Ethics Review Form for Mental Capacity Act (MCA) Studies (Lead Reviewer/REC Member)

The content and requests for further information included in this form should be discussed in the meeting as it is important that the review reflects the opinion of the entire Committee as opposed to the view of an individual member/s.

Electronically saved copies of this form should be deleted after the final opinion has been issued. Comments entered into the online version of this form in the HARP Reviewer Portal will be deleted automatically one month after the final opinion has been issued.

Note: This form includes the general ethical domains to be considered for all studies, additional considerations for MCA studies are bolded.

Compliance with the Mental Capacity Act (England and Wales), 2005 and the Mental Capacity Act (Northern Ireland) 2016

Under Section 31 of the Mental Capacity Act 2005 (England and Wales) and the equivalent Section 134 of the the Mental Capacity Act (Northern Ireland) 2016 the REC must be satisfied that a number of specific criteria are met in relation to the inclusion of adults lacking capacity to consent for themselves.

Meeting Date:

IRAS Project ID/REC Reference Number:

Study Title:

Brief overview of study (optional depending on REC practice)

1 .Social or Scientific Value; scientific design and conduct of the study (IRAS A6, A7-14, A57-62, A75)

Evaluation of a treatment, intervention, or theory that will improve health and well-being or increase knowledge. RECs should take into account the public interest in reliable evidence affecting health and social care. Use of accepted scientific principles and methods, including statistical techniques, to produce reliable and valid data.

• Is the research question important and necessary? Suitably representative public involvement in the planning of the study (A14-1) can provide the Committee with assurances that the people the research is intended to benefit think the research question is important and necessary.
• Is the research design and proposed statistical analysis able to answer the question?
• Is there equipoise; are all treatment arms viable options for the research

1.1 Relevance of the research to impairing condition

The REC must consider whether the research is connected with an impairing condition affecting research participants who are unable to consent, or with the treatment of the condition. An impairing condition means a condition which is attributable to (or causes or contributes to) an impairment or disturbance in the functioning of the mind or brain.

Treatment in this context includes the provision of any clinical treatment or other health and social care in connection with the impairing condition.

1.2 Justification for including adults lacking capacity to meet the research objectives

The REC must consider whether or not the research could be carried out as effectively if it was confined to research participants able to give consent, i.e. is it necessary to include research participants lacking capacity in order to meet the research objectives?

Comments/issues for discussion:

2 .Recruitment arrangements and access to health information, and fair participant selection (IRAS A16, A17- 1, A17-2, A27-29, A46, A47).

• Consider the inclusion and exclusion of potential research participants. The benefits and risks of research should be distributed fairly among all social groups and classes, taking particular account of age, disability, gender, race, religion or belief and sexual orientation, as well as economic status and culture. Suitably representative public involvement in the planning of the study can also provide assurances to the Committee that recruitment is likely to be equitable.
• Consider the population which is likely to be included in the research and what the needs of this group might be. Will it be feasible for provisions to be made available for potential participants who might have difficulty understanding English?
• How are research participants recruited? How does participation impact on their clinical care?

2.1 Arrangements for appointing consultees

The REC must be satisfied that reasonable arrangements will be in place to comply with Section 32 of the Mental Capacity Act 2005 (England and Wales) and the equivalent Section 135 of the Mental Capacity Act (Northern Ireland) 2016.

This requires the researcher, as part of the recruitment strategy, to identify and consult persons (consultees) to advise on whether a person lacking capacity should take part and, in their opinion, what the person’s wishes and feelings would be likely to be if they had capacity. The research team must take reasonable steps firstly to identify a personal consultee who is engaged in caring for the participant or is interested in their welfare (but not in a professional capacity or for remuneration) and is prepared to be consulted. If no such person is available, the research team should have a strategy for appointing nominated consultees who are independent of the project in conjunction with the host organisations at each site.

2.2 The arrangements for recruitment in an emergency setting (if applicable)

The Mental Capacity Acts allow for recruitment without prior consultation where treatment is to be provided as a matter of urgency and it is not reasonably practicable to identify and consult with a personal or nominated consultee beforehand. Enrolment may then take place:

(a) with the agreement of a doctor independent of the project; or, where this is also not reasonably practicable in the time available.

(b) in accordance with any procedure approved by the REC.

Where enrolment without prior consultation is proposed, the REC must be satisfied that this is justified in the circumstances. It should also ensure the researcher has procedures in place to seek consent from a capable research participant (if recovered) or to consult a consultee as soon as practicable after urgent treatment has been provided.

