Campus

GENERAL INFORMATION

FOR RESEARCHERS

FOR IACUC MEMBERS

Marquette University Animal Care and Use Program Post-Approval Monitoring of Approved Protocols:

According to the Guide for the Care and Use of Laboratory Animals, the Institutional Animal Care and Use Committee (IACUC) is responsible to oversee and evaluate the University’s animal program, procedures, and facilities to ensure they are consistent with the recommendations in the Guide, the regulations of the Animal Welfare Act, and the Public Health Service Policy on Humane Care and Use of Laboratory Animals.  A continuing program to audit approved animal use protocols is an essential component of a comprehensive Animal Care and Use program.

The IACUC has the responsibility to ensure that the procedures carried out in any Marquette laboratory or classroom is conducted as described in the approved protocol.  It is the policy of the IACUC to conduct post approval monitoring (PAM) of approved protocols to ensure continuing compliance; PAM is accomplished through other activities of the IACUC/Animal Care programs.  The PAM in this policy will involve site visits to specific investigator laboratories to discuss and observe the day-to-day application of approved IACUC protocols with, and by, the PI, lab, and staff listed on the protocol form.  This PAM program will serve as a more focused monitoring tool in the post-approval oversight of individual protocols approved by the IACUC.  While the Research Compliance Officer will serve as the primary liaison for the PAM, the IACUC will select one member to be present for consultations and assistance with the site visit.  For a detailed description of this PAM procedure please click here.

Post Approval Monitoring F.A.Q's

  1. What is Post Approval Monitoring?
  2. What are the goals of the PAM process?
  3. What are some of the benefits that a PI may gain from the PAM process?
  4. How does the PAM process protect my research?
  5. What are MU's obligations to regulatory bodies?
  6. Why do we need AAALAC certification?
  7. How are the protocols selected?
  8. How long will the assessment take?
  9. As the PI, what should I expect?
  10. What are the possible outcomes?
  11. When will I know of the outcomes?
  12. What if the PI is unable to attend the scheduled PAM meeting?

 

1. What is Post Approval Monitoring? Post approval monitoring is an examination of the research facility and study documents (approved protocols) to assure that animal subjects are protected, and the investigator is in compliance with applicable University and Federal regulations.  Conducting post approval monitoring will help to ensure that appropriate applications and supporting documents are implemented as approved, and any changes or adverse events/outcomes are reported. *Back to top

2. What are the Goals of the PAM process? The primary goals of the PAM program are to ensure animal well-being and to maintain regulatory compliance.  Associated with this, the process will facilitate the science by serving as a resource to the research community.  The PAM process is positioned to convey IACUC policies on matters of animal care and to identify education and training needs of laboratory staff.  Ultimately, the PAM process will confirm that the manner in which the IACUC understood and approved an animal protocol is consistent with the way its procedures are being performed. *Back to top

3. What are some of the benefits that a PI may gain from the PAM process? When scientific research involves animals, reliable results depend on proper and consistent animal care.  Animal protocols are approved with the principles of humane care and use of animals in mind.  These principles are transmitted by regulatory bodies, and compliance is mandatory.  Some of the possible benefits that may be gained from a review include but are not limited to: *Back to top

4. How does the PAM process protect my research? The PAM process wants to correct protocol issues internally so that regulatory agency inspectors are less likely to find problems.  Should PAM find that animals are harmed due to major deviation from the protocol; the IACUC may suspend that lab’s animal work until the practice is corrected.  This is one of the responsibilities of an IACUC, as mandated by federal regulations.  If a regulatory agency identifies the non-compliance situation, it may revoke research privileges for the entire campus.  It is better for the IACUC to suspend research in a single non-compliance lab than for a regulatory body to stop research in the entire institution due to the disregard for compliance in a single lab. *Back to top

5. What are MU's obligations to regulatory bodies?  In response to increasing oversight and consequences imposed by regulators, PAM has become the industries standard practice.  The IACUC is currently responsible for conducting a continuing review of approved protocols in accordance with Public Health Service Policy (IV.C.5.) and Animal Welfare Regulations (Sec2.31(d)). Marquette ‘s Institutional Official must sign an Animal Welfare Assurance Statement for OLAW, promising that MU will conduct animal research in accordance with federal policy, the Guide for the Care and Use if Laboratory Animals, and other applicable regulations.  In addition, MU must send a yearly record of its acquisition and disposal of animals by December 1st to the USDA.  The USDA conducts unannounced inspections of animal care facilities and has the authority to stop research if it determines that investigators do not treat animals in accordance with the law. The records of USDA inspections are available to the public. *Back to top

6. Why do we need AAALAC certification? Many private funding sources strongly recommend that grantees receiving support have animal programs with AAALAC accreditation.  The NIH, NSF, NASA, DOD, and VA consider AAALAC accreditation a commitment to excellence.  More than 750 institutions in 30 countries have earned AAALAC accreditation, thus it is an international symbol of quality.  AAALAC accreditation requires that we demonstrate not only that we meet the minimum standards required by law, but also that we take extra steps to achieve excellence in animal care and use and thus, promote scientific validity.  *Back to top

7. How are the protocols selected? Protocols are randomly selected from a pool of all approved IACUC protocols.  If a protocol has been selected, it does not necessarily mean the PI is doing something wrong.  Protocols can be selected for-cause from a complainant and/or unexpected outcomes reporting. *Back to top

8. How long will the assessment take? If your documents are complete and organized, the review will take about one hour.  If an investigator is not prepared, the review may take several hours. *Back to top

9. As the PI, what should I expect? You will be asked to pull records / lab notebook’s that demonstrate the protocol was followed as approved.  You will be asked questions about how the research project is going in relation to problems or adverse events.  The scope of review varies greatly depending on the research, and may include: *Back to top

10. What are the possible outcomes? There are several actions that could result from a PAM review.  They include but, are not limited to:

11. When will I know of the outcomes?The PAM review letter will be sent to the PI within 10 business days from the review date. *Back to top

12. What if the PI is unable to attend the scheduled PAM meeting?The preferred option would be to meet at a mutually agreeable time for both the PAM reviewers and the PI and their staff. If the PI is not able to attend the PI may designate a representative for the PAM review. *Back to top

 


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Mission Statement

The mission of the Office of Research Compliance, in cooperation with and in support of the Institutional Review Board, Institutional Animal Care and Use Committee, Radiation Safety Committee, and Institutional Biosafety Committee, is to facilitate safe and ethical research conducted by Marquette faculty, staff and students in the areas of human subjects, animal subjects, radiation safety and biosafety.