Seemingly lacking from the discussion regarding vaccine trials (1), is consideration of the legality and ethics of testing unproven products on those unable to give informed consent, specifically children.
The Montgomery 2015 ruling (2) made the ethical and legal position clear: the doctor’s role is to ensure that relevant information is presented to enable the patient to use it meaningfully. Legally, consent law has been clarified and aligns with GMC guidance. (3)
It is established that Doctors should always act in the best interests of children and young people. Parents can consent to investigations and treatment that are in the young person’s best interests. This is particularly the case in relation to treatment that does not have proven health benefits, and is relevant where preliminary reports have suggested no significant proven benefit (4), or even adverse events (5).
Research involving children and young people can benefit all children; but they may be vulnerable because they cannot always recognise their best interests, express their needs or defend their rights. Children and young people should not usually be involved in research if they object or appear to object in either words or actions, even if their parents consent. And potential therapeutic benefits for them should outweigh any foreseeable risks (3)
Since children appear to be less severely affected by SARS-CoV-2 exposure (6), do potential benefits outweigh possible harm?
In terms of legislation, it is clear that,” Informed consent given by a person with parental responsibility for a minor taking part in a clinical trial shall represent the minor’s presumed will; and the interests of the patient always prevail over those of science and society”.(7) Indeed, the principles regarding human medical experimentation were laid out clearly in the Nuremberg Code as early as 1947. (8).
In addition, the Children Act 1989 allocates duties to parents, and other agencies to ensure children are safeguarded and their welfare is promoted.
In the current situation, where parents have experienced weeks of 'lockdown', fearful stories in the media, and worries about the future, their psychological stress levels are likely to impact rational decision-making in terms of informed consent. In fight-or-flight mode, survival is uppermost and nuances lost. And consent under duress is invalid.(9)
Perhaps it is premature to subject children to unknown risks at this early stage?
Rapid Response:
Involving children in early vaccine trials
Dear Editor
Seemingly lacking from the discussion regarding vaccine trials (1), is consideration of the legality and ethics of testing unproven products on those unable to give informed consent, specifically children.
The Montgomery 2015 ruling (2) made the ethical and legal position clear: the doctor’s role is to ensure that relevant information is presented to enable the patient to use it meaningfully. Legally, consent law has been clarified and aligns with GMC guidance. (3)
It is established that Doctors should always act in the best interests of children and young people. Parents can consent to investigations and treatment that are in the young person’s best interests. This is particularly the case in relation to treatment that does not have proven health benefits, and is relevant where preliminary reports have suggested no significant proven benefit (4), or even adverse events (5).
Research involving children and young people can benefit all children; but they may be vulnerable because they cannot always recognise their best interests, express their needs or defend their rights. Children and young people should not usually be involved in research if they object or appear to object in either words or actions, even if their parents consent. And potential therapeutic benefits for them should outweigh any foreseeable risks (3)
Since children appear to be less severely affected by SARS-CoV-2 exposure (6), do potential benefits outweigh possible harm?
In terms of legislation, it is clear that,” Informed consent given by a person with parental responsibility for a minor taking part in a clinical trial shall represent the minor’s presumed will; and the interests of the patient always prevail over those of science and society”.(7) Indeed, the principles regarding human medical experimentation were laid out clearly in the Nuremberg Code as early as 1947. (8).
In addition, the Children Act 1989 allocates duties to parents, and other agencies to ensure children are safeguarded and their welfare is promoted.
In the current situation, where parents have experienced weeks of 'lockdown', fearful stories in the media, and worries about the future, their psychological stress levels are likely to impact rational decision-making in terms of informed consent. In fight-or-flight mode, survival is uppermost and nuances lost. And consent under duress is invalid.(9)
Perhaps it is premature to subject children to unknown risks at this early stage?
(1) https://www.bmj.com/content/369/bmj.m1679/
(2) https://www.bmj.com/content/357/bmj.j2224
(3) https://www.gmc-uk.org/ethical-guidance/ethical-guidance-for-doctors/goo...
(4) https://www.biorxiv.org/content/10.1101/2020.05.13.093195v1.full.pdf
(5) https://investors.modernatx.com/news-releases/news-release-details/moder...
(6) https://jamanetwork.com/journals/jama/fullarticle/2762130
(7) http://www.legislation.gov.uk/uksi/2004/1031/schedule/1/made
(8) https://www.nejm.org/doi/full/10.1056/NEJM199711133372006
(9) https://onlinelibrary.wiley.com/doi/pdf/10.1002/psb.281
Competing interests: No competing interests