These frequently asked questions (FAQ) are intended to provide general information, understanding and points of clarification as they relate to the HSE National Policy for Consent in Health and Social Care Research, (hereinafter referred to as the ‘Policy’). Responses provided should not be considered legal advice, nor used as a substitute for seeking qualified advice from the appropriate Research Ethics Committee (REC). HSE Research and Development can also be contacted, ResearchandDevelopment@hse.ie.
These FAQ were compiled by HSE R&D with the assistance of the expert panel who also facilitated the discussion at the policy launch (Cavalleri G, Cullen A, Doran P, Farrell C, Lyons B, Phelan L, Saunder J, Tierney E and Vereker E).
- Participant Information Leaflets, Consent Forms, REC, NREC and Imbalance of Power
- Key considerations for research involving children
- Genetic research, data for future uses and broad consent
- Consent declaration
- Explicit consent and the legal basis
- Capacity to consent in adults
- Consent in emergency situations
Participant Information Leaflets, Consent Forms, REC, NREC and Imbalance of Power
In terms of eConsent, the European Forum for Good Clinical Practice has established eConsent Initiative (https://efgcp.eu/project?initiative=eConsent) that may be useful.
- Important to consider all relevant aspects of valid consent but not necessarily including all elements of it in Participant Information Leaflet (PIL) and Informed Consent Form (ICF).
- Involving public and patient involvement (PPI) at all stages including development of PIL and Consent Form – striking balance between ‘General Data Protection Regulation/ GDPR language’ and what is understandable by prospective research participants, accessible and age-appropriate material
- Valid consent begins with the concept and design stage of PIL and ICF. PPI engagement at this stage of the research process ensures that the documents (or other forms of PIL) are presented in such a way that the information contained within them is clear, concise, easy to understand, age-appropriate and inclusive.
- If the PIL and ICF have been designed correctly with PPI participation, the relevant aspects of valid consent will be contained within the document without necessarily being detailed, e.g. of a PPI co-designed PIL resource, Cancer Research at St James’s Hospital and Trinity College Dublin, https://vimeo.com/710331023
- Other PIL/ informed consent (IC) options must be considered for consent to be valid and understood depending on the research being considered.
- The HRB National Clinical Trials Office (NCTO) has a useful resource page for researchers covering many aspects of health research, PPI/ working with the public/ designing PILs. It also has guidance for the public on engagement with researchers, please see https://ncto.ie/useful-resources/
- The National Bio-banking Working Group (NBWG) have published a paper in HRB Open Research entitled, 'Harmonising the human bio-banking consent process: an Irish experience', https://hrbopenresearch.org/articles/4-96
- All patient material should be informed by appropriate PPI consultation. From the REC point of view it needs to be readable and easily understandable. It also needs to be as short as possible and should not overwhelm the patient with too much detail. We have seen good examples where pharmaceutical firms, for example, have produced PILs with very comprehensive information covering everything they feel the patient needs to know sometimes as long as 80+ pages, but have then also provide summary PILs covering the basics that patients need to know in just a few pages (about 3 at most), so that the patient can just read that if they wish but will have the longer information sheet should they need to dip into it for further information. We find this works extremely well.
- As regards the consent forms we would urge all researchers to set them out using ‘layered consent’ with all the options listed and then tick boxes for the patient to agree with the various options/statements. We would argue that single boxes are preferable so that the patient either ticks the box or not as yes/no boxes might confuse particularly if any of the options are negatively phrased. So for instance we could have:
- ‘I have read and understood the Patient Information Leaflet about this research project. The information has been fully explained to me and I have been able to ask questions, all of which have been answered to my satisfaction’
- Important to note that researchers should check all consent forms in detail as patients may not have agreed to every statement on the form and note should be taken of this!
- Finally broad consent applies where participants are being asked to consent to Future Biomedical Research and secondary analysis of identifiable personal data. It is comprehensively covered in section 2.3 of the Policy but this should be used as a guideline on what can be covered in the layered consent form and should not be used as a comprehensive list of items that MUST be in the consent form. At all times consideration should be given to the readability and understandably of the consent forms to be given to the participants. Involvement of PPI representatives is essential when designing consent forms and information sheets of any kind. (Broad) consent must still be specific, explicit and as informed as possible. The researcher must be open and clear about the intended uses of the personal data and/or human biological material insofar that is foreseeable.
