Assessment of the Appropriateness of the i-CONSENT Guideline 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.

How do journals publishing palliative and end‐of‐life care research report ethical approval and informed consent?

“…Waivers should be explicitly stated, as they are considered exceptional in biomedical research and require approval from an ethical review committee (which establishes a connection between the need for review and consent statements). If presumed consent was employed in the study (Singleton & Wadsworth, 2006), additional details about how information was provided and whether re‐consent (Fons‐Martínez & Diez‐Domingo, 2021) was sought later should be provided. It is also important to specify from whom consent was sought, particularly in cases such as palliative care research, where both patients and their families may be involved.…”