The reality of informed consent: empirical studies on patient comprehension—systematic review

Pietrzykowski, Tomasz; Śmiłowska, Katarzyna

doi:10.1186/s13063-020-04969-w

Cited by 114 publications

(83 citation statements)

References 22 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…This may lead to research participants having difficulty understanding the information contained in PIL/ICFs prior to providing their consent to take part. Concerningly, a recent systematic review indicated that research participants often have a poor understanding of some of the key concepts needed to ensure valid informed consent [ 8 ].…”

Section: Introductionmentioning

confidence: 99%

Preparing accessible and understandable clinical research participant information leaflets and consent forms: a set of guidelines from an expert consensus conference

et al. 2021

View full text Add to dashboard Cite

Background In line with Good Clinical Practice and the Declaration of Helsinki, it is the investigator’s responsibility to ensure that research participants are sufficiently informed, to enable the provision of informed consent. The Participant Information Leaflet/Informed Consent Form is key to facilitating this communication process. Although studies have indicated that clinical research Participant Information Leaflets/Informed Consent Forms are not optimal in terms of accessibility, there is little or no specific guidance available. The aim of this research was to propose and agree a set of guidelines for academic researchers and sponsors for preparing accessible and understandable Participant Information Leaflets/Informed Consent Forms. Methods A literature review identified guidance for the preparation of patient-facing documents. Following critical appraisal, key recommendations were extracted and a set of recommendations which can be applied to clinical research Participant Information Leaflets/Informed Consent Forms were prepared. These recommendations were evaluated and amended by an Expert Consensus Conference consisting of a group of key stakeholders. The stakeholders included members of a Research Ethics Committee (both lay and expert), a patient advocate, experienced clinical researchers, a plain English editor and a Data Protection Officer. Consensus was reached regarding a final set of recommendations. Results 44 recommendations were agreed upon and grouped into five categories: Layout, Formatting, Content, Language and Confirming Readability. These recommendations aimed to maximize accessibility for lay participants, including readers with dyslexia, literacy or numeracy challenges, thereby improving the quality of the consent process. Conclusions More empirical research is needed to further improve the informed consent process for research participants. However, these recommendations are informed by the current literature and have been ratified by expert stakeholders. It is hoped that these recommendations will help investigators and sponsors to consistently and efficiently produce more accessible clinical research Participant Information Leaflets/Informed Consent Forms.

show abstract

Section: Introductionmentioning

confidence: 99%

Preparing accessible and understandable clinical research participant information leaflets and consent forms: a set of guidelines from an expert consensus conference

et al. 2021

View full text Add to dashboard Cite

show abstract

“…The website and the enhanced PIL/ICF contain the same informational content, but the website also includes some animations which support the written content. The animations on the website were developed in conjunction with the Educational Technology team at the School of Medicine, University College Dublin, and focus mainly on two aspects which have been demonstrated to be poorly understood by research participants: randomisation and risks/side effects [ 5 ]. The enhanced PIL/ICF is included as a supplementary file (see Additional file 2 ).…”

Section: Methodsmentioning

confidence: 99%

“…However, there is an increasing body of evidence, causing significant concern, over the true level of understanding of research participants. Recent systematic reviews have suggested that research study participants often have a poor understanding of vital concepts which are important in ensuring valid informed consent [ 4 , 5 ]. This includes concepts surrounding randomisation and the risks/side effects of participating, which participants find particularly difficult [ 6 – 10 ].…”

Section: Introductionmentioning

confidence: 99%

An enhanced participant information leaflet and multimedia intervention to improve the quality of informed consent to a randomised clinical trial enrolling people living with HIV and obesity: a protocol for a Study Within A Trial (SWAT)

O’Sullivan

Savinelli

O’Hare³

et al. 2022

Trials

View full text Add to dashboard Cite

Background It is the investigator’s responsibility to communicate the relevant information about a clinical trial to participants before they provide informed consent to take part. Systematic reviews indicate that participants often have a poor understanding of the concepts which are key to ensuring valid informed consent, such as randomisation and risks/discomforts. Paper-based participant information leaflets and informed consent forms (PIL/ICFs) are becoming longer and are often too complex for many participants. Multimedia interventions and enhanced PIL/ICFs have been trialled in an attempt to improve participants’ understanding of various aspects of research studies. However, there is insufficient empirical evidence to determine how effective such interventions are. This protocol describes a study to evaluate whether an enhanced PIL/ICF and website help research participants to understand important information about a human immunodeficiency virus (HIV) randomised clinical trial. Methods This Study Within A Trial (SWAT) is a prospective, multi-centre, randomised, controlled, parallel-group study embedded in a host clinical trial. The host trial (the SWIFT trial; EudraCT: 2019-002314-39) is a prospective, multi-centre, randomised, open-label, controlled trial investigating if semaglutide along with dietary advice assists individuals with HIV and obesity to lose weight, compared to dietary advice alone. For the SWAT, participants will be randomised in a 1:1 ratio to either the control (standard PIL/ICF) or the intervention (an enhanced PIL/ICF and a website which includes animations). The enhanced PIL/ICF and website were developed in line with the guidance from organisations which promote plain English and accessible public-facing materials in conjunction with HIV Ireland, a HIV advocacy organisation, and our previous work on consent documents. The primary outcome of the SWAT is the quality of informed consent, assessed by a validated comprehension test—the modified Deaconess Informed Consent Comprehension Test (DICCT). The DICCT will be administered within 48 h of consent to the host trial. The secondary is recall, measured by the modified DICCT questionnaire scores 2 weeks post-consent to the host trial. Discussion The results of this SWAT will add to the methodological evidence base on the use of multimedia to improve the quality of informed consent to randomised clinical trials. Trial registration ClinicalTrials.govNCT04174755. EudraCT 2019-002314-39. SWAT 160, Northern Ireland Hub for Trials Methodology Research SWAT repository (Clarke M, et al., Trials. 16:P209, 2015).

