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Not your parent’s NIH clinical trial

Nature Human Behaviour volume 2, pages 107–109 (2018)Cite this article

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The National Institutes of Health has broadened its definition and changed the reporting requirements for ‘clinical trials’. What are the implications for basic human behavioural and brain science?

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References

  1. What are clinical trials? National Heart, Lung, and Blood Institute https://www.nhlbi.nih.gov/studies/clinicaltrials (2012).

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

  4. Clinical trials. National Institute of Diabetes and Digestive and Kidney Diseases https://www.niddk.nih.gov/health-information/clinical-trials (2013).

  5. Wolfe, J. et al. Open letter to NIH director Francis Collins (iPetitions, 2017); http://ipetitions.com/petition/open-letter-nih-collins

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

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  7. Kaiser, J. Some scientists hate NIH’s new definition of a clinical trial. Here’s why. Science News https://doi.org/10.1126/science.aan7122 (19 July 2017).

  8. 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).

  9. Wolfe, J. The NIH clinical trials issue (continued): A good try but we still have a problem. Psychonomic Society https://featuredcontent.psychonomic.org/the-nih-clinical-trials-issue-continued-a-good-try-but-we-still-have-a-problem/ (13 September 2017).

  10. 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

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Acknowledgements

J.M.W. is President of The Federation of Associations of Behavioral and Brain Sciences (FABBS). N.G.K. is a member of the National Academy of Sciences.

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Authors and Affiliations

  1. Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, USA

    Jeremy M. Wolfe

  2. Massachusetts Institute of Technology (MIT), Cambridge, MA, USA

    Nancy G. Kanwisher

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  1. Jeremy M. Wolfe
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Correspondence to Jeremy M. Wolfe.

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The authors declare no competing interests.

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Wolfe, J.M., Kanwisher, N.G. Not your parent’s NIH clinical trial. Nat Hum Behav 2, 107–109 (2018). https://doi.org/10.1038/s41562-017-0262-7

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