Spring Your Research Forward with RIA!

March 26, 2024

As the weather turns warmer and summer plans are in the making, your partners in Research Integrity and Assurance (RIA) offer the following for continued research compliance:

1.  Spring IACUC Semi-Annual Inspections this April!

  • Princeton University is required, by Federal Mandate, to “inspect at least once every six months all of the institution’s animal facilities (including satellite facilities) using the Guide[i] as a basis for evaluation[ii], with the goal of ensuring that the institution adheres to the standards set forth in the Guide, the PHS Policy, the Animal Welfare Act and Regulations, and with Princeton’s own policies, guidelines, and SOPs.
  • The most common findings from the Fall 2023 inspections were:
    • Expired or unlabeled substances
    • Signage (incomplete, missing, old versions)
    • Expired scale calibration
    • Scavenging (charcoal canisters not labeled, weighed, or properly placed)
    • Recapped needles present in sharps container
  • RIA has developed a simple Semi-Annual Inspection Checklist/Self-Audit form to help labs get inspection ready.
  • If you have any questions, before, during, or after the inspection, please do not hesitate to ask the IACUC inspector(s) or contact RIA.
  • RIA and LAR will soon disseminate information regarding the cage identification sticker system for marking cages with individually housed animals.

2. Have new lab personnel to add?

  • New staff and students will need training and other clearances before working with hazards, animals, and human subjects.
  • Visit the RIA website for more information, or contact the specific RIA Office:
  • Ensure your research team is familiar with the approved activities to avoid off-protocol work, personnel injury, and non-compliance.
  • Distribute your approved IBC Registration, IACUC protocol(s), and IRB protocols to the lab members who are participating in the activities and review the content during lab meetings.
RIA Unit Website for Training Requirements Contact Information
IACUC https://ria.princeton.edu/animal-care-and-use/training [email protected]
IRB https://ria.princeton.edu/Human-Research/Training [email protected]
IBC https://ehs.princeton.edu/laboratory-research/biological-safety/biosafety-training-0 [email protected]

 

  • Ensure your research team is familiar with the approved activities to avoid off-protocol work, personnel injury, and non-compliance.
  • Distribute your approved IBC Registration, IACUC protocol(s), and IRB protocols to the lab members who are participating in the activities and review the content during lab meetings.

3. Tidy up your submissions for faster approval times.

  • RIAs IACUC, IRB, and IBC team members perform a pre-review of all applications submitted. These pre-reviews look for missing information, whether responses address the questions, and typographical, grammatical, consistency errors.
  • RIA offers the below tips for reducing reviewer questions and speeding up time to approval:

 

RIA Unit

Common missteps when completing applications

Helpful hints / reference materials

IACUC

The personnel listed on the IACUC protocol is not accurate.

Please review and update the list of personnel on a regular basis (please email the IACUC team for assistance)

Personnel have not completed the required training and/or medical clearance.

Please review the list of IACUC required training (according to species and activities to be conducted) and encourage your personnel to complete the training and medical clearance in a timely manner.

Procedure details (e.g., drug dose, time points) are inconsistent across sections of the protocol.

Please review the application for consistency before submitting.

Amendment applications are submitted without any changes to the application; only a summary of the changes is included amendment page.

Please make the necessary changes to the IACUC approved protocol in addition to providing the summary of the changes.

Please contact the IACUC or Post-Approval Monitor for assistance.

Responses to reviewer questions are provided in the reviewer comment boxes, but no changes to the application are made (and vice-versa).

When making revisions requested by reviewers, please respond to each individual comment AND make the corresponding change(s) in the IACUC protocol form (or indicate no change(s) is needed, if applicable).

Tutorials on eRIA functionality are available online.

The IACUC Protocol and IBC Registration are not congruent.

When submitting a new or modified IACUC protocol(s), review the associated IBC registration to ensure the animal activities are also included in IBC registration.

IRB

Principal Investigators have not yet met the University Research Board’s (URB) PI requirements.

Refer to the Principal Investigator Qualification Chart

In addition, Faculty that do not meet the PI eligibility criteria are welcome to apply for a PI Exception with the University Research Board (URB). The URB sets the PI-eligibility requirements and is distinct from the IRB. More information about the PI Exception process can be found at the below link:

https://research.princeton.edu/about-us/committees

Required IRB training has not been completed.

