Ethical, Legal, and Social Implications

Many ethical issues arise from the conduct of human microbiome research. These include the equitable selection of research participants, informed consent and respect for autonomy, data sharing and protection of privacy, invasiveness of sampling and minimization of research risks, and whether and how research results and incidental findings should be returned to participants. In addition to these issues associated with the conduct of the research itself, human microbiome research has many broader societal implications. These range from how the research findings will eventually be applied in both clinical and non-clinical contexts and how new products likely to arise from the research (for example, probiotics) will be regulated, to how this new knowledge will be understood by the public and how it will potentially alter people's conceptions of health and disease or even of what it means to be "human." In recognition of the importance of these issues, a portion of the HMP budget was allocated to the support of the studies below, designed to address the ethical, legal, and social implications of human microbiome research.
Information about the HMP consent process can be found under the Sampling Collection tab of Microbiome Analyses.

Project Title Principal Investigator(s) Institution(s)
Toward a Framework for Policy Analysis of Microbiome Research Mildred Cho, Pamela Sankar Stanford University, University of Pennsylvania

It is recognized that research on the human microbiome is important for its potential scientific and medical impact. The complexity of microbiome research, however, could change the way that genetics is studied and understood because it calls for a more complex, nuanced framework for defining and demonstrating causality. The understanding of the human microbiome could also disrupt traditional assumptions about definitions of species, self, disease and normality. It is also recognized that microbiome research can raise ethical, legal, and social issues. The mandate to study the ELSI issues of human microbiome research at this stage implicitly embraces the concept of preventive or prophylactic bioethics. While useful, such an approach can be less effective than desired at identifying ethical and social issues and minimizing harm if it occurs separately from the scientific community, or is conducted in the abstract and general rather than linked to actual features of planned or ongoing research. Our overall goal is to devise an approach to examine the ELSI issues associated with microbiome research. We propose to use the frameworks of Constructive Technology Assessment and Value-Sensitive Design because they are designed to evaluate research specifically incorporating social context and values, and are well suited to evaluating rapidly-moving and boundary-challenging technologies such as those used in microbiome research. We propose to use a dual concept of risk as a tool to link discussions of abstract questions about values and social implications with specific features of research. This analysis will be used to identify potential research design alternatives that could minimize value conflicts and could potentially be generalized to other genomic and biomedical research more broadly. Our specific aims are: AIM 1. To analyze how risk and benefit are conceptualized in research contributing to the understanding of the human microbiome and its applications, through: A) content analysis of scientific articles about microbiome-related research B) content analysis of microbiome articles in the lay media AIM 2. Determine the relationship between microbiome research questions or design, concepts of risk and benefit, and societal values, in order to inform research conduct, through: A) extended, structured interdisciplinary dialog with experts in microbiome research, technology assessment, and ethical and social analysis B) writing and disseminating white papers and articles.

Indigenous Communities and Human Microbiome Research Paul Spicer University of Oklahoma

This project is an investigation of the implications of research on ancient and contemporary human microbiomes for the social and ancestral identities of indigenous people. It will engage indigenous communities on the U.S. Southern Plains (Apache, Caddo, and Kiowa nations) and in the Andean region of Peru (Aymara, Quechua and Uros-descended communities). Community members will take part in focus groups, individual survey interviews, and public meetings to discuss the ways in which local variations in human microbiomes related to differences in environment, lifestyle and culture may have implications for health disparities, population histories, and social and ancestral identities. Local communities also will be engaged in discussions about how to conduct ethically and culturally appropriate microbiome research using contemporary samples from some members.

Federal Regulation of Probiotics: An Analysis of Existing Regulatory Framework Diane Hoffmann University of Maryland Baltimore

