Adults with Incapacity Amendment Act: consultation

Part 8 Proposals to Amend the AWI Act in Respect of the Governance of Incapacitated Adults Participating in Research

We are proposing a number of changes to Section 51 of the AWI Act and its associated Regulations (The Adults with Incapacity (Ethics Committee) (Scotland) Regulations 2002). This legislation governs the circumstances in which incapacitated adults can be involved in research as participants. These proposals would reform the processes for participation in research and the ethical review of research proposals involving adults with incapacity in Scotland. It is the intention that any amendments to legislation support high quality research that underpins a modernised, resilient and sustainable health system, while ensuring ethics review processes are efficient and robust, with the rights, safety, dignity and wellbeing of research participants prioritised throughout.

Background

As previously mentioned, there was a substantive consultation on AWI reform in 2018. Included in this consultation were proposals to reform the processes under which incapacitated adults can participate in research studies in Scotland. Responses to these proposals were received from a range of relevant stakeholders, including clinicians, organisations and members of the public. While broadly supportive, it was clear that the majority of respondents sought greater clarity and detail on these important reforms. A summary and analysis of the 2018 consultation responses was published by the Scottish Government^[71].

In response to this, the Scottish Government agreed to develop a focused set of more detailed proposals to amend Section 51 of the AWI Act that governs research, and how such amendments would impact adults with incapacity participating in this research. To assist in the development of these more detailed proposals, the Scottish Government’s Chief Scientist Office (CSO) set up a Working Group which was also tasked with clearly describing the approvals required before different types of studies can commence recruitment, and how and why the law, and therefore the approval system, is different for adults with incapacity in Scotland.

The group have developed a number of examples of real life scenarios depicting the effect of the current law in Scotland compared to the research environment across the UK; and have contributed towards the Scottish Government formulating a number of proposals that outline how the AWI Act could be amended to change both the manner in which incapacitated adults can participate in research, and how the ethical review of research studies involving these individuals is carried out. This part of the consultation sets out these proposals for reforming Section 51 of the AWI Act, and seeks views and comments from a wide range of stakeholders

Summarising the proposals

Upon its enactment in 2000, the AWI Act was a pioneering piece of legislation that enshrined the rights of incapacitated adults. These proposals outline amendments that aim to modernise and update how the AWI Act governs the manner in which incapacitated adults can participate in research. Whilst each proposal is expanded on and contextualised in later sections, in some instances with accompanying case studies, the proposals can be summarised as follows:

• Being allowed to establish more than one ethics committee that is capable of reviewing research proposals involving incapacitated adults in Scotland.

• Permitting adults with incapacity to be included in research studies without consent for those types of studies where consent is already not required from adults with capacity.
• Affording adults with incapacity the opportunity to participate in research studies that investigate conditions other than those responsible for their incapacity.
• Permitting waivers of consent to be applied in emergency situations to involve adults with incapacity in research in cases where it is not reasonably practical or feasible to seek consent from the individual’s guardian, welfare attorney or nearest relative.
• Expanding the list of individuals permitted to provide consent for adults with incapacity to take part in research.

Definitions

Defining research

Section 51 of the AWI Act specifically provides governance for how adults incapable of giving consent can participate in medical, surgical, dental, nursing or psychological research, subject to certain safeguards and exceptions.

In practice, this typically corresponds to the AWI Act governing activities that would fall within what is considered ‘health and social care research’.

The Health Research Authority (HRA) – a UK organisation that aims to safeguard the rights and interests of patients and members of the public involved in health and social care research – describes the role of health and social care research as the following^[72]:

“Health and social care research aims to find out new knowledge that could lead to changes to health treatments, policies or care. Without health and social care research, clinicians (doctors, nurses, dentists, social workers, and other health professionals) would continue to carry out their work the same way without knowing if a new treatment or approach would be more effective for the person they are supporting or treating.”

The UK Policy Framework for Health and Social Care Research^[73] is a set of guidelines that outlines principles of good practice and conduct in the area of health and social care research. The following definition of ‘research’ is adapted from the one provided in this Framework:

“Research is defined as the attempt to derive generalisable or transferable new knowledge to answer or refine relevant questions with scientifically sound methods. This excludes audits of practice and service evaluations. It includes activities that are carried out in preparation for or as a consequence of the interventional part of the research, such as screening potential participants for eligibility, obtaining participants’ consent and publishing results. It also includes non-interventional health and social care research (i.e. projects that do not involve any change in standard treatment, care or other services), projects that aim to generate hypotheses, methodological research and descriptive research.”

For clarity, throughout this consultation, any mention of ‘research’ is broadly in reference to activities or projects that would fall under the banner of health and social care research.

Research can take many forms: testing out new potentially life-saving drugs, studying blood samples or data provided by patients, or asking participants to fill out a survey or questionnaire. Research studies may involve a limited number of people, or several thousand. It may be conducted within a comparatively small geographical area, or it may be worldwide. The length of time a trial runs will also vary, and participants will be told the duration of the study before it begins.

However, regardless of the type of research performed in the health and social care sector across the UK, it is rigorously regulated, and many safeguards are in place to protect the rights, wellbeing, safety and dignity of research participants. In Scotland, most research studies involving people can only commence if the study has received both NHS Research & Development (R&D) permission, and a favourable opinion from a Research Ethics Committee (REC). Participant safety and confidentiality is of the utmost importance; and participants can request that all their information, data and samples from the trial or study be destroyed. The National Institute for Health and Care Research (NIHR) provides useful information and tackles some common misconceptions about health and social care research on their Be Part of Research website designed to promote and explain research to the public^[74].

