Article

Evaluation of informed consent in health research: a questionnaire survey

Department of Nursing Science, University of Kuopio, Kuopio, Finland.
Scandinavian Journal of Caring Sciences (Impact Factor: 0.89). 07/2009; 24(1):56-64. DOI: 10.1111/j.1471-6712.2008.00684.x
Source: PubMed

ABSTRACT 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.
A population-based questionnaire survey.
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).
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%.
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.
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.

0 Followers
 · 
212 Views
  • [Show abstract] [Hide abstract]
    ABSTRACT: Audits of the informed consent process are a key element of a clinical research quality assurance program. A systematic approach to such audits has not been described in the literature. In this paper we describe two components of the audit. The first is the audit of the informed consent document to verify adherence with federal regulations. The second component is comprised of the audit of the informed consent conference, with emphasis on a real time review of the appropriate communication of the key elements of the informed consent. Quality measures may include preparation of an informed consent history log, notes to accompany the informed consent, the use of an informed consent feedback tool, and the use of institutional surveys to assess comprehension of the informed consent process.
    Science and Engineering Ethics 08/2013; 20(2). DOI:10.1007/s11948-013-9461-4 · 1.52 Impact Factor
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: The conceptual complexity of the term voluntariness has resulted in relatively few empirical studies of the voluntariness component of consent to research. As the call for a formal assessment of voluntariness to be incorporated into the consent process intensifies, more researchers are responding to the challenge of developing a valid and reliable measure of voluntariness. The purpose of this article was to summarize and describe the empirical literature on voluntariness of consent. As part of a broader study on the voluntariness of consent to research, existing empirical studies of voluntariness of consent to research were reviewed to establish how voluntariness of consent to research has been assessed to date. Fifteen studies using different voluntariness assessment instruments were identified and included in the review. The review found that little attempt has been made to systematically collect data on the reliability and validity of voluntariness assessment instruments. No two instruments reviewed were found to be based on a shared conceptualization of voluntary consent to research.
    Journal of Empirical Research on Human Research Ethics 02/2015; 10(2):107-120. DOI:10.1177/1556264615571552 · 1.22 Impact Factor
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: To evaluate the psychometric properties of the Indonesian version of the Dutch National Prevalence Measurement of Care Problems. The questionnaire consists of 6 parts: patient characteristics (including pressure ulcer [PrU] risk; assessed by the Braden Scale) and care dependency (assessed by the Care Dependency Scale [CDS]), PrU categorization, prevention, treatment, and structural quality indicators at ward and hospital level.
    Advances in Skin & Wound Care 08/2014; 27(8):363-370. DOI:10.1097/01.ASW.0000452044.58375.43 · 1.63 Impact Factor