Review the IRB’s training requirements and complete the training before submitting

If the application did not auto-populate with the research personnel training record(s), please submit the IRB training certificate as a supporting document.

The application has not been signed by the Principal Investigator

Please review and sign the application before submitting; follow the below link for instructions: How to Conduct a PI Authorization

Document(s) that are referenced in the application are not submitted/uploaded for review.

Please review the application for completeness before submitting.

Final versions of all material to be provided to or meant to be seen or heard by participants, including data collection instruments, evaluation instruments, surveys, questionnaires, interview guides, videos, and screen shots must be uploaded to the Supporting Documents section of the application for IRB review.

The application and the corresponding study materials must be consistent.

Not sure if your research requires IRB approval? E-mail a 2-3 paragraph synopsis of the proposed activity to [email protected]. Please include the following in the synopsis:

  • Study funding
  • Purpose
  • Study procedures
  • Any draft study measurements (survey, questionnaire, and interview guide)

IBC

Activities are improperly classified (i.e., exempt work is listed as non-exempt and vice-versa).

The IBC Registration contains helpful information to help PIs determine what section(s) to complete and the classification of the activities proposed. Please let us know if additional guidance would be beneficial!

NIH’s Office of Science Policy (OSP) offers guidance on their webpage; please review the FAQs and Fact Sheets provided.

Lastly, do not hesitate to contact the IBC or the Biosafety Officer for help in determining classification(s) – we are happy to help!

Details of the associated risk(s) for the hazards to be used are missing.

 

This information is critical to protecting the safety of all personnel!

Activities that involve BSL2 and greater require a risk assessment (Section 10 of the registration) to be completed.

Often, the potential hazard(s) of the agent(s) being used are not provided in the application. Specifically, PIs need to indicate the signs/symptoms and pathogenicity of disease associated with each specific agent.

Please contact the Biosafety Officer for assistance in developing the risk assessment!

Lastly, to prevent laboratory-acquired infections please ensure all users have read the risk assessment and are trained in the practices and techniques required to ensure safety, and the procedures for dealing with accidents.

The personnel listed on the IBC Registration is not accurate.

Please review and update the list of personnel on a regular basis (please email the IBC team for assistance).

The IBC Registration and IACUC Protocol are not congruent.

When submitting a new or modified IBC registration, review the associated IACUC approved protocol(s) to ensure the animal activities are also included in the IACUC protocol(s).

Keep your IBC registration up-to-date with your research activities – submit a modification (amendment) before you begin any new experiments!

Updating your registration will update the risk assessment and keep personnel safe, and will also reduce time to approval of triennial (3-year) renewals.

4.  Regulatory changes have bloomed; what does this mean for you?

RIA Unit

Regulatory Change

Impact for Researchers

IACUC

  • The USDA eliminated the requirement for Annual Reviews of IACUC approved protocols.
  • As of October 2023, Princeton’s IACUC has stopped requiring annual reviews.
  • The USDA now includes birds (under certain circumstances*) as regulated animals.
  • Contact an LAR veterinarian if you capture and then transport and/or house birds

* In February 2023, the USDA released new welfare standards for birds (a.k.a. the new bird rule).  Per the new regulation, birds that are hatched in captivity and used for research are not considered a regulated/ covered species. All other birds are considered USDA-regulated and subject to the AWA Standards for birds. (Note: The PHS Policy and the Guide apply to all species when supported by PHS funds).

5.  Weeding out regulatory burden – the Post-Approval Monitor:

  • RIA’s Post-Approval Monitors are available to assist you with administrative processes and ensure continued compliance in your research programs!
  • Find out more about their services by reaching out:

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[i] Institute for Laboratory Animal Research. Guide for the Care and Use of Laboratory Animals 8th edn. (National Academies Press, Washington DC, 2011).

[ii] Public Health Service. PHS Policy on Humane Care and Use of Laboratory Animals (U.S. Department of Health and Human Services, National Institutes of Health, Bethesda, MD, 2015)