Frequently Asked Questions: Consent

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.

Clinicians are commonly involved in research. Where their research involves the recruitment of the patients/ clients/ service users (PCSU) for whom they provide care, this raises the possibility of imbalance of power having an impact on the agreement of the PCSU to participate. During the process of seeking and of obtaining consent it should be made unambiguously clear to the prospective research participant that their refusal to consent to be a research participant will not affect either the provision of care they receive or their clinician-PCSU relationship. It is important that the clinician/ scientist is aware of this possibility and seeks to mitigate it. One way would be for another individual, fully familiar with the research, to engage in the recruitment process. (This individual is commonly called a gate-keeper although strictly speaking a gate-keeper has a different role i.e. enabling confidential contacting of any research participants). Any possibility of a therapeutic misconception should also be avoided or corrected. In addition, it should be absolutely clear that refusal to consent to be a research participant will not impact on the clinician-PCSU relationship, or affect the PCSU’s care in any negative way.

Consent Forms should be used that reflect these requirements. HSE Research and Development will be developing supporting materials on both PILs and Consent Form.

The collection and usage of human biological samples for research is subject to obtaining the valid consent of the PCSU (please see Section 2 of the Policy). Samples can either be destroyed at the end of the research project or potentially retained for further research use subject to appropriate consent from research participants and various undertakings from the new research team (please see Section 2.3 of the Policy). It is important to distinguish between biological material samples (e.g., organs, tissue, blood, cells, and body fluids) and genetic data, either linked to the samples or derived from their analysis. The current thinking on this question is that biological material that contains deoxyribonucleic acid (DNA) cannot be anonymised as it is, in and of itself, a unique individual identifier. Scientific and technological advancements may possibly allow to de-anonymised biological samples that could originally be anonymised. However, to de-anonymising biological samples using such advancement without obtaining relevant consent would constitute a breach of regulatory frameworks and ethical standards and would be incompatible with good clinical practice and research. With regard to genome data, the EDPB has stressed the impossibility of definitively de-identifying biological samples when genome data is derived from such samples. The question whether genetic data can be considered anonymised where the controller carries out reasonable efforts and uses technically available means in order to prevent re-identification has been addressed by the EDPB. The EDPB points out that the possibility to anonymise genetic data remains an unresolved issue. In the interests of protecting the rights and freedoms of individual data subjects, it strongly advises that such genetic data is treated as personal data.

This Policy refers to health and social care research across the HSE and its associated Research Ethics Committees. HSE Research and Development are leading on the development and implementation of the HSE framework for the Governance, Management and Support of Research (2021) and HSE Roadmap for the Reform of Health and Social Care Research Ethics Committees (2022) aimed at standardising and streamlining approach to research across the system including ethics and governance, management and support. As part of this work, mutual recognition of REC opinions will be explored.

The onus remains on the researcher/ research team in this context. However, any amendments to the original study protocol and/ or its supporting materials such as PIL and Consent Form should be prospectively submitted to the relevant REC(s) for approval in advance. The researcher/ research team should also submit Annual Report and End of Study Report as per their Standard Operating Procedure (SOP) to the REC.

There is information on seeking PPI involvement at any stages of the study cycle, please see https://hseresearch.ie/patient-and-public-involvement-in-research/. Please also see information from the HRB-funded PPI Ignite Network and its various sites (Dublin City University, University of Galway, RCSI, Trinity College Dublin, University College Cork, University College Dublin and University of Limerick), https://ppinetwork.ie/. The Lead Sites sometimes offer seed funding to assist with involving PPI during pre-commencement phase.

The Policy does not mention covenantal ethics and does not cover different types of health and social care research such as participatory action research. However, it does discuss the prospective research participants’ best interests, welfare, respect, beneficence, justice and solidarity.

