Academic journal article Bulletin of the World Health Organization

Participants' Understanding of Informed Consent in Clinical Trials over Three Decades: Systematic Review and Meta-analysis/Comprehension Du Consentement Edaire Par Les Participants a Des Essais Cliniques Sur Trois Decennies: Revue Systematique et Meta-analyse/La Comprension del Consentimiento Informado Por Parte De Los Participantes De Ensayos Clinicos a Lo Largo De Tres Decadas: Revision Sistematica V Metaanalisis

Academic journal article Bulletin of the World Health Organization

Participants' Understanding of Informed Consent in Clinical Trials over Three Decades: Systematic Review and Meta-analysis/Comprehension Du Consentement Edaire Par Les Participants a Des Essais Cliniques Sur Trois Decennies: Revue Systematique et Meta-analyse/La Comprension del Consentimiento Informado Por Parte De Los Participantes De Ensayos Clinicos a Lo Largo De Tres Decadas: Revision Sistematica V Metaanalisis

Article excerpt

Introduction

Informed consent has its roots in the 1947 Nuremberg Code and the 1964 Declaration of Helsinki and is now a guiding principle for conduct in medical research. (1,2) Within its ethical and legal foundations, (3) informed consent has two specific goals in clinical research: (i) to respect and promote a participants autonomy; and (ii) to protect participants from harm. (4,5) Obtaining written informed consent from participants before enrolment in a study is an internationally accepted standard. (6-10)

Five concepts must be considered in establishing informed consent: voluntariness, capacity, disclosure, understanding and decision. (11,12) Voluntariness means that an individuals decision to participate is made without coercion or persuasion. Capacity relates to an individual's ability to make decisions that stems from his or her ability to understand the information provided. Disclosure involves giving research participants all relevant information about the research, including its nature, purpose, risks and potential benefits as well as the alternatives available. (13) Understanding implies that research participants are able to comprehend the information provided and appreciate its relevance to their personal situations. Decision is that made to participate, or not. (11,12)

The quality of informed consent in clinical research is determined by the extent to which participants understand the process of informed consent. (14) Understanding plays a pivotal role in clinical research because it directly affects how ethical principles are applied in practice. (15-17) Although the literature on informed consent began to accumulate in the 1980s, little is known about how patients' understanding has evolved as no meta-analysis has been previously performed. A systematic review considering literature up to 2006 found that only around 50% of participants understood all components of informed consent in surgical and clinical trials. (18) Another systemic review, which included data up to 2010, compared only the quality of informed consent in developing and developed countries. (19) The objective of this study was, therefore, to investigate the quality of informed consent in clinical trials in recent decades by performing a systematic review and meta-analysis of the data available.

Methods

We conducted a literature search of PubMed and Scopus using the following terms: "informed consent[mh] AND (comprehension[mh] OR decision makingjmh] OR knowledge[mh] OR perception [mh] OR communication [mh] OR understanding) AND (randomized controlled trials as topic[mh] OR clinical trial as topic[mh])". In addition, in a simple search of Scopus, we used: "allintitle: understanding OR comprehension OR knowledge OR decision OR perception OR communication "informed consent"." In Google Scholar, we used the keywords "informed consent" as the exact phrase and "understanding, comprehension, knowledge, decision, perception, communication" with the option with at least one of the words and selected "where my words occur in the title of the article". The search strategy was developed as previously described. (20) The searches covered all data entered up to October 2013. In addition, we analysed the reference lists of relevant articles. All studies identified were reviewed independently for eligibility by two of five authors and conflicts were resolved by seeking a consensus with other authors.

A study was eligible for inclusion if it assessed the participant's or the participant's guardian's understanding of informed consent (12) and at least one of the following components of the informed consent process: (8,21) therapeutic misconception (i.e. lack of awareness of the uncertainty of success); ability to name at least one risk; knowing that treatments were being compared; or understanding of: (i) the nature of the study (i.e. awareness of participating in research); (ii) the purpose of the study; (iii) the risks and side-effects; (iv) the direct benefits; (v) placebo; (vi) randomization; (vii) the voluntary nature of participation; (viii) freedom to withdraw from the study at any time; (ix) the availability of alternative treatment if withdrawn from a trial; or (x) confidentiality (i. …

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