|
|
Requirement for review by a Research Ethics Committee
Research that includes adults (16+ years) who lack capacity to consent (whether it is a clinical trial or other research considered 'intrusive') in England and Wales must be carefully reviewed by an appropriately 'flagged' Research Ethics Committee (REC) to ensure that the inclusion of adults who lack capacity is justified and that appropriate arrangements are in place for consulting others on the person’s behalf. It also considers any risks and benefits for participants, and that the safety of participants is ensured.
Full details of the requirements and processes are found on the Health Research Authority website. More details about the relevant legislation can be found on the Legal Frameworks page of this website.
Full details of the requirements and processes are found on the Health Research Authority website. More details about the relevant legislation can be found on the Legal Frameworks page of this website.
Research that is not a clinical trial of a medicinal product (a non-CTIMP study)
In England and Wales, sections 30-33 of the Mental Capacity Act 2005 (MCA) allows for ‘intrusive’ research to be carried out involving adults lacking capacity to consent provided that the research has been given a favourable opinion by an appropriate REC. Unlike other decisions covered by the MCA, such as those about medical treatment and care, best interests procedures do not apply to decisions about taking part in research as other safeguards are in place (see below). Instead, each individual decision is based on what the person would have decided if they had capacity to do so.
What conditions apply in section 31?
1. The research must be connected with an impairing condition affecting the participant or its treatment.
2. Research would not be as effective if only carried out with participants with capacity.
3. The research must either:
(a) Have the potential to benefit the participant without imposing a disproportionate burden,
OR
(b) Provide knowledge of the causes of, or treatment or care of others with, the same or a similar condition – in this case the research must involve negligible risk to the participant, not interfere significantly with their freedom of action or privacy, or be unduly invasive or restrictive.
4. Arrangements must be in place to comply with section 32 (consulting carers) and section 33 (additional safeguards).
Who can act as a consultee?
The researcher must have adequate arrangements in place for consulting consultees about whether a person lacking capacity should take part in the research.
Reasonable steps must be taken to identify a personal consultee who is someone 'engaged in caring for the person or is interested in their welfare' (s32). This is usually a family member. If no appropriate person can be identified who is willing to act as a personal consultee, the researcher may consult a nominated consultee, i.e. a person independent of the project. There is more information on the Consent and Consultation page and guidance is available on nominating a consultee for research involving an adult who lacks capacity to consent.
The consultee must be given information about the project and advise on whether the person should take part in the project, and what, in their opinion, the person's wishes and feelings about taking part in the project would be likely to be if they had capacity to decide. The consultee gives advice to the researcher rather than provide consent, and the researcher makes the decision whether to include the person in the project or not.
The advice of the consultee must be respected. If, at any time, the consultee advises the researcher that, in their opinion, the person's wishes and feelings would be likely to lead them to decline to take part in the project, they should not take part in it or be withdrawn from it unless withdrawal of treatment would involve significant risk to the participant’s health.
What additional safeguards apply?
Nothing must be done to which the participant appears to object unless it is to protect him/her from harm, or reduce or prevent pain or discomfort.
If the participant indicates he/she wishes to be withdrawn, this must be done without delay unless there would be a significant risk to his/her health.
They should not be included in research if that would be contrary to an advance decision they have made or any other form of statement e.g if the treatment under investigation in a study is included in an Advance Decision to Refuse Treatment.
In conducting the research, the interests of the participant must always be assumed to outweigh those of science and society.
For nominated consultees, what does 'no connection with the project' mean?
The guidance on nominating a consultee suggests that researchers should consider a wide range of possible connections to the particular study. For example, the consultee should not be someone who is involved or has a financial interest in the progress of the research. They should not be under the influence of the research team, either professionally or personally (e.g. be a junior member of staff whose career might be influenced by a senior member of the research team). They should also not have wider connections such as direct links to the funding of the study or with the REC that approved the project.
The guidance provides an example of someone living in a care home who might not have any close family but is close to a member of the care home staff. In this case, the member of staff could be approached to act as a nominated consultee. However, it would not be appropriate if the staff member was also undertaking research activities for the study, or if the home and its staff had a direct interest in the outcome of the research.
Some sites create a panel of staff who can act as a nominated consultee for any participants who do not have someone willing or able to act as a personal consultee. Other sites may identify a member of staff on each occasion.
What conditions apply in section 31?
1. The research must be connected with an impairing condition affecting the participant or its treatment.
2. Research would not be as effective if only carried out with participants with capacity.
3. The research must either:
(a) Have the potential to benefit the participant without imposing a disproportionate burden,
OR
(b) Provide knowledge of the causes of, or treatment or care of others with, the same or a similar condition – in this case the research must involve negligible risk to the participant, not interfere significantly with their freedom of action or privacy, or be unduly invasive or restrictive.
4. Arrangements must be in place to comply with section 32 (consulting carers) and section 33 (additional safeguards).
Who can act as a consultee?
The researcher must have adequate arrangements in place for consulting consultees about whether a person lacking capacity should take part in the research.
