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Authors
Scull, Tracy M. https://orcid.org/0000-0002-9894-8654
Malik, Christina V. https://orcid.org/0000-0001-9284-0004
Morrison, Abigail
Keefe, Elyse M.
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Funding
Funding for this research was provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (R44HD088254)
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Article History
Received: 27 September 2019
Accepted: 11 December 2019
First Online: 8 January 2020
Ethics approval and consent to participate
: This study protocol (Version 1) was approved by the innovation Research & Training Internal Review Board chaired by Dr. Barbara Davis Goldman on April 29, 2019. Informed consent will be obtained in accordance with 21 CFR Part 50 and the Declaration of Helsinki before protocol-specified procedures are carried out. The protocol is also designed to meet the Health and Human Services Regulations regarding the Protection of Human Subjects 45 CFR 46 – Subpart D.
: Not applicable.
: The project personnel, including PI Tracy Scull and Co-I Christina Malik, are employees at a small business that has a financial interest in the sale of <i>Media Aware</i>. Their conflict of interest is minimal and is further minimized through careful training of the data collectors and careful supervision of the data collection procedures. The data collected in the proposed studies will be entered into the computer by participants using a web-based data collection system. Furthermore, the data will be analyzed by an independent statistical consultant.
