Abstract
There are two significant ethical issues raised by this case – consent and confidentiality. Is it permissible to obtain consent only from the young person themselves, and should their confidentiality be assured in any circumstance?
Young people, below the age of 16, can consent to medical treatment if they are Gillick competent, and so have the maturity and understanding to provide that consent − to understand the nature and purpose of the treatment proposed, as well as its risks. It has come to be regarded by some as establishing the legal right of a competent young person to consent to participate in research. But this has not been established in law. The concept of Gillick competence has been established through case law in relation to medical treatment and so treatment that is judged by a medical practitioner to be in that young person’s interests. That is, it is expected to provide a direct benefit to that person and that the expected benefits outweigh any risks. But neither of these conditions is replicated in research contexts.
Some research is not expected to benefit the participants themselves directly but, rather, to benefit people like them. But even where research is expected to directly benefit the participants there is the issue of unknown risk. Research, by its very nature, can have unidentified risks, which makes it disanalogous to treatment where the risks are known with some certainty and so a doctor can make a well-founded judgment about whether it is in the young person’s interests. However, a young person could be competent to consent to medical treatment that carried a significant risk. If this is ethically permissible then it establishes that a young person could provide consent even in the face of potential significant risk or harm if the expected benefit accrues to them directly. But then we have an odd result: Gillick competence would extend to risky research that is expected to benefit a young person directly but not to unrisky research that is not expected to provide direct benefit.
So, rather than focus on an analogy between research and treatment based on expected direct benefit, we should focus on the ability to understand and consent to risk. But this interpretation and extension of the competence recognized in case law (in the form of Gillick competence) has not been tested and so established in a specific legal case. This is why guidance on consent (usually) states that best practice is to obtain the consent to the young person’s legal guardian and the assent of the young person themselves, with any dissent being respected.
However, a request for consent to participate in the proposed research could not, in many cases, be sought from the teenagers’ parents because the clinic provides services on a confidential basis. An approach to parents would reveal that the young person is receiving contraceptive advice and treatment. Gillick competent minors can consent to the provision of advice and receipt of contraceptive treatment in their own right and without parental knowledge if the treatment is, on balance, in their best interests. Primarily this concerns whether the young person would be sexually active even without contraception and so without protection against STDs and conception. This provides a justification and protection under law to provide contraception to young people below the legal age of consent.
Of course, some young people may be attending the clinic with parental knowledge. But many will not. Should there be a policy of requesting consent from parents when the teenager agrees to this and of obtaining consent from the young person themselves when they refuse to have their parents approached?
This policy begs the question of whether it would be ethically permissible to request consent from the teenagers in their own right. If it would, then there is no need to obtain parental consent even in cases where the parent(s) know their teenager is attending the clinic. The issue comes down to whether participating in the research poses a risk. Granted, the research probably could not be carried out unless consent could be taken from the teenagers themselves. But that is not, in itself, a reason to approve this.
The research could directly benefit the participants for it is, in part, being conducted to see how the clinic’s services could be improved. Some young users of the service could, therefore, benefit if improvements are identified and they continue to use the clinic after such improvements. But as the research is planned to last a year, and data analysis will then have to be carried out, any improvements that could be identified might be implemented after participants have stopped using the clinic on the basis of their increased age. Ethically permissible risk levels are lower for research that is not expected to directly benefit participants. So the risk level should be set at a level appropriate for research that it is not expected to provide direct benefit.
Given that the research mainly involves asking the teenagers about their activity and use of the service, it appears to pose no additional risk to service users. But they will be asked questions that could be distressing, such as whether they contracted STDs or how drug-taking or alcohol intake affects their behaviour. So there is a risk of psychological distress. Although the researchers are experienced in research with young people, it would be advisable to ensure that participants who reveal distress or problems are offered counselling. It would not be sufficient simply to provide information about where the young person could get help and advice for they might not have the confidence to take this up or arrange it themselves. Researchers have a duty of care to participants.
This brings us to the issue of confidentiality. Young people accessing medical services have a right to confidentiality, even in relation to illegal activity such as drug-taking, if this is, on balance, in their best interests − for example, if informing the police or their parents would cause more harm than good. Health professionals and social workers or counsellors need to consider the effects of a breach of trust on the young person and their subsequent behaviour. In many cases it will be best to maintain the confidential relationship with the young person so that support and advice can be offered which has a good prospect of mitigating any harm related to illegal activity.
But an exception occurs when the young person is being coerced into sexual activity or drug-taking: forced into illegal and harmful activity against their will. One of the research questions is designed to identify how much sexual activity is coerced. In such cases the researcher has a duty of care to inform Social Services, who are best placed to judge how to proceed, which could involve informing the police. Safeguarding duties apply to researchers as well as healthcare workers. Therefore, it would not be permissible to provide a blanket guarantee of confidentiality. It should be explained to the prospective participants that if safeguarding issues are identified their confidentiality cannot be maintained but that they will be informed if such a situation arises.
One further amendment I would suggest is that it would be good practice to advise the young person that as part of the process of considering whether to participate they should discuss it with their parents but that this is not a requirement of participation, i.e. a teenager who chooses not to do this will not be prevented from participating.
With these changes in place I would approve the research. It has the prospect of providing an important benefit to the target population of current and future service users.