Reducing Unnecessary Regulatory Burdens on Research
IDSA advocates for the reform of federal regulations that have created impediments to the conduct of critical infectious diseases research and ensuing improvements in patient care. In our 2009 "Grinding to a Halt" policy statement, IDSA highlighted unnecessary regulations that ultimately slow the pace of research, increase costs, and impact research training. Like the Institute of Medicine, we are particularly concerned about regulations that do not enhance patient protections, but instead create obstacles, including the unnecessary application of the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule to research.
IDSA encourages recent and ongoing efforts by the Department of Health and Human Services (HHS) to make significant changes to the Common Rule, the set of federal regulations governing human subjects research protections and the functioning of institutional review boards (IRBs). IDSA also works with other research and patient-oriented organizations to achieve changes in the HIPAA Privacy Rule and appropriate harmonization between the Privacy Rule and the Common Rule while also maintaining appropriate patient privacy safeguards.
See elsewhere, IDSA’s related efforts:
Research and Infrastructure