Am. J. Respir. Crit. Care Med., Vol 153, No. 2, 02 1996, 499-506.
The controversy over emergency research. A review of the issues and suggestions for a resolution
JH Karlawish and JB Hall
MacLean Center for Clinical Medical Ethics, University of Chicago, Pritzker School of Medicine, Illinois, USA.
Emergency research that occurs upon critically ill subjects in
circumstances that do not allow the subjects or their legally authorized
representatives to grant an informed consent is currently the subject of
great controversy. This Clinical Commentary reviews three issues that
dominate the debate: research risk assessment, the concept of a particular
kind of risk called minimal risk, and the regulations governing research on
human subjects. The theses of this article are that Institutional Review
Boards (IRBs) are not violating Office of Protection from Research Risks
(OPRR) regulations, that Food and Drug Administration (FDA) regulations do
not adequately address research design, and that emergency research fits
within the ethical standards of justice, respect for autonomy, and
beneficence. To defend these claims, the following points are argued: risk
assessment is a moral or transscientific exercise, minimal risk refers to
the increment of risk that the subject of the research faces, and that when
equipoise exists between experimental and standard therapies, this state of
uncertainty contributes to a study's justifications. In order to resolve
the emergency research controversy, certain regulations will need to be
rewritten and others reinterpreted, and a national board created to review
a proposed study's clinical relevance and whether the current state of
knowledge justifies a trial.
