Applying for ethics approval for research

Applying for ethics approval for research
Published:
June 2014
Lead Group:
Research
Country relevance:
UK wide
Introduction
Ethics review and approval are fundamental components of research activity. Identifying the most
appropriate process to follow is not necessarily straightforward, and is determined by factors such as the
characteristics of the research participants and where the research is taking place. The individual nature
of most research projects means that there is no simple ‘one size fits all’ recommendation.
This briefing, whilst unable to provide definitive advice for every situation, aims to offer general guidance,
together with signposting to those resources where more detailed information may be obtained.
Key areas covered:
1. Research governance in the United Kingdom.
2. Ethical principles.
3. University ethics approval.
4. Health and social care research ethics approval – Who’s Who?
5. Governance Arrangements for Research Ethics Committees (GAfREC).
6. Legislative requirements.
7. Research involving service users and carers of health and social care services.
8. Research involving health or social care staff.
9. Integrated Research Application System (IRAS).
10. Research outside of statutory services.
11. Local approvals or permissions for research.
12. College of Occupational Therapists’ research governance arrangements.
It should be noted that developments are constantly occurring in the field of research ethics and
governance, and researchers are therefore advised to check the most relevant websites for any recent
updates.
1. Research governance in the United Kingdom
There is no single framework that underpins health and social care research practice in the United
Kingdom (UK). Each of the four UK countries has, however, a research governance framework (RGF)
which sets out the broad principles, requirements and standards of good research governance
(Department of Health 2005, Scottish Executive Health Department 2006, Department of Health, Social
Services and Public Safety 2006, Wales. Welsh Assembly Government 2009).
Each country’s framework is similar in terms of content and purpose, identifying key standards for
research activity covering areas such as:
©College of Occupational Therapists
106-114 Borough High Street, Southwark, London SE1 1LB
www.COT.org.uk
Applying for ethics approval for research
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•
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Ethics.
Science.
Information.
Health, safety and employment.
Finance and intellectual property.
All researchers should be familiar with the content of the RGF most relevant to their research.
There are a number of requirements within the Research Governance Frameworks that need to be met
by the different individuals and organisations involved in the various stages of a research project. The
importance of identifying and understanding the responsibilities of key stakeholders (such as the
principal investigator, research funders, organisations and professionals providing care, and the
research sponsor), is paramount.
Researchers and students undertaking research must ensure that there is an identified research sponsor
for the project. The sponsor is the body or individual who takes overall responsibility for the management
of the project, ensuring that researchers have the necessary skills and resources, and that arrangements
are in place for the appropriate conduct and reporting of the project. This includes that the relevant
ethics review(s) are undertaken.
‘When the Health Research Authority (HRA) becomes a Non-Departmental Public Body
(NDPB), which is expected in late 2014, it will take responsibility from the Department of
Health for issuing guidance for research in England, in place of the Research
Governance Framework (RGF). The current version of the RGF will be withdrawn when
the new framework is published. The HRA and Devolved Administrations have
committed not to just update the RGF as a document, but to fundamentally review the
whole framework with an ambition to have a single framework for research across the
UK’.
Details at: http://www.hra.nhs.uk/about-the-hra/our-plans-and-projects/replacing-researchgovernance-framework.
2. Ethical principles
Ethical principles have been identified within the Research Governance Frameworks, and focus on the
following:
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The dignity, rights, safety and wellbeing of research participants must be paramount in any
research.
Independent scrutiny of research plans must occur.
Informed consent is at the centre of ethical research.
Information and data about participants must be treated confidentially.
As far as possible, participants should be involved in the design, conduct, analysis and reporting of
research.
Research should be reflective of the diversity of the population.
Risks should be kept to a minimum.
An independent ethics review is a requirement of the Research Governance Framework, but the
organisation or body which carries out this review will be influenced and determined by the nature of the
research project and, in particular, by its participants.
