Frequently Asked Questions - DoRC

    Protocol-Proposal Congruency

    How do I send a request for a congruency review for my proposal?

    You no longer need a form to request a congruency review for a proposal. You only need to send an email with the following information to dorc@yale.edu:

    1. Grant title
    2. PI of Grant
    3. Granting agency
    4. Agency award number, if applicable
    5. IRES record number (Grants and Contracts database number), if known
    6. PI of protocol and protocol number
    Do I need to submit an Add Title request or Modification form to add funding to an existing protocol?

    No, you no longer need to submit any form to request a congruency review.

    Do I need to send a copy of my proposal to the IACUC office?

    In most cases, we will be able to obtain a copy of the proposal from either eRA Commons (NIH database) or IRES (Grants and Contracts database). In the event that it is not available from either source, we will request an electronic copy of the proposal from the PI.

    Do I need a separate protocol for every award?

    No. Yale has a policy of one to many and many to one. This means you can have several awards linked to one protocol or one award linked to several protocols. The only stipulation is that the work described in the proposal is covered by the protocol.

    I submitted a competing continuation to an existing award, do I need to request a congruency review?

    Yes, a competing continuation is considered a new award. Even if it contains the exact same science, species, experiments etc. as the previous iteration of the proposal, a congruency review is required.

    My award is not funded by NIH, why is my proposal subject to PHS/NIH policy?

    Policy standards required by PHS are applied to all live vertebrate animal research at Yale to maintain process/program consistency University-wide. The NIH Office of Laboratory Animal Welfare (OLAW) discourages multiple standards of review, approval or compliance measures for different funding sources.

    How far in advance should I submit a new protocol application to cover work in a new proposal?

    When applying for a new protocol to cover work on a submitted proposal, please keep in mind that it can take some time for protocol approval.  Please submit a new protocol application as soon as possible and at least 60 days prior to the award start date. Please refer to the IACUC commitee schedule for submission deadline dates.

    What type(s) of funding should I include in my New Protocol Application?

    When applying for a new protocol application, all extramural funding that you want to be linked to this new application needs to be listed in the funding section. Please refer to Listing Awards for New Protocol Application.

    What type(s) of funding should I include in my 3 Year Renewal Application?

    When applying for a 3 Year renewal to an existing protocol, all active, extramural funding currently linked needs to be listed in the funding section of the renewal application. You can also list any funding you would like to add to your new protocol. Please refer to Listing Awards for 3 year Protocol Renewal.

    I don’t wish to associate my proposal with any of my current protocols. The scope of the research is sufficiently different that I would like to have a separate IACUC protocol for this proposal. What should I do?

    If for any reason you would prefer to generate a new protocol to cover the work outlined in your new proposal, submit the new protocol application to the IACUC as soon as possible and  60 days prior to likely award start date and list the proposal(s) in the funding section of the application.

    Do I need a congruency review if my proposal only involves custom antibody generation?

    Yes.  At Yale, IACUC approval is required for custom antibody generation.  Antibody generation can either be included in a full protocol application or requested using the Custom Antibody Generation protocol form.

    I am submitting a proposal to a funding agency that requires IACUC review and approval (March of Dimes, DoD etc.), what should I do?

    If your proposal requires an IACUC congruency review and approval prior to submission, please send the proposal and protocol information to dorc@yale.edu 30 days prior to the proposal submission deadline date.

    I submitted a revised application to NIH that was funded (e.g. -01A1) but my original application (e.g. -01) was already reviewed and approved for congruency. Do I need to request another review?

    Yes. Because the proposal was revised, that proposal must undergo a complete congruency review even if the animal work proposed remains unchanged.

    What if all of the animal work is not being done at Yale, but instead is being conducted at another institution? Do I still need a Yale IACUC protocol?

    While a congruency review is still required to verify the information in the proposal, a Yale IACUC protocol is not required.  Once verified that all animal work is conducted outside of Yale, DoRC will then request that the PI supply supplemental IACUC information from the institution(s) carrying out the animal work, even if the institution is a contract organization or a foreign institution.