To protect and serve: Public health law research to guide human research protections reforms at US departments of health

A lack of empirical information about operations, infrastructure, cost, and other features of human research protection programs (HRPPs) at State and Territorial Departments of Health (DOHs) exacerbate, stifle, or stymie efforts to measure how effective and efficient DOHs are at ensuring adequate protection of research subjects and their data. This paper is concerned with showing the lack of evidence base regarding DOHs and how this lack of data affects efforts at protecting human subjects and their data. Without information in these important areas, several unique problems will continue to plague research protection efforts at DOHs. Briefly, these problems include: (1) Of the 56 United States (US) States, Territories, and Districts, only 36 appear to operate their own Institutional Review Board (IRB) and it is not clear what the other 20 do to protect human subjects; (2) Parsing public health activities into research and practice can be vexing, an improper determination can produce adverse consequences, and much is unknown about how DOHs make this important distinction; (3) As political entities, it is possible that DOHs might exert undue pressure, influence, and interference on its HRPP and/or IRB, and the employees who serve on and operate them might not be protected from retaliation; and (4) Although a minimal cost can be estimated, it is not known how much it costs to operate an individual DOH IRB or HRPP or whether there are more cost effective human research protection mechanisms available.