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Review
. 2020 Feb;162(2):177-180.
doi: 10.1177/0194599819897067. Epub 2019 Dec 24.

Navigating the Informed Consent Process When Using Innovative Surgery

Daniel Wehrmann  1 , Glenn E Green  1 , Kevin J Weatherwax  2 , Andrew G Shuman  1   3
Affiliations
Review

Navigating the Informed Consent Process When Using Innovative Surgery

Daniel Wehrmann et al. Otolaryngol Head Neck Surg. 2020 Feb.
No abstract available

Keywords: expanded access; research ethics; surgical innovation.

PubMed Disclaimer

Conflict of interest statement

Competing interests: Glenn E. Green holds a patent on the technology referenced herein that has been licensed to Materialise.

Sponsorships or competing interests that may be relevant to content are disclosed at the end of this article

References

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    1. Youngerman BE, McKhann GM II. Innovation in surgery and evidence development: can we have both at once? Virtual Mentor 2015;17:41–48. - PubMed
    1. Jarow JP, Lurie P, Ikenberry SC, Lemery S. Overview of FDA’s expanded access program for investigational drugs. Ther Innov Regul Sci 2017;51:177–179. - PMC - PubMed
    1. Jarow JP, Lemery S, Bugin K, Khozin S, Moscicki R. Expanded access of investigational drugs: the experience of the Center of Drug Evaluation and Research over a 10-year period. Ther Innov Regul Sci 2016;50:705–709. - PMC - PubMed
    1. Lantos JD. The regulation of clinical research: what’s love got to do with it? Learn Health Syst 2018;2:e10048. - PMC - PubMed

Supplementary concepts