79C3C34C52B45572883A05D425EB0F82
Governance Arrangements forResearch Ethics Committees(2018):
https://www.hra.nhs.uk/media/documents/GAfREC_Final_v2.0_26.03.2020.pdf
http://leaux.net/URLS/ConvertAPI Text Files/7A4E28E95D7AFF1CB160947F55839850.en.txt
Examining the file media/Synopses/7A4E28E95D7AFF1CB160947F55839850.html:
This file was generated: 2020-12-01 07:17:06
| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Political / Illegal Activity
Searching for indicator unlawful:
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p.000027: standards set out in this document.
p.000027: 6.4 Compliance and accountability
p.000027: 6.4.1 Each REC must adopt standard operating procedures approved by or on behalf of its appointing authority, as
p.000027: well as by any other body whose approval is required by law. The head offices of the Research Ethics Service enable
p.000027: adoption by all RECs of standard operating procedures and other common working practices.
p.000027: 6.4.2 RECs act in accordance with their standard operating procedures and are ultimately accountable to their
p.000027: appointing authorities for their governance in this respect.
p.000027: 6.4.3 Standard operating procedures are publicly available from the Health Research Authority (www.hra.nhs.uk).
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p.000028: Glossary
p.000028:
p.000028:
p.000028: anonymised HSC
p.000028: intrusive research
p.000028: Anonymised in accordance with the Information Commissioner’s Office anonymisation code of practice
p.000028: Health and Social Care, the name for health and personal social services in Northern Ireland
p.000028: Section 30 of the Mental Capacity Act in England and Wales defines ‘intrusive research’ as research that (a) is carried
p.000028: out on, or in relation to, a person who lacks capacity to consent to it and (b) would be unlawful if it were carried
p.000028: out on, or in relation to, a person who had capacity to consent to it, but without his or her consent.
p.000028:
p.000028: Section 132 of the Mental Capacity Act (Northern Ireland) 2016 defines ‘intrusive research’ as research which is of a
p.000028: kind that would be unlawful if it were carried out:
p.000028:
p.000028: (a)on or in relation to a person who had capacity to consent to it; but (b)without that person’s consent.
p.000028: Intrusive research involving people who lack the capacity to consent to it requires a favourable REC opinion before it
p.000028: may begin. CTIMPs involving people who lack the capacity to consent are covered separately by the Clinical Trials
p.000028: Regulations.
p.000028:
p.000028:
p.000028: IR(ME)R MoDREC NHS
p.000028:
p.000028:
p.000028: REC
p.000028:
p.000028:
p.000028:
p.000028: relevant material
p.000028:
p.000028:
p.000028:
p.000028:
p.000028: UKECA
p.000028: Ionising Radiation (Medical Exposure) Regulations Ministry of Defence Research Ethics Committee
p.000028: National Health Service, the name for health services in England, health and social care services in Scotland and
p.000028: health services in Wales
p.000028: Research ethics committee, specifically one within the UK Research Ethics Service. NB the term ‘REC’ in this document
p.000028: should not be interpreted as referring to any other body that reviews the ethics of research.
p.000028: Section 53 of the Human Tissue Act defines ‘relevant material’ as any material consisting of or including human cells,
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Political / political affiliation
Searching for indicator party:
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p.000010: of the services listed in paragraph 2.3.4, who are recruited by virtue of their professional role, does not therefore
p.000010: require REC review except where it would otherwise require REC review under this document (for example, because there
p.000010: is a legal requirement for REC review, or because the research also involves patients or service users as research
p.000010: participants).
p.000010: 2.3.15 Market research may be undertaken by professional market researchers, e.g. for public health research or on
p.000010: behalf of pharmaceutical or medical device companies.
p.000010:
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p.000011: 11
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p.000011: Where such research is conducted by professional market researchers in accordance with the principles set out in the
p.000011: Market Research Society Code of Conduct or with the Legal and Ethical Guidelines issued by the British Healthcare
p.000011: Business Intelligence Association (BHBIA), it does not require REC review, except where otherwise required by law,
p.000011: e.g. if it requires approval under the Mental Capacity Acts.
p.000011: 2.3.16 At the request of the sponsor, chief investigator or host organisation, RECs may exceptionally review research
p.000011: excluded from the normal scope of review under paragraphs 2.3.13–2.3.15 where the Research Ethics Service agrees that
p.000011: the proposal raises material ethical issues. The parties responsible for managing those issues remain liable for the
p.000011: assessment which informs that management.
p.000011: 2.3.17 Research projects involving human subjects or their tissue or information may be undertaken on the premises of
p.000011: NHS/HSC or social care organisations by third party organisations, for example contract research organisations or
p.000011: research units owned by universities or voluntary organisations. Where the project falls within the scope of paragraphs
p.000011: 2.3.5–2.3.6 above, REC review is required. Where the project only involves care organisations insofar as it involves
p.000011: use of or access to the organisation’s premises or facilities, REC review is not required. Responsibility for
p.000011: considering and managing any risks relating to access to or use of the premises or facilities by visitors lies not with
p.000011: the Research Ethics Service but with the organisation concerned.
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p.000012: 12
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p.000012: 3 Role and remit
p.000012: 3.1 Summary
p.000012: 3.1.1 Research ethics committees (RECs) act as part of an efficient, accountable and independent Research Ethics
p.000012: Service to protect the dignity, rights, safety and well- being of people who take part in research.
p.000012: 3.2 Role of research ethics committees
p.000012: Protection of research participants
p.000012:
...
Searching for indicator political:
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p.000012: or belief, sex or sexual orientation. RECs should take these considerations into account in reviewing the ethics of
p.000012: research proposals, particularly those involving under-researched groups.
p.000012: Proportionate scrutiny
p.000012:
p.000012: 3.2.4 REC review is proportionate to the scale and complexity of the research proposed. Research proposals that
p.000012: present no material issues of research ethics do not warrant consideration at a full meeting of a REC. They should be
p.000012: identified on receipt in accordance with standard operating procedures so that the ethical review may be undertaken by
p.000012: a sub-committee of a REC. The REC’s opinion on such proposals may be given by the sub-committee. See paragraphs 5.5.1
p.000012: and 5.5.2.
p.000012: 3.2.5 Each research proposal is subject to review by no more than one REC within the UK Research Ethics Service,
p.000012: unless required by law or by a managed appeals process.
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p.000013: 13
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p.000013: Independence and impartiality
p.000013:
p.000013: 3.2.6 RECs are independent and impartial. A REC’s opinion must be free, and must be seen to be free, from conflicts
p.000013: of interest. This includes freedom from pressures of:
p.000013: a. political influence
p.000013:
p.000013: b. institutional affiliation
p.000013:
p.000013: c. trades union or profession-related interests
p.000013:
p.000013: d. direct or indirect financial inducement or any impression thereof
p.000013:
p.000013: e. coercion
p.000013:
p.000013: f. strategic concerns
p.000013:
p.000013: g. market forces
p.000013:
p.000013: h. agency-, discipline- or topic-related bias.
p.000013:
p.000013: 3.2.7 Although RECs may be appointed by bodies that have functions relating to care provision, their decisions are
p.000013: independent of care providers’ own managers, including their research managers. Care providers, regulators, RECs’
p.000013: appointing authorities and the UK Health Departments may not interfere in the deliberations or opinions of RECs RECs
p.000013: play no part in management decisions about the provision of care services or support for a research project.
p.000013: 3.2.8 The protection of research participants and the enabling of ethical research are best served by co-operation
p.000013: and communication between all those who share responsibility for the research. Except when it would compromise their
p.000013: independence, RECs should collaborate with regulators, actual and potential research participants, researchers,
p.000013: funders, sponsors, employers, organisations providing care and care professionals (see paragraph 5.4.2). RECs should
p.000013: also collaborate with one another, for example to share relevant information from previous applications or expertise in
p.000013: reviewing particular types of research.
p.000013: Competence and efficiency
p.000013:
p.000013: 3.2.9 REC review must be competent, timely and authoritative. The membership, ongoing training and performance
...
Political / stateless persons
Searching for indicator nation:
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p.000006: or likely to come into possession of, information from which the donor can be identified (England, Northern Ireland and
p.000006: Wales only)
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p.000007: b. relevant material from the living or the deceased that is not held on premises with a licence from the Human Tissue
p.000007: Authority for research (England, Northern Ireland and Wales only)
p.000007: c. organs retained from a post-mortem examination carried out on the instructions of the Procurator Fiscal (Scotland
p.000007: only)
p.000007: d. organs, tissue blocks or slides retained from a hospital post-mortem examination, or tissue blocks or slides
p.000007: retained from a post-mortem examination carried out on the instructions of the Procurator Fiscal, unless lawful
p.000007: authorisation has been given for use in research (Scotland only)
p.000007: e. analysis of human DNA in cellular material, where appropriate consent for the research is not in place from or on
p.000007: behalf of the person whose body manufactured the DNA. The researcher must not be in possession of, or likely to come
p.000007: into possession of, information from which the person whose body manufactured the DNA can be identified (UK-wide).
p.000007: Good practice requirements for research ethics committee review
p.000007:
p.000007: 2.3.4 This document applies, and REC review is required, where research relates to the following areas of the UK
p.000007: Health Departments’ responsibility:
p.000007: Nation Health Department Services
p.000007:
p.000007: England
p.000007: Department of Health and Social Care (England)
p.000007: NHS and adult Social Care
p.000007:
p.000007:
p.000007: Northern Ireland
p.000007: Department of health (Northern Ireland)
p.000007: Health and Social Care
p.000007:
p.000007:
p.000007: Scotland
p.000007: Scottish Government Health and Social Care Directorate
p.000007: NHS and adult Social Care
p.000007:
p.000007:
p.000007: Wales
p.000007: Department for Health and Social Services
p.000007: NHS and Social Care
p.000007:
p.000007:
p.000007: 2.3.5 REC review as described in this document is required if a specific research project involves any of the
p.000007: following:
p.000007: a. potential research participants identified in the context of, or in connection with, their past or present use5
p.000007: (Excludes research where participants have been identified because they have a condition that was diagnosed by the NHS
p.000007: in the past but where the research is being conducted independently of the NHS. , e.g. people with cancer which may
p.000007: have been diagnosed by the NHS but who are identified from a cancer charity’s contact list to be participants in a
p.000007: research project that is otherwise independent of the NHS.) of the services listed above
p.000007:
p.000007:
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p.000008: (including services provided under contract with the private or voluntary sectors), including participants recruited
p.000008: through these services as healthy controls
p.000008: b. potential research participants identified because of their status as relatives or carers of past or present users
p.000008: of these services
p.000008: c. use of previously collected tissue (i.e. any material consisting of or including human cells)6 (Including those
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p.000031:
p.000031:
p.000031: Yes Yes Yes Yes
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p.000031: No Yes No No
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p.000032: 32
p.000032:
p.000032: Annex B: Enforcement authorities
p.000032:
p.000032: Any updates to this list will be published at www.hra.nhs.uk.
p.000032:
p.000032:
p.000032: Jurisdiction
p.000032:
p.000032:
p.000032: Activity Relevant Body England Northern Ireland
p.000032: Scotland Wales
p.000032:
p.000032: Protection of service users from unsafe or inappropriate care
p.000032: Human Embryo Research
p.000032:
p.000032: Licensed storage of relevant materials for research purposes
p.000032: Research exposure to ionising radiation
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032: Clinical investigations of medical devices
p.000032:
p.000032: Clinical trial of investigational medicinal products
p.000032: Care Quality Commission
p.000032:
p.000032: Human Fertilisation and Embryology Authority
p.000032: Human Tissue Authority
p.000032:
p.000032: IR(ME)R
p.000032: Inspectorates23 (Each nation has its own IR(ME)R Inspectorate.
p.000032: This is a function of the Care Quality Commission in England and of the Department of Health (Northern Ireland), the
p.000032: Scottish Ministers and the Welsh Ministers in Northern Ireland, Scotland and Wales.)
