Evaluation of informed consent in health research: a questionnaire survey.
OBJECTIVE
Informed consent is ethically and legally required for all biomedical and health research involving human participants. This study analyses the realization of informed consent in health research from the point of view of healthy, voluntary adult participants. Empirical studies from this point of view are still rare.


METHODS
A population-based questionnaire survey.


METHODS
The study population consisted of 1410 men and women aged 57-78 years who are participants in a randomized controlled intervention trial on the effects of physical exercise and diet at Kuopio Research Institute of Exercise Medicine (eastern Finland).


METHODS
The data were collected in 2005-2007 using a questionnaire. The questionnaire was given to all able and willing participants (n = 1324) who were still involved in the exercise and diet study at the 3-month intervention visit. The response rate was 91%.


RESULTS
The defined key elements of informed consent were information, understanding, competence, voluntariness and decision-making. A majority of the participants estimated that these key elements were successfully realized in the exercise and diet intervention study.


CONCLUSIONS
Despite the general satisfaction with the informed consent process in the exercise and diet intervention study, a minority of the participants were dissatisfied with the information they had received or did not understand this information completely. These findings highlight the essential question: Did all of the participants truly give their genuine informed consent? This carefully executed study reveals objectively the difficulties in distribution of information to healthy adult volunteers.
Länsimies-Antikainen
Helena
H
Department of Nursing Science, University of Kuopio, Kuopio, Finland. ahantika@hytti.uku.fi
Laitinen
Tomi
T
Rauramaa
Rainer
R
Pietilä
Anna-Maija
AM
D000368:Aged; D035843:Biomedical Research; D003695:Delivery of Health Care; D005260:Female; D006801:Humans; D007258:Informed Consent / Q000941:ethics* / Q000592:standards*; D008297:Male; D008875:Middle Aged; D011795:Surveys and Questionnaires