©College of Occupational Therapists
106-114 Borough High Street, Southwark, London SE1 1LB
www.COT.org.uk
Applying for ethics approval for research
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The process of gaining ethics approval is sometimes perceived as a hurdle for those wishing to get
started in research, particularly when a project needs to be completed within a defined academic
timeframe. However, the value and necessity of having gained approval should not be overlooked.
Failing to meet ethical, legal and professional obligations amounts to research misconduct (Universities
UK 2012) and in some cases is unlawful (for example, when involving adults who lack capacity to
consent).
The determination of what ethics applications are necessary for a proposed research activity is
something that researchers must agree in collaboration with their research supervisors and/or research
team early on in the research project planning. It is crucial that adequate time for obtaining ethics
approval is included in the project timetable. Novice researchers who are seeking ethics approval for
the first time will benefit from discussing the requirements with a research supervisor, colleague and/or
a fellow research student who has previously been successful in seeking and gaining the necessary
ethics approval(s).
Most ethics approval bodies make details of their process and timescales available on their website,
and it is strongly recommended that information about the necessary requirements is clarified by a
researcher at the earliest opportunity.
In addition to independent ethics review, researchers must also consider the permissions that will be
required to enable them to undertake their research within specific organisations or locations.
Code of practice for research
For members who wish to access further information on research and ethical
issues the College recommends the UK Research Integrity Office’s Code of
Practice for Research. Promoting good practice and preventing misconduct
(UKRIO 2009), a reference tool to support researchers and research
organisations in the conduct of research of the highest quality. Drawing upon
UKRIO's experiences in addressing good conduct and misconduct in research,
the Code provides principles and standards for researchers and research
organisations. It also includes a Recommended Checklist for Researchers, a
one-page non-technical checklist for the key points of good practice in research,
based on the more detailed standards provided by the Code.
To download a copy visit: http://www.ukrio.org/publications/code-of-practice-for-research.
It is the responsibility of researchers, and sponsors of research, to decide what ethical review is
needed to meet statutory requirements. Researchers should carefully study the extensive guidance
and resources available on the HRA website at: http://www.hra.nhs.uk/research-community.
3. University ethics approval
If the proposed research is being undertaken in part fulfilment of an academic award (for example, an
MSc or PhD), the university will in most cases act as the research ‘sponsor’. This will also usually be
the situation for research being undertaken by employees of a university.
University research governance processes are usually hosted by a central or corporate research office
within the university, but individual faculties, schools, or research institutes will frequently have their
own ethics approval committee. Universities will have different systems; some may require
©College of Occupational Therapists
106-114 Borough High Street, Southwark, London SE1 1LB
www.COT.org.uk
Applying for ethics approval for research
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self-assessment for low risk projects. Others will signpost directly, for example, to an NHS Research
Ethics Committee if that is indicated, with subsequent notification to the University Committee.
Researchers are therefore advised to establish well in advance the process they will need to follow.
Information about a university’s procedures, necessary forms/online submission requirements, and
committee dates should be available from the research supervisor or the university website.
Whether or not other ethics approvals/permissions are necessary will be largely determined by where
the research is taking place (e.g. an NHS hospital) and who it involves (e.g. mental health service users
lacking capacity). If recruiting service users or carers via services which are the responsibility of the
UK Health Departments, then ethics approval will be required by a Research Ethics Committee
operating under the UK-wide Research Ethics framework (see also sections 4 - 9).
4. Health and Social Care Research Ethics Approval - Who’s Who?
The following list aims to provide an outline of the various organisations and committees involved in
ethics review for health and social care.
4.1 Health Research Authority (HRA)
The HRA was established on 1st December 2011 as a Special Health Authority, and will become a
Non-Departmental Public Body in late 2014. The purpose of the HRA is to protect and promote the
interests of patients and the public in health research and it aims, with partners, ‘to make the UK a
great place to do health research, to build confidence and participation in health research, and so
improve the nation’s health’.
A number of pilots and studies are in progress to take forward the HRA’s commitment to streamlining
research ethics approval and permission processes. Further information about the latest activities can
be found on the HRA website. Details at: http://www.hra.nhs.uk.
