Evaluation of informed consent in health research: A questionnaire survey
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.
Available from: Douglas Wassenaar
- "None of the studies reviewed described any standardization or norming procedures. Four (33.3%) of the 12 quantitative studies reviewed attempted to establish the validity of the instrument used (Barsdorf & Wassenaar, 2005; Dugosh et al., 2010; Lansimies-Antikainen et al., 2010; Miller et al., 2011). Two of the 4 studies reporting validity only assessed internal validity. "
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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 · 1.25 Impact Factor
Available from: Lena Inger Mårtensson
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ABSTRACT: A growing responsibility on the part of individuals to make decisions in health issues implies the need of access to health information and personal skills to comprehend the information. Health literacy comprises skills in obtaining, understanding and acting on information about health issues in ways that promote and maintain health. A lack of health literacy may have effects at both the individual and societal levels. There are thus reasons for health care professionals to gain a comprehensive understanding of health literacy. The aim of this review was to explore how health literacy is described in the scientific literature and to give a synthesis of its different meanings.
The review was based on approximately 200 scientific articles published 2000-2008. The analysis process was inspired by the methods of narrative literature review.
Two different approaches to health literacy became visible, one in which health literacy is expressed as a polarized phenomenon, focusing on the extremes of low and high health literacy. The definitions of health literacy in this approach are characterized by a functional understanding, pointing out certain basic skills needed to understand health information. The other approach represents a complex understanding of health literacy, acknowledging a broadness of skills in interaction with the social and cultural contexts, which means that an individual's health literacy may fluctuate from one day to another according to the context. The complex approach stresses the interactive and critical skills needed to use information or knowledge as a basis for appropriate health decisions. We conclude that health literacy is a heterogeneous phenomenon that has significance for both the individual and society. Future research will aim at the development of assessments that capture the broadness of skills and agents characteristic for health literacy as a complex phenomenon.
Scandinavian Journal of Caring Sciences 06/2011; 26(1):151-60. DOI:10.1111/j.1471-6712.2011.00900.x · 0.89 Impact Factor
Available from: ncbi.nlm.nih.gov
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ABSTRACT: The recent focus of federal funding on comparative effectiveness research underscores the importance of clinical trials in the practice of evidence-based medicine and health care reform. The impact of clinical trials not only extends to the individual patient by establishing a broader selection of effective therapies, but also to society as a whole by enhancing the value of health care provided. However, clinical trials also have the potential to pose unknown risks to their participants, and biased knowledge extracted from flawed clinical trials may lead to the inadvertent harm of patients. Although conducting a well-designed clinical trial may appear straightforward, it is founded on rigorous methodology and oversight governed by key ethical principles. In this review, we provide an overview of the ethical foundations of trial design, trial oversight, and the process of obtaining approval of a therapeutic, from its pre-clinical phase to post-marketing surveillance. This narrative review is based on a course in clinical trials developed by one of the authors (DJM), and is supplemented by a PubMed search predating January 2011 using the keywords "randomized controlled trial," "patient/clinical research," "ethics," "phase IV," "data and safety monitoring board," and "surrogate endpoint." With an understanding of the key principles in designing and implementing clinical trials, health care providers can partner with the pharmaceutical industry and regulatory bodies to effectively compare medical therapies and thereby meet one of the essential goals of health care reform.
Postgraduate Medicine 09/2011; 123(5):194-204. DOI:10.3810/pgm.2011.09.2475 · 1.70 Impact Factor
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