p.000032: Medicines and Healthcare Products Regulatory Agency
p.000032: Medicines and Healthcare Products Regulatory Agency
p.000032: Yes No No No
p.000032:
p.000032:
p.000032: Yes Yes Yes Yes
p.000032:
p.000032:
p.000032: Yes Yes No Yes
p.000032:
p.000032:
p.000032: Yes Yes Yes Yes
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p.000032: Yes Yes Yes Yes
p.000032:
p.000032:
p.000032: Yes Yes Yes Yes
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p.000033: 33
p.000033:
p.000033: Annex C: Research Ethics Service head office functions
p.000033:
p.000033: The head office of the Research Ethics Service in each nation:
p.000033:
p.000033: a. makes arrangements on behalf of appointing authorities for the appointment of such administrative and other staff
p.000033: for their research ethics committees (RECs) as it considers necessary to enable them to perform their functions;
p.000033: b. makes arrangements through their appointing authorities to provide RECs with such accommodation and facilities as
p.000033: it considers necessary to enable them to perform their functions (including arrangements for such administration,
p.000033: maintenance, cleaning and other services as it considers necessary);
p.000033: c. may fund RECs through, or on behalf of, their appointing authorities a sum in respect of each financial year equal
p.000033: to the amount of expenditure which it considers may be reasonably incurred by the RECs in that year for the purpose of
p.000033: performing their functions;
p.000033: d. may pay RECs through, or on behalf of, their appointing authorities such travelling and other allowances as it may
p.000033: determine;
p.000033: e. collaborates with appointing authorities on their behalf to establish sufficient provision for REC review,
p.000033: according to a common administrative structure so that applications are directed to an appropriate and convenient REC;
p.000033: f. ensures on behalf of appointing authorities that a rotation system (e.g. staggered tenure) is in place for REC
p.000033: members so as to achieve business continuity, the development and maintenance of expertise within each REC and the
p.000033: regular refreshment of debate;
p.000033: g. establishes and manages regional centres where appropriate to oversee the activity of RECs;
p.000033: h. supports appointing authorities in ensuring standard practice and a consistent approach, for the benefit of
p.000033: researchers and RECs alike; and
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Health / Healthy People
Searching for indicator healthy volunteers:
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p.000008: Service and Northern Ireland Prison Service are responsible require review by a REC as well as compliance with their
p.000008: own approval procedures
p.000008: c. social care research projects funded by the Department of Health and Social Care (England) involving adult social
p.000008: care service users as participants, which must always be reviewed by a REC within the Research Ethics Service for
p.000008: England
p.000008: d. research involving analysis of human DNA in acellular material9 (See paragraphs 70– 79 of the Human Tissue
p.000008: Authority’s Code of Practice E at www.hta.gov.uk ) (e.g. serum, processed plasma and processed semen) where appropriate
p.000008: consent for the research is not in place from or on behalf of the person whose body manufactured
p.000008:
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p.000009: 9
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p.000009: the DNA. The researcher must not be in possession of, or likely to come into possession of, information from which the
p.000009: person whose body manufactured the DNA can be identified.
p.000009: Other provisions for research ethics committee review
p.000009:
p.000009: 2.3.7 RECs may agree to consider applications in respect of activities preparatory to research (e.g. the
p.000009: establishment of research databases or tissue banks, or pre-trial advertising and screening for healthy volunteers) and
p.000009: research proposals which fall outside the normal scope described above, capacity permitting. When they do this, they
p.000009: must follow the relevant standard operating procedures.
p.000009: 2.3.8 REC review is always available to applicants in respect of research funded by any of the UK Health
p.000009: Departments.
p.000009: Exceptions
p.000009:
p.000009: 2.3.9 This document does not apply in England and Wales if social care research proposals are reviewed by a
p.000009: committee operating in accordance with the Economic and Social Research Council’s Framework for Research Ethics10(
p.000009: Framework for Research Ethics. Economic and Social Research Council, Jan 2015. https://esrc.ukri.org/ ), unless any of
p.000009: the following apply:
p.000009: a. the research involves deviating from standard social care
p.000009:
p.000009: b. the research involves NHS patients or users of NHS services as research participants (see paragraph 2.3.5)
p.000009: c. the research is a social care research project funded by the Department of Health and Social Care (England)
p.000009: involving adult social care service users as participants (see paragraph 2.3.6(c)
p.000009: d. there is a legal requirement for review by a REC (see paragraphs 2.3.1 to 2.3.3).
p.000009:
p.000009: With these conditions, the Framework for Research Ethics sets out principles, requirements and standards for review by
p.000009: university committees that are compatible with those set out in this document.
p.000009: 2.3.10 This document does not apply to research reviewed by the Ministry of Defence Research Ethics Committee
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Searching for indicator volunteers:
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p.000022: as an officer (see paragraph 4.2.15). Where the normal period of membership has expired, the appointing authority may
p.000022: exceptionally extend a member’s term while new members are appointed.
p.000022: 4.3.3 Former members may be reappointed to the same REC no sooner than two years after the end of their last term,
p.000022: or to another REC without interval.
p.000022: 4.3.4 Attendance at meetings of other RECs as a co-opted member, referee or observer is encouraged, in the
p.000022: interests of training and consistency.
p.000022: 4.3.5 Simultaneous membership of more than one REC is permitted with the approval of the appointing authorities
p.000022: concerned, as is deputy membership of other RECs. REC members are normally required to attend in full at least two
p.000022: thirds of all scheduled REC meetings in each year, barring exceptional circumstances. Attendance at scheduled
p.000022: sub-committee meetings should be taken into account. With the approval of the appointing authority, a REC member and
p.000022: his or her deputy may make arrangements to share responsibility for attendance. In this case, the REC member should
p.000022: attend at least as many scheduled meetings in each year as the deputy.
p.000022: 4.3.6 REC members may resign at any time.
p.000022:
p.000022: 4.3.7 REC members should normally allow publication of their full name and, if applicable, their profession and
p.000022: institutional affiliation. In the interests of transparency and probity, any potential conflict of interest should be
p.000022: recorded and published with these personal details.
p.000022: 4.3.8 REC members are unpaid volunteers. RECs may not charge an application fee or seek any other financial
p.000022: contribution or donation for or on considering a research proposal for which their review is required by Section 2.
p.000022: Members receive no payment for contributing to the review of applications at scheduled meetings or for attending such
p.000022: meetings.
p.000022: 4.3.9 Expenses incurred during the course of a REC member’s duties are reimbursed. These may cover travel,
p.000022: subsistence, domestic care and locum arrangements, but do not normally cover loss of earnings. Allowances may be
p.000022: offered to REC members for
p.000022:
p.000022:
p.000022:
p.000023: 23
p.000023:
p.000023: additional activities, e.g. appointment as an officer, acting as a point of contact to advise applicants or providing
p.000023: expert critique of research proposals as a referee.
p.000023: Training
p.000023:
p.000023: 4.3.10 As a condition of appointment, REC members must agree to take part in initial and continual training
p.000023: appropriate to their role.
p.000023: Confidentiality
p.000023:
p.000023: 4.3.11 REC members must maintain confidentiality regarding applications, meeting deliberations, information about
p.000023: research participants and related matters.
p.000023: Indemnity
p.000023:
p.000023: 4.3.12 Each REC member must be supplied with a personal statement regarding the indemnity provided by the appointing
p.000023: authority and its conditions.
p.000023: Conduct
p.000023:
p.000023: 4.3.13 The meetings and proceedings of RECs and their sub-committees are conducted in accordance with standard
p.000023: operating procedures.
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Health / Mentally Disabled
Searching for indicator disability:
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p.000012: Service to protect the dignity, rights, safety and well- being of people who take part in research.
p.000012: 3.2 Role of research ethics committees
p.000012: Protection of research participants
p.000012:
p.000012: 3.2.1 Whatever the research context, the interests of participants come first. Their dignity, rights, safety and
p.000012: well-being must be the primary consideration in any research proposal, as well as in REC review. RECs must be assured
p.000012: that there are proportionate safeguards to protect people taking part in research.
p.000012: Science and society
p.000012:
p.000012: 3.2.2 RECs act primarily in the interests of research participants. The interests of researchers and research are
p.000012: always secondary to the dignity, rights, safety and well- being of people taking part in research. RECs take into
p.000012: account the interests and safety of the researchers, as well as the public interest in reliable evidence affecting
p.000012: health and social care and enable ethical and worthwhile research of benefit to participants or to science and society.
p.000012: 3.2.3 The benefits and risks of taking part in research, and the benefits of research evidence for improved health
p.000012: and social care, should be distributed fairly among all social groups and classes. Selection criteria in research
p.000012: protocols should not unjustifiably exclude potential participants, for instance on the basis of economic status,
p.000012: culture, age, disability, gender reassignment, marriage and civil partnership, pregnancy and maternity, race, religion
p.000012: or belief, sex or sexual orientation. RECs should take these considerations into account in reviewing the ethics of
p.000012: research proposals, particularly those involving under-researched groups.
p.000012: Proportionate scrutiny
p.000012:
p.000012: 3.2.4 REC review is proportionate to the scale and complexity of the research proposed. Research proposals that
p.000012: present no material issues of research ethics do not warrant consideration at a full meeting of a REC. They should be
p.000012: identified on receipt in accordance with standard operating procedures so that the ethical review may be undertaken by
p.000012: a sub-committee of a REC. The REC’s opinion on such proposals may be given by the sub-committee. See paragraphs 5.5.1
p.000012: and 5.5.2.
p.000012: 3.2.5 Each research proposal is subject to review by no more than one REC within the UK Research Ethics Service,
p.000012: unless required by law or by a managed appeals process.
p.000012:
p.000012:
p.000012:
p.000012:
p.000013: 13
p.000013:
p.000013: Independence and impartiality
p.000013:
p.000013: 3.2.6 RECs are independent and impartial. A REC’s opinion must be free, and must be seen to be free, from conflicts
p.000013: of interest. This includes freedom from pressures of:
...
p.000018: rationale, aims, objectives and design of the research proposals that it reviews can be effectively reconciled with the
p.000018: dignity, rights, safety and well-being of the people who are likely to take part.
p.000018: 4.2.2 RECs are expected to reflect current ethical norms in society as well as their own ethical judgement. REC
p.000018: members may come from groups associated with particular interests but they are not representatives of those groups. REC
p.000018: members are appointed in their own right to participate in the work of a REC as equal individuals of sound judgement
p.000018: and relevant experience and are supported by training in research ethics and REC review.
p.000018: 4.2.3 A REC should contain a mixture of people who reflect the currency of public opinion (‘lay’ members), as well
p.000018: as people who have relevant formal qualifications or professional experience that can help the REC understand
p.000018: particular aspects of research proposals (‘expert’ members)17 (The term ‘professional member’ can imply someone whose
p.000018: job is to be a REC member (rather than an unpaid volunteer drawn from the care professions etc), so ‘expert member’ is
p.000018: used instead. For this reason, ‘experts by experience’ are counted as lay members.).
p.000018: 4.2.4 The Research Ethics Service as a whole should reflect the diversity of the adult population of society,
p.000018: taking account of age, disability, gender reassignment, marriage and civil partnership, pregnancy and maternity, race,
p.000018: religion or belief, sex and sexual orientation. This applies to both the lay and expert membership. Appointing
p.000018: authorities should take steps, with support from the relevant head office, to publicise the work of RECs and encourage
p.000018: applications for membership from groups who are under- represented.
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000019: 19
p.000019:
p.000019: Appointment of members
p.000019:
p.000019: 4.2.5 Appointment of members should be by an open and fair process, compatible with the Nolan standards. Vacancies
p.000019: should be filled following public advertisement in the press, and/or by advertisement via local, professional and other
p.000019: networks as most appropriate to the vacancy to be filled. Potential candidates should be required to complete an
p.000019: application form and be interviewed. There should be standard written procedures for application and selection, which
p.000019: should comply fully with equality and human rights legislation.
p.000019: Expert and lay members
p.000019:
p.000019: 4.2.6 Each REC should have expert members to ensure methodological and ethical expertise about research in care
p.000019: settings and in relevant fields of care, as well as professional expertise as care practitioners. This expertise should
p.000019: be appropriate to the types of research proposal the REC reviews.
...
Social / Access to Social Goods
Searching for indicator access:
(return to top)
p.000010: participants).
p.000010: 2.3.15 Market research may be undertaken by professional market researchers, e.g. for public health research or on
p.000010: behalf of pharmaceutical or medical device companies.
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000011: 11
p.000011:
p.000011: Where such research is conducted by professional market researchers in accordance with the principles set out in the
p.000011: Market Research Society Code of Conduct or with the Legal and Ethical Guidelines issued by the British Healthcare
p.000011: Business Intelligence Association (BHBIA), it does not require REC review, except where otherwise required by law,
p.000011: e.g. if it requires approval under the Mental Capacity Acts.
p.000011: 2.3.16 At the request of the sponsor, chief investigator or host organisation, RECs may exceptionally review research
p.000011: excluded from the normal scope of review under paragraphs 2.3.13–2.3.15 where the Research Ethics Service agrees that
p.000011: the proposal raises material ethical issues. The parties responsible for managing those issues remain liable for the
p.000011: assessment which informs that management.
p.000011: 2.3.17 Research projects involving human subjects or their tissue or information may be undertaken on the premises of
p.000011: NHS/HSC or social care organisations by third party organisations, for example contract research organisations or
p.000011: research units owned by universities or voluntary organisations. Where the project falls within the scope of paragraphs
p.000011: 2.3.5–2.3.6 above, REC review is required. Where the project only involves care organisations insofar as it involves
p.000011: use of or access to the organisation’s premises or facilities, REC review is not required. Responsibility for
p.000011: considering and managing any risks relating to access to or use of the premises or facilities by visitors lies not with
p.000011: the Research Ethics Service but with the organisation concerned.