How can consent be freely given when there is a clear imbalance of power between the data subject/ patient and the health care provider/ public authority/ HSE? e.g., recital 43. “That the inherent power imbalance (unconsciously or consciously) between the clinician/researcher and the prospective research participant does not interfere with the voluntary nature of the consent process”, this doesn't really address the heart of what power imbalance exists between health system and the patient/ data subject
Can a researcher categorically state/ warrant that biological samples taken can be "irrevocably anonymised"? For example, how can a prospective participant be assured (can this assurance be given?) that in the future no further biological or other scientific advances in identification emerge that would negate/ get around this anonymisation? In other words, can "irrevocable anonoymisation" be really guaranteed and if not, should this not be subject to a caveat?
Key considerations for research involving children
- A parent or other legally appointed guardian must provide consent on behalf of the child to participate in research and for processing of data
- The child’s assent to participate, and for the processing of their data for research purposes, should also be obtained tailored in a developmentally appropriate manner. Refusal to assent must be respected
- Consent to participate in research may need to be provided by the parents and/or Tusla, depending on the type of care arrangement; a care order or interim care order and voluntary care agreement. Tusla National Research Office (NRO) and Independent REC (REC) can advise (https://www.tusla.ie/research/tusla-research-office/about-the-national-research-office/_. Where children are the subject of ongoing and current court proceedings (in camera rule). The Court should always be told of any intended participation in research.
- Researchers must complete appropriate child protection training (e.g., mandatory Tusla or HSE Children First Training) and need to have evidence of current Garda Vetting before coming in contact with children
- For research involving full-term or preterm neonates or babies, the decision to consent to participate in research rests with their parent(s)/ legal guardian(s) and, in general, the same rules apply
- Further guidance is available in Section 5 of the Policy
- • Data that are fully and truly anonymised (i.e., data from which no individuals can be identified) fall outside the scope of both Directive (EU) 2016/680 and the General Data Protection Regulation (GDPR) https://www.dataprotection.ie/en/dpc-guidance/anonymisation-pseudonymisation However, sharing of anonymised data is subject to certain requirements such as a legally binding commitment that the recipients of the anonymised data will not take any steps to re-identify personal data.
- • Anonymising personal data constitutes processing in its own right. Where researchers intend to anonymise research participants’ personal data, including for further processing or making such anonymised data publicly available, they must seek the consent of the research participants for such processing, or the legal guardian in the event of a child.
- • The HSE National Policy for Consent in Health and Social Care Research combines consent required for data processing, as well as consent from an ethics perspective.
- • If this is anonymised survey data (e.g., no personal data involved), then it falls outside the Health Research Regulations and the issue of parental consent comes down to ethics (rather than being a data protection requirement).
- • Please see page 58 of the Policy that states:
- “A parent or other legally appointed guardian must provide consent on behalf of the child to participate in research. However, the type of research being carried out needs to be considered along with the age of consent; for example, for CTIMPs, a prospective research participant aged 16 years or older can legally consent to their own participation in the clinical trial. For all other research, a participant must be aged 18 years or older in order to consent. However, in all research circumstances, parental/ legal guardian consent is required for the processing of the participant’s personal data if they are aged under 18 years. Children may present themselves unaccompanied for healthcare treatment or assessment, but they cannot consent to participation in research unless the conditions detailed in Section 5.2.1 are met”.
- • The approving REC may need to understand and review the consent process to underpin the approach for parental/ legal guardian and child consent and assent for anonymised surveys, which may be a survey link to an agreed sample in accordance with a recruitment approach to provide information and parameters of consent rather than a speculative anonymous survey across social media channels, for example, where verification of consent, would be difficult and problematic.
- • Issuing informed participant information leaflets to parents/ guardians in advance of issuing the link to online survey to children could be considered as an initial step. Consent could potentially then be offered as an ‘opt-out’ for parents/ guardians.
Genetic research, data for future uses and broad consent
The performance of genetics research often requires the involvement of commercial partners, the use of data for future uses and on occasions it also involve encountering findings that were outside the original purpose of the study. How can all that be taken into account to ensure the consent sought is valid?
