How Informed is Consent? A Field Experiment

Last registered on November 30, 2020

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Pre-Trial

Trial Information

General Information

Title

How Informed is Consent? A Field Experiment

RCT ID

AEARCTR-0006829

Initial registration date

November 29, 2020

Initial registration date is when the trial was registered.

It corresponds to when the registration was submitted to the Registry to be reviewed for publication.

First published

November 30, 2020, 11:33 AM EST

First published corresponds to when the trial was first made public on the Registry after being reviewed.

Locations

Country

Pakistan

Region

Primary Investigator

Name

Alexandra Avdeenko

Affiliation

University of Mannheim

Contact Primary Investigator

Other Primary Investigator(s)

PI Name

Matthias Stelter

PI Affiliation

University of Mannheim

Contact Investigator

Additional Trial Information

Status

In development

Start date

2020-12-01

End date

2021-08-31

Keywords

Other

Additional Keywords

Ethics; Survey Methods; Data Collection; Randomized Control Trial

JEL code(s)

A13; C83; C93

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

Sponsors & Partners

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

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

Randomization Method

coded in the survey instruments (randomization on-site)

Randomization Unit

individual

Was the treatment clustered?

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.

Supporting Documents and Materials

IRB