August 2011

Alleviating the burden of compliance

FASEB promotes regulatory changes aimed at enhancing research. 

It should come as no surprise to working scientists that the U.S. biomedical research enterprise is highly regulated. Investigators and the institutions in which they work are subject to a vast array of reporting requirements, review procedures and training courses aimed at ensuring the safety of laboratory personnel, appropriate use of federal research dollars, human care and use of research animals, protection of human study participants, and even national security. While these regulations are intended to address serious and valid concerns, the cumulative burden of compliance has had a deleterious effect on scientific productivity. Scientists responding to a 2007 survey conducted by the Federal Demonstration Partnership estimated that 42 percent of the time they spent on federally funded research was devoted to administrative and regulatory activities, resulting in the expenditure of $97 million in salary support for principal investigators and co-investigators for activities related to grants administration – not research.

"FASEB is hopeful that the Obama administration’s interest in streamlining federal regulations 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." 

Fortunately, scientists aren’t the only ones concerned about regulatory burden. 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 that 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.

The U.S. Department of Health and Human Services, which has jurisdiction over 16 separate agencies including the National Institutes of Health, issued its preliminary plan for regulatory review in May. While HHS did single out some regulations designed to enhance research, other areas of concern to Federation of American Societies for Experimental Biology constituents were not addressed. The federation brought attention to these regulations in a June 30 letter to the department. FASEB stressed two general principles in its comments to HHS: 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 a number of specific regulatory areas. Citing the challenges of precisely measuring the time researchers spend on each of the many activities that make up their work days, FASEB urged HHS to eliminate effort reporting. It also encouraged the department to review myriad training courses investigators are required to take to streamline this training and identify topics for which retraining and recertification could be offered every two years rather than annually.

The ethical treatment of human research participants and the humane care and use of laboratory animals are of the utmost importance to FASEB. Regulations in both of these areas are, however, a major source of administrative effort for investigators. One way HHS could ease the burden on faculty, FASEB noted, is by clarifying the roles and responsibilities of federal agencies as compared with those of institutional animal care and use committees and institutional review boards regarding the review of the vertebrate animals and human subjects sections of grants, respectively. FASEB also advised HHS to 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. This would remove the disconnect between protocol approval times and grant length and greatly decrease the workload of both investigators and IACUCs.

With regard to human subject protections, FASEB encouraged HHS to exempt research from the Health Insurance Portability and Accountability Act Privacy Rule, a statute that has impeded biomedical research significantly while doing little to improve protections for human research participants. At a minimum, FASEB recommended that HHS harmonize the Privacy Rule with the Common Rule, the department’s comprehensive framework for reviewing and conducting research with human beings, so as to eliminate inconsistencies that hamper research.

FASEB is hopeful that the Obama administration’s interest in streamlining federal regulations 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. FASEB will continue to press for these changes, and we welcome input from the American Society for Biochemistry and Molecular Biology community as we continue our advocacy efforts in this critical area.

Jennifer A. Hobin ( is director of science policy in FASEB’s office of public affairs.

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