Date Published: April 28, 2009
Publisher: Public Library of Science
Author(s): Ruth Macklin, Ethan Cowan, Sara Lustigman
Partial Text: Conducting research in an emergency situation, such as an outbreak of disease, poses ethical challenges. These challenges differ according to the type of research: epidemiologic or clinical, and for the latter, whether the disease outbreak can be anticipated in advance. We address these three situations, proposing different potential solutions for each.
It might be thought that the problems related to obtaining consent from people in an outbreak situation could be overcome by an appeal to the clause in the US Code of Federal Regulations that permits a waiver of informed consent for research conducted in an emergency, the so-called final rules . However, the rule is inapplicable to the situation under discussion here. The rule is intended to apply to clinical situations, such as major trauma, cardiac arrest, or other incapacitating circumstances, in which prospective research participants are unable to grant consent. Under the rules, the situation must be life-threatening, requiring an immediate intervention, and there must be no standard treatment that could be used instead of an experimental intervention. Consent may be waived only when next of kin or a guardian is not present or cannot be reached in sufficient time before initiating the research. It is clear then, that the exception from informed consent requirements applies only to research in which individual patients in life-threatening situations must receive immediate treatment, and not the type of research conducted in an emergency response to an outbreak of infectious disease.
What solutions are available to ensure that public health research in disease outbreaks can proceed without undue delays and yet protect the rights and welfare of human beings who are surveyed, whose blood is drawn, or who receive experimental or off-label drugs? It might be argued that approval of a proposed investigation by a Ministry of Health can serve this purpose. However, approval by a Ministry of Health is not the equivalent of ethical review and clearance by a duly constituted committee. Both types of approval are necessary in research in non-emergency situations, but a governmental office is not equipped to do the same sort of review as a committee with expertise and experience in research ethics.
Some form of ethical oversight is needed to conduct an investigation of a disease outbreak, be it predictable or unanticipated. The mechanism and procedures can vary from that of an established ERC, acting in an expedited manner for minimal risk research, to development of a model protocol submitted to a committee for full review in advance of an anticipated future outbreak. Such safeguards can help to ensure that the rights and welfare of individuals are protected in disease outbreaks and that communities maintain trust in public health research and practice.