Open research questions
In order to be able to propose certain legal recommendations to the EU legislators, the CONTRACT Consortium has specified ten research questions, the outcome of which should provide possible solutions or improvements to existing gaps in the current regulatory framework. Only recently, the European Commission has made public its proposal for a new Clinical Trials Regulation. A number of aspects which are currently still being studied in this project may have been included therein. The proposed changes will however also be subject to CONTRACT’s scrutiny and hopefully they will be completed or complemented by the outcome of the Work Package 4 - Policy Recommendations.
The research questions regard the following topics:
1. Consent for re-use of data and for the future use of data – To what extent of use of data can trial subjects give their consent? Basically, this question refers to the finality principle of the use of personal data and the eventual limits thereof. This topic relates in other words to finding the balance of facilitating research and the protection of patients’ rights.
2. Timing of the informed consent – The current Clinical Trials Directive does not provide a specific timeframe that needs to be observed between obtaining the subject’s informed consent and the actual start of the trial. It only focuses on the ‘ample time’ that needs to be given to subjects to obtain sufficient information and to decide on participation, which is a lenient system on the hand and protects the subject’s rights and (sometimes precarious) situation on the other. Medical practice however shows that such regulatory structure is not apt to all situations that may occur.
3. Informed consent and contract law – To what extent does general contract law apply to informed consent? How can informed consent be revoked by the parties? Does a trial subject enjoy protection from consumer protection regulation?
4. Informed consent: negotiable? – Do trial subjects have an actual choice in consenting (or not) to treatment, participation in a clinical trial or the processing of their personal data? Choice, obviously yes. But is there any room for negotiation and, if so, at what level?
5. Multi-purpose consent – Consent is required for a multitude of things: treatment, participation in a clinical trial, biobanking, use and protection of personal data, … Is there a way of avoiding multiple documents? Can patients consent to a number of actions at the same time and/or in one document?
6. The right to know versus the right not to know – The autonomy question and the balance between an individual’s rights and those of third persons. And basically, this question reveals a paradox: how can one give informed consent to not be (further) informed?
7. e-Consent – Is e-consent the path to follow? And if so, does it need harmonisation on a European level?
8. New alternatives for consent – Alternatives for the current informed consent procedure may have certain (dis)advantages compared to today’s system. One may consider proxy consent by patient organisations, an opt-out system, … But also in protocol feasibility cases consent to preliminary scanning of the subject’s data may be a door to new alternatives.
9. Harmonisation, the way to go? – This is actually the key question in this series. It synthesizes the previous topics, but also relates to other aspects of European data protection as the new data protection regulation is well on its way. Furthermore, there may be a need for a harmonized quality of consent and consent forms. And what with the liability issues when European harmonized standards are not met? Needn’t their enforcement be harmonized as well?
10. Ethics of consent – Consent is more than a pure legal concept. In medical ethics the question is raised of the ethical minimum. As of what moment, treatment or complexity is consent desirable? Next to that, there is a not always so easy balance that needs to found between the scientific complexity of a trial protocol or treatment and the layman terms in which a subject or patient needs to be informed. Can face to face contact with the physician help close the gap in the case of e-consent and should such contact always be required or advisable?