For CTIMPs, Schedule 1 of the Clinical Trials Regulations as amended defines a legal representative, and Table 2 of the HRA guidance outlines the hierarchy of consent for incapacitated adults using personal or professional legal representatives.
Incapacitated adults should receive information at their level of understanding. If participants can form an opinion and assess the information, their explicit wishes should be considered. Part 5 of Schedule 1 of the Clinical Trials Regulations provides a list of conditions and principles that must be in place. The Clinical Trials Regulations define a minor as a person under Therapy options. Blood Cancer Arrow Pointing Down.
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User research Getting informed consent for user research. Give feedback about this page. From: User research community. Page contents:. Collecting and keeping evidence of consent Write your consent form in language your participants can understand, and provide it in a format they can use.
Getting consent for children or vulnerable adults If you want to do research with children or vulnerable adults people who are unable to take care of themselves or are at risk of harm or exploitation , you need to get informed consent both from the participant and from a parent, guardian, carer or other responsible adult. Related guides You may also find these guides useful: Finding participants for user research Managing user research data and participant privacy You might also want to read about the: Nuremberg Code Helsinki Declaration Economic and Social Research Council framework for research ethics.
From: User research community Last updated about 3 years ago. The EDPB considers that the legal basis for processing data relating to research activities conducted as part of the trial is less straightforward and offers several alternatives. For example, consent as a legal basis Article 6 1 a , in conjunction with consent as a condition to be satisfied for the processing of special category data Article 9 2 a. Alternatively, the legal basis for processing may either be public interest Article 6 1 e or the legitimate interest of the data controller Article 6 1 f , combined processing in the interest of public health Article 9 2 i or necessary for scientific research purposes Article 9 2 j , as the condition to be satisfied for the processing of special category data.
When considering the processing data for scientific purposes outside the remit of the clinical trial protocol itself, the Opinion suggests that any further processing may be considered to be compatible with the primary purpose of the clinical trial and as a result, a new legal basis and Article 9 condition may not be needed.
However, this raises some interesting and uncomfortable questions. The CTR specifically addresses the use of data outside the trial protocol for secondary purposes and allows the sponsor to ask the participant to consent to such secondary use of their data Article 28 2. However, we must remember that informed consent for trial participation is not the same as consent under the GDPR.
The EDPB recognises that to require another ground for secondary use would be inconsistent with the presumption of compatibility provided by Article 5 1 b of the GDPR, which provides that secondary processing should be compatible with the initial purpose so long as sufficient safeguards are in place. For now, and until any further guidance is forthcoming, the EDPB suggests that the presumption of compatibility should apply to secondary use so long as the safeguards outlined in Article 89 of the GDPR are in place e.
In summary, the Opinion appears to align with the position taken by the HRA and somewhat inconsistent with the position of the ICO that within the context of a clinical trial, consent may not be relied on for primary use processing of patient data in many clinical trials.
The EDPB goes on to say that there may well be an imbalance of powers between the patient and the trial sponsor. For example, it is certainly far from ideal that a data subject, namely a vulnerable patient, can consent to participate in a clinical trial and to all of the medical interventions that clinical trial participation entails, and yet may not be able to consent to the processing of their personal data in the same trial because of a perceived imbalance between the patient and researcher.
Furthermore, the Opinion appears to be somewhat inconsistent with detailed guidance on the processing of special category data recently published by the ICO in November 2.
The guidance reminds data controllers that consent is only valid if the individual is able to withdraw their consent at any time. Furthermore, the guidance also states that in order to rely on many of the conditions under Article 9 for processing special category data, you have to demonstrate that it would not be reasonable to obtain consent from individuals. This implies that the ICO has a preference for trial sponsors to rely on consent. Until the situation becomes any clearer, explicit consent for processing special category data remains the gold standard and reduces any risk, certainly in the UK.
Therefore, it is advisable for clinical trial sponsors to obtain informed consent for trial participation and a separate explicit consent to meet the requirements of the GDPR for the processing of special category data. It is also crucially important for trial sponsors to remember that if they do seek to rely on a different Article 9 condition instead of consent this may cause difficulties later on if the data regulator objects.
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