Regodón Wallin, Amanda
Tielsch, James M
Khatry, Subarna K
Mullany, Luke C
Englund, Janet A
Chu, Helen
LeClerq, Steven C
Katz, Joanne
Funding for this research was provided by:
Bill and Melinda Gates Foundation (Grant 50274)
National Institutes of Health (R01 HD092411)
Article History
Received: 31 August 2019
Accepted: 28 July 2020
First Online: 17 September 2020
Ethics approval and consent to participate
: The project was approved by the institutional review boards of the Cincinnati Children’s Medical Center (Cincinnati, OH, USA; IRB number: 2010 − 0776), Johns Hopkins Bloomberg School of Public Health (Baltimore, MD, USA; IRB number: 00002458), the Institute of Medicine at Tribhuvan University (Kathmandu, Nepal; IRB number: 6/069/690), and the Nepal Health Research Council (Kathmandu, Nepal; IRB number 268)). Institutional review boards at Seattle Children’s Hospital (Seattle, WA, USA; IRB number: 13188) and the University of Washington (Washington, DC, USA; IRB number 00000743) granted oversight to the institutional review board at Johns Hopkins Bloomberg School of Public Health. All participants in the community-based trial for which the data were originally collected gave oral informed consent. All the IRBs mentioned above approved oral consent. Given the low literacy level in the population and because it was deemed inappropriate for illiterate participants to sign a document they could not read. The verbal consent was documented by date and signature of the person conducting the consent. The clinical trials were prospectively registered at clinicaltrials.gov on Dec 17, 2009 (NCT01034254).
: Not applicable.
: The authors declare that they have no competing interests.