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Evaluation of informed consent: a pilot study

Authors

  • Helena Länsimies-Antikainen,

    1. Helena Länsimies-Antikainen MNSc RN PhD Student Department of Nursing Science and Department of Clinical Physiology, Kuopio University Hospital and University of Kuopio, Kuopio, Finland
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  • Anna-Maija Pietilä,

    1. Anna-Maija Pietilä PhD RN Professor Department of Nursing Science, University of Kuopio, Kuopio, Finland
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  • Tomi Laitinen,

    1. Tomi Laitinen MD Docent Department of Clinical Physiology, Kuopio University Hospital and University of Kuopio, Kuopio, Finland
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  • Ursula Schwab,

    1. Ursula Schwab PhD Docent Department of Clinical Nutrition, Kuopio University Hospital and University of Kuopio, Kuopio, Finland
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  • Rainer Rauramaa,

    1. Rainer Rauramaa MD Professor Kuopio Research Institute of Exercise Medicine, Kuopio, Finland
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  • Esko Länsimies

    1. Esko Länsimies MD Professor Emeritus Department of Clinical Physiology, Kuopio University Hospital and University of Kuopio, Kuopio, Finland
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Helena Länsimies-Antikainen:
e-mail: ahantika@hytti.uku.fi

Abstract

Title. 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.

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