Trial Participants: Informed Consent, GCP, Patient Involvement

6. Protection For Vulnerable Populations

REC’s should safeguard the rights, safety, and well-being of all participants in a clinical trial, thus, they pay special attention to trials that may include vulnerable populations or participants.

‘Individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation or of a retaliatory response associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate’.

Some examples of vulnerable participants are:
  • Anyone who could be pressured into taking part in the trial by a superior:
    • Healthcare staff.
    • Members of the armed forces.
    • Prisoners.

  • Anyone who is particularly vulnerable to coercion:
    • Patients with incurable or rare diseases.
    • People in nursing homes or the elderly.
    • Patients in emergency situations.
    • Pregnant women.
    • Ethnic minority groups.
    • People with special needs or who are incapable of giving consent.
    • Refugees or those from developing countries.
    • Children.