After a research study has undergone the necessary review, they can begin to recruit participants. Consent is an essential component of the recruitment process – by providing the necessary and relevant information in a comprehensible manner, individuals can make an informed decision about whether participating in a research study is suitable for them. Participants can change their mind and withdraw their consent and further participation in a trial at any point without giving a reason. Refusing to take part in research, or withdrawing consent at any time, will not impact the standard of care received.

Defining incapacity

For a number of reasons, not all individuals possess the capacity to make an informed decision regarding their own participation in a trial. Assessing the capacity of adults is not a simple process. The law in Scotland generally presumes that adults are capable of making personal decisions for themselves and managing their own affairs. Having a diagnosis of dementia, for example, does not necessarily mean that a person is incapable of making their own decisions. When assessing capacity, evidence of the individual’s ability to understand any potential risks, and a consistency in this understanding, is considered. Section 1(6) of the AWI Act defines a person over 16 as ‘incapable’ if they are incapable of:

• acting; or
• making decisions; or
• communicating decisions; or
• understanding decisions; or
• retaining the memory of decisions,
• by reason of mental disorder or an inability to communicate due to a physical disability that cannot be improved by an external aid.

Furthermore, incapacity is not always permanent, and the nature of an individual’s incapacity can be dependent on the condition or illness they are experiencing. The reasons for incapacity can be incredibly varied, and may include conditions like dementia, severe trauma caused by accidents that render individuals unconscious, learning difficulties, mental states such as delirium, amongst many others. Incapacity can also be temporarily caused by a particular treatment regime received by an individual (e.g. patients being placed in medically induced comas).

Research governance in the NHS in Scotland and the wider UK

As discussed above, section 51 of the AWI Act provides governance for how adults incapable of giving consent can participate in medical, surgical, dental, nursing or psychological research, subject to certain safeguards and exceptions. In Scotland, over 1,500 clinical research studies encompassing a range of conditions and specialities involving over 30,000 patients take place each year^[75]. Research in Scotland is robustly regulated and there is no intention to change that. Further information on research governance in Scotland can be found on the NHS Research Scotland website^[76]. Other guidance outlining principles of good practice in the area of health and social care research can be found in the UK Policy Framework for Health and Social Care Research^[77].

Research in the NHS can be broadly grouped into two categories. Clinical Trials of an Investigational Medicinal Product (CTIMP) involve trialling a new drug, or trialling an existing drug for a purpose distinct from the one for which it was originally approved. Studies that do not involve testing new drugs are categorised as non-CTIMP studies. Each of these two types of studies are governed in different ways across the UK.

It must be noted that social care research is not necessarily always conducted in an NHS setting. When it is not, it is thus not necessarily governed by the same set of rules and regulations outlined below. However, when a social care research study involves adults with incapacity in Scotland, it is typically reviewed by a specific NHS Research Ethics Committee (see Research Ethics Committees (RECs) below).

Clinical trials of investigational medicinal products (CTIMPs)

Existing regulations governing CTIMP studies originally came into UK law via EU Directive^[78], in the form of The Medicines for Human Use (Clinical Trials) Regulations 2004^[79] which, together with its amendments, are referred to as the Clinical Trial Regulations. The Medicines for Human Use (Clinical Trials) Regulations 2004 are currently under review and work is being performed to amend and update this legislation. Approval processes governing CTIMP research studies may therefore be subject to any amendments to existing legislation that may be implemented in the future. This legislation is a reserved matter under the UK Government. A general explanation of matters devolved to Scotland or reserved to the UK can be found on the Scottish Parliament’s website^[80].

In addition to Research Ethics Committee (REC) review and NHS R&D approval discussed above, CTIMP studies require an extra step of authorisation before they can commence. In practice, this involves applying to the Medicines and Healthcare products Regulatory Agency (MHRA) for a clinical trial authorisation.

When a researcher wishes to obtain permission for a potential participant to enter a study when they lack capacity and there is adequate time to consult, the UK Clinical Trials Regulations (henceforth known as ‘the Clinical Trials Regulations’) allow for a personal or professional legal representative to consent on behalf of the participant in order that they may be given the opportunity to participate in the trial^[81].

The Clinical Trials Regulations inserted provisions into Section 51 of the Act^[82] to allow for an incapacitated adult to enter a study in instances where there is inadequate time to consult the individual’s relevant representatives. This is permissible by means of an emergency provision or waiver of consent if:

• It has not been practicable to contact the adult’s guardian, welfare attorney or the adult’s nearest relative before the decision to enter the adult as a subject of the clinical trial is made and consent has been obtained by the individual’s primarily responsible doctor or somebody nominated by the relevant healthcare provider,
• Where treatment is being given, or is about to be given to the adult, the involvement of the individual in the study is a matter of urgency, and it is not reasonably practicable to obtain consent from the adult’s guardian, welfare attorney or nearest relative or from the individual’s primarily responsible doctor or somebody nominated by the relevant healthcare provider, and the action to be taken is in accordance with a procedure approved by Scotland A REC or any other Ethics Committee established or recognised under Part 2 of the Clinical Trials regulations or the Gene Therapy Advisory Committee.

