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.

According to the Committee for Medicinal Products for Human Use (CHMP), Guideline for Good Clinical Practice, vulnerable populations are defined as:

‘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.