Trial Participants: Informed Consent, GCP, Patient Involvement

7. Other Things To Consider When Dealing With Vulnerable Populations

• Researchers should sensitively explore the individual’s abilities and the nature of their special needs. Information about the trial may need to be presented to individuals in a different format. Individuals need to be given plenty of time to think about the trial and ask any questions that they have.
  
  
• Children and their parents/legal guardians should be involved in the informed consent process in proportion to the ability of the child to weigh the benefits and risks of the trial. This is known as assent.
  
  
• Special care must be taken to make sure elderly people do not feel pressured or coerced into taking part in a trial. • Prisoners should not be used as participants in a trial unless the trial is specifically looking at topics directly related to prisons or prisoners.
  
  
• Care must be taken to avoid healthcare staff feeling pressured to take part in a trial. Assumptions should also not be made about their knowledge of the trial and healthcare staff must be provided with the same detailed information about the trial as other participants.
  
  
• Special care must be taken not to overly emphasise the benefits of taking part in a trial in patients who have a rare disease or incurable disease for which there may be few treatment options.
  

Care must be taken to avoid unintentional coercion to individuals in developing countries by offering them incentives such as free health care in order to take part in the trial. Local regulations must be taken into account.