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

Research Involvement and Engagement

Thilo Kroll¹  Aoife Kelly²  Prasanth Sukumar²  Seán Driver³  Moira Hanbidge⁴  Orlaith McCarthy⁵  Lydia O’Sullivan⁶  Rachel Crowley⁷  Eleanor Coleman⁸  Alistair Nichol⁹  Peter Doran^1,10 

[1]Centre for Interdisciplinary Research, Education and Innovation in Health Systems, School of Nursing, Midwifery and Health Systems, University College Dublin, Dublin, Ireland

[2]Clinical Research Centre, School of Medicine, University College Dublin, Dublin, Ireland

[3]National Adult Literacy Agency, Dublin, Ireland

[4]Patient advocate, and graduate of the Irish Platform for Patients’ Organisations, Science and Industry (IPPOSI) Patient Education Programme in Health Innovation, Dublin, Ireland

[5]Saint Vincent’s University Hospital Research Ethics Committee, Dublin, Ireland

[6]School of Medicine and School of Nursing, Midwifery and Health Systems, University College Dublin, Dublin, Ireland and Health Research Board-Trials Methodology Research Network, National University of Ireland, Galway, Ireland

[7]Postal Address: Clinical Research Centre, Catherine McCauley Education and Research Centre, Dublin, Ireland

[8]School of Medicine, University College Dublin and Saint Vincent’s University Hospital Medical Research and Ethics Committee, Dublin, Ireland

[9]School of Medicine, University College Dublin, Dublin, Ireland and Health Research Board-Trials Methodology Research Network, National University of Ireland, Galway, Ireland

[10]School of Medicine, University College Dublin, Dublin, Ireland

[11] Clinical Research Centre, School of Medicine, University College Dublin, Dublin, Ireland

[12] Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, Australia

[13]Department of Intensive Care, Alfred Hospital, Melbourne, Australia

[14]School of Medicine, University College Dublin, Dublin, Ireland

[15] Clinical Research Centre, School of Medicine, University College Dublin, Dublin, Ireland

[16]Health Research Board-Trials Methodology Research Network, National University of Ireland, Galway, Ireland

关键词: Clinical research;    Clinical trials;    Informed consent;    Participant information leaflets;    Patient information leaflets;    Patient and public involvement;   

DOI  :  10.1186/s40900-021-00265-2

来源: Springer

【 摘 要 】

BackgroundIn 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.MethodsA 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.Results44 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.ConclusionsMore 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.

【 授权许可】

CC BY