4.2 NHS Research Ethics Committees
NHS Research Ethics Committees (RECs), geographically located across the UK, review research
taking place in or through the NHS, and other health and social care research as required by law or
policy. They are part of the National Research Ethics Service (NRES).
Only proposed research activity usually needs to be submitted for approval by an NHS REC. Service
evaluation and audit projects are subject to different review processes, and in health services this is
usually via NHS clinical governance departments. Researchers are advised to refer to the HRA
‘Defining Research’ leaflet, which explains how to differentiate research from other activities, available
at: http://www.hra.nhs.uk/resources/before-you-apply/is-it-research. The nature of the research
reviewed is defined within the Governance Arrangements for Research Ethics Committees as outlined
in section 5 below (Department of Health 2011).
Details about the UK RECs can be found at: http://www.hra.nhs.uk/about-the-hra/our-committees/nres.
4.3 Social Care Research Approvals
Social care has a wider interpretation of what requires review, and generally includes service
evaluations and audits. Variation remains in ethics review requirements for social care across the four
countries in the UK:
• England: either councils with social services responsibilities or the Social Care Research Ethics
Committee will reviews applications.
• Wales and Northern Ireland: social care research is reviewed by RECs in those countries.
©College of Occupational Therapists
106-114 Borough High Street, Southwark, London SE1 1LB
www.COT.org.uk
Applying for ethics approval for research
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•
Scotland: researchers are advised to contact the relevant organisation or council with social
services responsibilities for details of their specific requirements and procedures.
4.3.1 Social Care Research Ethics Committee (SCREC)
The SCREC was established in June 2009 with a remit to complement other RECs by filling gaps and
fulfilling specialist functions reviews. The SCREC reviews adult social care research study proposals,
intergenerational studies involving adults and children or families, use of social care databases and
some proposals for social science studies situated in the NHS from researchers based in England. It
reviews, in particular, research which:
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Has a site in both England and another United Kingdom country.
Is funded by the Department of Health.
Involves people lacking capacity.
Studies integrated services.
Is considered to have substantial ethical issues.
Has no access to other review systems.
A useful resource to assist in determining the options available for social care ethics approval is the
SCREC’s Securing ethics approval: The route map for social care researchers.
Details at: http://www.scie.org.uk/research/ethics-committee/files/routemap.pdf.
The SCREC website contains a wealth of information about their ethics review process, guidance and
FAQs about ethics requirements and applications: http://www.scie.org.uk/research/ethics-committee.
5. Governance Arrangements for Research Ethics Committees (GAfREC)
The Governance Arrangements for Research Ethics Committees (GAfREC) sets out the principles,
requirements and standards for those Research Ethics Committees (NRES and SCREC) that review
research proposals which plan to involve services that are the responsibility of the UK Health
Departments (Department of Health 2011). The revised arrangement which took effect from 1st
September 2011 supersedes that of 2001 and is termed the ‘harmonised edition’ due to the fact that it
applies to all four United Kingdom countries, and takes account of legal, policy and operational
developments since 2001.
REC review is required in each UK country where the research relates to health and/or social care
services which are the responsibility of that country’s Health Department. The country-specific
inclusions for health and social care are outlined in GAfREC as follows:
Table 1: UK Health Department Services (DH 2011, p9)
England
Department of Health
Wales
Department of Health and Social Services
Services: NHS and Adult Social Care
Services: NHS and Social Care
Scotland
Scottish Government Health
Directorates
Northern Ireland
Department of Health, Social Services and
Public Safety
Services: NHS
Services: Health and Social Care
©College of Occupational Therapists
106-114 Borough High Street, Southwark, London SE1 1LB
www.COT.org.uk
Applying for ethics approval for research
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Research not included within the remit as laid out in the Governance Arrangements for NHS Research
Ethics Committees (GAfREC) above should follow the governance arrangements for the applicable
host institution.
