Regulatory Compliance for NIH Grantees

Pursuant to a congressional request, GAO reviewed National Institutes of Health grantees' compliance with applicable federal regulations. GAO noted that: (1) researchers and administrators are increasingly concerned about the increase in regulations with which they must comply, but they also acknowledge that the regulations serve important safety goals; (2) researchers believe that certain regulations are inordinately burdensome and costly; (3) regulations that are considered burdensome and costly include those governing environmental protection, protection for human subjects, animal care and use, and conflict-of-interest disclosure; (4) the greatest cost of these regulations is attributed to the staff time devoted to compliance; (5) researchers cannot provide direct compliance cost data or determine how much of their grants they spend on compliance because their information systems cannot differentiate compliance costs from other costs; (6) some costs cannot be avoided even if federal regulations did not exist because they are part of good management and scientific and safety procedures; and (7) eliminating federal regulations may not reduce the compliance burden or cost, since institutions would still need to comply with state and local regulations.