The U.S. Department of Health and Human Services and 15 other Federal Departments and Agencies recently proposed changes to the Common Rule — a federal rule that protects study participants in federally sponsored research programs and safeguards protected health information. The changes may impact the way public health agencies conduct research and carry out other public health functions. A notice of proposed revisions was recently published in the Federal Register.
The proposed changes cover many important aspects of human subjects research protection and many of these changes, if adopted, could have profound effects on public health activities and research. For a brief, but more extensive summary of the proposed changes, please see a previous Network post. One of the most important potential changes to public health is the exclusion of public health surveillance activities from the Common Rule. Public health surveillance is an activity that has fallen within a gray area — is it research or is it a public health function, or both?
The new changes specifically exclude public health surveillance as an activity that is inherent to public health’s mission and therefore recognize it as a non-research activity. The rule also distinguishes between public health surveillance and epidemiological research, stating that the difference between the two can be determined from the purpose for the research, or context in which the activity is being conducted and the role of the public health authority. For example, if a public health agency is mandated by a state statute to conduct public health surveillance activities, this would be strong support for the activity being excluded from the Common Rule.
According to the proposed revisions, public health surveillance activities would include the collection and testing of biospecimens by or for a public health authority that are necessary to identify, monitor, assess, or investigate potential public health signals. Signals could include such things as a disease outbreak, injuries from consumer products or natural or man-made disasters.
A blanket exception for public health surveillance activities from the Common Rule means that these activities would not have to satisfy any regulatory requirements, nor would the activities undergo any type of review process. This could help streamline current public health surveillance operations and reduce compliance constraints, since data sources providing information for public health surveillance purposes are not required to obtain approval of their Institutional Review Boards (IRBs) and are not required to obtain a Public comment on the proposed changes requested. Specifically, they want to know whether the parameters of the exclusion are sufficiently clear to provide the necessary operational guidance, or whether any additional criteria or parameters should be applied to clarify or narrow the exclusion.
Comments on the proposed changes are due 90 days from September 8, 2015, the publication date in the Federal Register, to receive full consideration.
This post was developed by Jennifer Bernstein, J.D., M.P.H., Staff Attorney, Network for Public Health Law – Mid-States Region at the University of Michigan School of Public Health. The Network for Public Health Law provides information and technical assistance on issues related to public health. The legal information and assistance provided in this document does not constitute legal advice or legal representation. For legal advice, readers should consult a lawyer in their state.
Support for the Network is provided by the Robert Wood Johnson Foundation (RWJF). The views expressed in this post do not necessarily represent the views of, and should not be attributed to, RWJF.