In 2007, the National Institute of Health (NIH) started the Human Microbiome Project in order “to utilize technological advances to characterize the microbial communities that inhabit the human body and explore the relationships between the microbiota and their human hosts, including the effect that they may have on human health and disease, development, physiology, immunity, and nutrition.” Rosamond Rhodes, “Ethical issues in microbiome research and medicine,” BMC Medicine, Jun. 22, 2016. As analysts have noted, what we learn about the human microbiome “will change how medicine is practiced,” and “may also have implications for our…legal systems and for how we conceive of the ethics of medicine and biomedical research.” Id. Because of the ethical and legal issues that human microbiome research raises, expert witnesses will be called upon to explain these matters to lay people and finders of fact. This article examines legal issues surrounding human microbiome research and the role experts will play when such issues arise.
A number of legal issues are at play with respect to investigating the human microbiome and are discussed as follows.
Privacy & Confidentiality:
The difference between privacy and confidentiality is that confidentiality implies a professional set of safeguards of information, often by legal and medical practitioners. See, e.g., id. As one commentator explains, “The assurance of confidentiality is critical for the practice of medicine because it allows patients to freely share information.” Id. Moreover, although the ideas of privacy and confidentiality are often used interchangeably, “the difference may be critical in work on the human microbiome.” Id.
With respect to research on the human microbiome, legal and medical professionals will need to determine what information should be protected. See id. A conflict may occur in which some ethicists urge the utmost privacy of research samples, while practical considerations would discourage such strict limitations. See id. Many individuals do not realize, for example, that their own waste consists of microbiome material and, if collected and analyzed, can provide extensive information about a particular individual’s actions and relationships. See id. This means, functionally, that things we might never have previously deemed worthy of privacy protections (such as excrement) are, in fact, as revealing as set of fingerprints. Accordingly, legal and medical practitioners may need to rethink what components of microbiomes are worthy of certain protections, and where to set the limit regarding what material is confidential and what is not. Experts in genetics, microbiomes, medical ethics, and forensic medicine are just a few of the types of people who will play a role in helping to determine what limits should be placed on particular samples. These experts will undoubtedly be useful in the consultative stages, to assist legislators and medical professionals in setting the appropriate confidentiality provisions. Moreover, should litigation arise over whether a sample should be legally protected, these experts will be indispensable in explaining to jurors whether and how specific protections should exist. Experts in general privacy matters may also play an important function.
There are myriad views with respect to the ownership of human microbiomes. All sorts of perspectives exist, from the claim that a property right vests in an individual because their body is the “host” of particular microbiomes, to the argument that, in certain cases, the government should have rightful ownership of specific microbiomes, in order to conduct necessary research and/or for public health reasons. See id. An additional complicating factor is that whenever “knowledge from a microbiome study has commercial value,” there will be differing views on ownership and who should, accordingly, reap any economic gains from such ownership. Id. Scientists who make important discoveries may be one group that has a potentially legitimate claim to ownership of a given microbiome. Certainly, the individuals from which a microbiome came may also argue that they should have legal ownership rights to what they see as their own body’s material. There is yet to be litigation that involves the human microbiome, but certainly as research progresses, such lawsuits should be anticipated. It is certainly foreseeable that there will be competing property claims as human microbiome investigations continue, and in such cases, experts witnesses will play an invaluable role in parsing out such claims. Intellectual property experts will certainly be of great import in cases arising over the ownership/property rights of a claimant to a given microbiome. In addition, DNA experts, medical ethicists, and even economists are likely to play a part in the ultimate legal determination of an ownership claim of this sort. Moreover, one commentator has argued that “Although we not yet seen lawsuits involving the human microbiome, there have recently been a few legal rulings related to biological samples and genetic research that are relevant to the human microbiome.” Id.
Human Subject Research & Related Issues:
Research ethics have been discussed, regulated, and tinkered with as technology has progressed, and ethical protocols have evolved as our understanding of everything a particular type of research entails has expanded. Research standards of a fairly universal nature arguably began with the Nuremberg Code and the World Medical Association’s (WMA) Helsinki Agreement. See id. In addition, the U.S. came up with its own regulations to protect human subjects of scientific research, such as The Belmont Report and The Common Rule. See, e.g., id. Moreover, human subject research has enjoyed the protections of international guidelines that have grown over time, and that give “primacy to informed consent and privacy in contemporary research studies.” Id. In fact, the justification for the authority to conduct research on or involving human subjects has been understood to derive from a given subject’s informed consent. See id. Quite demonstrably, human autonomy and research participant rights have been prime considerations with respect to the right to conduct human subject research. See, e.g., id.
