Animal Care & Use Faculty Advocacy Committee Addresses PI Burdens
Conduct of pre-clinical research is largely governed by federal, state, and locally-instituted rules, regulations, policies, and guidelines. Such regulations and rules often cause undue administrative and regulatory burden, even upon the most seasoned investigators.
The University of Michigan’s Office of Research ensures all pre-clinical studies adhere to all required regulation and guidelines through its oversight bodies, including the Animal Care & Use Office (ACUO) and Institutional Animal Care & Use Committee (IACUC). The University and Program’s leadership understands the frustrations that can go along with such burdensome regulation.
Easing the Burden
In response, Dr. S. Jack Hu, the U-M Vice President for Research at the time, reached out to faculty members in 2017 to establish a new Animal Care and Use Faculty Advocacy Committee (ACU-FAC) to advise the Institutional Official in matters related to regulatory burden and methods to relieve it.
“The ACU-FAC was part three in the development of a Research Compliance Quality Assurance Program,” William Greer, BS, CPIA, LAT, CM, Assistant Vice President for Research - Animal Program Compliance Oversight and Director of the ACUO, explained. “The idea for part one and two was to engage faculty members with the idea to understand those compliance matters that create for them the most regulatory burden. Stage three was to have the faculty members help us mitigate the burden through their involvement. We tried to recruit faculty members from as many areas as possible to ensure an inclusive representation.”
According to the ACU-FAC website, some of the common study burdens include, “…Protocol reviews may take too long, protocol questions may feel inconsistent or redundant, and additional documentation seems like it takes too much time to complete.”
Hakam Tiba, MD, MS, current ACU-FAC Committee Chair, Research Assistant Professor, and Pre-clinical Critical Care Laboratory Director, and Brendan McCracken, ACU-FAC Committee member, Pre-clinical Critical Care Laboratory Assistant Director, both MCIRCC members, can attest to this and are working to bring about change.
“We are currently targeting large issues that affect a large number of PI’s,” said Dr. Tiba. “We are not policymakers, rather we look at current institutional policies, rules, and guidelines, identify areas of undue burden or inefficient practices and then provide recommendations for change.”
Greer reached out to Dr. Tiba when the committee was being established to act as chair. Tiba was already working with Greer as a scientist member of the IACUC.
Tiba describes the ACU-FAC as a “faculty-run committee which advocates for all faculty.” There is a core of faculty members whose research includes a variety of vertebrate animal activities across multiple disciplines. A support staff group including staff members from the ACUO and individual laboratories provide guidance and insight to the faculty regarding current institutional practices and regulations.
While they cannot touch the federal regulations in place, the institutional imposed regulations are what Tiba and McCracken specify as needing to be re-evaluated.
What’s Been Done
The ACU-FAC designed a survey to best gauge specific areas of concern, and dispersed it to PIs and laboratory personnel across the university. Over 300 responses were collected. Specific issues were then targeted, resulting in the change in a few guidelines and policies.
“We, the compliance office, regularly receive feedback through various ways leading to implemented changes that continue to have a positive impact on the PI community,” said Greer. “We have been able to implement policy changes suggested by faculty members, which in turn made their protocol submission process easier and more efficient. In addition, we have changed some policies to reflect practices that best suit faculty member’s situations in the lab.”
A specific example of policy changes that resulted from their work relates to tumor monitoring procedures. “We simplified it a lot,” said Dr. Tiba. “It was very cumbersome. PIs had to use ‘one form that fits all’ and the amount of scrutiny on that form was too much for some PIs, so we simplified the process. PIs have talked to veterinarians who are on the ACU-FAC about how their work process is now much easier with the tumor monitoring procedure changes.”
Another huge change implemented as a direct result of the ACU-FAC involved assignment of a PI proxy. Some tasks that were once required to be executed by the PI can now be conducted by a designated PI proxy.
“Brendan McCracken was really crucial in making that change” said Tiba.
“I was probably the biggest complainer of all of the things that I couldn’t do,” laughed McCracken. “The whole idea is to reduce the amount of burden on PIs. Being a proxy to my PI allows me and other lab managers around the University, at the PI’s discretion, to be able to make protocol scientific changes, add laboratory personnel, and manage shortcodes.”
Become Involved
As specified by Greer, “The ACU-FAC is an opportunity for faculty members to partner with the compliance offices with the idea that policies and guidelines should be implemented that reflect their current practices. Input is needed from faculty to help compliance understand their struggles, which will lead to decreased regulatory burden.”
Connecting with the ACU-FAC is in the best interest of the greater U-M research community. Sharing that they exist is much appreciated, but with a new year also comes the opportunity to add new faces to the roster. Joining the committee allows faculty and staff the chance to directly contribute to the positive changes surging through the U-M labs.
Learn more about the ACU-FAC. The committee is happy to talk to you and welcomes your ideas and concerns.