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000012: 12
p.000012:
p.000012: 3 Role and remit
p.000012: 3.1 Summary
p.000012: 3.1.1 Research ethics committees (RECs) act as part of an efficient, accountable and independent Research Ethics
p.000012: Service to protect the dignity, rights, safety and well- being of people who take part in research.
p.000012: 3.2 Role of research ethics committees
p.000012: Protection of research participants
p.000012:
p.000012: 3.2.1 Whatever the research context, the interests of participants come first. Their dignity, rights, safety and
p.000012: well-being must be the primary consideration in any research proposal, as well as in REC review. RECs must be assured
p.000012: that there are proportionate safeguards to protect people taking part in research.
p.000012: Science and society
p.000012:
p.000012: 3.2.2 RECs act primarily in the interests of research participants. The interests of researchers and research are
...
p.000014: Research (or other recognised standards of good practice, as applicable), the Data Protection Act and the Codes of
p.000014: Practice issued under the Mental Capacity Acts and Human Tissue Act.
p.000014: Compliance and enforcement
p.000014:
p.000014: 3.2.12 If REC review is required (see Section 2), organisations providing care must ensure that the research they
p.000014: host has a favourable REC opinion. The research may not begin until a favourable REC opinion has been given.
p.000014: 3.2.13 If REC review is required, sponsors may not allow any research they are sponsoring to begin without a
p.000014: favourable REC opinion.
p.000014: 3.2.14 The chief investigator is the researcher who takes primary responsibility for the design, conduct and
p.000014: reporting of the research. The chief investigator is responsible for the content of the REC application and for the
p.000014: scientific and ethical conduct of the research.
p.000014: 3.2.15 Although RECs must be assured about the planned ethical conduct and anticipated risks and benefits of any
p.000014: proposed research, they are not responsible for enforcement if the research turns out to be unsafe or is not carried
p.000014: out as agreed. This responsibility rests with the relevant regulators or comparable bodies, as well as with the
p.000014: researchers’ employer and sponsor and with the care organisations where the research takes place (or through which the
p.000014: researchers have access to participants, or their tissue or information) or where the researchers have contracts.
p.000014: Statutory enforcement authorities are listed in Annex B.
p.000014: 3.2.16 The Research Ethics Service should agree channels of communication with the relevant bodies in order to
p.000014: exchange advice. RECs should use these channels to alert
p.000014:
p.000015: 15
p.000015:
p.000015: the bodies responsible for enforcement if they have grounds to suspect that enforcement action is warranted.
p.000015: 3.2.17 RECs receive annual reports about the progress of the research they have reviewed. These reports reflect any
p.000015: developments affecting participants' dignity, rights, safety or well-being.
p.000015:
p.000015: 3.2.18 A REC should reconsider its favourable opinion in light of pertinent information13 (RECs are not expected to
p.000015: duplicate the ongoing checks for which others are responsible (see paragraph 5.4.2). For instance, safety reports in
p.000015: respect of research that is subject to Clinical Trials Regulations or Medical Devices Regulations are received and
p.000015: reviewed by the Medicines and Healthcare products Regulatory Agency.) that comes to its attention. If the REC consider
p.000015: that it would not have reached a favourable opinion had it been given that information during its initial review, it
p.000015: should notify the relevant statutory enforcement authority. Where the law does not specify the responsibility for
p.000015: enforcement, the REC should notify the chief investigator and the sponsor that its opinion is no longer favourable.
p.000015: 3.3 Remit
...
Social / Age
Searching for indicator age:
(return to top)
p.000012: Service to protect the dignity, rights, safety and well- being of people who take part in research.
p.000012: 3.2 Role of research ethics committees
p.000012: Protection of research participants
p.000012:
p.000012: 3.2.1 Whatever the research context, the interests of participants come first. Their dignity, rights, safety and
p.000012: well-being must be the primary consideration in any research proposal, as well as in REC review. RECs must be assured
p.000012: that there are proportionate safeguards to protect people taking part in research.
p.000012: Science and society
p.000012:
p.000012: 3.2.2 RECs act primarily in the interests of research participants. The interests of researchers and research are
p.000012: always secondary to the dignity, rights, safety and well- being of people taking part in research. RECs take into
p.000012: account the interests and safety of the researchers, as well as the public interest in reliable evidence affecting
p.000012: health and social care and enable ethical and worthwhile research of benefit to participants or to science and society.
p.000012: 3.2.3 The benefits and risks of taking part in research, and the benefits of research evidence for improved health
p.000012: and social care, should be distributed fairly among all social groups and classes. Selection criteria in research
p.000012: protocols should not unjustifiably exclude potential participants, for instance on the basis of economic status,
p.000012: culture, age, disability, gender reassignment, marriage and civil partnership, pregnancy and maternity, race, religion
p.000012: or belief, sex or sexual orientation. RECs should take these considerations into account in reviewing the ethics of
p.000012: research proposals, particularly those involving under-researched groups.
p.000012: Proportionate scrutiny
p.000012:
p.000012: 3.2.4 REC review is proportionate to the scale and complexity of the research proposed. Research proposals that
p.000012: present no material issues of research ethics do not warrant consideration at a full meeting of a REC. They should be
p.000012: identified on receipt in accordance with standard operating procedures so that the ethical review may be undertaken by
p.000012: a sub-committee of a REC. The REC’s opinion on such proposals may be given by the sub-committee. See paragraphs 5.5.1
p.000012: and 5.5.2.
p.000012: 3.2.5 Each research proposal is subject to review by no more than one REC within the UK Research Ethics Service,
p.000012: unless required by law or by a managed appeals process.
p.000012:
p.000012:
p.000012:
p.000012:
p.000013: 13
p.000013:
p.000013: Independence and impartiality
p.000013:
p.000013: 3.2.6 RECs are independent and impartial. A REC’s opinion must be free, and must be seen to be free, from conflicts
...
p.000018:
p.000018: 4.2.1 The membership of a REC should allow for a sufficiently broad range of experience and expertise so that the
p.000018: rationale, aims, objectives and design of the research proposals that it reviews can be effectively reconciled with the
p.000018: dignity, rights, safety and well-being of the people who are likely to take part.
p.000018: 4.2.2 RECs are expected to reflect current ethical norms in society as well as their own ethical judgement. REC
p.000018: members may come from groups associated with particular interests but they are not representatives of those groups. REC
p.000018: members are appointed in their own right to participate in the work of a REC as equal individuals of sound judgement
p.000018: and relevant experience and are supported by training in research ethics and REC review.
p.000018: 4.2.3 A REC should contain a mixture of people who reflect the currency of public opinion (‘lay’ members), as well
p.000018: as people who have relevant formal qualifications or professional experience that can help the REC understand
p.000018: particular aspects of research proposals (‘expert’ members)17 (The term ‘professional member’ can imply someone whose
p.000018: job is to be a REC member (rather than an unpaid volunteer drawn from the care professions etc), so ‘expert member’ is
p.000018: used instead. For this reason, ‘experts by experience’ are counted as lay members.).
p.000018: 4.2.4 The Research Ethics Service as a whole should reflect the diversity of the adult population of society,
p.000018: taking account of age, disability, gender reassignment, marriage and civil partnership, pregnancy and maternity, race,
p.000018: religion or belief, sex and sexual orientation. This applies to both the lay and expert membership. Appointing
p.000018: authorities should take steps, with support from the relevant head office, to publicise the work of RECs and encourage
p.000018: applications for membership from groups who are under- represented.
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000019: 19
p.000019:
p.000019: Appointment of members
p.000019:
p.000019: 4.2.5 Appointment of members should be by an open and fair process, compatible with the Nolan standards. Vacancies
p.000019: should be filled following public advertisement in the press, and/or by advertisement via local, professional and other
p.000019: networks as most appropriate to the vacancy to be filled. Potential candidates should be required to complete an
p.000019: application form and be interviewed. There should be standard written procedures for application and selection, which
p.000019: should comply fully with equality and human rights legislation.
p.000019: Expert and lay members
p.000019:
p.000019: 4.2.6 Each REC should have expert members to ensure methodological and ethical expertise about research in care
p.000019: settings and in relevant fields of care, as well as professional expertise as care practitioners. This expertise should
p.000019: be appropriate to the types of research proposal the REC reviews.
...
Social / Incarcerated
Searching for indicator liberty:
(return to top)
p.002006:
p.002006: Mental Capacity Act 2005 (Appropriate Body) (England) Regulations 2006
p.002006: Mental Capacity Act 2005 (Appropriate Body) (Wales) Regulations 2007
p.002006: Mental Capacity Act 2005 (Loss of Capacity During Research Project) (England) Regulations 2007
p.002006: Mental Capacity Act 2005 (Loss of Capacity During Research Project) (Wales) Regulations 2007
p.002006: Mental Capacity Act (Northern Ireland) 2016
p.002006: Yes No No No
p.002006:
p.002006: No No No Yes
p.002006:
p.002006: Yes No No No
p.002006:
p.002006:
p.002006: No No No Yes
p.002006:
p.002006:
p.002006: No Yes No No
p.002006:
p.002006:
p.002006:
p.002006:
p.002006:
p.002006:
p.002006:
p.002006:
p.002006:
p.002006:
p.002006:
p.002006:
p.000031: 31
p.000031:
p.000031:
p.000031:
p.000031:
p.000031: Extent of legal requirement for research ethics committee review
p.000031:
p.000031: Legislation England Northern Ireland
p.000031:
p.000031: Scotland Wales
p.000031:
p.000031:
p.000031: The Mental Capacity (Deprivation of Liberty) Regulations (Northern Ireland) 2019
p.000031: The Mental Capacity (2016 Act) (Commencement No.1) Order (Northern Ireland) 2019
p.000031: Psychoactive Substances Act 201622 (Scientific research carried out on humans is exempt from the scope of the act where
p.000031: it has been approved by a relevant ethics review body.)
p.000031:
p.000031: Residential Care Homes Regulations (Northern Ireland) 2005
p.000031: No Yes No No
p.000031:
p.000031:
p.000031: No Yes No No
p.000031:
p.000031:
p.000031: Yes Yes Yes Yes
p.000031:
p.000031:
p.000031:
p.000031:
p.000031: No Yes No No
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000032: 32
p.000032:
p.000032: Annex B: Enforcement authorities
p.000032:
p.000032: Any updates to this list will be published at www.hra.nhs.uk.
p.000032:
p.000032:
p.000032: Jurisdiction
p.000032:
p.000032:
p.000032: Activity Relevant Body England Northern Ireland
p.000032: Scotland Wales
p.000032:
p.000032: Protection of service users from unsafe or inappropriate care
p.000032: Human Embryo Research
p.000032:
p.000032: Licensed storage of relevant materials for research purposes
...
Searching for indicator prison:
(return to top)
p.000008: of these services
p.000008: c. use of previously collected tissue (i.e. any material consisting of or including human cells)6 (Including those
p.000008: who have died within the last 100 years) from which individual past or present users of these services are likely to be
p.000008: identified by the researchers either directly from that tissue or from its combination with other tissue or information
p.000008: in, or likely to come into, their possession.
p.000008: d. use of previously collected information which individual past or present users of these services are likely to be
p.000008: identified by the researchers either directly from that information or from its combination with other information in,
p.000008: or likely to come into, their possession.
p.000008: e. collecting tissue or information from users of these services
p.000008:
p.000008: unless any of the exceptions or other exclusions described in paragraph 2.3.9–2.3.17 apply.
p.000008: 2.3.6 REC review under this document is also required for:
p.000008:
p.000008: a. xenotransplantation (i.e. putting living cells, tissue or organs from animals into people), which, as a matter of
p.000008: Government policy7 (New interventional procedures are overseen and scrutinised by the National Institute for Health and
p.000008: Care Excellence (NICE). In addition to xenotransplantation, RECs may need to consider studies of other new procedures
p.000008: as advised by NICE.)8 (Xenotransplantation Guidance. Department of Health (England), Dec 2006. ), is recommended to
p.000008: take place in a controlled research context, carried out with a research protocol approved by a REC within the UK
p.000008: Research Ethics Service.
p.000008: b. health-related research involving offenders, for which Her Majesty’s Prison and Probation Service, Scottish Prison
p.000008: Service and Northern Ireland Prison Service are responsible require review by a REC as well as compliance with their
p.000008: own approval procedures
p.000008: c. social care research projects funded by the Department of Health and Social Care (England) involving adult social
p.000008: care service users as participants, which must always be reviewed by a REC within the Research Ethics Service for
p.000008: England
p.000008: d. research involving analysis of human DNA in acellular material9 (See paragraphs 70– 79 of the Human Tissue
p.000008: Authority’s Code of Practice E at www.hta.gov.uk ) (e.g. serum, processed plasma and processed semen) where appropriate
p.000008: consent for the research is not in place from or on behalf of the person whose body manufactured
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000009: 9
p.000009:
p.000009: the DNA. The researcher must not be in possession of, or likely to come into possession of, information from which the
p.000009: person whose body manufactured the DNA can be identified.
p.000009: Other provisions for research ethics committee review
p.000009:
p.000009: 2.3.7 RECs may agree to consider applications in respect of activities preparatory to research (e.g. the
p.000009: establishment of research databases or tissue banks, or pre-trial advertising and screening for healthy volunteers) and
p.000009: research proposals which fall outside the normal scope described above, capacity permitting. When they do this, they
p.000009: must follow the relevant standard operating procedures.