However, while participant rights have certainly been emphasized thus far, one component of human subject research that has so far largely been overlooked is the flip side of the coin, which is what a participant’s obligations may be. See id. The discussion of participant obligations has begun to emerge with respect to research taking place under the auspices of the Human Genome Project. See id. To wit, “[A]t this stage in the development of the science, researchers have expanded their focus from the diagnosis of individual genetic anomalies to the broader issues of understanding the human genome and its interactions with the microbiome…. As many have noted, studies to advance personalized medicine will require broad participation to provide the material for biobanks and sample banks. These efforts will raise issues of whether we should all contribute to the enterprise.” Id.
In other words, while the ethical and legal questions of how to safeguard participant rights and ensure informed consent are certainly present with human microbiome research, the flip side of that equation is the ethical and legal questions as to when, if ever, participants owe society an obligation to take part in human microbiome research for the sake of the research’s success. See, e.g. id. Both the issue of what rights human research subjects are entitled to and the question of what obligations they may owe are matters that may be best determined by the experts. Specifically, scientific and forensic experts, ethicists, and research professionals will all help to address these legal questions and to strike an appropriate balance between participant rights and responsibilities. Legal professionals at all levels will undoubtedly wish to avail themselves of expert opinion, whether they are crafting general legislation or litigating specific cases. Experts with experience in balancing ethical questions that involve human subject research, such as those who are well-versed with the Human Genome Project, may be able to provide useful analogies to help legal professionals determine how to best handle the competing ethical and legal issues at play in human microbiome research.
Public Health Considerations:
In addition to the aforementioned matters, specific issues are likely to arise with respect to human microbiome research and public health concerns. See id. As one analyst explains, “Because the microbiome is a factor in some infectious diseases, protecting public health requires disease surveillance and tracking. Data collection on disease outbreaks, births, and deaths is and will be critical in the design and implementation of effective disease prevention, outbreak control, and disaster response. Effective public health measures are based on data, but gathering personal information in an emergency may not allow for prior Institutional Review Board assessment or informed consent.” Id. In other words, there may be times when the urgent public health need will force researchers to override the ordinary informed consent protocols, and such emergencies will require a unique set of ethical and legal guidelines. In situations where the ordinary rules do not apply, lawmakers, medical professionals, judges, and juries will be forced to come up with ways of mitigating the dangers to individuals as much as possible, while addressing the larger public health need. In order to draft legal rules and make judicial policies that deal with these urgent situations, legal practitioners will require the assistance of experts. Expert witnesses will be invaluable consultants in helping to balance competing ethical concerns. In addition, since many public health emergencies arise on a case-by-case basis, the decisions made regarding these situations are likely to be made during litigation. Judicial decision-makers will need the guidance and opinions of public health experts, medical professionals, genetic experts, and others in related fields.
A second public health consideration involving human microbiome research is how to conduct such research in ways that take the public interest into account. For example, “[A]s research on the human microbiome leads to studies of prebiotic, probiotic (bacterial), and phage (viral) therapies, the risks to the public as well as research subjects will be relevant considerations.” Id. There are a number of ethical and legal issues at play here: First, whenever researchers “contemplate altering the human microbiome by inducing changes in naturally occurring collections of microbes, we need to be cognizant of the fact that people are both vectors and victims of disease.” Id. Accordingly, such alterations may cause unanticipated risks to the public by virtue of the nature of the research itself. Moreover, “microbial agents that are beneficial to some humans may be toxic to other humans and other organisms.” Id. Because human experiences differ when such alterations occur, some individuals may be endangered by certain manipulations of the microbiome. Since “microbes that may benefit some may be communicated to others and harm them, we will have to evaluate and assess the complex potential public health risks associated with studies.” Id. Each of these evaluations must take into account the complex public health issues and ultimately, come up with appropriate ethical and legal responses. Experts in public health, biomedicine, and similar fields can help legislators and adjudicators to determine what the appropriate responses are.
Analysts from every field ranging from the scientific community to regulatory agencies have urged continuing human microbiome research, touting the many potential benefits such research may offer society. Such research has already encountered a number of ethical and legal issues and will undoubtedly encounter more as scientists expand their investigations. Regardless of the specific issue, legal professionals will greatly benefit from the considered opinions of the many expert witnesses involved in the field, and legal decisions may be largely based upon such carefully thought-out expertise.
By: Kat S. Hatziavramidis, Attorney-at-Law