Vulnerable and non-competent subjects in clinical trials

From The Embassy of Good Science

Vulnerable and non-competent subjects in clinical trials

What is this about?

This page is about participation of vulnerable groups and non-competent subjects in clinical trials. Vulnerable groups include those who could easily be influenced to participate in research, out of fear or pressure. Examples of such groups include soldiers, immigrants and prisoners.[1] Non-competent subjects are those who do not have the legal autonomy to make decisions for themselves, such as children and people suffering from severe mental illness or dementia.

  1. Hughes J, Hunter D, Sheehan M, Wilkinson S, Wrigley A. European textbook on ethics in research. : Publications Office of the European Union; 2010.

Why is this important?

Throughout history, scientific experiments have been conducted on human beings without their consent, especially during the World War II. As a result, specific ethical guidelines for human experimentation were developed. One of the ethical milestones in clinical research is informed consent, a process in which researchers ask for a permission before enrolling participants in a trial.[1]The decision to participate has to be freely given, without pressure or conflicting interests, and based on appropriate information. Prisoners, soldiers, migrants, and other vulnerable groups are often unable to give consent in a way that satisfies the appropriate voluntary conditions. Children and patients with severe psychiatric conditions or dementia do not have the required legal capacity for granting consent.

  1. Nuremberg Code (1949). The Nuremberg Code. Trials of war criminals before the Nuremberg military tribunals under control council law

For whom is this important?

What are the best practices?

Since World War II, a lot has been said about human experimentation, and vulnerable groups in particular. Many different reports and guidelines have been developed and should be consulted when thinking about involving vulnerable and non-competent individuals. Start with the Declaration of Helsinki and don’t forget to check the appropriate regulations of your own country and institution.