However, it should be noted that aside from the provisions inserted into Section 51 of the Act, the overall processes that apply to CTIMPs (including further rules that would apply to CTIMPs on incapacitated adults or otherwise) are governed throughout the UK by these Clinical Trials Regulations, and not the AWI Act. Therefore, CTIMP studies lie outside the scope of the proposals outlined in this consultation.

Non-CTIMP studies

Whilst the proposals found in this consultation are not relevant to studies involving investigational medicinal products (CTIMPs), governance of all other research in NHS Scotland (referred to as non-CTIMPs) is devolved to Scotland and, in the case of research including incapacitated adults, is governed through the AWI Act and associated Regulations^[83]. In practice, when compared to the rest of the UK, this means adults with incapacity in Scotland involved in research may experience a different approach depending on the nature of the study.

In a non-CTIMP study in Scotland under the Act, when a researcher wishes to obtain permission for an incapacitated individual to enter a study, the individual’s guardian, welfare attorney or nearest relative can provide legal consent^[84]. Here, there are also additional conditions that must be met^[85], including:

• Research of a similar nature must not be able to be carried out on an adult who has capacity.
• The purpose of the research must be to obtain knowledge on the causes, diagnosis, treatment or care of the adult’s incapacity, or to obtain knowledge on the effect of treatment or care given during the adult’s incapacity which relates to that incapacity.

Under the analogous legislation in England and Wales (the Mental Capacity Act 2005) and Northern Ireland (the Mental Capacity Act (Northern Ireland) 2016), in a non-CTIMP study, when a researcher wishes to obtain permission for a potential participant who lacks capacity to enter a study, a personal consultee (similar to a personal legal representative) or nominated/professional consultee can provide permission^[86],[87]. In Scotland, in a non-CTIMP study, there is no provision for a nominated/professional consultee to provide consent for a potential participant to be involved in a research study in cases where the prospective participant lacks capacity.

If there is not adequate time to consult, in England, Wales and Northern Ireland, there is also the possibility of obtaining permission for a potential participant to enter a study through an emergency provision, or waiver of consent. This is also not possible in Scotland for non-CTIMP research studies.

Research Ethics Committees (RECs)

Most research proposals undertaken within the NHS or involving NHS patients – whether CTIMP or non-CTIMP – are reviewed by a Research Ethics Committee (REC)^[88]. Operating as part of a UK-wide Research Ethics Service, there are 12 RECs in Scotland which analyse hundreds of applications each year (over 380 between the beginning of April 2019 and the end of March 2020 alone)^[89]. Each REC is comprised of volunteer lay and expert members who all possess a diverse range of knowledge and expertise. RECs also act independently of researchers, funders and sponsors, allowing them to review research applications objectively and to ensure the wellbeing, safety and rights of participants are at the centre of the review process. However, only one REC (Scotland A REC – SAREC), established by regulation 2 of the Adults with Incapacity (Ethics Committee) (Scotland) Regulations 2002 made under Section 51(6) of the Act, may review research proposals involving incapacitated adults in Scotland. Further information about the activities of the RECs and the wider Scottish Research Ethics Service can be found on the NHS Research Scotland website^[90].

The proposals

The following sections provide background information and context which help to illustrate the issues that each of our proposals aim to address, including the questions we would like respondents to consider. As outlined above, CTIMP research is governed by a separate UK-wide piece of legislation (The Medicines for Human Use (Clinical Trials) Regulations 2004). The questions outlined throughout the rest of this paper only propose to amend Adults with Incapacity legislation, and thus will only apply to non-CTIMP research in Scotland.

Permitting the establishment of more than one ethics committee that is able to review research proposals involving adults with incapacity

Scotland A Research Ethics Committee (SAREC)

As discussed above, Scotland A Research Ethics Committee (SAREC) is the only REC in Scotland capable of reviewing research proposals that involve adults with incapacity. The AWI Act requires that an Ethics Committee be established by procedures, set out in the Adults with Incapacity (Ethics Committee) (Scotland) Regulations 2002. These regulations impose a strict set of criteria that ensures SAREC is comprised of members who possess a wide range of skills and expertise. At present, in order for SAREC to be quorate, there must be attendance by at least three members, which must include: the Chair, or in the Chair’s absence, the Vice-Chair or an Alternate Vice-Chair; one member who meets one of the expert requirements at (a) to (h) below; and one lay member.

The membership of this Committee shall, so far as practical, include at least:

(a) one person who has experience in relation to the treatment of adults who are incapable;

(b) one medical practitioner who provides primary medical services pursuant to Part I of the National Health Service (Scotland) Act 1978;

(c) one registered nurse or registered midwife;

(d) one registered medical practitioner having experience in clinical pharmacology;

(e) one pharmacist registered in Part 1 of the register maintained under article 19 of the Pharmacy Order 2010 or a registered person as defined by Article 2(2) of the Pharmacy (Northern Ireland) Order 1976;

(f) one registered medical practitioner who holds the position of hospital consultant;

(g) one registered medical practitioner having experience in the field of public health medicine;

(h) one member who is registered as a member of a profession to which the Health Professions Order 2001 applies; and

(i) three lay members

Before approval can be given for any research under Section 51 of the AWI Act, SAREC must take into account:

(a) the objectives, design, methodology, statistical considerations and organisation of the research;

(b) the relevance of the research and the study design;

(c) the justification of predictable risks and inconveniences weighed against the anticipated benefits for the research participants and future participants;

(d) the suitability of the lead researcher;

(e) the adequacy of the written information to be given and the procedure for obtaining

consent; and

(f) the arrangements for the recruitment of research participants.

