Types of Review, Submission Deadlines, & Review Timelines

Types of Review

According to the Animal Welfare Act (Title 9 CFR), the IACUC must review animal use activities at least annually. To meet this regulation, The Pennsylvania State University IACUC requires all investigators to submit a protocol Annual Review form.

Additionally, the PHS Policy requires that the IACUC complete a de novo review (three-year renewal) of animal activities after three years of approval. The de novo review requires that a new application be submitted for review and approval.  During the de novo review, the IACUC is not permitted to rely on previously submitted information and must review the renewal application as a stand-alone protocol.  Principal Investigators must include all study information and incorporate any previously-approved modifications into the renewal application.

Reviews for custom antibody protocols, preserved animal protocols, observational protocols, and minor protocol changes* are reviewed administratively, with an approximate review timeline of five (5) business days.

*Minor protocol changes:

  1. A change in title.
  2. A change in funding source.
  3. A change in personnel.
  4. A change in the animal source provided the new source is either from a PSU IACUC-approved protocol or from an approved vendor.
  5. A change in animal numbers provided the change is 10% or less than the originally approved number.
  6. A change in animal strain/line will be reviewed and approved by the IACUC Administrator and an ARP Veterinarian.
  7. Reuse of animals previously used in experimental procedures will be reviewed and approved by an ARP Veterinarian (see IACUC Policy 11, Reuse of Laboratory Research Animals)

Submission Deadlines & Review Timelines

Ninety, Seventy five, and Forty five days before the approval expiration date, the Principal Investigator will receive automated email notifications that the annual or three-year renewal is due. Whether closing or continuing the study, Principal Investigators must complete a review submission at least 45 days prior to the approval expiration date.

All submissions received by The Office for Research Protections will undergo pre-review by IACUC Staff. If the protocol involves surgery and/or procedures that may cause more than momentary pain or distress, the submission may be sent for veterinarian consult. Both the pre-review and veterinarian consult must be completed before the protocol can be sent to the IACUC for committee review and discussion.

Submissions that have completed pre-review and veterinarian consult by Wednesday at 5:00 p.m. will be sent to the committee for review. Submissions are assigned to review during a conference call which is conducted two Mondays after the Wednesday deadline. If PSU is closed on a Monday due to a holiday or inclement weather, the call takes place on the first day that PSU opens. Due to the PSU winter closing, conference calls do not typically occur during the week directly proceeding or directly after the winter closing.

IACUC annual and three-year renewal submissions (for existing, approved protocols) must be submitted at least 45 days prior to the approval expiration date.

Determination of whether an application must be reviewed during a full committee meeting can be made by any committee member at any time and, if the application is deemed as such, it will be reviewed at the next full meeting.

The IACUC will consider requests for a shorter review timeline to address unforeseen events or special research opportunities with a written request from the Principal Investigator. However, due to the volume of submissions that the committee reviews on a weekly basis, requests for a shorter review timeline should only be made in exceptional circumstances and can only be granted by the committee on a very limited basis.