alatrofloxacin and Meningitis

The ethics of conducting research in epidemic situations have yet to account fully for differences in the proportion and acuteness of epidemics, among other factors. While epidemics most often arise from infectious diseases, not all infectious diseases are of epidemic proportions, and not all epidemics occur acutely. These and other variations constrain the generalization of ethical decision-making and impose ethical demands on the individual researcher in a way not previously highlighted. This paper discusses a number of such constraints and impositions. It applies the ethical principles enunciated by Emmanuel et al.(1) to the controversial Pfizer study in Nigeria in order to highlight the particular ethical concerns of acute epidemic research, and suggest ways of meeting such challenges. The paper recommends that research during epidemics should be partly evaluated on its own merits in order to determine its ethical appropriateness to the specific situation. Snap decisions to conduct research during acute epidemics should be resisted. Community engagement, public notification and good information management are needed to promote the ethics of conducting research during acute epidemics. Individual consent is most at risk of being compromised, and every effort should be made to ensure that it is maintained and valid. Use of data safety management boards should be routine. Acute epidemics also present opportunities to enhance the social value of research and maximize its benefits to communities. Ethical research is possible in acute epidemics, if the potential challenges are thought of ahead of time and appropriate precautions taken.

Topics: Acute Disease; Administration, Oral; Adult; Anti-Infective Agents; Child; Confidentiality; Disease Outbreaks; Drug Industry; Ethics Committees, Research; Ethics, Research; Fluoroquinolones; Humans; International Cooperation; Meningitis; Nigeria; Parental Consent; Patient Selection; Randomized Controlled Trials as Topic; Reproducibility of Results; Research Design; Social Values; Therapeutic Human Experimentation

Topics: Anti-Infective Agents; Clinical Trials, Phase IV as Topic; Conflict of Interest; Drug Approval; Drug Industry; Fluoroquinolones; Humans; Informed Consent; Meningitis; Nigeria; Poverty; Research Support as Topic; Therapeutic Human Experimentation; Translational Research, Biomedical; Vulnerable Populations

To participate in health research, there is a need for well-administered informed consent. Understanding of informed consent, especially in international health research, is influenced by the participants' understanding of information and the meaning attached to the information communicated to them regarding the purpose and procedure of the research. Incorrect information and the power differential between researcher and participants may lead to participants becoming victims of harmful research procedures. Meningitis epidemics in Kano in early 1996 led to a response from drug companies, especially Pfizer, as well as humanitarian workers from Médecins Sans Frontiers, which resulted in an unethical trial. Pfizer's drug trial during the epidemics has left a lasting controversy, which has yet to be resolved. This paper examines the key issues surrounding the controversy, discusses the context of informed decision-making, the ethical issues and implications of the incident, and concludes with some recommendations. Relevant texts, journals, Internet materials, newspaper articles and documentary materials on the conduct of the Pfizer's Trovan trial have been consulted. Four types of action (act intuitively, act rationally, act ignorantly, and act contextually - based on information provided) are identified as possible options for decision making. Participants most likely acted in ignorance due to poor understanding of the information contained in the verbal informed consent administered, thereby raising ethical issues. It is concluded that health research ethics committees have an important role to play nationally and locally in overseeing research, and in avoiding future occurrences.

Topics: Anti-Infective Agents; Clinical Trials as Topic; Comprehension; Counseling; Developing Countries; Drug Industry; Educational Status; Ethics Committees, Research; Ethics, Research; Fluoroquinolones; Humans; Information Dissemination; Informed Consent; Internationality; Meningitis; Nigeria; Research Subjects; Researcher-Subject Relations; United States

Topics: Anti-Infective Agents; Child; Clinical Trials as Topic; Drug Industry; Fluoroquinolones; Humans; Informed Consent; Meningitis; Nigeria

Topics: Anti-Infective Agents; Child; Clinical Trials as Topic; Drug Industry; Fluoroquinolones; Humans; Meningitis; Nigeria; Parental Consent; Third-Party Consent