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Authors
Nichols, Deborah A. https://orcid.org/0009-0005-0886-1707
Steininger, Teresa L. https://orcid.org/0009-0005-9564-0901
Fuller, Douglas S. https://orcid.org/0000-0002-2448-5896
Kirby, M. Todd
Barker, Emily C. https://orcid.org/0009-0007-3186-8602
Whalen, Marisa
Alexander, Jessica K.
Akerman, Sarah
Plante, David T. https://orcid.org/0000-0003-2619-5654
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Funding
Funding for this research was provided by:
Jazz Pharmaceuticals
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Article History
Received: 6 December 2024
Accepted: 1 April 2025
First Online: 9 June 2025
Declarations
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: Deborah A. Nichols, Douglas S. Fuller, M. Todd Kirby, Marisa Whalen, Jessica K. Alexander, and Sarah Akerman are full-time employees of Jazz Pharmaceuticals who, in the course of this employment, have received stock options exercisable for, and other stock awards of, ordinary shares of Jazz Pharmaceuticals, plc. Teresa L. Steininger is a former full-time employee and current contract worker for Jazz Pharmaceuticals who has received shares of Jazz Pharmaceuticals, plc. Emily C. Barker has worked as an independent contractor and advisory board member for Jazz Pharmaceuticals and has received speaker honoraria from Jazz Pharmaceuticals. David T. Plante is a consultant and advisory board member for Jazz Pharmaceuticals. He has also served as a consultant/advisory board member for Alkermes, Harmony Biosciences, Centessa, and Takeda and a consultant for Aditum Bio, LLC, and Teva Pharmaceuticals (Australia).
: DUET is conducted in accordance with consensus ethical principles derived from international guidelines, including the Declaration of Helsinki and Council for International Organizations of Medical Sciences Ethical Guidelines, as well as applicable International Council of Harmonisation (ICH) Good Clinical Practice guidelines and applicable laws and regulations. Investigators obtain documented consent from all participants or their legal representative before participation in DUET. Informed consent forms meeting the requirements of 21 Code of Federal Regulations 50, local regulations, ICH guidelines, Health Insurance Portability and Accountability Act requirements (where applicable), Regulation (EU) 2016/679 General Data Protection Regulation requirements (where applicable), and the institutional review board/independent ethics committee or study site are signed by participants or their legal representatives and investigator or medically qualified designee and placed in participants’ medical records; a copy is also provided to participants or their legal representative. As per Advarra policy, engagement does not necessarily involve efforts to enroll people in studies; rather, it may consist in consulting with patient groups about such things as research priorities and study design and such activities do not typically require IRB review.
