Below you will find one announcement and two updates related to research compliance. The announcement is geared toward Graduate Advisors and the two reminders are geared toward researchers who work with animals. Click here for a list of more general compliance tips and reminders.

If you have questions about any of the following information, please contact Sharla Miles, Research Compliance Administrator, at 4-4875 or sharla_miles@shsu.edu. IRB specific questions should be sent to irb@shsu.edu and IACUC specific questions should be sent to iacuc@shsu.edu.

Announcement: Attention Graduate Advisors!

If your faculty supervise graduate students through the application process for Institutional Review Board, this reminder applies to your area or discipline:

All graduate students conducting research involving human subjects geared toward earning their Masters or Doctoral degree must submit a Final Report to close out their application file with the IRB Administrator at ORSP. To access a blank copy of the report, go to ORSP’s Resources page by clicking here. The report is located under Additional IRB Forms (post-initial IRB approval) under the IRB Documents ribbon. The Final Report must be emailed directly to irb@shshu.edu for inclusion in the student’s file. Please instruct students to complete this step in advance of their graduation date.

Compliance #1: The 2016 Changes to the Vertebrate Animals Section (VAS) of NIH Proposals

If your research involves vertebrate animals, then you will find the following information beneficial. The purpose of this announcement is to describe the recent changes to the VAS of the National Institutes of Health (NIH) grant application, as published by the NIH on October 13, 2015.

According to the NIH, the VAS update has a twofold purpose: (1) “[to] remove redundancy with Institutional Animal Care and Use Committee (IACUC) review while meeting the requirements of the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals” and (2) “simplify the VAS criteria to reduce burden on applicants.” Below is a summary of those changes:

  • A description of veterinary care is no longer required.
  • Justification for the number of animals has been eliminated.
  • A description of the method of euthanasia is required only if the method is not consistent with AVMA guidelines.

Moreover, there are updated VAS requirements by which PIs must abide. For a listing of these updated requirements, please see the NIH Notice.

Compliance #2: The Grant Proposal, the IACUC Protocol, and Congruence Reviews

The purpose of this announcement is to give all researchers who typically conduct research involving vertebrate animals at SHSU information on what to expect if they receive NIH funding for their research. While PIs are required to submit an IACUC protocol (aka IACUC Form C-Research application) with the university’s Research Compliance office, they must also include the same information in the Vertebrate Animals Section (VAS) of the NIH grant proposal.

The IACUC Administrator is then responsible for conducting an IACUC protocol-grant proposal congruence review. According to the Office of Laboratory Animal Welfare (OLAW), congruence is “an agreement between the animal activities described in a grant and the animal activities review and approved by the IACUC.” Congruence review is not just an NIH requirement; other federal agencies, including the National Science Foundation and the USDA National Institute of Food and Agriculture also require congruence between the IACUC protocol and the grant proposal.

The content that must be congruent between the IACUC protocol and the PI’s grant proposal includes, but is not limited to, the following areas: vertebrate species used in the potential research, total vertebrate animal numbers proposed, and procedures/methodology used in the research. OLAW has published a helpful a summary of a congruence review strategy.

The following is a timeline (source: University of Massachusetts Medical School) typical of congruence reviews:

Compliance Timeline