Post Approval Monitoring (PAM)
Post approval monitoring (PAM) assessments are collaborative, education-focused reviews of IACUC approved protocols. The purpose of the PAM program is to enhance animal welfare through routine monitoring of research and teaching activities. Benefits of PAM assessments include ensuring quality animal care and use, confirming regulatory compliance, fostering partnerships among researchers and the IACUC, promoting research success, and providing opportunities for teaching and learning.
Post approval monitoring self-assessment checklists may be used as a tool to maintain compliance through the life of a protocol. Reviewing the checklist in comparison with the approved AUP can help prevent protocol drift and prepare for a PAM assessment.
When a protocol is selected for a PAM assessment, the PI will be contacted by the PAM team to schedule a time and location for the visit. During the assessment, a PAM representative will meet with the PI to discuss protocol activity, review records and/or observe procedures, and gather PI feedback / concerns. A summary of each visit will be attached to the AUP’s InfoEd record, including highlights of best practices observed and opportunities for education/improvement. In InfoEd the summary will be accessible by the PI for viewing and commenting before it is presented to the IACUC at the next regularly scheduled meeting. The PAM team will communicate regularly with the PI after the assessment to summarize the meeting, answer questions and provide recommendations if applicable. Should a noncompliance be discovered during a PAM assessment, guidance in IACUC Policy 1.7 will be followed.
The IACUC Office utilizes post approval monitoring findings to assess and enhance the animal program at Clemson University. Program wide benefits and outcomes of post-approval assessments include the opportunity for targeted trainings, education, and ongoing development of study support resources.
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How are protocols selected for PAM assessments?
- Routine, random selection during the life of the protocol.
- Certain criteria will increase the probability of selection, including Pain Category E protocols, protocols using USDA covered species, protocols that experience instances of noncompliance, etc.
- Directed assessments
- Directed assessments may be conducted by a member of the PAM team as the result of a noncompliance, animal welfare concern, or as requested by the IACUC.
- Investigator requested assessments
- The PI may reach out to the IACUC Office and request a visit from the PAM team. PI requested assessments can be beneficial and provide education to the PI and research team.
- Routine, random selection during the life of the protocol.
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Will I be able to see what is presented to the IACUC?
The summary report will be available to the PI at any point during the process. On the form, the PI will also have the ability to provide comments and submit questions.
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What is presented to the IACUC?
The summary report will be presented to the IACUC. The summary will include positive highlights and best practices observed during the visit, findings or areas for improvement the PAM Team encountered during the visit along with any recommendations for improvement.
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What if the PAM Team finds something negative?
If a negative finding is found, the PAM Team will offer recommendations or best practice options at the end of the visit.
Should a noncompliance be discovered during a PAM assessment, guidance in IACUC Policy 1.7 will be followed.
If an animal welfare concern is witnessed, the Attending Veterinarian and IACUC Chair will be immediately informed.