6. Legislative requirements
Legislative requirements for review by an NHS REC or the SCREC are applicable in a number of
situations. The key areas most likely to be pertinent to occupational therapists are:
a) Capacity to consent
REC review is required where there is an intention to involve people who lack (or lose) the capacity to
give informed consent to take part (or to keep taking part) in the research.
In England and Wales the Mental Capacity Act (Great Britain. Parliament 2005), and in Scotland the
Adults with Incapacity (Scotland) Act (Scotland. Scottish Executive 2000), provide a legal requirement
that any research involving people who lack or lose the capacity to give informed consent, is subject to
ethics review by a REC recognised by the Secretary of State as an Appropriate Body for this purpose
(no equivalent legislation has yet been created in Northern Ireland).
Researchers should note that only NHS RECs and the SCREC are approved to review proposed
research involving adults who lack capacity. Approval from such a REC would be required even if the
research is not being undertaken with or via the NHS or social care (e.g. social enterprise or a charity).
Guidance and frequently asked questions are available from the HRA website on research involving
adults who lack capacity to consent for themselves.
b) Confidential patient information
Processing of confidential patient information without consent, where this would otherwise breach
confidentiality, requires REC review.
c) Nursing and care homes
REC review is required where research will involve patients who are cared for in private and voluntary
sector nursing homes (in England, Wales and Northern Ireland) and/or residents of residential care
homes (in Northern Ireland only).
7. Research involving service users and carers of health and social care services
GAfREC defines the relevant situations when ethics approval is required by an NRES research ethics
committee. These cover a spectrum of research activities within health and social care, not all of which
are likely to be directly applicable to occupational therapy researchers. The two key requirements
anticipated to be most relevant are that REC review is required where:
a)
b)
Potential research participants are identified from, or because of, their past or present use of the
services listed above [Table 1] (including services provided under contract with the private or
voluntary sectors), including participants recruited through these services as healthy controls.
Potential research participants are identified because of their status as relatives or carers of past or
present users of these services. (DH 2011, p9).
Researchers should also ascertain whether or not any of the other requirements within GAfREC are
applicable to their individual research project.
©College of Occupational Therapists
106-114 Borough High Street, Southwark, London SE1 1LB
www.COT.org.uk
Applying for ethics approval for research
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8. Research involving health or social care staff
The 2011 GAfREC states that NHS/SCREC research ethics committee approval is not required when
research involves staff of the services listed in Table 1 above, who are recruited by virtue of their
professional role (DH 2011, p12). Exceptions are outlined in GAfREC. This means that REC approval
is not required for researchers who solely wish to recruit occupational therapists or health/social care
professionals as participants.
However, in line with the RGFs, research projects should still undergo some form of independent
review. A university ethics approval process will in many cases be the way in which this requirement is
met, as will the ethics review process of an individual institution where this is applicable. It is essential
that a researcher is familiar with the relevant research governance and ethics approval guidance
documents to ensure that they are adhering to the necessary requirements. It is important to note that
research involving the staff of health or social care services continues to require permission from the
relevant care organisation(s). Local permission processes will apply (see section 11).
Researchers wishing to recruit participants via a Specialist Section are advised to read the COT
Briefing Research recruitment enquiries: information for Specialist Sections and researchers
(COT 2013), for further details. Specialist Sections can provide an invaluable means of recruitment.
However it is where the participants are working, rather than the mode of recruitment, that is important
and therefore recruitment via a Specialist Section does not override any necessary requirements for
local permissions.
9. Integrated Research Application System (IRAS)
IRAS was launched in January 2008 and is now the single system for applying for approvals and
permissions for both health and social/community care research in the UK which needs to be approved
by an NHS REC or the SCREC. All submissions and authorisations made via IRAS must be completed
electronically. Information about the application process is available at:
http://www.hra.nhs.uk/resources/applying-for-reviews/integrated-research-application-system-iras.
