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Microbiome research ethics looking at a ‘critical gap’

With a shift from observational to experimental research using human microbiomes, ethical questions associated with the research and use of microbiomes are on the rise, according to a presentation at the NIH’s microbiome workshop.

“The first phase of human microbiome research involves the initial focus on genomic characterization,” Mildred Cho, PhD, associate director of the Stanford Center for Biomedical Ethics, said during her presentation. “However, there are associated ethical, legal and social implications that arise from collecting and using data and samples.”

The concern is that the human microbiome defies categorization, according to Cho. The question then becomes, who or what is the subject of human microbiome research and is the human microbiome an organ, pathogen, superorganism or network.

“Categories are important from a political and ethical standpoint,” she said. “This leads to ambiguity of all of those involved. Those definitions and categories define what the ethical categories are.”

According to Cho, some of the ethical concerns associated with human microbiome research include:

  • informed consent;
  • return of results;
  • data sharing;
  • ownership;
  • privacy protection;
  • invasive sampling;
  • equitable subject selection; and
  • defining normalcy.

An example Cho used during the presentation was fecal microbiota transplantations. “In the absence of clear regulatory guidance and principles, what are the ethical obligations of physicians, academic or industry researchers with respect to FMT,” she said. “And, are there any ethical obligations in individuals who self-experiment with FMT and perhaps parents who might try and conduct a transplant in their children?”

Yet outside of regulations and structure, a “citizen scientist” may have advantages as well.

“You could be [participating in] work that is more relevant and might be cheap and fast to do. You may be able to recruit easily using crowdfunded studies [and] might enable research not otherwise funded,” Cho said.

However, as Cho noted, there are also possible downsides that may include concerns with internal and external validity, self-selection bias, equitable access and conflicts of interest.

It is unclear how individuals perform transplants on themselves and then if they have the obligation to disseminate the information after they gather results from their self-conducted study, she added.

There is also a question in this instance as to who is a scientist and what is a scientist, she said. If an activity is not intended to or cannot create generalizable knowledge, or if the process and outcomes are not disseminated, Cho asked if it could be called science.

“There is a critical gap to clarify the ethical obligations of all participants in human microbiome research to maximize benefits,” she said.

Reference: Cho M. Ethical issues in human microbiome research: Beyond the usual suspects. Presented at: The human microbiome: Emerging themes at the horizon of the 21st century; Aug. 16-18, 2017; Bethesda, MD.

Disclosure: Cho reports no relevant financial disclosures.

With a shift from observational to experimental research using human microbiomes, ethical questions associated with the research and use of microbiomes are on the rise, according to a presentation at the NIH’s microbiome workshop.

“The first phase of human microbiome research involves the initial focus on genomic characterization,” Mildred Cho, PhD, associate director of the Stanford Center for Biomedical Ethics, said during her presentation. “However, there are associated ethical, legal and social implications that arise from collecting and using data and samples.”

The concern is that the human microbiome defies categorization, according to Cho. The question then becomes, who or what is the subject of human microbiome research and is the human microbiome an organ, pathogen, superorganism or network.

“Categories are important from a political and ethical standpoint,” she said. “This leads to ambiguity of all of those involved. Those definitions and categories define what the ethical categories are.”

According to Cho, some of the ethical concerns associated with human microbiome research include:

  • informed consent;
  • return of results;
  • data sharing;
  • ownership;
  • privacy protection;
  • invasive sampling;
  • equitable subject selection; and
  • defining normalcy.

An example Cho used during the presentation was fecal microbiota transplantations. “In the absence of clear regulatory guidance and principles, what are the ethical obligations of physicians, academic or industry researchers with respect to FMT,” she said. “And, are there any ethical obligations in individuals who self-experiment with FMT and perhaps parents who might try and conduct a transplant in their children?”

Yet outside of regulations and structure, a “citizen scientist” may have advantages as well.

“You could be [participating in] work that is more relevant and might be cheap and fast to do. You may be able to recruit easily using crowdfunded studies [and] might enable research not otherwise funded,” Cho said.

However, as Cho noted, there are also possible downsides that may include concerns with internal and external validity, self-selection bias, equitable access and conflicts of interest.

It is unclear how individuals perform transplants on themselves and then if they have the obligation to disseminate the information after they gather results from their self-conducted study, she added.

There is also a question in this instance as to who is a scientist and what is a scientist, she said. If an activity is not intended to or cannot create generalizable knowledge, or if the process and outcomes are not disseminated, Cho asked if it could be called science.

“There is a critical gap to clarify the ethical obligations of all participants in human microbiome research to maximize benefits,” she said.

Reference: Cho M. Ethical issues in human microbiome research: Beyond the usual suspects. Presented at: The human microbiome: Emerging themes at the horizon of the 21st century; Aug. 16-18, 2017; Bethesda, MD.

Disclosure: Cho reports no relevant financial disclosures.

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