Federal Regulation of Probiotics: An Analysis of the Existing Regulatory Framework and Recommendations for Alternative Frameworks. This proposal requests funding to support an evaluation of existing regulatory frameworks and their appropriateness for the regulation of new probiotic products that are available in the market or will be available in the near future. The project will include a literature review, review of existing relevant statutes and regulations, and three day-long meetings that will each bring together 15-20 invited participants from the regulatory, scientific, biotechnology, government and academic communities to discuss whether the existing regulatory framework of foods, dietary supplements, and drugs is sufficient to ensure the safety of probiotics and accuracy of health-related claims made by sellers of products with probiotic components. The focus of the proposal is the regulation of probiotic products that are or will be available to consumers for human use without a prescription and probiotic products that are or will be available to human patients in the clinical setting. Additionally, the focus of the study will be only those commercial and clinical products that promote themselves as having, or make health-related claims based on, probiotic properties. The first meeting will focus on the science of probiotics - including the current state of probiotic research, current and future clinical applications of probiotics, current and future commercial uses of probiotics, and a discussion of the benefits and risks of consuming or using probiotics. The second meeting will focus on the adequacy of the current regulatory framework for consumer products that contain probiotics components. The third meeting will focus on developing an appropriate framework for the regulation of probiotics and making regulatory policy recommendations. Following the final meeting, the Investigators will prepare a paper or series of papers, with the help of meeting participants, that will include the following topics: a) current regulation of probiotics; b) documented benefits and risks of probiotics use; c) the adequacy of the current regulatory frameworks for the regulation of probiotics; and d) if appropriate, suggested alternative regulatory models for the regulation of probiotics.

Ethical, Legal, and Social Dimensions of Human Microbiome Research Amy McGuire Baylor College of Medicine

We propose an exploratory survey, parallel to the Human Microbiome Project (HMP), of the emergent ethical, legal, and social issues associated with human microbiome research. We will implement this study using in- depth interviews with key stakeholders in the HMP, including individuals who are recruited to the HMP but decline participation, study participants, and investigators and project leaders involved in planning for an conducting the first phases of the HMP. The overall goal of this project is to identify and analyze ethical, legal, and social issues related to human microbiome research and to develop ethically sound and empirically informed strategies for managing these issues in future research. This project has three Specific Aims: (1) Describe recruits and participants' ideas about the HMP (and participants' experiences of the HMP) as it relates to them physically, socially, and culturally and as it relates to their notions of health and disease, (2) Describe the ethical, legal, and social challenges of conducting the HMP from the perspective of study investigators and project leaders at the NIH, and (3) Provide a forum for interdisciplinary exchange with representative stakeholders (including study participants, members of the research team, and outside experts) to develop recommendations for the responsible management of ethical, legal, and social issues identified in Specific Aims 1 and 2.

Publications: Ethical, legal and social considerations in conducting the Human Microbiome Project

Human Microbiome Research and the Social Fabric Rosamond Rhodes Mount Sinai School of Medicine of NYU

Learning more about the human microbiome is likely to change the way medicine is practiced. It may also have implications for our society and our legal system and important implications for how we conceive and address the ethics of medicine and biomedical research. The goal of our project will, therefore, be identifying the ethical, social, and legal implication raised by the study of the human microbiome so as to provide insight and guidance for scientists who will be engaged in the work and members of our society who will be asked to cooperate in the studies and to live with the consequences. Our project will bring together an interdisciplinary team of 27 health professionals, scientists, and scholars from the humanities and social sciences to explore key issues through an intense process of mutual education, group discussion, consensus formation, writing, critiquing, and confirming our views. With that background we will go on to engage a broader community in a series of discussions of the topics. This series of Community Conversations on Developing Science will be designed to provide skill-based education to our audience, to engage participants in a dialogue about the issues, and to elicit their views in a process that could be called "community consultation." Combining what we learn from our group's research and discussions with the input that we gather from community consultation, we will prepare a volume for publication on the ethical, legal and social implications of the human microbiome and a set of materials to be used by others to inform scientists and our society about these matters. The working hypothesis of our project is that the human microbiome may or may not raise entirely unique issues, but that considering theoretical issues from the vantage point of the human microbiome will allow us to reexamine policies and positions in a new light. We will be trying to locate our understanding of the microbiome within the existing rich and intricately textured social fabric by identifying relevant models and points of comparison for grounding our responses. Seeing issues from the new vantage point of research on the human microbiome will spur us to ask and answer questions about the conceptual foundation of accepted principles and distinctions, about the relative importance of previously accepted commitments, and about how they fit within the warp and weft of two broadly shared values: individual liberty and the social good. We envision several distinct ethical, legal, and social domains in which research on the human microbiome is likely to have significant implications: human subject research; sample banking and biobanking; public health; privacy; property and commercialization; personhood, personal identity, and normalcy.

Patient Perceptions of Bioengineered Probiotics and Clinical Metagenomics Richard Sharp, Ruth Farrell Cleveland Clinic

Abstract not available at this time.

Publications: Helping Patients Make Informed Choices About Probiotics: A Need for Research

Member Organizations