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How Informed is Consent? A Field Experiment
Last registered on November 30, 2020

Pre-Trial

Trial Information
General Information
Title
How Informed is Consent? A Field Experiment
RCT ID
AEARCTR-0006829
Initial registration date
November 29, 2020
Last updated
November 30, 2020 11:33 AM EST
Location(s)
Region
Primary Investigator
Affiliation
University of Mannheim
Other Primary Investigator(s)
PI Affiliation
University of Mannheim
Additional Trial Information
Status
In development
Start date
2020-12-01
End date
2021-08-31
Secondary IDs
Abstract
Field experiments improve the credibility of economic research and we observe an ever-increasing number of experiments in developing countries. These studies are often based on survey data. At the same time, research on the ethical aspects of collecting survey data in developing countries remains scarce. There is, however, a responsibility to engage with the ethical requirements of survey data collection. In this paper, we investigate informational constraints to consent of potential survey participants. First, we test whether survey participants are sufficiently informed about what happens to their data and their rights. Further, we experimentally test whether an interactive, audio-visual supported approach can improve how well informed they are. In this approach, the content of the consent form is presented in a structured dialog and illustrated with a short video. We further investigate implications on response behavior and data quality.
External Link(s)
Registration Citation
Citation
Avdeenko, Alexandra and Matthias Stelter. 2020. "How Informed is Consent? A Field Experiment." AEA RCT Registry. November 30. https://doi.org/10.1257/rct.6829-1.0.
Experimental Details
Interventions
Intervention(s)
We will randomly vary an alternative approach of presenting the consent form, combining an audio-visual component with a scripted process, in a survey data collection.
Intervention Start Date
2020-12-01
Intervention End Date
2021-04-01
Primary Outcomes
Primary Outcomes (end points)
Three main outcomes of interest: (1) ethical aspects related to different levels of being informed, (2) data quality, and (3) external validity. With our survey instrument we try to measure objective knowledge and subjective understanding of the study purpose, the voluntary nature of participation, the data confidentiality, and rights w.r.t. data protection.
Primary Outcomes (explanation)
A. Knowledge about Rights and about Implications of Participating
Main outcomes:
Summary score: Rights w.r.t. data protection
Summary score: Purpose
Summary score: Voluntary participation
Summary score: Data confidentiality
Overall knowledge summary score (mean of all seven one-item scores)
Indicator for sufficiently informed respondents (Indicator for when the Overall knowledge summary score is above 70%.
Overall subjective understanding summary score (mean of all 4 one-item scores)
Indicator for “I understood this well” OR “I understood this very well” to: “The purpose of this survey.”
Indicator for “I understood this well” OR “I understood this very well” to: “My participation in the interview is fully voluntary.”
Indicator for “I understood this well” OR “I understood this very well” to: “How the confidentiality of my information is ensured.”
Indicator for “I understood this well” OR “I understood this very well” to: “My rights with respect to data protection and storage.”
To analyze the relation of subjective and actual understanding of respondents:
Y5.i: Respondent type w.r.t. purpose: high actual and subjective understanding; low actual but high subjective under- standing; low actual and low subjective understanding; high actual but low subjective understanding
Y5.ii: Respondent type w.r.t. voluntary nature: high actual and subjective understanding Y5.iii: Respondent type w.r.t. confidentiality: high actual and subjective understanding
Y5.iv: Respondent type w.r.t. rights: high actual and subjective understanding
B. Data Quality

Y6.i: Indicator for whether the (guardian of the) potential respondent gave consent to be inter- viewed by providing oral consent
For robustness:
Y6.ii: Indicator for whether the (guardian of the) potential respondent gave consent (and if needed assent) to be interviewed by providing oral consent
Y7.i: Share of all “refuse to answer” replies among sensitive questions
For robustness:
Y7.ii: Share of all “refuse to answer” replies among all questions
Y7.iii: Share of all “refuse to answer” and “don’t know” replies among all questions
Y7.iv: Share of all “refuse to answer” and “don’t know” replies among sensitive questions
A question is considered to be sensitive, if at least one respondent refused to answer the question among all respondents. Note that this outcome can be measured for those who gave consent and thus will be analyzed for respondents only.
Y8.i: Share of inconsistencies of all potential inconsistencies
Y8.ii: Number of modules of with non-differentiation responses (“straightlined” responses)
Y8.iii: Interview duration after consent
Y8.iv: Interview speed (time per question asked, i.e. duration of interview/ number of questions after consent)
C. Sample Composition
Y9.i: Respondent’s age
Y9.ii: Respondent’s sex
Y9.iii: Respondent’s education

Further, due to limitation in questionnaire space, we chose to only pose all questions required to measure outcomes such as how informed to only 12%, the 6% in the Audio-visual Supported and Scripted Interactive Consent Form group and 6% in the control group, while the remaining 88% only see two questions chosen at random.
Secondary Outcomes
Secondary Outcomes (end points)
Secondary Outcomes (explanation)
Experimental Design
Experimental Design
We plan to implement the experiment alongside an already planned data collection in rural Pakistan. Thus potential effects are established in a real rather than a laboratory setting. In more detail, we will have a sample of over 7500 respondents, whereby more than half of participants will need to provide assent (because respondent is under age of 18) and a consent will be provided by a guardian. Since the study is an independent add-on to a different study, we want to minimize any potential influence on the main survey. Therefore the majority will be randomize on-site to the control group (50%), while the intervention will be assigned to the Audio-visual Supported Consent Form treatment (44%), and only some respondents will be assigned to the full Audio-visual Supported and Scripted Interactive Consent Form treatment (6%).
Experimental Design Details
Not available
Randomization Method
coded in the survey instruments (randomization on-site)
Randomization Unit
individual
Was the treatment clustered?
No
Experiment Characteristics
Sample size: planned number of clusters
no clusters
Sample size: planned number of observations
>7500 individuals
Sample size (or number of clusters) by treatment arms
Control group (50%)
Treatment arm 1: Audio-visual Supported Consent Form treatment (44%)
Treatment arm 2: full Audio-visual Supported and Scripted Interactive Consent Form treatment (6%)
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
Depending on what we expect, we are powered to detect changes of less than 5% in consent rates and can detect changes in our measure of objective understanding of 0.2. We therefore deem the study sufficiently powered, considering that these calculations are conservative. Changes of much less than 5% in consent rates do not seem to be too relevant as well as changes in understanding of less than 0.2 (on a scale from -1 to 1). A more detailed calculation is presented in the registered PAP.
IRB
INSTITUTIONAL REVIEW BOARDS (IRBs)
IRB Name
Research and Development Solutions (Pakistan)
IRB Approval Date
2020-10-29
IRB Approval Number
IRB00010843
IRB Name
University of Mannheim
IRB Approval Date
2020-05-25
IRB Approval Number
N/A
Analysis Plan

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