Before starting any healthcare treatment, a patient must first give his or her consent to the treatment because without such prior consent, the treatment could, from a legal standpoint, potentially amount to a trespass and battery. Similarly, in clinical trials, informed consent must be obtained by sponsors from each trial subject prior to his or her participation in the trial. But what does “informed consent” mean and why is informed consent so often the subject matter of claims and litigation?
The new Clinical Trials Regulations1 came into operation on 31 January 2022 and any clinical trials being submitted from 1 February 2022 onwards are now governed by these regulations. The EU regulations governing clinical trials2, which we’ll refer to as ‘the regulations' for the rest of this insight, provide for certain requirements in relation to obtaining informed consent from trial subjects, including requiring the trial investigator3 to provide each trial subject with information during an interview. The regulations also require this interview to be conducted before the trial subjects start their participation in the trial, and in a language which is easily understood by them. Each trial subject must also be given the opportunity to ask questions at any time and be given adequate time to consider his or her decision to participate.
For informed consent to be deemed compliant with the regulations, the Health Products Regulatory Authority (HPRA), the national authority for authorising clinical trials, requires evidence that trial subjects were interviewed by the investigator and that written consent was obtained by the investigator. Where a trial subject is unable to write, the consent can be recorded through alternative means, such as through an audio or video recording.
One could argue the process for securing informed consent in accordance with the regulations is quite straight forward, therefore, it should be non-problematic. However, in our extensive experience, informed consent, or the alleged lack thereof, is almost routinely pleaded in medical malpractice claims and the absence and/or quality of supporting evidence documenting the consent process significantly compromises the defensibility of such claims.
For consent to a clinical trial to be valid, the consent must be given:
There is a presumption of capacity for an adult trial subject in terms of deciding whether to participate in a clinical trial. To assess a person’s capacity to make such a decision, the Assisted Decision-Making (Capacity Act) 2015, whilst yet to be implemented, can be of guidance and provides for a four-stage test to determine an individual’s mental capacity. This test indicates an individual will be deemed to lack capacity to make a decision if he or she is unable to:
Where a trial subject who is incapacitated has not given or refuses to give informed consent to participate in a clinical trial, his or her legal representative may furnish such consent on behalf of the subject. In our experience, communication issues on the part of both investigator and/or subject, very often render this aspect of consent problematic, as investigators do not always confirm with certainty that the trial subject fully understands the information being shared, particularly in relation to the potential risks and side-effects of the trial.
Trial subjects must be able to consent to participate in a clinical trial freely and without coercion. The regulations state that no undue influence, including that of a financial nature, may be exerted on subjects to participate in a clinical trial. Furthermore, the trial subjects must be informed of their right to refuse to participate and to withdraw from the trial at any time without being subject to any resulting detriment.
The information shared with the trial subject must be comprehensive, concise, clear and relevant. It is important information is communicated in a form that is understandable to a layperson. In essence, the information shared should enable the trial subject to understand the nature, objectives, benefits, implications, risks and inconveniences of the clinical trial, as well as the conditions under which it is to be conducted, including the expected duration of the trial subject’s participation in the trial.
Where relevant, a trial subject should be advised on possible treatment alternatives, including follow-up measures, if his or her participation in the trial is discontinued. It is also necessary to ensure this information is recorded in writing and made available to the trial subject.
This information aspect of informed consent has proven to be quite litigious and we must look to the Courts for guidance in terms of the level of information that should be shared with patients and trial subjects to understand what constitutes valid informed consent. Essentially, the Courts have adopted a “reasonable patient test” which requires a doctor to disclose all material risks of the proposed treatment to the patient. For elective procedures, such as a clinical trial, this includes any risk, remote or otherwise, of grave consequences involving severe pain stretching for an appreciable time into the future5.
Whilst the regulations are helpful in providing a framework for the mechanics of informed consent in clinical trials, unfortunately, informed consent in life sciences and healthcare is never black and white. There are many nuances in interpretation and application that regularly give rise to claims and litigation.
All life sciences organisations would be well-advised to err on the side of caution in ensuring consent is properly obtained and documented: some judges have little difficulty imagining a fast-talking doctor and an overwhelmed patient who is not being given all they need to provide fully informed consent. Our advice to life sciences organisations is to always maintain a professional and ethical respect for the autonomy of the trial subject and to ensure sufficient time is devoted to the pre-trial interview to allow for adequate dialogue and discussion, including warnings, with the trial subject in a manner he or she easily understands. Fully documenting this discussion is always essential.
At WTW, our Life Sciences Team fully appreciates the area of informed consent can be a minefield for organisations in the life sciences sector. With our wealth of experience and expertise, we can help demystify contentious issues, such as determining the capacity of trial subjects, disclosure of risks and information, conducting clinical trials in emergency situations and the like. With our insight articles, webinars and comprehensive suite of services, we are here to assist you in safely navigating the potential hazards.
1 Clinical Trials Regulation 2022 as implemented by Statutory Instrument No. 40/2022 European Union (Clinical Trials on Medicinal Products for Human Use) Regulations 2022
2 Required by both the European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations 2004 (SI 190/2004) for existing clinical trials and the Clinical Trials Regulations (SI 40/2022) for clinical trials submitted from 1 February 2022 onwards.
3 Or a registered medical practitioner, registered dentist or a registered nurse whose training, experience and qualifications have been assessed by the investigator and deemed appropriate to qualify him or her to conduct the interview.
4&5 Geoghegan v Harris [2003] 3 IR 536
