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

Abstract

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.

Reflections on contributing to health research: A qualitative interview study with research participants and patient advisors

“…This raises questions about truly informed consent, and also highlights that we, as researchers, need to do better in co-designing user-friendly research PLOS ONE materials. A recent consensus exercise involving researchers, ethics committee members and PPI members generated evidence-and experience-informed guidance for designing accessible participant information sheets and consent forms [47]. This included layout, formatting, language, content and readability checking.…”

Medico-Legal Issues in Cremation: Comparative Analysis of International Legislation

“…The production of an adequate consent form [ 62 , 63 ] for collection, custody and further analysis of biological samples from deceased subjects is as much of critical importance as it still is a vastly unexplored ground [ 64 ], which is only partially addressed with the premise that if it is known that the deceased did not hold any objection to the procedure, a presumption of altruistic intent could take place and, in this case, a next-of-kin could authorize the sampling [ 65 ].…”

Consumer perspectives on simplified, layered consent for a low risk, but complex pragmatic trial

“…The second, ‘the nocebo effect’, where the way information is communicated, leads participants to experience side effects only because they expected them [ 9 ]. Consequently, researchers, bioethicists and consumers call for a more balanced representation of a study’s benefit-risk ratio [ 10 , 11 ] especially for certain adaptive trials where there are increasing odds of benefit and reduced odds of harm as the trial progresses [ 12 , 13 ].…”