Mental Capacity – a REC chair’s PerspectiveJan DownerChair London-Harrow REC

REC Approval –adults lacking capacity

Take you through the the process & deliberations of a REC , it isn’t just about checking the Patient Information Sheets!

Important that right at the beginning when planning and designing a study researchers consider the requirements needed for REC approval .

People who may lack capacity to consent

•Dementia•Mental illnesses•Significant learning disabilities•Confusion, drowsiness, or loss of

consciousness e.g. trauma, stroke, or heavily sedated/seriously ill needing intensive care, serious accident

•Drug overdose/withdrawal

Incapacity can be

•Permanent

•Temporary when an individual regains capacity during the research

•Develop lack of capacity during the research

•Emergency situation

Assessing capacity (1) A person is unable to make a decision for himself if he has an impairment of the mind or brain and as a result is unable to

• Understand the information about the study

• Retain that information sufficiently long enough

• Weigh up that information to understand the consequences of the options and use that information to make a decision

• Communicate his decision (by any means)

Thus it does not involve a specific test Make sure the information has been provided in the most suitable way e.g. Using pictures to help understanding, best time of day etc.

Papaver Rhoeas

Common poppy

Assessing capacity (2)•People with a duty of care must assess

capacity to make a particular decision at the particular time

•Researchers must be able to assess capacity when recruiting participants – or seek an opinion from the person’s clinical team or expert advice from other professionals

Thus Assessment is decision and time specific

Who do you ask for advice about an adult who lacks capacity

Relative, friend or carer who is not paid or acting in a professional capacity can give advice.

If not available a person not connected with the study can be nominated to give advice reflecting the best interests of the person who lacks capacity e.g. GP

All the above individuals must have an interest in the person’s welfare

Firstly which regulations apply?

A Clinical Trial of a Medicinal Product (CTIMP study) is considered under the Medicines for Human Use (Clinical Trials) 2004 regulations, slight differences in Scotland

All other non-CTIMP studies are considered under the Mental Capacity Act 2005 England & Wales- different in Scotland (Adults with incapacity Act 2000) and in Northern Ireland (common law)

Both apply to adults over 16 years

Differences between Clinical Trials(CT) regulations & MCA 2005

• CTIMPs a researcher seeks informed consent from a legal representative which legally represents the person’s presumed will whereas in all other types of research (non- CTIMPs) a researcher seeks advice from a consultee

• For CTIMPs there is a higher threshold to justify inclusion of adults lacking capacity into a research study- there should be a benefit or involve ‘no risks at all’. In non-CTIMPs under the MCA if there are no benefits, risks should be minimal or negligible.

Common Law

In England and Wales no one can provide consent for another adult (apart from CT regulations)

Advice is given supported by a signed declarationunder the conditions imposed in sections 30 -33 of the Mental Capacity Act 2005

Benefits / Minimal risk

•Minimal risk – very slight & temporary negative impact on the person

•Difficult in a randomised controlled trial where equipoise is in place

Starting to plan a study • CTIMP or non CTIMP –this will affect the recruitment

process• Could this research be done with participants who

have capacity to give consent?• How do you plan to recruit study participants and

obtain the necessary permissions?• Need to allow sufficient time to seek a suitable person

to give consent(CTIMPs) or advice(Non CTIMPS)• Consult with potential participants and their carers

about all aspects of the study including information sheets.

• Important to do all these things at the planning stage not just when applying for ethical approval

REC looks at

•Suitability of the researcher – training/experience/supervision

•Peer review•Patient/carer/relative involvement in the

design and information sheets•How a legal representative or consultee is

identified•How & who will obtain advice or consent

Rec information

•IRAS form •Protocol•Information sheets •Discussion with the researcher at the REC

meeting

MCA 5 principles• Assume everyone has capacity unless it is

established that they lack capacity• All practical help to make a decision must be

tried• An unwise decision does not equate with a lack

of capacity• Acts or decisions on behalf of people who lack

capacity must be in their best interests• Before any act or decision the responsible

person must consider whether the purpose could be achieved in a less restrictive way

MCA 2005 Criteria for approval under sections 30 -33 1. The research is connected with an

impairing condition affecting participants who are unable to consent, or with the treatment of the condition.

2. The research could not be carried out as effectively if confined to participants able to consent

3. MCA 2005 Criteria for approvalThe research has to either:-Potential benefit without any disproportionate burden

ORProvide knowledge of the causes, treatment, or care of the condition or a similar condition when

-Risk to participants is negligible -There is no significant interference with their freedom or privacy -Research is not unduly invasive or restrictive

4. Consultee Reasonable arrangements are in place to consult another person (consultee) for advice on whether the person should take part & what their wishes and feelings might be

• A personal consultee will be identified , either a relative, friend or carer not in a professional +/or a paid capacity who is interested in the person’s wellbeing

• If a personal consultee is not available demonstrate arrangements are in place to appoint a nominated consultee who has no contact with the project.

