Clearly for many students the answer is yes. Participation in clinical trials does sound attractive; financial reward whilst making a contribution to society.   Yet as the news hit this week that six previously healthy men are in intensive care following their participation in trials of the drug TGN1412, attention is drawn to the legal rights of those who volunteered.

If we sign a consent form and undergo medical treatment, cosmetic surgery or in this case participate in drugs trials, are we excluded from the right to legal redress should something go wrong? 

Legally no, there is still a course of action open to us if the treatment we received can be classed as negligent.  It is necessary to show that the treatment was substandard (for example an incorrect dose being administered) and that it resulted in injury. The law ensures that we cannot be made to sign away our rights to a compensation claim where there has been negligence which has resulted in personal injury or death.

However the law in relation to the supply and use of new products is complex and if there is a problem with the product itself, which has caused harm, there may be a defence.

A volunteer about to participate in a clinical trial must have the risks involved explained to him along with any known side effects. The form he will sign will also set out what 'goodwill' compensation will be available if any thing went wrong. This is in addition to his legal rights to compensation for negligent treatment, not instead of them.

However many are critical of the wording of the government agreed statement, which  appears on the consent forms, which is hardly written in clear straightforward terms. It states;

“[the sponsor] will pay compensation for [non-negligent harm]. Any payment will be without legal commitment.”

Are all volunteers clear that this refers to discretionary compensation only? Or that they may still have to pursue a case for compensation through the courts if something went wrong?

Are we sure of our rights in more everyday situations? For example when we go to the hairdresser or beauty parlour?  Do we dare complain about, as one judge put it, 'the haircut from hell?'  Legally we can.  You may have consented to having your hair dyed and cut, but you did not consent to it turning green and falling out. Under the law each time we go into a salon the individual undertaking the work owes us a duty of care and, if this is not upheld, and injury results, we may have a claim. A simple guide, such as Lawpack's "Trip and Slip - a Guide to Making Personal Injury Claims" can give advice and guidance.

A situation like the TGN1412 trial may have never have been seen before, but remember the law can also help in more common circumstances whenever we entrust our health or looks into another's hands. 

Penny Heighway is a partner in Henman’s personal injury department. Henmans has a long established personal injury practice, handling claims nationally for both claimants and defendants, from an Oxford base. Penny handles all types of personal injury claims, specialising in accidents at work and industrial injury cases.

 

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