Created by on 7/12/2011 12:00:00 AM

In January, President Obama issued an Executive Order directing federal agencies to design cost effective, evidence-based regulations that are compatible with economic growth, job creation, and competitiveness, and which rely on the best, most innovative, and least burdensome tools to achieve regulatory ends. The President also directed each agency to consider how best to review existing rules to determine if they are outmoded, ineffective, insufficient, or excessively burdensome. Following Obama’s order, the U.S. Department of Health and Human Services (HHS) developed and sought stakeholder feedback on its preliminary plan for regulatory review. FASEB took the opportunity to encourage the department to explore ways to lighten the substantial regulatory load currently burdening the biomedical research community.

In its June 30th letter to HHS, FASEB stressed two general principles: 1) the department should establish mechanisms to evaluate the need for both proposed and existing regulations, as well as the impact the implementation of those regulations have, or are expected to have, on the research enterprise, and 2) it should make every effort to harmonize regulations and guidance within HHS and among federal agencies. FASEB also offered recommendations in specific regulatory areas urging HHS to eliminate effort reporting; streamline and reduce the frequency of the myriad training courses investigators are required to take; eliminate the requirement that animal care and use protocols be reviewed every three years and replace it with a requirement to match the period of the animal protocol to the length of the grant; clarify the delineation of responsibilities between federal agencies and institutional animal care and use committees and institutional review boards with respect to the review of the vertebrate animals and human subjects sections of grants; and exempt research from the Health Insurance Portability and Accountability Act Privacy Rule.

FASEB is hopeful that the administration’s focus on regulatory review will result in changes that allow investigators to devote more time to their research, enhance scientific productivity, and speed the generation of new knowledge related to human health and disease.