(1) Consent to health and social care research is an informed, explicit and un-coerced agreement based on trust.
(2) Researchers hold obligations based on this trust:
- To ensure research participants (RPs) understand what the agreement entails;
- To ensure that RPs can easily withdraw their data/ bio-samples from a study, or seek their destruction, at any point where this is still possible;
- To ensure that RPs do not feel obligated or pressurised to engage in a study, particularly where a therapeutic relationship exists between investigator and RP;
- To avoid any therapeutic misconception; and ensure that the RP understands that they will not be disadvantaged in any way should they decline to consent to participation;
- To ensure the RP’s safety in the study, insofar as possible.
- Is unaware of;
- Does not understand;
- Has not agreed to;
- Or exposes the RP to risks of which they have not been advised, or to which they have not agreed.
(4) Thus, where there are options available within a particular study, researchers should engage in a process of Tiered Consent:
- Where it is possible, RPs should be able to choose from a menu allowing them to consent, or not, to specific elements of a study including:
- for what their data/bio-samples will be used;
- to where their data/bio-samples will be sent (distinctions between geographic regions in respect of data protection standards may be relevant here);
- and to whom (distinctions between academic and commercial enterprises may be important here);
- whether the data/bio-samples will be irrevocably anonymised prior to any sharing; and if not,
- what control the RP will have over any future use of their data/bio-samples by such third parties.
(5)‘Broad’ consent is consent obtained for additional secondary use of biological material and/or personal data for future research that has not yet been specifically defined. The principles outlined above hold true for ‘broad’ consent. In addition:
- The possibility of secondary use must be clearly set out in a separate space in the Participant Information Leaflet, and also in a separate area on the consent form;
- Participation must be clearly labelled as optional;
- Where future research is considered, a comprehensive research plan must be laid out. This must contain as much specific information as is available.
(6) There are two primary mechanisms for managing consent for secondary research.
- The first (dynamic consent) is for a researcher, having set out a comprehensive research plan, to seek permission to re-contact the participant in order to engage in an explicit consent process for each secondary usage of bio-samples/personal data.
- The second is to seek consent to irrevocably anonymise all of the data/bio-samples prior to secondary usage.
(7) Where neither of these primary mechanisms is possible or feasible
- Researchers should identify why these mechanisms are not possible or feasible;
- Researchers must engage a series of additional protections.
(8) Additional protections in ‘Broad’ Consent:
- Transparency measures: information about secondary research must be provided to the RP in an accessible way of which they are aware (e.g. through regularly updated website);
- Each new study must be reviewed by a REC before commencement;
- The use of data/bio-samples is restricted to the area of research indicated in initial consent;
- The sharing of data/bio-samples is restricted to the geographic areas indicated in initial consent;
- There is a clear, accessible, and continuous possibility for the RP to withdraw their data from a secondary research study specifically, or secondary research in general.
- There must be sufficient data protection and security safeguards.
(9) Genetic analysis should always be specifically indicated as a standalone consent choice.
- The type of genetic analysis likely to be undertaken must be identified, along with the relevant risks;
- Whole genome sequencing always requires explicit consent, including:
- outlining the risks entailed in such analysis being performed; and
- the possibility ownership of such data by private or commercial interests.
- The right to withdraw genetic data, and clear information on how to do so, must always be provided.
(10) Assessing the validity of ‘Broad’ Consent:
- Would the RP be surprised to discover:
- How / for what their data/bio-samples are being, or have been, used;
- Or by whom;
- Or where.
- There should be no surprises - all of this should be clarified through specific consent or transparency measures.
There are legitimate reasons why consent may not be feasible to obtain, such as for example:
- when participants lack decision-making capacity as a result of their physical health,
- when participants lack decision-making capacity due to their mental/ cognitive ability,
- when participants are lost to follow up and cannot be re-contacted, or
- when research involves the processing of large scale data from a significant number of participants, across a number of research sites
More specifically, re-consent is required from the research participant as soon as is practicable if the research participant turns 18 years old (or 16 years old in the case of a clinical trial) during the course of the research study, and also in respect of the retention of biological material/personal data acquired during studies that have been completed, with the intention of using them in secondary research. Where reasonable efforts to contact participants fail, an application to the HRCDC for ongoing use of the data may be made (see Section 6.9). Biological material, and the personal data associated with the material, gathered for clinical purposes (diagnosis, treatment, etc.), without additional and appropriate consent for research, cannot generally be used for research purposes (see also Sections 6.2, 6.5, 6.6, and 6.7). Only in exceptional and rare circumstances, in the case of historical collections, when it is believed that the public interest in carrying out the research significantly outweighs the public interest in requiring the explicit consent of the participant, and obtaining that participant’s consent is not possible, the researcher should apply for a consent declaration from the HRCDC for the use of the data associated with the biological materials.
