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Can obtaining informed consent alter self-reported drinking behaviour? A methodological experiment.
Lambert Felix1, Patrick Keating2, Jim McCambridge3,4
1Department of Social & Environmental Health Research, Faculty of Public Health & Policy, London School of Hygiene & Tropical Medicine, London, UK. lambert.felix@lshtm.ac.uk.
BMC Medical Research Methodology
|April 25, 2015
Summary
Informed consent procedures do not significantly alter self-reported alcohol use. However, study settings may influence participant reporting behavior, warranting further investigation into environmental effects on sensitive data collection.
Area of Science:
- Health research ethics
- Psychological research methodology
- Behavioral science
Background:
- Informed consent is crucial for ethical health research.
- The consent process may impact participant reporting of sensitive behaviors.
- Evidence on research participation effects requires further investigation.
Purpose of the Study:
- To evaluate the impact of informed consent procedures on self-reported drinking behavior.
- To assess changes in Alcohol Use Disorder Identification Test (AUDIT) scores due to consent.
- To address gaps in understanding research participation effects.
Main Methods:
- A two-arm, double-blind, randomized controlled trial was conducted with university students.
- Participants were allocated to receive either an informed consent form with the AUDIT questionnaire or the AUDIT questionnaire alone.
- The primary outcome was the mean AUDIT score; the secondary outcome was the proportion scoring 8 or more.
Main Results:
- No statistically significant difference was observed in the primary outcome (mean AUDIT score) between groups.
- A statistically significant difference in the secondary outcome was found only in the run-in phase, not overall.
- Differences between phases suggest that study setting influences reporting behavior.
Conclusions:
- Informed consent completion does not appear to significantly alter self-reported alcohol consumption.
- The influence of study settings on participant reporting behavior requires further research.
- Methodological experiments are valuable for understanding research participation effects.