SAREC is the only committee capable of reviewing research proposals involving incapacitated adults in Scotland. Experience from operating during the COVID-19 pandemic response amplified some concerns that this may represent an operational weakness in capacity and resilience in the system. To support the COVID-19 response, the Scottish Government made Scottish Statutory Instrument SSI 2020/151 to provide for a degree of flexibility in SAREC’s operations, but this was not designed to be a long term solution, especially outside of an emergency response.

If a second committee were to be constituted, to help further improve the flexibility and resilience of the system, it could be subject to provisions that outline different procedures than are currently in place for SAREC (such as distinct membership composition requirements).

Another major consequence of the current system is that there is no right of appeal should applicants wish to challenge an unfavourable ethical opinion issued by SAREC. This is unlike all other committees throughout the UK, for which applicants have the right to appeal.

Amending the AWI Act to permit the establishment of more than one committee that is able to review AWI research proposals would boost capacity within the system, and allow for an appeals process in Scotland for AWI research studies. These changes would help to support a more efficient and resilient system, fit for purpose, as Scotland looks to grow the delivery of high quality clinical research.

Question

91. Should the AWI Act be amended to allow the creation of more than one ethics committee capable of reviewing research proposals involving adults lacking capacity in Scotland?

Permitting adults with incapacity to be included in research studies without consent for the types of studies where consent is already not required from adults with capacity

Case study: Large scale research studies that make use of NHS patient data sets

Many research studies only wish to make use of NHS patient data; rather than measuring the effectiveness of new treatments or interventions on patients. In particular, it can be common for researchers to want to make use of data that is recorded from patients during routine clinical care (which could include identifiable data or non-identifiable data. Identifiable data is data through which it is possible to ascertain the identity of the individual from which the data was taken). In these cases, researchers may have to prospectively gather such data during routine care with the intention of using it for research purposes in the future; or want to make use of existing patient data sets that have already been collected. It is also common for such studies to make use of data that comes from large numbers of NHS patients.

Generally, when researchers wish to make use of NHS Scotland patient data in this manner that comes from more than one NHS Health Board they have to apply to the Public Benefit and Privacy Panel for Health and Social Care (PBPP)^[91] for approval. In addition to the Panel being satisfied that the proposed data processing by researchers will be conducted in a safe, proportionate and secure manner, that the public interest will be advanced and there is a demonstrable need for researchers to process patient data, there is an expectation that patients should be informed and provide consent when their data is processed for purposes other than standard clinical care. However, it is understood that this is not always practical or possible. In cases such as this, PBPP will require a clear explanation and justification for researchers proceeding without participant consent before approving their application. PBPP follows a number of guiding principles^[92] when assessing applications, in addition to the Caldicott Principles^[93] and Data Protection Principles^[94].

In instances where researchers only wish to use patient data from a single NHS Board, they seek approval from that Board’s Caldicott Guardian^[95] instead of PBPP. A Caldicott Guardian is an individual who is responsible for ensuring that personal health and social care data is processed and stored legally, ethically, and appropriately in an organisation. The appointment of a Caldicott Guardian in each NHS organisation for safeguarding patient data in this manner was one of the central recommendations resulting from the 1997 Caldicott Report on the review of patient identifiable information^[96].

Applying for Caldicott Guardian or PBPP approval is a distinct process from receiving a favourable ethical opinion from a Research Ethics Committee. For research studies involving patient data, researchers will often have to seek approval from both a Research Ethics Committee and PBPP/Caldicott Guardian. The HRA’s decision tool is a useful resource that can be used by researchers who are unsure if their particular research study requires REC review.

So whilst there are specific pathways available to researchers to ensure they can safely and appropriately process routinely gathered patient data (identifiable or otherwise) for research purposes without consent in specific circumstances; for adults with incapacity to participate in research, consent being obtained from an appropriate decision-maker is always a necessary requirement under the AWI Act^[97].

For any research studies that wish to make use of patient data collected from incapacitated adults, researchers would have been required to obtain consent from a relative or other surrogate decision-maker for every incapacitated participant prior to the data being processed as part of the study. This is the case both for data that is prospectively gathered during routine care in the knowledge it will also be used for research; and when data has already been collected and is held in existing NHS datasets. For large studies that involve thousands of patients, seeking consent on behalf of participants – whether they have capacity or not – is often unfeasible.

With regards to the other UK nations, the respective pieces of legislation in these countries can allow this type of research to be carried out without needing consent from each individual participant lacking capacity.

For example, in England and Wales, if it is not feasible to obtain patient consent for the use of identifiable data about them, an application can be made to the Confidentiality Advisory Group (CAG)^[98] for support under Section 251 of the NHS Act 2006 to disclose this data for use in research that is of public benefit with a medical purpose. This is because such support sets aside the common law duty of confidentiality. Approval is subject to certain conditions (notably, the implementation of safeguards and transparency). Other examples of types of research where no consent is required to lawfully involve a person in a research study in England and Wales (regardless of whether they possess capacity or not) can be found on page 205 of the Mental Capacity Act 2005 Code of Practice^[99]. Such research is defined as ‘non-intrusive research’. Other examples of ‘non-intrusive research’ are highlighted on the HRA’s website^[100].