One of the principles now embodied in GAfREC is that ethics review should be proportionate to the
scale and complexity of the research proposed. Therefore if research does not present any material
ethical issues, it may be reviewed by a proportionate review sub-committee of a REC. Details on what
constitutes ‘no material ethical issues’ and how proportionate approval can be requested are available
on the HRA website: http://www.hra.nhs.uk/resources/applying-to-recs/nhs-rec-proportionate-reviewservice.
A Central Booking System is in place which is a telephone booking service that identifies and
allocates applications to an appropriate Research Ethics Committee.
If clarification is needed at any stage in terms of the requirements and processes for applying to a
REC, there are two key avenues for researchers to seek advice:
• The local REC whose details can be obtained via the NRES website at:
http://www.nres.nhs.uk/contacts/nres-committee-directory.
• The National Research Ethics Service (NRES) at: [email protected].
It is important to ask for any advice in writing. This could be valuable in providing evidence in
circumstances when REC approval is not required, but when information is necessary to support local
permission requests or any future submission for journal publication and/or an abstract for a scientific
conference.
©College of Occupational Therapists
106-114 Borough High Street, Southwark, London SE1 1LB
www.COT.org.uk
Applying for ethics approval for research
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10. Research outside of statutory services
Researchers should note that conducting research outside statutory health and social care
organisations (for example, with or via a charity, in schools or independent practice) does not remove
the need for an independent ethics review. Researchers must check with individual organisations what
their requirements are before planning such research activity.
The ethics approval process may seem less clear where research is likely to involve users or carers
receiving a service from a charitable or voluntary sector organisation; via a social enterprise; third or
independent sector service. GAfREC clarifies that if the service is being provided under contract to
health or social care services within the responsibility of the relevant Health Department (DH
2011, p9), then REC approval within the UK framework is required.
If the service is not being provided through a relevant country Health Department, it is still important to
seek independent review for a research project. This may be via a university ethics committee (if
applicable) or individual organisational arrangement. GAfREC does facilitate the option of review by a
REC under exceptional cases where the research, whilst not normally within its remit, has material
ethical issues (DH 2011, p13).
If there are legislative requirements associated with the research (Section 6), then ethics review must
be sought from an approved body (NHS REC or SCREC).
Researchers working in non-statutory or independent sector organisations may have more difficulty
finding an appropriate forum to undertake a review and should seek advice from their employer. Selfemployed independent practitioners may need to obtain advice from NRES or the SCREC if there are
substantial ethical issues and no access to other review systems, make enquiries with the organisation
from which they wish to recruit (e.g. charity, 3rd sector body), or possibly buy in consultancy expertise
for an independent review.
11. Local approvals or permissions for research
Individual organisations should have a process by which approval and/or permission is given for
research to take place. Any organisation within which a researcher wishes to carry out their research
can apply their own qualifying conditions, and it remains their prerogative to withhold access (e.g. if
they think the research is too disruptive or will not deliver benefits).
11.1 NHS R&D approvals/permissions
The HRA advise that researchers wishing to conduct research in the NHS (or Health and Social Care
(HSC) in Northern Ireland) must obtain NHS or HSC management permission (also referred to as R&D
approval) for each NHS/HSC research site.
If your research is to be conducted on the premises of a NHS organisation, with NHS patients or with
NHS staff, then the local NHS R&D office will need to give permission. Coordinated systems for NHS
R&D review are in place across the UK but not all studies will necessarily be eligible, and an
application may need to be made direct to the relevant R&D Office(s).
Applications for NHS management permission for research are prepared in IRAS. Currently, obtaining
permissions, particularly for multi-site activities, can be much more complex and time consuming than
researchers may anticipate (Whitehead et al 2011). It is essential that adequate time is factored in for
this process. Information is available at:
http://www.hra.nhs.uk/research-community/applying-for-approvals/nhs-management-permission.
©College of Occupational Therapists
106-114 Borough High Street, Southwark, London SE1 1LB
www.COT.org.uk
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Depending on the type of research and the procedures involved, a researcher may also need to apply
for other approvals in addition to (or in some cases instead of) applications for ethical approval.
