The Ellen Roche case is a case wherein a healthy volunteer participated in a National Institutes of Health funded research on the natural defenses of healthy individuals against asthma. The purpose of the study is to “gain a better understanding of the pathophysiology of asthma, specifically the mechanism of airway hyperresponsiveness”. Under the experiment Roche and the other subjects are required to inhale hexamethonium, a ganglionic blocker. The subjects will be paid $365 for participating in the experiment. After almost a month of participating in the research, Roche died due to progressive hypotension and multi-organ failure, which was attributed to her inhalation of hexamethonium.
In the case of Roche, the Food and Drug Administration (FDA) cited that one of the violations of the said research is the lack of informed consent; that is, it was inadequate and misleading. The risks stated in the consent form only mentioned that the subject’s blood pressure may go down, and that the drug inhaled may cause dizziness. The other potential toxic effects were not stated such as the fact that hexamethonium was experimental and was not approved by the FDA.
The Roche case paved the way to a strengthening and standardization of procedures for literature reviews and the reporting of adverse outcomes to the review boards. Moreover, the results of the investigation of the Roche case led to a requirement that investigators should obtain a written response from the FDA regarding the use of substances which are unapproved for clinical research
The Roche case started a move towards the improvement of the roles of various groups in researches conducted. These groups include investigators, institutional review boards (IRB), sponsors, and the institutions where the research will be conducted. The importance of using medical librarians and professional searchers are further emphasized in this case. As observed from the Roche case, there was negligence on the investigators’ research procedure as he focused only on a limited number of resources; thus, failing to identify the dangers of hexamethonium.
Because of the Roche case, it became necessary that the composition of the IRBs should include individuals that come from a broad range of expertise and whose primary interests are in non-scientific areas. The FDA review recommended that individual reviews of ongoing projects should be done by the IRB, backed up by documented minutes of their meetings.
The Ellen Roche case is significant in that it has paved the way to improvements in the development of ethical practices. It is unfortunate though that a life has to be sacrificed before changes were made in the field of medical research.
Works Cited
Perkins, Eva. "Johns Hopkins’ tragedy: Could librarians have prevented a death?" 7 August 2001. newsbreaks.infotoday.com. Web. 20 February 2014 <http://newsbreaks.infotoday.com/nbreader.asp?ArticleID=17534>.
Steinbrook, Robert. "Protecting research subjects - The crisis at John Hopkins." The New England Journal of Medicine (2002): 716-720.
