Ethics, research governance and consent

All research undertaken in care homes must be approved by an ethics committee and meet the legal requirements outlined in the Mental Capacity Act 2005. It is also important to consider aspects such as research management and governance permissions, insurance and support requirements. Ethics can be complex and researcher might receive conflicting advice. There is currently little national guidance on how this can be applied in the care home sector therefore it is important to find out what is required locally for small scale studies as this may be different than for national multi-centre sites.

The NIHR School for Social Care Research methods reviews on research with people at the end-of-life (many of whom are in care homes) provides detail on obtaining ethical permissions in social care research and the approval processes. The SSCR Methods Review also provides information on research governance.

Researchers should consider the following processes for all studies in care homes:

Update 6th September 2017 - The Health Research Authority (HRA) is currently reviewing its guidance and processes around research which is conducted outside the NHS setting e.g. Care Homes, Hospices etc. The HRA contact on this topic is Catherine Adams, Senior Assessor for any queries on this topic, your R&D teams can makde contact by emailing hra.queries@nhs.net

RESEARCH ETHICS AND GOVERNANCE

Before a study can begin a researcher may need to seek several different approvals depending on the type of research being carried out.  These include approval by the relevant research ethics committee, local authority research governance, the care home owner and other NHS permissions where required.

Experienced researchers recommend allocating sufficient time to this process, as time is needed to get all permissions in place. Guidance for permissions required for research can be found at the Health Research Authority (HRA) website under the ‘Research Community’ section.

ETHICAL REVIEW

Researchers need to consider which type of ethical review is most appropriate for the research they are undertaking. For studies that involve the NHS then ethical review should be carried out by an NHS Research Ethics Committee and applications are made using the Integrated Research Application System (IRAS). If participants lack capacity, then the committee must be flagged as having appropriate Mental Capacity Act 2005 expertise. Full guidance about how to start the NHS research ethics process through IRAS can be found at the HRA website.

If participants who lack capacity are to be included in the research, their inclusion is likely to require justification in order to gain a favourable ethical opinion, and a HRA i.e. NHS / Social Care ethics review will be required (University only will not be sufficient).

Alternatively, where the approach to data collection for a study uses social science methods, and the research does not involve in any change in treatment or clinical practice for the participant then ethical review can be undertaken by the Social Care Research Ethics Committee (SCREC).  SCREC is Health Research Authority (HRA) REC, and is flagged to review studies involving participants that lack capacity to consent. Full guidance about how to start the Social Care research ethics process through IRAS can be found at the HRA website.

To obtain advice about the most appropriate ethical review for their studies if there is any doubt, researchers should speak to an NHS Research Ethics Committee (REC) in their region or contact the SCREC Manager at the HRA.

The remit of the Social Care REC is as follows:

1. Social care studies funded by the Department of Health.

  • Research commissioned directly through the Policy Research Programme.
  • Health and Social Care Information Centre (HSCIC) studies (i.e. those to be designed by HSCIC for implementation by Councils with Adult Social Services Responsibilities, who do not then individually need to seek additional review).
  • Studies commissioned by or through National Institute for Health Research (NIHR) School for Social Care Research.
  • Social care studies funded (in rare cases) through NIHR.

2.       Social care research that involves people lacking capacity in England and Wales and requires approval under the Mental Capacity Act 2005. The Social Care REC is recognised by the Secretary of State as an Appropriate Body for this purpose.

3.       Social care research involving sites in England and another United Kingdom country.

4.       'Own account' research undertaken by Councils with social services responsibilities, where the Chief Investigator and/or sponsor feels there are substantial ethical issues.

5.       Studies of integrated services (health and social care), provided that there is no clinical intervention involved.

6.       Studies taking place in NHS settings with NHS patients where the approach uses social science or qualitative methods, provided that the research does not involve any change in treatment or clinical practice.

7.       Intergenerational studies in social care, where both adults and children, or families, are research participants.

8.       Other social care studies not suitable for review by other NRES RECs, subject to the capacity of the Social Care REC. This could include service user-led research.

9.       Adult social care research involving changes in, or the withdrawal of, standard care.

Social care research does not require review by the Social Care REC if it is reviewed by another committee operating in accordance with the ESRC's Framework for Research Ethics, unless sections 1 or 9 above apply or the research involves NHS patients or service users as research participants. A review is required if there is a legal requirement for REC review e.g. under the Mental Capacity Act. Student research within the field of social care should ordinarily be reviewed by a University REC (UREC). If a UREC review is not available to a student, they can contact the Co-ordinator for advice.