The Mental Capacity Act 2005 (which applies in England and Wales, not Scotland) only provides governance for ‘intrusive research’^[101] – research in which it would be unlawful to carry out on a person with capacity without their consent. Therefore, any provision outlined in the Mental Capacity Act (such as the research being connected with an impairing condition affecting the person lacking capacity, or the researchers having to locate an appropriate person to consult with about the suitability of an individual with incapacity to take part in a given study) do not apply to non-intrusive research practices, such as processing identifiable patient data with section 251 support.

Thus, in England and Wales, researchers do not have to identify a consultee to discuss participation for adults with incapacity for non-intrusive research. In cases where researchers want to make use of identifiable patient data in this manner, they must apply to the HRA’s Confidentiality Advisory Group (CAG). However, before approaching CAG, researchers must explore all other practical alternatives and clearly demonstrate that seeking consultee advice is not practical in their particular circumstances. The CAG will review the research application and provide expert advice to the HRA about whether or not it should be approved to allow researchers access to such data without patient consent. More information about the CAG can be found on the HRA’s website^[102].

Currently in Scotland, regardless of Caldicott Guardian or PBPP approval, Scotland A REC would not be able to review and approve any research study involving data taken from incapacitated adults without consent being sought from a guardian, welfare attorney or nearest relative; even if it is possible for research studies involving data taken from adults with capacity to be approved and proceed without consent under certain circumstances.

The above case study highlights that it can be very difficult to conduct large scale studies using data taken from adults with incapacity in Scotland; risking their exclusion in instances where it is unfeasible to obtain consent from the individual’s surrogate decision-maker. Ultimately, this can lead to situations where data collected from an adult with capacity can be included in a research study without their consent, but data collected from an adult with incapacity could not.

Practically speaking, the research studies discussed in this section and impacted by the proposals outlined later in this section (questions 92 & 93) would not include interventional studies. Interventional studies are research studies in which a new or changed treatment or care is tested on participants. These proposals would only affect non-interventional studies; primarily non-interventional studies that involve patient data taken from adults with incapacity.

To clarify, as mentioned above, so long as the appropriate approval is in place (information governance approval through Caldicott Guardian/PBPP and, where appropriate, REC favourable opinion), it is possible for adults with capacity to be included as participants in the following types of non-interventional research without giving consent; but not adults with incapacity:

• Research studies that involve prospectively gathering NHS patient data (identifiable or otherwise) during routine care with the intention of subsequently using the data for research purposes.
• Research studies that wish to make use of existing NHS patient data sets (identifiable or otherwise).

This imbalance in approach risks the integrity of research outcomes and healthcare benefits for adults with incapacity if they continue to be excluded from such studies.

In terms of participating in research, we are seeking views on the principle of allowing adults with incapacity to be included as participants in research studies without consent, in instances where adults with capacity are already able to be included as participants without consent.

Question

92. In research studies for which consent is not required for adults with capacity to be included as participants, should adults with incapacity also be permitted to be included as participants without an appropriate person providing consent for them?

This general principle would avoid situations in research studies that involve, for example, data taken from adults with incapacity being unintentionally excluded due to it being incredibly impractical to seek consent from an appropriate person for each incapacitated participant; whilst unconsented data from adults with capacity can be used in the study if the appropriate approvals are in place.

One example of how this general principle could be implemented in a practical way would be to provide Scotland A REC (or any other ethics committee constituted under Regulations made by the Scottish Ministers in the future) with the ability to determine that, just like the current practice for studies involving participants with capacity, there will be certain special circumstances in which researchers would not be required to obtain consent to involve adults with incapacity in research studies.

If this proposal were to be implemented, the relevant ethics committee would only rule that a study involving adults with incapacity could proceed without obtaining consent if they would be content that an ethics committee would also provide a favourable opinion to such a study proposing to involve adults with capacity as participants without consent.

As discussed before, this in practice would not apply to interventional studies, and, just like the current situation where RECs review such applications involving participants with capacity, Scotland A REC (or any other ethics committee constituted under Regulations made by the Scottish Ministers in the future) would need to be satisfied that the wellbeing and rights of the participants are protected and that researchers have a sound justification for proceeding without consent. In addition to REC review, an extra safeguard is also in place for research studies involving patient data in Scotland. As mentioned above, at present such studies involving participants with capacity generally require separate information governance oversight and approval from a Caldicott Guardian (when patient data comes from a single NHS Board) or PBPP (when access to patient data is requested from more than one NHS Board); and it is common practice currently for RECs to confirm that this approval is in place before a favourable opinion is provided and the research study can commence.

If implemented, the central aim of this proposal would be to allow incapacitated participants to follow the same research approval pathways that are already in place for participants with capacity.

As with the other questions posed throughout this consultation, this proposal is made with the principle of equality in mind, to ensure adults with incapacity are not disadvantaged when it comes to accessing research.

Question

93. Should Scotland A REC (or any other ethics committee constituted under Regulations made by the Scottish Ministers in the future) have the ability to determine that consent would not be required for adults with incapacity to be included as research participants, when reviewing studies for which consent would also not be required to include adults with capacity as research participants?

Pathways for emergency waivers of consent

Case study: Recovering from trauma

Patients attending the emergency department with trauma, for example after a car accident, may not have capacity due to the injuries they received rendering them unconscious. These patients are seriously ill and sometimes may not survive. It is important that new treatments are tested to see whether they can improve survival.

