Table 4

Recommendations for improving informed consent and consent rate

ChallengesRecommendations
Risk (mis)communicationProvide training to recruiting doctors and consent takers to improve communication of trial information and better manage patients’ and representatives’ expectations of risk
Emotional distress of patients and representatives

  1. Provide training to recruiting doctors and consent takers to improve interpersonal skills to

  2. be more sensitive to patients’ circumstances and approach patients and representatives at an appropriate time.

  3. be more empathetic and manage negative emotions of patients and representatives.

Refusals due to trial-related barriers

  1. Involve patients and representatives in study design including informed consent process.

  2. Identify local cultural barriers of consent among patients and representatives; address the manageable barriers (eg, logistics, cost, social isolation) accordingly.

Refusals due to misperception of clinical trialsPublic engagement to increase awareness and trust in clinical trials.