Unruh, Mark http://orcid.org/0000-0001-7103-656X
Cukor, Daniel
Rue, Tessa
Abad, Kashif
Roumelioti, Maria-Eleni
McCurry, Susan M.
Heagerty, Patrick
Mehrotra, Rajnish
Funding for this research was provided by:
National Institutes of Health (R01 DK 115468)
Article History
Received: 4 October 2020
Accepted: 14 October 2020
First Online: 20 October 2020
Ethics approval and consent to participate
: University of Washington IRB Subcommittee A approved this study. Study ID: Study00004678. UW and UNM IRB approval has been obtained before beginning any study activities. The UNM IRB’s protocol No for this study is HRP-508. Since IRB Committee members are not fixed, we cannot name them here.All sites participating in this study are using the same basic process to consent participants. The informed consent document has been structured such that it enables potential participants to indicate which aspects of study they may not be willing to engage in. The consent covers all aspects of screening, baseline testing and subsequent follow-up visits.Investigators and IRB approved research coordinators are responsible for obtaining consent. All personnel obtaining informed consent have completed Collaborative Institutional Training Initiative (CITI) training and received training from the principal investigator (PI) for consenting procedures in line with the Human Research Protections Office (HRPO) standard operating procedures (SOP) for Informed Consent. A document of informed consent is being used for this study. A copy of the signed/dated informed consent form is being given to the subject.The PI holds regular communication with the locations to confirm that: all research staff are competent, properly trained; they have the most current version of the protocol, consent documents, and HIPAA authorization; any further modifications are communicated to sites and implemented only after IRB approval; both study sites safeguard all research data; any non-compliance with the study protocol or applicable requirements are reported immediately to the PI; all adverse events, interim results and study closure determinations are communicated via email and/or teleconference between the PI and study staff.
: Not applicable.
: The authors declare that they have no competing interests. Funding/assistance was not received from a commercial organization.