Further information is provided on the HRA website.
11.2 Social Services approvals/permissions
Councils with social services responsibilities will generally have their own procedures for giving
permission for research to be carried out within their services. It is advisable to contact the relevant
council/local authority(s) at the earliest opportunity to establish their requirements.
In cases where a researcher wants to carry out research with adults in four or more councils in
England, they should apply to the Association of Directors of Adult Social Services Research Group for
support and permission (who will require a valid ethics review and will also charge a fee to researchers
seeking its support). Details at: http://www.adass.org.uk/Research-Home.
A similar process exists for research involving four or more children’s services departments,
coordinated by the Association of Directors of Children’s Services Ltd.
Details at: http://www.adcs.org.uk/research/index.html.
12. College of Occupational Therapists’ research governance arrangements
The College’s research governance arrangements were developed in response to the publication of the
national Research Governance Frameworks for Health and Community/Social Care.
These arrangements are in place to:
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Ensure the quality and ethical integrity of research and related activity involving members.
Prevent groups of members from being over-consulted and the replication of research activities.
Ensure activities being carried out are sound, and that any decisions subsequently based on them
are better informed.
Provide a level of protection for staff and members in terms of potential risks to individuals or the
organisation.
When acting as research sponsor, the College is responsible for ensuring an appropriate process of
scientific critique that demonstrates the research, or other project proposal, is worthwhile and of high
scientific quality. This includes research, audit, service evaluation or service development projects
(including membership surveys) initiated by College staff, College Specialist Sections (which are
business groups of the College) or Regional Groups. Approval for such projects (research, service
evaluations, audits and service developments) must be sought formally via submission to the College’s
ethics approval process.
Review through the College’s process may also be required where activity is being undertaken on
behalf of the College, a Specialist Section or Regional Group.
The College’s Research Governance Policy is available on the website at:
http://www.cot.org.uk/research-governance/cot-research-governance-arrangements.
Additional information is also available about recruiting occupational therapists for research at:
http://www.cot.co.uk/research-governance/recruiting-ots-research.
©College of Occupational Therapists
106-114 Borough High Street, Southwark, London SE1 1LB
www.COT.org.uk
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References
College of Occupational Therapists (2013) Research recruitment enquiries: information for Specialist
Sections and researchers. (COT Briefing). London: COT.
Department of Health (2005) Research governance framework for health and social care. 2nd ed. London:
DH.
Department of Health (2011) Governance arrangements for research ethics committees: a harmonised
edition. (Updated April 2012). London: DH. Available at:
http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_126474
Accessed 02.06.14.
Department of Health, Social Services and Public Safety (2006) Research governance framework for
health and social care. Belfast: DHSSPS.
Great Britain. Parliament (2005) Mental Capacity Act 2005 (c.9). London: Stationery Office.
Scotland. Scottish Executive (2000) Adults with Incapacity (Scotland) Act 2000. Edinburgh: Stationery
Office.
Scottish Executive Health Department (2006) Research governance framework for health and community
care. 2nd ed. Edinburgh: SEHD.
Universities UK (2012) The concordat to support research integrity. London: Universities UK. Available at:
http://www.universitiesuk.ac.uk/highereducation/Documents/2012/TheConcordatToSupportResearchIntegr
ity.pdf
Accessed 02.06.14.
Wales. Welsh Assembly Government (2009) Research governance framework for health and social care
in Wales. 2nd ed. Cardiff: Welsh Assembly Government.
Whitehead P, Drummond A, Fellows K (2011) Research governance and bureaucracy for multi-site
studies: implications for occupational therapy research. British Journal of Occupational Therapy, 74(7),
355-358.
Need further information or advice?
Contact: COT Research and Development Team
Email: [email protected] or Tel: 020 7450 2335
©College of Occupational Therapists
106-114 Borough High Street, Southwark, London SE1 1LB
www.COT.org.uk
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