...
Social / Occupation
Searching for indicator job:
(return to top)
p.000018:
p.000018: 4.1 Summary
p.000018: 4.1.1 Research ethics committees (RECs) harmonise public and professional opinion in reaching decisions about
p.000018: proposed research. Their members reflect the diversity of society and do not represent vested interests.
p.000018: 4.2 Composition of research ethics committees
p.000018: Nature of membership
p.000018:
p.000018: 4.2.1 The membership of a REC should allow for a sufficiently broad range of experience and expertise so that the
p.000018: rationale, aims, objectives and design of the research proposals that it reviews can be effectively reconciled with the
p.000018: dignity, rights, safety and well-being of the people who are likely to take part.
p.000018: 4.2.2 RECs are expected to reflect current ethical norms in society as well as their own ethical judgement. REC
p.000018: members may come from groups associated with particular interests but they are not representatives of those groups. REC
p.000018: members are appointed in their own right to participate in the work of a REC as equal individuals of sound judgement
p.000018: and relevant experience and are supported by training in research ethics and REC review.
p.000018: 4.2.3 A REC should contain a mixture of people who reflect the currency of public opinion (‘lay’ members), as well
p.000018: as people who have relevant formal qualifications or professional experience that can help the REC understand
p.000018: particular aspects of research proposals (‘expert’ members)17 (The term ‘professional member’ can imply someone whose
p.000018: job is to be a REC member (rather than an unpaid volunteer drawn from the care professions etc), so ‘expert member’ is
p.000018: used instead. For this reason, ‘experts by experience’ are counted as lay members.).
p.000018: 4.2.4 The Research Ethics Service as a whole should reflect the diversity of the adult population of society,
p.000018: taking account of age, disability, gender reassignment, marriage and civil partnership, pregnancy and maternity, race,
p.000018: religion or belief, sex and sexual orientation. This applies to both the lay and expert membership. Appointing
p.000018: authorities should take steps, with support from the relevant head office, to publicise the work of RECs and encourage
p.000018: applications for membership from groups who are under- represented.
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000019: 19
p.000019:
p.000019: Appointment of members
p.000019:
p.000019: 4.2.5 Appointment of members should be by an open and fair process, compatible with the Nolan standards. Vacancies
p.000019: should be filled following public advertisement in the press, and/or by advertisement via local, professional and other
p.000019: networks as most appropriate to the vacancy to be filled. Potential candidates should be required to complete an
p.000019: application form and be interviewed. There should be standard written procedures for application and selection, which
...
Searching for indicator occupation:
(return to top)
p.000037: b. establishing or recognising RECs to act in relation to such descriptions or classes of research as it considers
p.000037: appropriate;
p.000037: c. varying the extent to or relation in which RECs act under (a) and (b);
p.000037:
p.000037: d. abolishing or revoking the recognition of RECs which it has established or recognised;
p.000037:
p.000037: e. monitoring the extent to which RECs adequately perform their functions, including through annual reports from RECs
p.000037: it has recognised;
p.000037: f. approving standing orders and standard operating procedures for the regulation of the proceedings and business of
p.000037: RECs; and
p.000037: g. approving variations to or revocation or suspension of orders or procedures made or adopted under (f).
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000038: 38
p.000038:
p.000038: Annex G: Management information about research ethics committees
p.000038:
p.000038: The head office should maintain information, at least on an annual basis, about the following:
p.000038:
p.000038: a. the REC’s name, address and other contact details;
p.000038:
p.000038: b. the type of REC, including details of any recognition by UKECA and/or designation by the Research Ethics Service
p.000038: for review of certain types of research proposal;
p.000038: c. details of the officers and staff of the REC;
p.000038:
p.000038: d. details of the membership of the REC, including for each member and deputy member their occupation, expert/lay
p.000038: status, initial date of appointment, and where applicable the date on which the term of membership expired or the
p.000038: member resigned;
p.000038: e. the current register of members’ interests;
p.000038:
p.000038: f. the attendance record of each member and deputy member during the year;
p.000038:
p.000038: g. a list of full meetings held during the year, including their dates and the number of members attending;
p.000038: h. the training record of each member and deputy member; and
p.000038:
p.000038: i. a list of the applications reviewed during the year, including the final decision reached on each application and
p.000038: the time taken to complete the review (or the current status of the review).
p.000038: In the case of clinical trials of investigational medicinal products, the REC must, within six months from the end of
p.000038: each financial year, prepare a report on its activities during that year, which shall include a list of the
p.000038: applications made to the REC in accordance with regulation 14 of the Medicines for Human Use (Clinical Trials)
p.000038: Regulations 2004 and the decisions made by the REC in relation to those applications. The REC must send a copy of the
p.000038: report to, on behalf of UKECA, the Health Research Authority.
p.000038:
p.000038:
p.000038:
p.000038:
p.000038:
p.000038:
p.000038:
p.000038:
p.000038:
p.000038:
p.000038:
p.000038:
...
Social / Police Officer
Searching for indicator officer:
(return to top)
p.000016: RECs in Wales
p.000016: Department for Health and Social Services
p.000016:
p.000016:
p.000016: Health Research Authority
p.000016: Recs in England14 (the HRA performs some functions relating to management of the UK research ethics service outside of
p.000016: England (see paragraphs 3.3.7, 3.3.8, glossary and annex E)
p.000016: Department for Health and Social Care (England)
p.000016:
p.000016:
p.000016: Office for Research Ethics Committees Northern Ireland
p.000016: RECs in Northern Ireland
p.000016: Department of Health (Northern Ireland)
p.000016:
p.000016:
p.000016: 3.3.5 The head offices work with each other to maintain a consistent approach, on behalf of appointing authorities,
p.000016: to the operations of all RECs within the UK Research Ethics Service. The responsibilities and functions of the head
p.000016: offices are listed in Annex C.
p.000016: 3.3.6 Appointing authorities are the bodies that establish RECs, appoint and indemnify their members, seek their
p.000016: recognition if the law requires it and monitor their performance15 (The relevant head office is responsible for
p.000016: day-to-day and ad hoc management of the operation and performance of RECs). Each appointing authority identifies a
p.000016: named senior person, who is not otherwise directly involved in the management of Research Ethics Service staff, who has
p.000016: responsibility for governance of the RECs on behalf of the chief executive (unless the named officer is the chief
p.000016: executive). The chief executive has overall accountability. The responsibilities and functions of appointing
p.000016: authorities are listed in Annex D.
p.000016: 3.3.7 The head office of the Research Ethics Service for England, the Health Research Authority, performs some
p.000016: functions on behalf of the other head offices. It also acts in respect of some UK-wide functions and for the Devolved
p.000016: Administrations and the UK Ethics Committee Authority (UKECA), which is the statutory body that recognises RECs for the
p.000016: review of clinical trials of investigational medicinal products. Functions performed by the Health Research Authority
p.000016: are listed in Annex E. Functions performed by UKECA are listed in Annex F.
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000017: 17
p.000017:
p.000017: 3.3.8 The Health Research Authority has established a National Research and Ethics Advisers’ Panel to provide it
p.000017: with a transparent source of advice and expertise to enable it to fulfil its statutory functions within an overall
p.000017: UK-wide framework for research ethics and broader research governance16 (For further details, see the panel’s terms of
p.000017: reference at www.hra.nhs.uk). The panel is a resource available to the UK Research Ethics Service and to the appointing
...
p.000019: should comply fully with equality and human rights legislation.
p.000019: Expert and lay members
p.000019:
p.000019: 4.2.6 Each REC should have expert members to ensure methodological and ethical expertise about research in care
p.000019: settings and in relevant fields of care, as well as professional expertise as care practitioners. This expertise should
p.000019: be appropriate to the types of research proposal the REC reviews.
p.000019: 4.2.7 Lay members are people who are not employed in health or care professions or whose primary professional
p.000019: interest is not health- or care-related research. At least a third of each REC’s membership should be lay.
p.000019: 4.2.8 The Research Ethics Service head offices should adopt and publish operational definitions of expert and lay
p.000019: members, taking into account other applicable requirements (see paragraph 4.2.12), and support RECs and their
p.000019: appointing authorities to ensure an appropriate balance of members.
p.000019: Affiliations
p.000019:
p.000019: 4.2.9 RECs are constituted, and operate, independently of organisations that sponsor, conduct or host research.
p.000019: Members absent themselves during consideration of research proposals that could be seen to create a conflict of
p.000019: interest. REC meetings should be attended so as to accommodate these absences while remaining quorate.
p.000019: Quorum
p.000019:
p.000019: 4.2.10 For the purpose of effective debate, a REC normally has no more than 18 members in total. A quorate meeting is
p.000019: one attended by no fewer than seven members, including:
p.000019: a. the chair or other officer
p.000019:
p.000019: b. at least one expert member
p.000019:
p.000019: c. at least one lay member.
p.000019:
p.000019: 4.2.11 Each REC should be constituted so that it can function quorately for the duration of its scheduled meetings.
p.000019: 4.2.12 Where other membership, composition or attendance criteria are specified, e.g. in law, for RECs reviewing
p.000019: certain types of research proposal18 (For instance, the REC
p.000019:
p.000019:
p.000019:
p.000019:
p.000020: 20
p.000020:
p.000020: constituted by regulations made under the Adults with Incapacity (Scotland) Act 2000 and associated statutory
p.000020: instruments, RECs that review clinical trials of investigational medicinal products or research funded by the US
p.000020: government.), guidance enabling RECs to convene in accordance with the requirements set out in this document as well as
p.000020: the additional specifications is available from the Health Research Authority website, www.hra.nhs.uk19 (Standard
p.000020: Operating Procedures for Research Ethics Committees. www.hra.nhs.uk).
p.000020: Officers
p.000020:
p.000020: 4.2.13 Each REC has a chair, a vice-chair and an alternate vice-chair. These officers are appointed from among the
p.000020: REC’s members by the relevant appointing authority, after consulting the REC. If all three are unavailable, another
p.000020: member or an appointed officer from a different REC will be acting chair.
p.000020: 4.2.14 Candidates for office are expected to have at least one year’s experience as a member of a REC. Appointees
p.000020: should receive any necessary supplementary training (e.g. in chairing skills) prior to taking office.
p.000020: 4.2.15 Officers are appointed for a specified period not exceeding five years. Officer appointments may be renewed
p.000020: (and exceptionally extended) in the same way as member appointments (see paragraph 4.3.2). An acting chair’s
p.000020: appointment ceases when one of the other officers becomes available again or when his or her term as a member expires,
p.000020: whichever is sooner.
p.000020: 4.2.16 Officers may resign from office at any time. They may continue as members of the REC, subject to the
p.000020: disqualification and resignation procedures of its appointing authority.
p.000020: Deputies
p.000020:
p.000020: 4.2.17 REC members may have deputies to enable the REC to perform its duties and meet quorately, while accommodating
p.000020: absences.
p.000020: 4.2.18 Deputies of expert members must be eligible for appointment in their own right as expert members. Deputies of
p.000020: lay members must be eligible for appointment in their own right as lay members. Deputies are appointed by the REC’s
p.000020: appointing authority.
p.000020: 4.2.19 Deputies do not count towards the quorum or vote on decisions unless the members for whom they deputise are
p.000020: absent.
p.000020: Referees
p.000020:
p.000020: 4.2.20 RECs may seek advice from specialist referees on any aspects of a research proposal that fall beyond the
p.000020: members’ expertise. RECs may seek referees’ advice at their discretion or because the law requires them to do so.
p.000020: Referees’ advice should only be sought on issues material to the REC’s review of the research proposal, i.e. issues of
p.000020: research ethics.
