Electronic Consent of Numerous Subjects Employing Novel Techniques Trial (ECONSENT)

Duke University

Status

Withdrawn

Conditions

Informed Consent

Treatments

Other: ResearchKit Consent

Study type

Interventional

Funder types

Other

Identifiers

NCT02799407

Pro00070430

Details and patient eligibility

About

Full description

The purpose of this study is to compare the modular, multi-tiered consent process featured in Apple's ResearchKit (RK) to the standard consent process. The primary objective is to determine whether participants using the ResearchKit consent form have a significantly higher comprehension of the elements of consent than participants using the standard consent form. Through this two-arm randomized controlled trial (RCT) 120 participants will be asked to read through either a ResearchKit multi-tiered consent form administered on an iPod Touch device or a standard long-form consent form administered via paper and give their informed consent for a sham research study on health tracking apps. The participants will then be asked to answer a short series of questions (5 minutes) about the consent process in order to measure their subjective and objective comprehension. The main risk from this study is loss of confidentiality of responses, however this risk should be minimal given that protected health information (PHI) will only be collected on the consent document and all information will be stored on Duke Box in a private folder only accessible by the study team.

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Age > 18 years
Able to read and understand study materials which are presented in English
Owns or has access to a smartphone or other smart device such as a tablet or iPod

Exclusion criteria

Any physical limitations which prevent the participant from using mobile and/or touch screen technologies
Employed in a research position, clinical care position, or position which has regular exposure to clinical research