APS Suggests Ways to Reduce Regulatory Burden

In response to a request for information from the National Science Board (NSB), the APS offered suggestions for reducing the administrative burdens associated with federally-sponsored research. The NSB is the governing board for the National Science Foundation and also provides policy advice to the President and Congress.

In March, 2013, the NSB’s Task Force on Administrative Burden asked the scientific community to provide input on ways to reduce so-called regulatory burdens associated with research. The American Physiological Society (APS) participated in FASEB’s effort to develop comprehensive comments and offered up its own commentary on ways to reduce burdens associated with laboratory animal care. The objective, as APS noted, “is to ensure animal welfare while minimizing unnecessary burden.”

The APS pointed out that “risk intolerance is an important source of regulatory burden” both for oversight agencies and institutional compliance offices. “Seeking to reduce risk is a reasonable goal that is compatible with efficient research practices,” the APS comments stated. “However, a risk intolerant mentality encumbers research with burdensome procedures.” For that reason, the APS said, “The problem of risk tolerance will have to be addressed before meaningful progress can be made toward actually reducing administrative burden.”

The APS called for a halt to de facto regulatory changes made by oversight agencies. These are changes that do not undergo the notice and comment process required by law when new regulations are promulgated. Instead, agencies may simply issue policy statements that re-interpret regulations, turning recommended practices (“should” statements) into requirements (“must” statements). This produces what has been called “regulatory creep.” The APS urged agencies to “refrain from modifying their regulations without consulting the regulated community.”

The APS comments urged a clarification of the responsibilities of funding agency review panels and institutional animal care and use committees (IACUCs) to avoid duplication of effort. Specifically, APS suggested that scientific review panels not re-review animal use protocols that have already been approved by an applicant’s IACUC.  In addition, to reduce the workload for both investigators and IACUCs, the APS suggested that animal use protocols be approved for 5 years at a time so that in most cases they will not need to be reviewed again until the grant itself is renewed.

Multiple overlapping inspections are another source of burden. Strategies APS recommended for reducing the burden of inspection included designating a few IACUC members to conduct an inspection rather than requiring the participation of the whole committee. In addition, inspections should be combined whenever possible. For example, a semi-annual inspection might be combined with a post-approval monitoring or AAALAC site visit.

The APS noted that while training is important to ensure the competence of those who work with animals, “unnecessary or repetitive training is burdensome” and urged institutions to seek ways to avoid this. Training should be tailored to activities pertinent to an individual’s position in the foreseeable future. While those who are new to the field need comprehensive training, those who have done comparable work at other institutions may need less. Where it is feasible to do so, animal care staff should “assess individuals’ prior training and experience through training records and observation,” which may make it possible to arrange for specific training to address areas of need. However, the APS noted, “While it would be helpful to encourage institutions to consider developing a flexible approach to training, it is ultimately up to the institution to decide how to proceed” since the institution bears the responsibility for the actions of its personnel. It was suggested nonetheless that institutions to “provide those who undergo training with documentation detailing what subjects they have completed successfully” to facilitate transferability of training. In addition, institutions may wish to “consider adopting widely-available standardized modules that meet their training needs.”