Every clinician in sport and exercise medicine (SEM) will at some point be asked to provide, endorse or advise against a treatment that is not established, and how that is handled says more about professional standards than almost anything else in this category. The situation is genuinely difficult: the patient is often in pain and out of options, the treatment may be low risk, the clinician may believe it will help, and the alternative on offer is the slow and unglamorous work of rehabilitation. This page covers the distinction between innovation and research, what consent has to achieve when a treatment is unproven, the specific problems created by money and by desperation, and how to advise an athlete who is going abroad. The general principles of consent for a procedure are covered in the related material.
What separates innovation from research?
The distinction that carries most weight is between innovation and research. Innovation is a clinical decision, made for the benefit of a particular patient in front of you, where the usual options have been exhausted or are unsuitable; it is exceptional rather than routine, and even then outcomes should be recorded and shared so that others learn from it. Research is the systematic investigation of a question in order to generate generalisable knowledge, and it requires a protocol, ethics committee approval and, for a medicinal product, regulatory authorisation. The line matters because it is so often crossed without acknowledgement: a clinician who offers the same unproven treatment to a series of patients, charges for it and reports the results is doing research without approval, whatever it is called on the website. The correct response to a promising innovation is not to repeat it quietly but to move it into a properly designed study, which also protects the clinician.
Innovation is a one-off clinical decision for an individual patient, while systematic repeated use to generate knowledge is research and requires a protocol and ethics approval, whatever it is called.
Several supporting principles follow. Where an intervention is genuinely uncertain, that uncertainty is itself the argument for a trial rather than for charging patients to receive it. Where a patient is asked to pay a substantial sum for an unproven intervention, the ethical position weakens considerably, because cost transfers risk to the patient and creates a direct financial interest for the provider. Where outcomes are not recorded or shared, no knowledge is generated and the patient has taken a risk that benefits nobody else. And where an innovation is offered without any intention of ever subjecting it to formal evaluation, the innovation exception is being used as cover for commercial practice, which is the distinction that professional bodies and regulators have drawn repeatedly in this field.
How should consent, money and requests for advice be handled?
Consent for an unproven treatment has to do more work than consent for an established one. It must state plainly that the treatment is not established, describe what is known and, more importantly, what is not, set out the reasonable alternatives including doing nothing and continuing rehabilitation, and be explicit about cost and about who benefits financially. The specific risk to guard against is the therapeutic misconception, in which a patient believes that anything offered by a doctor in a clinical setting must be known to work; the language used in the consultation either reinforces or corrects that belief. Words such as regenerative and the phrase stem cell treatment do particular damage, because they imply a demonstrated biological effect. It also matters that the clinician's own conflicts are disclosed, including where they hold an interest in a device or clinic, and that declining is presented as a reasonable choice rather than as giving up.
Five red flags identify a clinic offering unproven treatment irresponsibly: guaranteed outcomes, payment before diagnosis is confirmed, no published protocol, no follow-up arrangements, and treatment outside any authorised trial or lawful route.
The hardest version of this conversation is the athlete who has already decided to travel abroad for a treatment you would not offer. Refusing to engage achieves nothing except that they go without advice. The better approach is to establish exactly what is proposed and what it contains, explain honestly what is and is not known, and set out the practical risks that are easy to overlook: the financial cost, the procedural risks of the intervention itself, the risk of harm from a poorly characterised product, the absence of follow-up if a complication develops after returning home, the anti-doping position for a competing athlete, and the opportunity cost of delaying treatment that works. Red flags are worth naming explicitly: guaranteed outcomes, payment before a diagnosis is confirmed, no published protocol, no follow-up arrangements, and treatment offered outside any authorised trial or lawful route. If they proceed anyway, the professional response is to document the discussion, offer to review them afterwards and maintain the relationship, because a patient who has had a complication abroad needs a clinician who will still see them. Finally, there is a duty in the other direction: promoting or endorsing unproven treatments, whether in a clinic or on social media, carries professional risk, and a clinician who lends their credibility to a product they cannot justify has made themselves part of the problem.
Exam Tips
•Innovation is an exceptional clinical decision for an individual patient; systematic repeated use to generate knowledge is research and requires a protocol, ethics approval and, for a medicinal product, regulatory authorisation.
•Offering the same unproven treatment to a series of patients, charging for it and reporting the results is research without approval, whatever it is called.
•Genuine uncertainty is an argument for a properly designed trial rather than for charging patients to receive the intervention.
•Consent for an unproven treatment must state that it is not established, describe what is not known, set out alternatives including doing nothing, and disclose cost and financial interests.
•Guard against the therapeutic misconception, and avoid language such as regenerative or stem cell treatment that implies a demonstrated effect.
•With an athlete travelling abroad, establish what is proposed, explain the risks including absent follow-up and anti-doping status, name the red flags, document the discussion and maintain the relationship.