Regulation of medical research is hampering improvement in US health care, critics sayBMJ 2009; 339 doi: https://doi.org/10.1136/bmj.b3370 (Published 20 August 2009) Cite this as: BMJ 2009;339:b3370
- Bob Roehr
- 1Washington, DC
Regulations and practices in the United States designed to protect patients and their privacy are impeding medical research and in some instances making it prohibitively expensive, a leading medical society says.
The rules are hindering improvements in care, says the Infectious Disease Society of America in an article in Clinical Infectious Diseases (2009;49:328-35, doi:10.1086/605454). The society is seeking to clarify and simplify the regulations while maintaining protection of patients.
A big obstacle, the society’s article says, is the Health Insurance Portability and Accountability Act, enacted in 1996 to protect patients in care, with a rolling series of implementation dates. But research carried out with informed consent is a very different situation from standard health care, said William Burman, director of the infectious disease clinic at Denver Public Health and head …