Development and Evaluation of Software for Obtaining Informed Consent
Abstract
Obtaining informed consent (IC) in studies under Institutional Review Board (IRB) oversight is a requirement per 32 CFR 219.116. Traditional means of obtaining IC via paper forms can be inconvenient for field studies or where travel is required and are prone to various IC form discrepancies. The U.S. Army Combat Capabilities Development Command (CCDC) Army Research Laboratory (ARL) Human Research Protection Program (HRPP) is developing, evaluating, and implementing an IC form system that addresses the challenges inherent in traditional methods via a software application called Informed Consent (IC ). While commercial off-the-shelf (COTS), open-source, and proprietary electronic IC applications already exist and have been investigated for use in clinical and research settings, these solutions are unsatisfactory for several reasons: 1) CCDC Army Research Laboratory studies are frequently conducted in environments without internet access, 2) extant applications do not meet all requirements of the ARL HRPP, and 3) cost and information-assurance requirements make installation of COTS enterprise software prohibitive. The purpose of this report is to review the development of the IC+ app - including requirements, features, and screenshots and discuss the results of evaluation efforts conducted with researchers to assess its performance, usability, and benefits or limitations.
Document Details
- Document Type
- Technical Report
- Publication Date
- Aug 01, 2020
- Accession Number
- AD1108056
Entities
People
- Christopher Garneau
- Jennifer Biladeau
- Kristin E. Schaefer
- Theresa Straut