The IACUC uses two electronic submission and review systems: CATS IACUC and PRAMS. The IACUC is now transitioning from PRAMS to CATS IACUC, where all submissions will soon be sent and reviewed.
Currently, all new IACUC applications and triennial renewals must be submitted through CATS IACUC. The IACUC will continue to use PRAMS for protocol amendments and annual reviews for protocols initially approved or started in PRAMS on January 1, 2018 or before. Investigators must also use PRAMS for preserved animal applications for both teaching and research.
Do you need to submit an application to IACUC for the use of animals in research or teaching? Explore the FAQs below. If you are still unsure or need additional help, please contact us at 814-865-1775 or ORP-IACUC@psu.edu.
Basically, if your activity involves vertebrate animals conducted under the auspices of the University, submit an application to the Office for Research Protections for review and approval by the IACUC.
According to Penn State Policy RP04, all animal activities, whether sponsored or unsponsored, conducted under the auspices of the University fall under the jurisdiction of the IACUC.
But, what is a vertebrate animal?
A vertebrate animal is any non-human animal possessing a well-developed nervous system as characterized by the presence of a dorsal notochord protected by a vertebral column.
What if I'm using animal tissue or established cell lines?
- Animal tissue or parts collected from euthanized animals covered by approved IACUC protocols or from USDA inspected slaughterhouses, are exempt from IACUC review and approval. The principal investigator of the IACUC protocol is still responsible for ensuring that all tissue is disposed of appropriately. Investigators collecting material from USDA slaughterhouses need to dispose of the tissue in an appropriate manner. The Office for Research Protections is to be contacted if there are any questions regarding tissue disposal.
- Established cell lines, as well as biological fluids and foods available as standard inventory from a conventional commercial supplier, are exempt from IACUC review and approval.
What about preserved whole animals?
The use of whole animals (live or dead) requires IACUC review and approval.
If University faculty, staff, administrators, or students use vertebrate animals in a University activity, an application must be submitted to the Office for Research Protections (ORP) for review and approval by the Institutional Animal Care and Use Committee (IACUC).
Policy RP04 is applicable to all Penn State colleges and locations except the College of Medicine located at the Hershey Medical Center. The College of Medicine maintains a separate assurance with the Office of Laboratory Animal Welfare for compliance.
University activities involving the use of vertebrate animals at other institutions must receive IACUC approvals from both the cooperating institution and Penn State University. In the case of collaboration between the College of Medicine at Hershey and any other University location, the College of Medicine at Hershey will be treated as a cooperating institution.
A principal investigator can be a faculty member, post-doctoral student, or staff member. For post-doctoral students serving as principal investigators, their supervising faculty member must be listed as an adviser and sign on the designated line. For staff serving as a principal investigator, their unit manager/leader must sign the application on the designated line. All principal investigators are required to have their department head sign the application on the designated line.
Although graduate and undergraduate students cannot serve as principal investigators, they can be listed as co-investigators with a faculty member serving as the principal investigator.
When am I required to submit to the IACUC?
When using any vertebrate animal in activities as defined by Penn State Policy RP04, Care and Use of Vertebrate Animals, at or under the auspices of The Pennsylvania State University.
Who may serve as the principal investigator of an IACUC protocol?
For all IACUC applications, a principal investigator can be a faculty member, post-doctoral student, or staff member. Although graduate and undergraduate students cannot serve as principal investigators, they can be listed as co-investigators with a faculty member serving as the principal investigator. For post-doctoral students serving as principal investigators, their supervising faculty member must be listed as a co-investigator.
How do I submit an IACUC application for review?
Protocol and Review Management System (PRAMS) at http://prams.psu.edu/.
Am I required to submit permits with my application?
The IACUC does not require the principal investigator to provide copies of permits (e.g., PA Game Commission, Bird Banding, US Fish and Wildlife Service) prior to approval. However, if the research mandates a permit requirement, it is principal investigator’s responsibility to acquire such permits prior to conducting the research described in the IACUC protocol.
Who is required to complete the IACUC and Occupational Health Training?
All individuals, including faculty, staff, technicians,students, volunteers and visitors working with animals in activities at or under the auspices of The Pennsylvania State University are required to complete the IACUC and Occupational Health Training.
May a High School student conduct research or work (paid or unpaid) in my laboratory?
Please see: https://www.research.psu.edu/iacuc/submission_faq.
What is the time period for the review of an IACUC application?