In 2017, the E-FIT1 trial^[103] tested one such treatment. Fibrinogen is a component of blood that performs a key role in the clotting process following injury, and its levels are known to fall in trauma patients. The trial studied whether replacing fibrinogen would reduce bleeding and improve survival.

In Scotland, trauma patients were able to take part in this study because the fibrinogen used was classified as a drug (or Investigational Medicinal Product; IMP). Thus, even though the study involved adults with incapacity, it was governed by CTIMP regulations – the UK Clinical Trials Regulations which inserted relevant provision into the AWI Act. In an emergency situation such as an individual experiencing a trauma, section 51(3A) of the AWI Act offers the provision for waivers of consent to be applied in certain circumstances. This allows for patients with incapacity to be enrolled in a study and receive research treatment in urgent situations without firstly seeking consent from an appropriate third person (guardian, welfare attorney or nearest relative) if it is not practicable to do so.

These waivers of consent are only applied in very specific circumstances, predominantly in emergency situations where treatment has to be applied to the patient urgently and there is not sufficient time to firstly locate and consult an appropriate representative of the patient who has lost capacity. Under section 51(3A) of the AWI Act this waiver of consent to allow a patient to receive immediate research treatment only applies if an ethics committee has approved the study and a professional representative, in this case the doctor leading the trauma team, agrees that the patient should be entered into the study. Consent can then be sought from the patient at a later time, when they regain consciousness and capacity, where they can decide if they wish to continue participating in the research treatment (in this instance, receiving fibrinogen). If the participant does not regain capacity, consent can be sought from the appropriate representative (e.g. nearest relative) when practicable.

In 2017, a similar trial called CRYOSTAT-2^[104] opened in England. This tested whether a product called cryoprecipitate could reduce mortality in trauma patients, in a similar manner to the fibrinogen used in the E-FIT 1 trials. Cryoprecipitate is a frozen donated blood product containing fibrinogen. Cryoprecipitate is natural and is licensed as a blood product, as opposed to manufactured like the fibrinogen in the E-FIT 1 trials. Because of this, cryoprecipitate is not classified as a drug. Treating with cryoprecipitate is therefore not governed by the Clinical Trials Regulations; meaning that, when the study involves treating adults with incapacity, it is governed by the AWI Act in Scotland, the Mental Capacity Act 2005 in England and Wales, and the Mental Capacity Act (Northern Ireland) 2016 in Northern Ireland.

Whilst, similarly to the Clinical Trials Regulations, both Mental Capacity Acts mentioned above have provision for emergency waivers of consent^[105],[106] in situations like the CRYOSTAT-2 trial; the AWI Act does not. Under the Act, seeking consent for adults with incapacity to participate in non-CTIMP research is a necessity in Scotland, even in emergency situations like those mentioned above where it is not always possible to find and seek consent from an incapacitated adult’s appropriate representative in a relevant timeframe for the research study. Therefore, studies such as CRYOSTAT-2 would be unlawful in Scotland. As such, Scottish patients were not involved in the study, and were not offered this potentially life-saving treatment.

There are a number of other studies in the area of emergency medicine that are currently incompatible with the terms of the AWI Act in Scotland as a result of the AWI Act lacking such provision, including but not limited to:

• The Spinal Immobilisation Study (SIS)^[107] which aims to assess neck immobilisation in patients who are suspected of a spinal injury in the pre-hospital and emergency setting.
• The SWIFT trial (Study of Whole blood In Frontline Trauma)^[108] in England and Wales. Akin to the cryoprecipitate treatment mentioned above, whole blood is also natural and is licensed as a blood product and not a drug. It is therefore not governed by section 51(3A) of the AWI Act that relates to CTIMP studies, and patients with incapacity in Scotland would have to be excluded from the study as it would be governed by other subsections of section 51 of the Act.
• The CoMiT-ED Trial (Conservative Management in Traumatic Pneumothoraces in the Emergency Department)^[109] aiming to find out whether a collapsed lung (pneumothorax) due to injury (trauma) can be safely and effectively treated without immediately inserting a tube into the chest.
• The AIRWAYS 3 Trial^[110], which aims to test a new method of treatment for patients that experience in-hospital cardiac arrest. The study will compare whether inserting a new type of airway device in the throat to assist and improve breathing is more effective than the current method of tracheal intubation (placing a breathing tube in the windpipe).

As mentioned above, the severe nature of the conditions experienced by patients eligible for the aforementioned studies means that delivering treatment is a matter of urgency, and that seeking consent from surrogate decision-makers is often not practicable. The current AWI Act offers no provision for emergency waivers of consent to be applied for this type of non-CTIMP research, preventing patients with incapacity from being enrolled in suitable research studies and receiving treatment, before then seeking consent from the appropriate persons at a later time. As a result, in Scotland, trauma and emergency research is only able to focus on better providing the care we know helps patients and, not on establishing new and improved treatments via research for patients suffering from these conditions. The following two proposals put forward two pathways that would permit waivers of consent to be applied in special circumstances.

Amending the AWI Act to allow emergency waivers of consent to be applied in specific situations would offer adults lacking capacity additional opportunities to participate in relevant non-CTIMP research studies. This would be where it is necessary to provide the research intervention and/or practice as a matter of urgency and it is not practicable to firstly obtain consent from an appropriate representative (guardian, welfare attorney, or nearest relative of the individual).

