The research ethics issues involved in the Human Microbiome Project paralleled very closely those that are raised by human genetics research, said Dr. Amy McGuire, associate professor in the Center for Medical Ethics and Health Policy at Baylor College of Medicine, whose federally funded research looked at the ethics of the project.
The National Institutes of Health funded several projects looking at the Ethical, Legal and Social Implications of the Human Microbiome Project. McGuire’s project focused on issues involved in the ethics of conducting the research itself.
"We interviewed scientists and NIH project leaders involved in the Human Microbiome Consortium," said McGuire, "as well as individuals recruited here at Baylor to participate in the healthy cohort study," a project that seeks to define bacterial, fungal, viral and other microbes that co-inhabit our bodies with human cells. An initial report on her work will appear in the July issue of the Journal of Empirical Research on Human Research Ethics. McGuire and her colleagues asked investigators and individuals recruited to participate in the project questions designed to elicit their concerns and hopes for the project.
"The core ELSI issues in human genetics were the issues arising in different ways in the Human Microbiome Project," she said. For example, concerns about how data generated from the project could be shared without violating individual privacy were central, but the main concern in the Human Microbiome Project related to the effectiveness of methods used to filter human genetic information out of the microbial sequence, which was shared publicly.
The project also involved important philosophical, clinical, and legal questions, McGuire said.
"If we have more microbial DNA in and on our bodies than human, what does it mean to be human?" she asked. "Who owns the microbes and what legal and social implications does the answer to that question have? How should the products of microbiome research be regulated and what type of evidence should be required to substantiate health-related claims for probiotic foods, like yogurt?"
Others who took part include: Dr. Sheryl A. McCurdy of The University of Texas School of Public Health at Houston; Drs. Simon Whitney, James Versalovic and Wendy Keitel, all of BCM.
Funding for this work came from: NIH Common Fund and NHGRI R01-HG004853.