With the 60 or so sets of regulations being imposed on research programs, it is important to be sensitive to the cumulative impact that these have on the institution and its investigators to fully appreciate the impact of regulatory burden. Several crosscutting factors associated with burden emerge in examining the five sets of regulations. In many instances these factors are interrelated and may be synergistic in a negative sense. These factors are important as they define the implementation approach for resolving the issues that have been identified. Regulations that dictate process often limit flexibility without enhancing results.
Regulations administered by multiple agencies impose inconsistent requirements.
The regulation of science by non-science agencies often results in additional regulatory burden. Better communication between Federal agencies and research institutions can be expected to reduce regulatory burden. The specific instances of regulatory burden that have been identified in the five areas under examination are consistently associated with more than one of these factors. In some cases, all four factors may be at play. As NIH develops its strategy for relieving regulatory burden, it must take these factors into consideration.