Informed Consent and Participant Respect in Clinical Trials: A Mixed-Methods Study on Patient Experiences in Oncology Trials

Abstract

Clinical trials in oncology, in particular, are built on informed consent as a fundamental ethical requirement, the patient experience impacts trial participants and outcomes. In this mixed methods study, we sought to elucidate patient experiences concerning informed consent and respect during oncology trials. A combination of quantitative surveys and qualitative interviews was used to assess participants’ perceptions of the informed consent process and the respect shown by trial personnel. Thematic analysis of interview data was accompanied by statistical analysis. Our findings showed that many patients had difficulty understanding complex consent information because of emotional distress and the use of medical jargon. However, individuals who felt respected by trial staff reported greater satisfaction with the consent process. Communication was key (clear communication, active listening, personal support), among other things. Improving patient experiences in oncology trials necessitates boosting the informed consent process by refining text and building a culture of respect. Effects of these changes can include strengthening of ethical standards and encouraging patient engagement both of which will positively impact the success of clinical research.