Reasonable steps must be taken to identify a personal consultee who is someone 'engaged in caring for the person or is interested in their welfare' (s32). This is usually a family member. If no appropriate person can be identified who is willing to act as a personal consultee, the researcher may consult a nominated consultee, i.e. a person independent of the project. There is more information on the Consent and Consultation page and guidance is available on nominating a consultee for research involving an adult who lacks capacity to consent.
The consultee must be given information about the project and advise on whether the person should take part in the project, and what, in their opinion, the person's wishes and feelings about taking part in the project would be likely to be if they had capacity to decide. The consultee gives advice to the researcher rather than provide consent, and the researcher makes the decision whether to include the person in the project or not.
The advice of the consultee must be respected. If, at any time, the consultee advises the researcher that, in their opinion, the person's wishes and feelings would be likely to lead them to decline to take part in the project, they should not take part in it or be withdrawn from it unless withdrawal of treatment would involve significant risk to the participant’s health.
What additional safeguards apply?
Nothing must be done to which the participant appears to object unless it is to protect him/her from harm, or reduce or prevent pain or discomfort.
If the participant indicates he/she wishes to be withdrawn, this must be done without delay unless there would be a significant risk to his/her health.
They should not be included in research if that would be contrary to an advance decision they have made or any other form of statement e.g if the treatment under investigation in a study is included in an Advance Decision to Refuse Treatment.
In conducting the research, the interests of the participant must always be assumed to outweigh those of science and society.
For nominated consultees, what does 'no connection with the project' mean?
The guidance on nominating a consultee suggests that researchers should consider a wide range of possible connections to the particular study. For example, the consultee should not be someone who is involved or has a financial interest in the progress of the research. They should not be under the influence of the research team, either professionally or personally (e.g. be a junior member of staff whose career might be influenced by a senior member of the research team). They should also not have wider connections such as direct links to the funding of the study or with the REC that approved the project.
The guidance provides an example of someone living in a care home who might not have any close family but is close to a member of the care home staff. In this case, the member of staff could be approached to act as a nominated consultee. However, it would not be appropriate if the staff member was also undertaking research activities for the study, or if the home and its staff had a direct interest in the outcome of the research.
Some sites create a panel of staff who can act as a nominated consultee for any participants who do not have someone willing or able to act as a personal consultee. Other sites may identify a member of staff on each occasion.
Clinical trial of investigational medicinal product (CTIMPs)
Clinical trials that fall under the Medicines for Human Use (Clinical Trial) Regulations 2004 must also be reviewed by a recognised Research Ethics Committee (REC) and licensed by the MHRA. Schedule 1 Part 5 of the Regulations provides the conditions and principles that apply to clinical trials in relation to adults who lack capacity.
What conditions apply?
The clinical trial must relate directly to a life-threatening or debilitating clinical condition from which a potential participant suffers.
There must be grounds to expect that administering the medicinal product to be tested in the trial will produce a benefit to the participant that outweighs the risks (or will result in no risk at all).
The clinical trial must be essential to validate data obtained either:
(a) in other clinical trials involving participants who are able to give informed consent
OR
(b) by other research methods.
No incentives or financial inducements may be given to a participant or their legal representative, except provision for compensation in the event of injury or loss.
What are the principles that apply?
Informed consent given by a legal representative represents the presumed will of the person who lacks capacity.
The clinical trial must be designed to minimise pain, discomfort, fear and any other foreseeable risk in relation to the disease and the cognitive abilities of the patient.
The legal representative must be informed about the objectives, risks and inconveniences of the trial and the conditions under which it is to be conducted. The legal representative can withdraw the person who lacks capacity from the trial at any time by revoking their informed consent.
The person who lacks capacity should be informed about the trial, its risks and its benefits, according to their ability to understand the information. If they are able to assess the information and form an opinion, then any refusal to participate in the trial, or wish to be withdrawn from it, should be considered by the researcher.
The interests of the participant must always prevail over those of science and society.
Who can act as a legal representative?
Someone who is suitable 'by virtue of their relationship' and is available and willing can act as a personal legal representative, this is usually a family member although it may be a close friend. There is more information on the Consent and Consultation page.
If there is no-one to act as a personal legal representative, then someone who is not connected with the trial can act as a professional legal representative. This is usually the doctor primarily responsible for the person's medical treatment or someone nominated by the relevant health care provider.
Some sites create a panel of medical staff to act as a professional legal representative for any participants who do not have someone willing or able to act as a personal legal representative. Other sites may identify a member of staff each time, meaning that it might be someone different acting as a legal representative.
What conditions apply?
The clinical trial must relate directly to a life-threatening or debilitating clinical condition from which a potential participant suffers.
There must be grounds to expect that administering the medicinal product to be tested in the trial will produce a benefit to the participant that outweighs the risks (or will result in no risk at all).
The clinical trial must be essential to validate data obtained either:
(a) in other clinical trials involving participants who are able to give informed consent
OR
(b) by other research methods.
