Electronic Consent of Numerous Subjects Employing Novel Techniques Trial

Duke University

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Conditions

Informed Consent

Interventions

ResearchKit ConsentOTHER

Multi-tiered consent form using the Apple ResearchKit Platform.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Participant comprehension, as measured by Qualtrics survey

Participants will complete a questionnaire about the consent form after reading through the consent which will assess their comprehension of the contents of the consent process.

Time frame: at study conclusion, an average of 15 minutes

Data from ClinicalTrials.gov

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