The Social Care REC does not consider any research involving clinical interventions. Such research should be reviewed by another appropriate REC within the NRES.

The two documents embedded for download in the sidebar confirm which studies need to be reviewed by a REC.

Governance Arrangements for RECs (GAfREC) and an algorithm

Does my project require review by a REC?  

These documents also give details of the exemption for review if studies are reviewed in accordance with the ESRC’s Framework for Research Ethics.

As you will see paragraph 2.3.8A of GAfREC provides an exception from the normal requirement for review by a REC within the UK Departments' Research Ethics Service where a research project (adult social care) is reviewed by another committee operating in accordance with the Economic and Social Research Council's Framework for Research Ethics, unless any of the following apply:

  1. the research involves withdrawing standard care;
  2. the research involves NHS patients or service users as research participants;
  3. the research is a social care research project funded by the Department of Health in England; or
  4. there is a legal requirement for REC review of the research (e.g. the research involves those lacking capacity to consent, which requires review in accordance with the Mental Capacity Act 2005)

The effect of this exception is that some social care research (e.g. student research) does not require REC review, provided that it is reviewed by a committee operating in accordance with the ESRC Framework (for example, a UREC).  Projects meeting these criteria should normally be reviewed by a UREC or another committee where possible.  However, applications may be made to the Social Care REC where review by another committee is not available.

Further clarification can be found in the algorithm.  The sections relating to social care can be found in Section C, page 8 and Section 7, pages14 and 15.

Researchers should note that REC review for social care research in England (adult social care only), Wales and Northern Ireland (adult and children' social care) is still required where:

  1. a legal requirement applies (e.g. under the Mental Capacity Act)
  2. the study has DH funding
  3. the study involves withdrawing any aspect of standard care from social care users
  4. the study involves NHS patients recruited in the social care setting, or a mix of NHS patients and social care users; or
  5. review by another REC operating in accordance with the ESRC Framework is not available.

SOCIAL SERVICES PERMISSIONS

Review by the Local Authority may also be required in areas where local authority social services have funding responsibilities for people who live in care homes.  Many local authorities have a research governance process but others do not and researchers are advised to write to or contact the Director for more information about whether review is required.  Contact details can be found at the research group of the Association of Directors of Social Services (ADASS) website.

Where research is taking place in four or more local authority areas then ADASS central approval should be obtained. The ADASS guidelines, which can be found on the ADASS website, provide information for researchers to support them through this process. It is important to include the costs of this in the application for funds since a fee has to be paid to ADASS for this service.

New rules published by the Health Research Authority say: “Site-Specific Assessment (SSA) forms and accompanying documentation for non-NHS sites should be submitted to the main REC which is responsible for reviewing the full research ethics application”. Rules published by the Health Research Authority say that Site-Specific Assessment (SSA) forms and accompanying documentation for non-NHS sites should be submitted to the main REC reviewing the full research ethics application (Where volunteers may be subject to the Mental Capacity Act). More information can be found here.

We recommend speaking to the REC that approved your study (not the REC that is local to your non-NHS sites) about how much information you need to submit.

NHS RESEARCH PERMISSIONS

When research involves NHS patients (or their organs, tissue or data), or is hosted in or through the NHS, studies must undergo a research governance review and written permission is required from each NHS organisation involved. For details on NHS Permissions and how to obtain them visit the NIHR CRN Website.

For care home research Trust NHS permissions will be required if the care home residents are identified via the NHS (through their GP records or their secondary care records).  It would also be required if the care home study involved the delivery of an NHS intervention to a care home population.

There is some debate as to what permissions are required for studies which take place wholly outside the NHS and within the care home environment only. Local Clinical Commissioning Groups (CCGs) may have an interest in care home research taking place within their area but there are differing views about the need to get ‘formal’ approval from them. Most care homes are private businesses and when planning a care home study, and until regulations for this requirement have been agreed nationally, it is advisable to notify the organisation/lead for research in the pertinent CCG(s). This may be a Commissioning Support Unit or a CCG leading research for other CCGs. Your Local Clinical Research Network will be able to sign post you to the appropriate contact.

Local ENRICH teams and Local Clinical Research Networks will also be able to advise on any local processes that are in place.

CARE HOME PERMISSIONS

What will be required is formal permission from the care home owner as well as the manager. There is no fixed format for this permission but written agreement is advisable, ensuring that the owner has a full understanding of the study requirement, protocols and any risks and resource requirements.

