Assessment of the appropriateness of the i-CONSENT guidelines recommendations for improving understanding of the informed consent process in clinical studies

Abstract

Background The H2020 i-CONSENT project has developed a set of guidelines that offer ethical recommendations and practical tools aimed at making the informed consent process in clinical studies more comprehensive, tailored, and inclusive. An analysis of the appropriateness of some of its novel recommendations was carried out by a group of experts representing different stakeholders. Methods An adaptation of the RAND/UCLA Appropriateness Method was used to assess the level of agreement on the recommendations among 14 representatives of different stakeholders, including patients, regulators, investigators, ethics experts, and the pharmaceutical industry. The process included two rounds of rating and a virtual meeting. Results Fifty-three recommendations were evaluated. After the first round, 34 recommendations were judged “appropriate”; 19 were judged “uncertain”; and none was judged “inappropriate”. After the second round, 9 “uncertains” changed to “appropriate”. All recommendations rated medians of 6.5–9 on a 1–9 scale (1 = “extremely inappropriate”, 5 = “uncertain”, 9 = “extremely appropriate”). The sections “General recommendations” and “Gender perspective during the consent process for clinical studies” showed the highest “uncertainty” rating. The four keys to improving the understanding of the ICP in clinical studies are to: (1) consider consent a two-way continuous interaction that begins at the first contact with the potential participant and continues until the end of the study; (2) improve investigators’ communication skills; (3) co-create the information; and (4) use a layered approach, including information to compensate for the potential participant’s possible lack of health literacy and a glossary of terms. Conclusions The RAND/UCLA method has demonstrated validity for assessing the appropriateness of recommendations in ethical guidelines. The recommendations of the i-CONSENT guidelines were mostly judged “appropriate” by all stakeholders involved in the informed consent process.

Issues About Digital Informed Consent in Clinical Research

“…7,9 On the other hand, with these various advantages, digital format informed consent has its own challenges, especially the form of a mutually agreed standard format, and the openness of information that can be accessed by the subject if at any time there is a change in content. 1,9 To answer these challenges, the H2020 i-CONSENT project conducted a multi-faceted literature review and systematic review to establish "The Guidelines for Tailoring the Informed consent Process in Clinical Studies". After testing using the RAND/UCLA method it is declared as "appropriate" by policy makers in Europe.…”

“…After testing using the RAND/UCLA method it is declared as "appropriate" by policy makers in Europe. 1 i-CONSENT is an acronym, and a key element of the informed consent process as follows. 11 1. i: Information Complete and clear information is essential for the potential participant to be able to make an autonomous decision 11…”

“…This is to further provide convenience and comfort to the community which of course requires a lot of time. 1 Good research will provide a "complete" picture and solution of an "event" in the community with evidence-based and able to be integrated in the values and policies of a company or state. What is known is that some policies in the company are "direct language transfer", without adjustments based on local conditions.…”

“…5 Informed consent is a concrete form of moral and ethical values that urgently needs to be emphasized, especially in research that requires the role of humans as subjects and is commonly associated with experimental research. 1,6,7 The provision of understandable information to the subject is necessary to achieve the purpose of informed consent, namely respecting and promoting patient autonomy and protecting patients from dangerous risk (do no harm principal). 6,8 Informed consent itself consists of two: print-out and digital forms, along with the times many parties began to examine how the role of informed consent, the advantages of the shortcomings between print and digital, the application of good digital informed consent, and how information about research should be conveyed to the research subject so that it is easy to understand and in accordance with moral and ethical standards.…”

Keys to improving the informed consent process in research: Highlights of the i‐CONSENT project

“…The RAND/UCLA method for validating clinical guidelines was used to analyse and validate the appropriateness of the main recommendations, particularly the most innovative aspects. 5 The evaluation panel comprised patient representatives, investigators, experts in ethics, pharmaceutical industry representatives and regulators, all of them external to the project. Fifty‐three recommendations were evaluated.…”