Potential research participants’ use of information during the consent process: A qualitative pilot study of patients enrolled in a clinical trial

Abstract

There is increasing evidence that clinical trial participants are uninformed about the trials in which they participate, raising ethical concerns regarding informed consent. The aim of this pilot study was to explore clinical trial participants' use of consent discussions and information sheets when considering participating in clinical trials research. A qualitative, interview-based pilot study was designed in order to elicit, through dialogue, details of the reasons for participants' use of, and preferences regarding, different modes of information provision. Semistructured interviews were undertaken with two different groups of patients who were participants in the Reinforcement of Closure of Stoma Site trial. The first group comprised newlyconsented trial participants, who had been recruited up to 72 hours before our interview; the second group comprised patients attending a follow-up clinic 12 months after joining the trial. Thirteen participants were recruited in total: three newly-consented patients, and ten followup patients. The study found that participants' use of consent discussions to gain information about clinical trials was varied, and that they only minimally used information sheets after providing initial consent for the trial. Participants demonstrated varying degrees of knowledge about the trial, with some having forgotten that they were still involved in the trial. Participants reported a high level of trust in medical staff as a reason for not seeking more information about the trial. Some participants reported dissatisfaction with the timing of information provision. Some were amenable to novel ways of receiving trial information, such as web-based methods. The pilot study demonstrated the feasibility of a larger study into the provision of information to prospective clinical trial participants. The results suggest that considering alternative ways of providing information and the appropriateness of existing information provision may be acceptable to and useful for potential trial participants.

Parents’ and Childcare Workers’ Perspectives Toward SARS-CoV-2 Test and Surveillance Protocols in Pre-school Children Day Care Centers: A Qualitative Study Within the German Wü-KiTa-CoV Project

“…Similarly, our analysis found that brief and timely information about the surveillance protocols and transparent and easy communication with the test teams helps to build trust and to encourage participation and thus were perceived to be important and helpful in implementing the intervention. In a study of participants' use of and preferences on different types of information provision, Jenkins et al found that a high level of trust in medical staff might be a reason for not seeking more information about the study (26). In a casestudy Enria et al showed that an approach to participants that entails active and inclusive dialogue, rather than topdown communications, helped to build up trust in the trial teams and, therefore, engagement and participation (27).…”

Endometrial scratch to increase live birth rates in women undergoing first-time in vitro fertilisation: RCT and systematic review

“…However, including such information would be at odds with some participants in the qualitative study reporting that the amount of information received prior to recruitment was 'overwhelming', and other research that suggests that participants prefer shorter versions of the PIS and that some participants only minimally use the PIS prior to consent. 100,101 Other studies have also reported that participants overestimate the benefits, and underestimate the risks, of participating in research; 102,103 however, to our knowledge, this is the first time that this has been described in those participating in a fertility trial. In this trial, underestimation of the potential harms may have been exacerbated by the timesensitive nature of fertility treatment; both clinicians and patients have been reported to feel the need to improve the outcomes of treatment immediately following a failed treatment cycle.…”

“…Including this information in the PIS is at odds with participants in this study stating that the information provided to them was 'overwhelming', and other research that suggests that participants prefer shorter information sheets 101 and that participants only minimally use the PIS. 100 However, future research should seek trial participants' views on how evidence regarding the potential harms of a procedure, or at least the unknowns, should be imparted, including the medium (i.e. PIS or face to face) and how the information should be structured in order to not unnecessarily perturb potential participants about participating in research.…”

Regulatory compliance and readability of informed consent forms in industry-sponsored drug development clinical trials

“…29 Consequently, crucial information may be difficult to find, and the form is seldom read anyway. 30…”

“…29 Consequently, crucial information may be difficult to find, and the form is seldom read anyway. 30 Although there appears to be agreement on the essential elements of informed consent, the degree of information that an ICF should offer is controversial. [31][32][33] Some critiques express concerns regarding excessive details on certain elements, many of which go beyond what is important to decision-making and may distract potential research participants from more crucial information.…”