5. Information for consultees• Role and responsibilities:-

Are they willing & able to give advice Do they think the research would upset the person Consider past & present wishes of the person Did the person make any advance directives Is it likely that they would have wished to take part Understand they are not providing consent for the person but giving advice Aware they do no not have to act as a consultee • Study details Either provided with specific study information which should include the above points or the PIS with the above details in a separate letter.

6. REC is satisfied additional safeguards are in place that:- • A participant can be withdrawn if they or the

consultee so advises unless discontinuation puts their health at risk

• There is nothing to which participants appear to object unless it is to prevent harm or reduce pain or discomfort

• There is nothing contrary to an advance decision or directive

MCA criteria

Interests of the person must be assumed to outweigh those of science or society

Useful help

Guidance on nominating a consultee for research involving adults who lack capacity to consent

Issued by the secretary of State and the Welsh Ministers in accordance with section 32(3) of the Mental Capacity Act 2005

Emergency research : enrolling participants - MCA

• REC must be satisfied that advice whether or not to include an individual in the study is obtained from a doctor not connected with the study

• If such advice is not practicable other appropriate arrangements must be in place as agreed by the REC e.g. paramedic studies +/- adrenaline at a cardiac arrest. Even if a relative/friend/carer is present may not be appropriate to discuss research then as clinical issues are paramount

• Consent from the person or advice from a consultee must be obtained as soon as practicable following treatment

Emergency research Clinical Trials Regamendment 2006•Requirement for consent before study

starts can be waived if:•Treatment needs to be given urgently and•Action is needed urgently for the purpose

of the trial and•Not reasonably practicable to obtain

informed consent from a parent/legal representative prior to entering the trial

Emergency research CT regulations

•Procedures to enrol a person must be approved by a REC prior to consent being obtained

• Consent to continue in the trial must be sought from the person or a legal representative as soon as practicable following treatment

REC process for CTIMP

• Basic ethical principles are the same for CTIMP & non-CTIMP research

• Research must be related to the condition contributing to the impairment of the mind or brain

• Presumed benefits should outweigh the risks• Approved by an approved body this is a

Research Ethics Committee• The REC receives advice from an expert in

both the underlying condition and current management options

Essential resource

Health Research Agency

Consent and Participant Information Sheet Preparation Guidance

www.hra-decisiontools.org.uk/consent/

Documentation required for studies under the MCAct • Patient information sheet & consent form–

participants with capacity, pictorial, verbal etc.• Personal Consultee information and declaration

form (consent is not given) if the person lacks capacity

• Carer information sheet and consent form if they are a participant in the research too

• Information in an accessible form, simple language etc. to inform a participant +/- an assent form

• If required a nominated consultee information and declaration form

Additional documentation•Participants who regain capacity will require

an information sheet to explain the role of the consultee, what has happened so far in the research and the options open to them which are:

Consent to study participation & remaining in the study or Withdraw from the study•Brief information about a study for

participants/carer if research is in an emergency

CT Regulations - Documentation• Patient information sheet & consent form–

participants with capacity, pictorial, verbal etc.• Personal Legal representative information and

consent form if the person lacks capacity • Carer information sheet and consent form if

they are a participant in the research too• Information in an accessible form, simple

language etc. to inform a participant +/- an assent form

• If required a Professional Legal Representative and consent form

Additional Documentation CT regs

•Participants who regain capacity will require an information sheet to explain the role of the legal representative, what has happened so far in the research and the options open to them which are:

Consent to remain in the study or Withdraw from the study•Brief information about a study for

participants/carer if research is in an emergency

Loss of capacity during research MCA

•Withdraw participant, anonymise or destroy data

•Withdraw participant, retain identifiable data-requires specific advance consent anticipating later loss of capacity

•Participant remains in the study undergoing further research – requires MCA approval from a REC and consultee advice

Loss of capacity during research CT regulations

If Consent to take part in a CTIMP study was given by a capable adult who subsequently loses capacity, the consent previously given remains legally valid.

REC would expect this to be mentioned in the PIS

Thank you

A research ethics committee  protects the rights, safety, dignity and wellbeing of research participants.

Resources• Health Research Agency

www.hra.nhs.uk• Social Care Institute for Excellence

www.scie.org.uk• BMA mental capacity tool kit

www.bma.org.uk• MRC Ethics guide

www.mrc.ac.uk/documents/pdf/medical-research-adults-who-cannot-consent/

• “Research involving adults who lack capacity: how have research ethics committees interpreted the requirements?” M Dixon-Woods & E L Angell J. Med. Ethics;35;377-381 – a useful flow diagram