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000021: 21
p.000021:
...
p.000021: External observers play no part in the deliberations of the REC.
p.000021: 4.2.23 Representatives of the relevant Research Ethics Service head office may attend and observe meetings at any
p.000021: time, with prior notification.
p.000021: Advice to applicants
p.000021:
p.000021: 4.2.24 RECs should take steps to facilitate communication with their potential or actual applicants. A REC may
p.000021: designate a point of contact for more detailed discussion. This includes advice about whether a proposed activity
p.000021: requires REC review, or the content, submission or review of an application. The point of contact may be any of
p.000021: the REC’s members (including those appointed as officers) or administrative staff.
p.000021:
p.000021: Delegation
p.000021:
p.000021: 4.2.25 A REC may appoint sub-committees consisting of its members. Sub-committees, committee officers and
p.000021: administrative staff may exercise any of the REC’s functions on its behalf, in accordance with standard operating
p.000021: procedures. In particular, sub- committees may review and give an opinion of:
p.000021: a. research proposals that present no material ethical issues
p.000021:
p.000021: b. information further to earlier review in full committee
p.000021:
p.000021: c. substantial amendments
p.000021:
p.000021: d. annual progress reports (see paragraph 3.2.17).
p.000021:
p.000021: 4.2.26 If a REC issues a provisional opinion reached in full committee, it may delegate the responsibility for
p.000021: determining its final opinion to the chair or other officer, or to a sub- committee of specified members.
p.000021: 4.2.27 Responsibilities of REC officers may be delegated to administrative staff where the matters are
p.000021: administrative, in accordance with standard operating procedures. In particular, administrative staff may check
p.000021: evidence provided by applicants in response to requests for further information and issue letters confirming the REC’s
p.000021: opinion.
p.000021: 4.3 Conditions of membership
p.000021: Terms of appointment
p.000021:
p.000021: 4.3.1 Written terms of appointment for REC members should include the following:
p.000021:
p.000021:
p.000022: 22
p.000022:
p.000022: a. duration of appointment
p.000022:
p.000022: b. renewal policy
p.000022:
p.000022: c. disqualification and resignation procedures
p.000022:
p.000022: d. policy concerning declaration of interests
p.000022:
p.000022: e. details of allowable expenses.
p.000022:
p.000022: 4.3.2 REC members are appointed for fixed terms not exceeding five years. Appointments may be renewed. However,
p.000022: members should not normally serve more than two consecutive terms of five years on the same REC. Where a member is
p.000022: appointed as an officer during their second term, their membership may be extended until the completion of their term
p.000022: as an officer (see paragraph 4.2.15). Where the normal period of membership has expired, the appointing authority may
p.000022: exceptionally extend a member’s term while new members are appointed.
p.000022: 4.3.3 Former members may be reappointed to the same REC no sooner than two years after the end of their last term,
p.000022: or to another REC without interval.
p.000022: 4.3.4 Attendance at meetings of other RECs as a co-opted member, referee or observer is encouraged, in the
p.000022: interests of training and consistency.
p.000022: 4.3.5 Simultaneous membership of more than one REC is permitted with the approval of the appointing authorities
p.000022: concerned, as is deputy membership of other RECs. REC members are normally required to attend in full at least two
p.000022: thirds of all scheduled REC meetings in each year, barring exceptional circumstances. Attendance at scheduled
p.000022: sub-committee meetings should be taken into account. With the approval of the appointing authority, a REC member and
p.000022: his or her deputy may make arrangements to share responsibility for attendance. In this case, the REC member should
p.000022: attend at least as many scheduled meetings in each year as the deputy.
p.000022: 4.3.6 REC members may resign at any time.
p.000022:
p.000022: 4.3.7 REC members should normally allow publication of their full name and, if applicable, their profession and
p.000022: institutional affiliation. In the interests of transparency and probity, any potential conflict of interest should be
p.000022: recorded and published with these personal details.
p.000022: 4.3.8 REC members are unpaid volunteers. RECs may not charge an application fee or seek any other financial
p.000022: contribution or donation for or on considering a research proposal for which their review is required by Section 2.
p.000022: Members receive no payment for contributing to the review of applications at scheduled meetings or for attending such
p.000022: meetings.
p.000022: 4.3.9 Expenses incurred during the course of a REC member’s duties are reimbursed. These may cover travel,
p.000022: subsistence, domestic care and locum arrangements, but do not normally cover loss of earnings. Allowances may be
p.000022: offered to REC members for
p.000022:
p.000022:
p.000022:
p.000023: 23
p.000023:
p.000023: additional activities, e.g. appointment as an officer, acting as a point of contact to advise applicants or providing
p.000023: expert critique of research proposals as a referee.
p.000023: Training
p.000023:
p.000023: 4.3.10 As a condition of appointment, REC members must agree to take part in initial and continual training
p.000023: appropriate to their role.
p.000023: Confidentiality
p.000023:
p.000023: 4.3.11 REC members must maintain confidentiality regarding applications, meeting deliberations, information about
p.000023: research participants and related matters.
p.000023: Indemnity
p.000023:
p.000023: 4.3.12 Each REC member must be supplied with a personal statement regarding the indemnity provided by the appointing
p.000023: authority and its conditions.
p.000023: Conduct
p.000023:
p.000023: 4.3.13 The meetings and proceedings of RECs and their sub-committees are conducted in accordance with standard
p.000023: operating procedures.
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000024: 24
p.000024:
p.000024: 5 Requirements of research ethics committee review
p.000024: Summary
p.000024: 5.1.1 There is a standard process for applying to a research ethics committee. Research ethics committees (RECs)
p.000024: also review applications in accordance with standards.
...
Social / Racial Minority
Searching for indicator race:
(return to top)
p.000012: 3.2 Role of research ethics committees
p.000012: Protection of research participants
p.000012:
p.000012: 3.2.1 Whatever the research context, the interests of participants come first. Their dignity, rights, safety and
p.000012: well-being must be the primary consideration in any research proposal, as well as in REC review. RECs must be assured
p.000012: that there are proportionate safeguards to protect people taking part in research.
p.000012: Science and society
p.000012:
p.000012: 3.2.2 RECs act primarily in the interests of research participants. The interests of researchers and research are
p.000012: always secondary to the dignity, rights, safety and well- being of people taking part in research. RECs take into
p.000012: account the interests and safety of the researchers, as well as the public interest in reliable evidence affecting
p.000012: health and social care and enable ethical and worthwhile research of benefit to participants or to science and society.
p.000012: 3.2.3 The benefits and risks of taking part in research, and the benefits of research evidence for improved health
p.000012: and social care, should be distributed fairly among all social groups and classes. Selection criteria in research
p.000012: protocols should not unjustifiably exclude potential participants, for instance on the basis of economic status,
p.000012: culture, age, disability, gender reassignment, marriage and civil partnership, pregnancy and maternity, race, religion
p.000012: or belief, sex or sexual orientation. RECs should take these considerations into account in reviewing the ethics of
p.000012: research proposals, particularly those involving under-researched groups.
p.000012: Proportionate scrutiny
p.000012:
p.000012: 3.2.4 REC review is proportionate to the scale and complexity of the research proposed. Research proposals that
p.000012: present no material issues of research ethics do not warrant consideration at a full meeting of a REC. They should be
p.000012: identified on receipt in accordance with standard operating procedures so that the ethical review may be undertaken by
p.000012: a sub-committee of a REC. The REC’s opinion on such proposals may be given by the sub-committee. See paragraphs 5.5.1
p.000012: and 5.5.2.
p.000012: 3.2.5 Each research proposal is subject to review by no more than one REC within the UK Research Ethics Service,
p.000012: unless required by law or by a managed appeals process.
p.000012:
p.000012:
p.000012:
p.000012:
p.000013: 13
p.000013:
p.000013: Independence and impartiality
p.000013:
p.000013: 3.2.6 RECs are independent and impartial. A REC’s opinion must be free, and must be seen to be free, from conflicts
p.000013: of interest. This includes freedom from pressures of:
p.000013: a. political influence
p.000013:
p.000013: b. institutional affiliation
p.000013:
...
p.000018: dignity, rights, safety and well-being of the people who are likely to take part.
p.000018: 4.2.2 RECs are expected to reflect current ethical norms in society as well as their own ethical judgement. REC
p.000018: members may come from groups associated with particular interests but they are not representatives of those groups. REC
p.000018: members are appointed in their own right to participate in the work of a REC as equal individuals of sound judgement
p.000018: and relevant experience and are supported by training in research ethics and REC review.
p.000018: 4.2.3 A REC should contain a mixture of people who reflect the currency of public opinion (‘lay’ members), as well
p.000018: as people who have relevant formal qualifications or professional experience that can help the REC understand
p.000018: particular aspects of research proposals (‘expert’ members)17 (The term ‘professional member’ can imply someone whose
p.000018: job is to be a REC member (rather than an unpaid volunteer drawn from the care professions etc), so ‘expert member’ is
p.000018: used instead. For this reason, ‘experts by experience’ are counted as lay members.).
p.000018: 4.2.4 The Research Ethics Service as a whole should reflect the diversity of the adult population of society,
p.000018: taking account of age, disability, gender reassignment, marriage and civil partnership, pregnancy and maternity, race,
p.000018: religion or belief, sex and sexual orientation. This applies to both the lay and expert membership. Appointing
p.000018: authorities should take steps, with support from the relevant head office, to publicise the work of RECs and encourage
p.000018: applications for membership from groups who are under- represented.
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000019: 19
p.000019:
p.000019: Appointment of members
p.000019:
p.000019: 4.2.5 Appointment of members should be by an open and fair process, compatible with the Nolan standards. Vacancies
p.000019: should be filled following public advertisement in the press, and/or by advertisement via local, professional and other
p.000019: networks as most appropriate to the vacancy to be filled. Potential candidates should be required to complete an
p.000019: application form and be interviewed. There should be standard written procedures for application and selection, which
p.000019: should comply fully with equality and human rights legislation.
p.000019: Expert and lay members
p.000019:
p.000019: 4.2.6 Each REC should have expert members to ensure methodological and ethical expertise about research in care
p.000019: settings and in relevant fields of care, as well as professional expertise as care practitioners. This expertise should
p.000019: be appropriate to the types of research proposal the REC reviews.
p.000019: 4.2.7 Lay members are people who are not employed in health or care professions or whose primary professional
p.000019: interest is not health- or care-related research. At least a third of each REC’s membership should be lay.
...
Social / Religion
Searching for indicator belief:
(return to top)
p.000012:
p.000012: 3.2.1 Whatever the research context, the interests of participants come first. Their dignity, rights, safety and
p.000012: well-being must be the primary consideration in any research proposal, as well as in REC review. RECs must be assured
p.000012: that there are proportionate safeguards to protect people taking part in research.
p.000012: Science and society
p.000012:
p.000012: 3.2.2 RECs act primarily in the interests of research participants. The interests of researchers and research are
p.000012: always secondary to the dignity, rights, safety and well- being of people taking part in research. RECs take into
p.000012: account the interests and safety of the researchers, as well as the public interest in reliable evidence affecting
p.000012: health and social care and enable ethical and worthwhile research of benefit to participants or to science and society.
p.000012: 3.2.3 The benefits and risks of taking part in research, and the benefits of research evidence for improved health
p.000012: and social care, should be distributed fairly among all social groups and classes. Selection criteria in research
p.000012: protocols should not unjustifiably exclude potential participants, for instance on the basis of economic status,
p.000012: culture, age, disability, gender reassignment, marriage and civil partnership, pregnancy and maternity, race, religion
p.000012: or belief, sex or sexual orientation. RECs should take these considerations into account in reviewing the ethics of
p.000012: research proposals, particularly those involving under-researched groups.
p.000012: Proportionate scrutiny
p.000012:
p.000012: 3.2.4 REC review is proportionate to the scale and complexity of the research proposed. Research proposals that
p.000012: present no material issues of research ethics do not warrant consideration at a full meeting of a REC. They should be
p.000012: identified on receipt in accordance with standard operating procedures so that the ethical review may be undertaken by
p.000012: a sub-committee of a REC. The REC’s opinion on such proposals may be given by the sub-committee. See paragraphs 5.5.1
p.000012: and 5.5.2.
p.000012: 3.2.5 Each research proposal is subject to review by no more than one REC within the UK Research Ethics Service,
p.000012: unless required by law or by a managed appeals process.
p.000012:
p.000012:
p.000012:
p.000012:
p.000013: 13
p.000013:
p.000013: Independence and impartiality
p.000013:
p.000013: 3.2.6 RECs are independent and impartial. A REC’s opinion must be free, and must be seen to be free, from conflicts
p.000013: of interest. This includes freedom from pressures of:
p.000013: a. political influence
p.000013:
p.000013: b. institutional affiliation
p.000013:
p.000013: c. trades union or profession-related interests
p.000013:
p.000013: d. direct or indirect financial inducement or any impression thereof
p.000013:
...
p.000018: members may come from groups associated with particular interests but they are not representatives of those groups. REC
p.000018: members are appointed in their own right to participate in the work of a REC as equal individuals of sound judgement
p.000018: and relevant experience and are supported by training in research ethics and REC review.
p.000018: 4.2.3 A REC should contain a mixture of people who reflect the currency of public opinion (‘lay’ members), as well
p.000018: as people who have relevant formal qualifications or professional experience that can help the REC understand
p.000018: particular aspects of research proposals (‘expert’ members)17 (The term ‘professional member’ can imply someone whose
p.000018: job is to be a REC member (rather than an unpaid volunteer drawn from the care professions etc), so ‘expert member’ is
p.000018: used instead. For this reason, ‘experts by experience’ are counted as lay members.).
p.000018: 4.2.4 The Research Ethics Service as a whole should reflect the diversity of the adult population of society,
p.000018: taking account of age, disability, gender reassignment, marriage and civil partnership, pregnancy and maternity, race,
p.000018: religion or belief, sex and sexual orientation. This applies to both the lay and expert membership. Appointing
p.000018: authorities should take steps, with support from the relevant head office, to publicise the work of RECs and encourage
p.000018: applications for membership from groups who are under- represented.
