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Authors
Waddell, Elizabeth Needham
Baker, Robin
Hartung, Daniel M.
Hildebran, Christi J.
Nguyen, Thuan
Collins, Deza’Rae M.
Larsen, Jessica E.
Stack, Erin
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Bialas, Tina
Bielavitz, Sarann
Gregg, Jessica
Korthuis, P. Todd
Kunkel, Lynn
Lee, Joshua D.
Leichtling, Gillian
Meyer, Dawnell L.
Nichols, Ceilidh
Wiest, Katharina
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Funding
Funding for this research was provided by:
Centers for Disease Control and Prevention (CE003008)
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Article History
Received: 12 November 2019
Accepted: 7 April 2020
First Online: 10 July 2020
Ethics approval and consent to participate
: ROAR was reviewed and approved by the Oregon Health & Science University Institutional Review Board (IRB): STUDY00019102 approved March 1, 2019. The OHSU IRB (FWA00000161; IRB00000471) complies with 45 CFR Part 46, 21 CFR Parts 50 and 56, and other federal and Oregon laws and regulations, as applicable, as well as ICH-GCP codes 3.1–3.4, which outline Responsibilities, Composition, Functions, and Operations, Procedures, and Records of the IRB. Per the federal Office of Human Research Protections (FWA00000161), ROAR is in accordance with 45 CFR 46, Subpart C, for the inclusion of participants who are prisoners.
: Not applicable.
: The authors declare that they have no competing interests. Alkermes donated samples of XR-NTX to the Oregon Department of Corrections for participants to initiate treatment prior to release from prison. Donated medication received was received by the Oregon Department of Corrections and is used within the correctional health system only.
