Evaluation of informed consent: a pilot study.

AIM

This paper is a report of a study to describe and analyse the use of informed consent in clinical research, from the point of view of voluntary adult research participants, in order to develop and test an interview schedule for the evaluation of informed consent.

BACKGROUND

Informed consent is one of the central ethical research principles in healthcare research, but empirical research on this topic is still scarce. To evaluate and develop the ethical quality of scientific research, there is a need to explore the meaning and implications of informed consent for research participants.

METHOD

The data were collected in 2004 by interviews using an interview schedule created for this study by the first author and discussed in a multidisciplinary group. The response rate was 81%. The sample consisted of 32 patients with a metabolic syndrome who were participants in a project evaluating the effects of betaine on cardiovascular risk factors.

FINDINGS

Participants stated that the key elements of informed consent are information, understanding and decision-making, and that competence is an essential factor in the reception and understanding of information and making an independent decision about participation. Our interview schedule was found to be useful in the investigation of informed consent.

CONCLUSION

This study strengthened the perception that more extensive research about research participants is needed.