On March 11, 2011 a massive undersea megathrust earthquake occurred off the eastern coast of Japan’s Oshika Peninsula of Tohoku. It killed thousands of people, with many more reported missing. Moreover, damage resulting from the tsunami that followed the earthquake displaced more than 340,000 people from their homes and crippled medical services in the area. Recovery efforts continue to this day, and as of July 2013 more than 290,000 people were still unable to return home.
In the months following the disaster, the Tohoku Medical Megabank Organization (ToMMo) at Tohoku University initiated a biobanking project focused primarily on a long-term cohort study of earthquake and tsunami survivors. Alongside data collection, the project aimed to improve local healthcare conditions and stimulate recovery efforts with long-term goals for the area.
However, the ToMMo biobanking project and other similar studies provoked criticism from citizens concerned about survivor exploitation. Matsui and Tashiro (2014) describe these concerns in their analysis of ethical issues that surround harvesting data from survivors in the immediate aftermath of a disaster.1
The main complaint cited by citizens revolves around the lack of consultation in the initial planning stages, in which the local community in general and the survivors in particular appeared to play no part. More specifically, the population voiced concerns over exploitation of survivors in the push to gather data and diversion of funds from healthcare provision despite assurances that the project would promote recovery.
In tackling these issues, Matsui and Tashiro quote from sections of the Declaration of Helsinki, an ethical code developed by the World Medical Association to guide human experimentation, invoked by critics to show why the biobanking project might be unethical: “Medical research involving a disadvantaged or vulnerable population or community is only justified if the research is responsive to the health needs and priorities of this population or community and if there is a reasonable likelihood that this population or community stands to benefit from the results of the research.” (Provision 17, 2008 Declaration).
Although the ToMMo project supplies medical personnel described as young physician-researcher fellows, the authors suggest that survivors have an immediate need for more experienced clinical help. They acknowledge that the contribution to medical science should be far-reaching but suggest that the proposed benefits accruing from the biobanking project may not reach the donors and community in the affected areas themselves. To support this view, they cite Provision 26 of the Declaration of Helsinki: “When seeking informed consent for participation in a research study the physician should be particularly cautious if the potential subject is in a dependent relationship with the physician or may consent under duress. In such situations the informed consent should be sought by an appropriately qualified individual who is completely independent of this relationship.”
Pre-earthquake, the area experienced sub-optimal medical provision, which was made worse by the severe damage resulting from the earthquake and tsunami. According to the authors, many of these facilities remained closed despite 40% of survivors reporting ongoing health problems. By associating biobank participation with future medical care, detractors of the plan argued that participating survivors would feel under duress and unable to consent freely.
Matsui and Tashiro note that since receiving criticism, the biobanking project administrators have been reaching out to the local communities, seeking to improve their methodology. They also note, however, that despite embarking on analysis of ethical, legal and social issues, the project administrators have not made their findings publicly available.
In summarizing their review, the two authors note that existing guidelines on human experimentation come from clinical trials, where the participating community reasonably expects to receive benefit from the research findings. However, with long-term studies of individuals in post-disaster situations, they suggest that ignoring immediate donor/survivor needs unnecessarily burdens an already vulnerable population in crisis.
Matsui and Tashiro’s thoughtful analysis and ensuing recommendations form useful reading material for biobankers who are considering or are involved in post-disaster survivor biobanking projects.
1. Matsui, K. and Tashiro, S. (2014) “Ethical challenges for the design and conduct of mega-biobanking from Great East Japan Earthquake victims,” BMC Medical Ethics 15:55.