Researchers have a duty to make sure that potential clinical trial participants fully understand the trial and what their involvement means. Potential participants who have a greater knowledge of the clinical trial process are more likely to take part in clinical trials. (Randomized clinical trials in oncology: understanding and attitudes predict willingness to participate. Ellis PM, Butow PN, Tattersall MH, Dunn SM, Houssami N (2001. J Clin Oncol 19:3554–61.)
When speaking with potential participants:
- Follow the sequence 1) explain the disease or condition, 2) describe current best proven treatment and 3) present the option represented by the clinical trial. Ensure that the potential participant understands what is involved in each step before moving to the next one.
- Break the informed consent conference into two separate meetings if your patient would prefer this or if you think two sessions would improve understanding.
- Use the consent document as a communication tool by providing copies, encouraging reading and referring to sections of the document during the meeting(s).
- Discuss treatment options outside of the clinical trial and explain how the trial intervention differs from established interventions and current standard care or treatment.
- Explain at least three times that trial participation is voluntary.
- Explain the right to withdraw at any time and what withdrawal might mean at different stages in the trial (e.g. prior to administration of the new treatment and once data has been collected and de-identified).
- For randomised trials, explain the randomisation process and what this means regarding access to the new intervention.
- Discuss any potential conflict of interest you may have as an investigator.
- Be prepared to give an answer if the prospective participant asks if you personally would enrol in the trial or if you would advise one of your family members to enrol.