In a world where half of all clinical trial delays are caused by patient recruitment problems there is always pressure to streamline and simplify the recruitment process, including getting informed consent from trial subjects. As a result new forms of consent are appearing in the US and elsewhere, but how legal are they in the UK and other parts of the EU?
Properly carried out, the results of randomised controlled trials are highly likely to achieve regulatory acceptance, but such trials typically require large target sample sizes. In addition, modern trials are becoming increasingly complex, and this impacts on the consent process – just what does the subject understand of the trial and his or her involvement in it? Figures suggest that trials now take up 30% of big pharma’s development budgets, with delays caused by slow patient recruitment hitting those budgets hard. As a result, many industry players are thinking up new ways to recruit patients; some are even thinking of using Twitter!
Whilst the traditional paper form of consent has a lot going for it (it is signed and is clearly a “legal document”), there are drawbacks; a consent form can be lengthy, complex and ultimately overwhelming even to reasonably well educated subjects, and this in turn might call into question the legal effectiveness on the apparent “informed consent”. Some within the industry have therefore proposed a “magazine layout” which has a friendlier, more familiar format and is not as “dense” as the traditional form. Others have been even more radical and proposed graphic tools designed to help with reasoning and the communication of complex ideas. It is claimed that such an approach can effectively transfer knowledge of treatments, risks, and prognosis in a manner that offsets any educational disadvantages. In addition, multi‐media approaches, involving video in particular, have been suggested, again with the intention of getting past any lack of formal education on the part of the patient, with the patient being able to re-watch the video on disc or computer at home as often as he or she likes.
The law
The law on this area is to be found in Schedule 1 to the Medicines for Human Use (Clinical Trials) Regulations 2004 (as amended). Since the Regulations transpose the provisions of the European Clinical Trials Directive (EC2001/20) into English law the general approach of the Regulations should be found in other EU member states. Paragraph 3(1) of Part 1 of Schedule 1 to the Regulations, (which implements Article 2(j) of the EU Directive) defines informed consent:
A person gives informed consent to take part in a clinical trial only if his decision:
(a) is given freely after that person is informed of the nature, significance, implications and risks of the trial; and
(b) either:
(i) is evidenced in writing, dated and signed, or otherwise marked, by that person so as to indicate his consent, or
(ii) if the person is unable to sign or to mark a document so as to indicate his consent, is given orally in the presence of at least one witness and recorded in writing.
Part 3 of Schedule 1 to the Regulations (implementing Article 3(2) to the EU Directive) contains further conditions on the giving of informed consent by a capable adult:
1. The subject has had an interview with the investigator, or another member of the investigating team, in which he has been given the opportunity to understand the objectives, risks and inconveniences of the trial and the conditions under which it is to be conducted.
2. The subject has been informed of his right to withdraw from the trial at any time.
3. The subject has given his informed consent to taking part in the trial.
4. The subject may, without being subject to any resulting detriment, withdraw from the clinical trial at any time by revoking his informed consent.
5. The subject has been provided with a contact point where he may obtain further information about the trial.
It is clear from the wording of Paragraph 3(1) that unless a subject is physically unable to sign or make his or her mark then such a signature or mark is required in all cases. So does that mean that the Informed Consent Form in its “ink on the page legal document” incarnation is the only form acceptable to the law? Not necessarily.
As far back as 2001 the Law Commission advised that “Digital signatures, scanned manuscript signatures, typing one’s name (or initials) and clicking on a website button are, in our view, all methods of signature which are generally capable of satisfying a statutory signature requirement. We say that on the basis that it is function, rather than form, which is determinative of the validity of a signature. These methods are all capable of satisfying the principal function: namely, demonstrating an authenticating intention.” In other words, since English law has for many years recognised “signatures” in a number of formats, an online format will be equally acceptable. It is already possible, therefore, for a trial subject to review informational material in a multi-media format and to indicate his or her informed consent electronically – even by clicking on a simple “I accept” button.
Of course the information and the form of consent will still need to be clear and unambiguous and satisfy the requirements of ethics committees and regulators, but in principle there is nothing in English law to stop subjects being recruited in a far more efficient, electronically-based way.
© Taveners 2010