What steps must be taken prior to submitting an Application?
- Determine who is the Data Controller
- Determine if you are processing identifiable or pseudonymised personal data.
- Determine if you have explicit consent
- Determine what is the scope of the declaration being applied for if explicit consent has not been obtained
- Undertake a Data Protection Impact Assessment to identify risks and mitigating actions
- Consult with the Data Protection Officer of the Data Controller
- Ensure research ethics approval or provisional approval has been granted for the project
- Consider if reasonable efforts can be made to contact the data subject to obtain explicit consent for the health research
When applying for a consent declaration
- A case must be made that the public interest in carrying out the health research significantly outweighs the public interest in requiring the explicit consent of the data subject together with a statement setting out the reasons why it is not proposed to seek the consent of the data subject for the purposes of the health research.
- Provide evidence that Patient Public Involvement (PPI) engagement has been carried out where possible – to get representative views in the absence of obtaining consent.
- Provide evidence that technical and organisational data protection measures (security, access, data minimisation, robust pseudonymisation measures, transparency measures etc)
- Provide evidence that obtaining consent or re-consenting is not possible.
- Robust and well considered assent and deferred consent protocols should be developed, in the event a participant may regain decision-making capacity.
It is strongly advised that researchers review the HRCDC website, including the recent guidance on important amendments that came into effect in January 2021. The website contains a log of all application, decisions, and importantly conditions attached to declarations and recommendations made by the HRCDC, to safeguard the rights and freedoms of those unable to consent for themselves. Please see https://hrcdc.ie/.
Explicit consent and the legal basis
When the research involves the processing of personal data the consent must be not only be valid from an ethical perspective but also from a data processing perspective. We have also heard of consent as the legal basis for the processing of personal data. What is the difference between these concepts?
Established ethical standards aim to protect individuals against being included in research projects against their will and/or without their knowledge. Informed consent to participate in a research project is a necessary ethical requirement.
Simultaneously, processing or further processing personal data may be required to conduct the research. A number of International, European and Domestic legal instruments, including common law for Ireland, regulate the distinct but closely related rights to personal data protection and rights to privacy including the GDPR and Health Research Regulations (HRR).
Obtaining the explicit consent of prospective research participants prior to starting the project is a mandatory legal requirement under [reg 3(1)(e) of] the HRR which lists explicit consent as one of the “suitable and specific measures to be taken prior to starting the project to safeguard the fundamental rights and freedoms of the research participants”. This is often referred to as “explicit consent as a safeguard”.
In addition and separately, the GDPR requires the processing of personal data to be lawful, meaning to comply with one of the lawful grounds listed in Art. 6, and when special categories of data are processed with one of the conditions set in Article 9. The lawful basis used will determine whether certain rights apply. Consent is listed as one of the possible lawful grounds for processing personal data, and explicit consent as a condition. This is often referred to as “consent as a legal basis”.
Few important points:
- Other legal bases may be more appropriate. In particular, the European Data Protection Board (EDPB, this is a collective of European data protection regulators) underlines situations where there is a clear imbalance of power between the data subject and the controller such as Clinical Trials Regulation (CTR) (ref. Opinion 3/2019);
- The ethical requirements of explicit consent for participation and explicit consent as a safeguard when processing personal data are separate and must be met independently of the legal basis being used;
- Lastly, a number of criteria and conditions must be met to obtain valid consent.
This is a complex area and some regulated exemptions may apply. What constitutes consent, the validity of consent, and exemptions that may apply are addressed in the Policy.
