-IRT will conduct the ancillary review process to obtain MRRC PRC approval, before sending the protocol to the IRB for review. If the MRRC PRC requests revisions the IRB will inform the investigator via IRES IRB. Once the investigator submits the requested revisions back, the HRPP-IRT will request review of the revisions by the MRRC PRC.
When final MRRC PRC approval is obtained, the HRPP-IRT will receive documentation of the approval for our records, the PI will receive communication via email from the MRRC PRC and if all other IRT revisions are complete the protocol will be sent to the IRB For review.
July 12, 2022
Changes regarding Yale IRB and HRPP Review Fees
On July 12, 2022, Researchers, Research Staff, and Business Offices received emailed communication from Pamela Caudill, Senior Associate Provost, Research Administration & Institutional Official; Brian Smith, Deputy Dean for Research, (Clinical and Translational); Co-Director, Yale Center for Clinical Investigation (YCCI); Arnim Dontes, Deputy Dean, YSM Finance & Administration, and Linda Coleman, Director, Human Research Protection Program regarding upcoming changes in Yale IRB and HRPP Review Fees.
The communication explained that effective September 1, 2022, Yale University is implementing a change to the process regarding IRB and HRPP review fees. There is NO change to the HRPP/IRB fee schedule or which studies are considered billable.
Detailed description of the change:
- Currently, the HRPP invoices IRB and HRPP fees in two ways: 1) by charging the sponsor directly (YCCI has done it on the HRPP’s behalf), or 2) by creating journal entries in Workday for certain billable activities.
- Effective September 1, 2022, Yale is streamlining this process so that ALL billable activities are charged by the HRPP to the departments via journal entries. YCCI will be available to help to recoup the money from the sponsor on the department’s behalf; however, the financial responsibility rests solely with the Department.
- Note: If a department has NOT used YCCI services for sponsor invoicing, it can either recoup the money from the sponsor on its own or it can consider using YCCI to help collect it on its behalf. If the investigator would like to have YCCI start working with the investigator’s team to recoup money from the sponsor on their behalf, the investigator’s Business Office can contact YCCI Billing at firstname.lastname@example.org.
How the change affects investigators:
- The HRPP will charge for IRB review at the time of a final IRB approval/determination, beginning with approvals/determinations issued on or after September 1, 2022. The HRPP will ask for the Chart of Accounts (COA) number, the name of the Business Office contact, and other associated information in the IRB/HRPP Submission Form. Yale understands that at the time of initial IRB review, the sponsor award account is not yet available. Business Offices are asked to have a general departmental COA available so that the initial review fees can be charged to this account. Alternatively, if an “at-risk” account has been created, then that COA may be supplied. All following submissions will be charged to the COA for the award (or the general COA until the COA is set up).
- When an initial study is submitted for IRB review or a request is made to use an external IRB, the HRPP Institutional Review Team designee will notify the Business Office contact via email that a new invoiceable submission has been received. This will alert them to expect a journal entry when a final IRB approval/determination or an authorization to use an external IRB is issued.
Available training and follow-up information
- A live virtual information session regarding IRB and HRPP billing is scheduled on August 16, 2022, at 9 am. Registration is available through Training Management System.
- The HRPP will also post a recorded slide presentation on the HRPP website after this session.