The ethical challenges in the 2009 study of Osrin et al. are consent from cluster guardians, consent by individuals, benefits to control areas and requests by participants. The ethical issues that revolved around cluster guardianship noted in this study are the participants’ perceived adequate information about the trial according to the guidelines of the Declaration of Helsinki. In a complex society or in a society where participation is decided by the concept of a utilitarian judgment there will always be a burning concern for the guaranteed unalloyed voluntary nature of involvement. While cluster randomized controlled trials have been around for a long time, there is a growing concern to evaluate the delivery of health services, public education, and policy on social care (Edwards et al., 1999). Utilitarianism and Kantian ethics are the two most important moral traditions that the ethical aspects of medical practice and medical research are most often discussed. Concerned with increasing social utility (value), utilitarianism, in the long run, the social utility will not be served by demanding that individuals be self-sacrificing for the common good. The collective decision of a local guardian or representative may be contested given that communities are usually amalgams of smaller communities. There is the question whether the decision is in the best interest of the participants or the expected interest is based on the hidden personal agenda of the cluster guardian. It is a matter of distributive justice whereby utility and disutility, benefits and costs, are distributed as fairly and evenly as possible across society (Edwards et al. 1999). On the other hand, Kantian tradition refers to our moral duty to respect a person’s autonomy, significant in individual-cluster trials that differ with the paramount importance of the utilitarian welfare of the cluster in cluster-cluster trials.
Positioning ourselves as researchers within the ethical folds, and not cross the thin red line of a moral dilemma; we should remember that ethics establish the fundamental principles of “right and wrong.” While laws may set the legal parameters that govern data use, ethics are critical to the appropriate management and use of research data. The burning questions are: Do we have the prior knowledge on the unethical collection of the data? Did we learn about the breach after we are done analyzing the data? I believe, it is our responsibility to assess the quality and the manner data was collected. Even if the intent of the research is for the better good, we should not be blinded by the urgency of the endeavor and justify the beneficial outcomes at the expense of the suffering of the participants. Using a secondary data obtained unethically for the better good that could impact a community, presents a blur between right and wrong. Would the use of unethically collected secondary data a personal choice? Assuming that the institutional review board (IRB) approved the use of such data, would it give us the option to use the data for the common goods? A point to ponder, given that the Nuremberg Code was not established until after World War II, the collection of NAZI experiments could not be considered “illegal’ (Vollmann, 1996). Given this scenario, would current researchers be free to use the data from these experiments for ethical and beneficial results? Would it justify the use of Dr. Sigmund Racher’s data on hypothermia and altitude experiments at Dachau to inform on ethically sound studies on hypothermia prevention and treatment? The study of Dr. Robert Pozos of the University of Minnesota was denied publication in the New England Journal of Medicine (NEJM) after using Dr. Racher’s data on rewarming techniques to fill in critical gaps in his research (Cohen, 1990). Having this said, personally, regardless how comprehensive the secondary data, if unethically aggregated, I would refrain from using such data even if the data could have a positive outcome. Within the argument of guilty by association, I believe that using unethically collected research data; we are as guilty as the person/individuals who collected the data. The best recourse is to look for a more superior data that follows the prescribed ethical guidelines. On the other hand, if the data could lead to discovery to save lives of the many, for example, a vaccine to prevent the spread of an infectious disease, or prevent a bioterrorism event, then it is justifiable to use such data considering the benefits outweigh the harms of the methods.
Cohen, B. (1989). The ethics of using medical data from Nazi experiments. Journal of Halacha and Contemporary Society, 103-126.
Edwards, S. J., Braunholtz, D. A., Lilford, R. J., & Stevens, A. J. (1999). Ethical issues in the design and conduct of cluster randomised controlled trials. British Medical Journal, 318(7195), 1407.
Ford, N., Mills, E. J., Zachariah, R., & Upshur, R. (2009). Ethics of conducting research in conflict settings. Confl Health, 3(7).
Osrin, D., Azad, K., Fernandez, A., Manandhar, D. S., Mwansambo, C. W., Tripathy, P., & Costello, A. M. (2009). Ethical challenges in cluster randomized controlled trials: experiences from public health interventions in Africa and Asia. Bulletin of the World Health Organization, 87(10), 772-779.84-887.
Steinberg, J. (2015). The Ethical Use of Unethical Human Research. New York University, nd Web, 30.
Vollmann, J., & Winau, R. (1996). Informed consent in human experimentation before the Nuremberg code. BMJ: British Medical Journal,313(7070), 1445.