Capacity to consent in adults
The response to this FAQ bears in mind that intellectual disability is a broad term that refers to a continuum of disability from mild to severe. It highlights how researchers should support potential participants to make their own decisions in so far as possible, and what to do where it becomes clear that a participant with intellectual disability lacks the capacity to make their own decision to consent. The approach outlined in the Policy is in line with the overall spirit of the document which emphasises:
- the rights and autonomy of individuals to participate in research if they chose to
- that sees research participants as partners
- that frames consent as a process of engagement rather than a single event; and
- that puts PPI at the heart of research design.
The overarching message in the Policy therefore, is not to unfairly or arbitrarily exclude adults who have may have capacity difficulties from participating in research that might benefit them, or that might benefit their peers or community.
At the same time, it is equally important to ensure those who may lack capacity are not included in research inappropriately and researchers should put in place safeguards to protect their rights and interests. Pending the commencement of the Assisted Decision Making Act 2015 (amended and passed into law late in 2022 and due to commence in 2023), the Policy also reflects some of the Act’s key principles, which include:
- The presumption that a person has capacity to make a decision until the contrary is shown
- A functional approach to assessing capacity – which means the assessment is about a specific decision that needs to be made at a specific time because capacity is something that can change over time or from one context to another; and
- Respect for individual autonomy and dignity that emphasises a persons will and preference as opposed to a perception of others think is in their ‘best interest’.
The Policy therefore stresses a public patient involvement approach to the development of the consent process and the information materials. This means involving people with intellectual disabilities in helping to tailor the process and materials to meet the needs of prospective participants; providing support for example with plain English leaflets, the use of pictures, videos or visuals, and opportunities for conversations about what the research involves.
It also discusses how prospective participants should be encouraged to involve someone who understands their will and preference to support them in the consent process. While the researcher should consult with others familiar with the prospective participant’s needs, to help ascertain their capacity, it is the responsibility of the researcher to obtain valid consent by being clear about four things:
- that the person can understand the information
- can retain it for long enough to reach a decision
- can use it in making that decision, and
- is able to communicate their decision - for instance by talking, writing, sign language or through assistive technology.
In cases where it becomes clear that a person with intellectual disability does not have the capacity to make their own decision to consent, then the researcher can obtain assent from the support person. However, it is important to understand that this assent is a safeguard, and is not a valid consent. In these cases, the researcher will need to get a consent declaration from the Health Research Consent Declaration Committee (HRCDC) before involving a person who lacks capacity in a study. This involves being able to show that the public interest in doing the research significantly outweighs the legal requirement for the explicit consent of the participant.
Once commenced, the Assisted Decision-Making Act this will provide a clear, legal basis for adults with capacity issues to participate in health and social care research, in line with their will and preference, where they have a decision supporter in place.
The HSE will then update Section 4 of the Policy document to reflect in more detail the provisions of the Act.
It is important to note that the enrolment of those who may lack capacity in clinical trials and investigations is a separate matter governed by EU regulation, and Section 4 also includes information on these requirements.
Can researchers actually assess capacity? Capacity assessment in ID is complicated. Researchers in ID would probably rely on Psychologists to formally assess capacity in potential research participants. However, multidisciplinary staff working in ID services simply do not have the time to assess capacity to facilitate research.
- The research should only be undertaken if the required knowledge cannot be obtained by conducting research involving adults with decision-making capacity.
- The research is either expected to provide a direct benefit to the participants, or to significantly contribute to the generation of knowledge about the cause, or treatment, of the impairing or similar condition.
- The will and preferences of the prospective participant must be taken into account if ascertainable.
- A person or persons (including an advocate) with an ongoing close relationship with the prospective participant should also be asked about their belief that the research is in accordance with their best interpretation of the will and preferences of the prospective participant, or known as a result of having been previously stated. Their agreement that the research study is in keeping with the will and preferences of the prospective participant is required.
- In some cases, the prospective participant may be able to identify the person(s) closest to them who is/are familiar with their will and preferences, and who they wish to be involved in the discussion.
- If there is nobody who has an ongoing close relationship with the prospective research participant and who is available or willing to be engaged, an independent advocate with the skill set to ascertain the will and preferences of the prospective research participant should be sought.
If the research study involves the processing of personal data, a consent declaration from the HRCDC is required before study start-up, in addition to ethics approval from an appropriate REC.