Firstly, we ask if the AWI Act should be amended to permit researchers to consult with a medical practitioner not associated with the research study regarding the suitability of a particular adult with incapacity to participate in the study. If the researcher and medical practitioner are in agreement, the individual can participate in the study. The appropriate representative of the individual (or the individual themself if they regain capacity during the research project) can then be consulted at the nearest practicable time, and decide whether the individual should continue participating in the research study.

Question

94. Should the AWI Act be amended to allow researchers to consult with a registered medical practitioner not associated with the study and, where both agree, to authorise the participation of adults with incapacity in research studies in emergency situations where an urgent decision is required and researchers cannot reasonably obtain consent from a guardian, welfare attorney or nearest relative in time?

In certain cases it may not even be practical, or there may not even be sufficient time, for researchers to consult with a registered medical practitioner in this manner. In such urgent cases, the AWI Act could be amended to permit researchers to enrol adults with incapacity in studies without the consent of their guardian, welfare attorney or nearest relative; or consulting a registered medical practitioner as outlined in the proposal above. This would only be possible in situations where the researchers act in a manner that adheres to protocols outlined in advance in their research application and which have undergone ethical review by Scotland A REC (or any other ethics committee constituted by Regulations made by the Scottish Ministers in the future).

Amending the AWI Act in this manner would provide another pathway for emergency waivers of consent to be provided for adults with incapacity in addition to the proposal described above (Q94).

If this were to be adopted in Adults with Incapacity legislation, researchers could enrol incapacitated patients in research studies without the consent of an appropriate representative of the individual. To reiterate, this would only apply in very specific emergency situations, namely:

• It is necessary to take action for the purposes of the specific research study in question as a matter of urgency, and
• It is not practical or feasible to obtain consent from the individual’s usual appropriate decision-maker, and
• It is not practical or feasible to obtain consent from a registered medical practitioner (note: this would only apply if the above proposal (Q94) were to be implemented)
• The researchers act in accordance with procedures they outlined in their research application, which has been approved by Scotland A REC (or any other ethics committee constituted by Regulations made by the Scottish Ministers in the future)

If an incapacitated adult is enrolled in a study in this manner, at the nearest practicable time, their appropriate decision-maker (e.g. guardian, welfare attorney or nearest relative) would be approached and asked whether the individual should continue to participate in the study.

Question

95. Should the AWI Act be amended to allow researchers to enrol adults with incapacity in research studies without the consent of an appropriate representative of the adult, in emergency situations where a decision to participate in research must be made as a matter of urgency, where researchers cannot reasonably obtain consent from an appropriate representative of the adult, and where researchers act in accordance with procedures that have been approved by Scotland A REC (or any other ethics committee constituted by regulations made by the Scottish Ministers)?

Expanding the list of approved persons who can provide consent for adults with incapacity participating in research

In its current form, the AWI Act only permits a guardian, welfare attorney or nearest relative to provide consent for adults with incapacity to participate in non-CTIMP research^[111]. In circumstances where these surrogate decision-makers cannot be reached, there is no pathway in the AWI Act that allows adults with incapacity to participate in non-CTIMP studies.

Outside of the concept of waivers of consent applied in urgent and emergency situations as discussed in the previous section, another option that would increase the number of routes available to adults with incapacity to participate in research could be to expand the list of approved persons who can provide consent on their behalf. An example of this could be to amend the AWI Act to include a provision for researchers to nominate an individual to consult with about the suitability of involving a particular adult with incapacity in a research project. This nominated person would be somebody involved in the professional care of that individual (e.g. their GP, nurse or social care worker), provided they are not associated with the research project in question. However, as long as the nominated person has a professional duty of care for the incapable adult in question, there would be no requirement for the nominated person to belong to a particular profession.

The exact nature of how nominated persons are selected would be specified in each research proposal that would be submitted to Scotland A REC (or any other ethics committee constituted by regulations made by the Scottish Ministers) for review and approval. If both the researcher and nominated person agree that it would be appropriate for the individual to participate in a particular research project, they can be enrolled in the study. However, if at any time the nominated person believes it is no longer suitable for the individual to participate, they will be withdrawn from the study.

Unlike the previous proposals (Q94 and Q95), it is important to note that such a provision could be used even outside of urgent and emergency situations.

Implementing this change to the AWI Act would expand the list of individuals permitted to provide consent for adults with incapacity, providing these individuals with more pathways to participate in research where appropriate. Whilst such a provision could be used even outside of emergency situations, researchers would only be able to nominate a professional consultee (a person with a professional duty of care for an adult with incapacity, e.g. the individual’s carer, nurse, social care worker or GP) to provide consent for the incapacitated adult to participate research study if the researchers have already made reasonable steps to try and contact a guardian, welfare attorney, or nearest relative of the individual without success, and the nominated person is not associated with the research study in question.

Question

96. Should the AWI Act be amended to permit researchers to nominate a professional consultee to provide consent for adults with incapacity to participate in research, in instances where researchers cannot reasonably obtain consent from a guardian, welfare attorney or nearest relative?

