To protect and serve: Public health law research to guide human research protections reforms at US departments of health
Tuesday, November 5, 2013
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.
Ethics, professional and legal requirements
Public health or related laws, regulations, standards, or guidelines
Evaluate public health legal research methods to guide human research protection reforms at United States Departments of Health
Keyword(s): Law, Ethics
Presenting author's disclosure statement:
Qualified on the content I am responsible for because: I am a former Director of Human Research Ethics at a state department of health; I teach public health ethics, law, and policy in an MPH and PhD program; I conduct research on departments of health regarding their research protection systems.
Any relevant financial relationships? Yes
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||Public health legal research
Researcher to determine feasibility of an independent, national, public health Institutional Review Board
I agree to comply with the American Public Health Association Conflict of Interest and Commercial Support Guidelines,
and to disclose to the participants any off-label or experimental uses of a commercial product or service discussed
in my presentation.