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

Simon Paul Jenkins,Melanie J Calvert,Heather Draper

doi:10.1371/journal.pone.0234388

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. Semi-structured 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 newly-consented 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 follow-up 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.

Highlights

Clinical trials provide valuable evidence on the efficacy and effectiveness of healthcare interventions and this evidence can inform clinical practice and health policy
We report the results of pilot work aimed at determining: 1) the extent to which potential participants, at the time of giving consent, rely on information sheets and/or consent discussions to inform their decision to participate; 2) the extent to which participants consult their information sheet at other points during a trial, and for what purposes
According to Good Clinical Practice (GCP) guidelines, the consent discussion should recap the main points in the information sheet, which is typically provided ahead of time

Summary

Introduction

Clinical trials provide valuable evidence on the efficacy and effectiveness of healthcare interventions and this evidence can inform clinical practice and health policy. While theoretical and practical objections to the use of informed consent to preserve autonomy have been raised (for example, it cannot be obtained from those without capacity to consent, and produces quandaries when applied to the vulnerable or dependent, whose consent may not be valid if they feel coerced [5]), the process remains a legal prerequisite for the inclusion of humans as participants in most forms of research. Participant information sheets (PIS) are routinely provided as a basis for discussion between the potential research participant and the healthcare/research team about taking part. Studies have concluded that research participants’ recall of information about the trial on which they are enrolled is low, and they are often unaware of the aim of the trial and the fact that their participation is voluntary [18,19]

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Discussion

Conclusion