Comments/issues for discussion:

3 .Favourable Risk Benefit Ratio; Anticipated benefits/risks for research participants present and future (IRAS A18- 25 & part B3 if radiation, and part B 5 if tissue samples are included).

Is there evidence that the following factors have been considered? Benefits/risks for individual research participants, including steps that have been taken to minimise or eliminate the risk, hazards, discomfort, and distress and enhancement of potential benefits. Whether the risk to the research participants are proportionate to the benefits to the research participant and society; and

• Whether the balance between risk and benefit is equitable?

Suitably representative public involvement in the planning of the study can provide the Committee with assurances in relation to the points above.

3.1 Balance between benefit and risk, burden and intrusion

The REC must be satisfied that one of the following criteria is met by the research:

a) The research is of potential benefit to research participants lacking capacity without imposing a disproportionate burden

or:

b) The research is intended to provide knowledge of the causes or the treatment or care of the condition affecting participants lacking capacity or of a similar condition, and additionally:

• The risk to participants is likely to be negligible
• The research will not significantly interfere with their freedom of action or privacy
• The research will not be unduly invasive or restrictive.

Comments/issues for discussion:

4. Care and protection of research participants; respect for potential and enrolled research participants’ welfare and dignity (IRAS A8, A12, A14, A25, A50-53, A76, A77).

Consider the following:

• permitting withdrawal from the research
• protecting privacy through confidentiality
• informing participants of newly discovered risks or benefits
• informing participants of results of research
• maintaining welfare of participants
• Arrangements and feedback at the end of the study?
• Do the researchers demonstrate an awareness of research transparency? (For example, study registration, sharing of results, plans for publication)
• Provision of appropriate indemnity and insurance e.g. negligent/ non-negligent harm. (Note: RECs only need to consider this for studies taking place outside of the NHS. For studies involving the NHS/HSC, the insurance information will be checked as part of assessing the application for HRA and HCRW Approval ((for studies led from England or Wales)) or as part of the study wide review ((for studies led from Scotland or Northern Ireland)).

Data protection and research participant’s confidentiality (IRAS A36 - 43)

• Where and how will data be stored?
• Will the data be anonymised/pseudonymised. Pseudonymised data can be restored to its original state with the addition of information which then allows individuals to be re-identified.
• How long will the data be stored for?
• Who will access the data?
• Are research participants, informed that access to their medical notes may be required?
• Are arrangements made to deal with incidental disclosure

4.1 Additional safeguards

The REC must be satisfied, from the information in the application and any further assurances given during the review that the additional safeguards set out in Section 33 of the Mental Capacity Act 2005 (England and Wales and the equivalent Section 137 of the Mental Capacity Act (Northern Ireland) 2016 will be complied with during the conduct of the research.

These additional safeguards are as follows:

Nothing will be done in the course of the research:

(a) to which research participants lacking capacity appear to object (unless it is to protect them from harm or reduce/prevent pain or discomfort)

(b) which would be contrary to any known advance decision or statement they have made.

If research participants indicate in any way that they wish to be withdrawn from the project, they must be withdrawn without delay, except where this involves stopping treatment and there could be a significant risk to their health.

Research participants lacking capacity must also be withdrawn if any of the criteria set out in Section 32 of the Mental Capacity Act 2005 (England and Wales) and the equivalent Sections 135 and 136 of the Mental Capacity Act (Northern Ireland) 2016 no longer apply.

In conducting the research, the interests of research participants must be assumed to outweigh those of science and society.

Comments/issues for discussion:

5. Informed consent process and the adequacy and completeness of research participant information (IRAS A30-34, A46, A49 & Informed Consent Documentation).

Provision of information to research participants about the purpose of the research, its procedures, potential risks, benefits, and alternatives, so that the individual understands this information and can make a voluntary decision whether to enrol and continue to participate. Suitably representative public involvement in the design of the informed consent process and informed consent documentation can provide assurances to the Committee regarding these points. Is the language used clear and understandable to the research participants it is aimed at? If the research will include children, has age appropriate information been provided?