show abstract

“…43 A systematic review concluded that, in general, patients demonstrated lower levels of comprehension regarding aspects of consent, whilst crucial information, including benefit-risk, voluntariness and the relation between clinical trials and standard therapy are poorly understood by many participants; severely compromising existing practices intended to provide a sound ethical rationale for research with human subjects. 44 Therapeutic misconceptions. Research participants, often with pre-existing conditions, may be susceptible to overestimating the benefits/underestimating the risks of early phase trials and may misunderstand the distinctions between research and individualised care, -a concern referred to as the 'therapeutic misconception'.…”

Section: What Constitutes 'Adequate' Informed Consent?mentioning

confidence: 99%

Improving patient informed consent for haemophilia gene therapy: the case for change

Woollard¹,

Gorman

Rosenfelt

2021

Therapeutic Advances in Rare Disease

View full text Add to dashboard Cite

Adeno-associated virus-based gene therapy points to a coming transformation in the treatment of people living with haemophilia, promising sustained bleed control and potential improvement in quality of life. Nevertheless, the consequences of introducing new genetic material are not trivial. The perceived benefits should not minimise the challenges facing patients in understanding the long-term risks and providing a valid and meaningful informed consent, whether in a research or clinical setting. Informed consent is a fundamentally important doctrine in both medical ethics and health law, upholding an individual’s right to define their personal goals and make their own autonomous choices. Patients should be enabled to recognise their clinical situation, understand the implications of treatment and integrate every facet of their life into their decision. This review describes informed consent processes for haemophilia gene therapy clinical trials, factors affecting patients’ decision making and the availability of patient-centred decision support interventions, to ensure that patients’ interests are being protected. Regulatory guidance has been published for physicians and manufacturers in haemophilia on informed consent, including for gene therapy, while best-practice recommendations for patient–physician discussions are available. In all settings, however, communicating and presenting highly technical and complex therapeutic information is challenging, especially where multiple barriers to scientific knowledge and health literacy exist. We propose several evidence-informed strategies to enhance the consent procedure, such as utilising validated literacy and knowledge assessment tools as well as participatory learning environments over an extended period, to ensure that patients are fully cognisant of the consent they give or deny. Further research is needed to define new, creative approaches for patient education and the upholding of ethical values in the informed consent process for gene therapy. The lessons learnt and approaches developed within haemophilia could set the gold standard for good practice in ensuring ethical preparedness amidst advances in genetic therapies. Plain language summary Improving the informed consent process for people living with haemophilia considering gene therapy. Gene therapy is the process of replacing faulty genes with healthy ones. In haemophilia, gene therapy involves introducing a working copy of the gene for the clotting factor that patients are missing. Following treatment, patients should begin producing their own clotting factor normally. However, people living with haemophilia (PwH) need to be fully informed regarding the potential benefits and risks of gene therapy and what this means for them, whether as part of a research study or routine medical care. Patients must be respected and supported to make decisions about their own health and wellbeing, recognising their legal and moral right to set personal goals and make treatment choices. For this to happen in practice, patients should be aware of their individual health needs, understand the effects of treatment and consider lifestyle preferences in relation to their decisions. This article attempts to describe how informed consent is obtained in haemophilia gene therapy clinical trials, what affects a patient’s ability to make decisions and the availability of information and support to respect and protect the interests of PwH. Regulators responsible for approving medical products have published guidance on informed consent for physicians and pharmaceutical manufacturers in haemophilia, including for gene therapy. Recommendations have been made about the best ways for PwH to discuss gene therapy with their physicians. Yet, poor communication of complex topics, such as gene therapy, can be problematic, especially if patients lack the skills and confidence to understand and discuss the science, or for physicians with limited time in clinic. We propose strategies to improve the consent process, so patients can feel more able to make informed decisions about new treatments. Further research is needed to find new, creative approaches for educating patients and ensuring that the informed consent process for gene therapy in haemophilia is ethical.

show abstract

The reality of informed consent: empirical studies on patient comprehension—systematic review

Cited by 114 publications

References 22 publications

Preparing accessible and understandable clinical research participant information leaflets and consent forms: a set of guidelines from an expert consensus conference

Preparing accessible and understandable clinical research participant information leaflets and consent forms: a set of guidelines from an expert consensus conference

An enhanced participant information leaflet and multimedia intervention to improve the quality of informed consent to a randomised clinical trial enrolling people living with HIV and obesity: a protocol for a Study Within A Trial (SWAT)

Improving patient informed consent for haemophilia gene therapy: the case for change

Contact Info

Product

Resources

About