HSE Research and Development are leading on the development and implementation of the HSE framework for the Governance, Management and Support of Research (2021) and HSE Roadmap for the Reform of Health and Social Care Research Ethics Committees (2022) aimed at standardising and streamlining approach to research across the system including ethics and governance, management and support. As part of this work, mutual recognition of REC opinions will be explored. Once this work is completed, it is hoped that turnaround times for multisite studies will be reduced. This will be further assisted by the development, piloting and rollout of the National Research Electronic Management System (NERMS).

• 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.

Secondary findings are results that are actively sought in addition to the primary target of a test or procedure. ‘Secondary findings’ in the genetic context refers to the American College of Medical Genetics and Genomics’ list for adults and paediatric patients. Secondary research in the context of this Policy refers to additional research carried out on the data and/or tissue acquired during a (primary) research process. The scope of secondary research (where a new consent process has not taken place) is limited, as indicated in the definition of ‘broad informed consent’. It is recommended that, whenever possible and appropriate, a tiered consent format be used in order to allow a prospective participant to select from, and to consent to, a graduated set of consent options. This tiered format is recommended for use with biobanks and genomic databases in particular. When a secondary use for research purposes includes genetic analysis, this should always be specifically indicated as a standalone consent choice. The type of genetic analysis likely to be undertaken must be identified. Whole genome sequencing requires explicit consent, including outlining the risks entailed in such analysis being performed, and the possible ownership of such data by private or commercial interests. The right to withdraw genetic data, and clear information on how to do so, must also be provided. (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.

(see Section 2.3 of the HSE National Policy for Consent in Health and Social Care Research, 2023)

Principles:

(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.

(3) Researchers hold RPs bio-samples and data ‘in trust’, which precludes researchers from utilising (including sharing) bio-samples or data in ways that the RP:

• 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.

Broad consent 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.

This is not stipulated in Section 6.1, however, such materials stored for secondary research uses may not be specifically known at the time of collection, and care must be taken to ensure that valid consent for secondary research is in place (see Sections 2.3 and 2.4).

When health research involves the processing of personal data (de-identified/ pseudonymised) from a participant, where explicit consent cannot be obtained, a consent declaration must be sought from the Health Research Consent Declaration Committee (HRCDC) for the processing of personal data for research. For more information on what is personal data, please see - https://www.dataprotection.ie/en/dpc-guidance/what-is-personal-data

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/.

It is very important to distinguish between the ethical requirements of explicit consent for participation in a research project, and explicit consent used as a necessary safeguard or to legitimise the processing of personal data. Here the FAQ will solely focus on the distinction.

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.

Section 4 of the Policy provides helpful guidance on the process of consent for adults who may lack decision-making capacity, which includes for instance those with intellectual disability.

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.

Capacity should be assessed using a functional approach (not from a medical perspective) on a time-specific and issue-specific basis (Section 4.2). The responsibility to determine capacity to consent lies with the researcher and it must be valid. The researcher must be satisfied that the prospective research participant has understood the research-study-related information provided, retained it long enough to reach a decision, used and weighed it as part of making a decision, and is able to communicate their decision to participate (as per Section 4.2). The researcher should engage with treating clinicians and relevant healthcare professionals who are familiar with the prospective research participant’s condition in order to ascertain the prospective participant’s decision-making capacity, the responsibility for ensuring that valid consent is obtained lies with the researcher.

Adults who lack decision-making capacity must not be unfairly excluded from research participation, but in order to ensure that their rights, interests, and dignity are protected.

• 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.

Please see Section 6.9. It states that deferred consent can be used in emergency situations where the prospective participant is unable to give consent by reason of physical or mental incapacity (traumatic brain injury, they are unconscious in an intensive care unit, etc.), and their vital (health) interests are engaged, requiring urgent intervention (for which available treatments are unproven or unsatisfactory) as long as REC approval is already in place. The type of medical situation/emergency involved creates an urgency for a decision to be made on treatment and it falls, in the circumstances, to the clinician to make a decision that they feel will benefit the patient’s care. In these circumstances, the research may proceed until the participating individual has the capacity to give consent.