NIH policies on experimental studies with humans

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 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).

    Article  PubMed  PubMed Central  Google Scholar 

  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

    Google Scholar 

  4. 4.

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

    CAS  Article  PubMed  Google Scholar 

  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).

    Article  PubMed  Google Scholar 

  7. 7.

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

    Article  Google Scholar 

  8. 8.

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

    CAS  Article  PubMed  PubMed Central  Google Scholar 

  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).

    Article  PubMed  PubMed Central  Google Scholar 

  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).

    Article  PubMed  PubMed Central  Google Scholar 

  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).

    CAS  Article  PubMed  PubMed Central  Google Scholar 

  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).

    CAS  Article  PubMed  PubMed Central  Google Scholar 

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

Authors

Corresponding author

Correspondence to William T. Riley.

Rights and permissions

Reprints and Permissions

About this article

Verify currency and authenticity via CrossMark

Cite this article

Riley, W.T., Riddle, M. & Lauer, M. NIH policies on experimental studies with humans. Nat Hum Behav 2, 103–106 (2018). https://doi.org/10.1038/s41562-017-0265-4

Download citation

Further reading