King’s College London researchers have been given the green light to move towards an “opt-out” consent model for certain studies involving under-18 participants, meaning children may be recruited by default unless a parent actively intervenes, according to documents seen by Roar.
The College’s Research Ethics Committee has allowed some researchers to move away from the traditional “opt-in” model – where parents are required to sign-off on participation – to a system where consent is assumed if no objection is received.
The committee clarified that this is a case-by-case rule that requires a “strong justification” by researchers – and does not provide a blanket rule to bypass parents of under-18s.
They also confirmed that 16-17 year olds’ decisions to consent should not be overriden by parents – and that researchers are not required to disclose involvement to parents in all instances.
Internal documents reveal the committee’s concern about “potential damage to King’s reputation” from the new “opt-out” system if misunderstood by the public, requiring strong safeguards to be put in place for the scheme.
Any study involving under-18s traditionally has to go through enhanced ethics approval before it can begin. In the past, researchers would always have to obtain explicit written permission from parents before their children were allowed to participate in a study.
With approval from the Ethics Committee, this rule can now be waived in certain circumstances. Certain “high-risk” triggers would also require opt-in consent, including distressful/illegal activities or studies involving protected characteristics.
King’s has seen an increase in research applications for 16-17 year olds, according to the documents, with its handling of studies involving children under increasing scrutiny.
A spokesperson for King’s College London said:
“For centuries King’s has been at the forefront of clinical research, advancing understanding of how we address a vast range of health problems and contributing to some of the most important breakthroughs in history.
“We carry out that research to extremely rigorous ethical standards, ensuring the highest levels of integrity on every project, and protecting the rights, dignity, health, safety and privacy of people involved in our research.
“The ‘opt-out’ system for healthy volunteers under the age of 16 does not deviate from those high standards, and has been commonly used by many Research Ethics Committees for years. Judged on a case-by-case basis, it is only being considered where a robust justification is provided and where the research project would be impossible or seriously impaired otherwise.
“It is also essential that clear evidence is provided that engagement has been undertaken with parents and schools and the appropriate safeguards are in place. Individuals aged 16-17 are, in law, capable of providing informed consent for participation in research and our approach reflects this, as is standard practice.”
About the author
