Comment | Published:

NIH policies on experimental studies with humans

Nature Human Behaviourvolume 2pages103106 (2018) | Download Citation

The recently updated US National Institutes of Health clinical trials policies will apply broadly to studies involving experimental manipulations of humans. These studies will require registration and reporting in ClinicalTrials.gov, grant application submission under a clinical trials funding opportunity announcement, and Good Clinical Practice training for investigators.

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.

    Hudson, K. L., Lauer, M. S. & Collins, F. S. JAMA 316, 1353–1354 (2016).

  2. 2.

    Notice of revised NIH definition of “clinical trial” (NIH, 23 October 2014); https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-015.html

  3. 3.

    Clinical trials registration and results information submission. Fed. Reg 81, 64982–651517 (21 September 2016); https://www.gpo.gov/fdsys/pkg/FR-2016-09-21/pdf/2016-22129.pdf

  4. 4.

    Roskies, A. L. Neuron 96, 14–16 (2017).

  5. 5.

    Reardon, S. Brain researchers in uproar over NIH clinical-trials policy. Nature News http://www.nature.com/news/brain-researchers-in-uproar-over-nih-clinical-trials-policy-1.22550 (1 September 2017).

  6. 6.

    De Angelis, C. et al. N. Engl. J. Med. 351, 1250–1251 (2004).

  7. 7.

    Ross, J. S. et al. Br. Med. J. 344, d7292 (2012).

  8. 8.

    Gordon, D. et al. N. Engl. J. Med. 369, 1926–1934 (2013).

  9. 9.

    National Institutes of Health: Additional Data Would Enhance the Stewardship of Clinical Trials across the Agency GAO-16-304 (Government Accountability Office, 2016); https://www.gao.gov/products/gao-16-304

  10. 10.

    Arango, J. et al. Ther. Innov. Regul. Sci. 50, 480–486 (2016).

  11. 11.

    Federal policy for protection of human subjects, 45 CFR § 46 (2009); https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html

  12. 12.

    Constitution of WHO: principles. WHO http://www.who.int/about/mission/en/ (1946).

  13. 13.

    NIH definition of clinical trial case studies. National Institutes of Health https://grants.nih.gov/policy/clinical-trials/case-studies.htm (2017).

  14. 14.

    Clinical trials. WHO http://www.who.int/topics/clinical_trials/en/ (2015).

  15. 15.

    Williams, R. J., Tse, T., Harlan, W. R. & Zarin, D. A. CMAJ 182, 1638–1642 (2010).

  16. 16.

    Rigor and reproducibility. National Institutes of Health https://www.nih.gov/research-training/rigor-reproducibility (2016).

  17. 17.

    Nosek, B. A. et al. Science 348, 1422–1425 (2015).

  18. 18.

    PRS User’s Guide Section 9 (US National Library of Medicine, 2017); https://prsinfo.ClinicalTrials.gov/prs-users-guide.html#section9

  19. 19.

    Federal policy for protection of human subjects, Vol. 82 Fed. Reg. 7149–7274 (19 January 2017); https://www.gpo.gov/fdsys/pkg/FR-2017-01-19/html/2017-01058.htm

  20. 20.

    Collins, F. S. et al. Science 351, 1405 (2016).

Download references

Acknowledgements

We thank our NIH Office of Science Policy colleagues, particularly K. Elzarrad and V. Gordon, for their efforts to turn principles into policies.

Author information

Affiliations

  1. National Institutes of Health, Bethesda, MD, USA

    • William T. Riley
    • , Melissa Riddle
    •  & Michael Lauer

Authors

  1. Search for William T. Riley in:

  2. Search for Melissa Riddle in:

  3. Search for Michael Lauer in:

Corresponding author

Correspondence to William T. Riley.

About this article

Publication history

Published

DOI

https://doi.org/10.1038/s41562-017-0265-4

Further reading

Newsletter Get the most important science stories of the day, free in your inbox. Sign up for Nature Briefing