Autumn’s Nine From RIA

Sept. 10, 2024

"By all these lovely tokens, September days are here. With summer's best of weather and autumn's best of cheer." -Helen Hunt Jackson

  1. COI in eRIA

    Beginning in 2025 the COI disclosure system will join the eRIA suite. Stay tuned for training, outreach and more information this Fall! 

    Find out more about COI on the RIA-COI website or email [email protected].

  2. Submission Timelines to Avoid Troubles

    The time to approval for an IACUC, IBC, and IRB application varies depending on many factors, which include:

    • The quality of the submission received
      • Is the application complete?
      • Do the responses address the questions?
      • Is the information consistent across different sections of the application?
      • Have all required attachments been uploaded and in the proper format?
      • Has the submission been signed by the PI?
      • Is all required and applicable training and medical clearances completed?
    • Timeliness of PI and reviewers
      • Are the reviewers delayed in submitting their review?
      • How quickly did the PI return a revised application?
        • Are all the reviewer comments addressed (e.g., have changes been made to the application)?
        • Have responses to the comments been entered in eRIA?
    • Whether Full Committee Review (FCR) is required
      • The IACUC has set criteria to determine whether a protocol or amendment requires FCR (refer to IACUC Policy #115 IACUC Review of Proposed Activities)
      • The IBC must review non-exempt activities (per NIH Guidelines) via FCR
      • The convened IRB reviews human subjects research studies that pose greater than minimal risk of harm to subjects

    To avoid delays in obtaining approval or a lapse in approval (for triennial renewals), please review these submission timelines:

    • The IACUC requires at least 4 weeks prior to the monthly IACUC meeting to get an application on the FCR agenda.
    • The IBC requires at least 4 weeks prior to the IBC meeting to get an application on the FCR agenda (note, the IBC currently meets every 2 months).
    • The IRB recommends allotting at least two months for study approval.

  3. Regulatory Updates for IBC Registration and IACUC Protocol Forms

    In April 2024, NIH’s Office of Science Policy (OSP) published a revision to the NIH Guidelines for Research Involving Recombinant and Synthetic Nucleic Acid Molecules. 

    Princeton University’s IBC Registration and IACUC Protocol forms have been updated to align with these regulatory changes. Specifically

    1. (IBC) The term “helper virus” has been changed to “helper system (e.g., helper viruses, packaging cell lines, transient transfection systems, replicon systems)”

    2. (IBC & IACUC) Questions have been added to identify the use of Gene Drive Modified Organisms (GDMOs).

      GDMO research involves genetic editing mechanisms that will intentionally propagate a specific allele/genotype throughout a population by favorably skewing/increasing the probability that the allele will be transmitted to offspring more than the natural Mendelian inheritance of 50% probability? This may include the use of nuclease editing tools such as zinc finger nucleases, TALENs and CRISPR/Cas technology. 

      Note: GMDOs require a minimum of ABSL2 containment.

    3. (IBC) Section 10 “Risk Assessment” has been expanded to improve the risk assessment and ensure safety (Note – some of these changes will not be implemented until later in the year).

  4. October 2024 Semiannual Inspections

    The IACUC is required, by federal regulation, to inspect at least once every six months all of the institution’s animal facilities (including satellite facilities) using the Guide as a basis for evaluation.

    While these inspections are an opportunity for the IACUC to learn more about your research and lab spaces, we hope you will take the opportunity to engage with your IACUC members and provide them with feedback on the program!

    As a reminder, RIA’s Post-Approval Monitoring program has developed Semiannual Inspection Self-Assessment tools to help you prepare:

  5. AAALAC Web Page 

    In early 2025 (January – March), Princeton University’s Animal Care and Use Program (ACUP) will undergo a re-accreditation site visit by AAALAC.

    An AAALAC web page has been created to keep you informed and up to date – Bookmark the page and visit often! 

    LAR and RIA will hold short, in-person AAALAC Review & Planning Meetings – at least one member of each lab must attend one of the sessions:

    1. Thursday September 26th, 2:00 – 2:30pm (PNI Rm 101)
    2. Tuesday October 1st, 2:30 - 3:00 PM (PSH Rm 125)

    Click here to register (we have AAALAC swag!)

  6. Animal Bites/Scratches, Exposures to Hazards, and Other Laboratory Injuries

    Accidents can occur when working with animals and/or hazardous agents and personnel safety is important!

    Knowing how to obtain medical care and to whom to report an accident is vital to your safety and, potentially, the institution’s community.

    Follow EHS’ process to clean it, get treated, and report it if you experience an:

    1. Animal-related incident (e.g., bites, scratches, cuts, abrasions, splashes).

    2. Exposure to or a spill of a hazardous agent(s) (involving animals or in the lab) (i.e., contact with broken skin, eyes, nose, mouth, other mucous membranes, a percutaneous injury with a contaminated sharp, or contact with an infectious agent over a large area of apparently intact skin).

      Please contact EHS for more information.

  7. Grants and the IACUC: Changes to IACUC Verification

    The NIH Grants Policy Statement (GPS) requires “verification of IACUC approval of those sections of the application that involve use of vertebrate animals”.

    1. Verification of IACUC approval, commonly referred to as a “congruency review” between the grant and the IACUC approved protocol(s), is completed by RIA’s IACUC team members. 

      When Verification of IACUC Approval is requested at Just in Time (JIT), a “congruency letter” is provided for submission back to the funding agency.

      When RIA performs this congruency review, if any changes to the IACUC protocol are required to achieve congruency, RIA will contact the PI with the specifics of what needs to be added to the current IACUC protocol (or if a new protocol is needed). 

      A congruency letter will not be issued until congruency is achieved and the amendment or protocol is IACUC approved.

    2.  in April 2024, NIH amended Section 4.1.1.2 of the GPS to clarify that when an applicant provides the date of IACUC approval (in the grant application), they are “verifying that there is congruence between the application and the IACUC-approved protocol”.

      Consequently, please review your IACUC approved protocol(s) prior to submitting your grant application with an IACUC approval date. 

      RIA team members are available to assist with congruency review.

    3. Please do not send your IACUC approved protocol to anyone outside of the institution without consulting with RIA.

  8. Obtaining Medical Surveillance Clearance for Research with Animals

    All personnel working with animals must obtain medical surveillance clearance from Occupational Health Services. 

    IACUC approval cannot be granted until clearance for all species and activities (including field work!) is obtained. Incomplete clearance (i.e., if the completed medical surveillance questionnaire is missing species or activities) will result in a delay in IACUC approval.

    Please visit EHS’ Medical Clearance and Safety Training for Animal Researchers webpage for more information.

  9. Reflections, Suggestions, and Ideas?

    As a new academic year begins, RIA would love to hear from you! 

    • How can we improve?
    • What do we do well?
    • Do you have ideas to share?

Please take a moment to complete this anonymous survey and share your thoughts.

Previous versions of RIA’s Newsletters are always available for viewing on the RIA website