Allowing adults with incapacity to participate in a wider range of research studies

As of now, the AWI Act only permits individuals with incapacity to participate in research that cannot be carried out on an adult who has capacity and that the research in question hopes to obtain knowledge about ‘the causes, diagnosis, treatment or care of the adult’s incapacity; or the effect of any treatment or care given during his incapacity to the adult which relates to that incapacity’^[112]. In other words, there is no provision in the AWI Act that permits adults with incapacity to participate in research relating to any other medical conditions that individual may experience that are not linked to the individual’s incapacity; or indeed research of any other nature.

Case study: Multimorbidity and an aging population

As people age, their risk of developing certain conditions increases. For example, bearing in mind that National Records of Scotland figures for 2019 estimate that 19% of Scotland’s population is aged 65 and above^[113], the below conditions appear to be greatly overrepresented in older people:

Dementia: estimates suggest 96.7% of individuals diagnosed with dementia in 2020 in Scotland were aged 65 and above^[114].

Type 2 Diabetes: of the 278,143 individuals with Type 2 Diabetes in Scotland recorded in the 2020 Scottish Diabetes Survey, 57.7% were aged 65 and above^[115].

Cancer: 34,133 individuals were diagnosed with cancer in Scotland in 2019, with 76% of such diagnoses occurring in individuals aged 60 and above^[116].

Individuals can also experience multiple conditions, such as those outlined above, simultaneously. Living with more than one chronic condition at the same time is known as multimorbidity. Despite affecting a broad range of individuals across many age groups, multimorbidity is more prevalent in older people^[117]. With the age profile of Scotland’s population predicted to increase in the coming years – with the proportion of the population above the pensionable age estimated to increase to 22.9% by 2043^[118] – rates of multimorbidity are also likely to rise in Scotland.

This is not a phenomenon restricted to Scotland. A high prevalence of multimorbidity in older populations is observed across many regions of the world^[119]. All of this data points towards a higher likelihood of adults with incapacity experiencing multimorbidity as they age, and living with conditions that do not necessarily relate to their incapacity. The current form of the AWI Act precludes incapacitated individuals with multimorbidity from participating in studies for conditions they experience that do not relate to their incapacity. One way in which this issue could be resolved would be to amend the AWI Act in a manner that does not restrict the type of research studies incapacitated individuals can participate in to those that investigate conditions related to their incapacity. This, however, could be achieved in one of several ways. For example, the AWI Act could be amended to allow adults with incapacity to participate in:

• Research into conditions arising as a consequence of the adult’s incapacity, or;
• Research into any condition – related to their incapacity or not – that the adult experiences, or;
• Any type of research.

Each of these possibilities are discussed below.

It can be the case that adults with incapacitating conditions are predisposed to suffering from other conditions. For example, the symptoms associated with dementia can place people with such a condition at a higher risk of suffering a fall^[120], which can consequently lead to serious injuries such as hip fractures in some instances. A strict reading of the current Act may preclude dementia patients with incapacity from participating in hip fracture studies, since hip fractures do not necessarily directly relate to the individual’s incapacity in the manner that is stipulated in the Act. One possibility would be to amend the AWI Act to allow adults with incapacity to participate in research projects that also involve any conditions that arise as a consequence of the adult’s incapacity:

Question

97. In addition to being permitted to participate in research that investigates the cause, diagnosis, treatment or care of their incapacity, should the AWI Act be amended to allow adults lacking capacity to participate in research that investigates conditions that may arise as a consequence of their incapacity?

Unlike the above example that highlighted potential injuries or conditions that may arise as a consequence of an individual’s incapacity, there are also cases where some individuals may experience a medical condition that is completely unrelated to their incapacity. For example, some people may experience chronic conditions or illnesses before then developing a condition that may cause them to lose capacity. In these instances, under the current Act, such individuals may not be permitted to participate in research that investigates the original chronic condition they started to experience before they developed a separate condition that resulted in their loss of capacity. One proposal to resolve this would be to amend the AWI Act to allow adults with incapacity to participate in research studies that investigate any condition they may experience – regardless of whether it relates to their incapacity or not.

Question

98. In addition to being permitted to participate in research that investigates the cause, diagnosis, treatment or care of their incapacity, should the AWI Act be amended to allow adults lacking capacity to partake in research that investigates conditions they experience that do not relate to their incapacity?

Research should lead to novel care and treatment regimens that are widely applicable across the population. Developing processes where a wider range of people, including adults with incapacity, can participate in research is likely to make the outcomes of such studies more robust and applicable to the population as a whole. In addition, by excluding adults with incapacity from participating in certain types of research, we may risk research outcomes not catering to the needs of these individuals. For example, whilst people may not currently experience a particular condition, they could be at risk of developing that condition in the future as a result of their genetic predisposition, their age, or other pre-existing conditions they experience.

In situations such as this, it is important to understand how people at risk of developing a particular condition can take steps to reduce their chances of developing that condition. By allowing adults with incapacity to participate in research studies that may explore conditions that they do not personally experience, this opens up the possibility for adults with incapacity to participate in preventative research studies for conditions they could be at an elevated risk of developing. This in turn could improve our understanding of the progression of these conditions and help provide insights into the steps that adults with incapacity can take to help reduce their chances of developing conditions in the future.

To summarise, a further possibility would be to amend the AWI Act to allow adults with incapacity to participate in any type of research; provided that the same stringent safeguards and checks are applied to ensure the wellbeing and rights of these individuals:

Question

99. Should the AWI Act be amended to allow adults with incapacity the opportunity to participate in any research; regardless of whether the research explores conditions that relate to their incapacity or investigates conditions that they experience themselves?