• Does the documentation include all the procedures as described in the protocol? Have uncertainty and randomisation been explained to the research participant?
• Is consent taken as part of a process with research participants having adequate time to consider the information, and opportunity to ask questions?
• Is it clear to what the research participant consents or assents?
• Is there any inducement?
• Is consent obtained to allow GP’s to be informed?
• IRAS A35 – What steps would be taken if a participant lost capacity during the study? Subject to ethical approval, tissue samples and data already collected may be retained in identifiable form and used in the research provided that properly informed and expressed consent for this was given prior to the onset of incapacity. If the applicant states that the participant would remain in the study following the loss of capacity and would undergo further interventions and procedures (including the collection of new samples and/or personal data) this would constitute "intrusive research" for the purposes of the Mental Capacity Act 2005 in England and Wales and would require approval under Section 30 of the Act. In Scotland, approval would be required under section 51 of the Adults with Incapacity (Scotland) Act 2000. In Northern Ireland approval would be required under the equivalent Section 132 of the Mental Capacity Act (Northern Ireland) 2016.

5.1 Information for consultees

The REC must be satisfied that appropriate information will be provided to consultees about the research and their role as a consultee. There is no statutory requirement for the consultee to sign a form, but it is strongly recommended that the researcher uses a Consultee Declaration Form to confirm that the consultee has received the information, has had the opportunity to ask questions and has advised they have no objection to the participation of the person lacking capacity. A template for the declaration is set out in the HRA guidance on information sheets. Where carers will also be recruited as research participants in their own right, the information sheet should distinguish clearly between the two roles and the carer should sign a consent form separate from the consultee declaration sheet.

Comments/issues for discussion:

6. Suitability of the applicant and supporting staff (investigator CV & IRAS A47, A48)

Medical research must be conducted only by individuals with the appropriate scientific training and qualifications. Research on patients or healthy volunteers requires the supervision of a competent and appropriately qualified physician or other health care professional.

• Are the applicant and supporting staff suitably qualified and do they have experience relevant to the proposed research?
• Are the local facilities and arrangements suitable?
• Have any conflicts of interest been considered?
• Has the safety of the research team been considered? (Note: RECs should not request copies of lone worker policies or information regarding research contracts or research passports. Employers and study sponsors are responsible for ensuring that this documentation is in place).

Comments/issues for discussion:

7. Independent review (IRAS A54-56)

Review of the design of the research trial, its proposed research participant population, and risk-benefit ratio by individuals unaffiliated with the research. The REC may be satisfied with credible assurances that the research has an identified sponsor and that it takes account of appropriate scientific peer review.

Comments/issues for discussion:

8. Suitability of supporting information

For example: GP letter, interview schedules, questionnaires, lone working policies.

Comments/issues for discussion:

9. Other general comments

For example: missing information, typographical errors, application errors.

(IRAS A6-1) questions arising from the Initial Assessment for REC Form (for studies involving the NHS and led from England or Wales).

Note: A request to change the research summary should only ever be listed as a recommendation. The summary will be published on the HRA website together with the REC’s opinion.

Comments/issues for discussion:

10. Issuing an Ethical Opinion - Key Principles for Requesting Further Information (RFI)

When the REC decides to issue a Provisional Opinion or a Favourable Opinion with Conditions decision, a request for further information (RFI) is sent to the applicant in order that the relevant changes can be addressed.

It is important that requests for further information are clearly articulated so that the applicant fully understands what is required and can provide a comprehensive response. It is also important that requests for further information and document changes have been agreed by the Committee as a whole (with the exception of minor spelling and typographical errors).

Please reflect on the following principles, when requesting further information from the applicant:

1. A request for further information should be focused on issues that if not resolved could cause the study to be rejected. The REC should consider carefully why it is asking for something. What are the implications of not requesting a particular point? How can the request be articulated clearly in the decision outcome?
2. Where specific changes are requested, the rationale for them should be provided. The request should describe the issue in a full sentence or paragraph. The more specific this can be the better. The REC should be absolutely clear about what it is asking and what response it requires to address the issue (if the REC isn’t clear about what is required then the applicant won’t be clear either).
3. Where a comment is being made for applicants/sponsors to take account of in the future (e.g. other applications or future updates of a document or suggestion for improvement) they should be clearly indicated. Clearly state what are mandatory requirements to address before a favourable opinion can be issued and which are suggestions or advice only.
4. Where an open request is being made, such as where further justification or clarification is requested, the rationale for this should be clearly indicated. This is particularly important where there may be an additional action based on the response received, such as a corresponding update to the Participant Information Sheet (PIS). If a corresponding change to a document will be required, then this should be mentioned in the initial request for further information.
5. It should always be clear for the sponsor that an updated version of the relevant documents should be provided when responding to the RFI.