Preliminary analysis of the research ethics infrastructure at US and territorial departments of health for making the distinction between public health research and practice

This project investigates how State and Territorial Departments of Health (“Departments”) determine whether public health activities are research or practice (“the determination”). Misclassification can lead to adverse consequences. If research is determined to be practice, required ethical subject protections will be absent; if practice is determined to be research, public health projects, where quick intervention is essential, will be needlessly delayed. Parsing activities into human subjects research (which requires Institutional Review Board (IRB) oversight) and practice (which does not) can be vexing. The Centers for Disease Control (CDC) and Council of State and Territorial Epidemiologists (CSTE) have guidance to help. However, much is unknown about how Departments distinguish research from practice, including: (1) who makes the determination; (2) the extent of awareness and use of CDC and CSTE guidance; and (3) what Department infrastructure, policies, and procedures exist.

Using public information, in this first project phase, we determined how many states and territories operate an IRB and have federalwide assurances (FWAs). We also searched Department websites for mention of research versus practice information.

Findings (by state / territory) include: (1) IRBs=39/1; (2) active FWAs=44/3; (3) inactive FWAs=5/0; (4) website mentions CSTE=4/0; mentions CDC=1/0; both CSTE and CDC=4/0; and other information=13/0. These data suggest some awareness of this public health issue and help to answer research questions 2 and 3. In order to answer question 1, additional data are needed. We propose to use mixed methods research to answer this, and other related, questions in future phases of this project.