IACUC submission deadlines and the review timeline are online here. Reviews for custom antibody protocols, preserved animal protocols, and minor protocol changes* are reviewed administratively, with an approximate review timeline of five (5) business days. Additional details about the IACUC review process can be found here.
*Minor protocol changes:
- A change in title.
- A change in funding source.
- A change in personnel.
- A change in the animal source provided the new source is either from a PSU IACUC-approved protocol or from an approved vendor.
- A change in animal numbers provided the change is 10% or less than the originally approved number.
- A change in animal strain/line will be reviewed and approved by the IACUC Administrator and an ARP Veterinarian.
Who do I contact regarding the housing of animals?
Contact the following facility coordinators: Jennifer Kuhns at 814-865-1495 (small laboratory animals); Randy Swope at 814-863-3658 (livestock); Lester Griel, Jr. at 814-865-7696 (Mastitis); Dirk Wise at 814-863-0510 (poultry).
When do I have to conduct a literature search for alternatives?
- According to the Animal Welfare Act, Policy 12, animal procedures that may cause pain or distress require a literature search for alternatives.
If I conduct a literature search for alternatives, what information do I need to submit to the IACUC about my search results?
A minimal written narrative must include:
- databases searched or other sources consulted;
- the date the search was conducted;
- the years covered by the search;
- the keywords and/or search strategy used, and;
- a brief statement summarizing the outcome of your search stating that no acceptable alternatives were found or why potential alternatives cannot be used.
The narrative should be such that the IACUC can readily assess whether the search topics were appropriate and whether the search was sufficiently thorough.
All protocol changes, no matter how minor, must be submitted to the IACUC for review and approval, via Protocol Review and Management System (PRAMS) http://prams.psu.edu/, prior to the change being implemented.
First, carefully review your new grant and existing IACUC approved protocol(s) to ensure that all animal procedures listed in the grant are covered by an existing IACUC approved protocol(s). If all of the new grant’s procedures are not included on an approved protocol, then you must complete and submit a modification to your protocol on PRAMS (http://www.prams.psu.edu/). You will need to indicate the change in funding source and add any new procedures. You are also able to upload your grant documentation via the modification process on PRAMS if you choose. If all of the new grant’s procedures are included on an IACUC approved protocol, then you will still need to submit a modification via PRAMS in order to indicate the new funding source for your research. Please note that if your new grant has very different procedures or research objective(s) than what you are already approved to do, then you will likely need to submit a new protocol application on PRAMS. Contact the Office for Research Protections IACUC staff with questions if you are unsure.
When a high school student will conduct research or work (paid or unpaid) at Penn State University, the "High School Students in the Laboratory" form must be completed to ensure that the student has received the appropriate instruction and parental consent. This form is online at https://ehs.psu.edu/sites/ehs/files/high_school_students_in_labs_-_final_3.docx.
No. The approval expiration date will remain the same as when the protocol was originally approved or last renewed.
Forty five days before the approval expiration date, the Principal Investigator will receive an automated email notification that your annual or three-year renewal is due. Whether closing or continuing the study, Principal Investigators must complete an annual review submission via Protocol Review and Management System (PRAMS) : http://prams.psu.edu/ at least 30 days prior to the approval expiration date. If the project requires a three-year renewal application, the new application must be submitted at least 30 days prior to the approval expiration to allow time for review and approval.
Federal regulations require that the IACUC complete a de novo review 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 application. Principal Investigators must include all study information and incorporate any previously-approved modifications into the renewal application. IACUC applications can be found online here.
Please refer to the animal numbers memo included in every new approval letter and annual review approval letter. Between annual reviews, the PRAMS Animal Subject Census feature provides more current animal numbers as it includes animals added via modification, ordered from the Animal Resource Program, and reported as transferred to other protocols.
A protocol will expire if the Principal Investigator (PI) does not return the required Annual Review (AR) Form or three-year renewal application (required after every third year of approval) at least 30 days prior to the current approval expiration date. Reminder emails are sent to the PI forty-five days prior to the approval expiration date.
Note: Annual Review Forms submitted later than 30 days prior to the current approval expiration date may not be accepted and the PI may be required to submit a new application for review and approval.
A protocol will be withdrawn from consideration either at the PI's request or if the PI fails to respond to two requests for additional information. In either case, a new IACUC application will need to be submitted for review and approval by the Institutional Animal Care and Use Committee (IACUC) prior to working with animals.
If a protocol expires or is withdrawn from consideration, no animal activities may be conducted until a new IACUC Application is approved by the Institutional Animal Care and Use Committee (IACUC).
The Principal Investigator is responsible for ensuring that his/her approval does not lapse.