Sinclair, Susan M.
Jones, Judith K.
Miller, Richard K.
Greene, Michael F.
Kwo, Paul Y.
Maddrey, Willis C.
Clinical trials referenced in this document:
Documents that mention this clinical trial
The Ribavirin Pregnancy Registry: An Interim Analysis of Potential Teratogenicity at the Mid-Point of Enrollment
https://doi.org/10.1007/s40264-017-0566-6
Funding for this research was provided by:
Genentech, a member of the Roche Group
Teva Pharmaceutical Industries
Zydus Pharmaceuticals USA, Inc.
Kadmon Pharmaceuticals, LLC
Aurobindo Pharma USA
Merck
Sandoz Pharmaceuticals Inc.
Article History
First Online: 8 July 2017
Compliance with Ethical Standards
:
: The protocol for the Ribavirin Pregnancy Registry conforms to the ethical guidelines of the 1975 Declaration of Helsinki and is approved by Western IRB (WIRB). The Institutional Review Board (IRB) has waived documentation of informed consent in accordance with federal regulations [21 CFR 56.109(c)(1)], which allows the registry to verbally consent patients over the telephone [CitationRef removed]. The IRB has also approved a waiver of the informed consent process when a healthcare provider contacts the registry and provides registration and follow-up anonymously using a registry-assigned tracking number rather than personal identifiers.
: This registry receives financial support from Aurobindo Pharma USA; Genentech, a member of the Roche Group; Kadmon Pharmaceuticals, LLC, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.; Sandoz Pharmaceuticals Inc.; Teva Pharmaceuticals USA, Inc.; and Zydus Pharmaceuticals USA, Inc.
: Susan Sinclair serves as the principal investigator for the registry and is reimbursed for her time through INC Research. Judith K. Jones, Richard K. Miller, Paul Y. Kwo, and Willis C. Maddrey are members of the Scientific Advisory Board, reimbursed for their time by the sponsors, and have no conflicts of interest that are directly relevant to the content of this study. Michael F. Greene is an unpaid Scientific Advisory Board member and has no conflicts of interest that are directly relevant to the content of this study.
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