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000019: 19
p.000019:
p.000019: Appointment of members
p.000019:
p.000019: 4.2.5 Appointment of members should be by an open and fair process, compatible with the Nolan standards. Vacancies
p.000019: should be filled following public advertisement in the press, and/or by advertisement via local, professional and other
p.000019: networks as most appropriate to the vacancy to be filled. Potential candidates should be required to complete an
p.000019: application form and be interviewed. There should be standard written procedures for application and selection, which
p.000019: should comply fully with equality and human rights legislation.
p.000019: Expert and lay members
p.000019:
p.000019: 4.2.6 Each REC should have expert members to ensure methodological and ethical expertise about research in care
p.000019: settings and in relevant fields of care, as well as professional expertise as care practitioners. This expertise should
p.000019: be appropriate to the types of research proposal the REC reviews.
p.000019: 4.2.7 Lay members are people who are not employed in health or care professions or whose primary professional
p.000019: interest is not health- or care-related research. At least a third of each REC’s membership should be lay.
p.000019: 4.2.8 The Research Ethics Service head offices should adopt and publish operational definitions of expert and lay
...
Searching for indicator religion:
(return to top)
p.000012: Protection of research participants
p.000012:
p.000012: 3.2.1 Whatever the research context, the interests of participants come first. Their dignity, rights, safety and
p.000012: well-being must be the primary consideration in any research proposal, as well as in REC review. RECs must be assured
p.000012: that there are proportionate safeguards to protect people taking part in research.
p.000012: Science and society
p.000012:
p.000012: 3.2.2 RECs act primarily in the interests of research participants. The interests of researchers and research are
p.000012: always secondary to the dignity, rights, safety and well- being of people taking part in research. RECs take into
p.000012: account the interests and safety of the researchers, as well as the public interest in reliable evidence affecting
p.000012: health and social care and enable ethical and worthwhile research of benefit to participants or to science and society.
p.000012: 3.2.3 The benefits and risks of taking part in research, and the benefits of research evidence for improved health
p.000012: and social care, should be distributed fairly among all social groups and classes. Selection criteria in research
p.000012: protocols should not unjustifiably exclude potential participants, for instance on the basis of economic status,
p.000012: culture, age, disability, gender reassignment, marriage and civil partnership, pregnancy and maternity, race, religion
p.000012: or belief, sex or sexual orientation. RECs should take these considerations into account in reviewing the ethics of
p.000012: research proposals, particularly those involving under-researched groups.
p.000012: Proportionate scrutiny
p.000012:
p.000012: 3.2.4 REC review is proportionate to the scale and complexity of the research proposed. Research proposals that
p.000012: present no material issues of research ethics do not warrant consideration at a full meeting of a REC. They should be
p.000012: identified on receipt in accordance with standard operating procedures so that the ethical review may be undertaken by
p.000012: a sub-committee of a REC. The REC’s opinion on such proposals may be given by the sub-committee. See paragraphs 5.5.1
p.000012: and 5.5.2.
p.000012: 3.2.5 Each research proposal is subject to review by no more than one REC within the UK Research Ethics Service,
p.000012: unless required by law or by a managed appeals process.
p.000012:
p.000012:
p.000012:
p.000012:
p.000013: 13
p.000013:
p.000013: Independence and impartiality
p.000013:
p.000013: 3.2.6 RECs are independent and impartial. A REC’s opinion must be free, and must be seen to be free, from conflicts
p.000013: of interest. This includes freedom from pressures of:
p.000013: a. political influence
p.000013:
p.000013: b. institutional affiliation
p.000013:
...
p.000018: 4.2.2 RECs are expected to reflect current ethical norms in society as well as their own ethical judgement. REC
p.000018: members may come from groups associated with particular interests but they are not representatives of those groups. REC
p.000018: members are appointed in their own right to participate in the work of a REC as equal individuals of sound judgement
p.000018: and relevant experience and are supported by training in research ethics and REC review.
p.000018: 4.2.3 A REC should contain a mixture of people who reflect the currency of public opinion (‘lay’ members), as well
p.000018: as people who have relevant formal qualifications or professional experience that can help the REC understand
p.000018: particular aspects of research proposals (‘expert’ members)17 (The term ‘professional member’ can imply someone whose
p.000018: job is to be a REC member (rather than an unpaid volunteer drawn from the care professions etc), so ‘expert member’ is
p.000018: used instead. For this reason, ‘experts by experience’ are counted as lay members.).
p.000018: 4.2.4 The Research Ethics Service as a whole should reflect the diversity of the adult population of society,
p.000018: taking account of age, disability, gender reassignment, marriage and civil partnership, pregnancy and maternity, race,
p.000018: religion or belief, sex and sexual orientation. This applies to both the lay and expert membership. Appointing
p.000018: authorities should take steps, with support from the relevant head office, to publicise the work of RECs and encourage
p.000018: applications for membership from groups who are under- represented.
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000019: 19
p.000019:
p.000019: Appointment of members
p.000019:
p.000019: 4.2.5 Appointment of members should be by an open and fair process, compatible with the Nolan standards. Vacancies
p.000019: should be filled following public advertisement in the press, and/or by advertisement via local, professional and other
p.000019: networks as most appropriate to the vacancy to be filled. Potential candidates should be required to complete an
p.000019: application form and be interviewed. There should be standard written procedures for application and selection, which
p.000019: should comply fully with equality and human rights legislation.
p.000019: Expert and lay members
p.000019:
p.000019: 4.2.6 Each REC should have expert members to ensure methodological and ethical expertise about research in care
p.000019: settings and in relevant fields of care, as well as professional expertise as care practitioners. This expertise should
p.000019: be appropriate to the types of research proposal the REC reviews.
p.000019: 4.2.7 Lay members are people who are not employed in health or care professions or whose primary professional
p.000019: interest is not health- or care-related research. At least a third of each REC’s membership should be lay.
...
Social / Trade Union Membership
Searching for indicator union:
(return to top)
p.000012: or belief, sex or sexual orientation. RECs should take these considerations into account in reviewing the ethics of
p.000012: research proposals, particularly those involving under-researched groups.
p.000012: Proportionate scrutiny
p.000012:
p.000012: 3.2.4 REC review is proportionate to the scale and complexity of the research proposed. Research proposals that
p.000012: present no material issues of research ethics do not warrant consideration at a full meeting of a REC. They should be
p.000012: identified on receipt in accordance with standard operating procedures so that the ethical review may be undertaken by
p.000012: a sub-committee of a REC. The REC’s opinion on such proposals may be given by the sub-committee. See paragraphs 5.5.1
p.000012: and 5.5.2.
p.000012: 3.2.5 Each research proposal is subject to review by no more than one REC within the UK Research Ethics Service,
p.000012: unless required by law or by a managed appeals process.
p.000012:
p.000012:
p.000012:
p.000012:
p.000013: 13
p.000013:
p.000013: Independence and impartiality
p.000013:
p.000013: 3.2.6 RECs are independent and impartial. A REC’s opinion must be free, and must be seen to be free, from conflicts
p.000013: of interest. This includes freedom from pressures of:
p.000013: a. political influence
p.000013:
p.000013: b. institutional affiliation
p.000013:
p.000013: c. trades union or profession-related interests
p.000013:
p.000013: d. direct or indirect financial inducement or any impression thereof
p.000013:
p.000013: e. coercion
p.000013:
p.000013: f. strategic concerns
p.000013:
p.000013: g. market forces
p.000013:
p.000013: h. agency-, discipline- or topic-related bias.
p.000013:
p.000013: 3.2.7 Although RECs may be appointed by bodies that have functions relating to care provision, their decisions are
p.000013: independent of care providers’ own managers, including their research managers. Care providers, regulators, RECs’
p.000013: appointing authorities and the UK Health Departments may not interfere in the deliberations or opinions of RECs RECs
p.000013: play no part in management decisions about the provision of care services or support for a research project.
p.000013: 3.2.8 The protection of research participants and the enabling of ethical research are best served by co-operation
p.000013: and communication between all those who share responsibility for the research. Except when it would compromise their
p.000013: independence, RECs should collaborate with regulators, actual and potential research participants, researchers,
p.000013: funders, sponsors, employers, organisations providing care and care professionals (see paragraph 5.4.2). RECs should
p.000013: also collaborate with one another, for example to share relevant information from previous applications or expertise in
p.000013: reviewing particular types of research.
p.000013: Competence and efficiency
p.000013:
p.000013: 3.2.9 REC review must be competent, timely and authoritative. The membership, ongoing training and performance
p.000013: management of RECs, as well as the operational and administrative support they receive, are arranged to maximise the
...
Social / Unemployment
Searching for indicator not employed:
(return to top)
p.000018: religion or belief, sex and sexual orientation. This applies to both the lay and expert membership. Appointing
p.000018: authorities should take steps, with support from the relevant head office, to publicise the work of RECs and encourage
p.000018: applications for membership from groups who are under- represented.
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000019: 19
p.000019:
p.000019: Appointment of members
p.000019:
p.000019: 4.2.5 Appointment of members should be by an open and fair process, compatible with the Nolan standards. Vacancies
p.000019: should be filled following public advertisement in the press, and/or by advertisement via local, professional and other
p.000019: networks as most appropriate to the vacancy to be filled. Potential candidates should be required to complete an
p.000019: application form and be interviewed. There should be standard written procedures for application and selection, which
p.000019: should comply fully with equality and human rights legislation.
p.000019: Expert and lay members
p.000019:
p.000019: 4.2.6 Each REC should have expert members to ensure methodological and ethical expertise about research in care
p.000019: settings and in relevant fields of care, as well as professional expertise as care practitioners. This expertise should
p.000019: be appropriate to the types of research proposal the REC reviews.
p.000019: 4.2.7 Lay members are people who are not employed in health or care professions or whose primary professional
p.000019: interest is not health- or care-related research. At least a third of each REC’s membership should be lay.
p.000019: 4.2.8 The Research Ethics Service head offices should adopt and publish operational definitions of expert and lay
p.000019: members, taking into account other applicable requirements (see paragraph 4.2.12), and support RECs and their
p.000019: appointing authorities to ensure an appropriate balance of members.
p.000019: Affiliations
p.000019:
p.000019: 4.2.9 RECs are constituted, and operate, independently of organisations that sponsor, conduct or host research.
p.000019: Members absent themselves during consideration of research proposals that could be seen to create a conflict of
p.000019: interest. REC meetings should be attended so as to accommodate these absences while remaining quorate.
p.000019: Quorum
p.000019:
p.000019: 4.2.10 For the purpose of effective debate, a REC normally has no more than 18 members in total. A quorate meeting is
p.000019: one attended by no fewer than seven members, including:
p.000019: a. the chair or other officer
p.000019:
p.000019: b. at least one expert member
p.000019:
p.000019: c. at least one lay member.
p.000019:
p.000019: 4.2.11 Each REC should be constituted so that it can function quorately for the duration of its scheduled meetings.
p.000019: 4.2.12 Where other membership, composition or attendance criteria are specified, e.g. in law, for RECs reviewing
p.000019: certain types of research proposal18 (For instance, the REC
p.000019:
p.000019:
p.000019:
p.000019:
p.000020: 20
p.000020:
...
Social / embryo
Searching for indicator embryo:
(return to top)
p.000031: The Mental Capacity (2016 Act) (Commencement No.1) Order (Northern Ireland) 2019
p.000031: Psychoactive Substances Act 201622 (Scientific research carried out on humans is exempt from the scope of the act where
p.000031: it has been approved by a relevant ethics review body.)
p.000031:
p.000031: Residential Care Homes Regulations (Northern Ireland) 2005
p.000031: No Yes No No
p.000031:
p.000031:
p.000031: No Yes No No
p.000031:
p.000031:
p.000031: Yes Yes Yes Yes
p.000031:
p.000031:
p.000031:
p.000031:
p.000031: No Yes No No
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000032: 32
p.000032:
p.000032: Annex B: Enforcement authorities
p.000032:
p.000032: Any updates to this list will be published at www.hra.nhs.uk.
p.000032:
p.000032:
p.000032: Jurisdiction
p.000032:
p.000032:
p.000032: Activity Relevant Body England Northern Ireland
p.000032: Scotland Wales
p.000032:
p.000032: Protection of service users from unsafe or inappropriate care
p.000032: Human Embryo Research
p.000032:
p.000032: Licensed storage of relevant materials for research purposes
p.000032: Research exposure to ionising radiation
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032: Clinical investigations of medical devices
p.000032:
p.000032: Clinical trial of investigational medicinal products
p.000032: Care Quality Commission
p.000032:
p.000032: Human Fertilisation and Embryology Authority
p.000032: Human Tissue Authority
p.000032:
p.000032: IR(ME)R
p.000032: Inspectorates23 (Each nation has its own IR(ME)R Inspectorate.
p.000032: This is a function of the Care Quality Commission in England and of the Department of Health (Northern Ireland), the
p.000032: Scottish Ministers and the Welsh Ministers in Northern Ireland, Scotland and Wales.)
p.000032: Medicines and Healthcare Products Regulatory Agency
p.000032: Medicines and Healthcare Products Regulatory Agency
p.000032: Yes No No No
p.000032:
p.000032:
p.000032: Yes Yes Yes Yes
p.000032:
p.000032:
p.000032: Yes Yes No Yes
p.000032:
p.000032:
p.000032: Yes Yes Yes Yes
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032: Yes Yes Yes Yes
p.000032:
p.000032:
p.000032: Yes Yes Yes Yes
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000033: 33
p.000033:
...
