Comment | Published:

Regulating microbiome manipulation

A crucial consideration for the clinical application of any burgeoning science is when the understanding of that field can be implemented without the risk of unforeseen harm. In our opinion, the need for caution is particularly urgent with respect to increasingly prevalent applications of microbiome science to medicine.

Access optionsAccess options

Rent or Buy article

Get time limited or full article access on ReadCube.

from$8.99

All prices are NET prices.

References

  1. 1.

    Carlucci, C., Petrof, E. O. & Allen-Vercoe, E. EBioMedicine 13, 37–45 (2016).

  2. 2.

    van Nood, E. et al. N. Engl. J. Med. 368, 407–415 (2013).

  3. 3.

    Gupta, A., Cifu, A. S. & Khanna, S. JAMA 320, 1031–1032 (2018).

  4. 4.

    Hoffman, D. et al. Science 358, 1390–1391 (2017).

  5. 5.

    Sachs, R. E. & Edelistein, C. A. J. Law Biosci. 6, 396–415 (2015).

  6. 6.

    Woodworth, M. H. et al. New Bioeth. 23, 210–218 (2017).

  7. 7.

    Woodworth, M. H. et al. J. Clin. Micro. 55, 1002–1010 (2017).

  8. 8.

    Enforcement Policy Regarding Investigational New Drug Requirements for use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection not Responsive to Standard Therapies. Draft Guidance for Industry (US FDA, 2016).

  9. 9.

    Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion: Draft Guidance for Industry (ed. Center for Biologics Evaluation and Research) (US FDA, 2016).

  10. 10.

    Kristensen, N. B. et al. Genome Med. 8, 52 (2016).

  11. 11.

    Thomas, S. et al. Cancer Res. 77, 1783–1812 (2017).

  12. 12.

    Aagaard, K. FASEB J. 27, 1012–1022 (2012).

Download references

Author information

Competing interests

The authors declare no competing interests.

Correspondence to Kjersti Aagaard.

Rights and permissions

Reprints and Permissions

About this article

Verify currency and authenticity via CrossMark