By Melissa Hunsley
Last fall I conducted an informal survey of IACUC administrators about their Post Approval Monitoring (PAM) programs, focusing on the success rate of PAM programs, and the reasons for success or lack of success. Fifty eight percent of people said they considered their PAM program to be “successful” (n=60). The follow up question for this was “why?” to which 73% of respondents replied it was because their researchers have “bought into” their program. Close behind at 71% was that their PAM program has “competent, likeable, fair PAM staff”.
Everyone with a PAM program, or thinking of starting one, should pay close attention to these points. Yes, it is often difficult to gain support (and funding) from higher-level administrators for yet another research administration program such as post-approval monitoring. However, when you are successful in obtaining support for a program, it is absolutely essential that you put the initial work into gaining acceptance from the people who will be monitored. Hiring a post approval monitor (or assigning this duty to existing staff), giving them a police cap and badge, and sending them off into research land to dole out citations will not win you much support from your community. In most situations the researchers will be apprehensive (at best) about a new program where they will be the focus of compliance monitoring. So what can you do to ease their fears?
After writing and approving the policies describing your PAM program, the SOPs for protocol audits and lab inspections, and the monitoring schedule, you can decide how to introduce the program to your researchers. One idea is to put together a “welcome packet” with the facts, figures, authority given to you by the IACUC and IO, and maybe a cartoon or two to soften the mood. Explain the procedures, the monitoring schedule, and introduce your staff. Also consider hosting several (i.e. not just one) town hall meetings. Have speakers at the meetings with sufficient authority- the IACUC Chair, the IO, influential department chairs, etc. Serve coffee and cookies, and advertise well. Does your institution have several campuses? Host a town hall meeting at every campus so people don’t have to travel. Are you at a college or university with new students each fall? Host a town hall meeting at the beginning of each school year to introduce the program to newcomers.
Explain to everyone just what the PAM personnel will be doing, and what the goal of the program is. Are you expecting an AAALAC site visit next year? Maybe the goal is to have a stellar final report from them with no mandatory items for correction. Expecting a visit from the USDA any day? Maybe the goal is to have no citations. Explain what the expectations are, but also reassure people that the PAM staff are not meant to be police, but meant to be “partners in compliance” or whatever your catch phrase may be. Many institutions label the PAM staff as “PAM liaisons” or other such language that de-emphasizes the police-like nature. Whatever your model, remember the old phrase: you catch more flies with honey than vinegar.
Finally, don’t forget your veterinary and husbandry staff! They will be monitored also, and surely some of the expired drugs and incomplete records you will find (and unfortunately once you start looking – you will find) will belong to husbandry and veterinary staff. They could need separate training sessions, where specific examples of what you are looking for are presented. In addition, don’t forget that your husbandry staff are the “eyes and ears” of the animal facility. Develop a relationship with them. Attend their staff meetings, talk to them about the things they see and hear every day in the facility. Most of all listen to them. They should know that you are there for them if they see something they have a question about or feel uncomfortable with. They should also know that if they do report something to you: first, there will be no reprisals against them, and second, you have the authority to do something about it. If they tell you something in confidence and you don’t look into it, and/or you don’t follow up with them about what was done, your credibility (and that of the PAM program) goes out the window.
Post-approval monitoring does not need to be a painful process. As the 8th ed. of the Guide says, “PAM programs are more likely to succeed when the institution encourages an educational partnership with investigators.” (p 34). It will be up to you to nourish these vital relationships within your program.
Melissa Hunsley, ACUP Consulting
Melissa is the owner of ACUP Consulting, a company that provides educational and affordable training for small and large institutions. She was a speaker for the 2013 "The Art of Auditing" Conference. View proceedings under "The Age of Auditing" Conference announcement here.