Document is current
Any future updates will be listed below
-
Authors
-
Funding
Funding for this research was provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (RHD095187A)
- License Information
-
More Information
Article History
Received: 19 September 2024
Accepted: 7 June 2025
First Online: 4 July 2025
Declarations
:
: The study protocol, the informed consent forms, participant recruitment materials, and additional study-related documents will be reviewed and approved by the IRB Office of NU, which is responsible for protecting the rights and welfare of human research participants. In addition to yearly reviews that include progress and safety reports, the IRB Office also reviews any modifications to the study protocol, the informed consent forms, participant recruitment materials, and additional study-related documents made throughout the year.All study participants are asked to review the informed consent document in the presence of a research team member that can address their questions and concerns before being asked to sign and provide written, informed consent for their participation in the study.Written informed consent will be obtained from each participant at entry into the study. Informed consent is obtained by the following process:1. The participant will be asked to review the study consent form.2. A trained member of the study team will meet with the participant to review the form, to confirm the participant’s understanding of the study, and to answer any questions that the participant might have.3. Once the participant demonstrates understanding of the study and agrees to participate in the study, the consent will be signed in the presence of study team member, who will also witness the document.
: See Appendix A.
: Dr. Jun Yao, co-author and primary investigator, developed the investigational device for this study. Three authors (Carmona, Drogos, and Yao) have ownership stakes in ReIn-Hand Technologies, Inc., the corporation that currently holds the exclusive license for this investigational device. Importantly, the corporation was founded after applying for, and receiving, NIH funding; and the corporation has not received any funding as part of this project. Northwestern University owns the patent for this device.