No incentives or financial inducements may be given to a participant or their legal representative, except provision for compensation in the event of injury or loss.
What are the principles that apply?
Informed consent given by a legal representative represents the presumed will of the person who lacks capacity.
The clinical trial must be designed to minimise pain, discomfort, fear and any other foreseeable risk in relation to the disease and the cognitive abilities of the patient.
The legal representative must be informed about the objectives, risks and inconveniences of the trial and the conditions under which it is to be conducted. The legal representative can withdraw the person who lacks capacity from the trial at any time by revoking their informed consent.
The person who lacks capacity should be informed about the trial, its risks and its benefits, according to their ability to understand the information. If they are able to assess the information and form an opinion, then any refusal to participate in the trial, or wish to be withdrawn from it, should be considered by the researcher.
The interests of the participant must always prevail over those of science and society.
Who can act as a legal representative?
Someone who is suitable 'by virtue of their relationship' and is available and willing can act as a personal legal representative, this is usually a family member although it may be a close friend. There is more information on the Consent and Consultation page.
If there is no-one to act as a personal legal representative, then someone who is not connected with the trial can act as a professional legal representative. This is usually the doctor primarily responsible for the person's medical treatment or someone nominated by the relevant health care provider.
Some sites create a panel of medical staff to act as a professional legal representative for any participants who do not have someone willing or able to act as a personal legal representative. Other sites may identify a member of staff each time, meaning that it might be someone different acting as a legal representative.
Emergency research
Emergency research can be very challenging in terms of obtaining consent from people who are acutely unwell. In emergency situations, adults who lack capacity to consent for themselves can be recruited into research without prior consent, providing certain conditions are met. Guidance is provided on the Health Research Authority website.
What conditions apply?
For Clinical Trials of Investigational Medicinal Products (CTIMPs) in the UK, adults lacking capacity can be enrolled in emergency when:
Similarly, for intrusive research under the Mental Capacity Act 2005 in England and Wales, adults lacking capacity can be included without prior advice if:
For all types of research, the procedure must be approved by an appropriate NHS Research Ethics Committee, and a legal representative or consultee must be approached as soon as possible to provide consent or advice on the participant's likely wishes and preferences.
Adults recruited without prior consent or consultation may regain their capacity to give consent, and their own consent to continue their participation must be sought in these situations (see the Research Conduct page).
The legal frameworks governing non-CTIMP studies in Scotland does not provide any 'exemptions' from the requirement for consent from a Welfare Attorney/Guardian or Nearest Relative for adults not able to consent for themselves, even in emergency situations.
What conditions apply?
For Clinical Trials of Investigational Medicinal Products (CTIMPs) in the UK, adults lacking capacity can be enrolled in emergency when:
- The treatment needs to be given urgently;
- It is also necessary to take urgent action to administer the treatment for the purposes of the trial
- It is not reasonably practicable to obtain consent from a legal representative
Similarly, for intrusive research under the Mental Capacity Act 2005 in England and Wales, adults lacking capacity can be included without prior advice if:
- It is necessary to ‘take action for the purposes of the research’ as a matter of urgency
- It is not reasonably practicable to seek advice from a consultee
- There is agreement from a registered medical practitioner who is not involved in the organisation or conduct of the research project or, if it is not reasonably practicable in the time available to obtain that agreement, follows the process as approved by an appropriate NHS Research Ethics Committee
For all types of research, the procedure must be approved by an appropriate NHS Research Ethics Committee, and a legal representative or consultee must be approached as soon as possible to provide consent or advice on the participant's likely wishes and preferences.
Adults recruited without prior consent or consultation may regain their capacity to give consent, and their own consent to continue their participation must be sought in these situations (see the Research Conduct page).
The legal frameworks governing non-CTIMP studies in Scotland does not provide any 'exemptions' from the requirement for consent from a Welfare Attorney/Guardian or Nearest Relative for adults not able to consent for themselves, even in emergency situations.
Research ethics resources
These resources are intended to support the design of ethical studies, and when seeking ethical approval.
Reviewing researchWebsite that offers a guide for those reviewing research involving adults with impaired capacity to consent. A separate page covers research in emergency situations
|
MRC Ethics GuideMRC guidance sets out the general principles for assessing whether individuals have the capacity to consent to participation in research. It also discusses participation in research projects when capacity is lacking
|
Deferred consentGuide to the design and review of emergency research when it is proposed that consent and consultation be waived, including a practical framework of ‘questions and considerations’ for those developing or reviewing such research
|
Ethics for Dementia ResearchThe DEEP-Ethics Gold Standards draw together principles which have been identified by people with dementia who are involved in research (or are wanting to be involved) including a checklist for researchers (with and without dementia) who are planning a research project involving people with dementia
|
Video learning
|
Example IRAS form: emergency researchPublicly available IRAS form from the RECOVERY-Supportive Care study from April 2020. This is an emergency COVID-19 non-CTIMP study which received a favourable ethical opinion to enrol patients without prior consent (deferred consent)
|