Social / employees
Searching for indicator employees:
(return to top)
p.000010: of or including cells11 (Guidance on identifying ‘relevant material’ for the purposes of the Human Tissue Act 2004,
p.000010: i.e. material consisting of or including human cells, is published by the Human Tissue Authority at www.hta.gov.uk.),
p.000010: unless it is required by law under paragraph 2.3.3(e) above, or where the research involves analysis of human DNA in
p.000010: acellular material where it is not within the terms of consent for research from the person whose body manufactured the
p.000010: DNA under paragraph 2.3.6(d), or where the research also involves use of identifiable information about patients or
p.000010: service users under paragraph 2.3.5 (c & d).
p.000010: Other exclusions
p.000010:
p.000010: 2.3.13 Care providers owe a duty of care to users of their services. They are responsible for ensuring that ethical
p.000010: issues and risks in the course of the care they provide are considered. RECs are not expected to consider applications
p.000010: in respect of activities that are not research, for example clinical or other non-financial audit, service evaluation
p.000010: and public health surveillance. Guidance on differentiating research from such activities is available from the Health
p.000010: Research Authority’s on-line decision tools (www.hra.nhs.uk) REC members who give advice on the ethics of such
p.000010: activities should make it clear that they are not doing so in their capacity as a REC member.
p.000010: 2.3.14 Employers owe a duty of care to their employees that is different from the duty of care that care providers
p.000010: owe to users of their services. RECs are not expected to assume employers’ responsibilities or liabilities, or to act
p.000010: as a substitute for employers’ proper management of health and safety in the workplace. It is for employers to ensure
p.000010: that they are fulfilling their duties as employers when their employees take part in research. Research involving staff
p.000010: of the services listed in paragraph 2.3.4, who are recruited by virtue of their professional role, does not therefore
p.000010: require REC review except where it would otherwise require REC review under this document (for example, because there
p.000010: is a legal requirement for REC review, or because the research also involves patients or service users as research
p.000010: participants).
p.000010: 2.3.15 Market research may be undertaken by professional market researchers, e.g. for public health research or on
p.000010: behalf of pharmaceutical or medical device companies.
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000011: 11
p.000011:
p.000011: Where such research is conducted by professional market researchers in accordance with the principles set out in the
p.000011: Market Research Society Code of Conduct or with the Legal and Ethical Guidelines issued by the British Healthcare
p.000011: Business Intelligence Association (BHBIA), it does not require REC review, except where otherwise required by law,
p.000011: e.g. if it requires approval under the Mental Capacity Acts.
p.000011: 2.3.16 At the request of the sponsor, chief investigator or host organisation, RECs may exceptionally review research
p.000011: excluded from the normal scope of review under paragraphs 2.3.13–2.3.15 where the Research Ethics Service agrees that
p.000011: the proposal raises material ethical issues. The parties responsible for managing those issues remain liable for the
p.000011: assessment which informs that management.
p.000011: 2.3.17 Research projects involving human subjects or their tissue or information may be undertaken on the premises of
...
Social / gender
Searching for indicator gender:
(return to top)
p.000012: Service to protect the dignity, rights, safety and well- being of people who take part in research.
p.000012: 3.2 Role of research ethics committees
p.000012: Protection of research participants
p.000012:
p.000012: 3.2.1 Whatever the research context, the interests of participants come first. Their dignity, rights, safety and
p.000012: well-being must be the primary consideration in any research proposal, as well as in REC review. RECs must be assured
p.000012: that there are proportionate safeguards to protect people taking part in research.
p.000012: Science and society
p.000012:
p.000012: 3.2.2 RECs act primarily in the interests of research participants. The interests of researchers and research are
p.000012: always secondary to the dignity, rights, safety and well- being of people taking part in research. RECs take into
p.000012: account the interests and safety of the researchers, as well as the public interest in reliable evidence affecting
p.000012: health and social care and enable ethical and worthwhile research of benefit to participants or to science and society.
p.000012: 3.2.3 The benefits and risks of taking part in research, and the benefits of research evidence for improved health
p.000012: and social care, should be distributed fairly among all social groups and classes. Selection criteria in research
p.000012: protocols should not unjustifiably exclude potential participants, for instance on the basis of economic status,
p.000012: culture, age, disability, gender reassignment, marriage and civil partnership, pregnancy and maternity, race, religion
p.000012: or belief, sex or sexual orientation. RECs should take these considerations into account in reviewing the ethics of
p.000012: research proposals, particularly those involving under-researched groups.
p.000012: Proportionate scrutiny
p.000012:
p.000012: 3.2.4 REC review is proportionate to the scale and complexity of the research proposed. Research proposals that
p.000012: present no material issues of research ethics do not warrant consideration at a full meeting of a REC. They should be
p.000012: identified on receipt in accordance with standard operating procedures so that the ethical review may be undertaken by
p.000012: a sub-committee of a REC. The REC’s opinion on such proposals may be given by the sub-committee. See paragraphs 5.5.1
p.000012: and 5.5.2.
p.000012: 3.2.5 Each research proposal is subject to review by no more than one REC within the UK Research Ethics Service,
p.000012: unless required by law or by a managed appeals process.
p.000012:
p.000012:
p.000012:
p.000012:
p.000013: 13
p.000013:
p.000013: Independence and impartiality
p.000013:
p.000013: 3.2.6 RECs are independent and impartial. A REC’s opinion must be free, and must be seen to be free, from conflicts
p.000013: of interest. This includes freedom from pressures of:
p.000013: a. political influence
p.000013:
...
p.000018: rationale, aims, objectives and design of the research proposals that it reviews can be effectively reconciled with the
p.000018: dignity, rights, safety and well-being of the people who are likely to take part.
p.000018: 4.2.2 RECs are expected to reflect current ethical norms in society as well as their own ethical judgement. REC
p.000018: members may come from groups associated with particular interests but they are not representatives of those groups. REC
p.000018: members are appointed in their own right to participate in the work of a REC as equal individuals of sound judgement
p.000018: and relevant experience and are supported by training in research ethics and REC review.
p.000018: 4.2.3 A REC should contain a mixture of people who reflect the currency of public opinion (‘lay’ members), as well
p.000018: as people who have relevant formal qualifications or professional experience that can help the REC understand
p.000018: particular aspects of research proposals (‘expert’ members)17 (The term ‘professional member’ can imply someone whose
p.000018: job is to be a REC member (rather than an unpaid volunteer drawn from the care professions etc), so ‘expert member’ is
p.000018: used instead. For this reason, ‘experts by experience’ are counted as lay members.).
p.000018: 4.2.4 The Research Ethics Service as a whole should reflect the diversity of the adult population of society,
p.000018: taking account of age, disability, gender reassignment, marriage and civil partnership, pregnancy and maternity, race,
p.000018: religion or belief, sex and sexual orientation. This applies to both the lay and expert membership. Appointing
p.000018: authorities should take steps, with support from the relevant head office, to publicise the work of RECs and encourage
p.000018: applications for membership from groups who are under- represented.
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000019: 19
p.000019:
p.000019: Appointment of members
p.000019:
p.000019: 4.2.5 Appointment of members should be by an open and fair process, compatible with the Nolan standards. Vacancies
p.000019: should be filled following public advertisement in the press, and/or by advertisement via local, professional and other
p.000019: networks as most appropriate to the vacancy to be filled. Potential candidates should be required to complete an
p.000019: application form and be interviewed. There should be standard written procedures for application and selection, which
p.000019: should comply fully with equality and human rights legislation.
p.000019: Expert and lay members
p.000019:
p.000019: 4.2.6 Each REC should have expert members to ensure methodological and ethical expertise about research in care
p.000019: settings and in relevant fields of care, as well as professional expertise as care practitioners. This expertise should
p.000019: be appropriate to the types of research proposal the REC reviews.
p.000019: 4.2.7 Lay members are people who are not employed in health or care professions or whose primary professional
...
Social / philosophical differences/differences of opinion
Searching for indicator opinion:
(return to top)
p.000012: account the interests and safety of the researchers, as well as the public interest in reliable evidence affecting
p.000012: health and social care and enable ethical and worthwhile research of benefit to participants or to science and society.
p.000012: 3.2.3 The benefits and risks of taking part in research, and the benefits of research evidence for improved health
p.000012: and social care, should be distributed fairly among all social groups and classes. Selection criteria in research
p.000012: protocols should not unjustifiably exclude potential participants, for instance on the basis of economic status,
p.000012: culture, age, disability, gender reassignment, marriage and civil partnership, pregnancy and maternity, race, religion
p.000012: or belief, sex or sexual orientation. RECs should take these considerations into account in reviewing the ethics of
p.000012: research proposals, particularly those involving under-researched groups.
p.000012: Proportionate scrutiny
p.000012:
p.000012: 3.2.4 REC review is proportionate to the scale and complexity of the research proposed. Research proposals that
p.000012: present no material issues of research ethics do not warrant consideration at a full meeting of a REC. They should be
p.000012: identified on receipt in accordance with standard operating procedures so that the ethical review may be undertaken by
p.000012: a sub-committee of a REC. The REC’s opinion on such proposals may be given by the sub-committee. See paragraphs 5.5.1
p.000012: and 5.5.2.
p.000012: 3.2.5 Each research proposal is subject to review by no more than one REC within the UK Research Ethics Service,
p.000012: unless required by law or by a managed appeals process.
p.000012:
p.000012:
p.000012:
p.000012:
p.000013: 13
p.000013:
p.000013: Independence and impartiality
p.000013:
p.000013: 3.2.6 RECs are independent and impartial. A REC’s opinion must be free, and must be seen to be free, from conflicts
p.000013: of interest. This includes freedom from pressures of:
p.000013: a. political influence
p.000013:
p.000013: b. institutional affiliation
p.000013:
p.000013: c. trades union or profession-related interests
p.000013:
p.000013: d. direct or indirect financial inducement or any impression thereof
p.000013:
p.000013: e. coercion
p.000013:
p.000013: f. strategic concerns
p.000013:
p.000013: g. market forces
p.000013:
p.000013: h. agency-, discipline- or topic-related bias.
p.000013:
p.000013: 3.2.7 Although RECs may be appointed by bodies that have functions relating to care provision, their decisions are
p.000013: independent of care providers’ own managers, including their research managers. Care providers, regulators, RECs’
p.000013: appointing authorities and the UK Health Departments may not interfere in the deliberations or opinions of RECs RECs
p.000013: play no part in management decisions about the provision of care services or support for a research project.
p.000013: 3.2.8 The protection of research participants and the enabling of ethical research are best served by co-operation
p.000013: and communication between all those who share responsibility for the research. Except when it would compromise their
p.000013: independence, RECs should collaborate with regulators, actual and potential research participants, researchers,
p.000013: funders, sponsors, employers, organisations providing care and care professionals (see paragraph 5.4.2). RECs should
p.000013: also collaborate with one another, for example to share relevant information from previous applications or expertise in
p.000013: reviewing particular types of research.
p.000013: Competence and efficiency
p.000013:
p.000013: 3.2.9 REC review must be competent, timely and authoritative. The membership, ongoing training and performance
p.000013: management of RECs, as well as the operational and administrative support they receive, are arranged to maximise the
p.000013: quality, rigour and promptness of REC review and the efficiency of their decision-making processes. A REC should give
p.000013: its opinion within sixty calendar days of receipt of a valid application12 (Except where (a) the application relates to
p.000013: a clinical trial of an investigational medicinal product (CTIMP) for gene therapy or somatic cell therapy or the
p.000013: product contains a genetically modified organism, in which case the REC must give an opinion within 90 days, or 180
p.000013: days if a specialist group or committee is consulted; or (b) the application relates to a CTIMP for xenogeneic cell
p.000013: therapy, in which case no time limit applies.) The sixty-day period excludes the time an applicant may
p.000013:
p.000013:
p.000013:
p.000013:
p.000014: 14
p.000014:
p.000014: take to supply additional information requested by the REC. RECs may make a request for additional information only
p.000014: once, which must be in writing.
p.000014: 3.2.10 RECs must operate according to the law in the conduct of their business, for example by following due process
p.000014: and complying with their own standard operating procedures. They must also have regard to statutory provisions for
p.000014: ethical review of particular types of research, e.g. the requirements for a favourable opinion of a clinical trial
p.000014: under the Medicines for Human Use (Clinical Trials) Regulations or for approving research involving adults lacking
p.000014: capacity under the Mental Capacity Acts or the Adults with Incapacity (Scotland) Act. Guidance on the application of
p.000014: this legislation to ethical review and REC operating procedures is provided by the Research Ethics Service head
p.000014: offices.
