A need to simplify informed consent documents in cancer clinical trials. A position paper of the ARCAD Group

Abstract

BackgroundIn respect of the principle of autonomy and the right of self-determination, obtaining an informed consent of potential participants before their inclusion in a study is a fundamental ethical obligation. The variations in national laws, regulations, and cultures contribute to complex informed consent documents for patients participating in clinical trials. Currently, only few ethics committees seem willing to address the complexity and the length of these documents and to request investigators and sponsors to revise them in a way to make them understandable for potential participants. The purpose of this work is to focus on the written information in the informed consent documentation for drug development clinical trials and suggests (i) to distinguish between necessary and not essential information, (ii) to define the optimal format allowing the best legibility of those documents.MethodsThe Aide et Recherche en Cancérologie Digestive (ARCAD) Group, an international scientific committee involving oncologists from all over the world, addressed these issues and developed and uniformly accepted a simplified informed consent documentation for future clinical research.ResultsA simplified form of informed consent with the leading part of 1200–1800 words containing all of the key information necessary to meet ethical and regulatory requirements and ‘relevant supportive information appendix’ of 2000–3000 words is provided.ConclusionsThis position paper, on the basis of the ARCAD Group experts discussions, proposes our informed consent model and the rationale for its content.

A randomized controlled study of a consent intervention for participating in an NIH genome sequencing study

“…The decisional conflict scale developed by O'Connor examines several elements including lack of information about alternatives and their consequences, unclear values, and lack of support or advice [13]. The 16-item scale is scored on a Likert scale ranging from 'strongly disagree' (6) to 'strongly agree' (0). A low score on the decisional conflict scale indicates less decisional conflict about choosing whether to participate in genome sequencing.…”

“…More broadly beyond genome sequencing studies, efforts have commenced to reduce the complexity of consent information provided to prospective participants in a variety of research contexts [6,7]. Prior research has found that many individuals fail to comprehend consent information [8], and that consent documents have increased in length over time, with concerns raised that long consent forms are less likely to be read [9].…”

ESMO Clinical Research Observatory (ECRO): improving the efficiency of clinical research through rationalisation of bureaucracy

“…This leads to an excess of information that becomes unmanageable and prevents investigators from being effectively updated on the safety of investigational drugs. Another example is the high number of informed consent versions generated in some studies and their complexity, which are difficult to understand by patients, 11 and may even generate distrust of the study and the research team.…”

“…Adequate procedures, such as interpreting and periodically summarising the available information, should be evaluated. ECRO will employ the following methods to attain its objectives (box 1): 12 ; the occurrence and causes of excessive delays in starting treatment in cancer patients due to centralised molecular testing [13][14][15] ; the broadening of eligibility inclusion criteria in clinical trials, to avoid disparities in care [16][17][18] ; the consequences of outsourcing the monitoring of trials 7 ; the need to simplify informed consents 11 and so on. 3.…”

Development and testing of a guideline document to provide essential information for patient decision making regarding cancer clinical trials

“…Researchers have suggested that clinical trial consent forms do not adhere to best practice recommendations. Evidence shows medical jargon, and the overwhelming nature of information provided limits the value of the consent form as a source of patient decision making (Bleiberg et al., 2017). In a study analysing 13 cancer trial consent forms covering phase I, II and III trials, the average word count was 4,562 words or 18 pages (2,644–6,977 words, 11–28 pages).…”