Where a study takes place inside the NHS and within a care home setting, current advice would be to seek permissions as outlined above from all parties (but not two NRES committees since SCREC is part of this).

CONSENT

It is vital that researchers working with people who lack decision making capacity fully understand the implications of the Mental Capacity Act 2005 in England and Wales (in Scotland - Adults with Incapacity (Scotland) Act 2000).

Clinical trials of an investigational medicinal product (a trial involving a medicine or medical device) are not covered under the Mental Capacity Act 2005, but by the Medicines for Human Use (Clinical Trials) Regulations 2004. This has specific provisions for the inclusion of adults lacking capacity.

The processes of obtaining consent for research from a person living in a care home is not significantly different from those encountered in any studies of neurodegenerative disorders where capacity to consent changes or is absent. Researchers should follow normal best practice guidance and governance arrangements. In many care homes researchers have found that some residents are not able to give informed consent to taking part in research, this should be considered by all researchers.

Further information on the legal requirements of the Mental Capacity Act 2005 is available in its Code of Practice. SCIE's resources also outline what is required when making the sometimes difficult decisions surrounding mental capacity and proxy decision-making. It may further be useful to appoint a personal a consultee or nominee to give advice about the person’s wishes and the need to allow time to do this in any consent process.

Consent, including advanced consent, of older adults to research in care homes: a qualitative study of stakeholders’ views in South Wales (Wood et al 2013)

NIHR CLINICAL RESEARCH NETWORK (CRN) PORTFOLIO

The ENRICH Research Ready Care Home Network provides support for all forms of research in care homes. However the support it can provide varies depending on how the study is designed and funded. Studies which are eligible for inclusion to the NIHR CRN Portfolio can receive support with identification and recruitment of participants provided via NHS service support as long as this activity is carried out by NHS clinical research network staff. Information about eligibility for the NIHR CRN Portfolio can be found at NIHR CRN Website. This topic is also discussed further within the Costs of Conducting Research in Care Homes section.

Studies funded by the NIHR and impacting on the NHS may also be eligible. Clarity and national guidance about eligibility of care home studies for inclusion in the NIHR CRN Portfolio is currently being sought.

INSURANCE FOR RESEARCH

It is important that researchers ensure that all aspects of the research are properly insured.

If what the care home staff are doing for the research is part of their normal duties then their usual indemnity should cover them.

If what care home staff are doing is not within what might be considered normal duties then existing insurance may not provide cover. For example, if as part of the research, care home staff are trained to run an exercise group the researcher should ensure that appropriate indemnity is in place. Additional indemnity cover may therefore be required by care homes. Any associated additional time and costs should be taken into consideration by researchers during the design and costing of research studies.

Researchers must also ensure that all the direct research activity will be covered by the sponsor and the sponsor would be liable for any non-negligent harm.

"If we want to improve the care people receive, there is one sure fire way to do it. It’s to involve people in decisions about their lives. In too many care services, people are not consulted about what happens to them."

David Tares, Lay Assessor, Care Inspectorate, April 2013

Care Home Research in Scotland

The principles of how to establish and deliver research within the care home sector are the same in Scotland as in England.  The differences are in the legislation and regulatory bodies which cover Scotland. This includes the Adults with Incapacity (Scotland) Act 2000:

This Act aims to protect people who lack capacity to make particular decisions, but also to support their involvement in making decisions about their own lives as far as they are able to do so. Anyone authorised to make decisions made on behalf of someone with impaired capacity must apply the five principles of: 1.) benefit; 2.) least restrictive option; 3.) take account of the wishes of the person; 4.) consultation with relevant others; 5.) encourage the person to use existing skills and develop new skills. More information can be found on the website.

Supervision and regulation

Under the Act, four public bodies are involved in the regulation and supervision of those authorised to make decisions on behalf of a person with incapacity. These are: the Office of the Public Guardian (Scotland), the Mental Welfare Commission for Scotland, the courts and local authorities.

Consent to Research (Part 5 of the Act). The Act permits medical research involving an adult incapable of giving consent subject to certain safeguards and exceptions.

The other difference is with the Care Inspectorate who ensures that through their regulatory and scrutiny functions:

  • Vulnerable people are safe
  • The quality of these services improves
  • People know the standards they have a right to expect
  • They can report publicly on the quality of these services across Scotland
  • They can support and encourage the development of better ways of delivering these services.

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