p.000014: 3.2.11 A REC must not give a favourable opinion where it knows the research will break the law. However, it is not
p.000014: the role of the REC to offer a legal opinion on research proposals, although it may advise the researcher, sponsor or
p.000014: host organisation whenever it considers that legal advice might be helpful to them. Researchers, sponsors and
p.000014: organisations where research is carried out remain responsible for making sure the research is conducted in accordance
p.000014: with the requirements of law, relevant regulators and guidance, e.g. the UK Policy Framework for Health and Social Care
p.000014: Research (or other recognised standards of good practice, as applicable), the Data Protection Act and the Codes of
p.000014: Practice issued under the Mental Capacity Acts and Human Tissue Act.
p.000014: Compliance and enforcement
p.000014:
p.000014: 3.2.12 If REC review is required (see Section 2), organisations providing care must ensure that the research they
p.000014: host has a favourable REC opinion. The research may not begin until a favourable REC opinion has been given.
p.000014: 3.2.13 If REC review is required, sponsors may not allow any research they are sponsoring to begin without a
p.000014: favourable REC opinion.
p.000014: 3.2.14 The chief investigator is the researcher who takes primary responsibility for the design, conduct and
p.000014: reporting of the research. The chief investigator is responsible for the content of the REC application and for the
p.000014: scientific and ethical conduct of the research.
p.000014: 3.2.15 Although RECs must be assured about the planned ethical conduct and anticipated risks and benefits of any
p.000014: proposed research, they are not responsible for enforcement if the research turns out to be unsafe or is not carried
p.000014: out as agreed. This responsibility rests with the relevant regulators or comparable bodies, as well as with the
p.000014: researchers’ employer and sponsor and with the care organisations where the research takes place (or through which the
p.000014: researchers have access to participants, or their tissue or information) or where the researchers have contracts.
p.000014: Statutory enforcement authorities are listed in Annex B.
p.000014: 3.2.16 The Research Ethics Service should agree channels of communication with the relevant bodies in order to
p.000014: exchange advice. RECs should use these channels to alert
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p.000015: the bodies responsible for enforcement if they have grounds to suspect that enforcement action is warranted.
p.000015: 3.2.17 RECs receive annual reports about the progress of the research they have reviewed. These reports reflect any
p.000015: developments affecting participants' dignity, rights, safety or well-being.
p.000015:
p.000015: 3.2.18 A REC should reconsider its favourable opinion in light of pertinent information13 (RECs are not expected to
p.000015: duplicate the ongoing checks for which others are responsible (see paragraph 5.4.2). For instance, safety reports in
p.000015: respect of research that is subject to Clinical Trials Regulations or Medical Devices Regulations are received and
p.000015: reviewed by the Medicines and Healthcare products Regulatory Agency.) that comes to its attention. If the REC consider
p.000015: that it would not have reached a favourable opinion had it been given that information during its initial review, it
p.000015: should notify the relevant statutory enforcement authority. Where the law does not specify the responsibility for
p.000015: enforcement, the REC should notify the chief investigator and the sponsor that its opinion is no longer favourable.
p.000015: 3.3 Remit
p.000015: 3.3.1 RECs established and operating in accordance with the principles, requirements and standards set out in this
p.000015: document are recognised by the Department of Health (Northern Ireland), the Scottish Ministers, the Secretary of State
p.000015: for Health and Social Care and the Welsh Ministers.
p.000015: 3.3.2 Together, these RECs – as well as head offices that co-ordinate the development and management of their
p.000015: operations – form the UK Research Ethics Service.
p.000015: 3.3.3 In general, any REC anywhere in the Research Ethics Service may carry out the review required by Section 2.
p.000015: Specific RECs within the Research Ethics Service may be recognised, or otherwise designated, for review of certain
p.000015: types of research proposal, according to legal, policy or operational requirements.
p.000015: 3.3.4 Each head office within the Research Ethics Service is accountable to the relevant Health Department:
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p.000016: Head office
p.000016: Remit
p.000016: Accountability
p.000016:
p.000016:
p.000016: Chief Scientist Office
p.000016: RECs in Scotland
p.000016: Scottish Government Health and Social Care Directorate
p.000016:
p.000016:
p.000016: Health and Care Research Wales Ethics Service
p.000016: RECs in Wales
p.000016: Department for Health and Social Services
...
p.000016: are listed in Annex E. Functions performed by UKECA are listed in Annex F.
p.000016:
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p.000017:
p.000017: 3.3.8 The Health Research Authority has established a National Research and Ethics Advisers’ Panel to provide it
p.000017: with a transparent source of advice and expertise to enable it to fulfil its statutory functions within an overall
p.000017: UK-wide framework for research ethics and broader research governance16 (For further details, see the panel’s terms of
p.000017: reference at www.hra.nhs.uk). The panel is a resource available to the UK Research Ethics Service and to the appointing
p.000017: authorities of the RECs within that service.
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p.000018:
p.000018: 4 Composition and membership
p.000018:
p.000018: 4.1 Summary
p.000018: 4.1.1 Research ethics committees (RECs) harmonise public and professional opinion in reaching decisions about
p.000018: proposed research. Their members reflect the diversity of society and do not represent vested interests.
p.000018: 4.2 Composition of research ethics committees
p.000018: Nature of membership
p.000018:
p.000018: 4.2.1 The membership of a REC should allow for a sufficiently broad range of experience and expertise so that the
p.000018: rationale, aims, objectives and design of the research proposals that it reviews can be effectively reconciled with the
p.000018: dignity, rights, safety and well-being of the people who are likely to take part.
p.000018: 4.2.2 RECs are expected to reflect current ethical norms in society as well as their own ethical judgement. REC
p.000018: members may come from groups associated with particular interests but they are not representatives of those groups. REC
p.000018: members are appointed in their own right to participate in the work of a REC as equal individuals of sound judgement
p.000018: and relevant experience and are supported by training in research ethics and REC review.
p.000018: 4.2.3 A REC should contain a mixture of people who reflect the currency of public opinion (‘lay’ members), as well
p.000018: as people who have relevant formal qualifications or professional experience that can help the REC understand
p.000018: particular aspects of research proposals (‘expert’ members)17 (The term ‘professional member’ can imply someone whose
p.000018: job is to be a REC member (rather than an unpaid volunteer drawn from the care professions etc), so ‘expert member’ is
p.000018: used instead. For this reason, ‘experts by experience’ are counted as lay members.).
p.000018: 4.2.4 The Research Ethics Service as a whole should reflect the diversity of the adult population of society,
p.000018: taking account of age, disability, gender reassignment, marriage and civil partnership, pregnancy and maternity, race,
p.000018: religion or belief, sex and sexual orientation. This applies to both the lay and expert membership. Appointing
p.000018: authorities should take steps, with support from the relevant head office, to publicise the work of RECs and encourage
p.000018: applications for membership from groups who are under- represented.
p.000018:
p.000018:
p.000018:
p.000018:
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p.000019:
p.000019: Appointment of members
p.000019:
p.000019: 4.2.5 Appointment of members should be by an open and fair process, compatible with the Nolan standards. Vacancies
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p.000020: research ethics.
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p.000021: 4.2.21 Referees do not count towards the quorum or vote on decisions. They are not involved in any REC business apart
p.000021: from advising on the issues put to them. Their advice is recorded in the minutes of the relevant REC meeting.
p.000021: Observers
p.000021:
p.000021: 4.2.22 REC meetings are not public meetings. External observers may attend following a written invitation which
p.000021: states the terms and conditions of their attendance. Attendance will be agreed by the REC and minuted accordingly.
p.000021: External observers play no part in the deliberations of the REC.
p.000021: 4.2.23 Representatives of the relevant Research Ethics Service head office may attend and observe meetings at any
p.000021: time, with prior notification.
p.000021: Advice to applicants
p.000021:
p.000021: 4.2.24 RECs should take steps to facilitate communication with their potential or actual applicants. A REC may
p.000021: designate a point of contact for more detailed discussion. This includes advice about whether a proposed activity
p.000021: requires REC review, or the content, submission or review of an application. The point of contact may be any of
p.000021: the REC’s members (including those appointed as officers) or administrative staff.
p.000021:
p.000021: Delegation
p.000021:
p.000021: 4.2.25 A REC may appoint sub-committees consisting of its members. Sub-committees, committee officers and
p.000021: administrative staff may exercise any of the REC’s functions on its behalf, in accordance with standard operating
p.000021: procedures. In particular, sub- committees may review and give an opinion of:
p.000021: a. research proposals that present no material ethical issues
p.000021:
p.000021: b. information further to earlier review in full committee
p.000021:
p.000021: c. substantial amendments
p.000021:
p.000021: d. annual progress reports (see paragraph 3.2.17).
p.000021:
p.000021: 4.2.26 If a REC issues a provisional opinion reached in full committee, it may delegate the responsibility for
p.000021: determining its final opinion to the chair or other officer, or to a sub- committee of specified members.
p.000021: 4.2.27 Responsibilities of REC officers may be delegated to administrative staff where the matters are
p.000021: administrative, in accordance with standard operating procedures. In particular, administrative staff may check
p.000021: evidence provided by applicants in response to requests for further information and issue letters confirming the REC’s
p.000021: opinion.
p.000021: 4.3 Conditions of membership
p.000021: Terms of appointment
p.000021:
p.000021: 4.3.1 Written terms of appointment for REC members should include the following:
p.000021:
p.000021:
p.000022: 22
p.000022:
p.000022: a. duration of appointment
p.000022:
p.000022: b. renewal policy
p.000022:
p.000022: c. disqualification and resignation procedures
p.000022:
p.000022: d. policy concerning declaration of interests
p.000022:
p.000022: e. details of allowable expenses.
p.000022:
p.000022: 4.3.2 REC members are appointed for fixed terms not exceeding five years. Appointments may be renewed. However,
p.000022: members should not normally serve more than two consecutive terms of five years on the same REC. Where a member is
p.000022: appointed as an officer during their second term, their membership may be extended until the completion of their term
p.000022: as an officer (see paragraph 4.2.15). Where the normal period of membership has expired, the appointing authority may
p.000022: exceptionally extend a member’s term while new members are appointed.
p.000022: 4.3.3 Former members may be reappointed to the same REC no sooner than two years after the end of their last term,
p.000022: or to another REC without interval.
p.000022: 4.3.4 Attendance at meetings of other RECs as a co-opted member, referee or observer is encouraged, in the
p.000022: interests of training and consistency.
p.000022: 4.3.5 Simultaneous membership of more than one REC is permitted with the approval of the appointing authorities
p.000022: concerned, as is deputy membership of other RECs. REC members are normally required to attend in full at least two
...
p.000023: research participants and related matters.
p.000023: Indemnity
p.000023:
p.000023: 4.3.12 Each REC member must be supplied with a personal statement regarding the indemnity provided by the appointing
p.000023: authority and its conditions.
p.000023: Conduct
p.000023:
p.000023: 4.3.13 The meetings and proceedings of RECs and their sub-committees are conducted in accordance with standard
p.000023: operating procedures.
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p.000024: 24
p.000024:
p.000024: 5 Requirements of research ethics committee review
p.000024: Summary
p.000024: 5.1.1 There is a standard process for applying to a research ethics committee. Research ethics committees (RECs)
p.000024: also review applications in accordance with standards.
p.000024: 5.1 Applying for research ethics committee review
p.000024: 5.2.1 Applications to RECs should be made in accordance with a process set out in standard operating procedures for
p.000024: RECs and in written guidance for applicants. This process covers the application from submission to opinion and on to
p.000024: subsequent notification of substantial amendments, annual progress reporting etc.
p.000024: 5.2.2 The Research Ethics Service should be prepared to offer accurate advice and guidance to potential and actual
p.000024: applicants (see paragraphs 3.3.8 and 4.2.24). This includes being able to answer queries about whether REC review is
p.000024: required (see Section 2), the application process (including the requirements for a valid application) and the review
p.000024: process (including the issues RECs consider before reaching an opinion).
p.000024: 5.2.3 There is a managed process for allocating REC applications to an appropriate REC (see paragraph 3.3.3). As
p.000024: far as possible, it takes into account what will be convenient to the applicant.
p.000024: 5.2 Requirements for a favourable opinion
p.000024: 5.3.1 A REC gives a favourable opinion if it is assured about the ethical issues presented by the proposed
p.000024: research. These issues may vary, depending on the research in question. REC members receive training and guidance about
p.000024: the issues they should consider, both in general and in particular cases. The training and guidance reflect recognised
p.000024: standards for ethical research, such as the Declaration of Helsinki 20(World Medical Association Declaration of
p.000024: Helsinki: Ethical Principles for Medical Research Involving Human Subjects. World Medical Association, Oct 2013.
p.000024: www.wma.net/policies-post/wma-declaration- of-helsinki-ethical-principles-for-medical-research-involving-human-subjects
p.000024: The latest version of the Declaration should normally be used, insofar as it is compatible with UK law. NB: The Medical
p.000024: Devices Regulations 2002 implement Council Directive 93/42/EEC, which specifies the September 1989 version. The
p.000024: Medicines for Human Use (Clinical Trials) Regulations 2004 specify the October 1996 version.) and take account of
p.000024: applicable legal requirements.
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p.000025: 25
p.000025:
p.000025: 5.4 Principles of research ethics committee review
p.000025: 5.4.1 RECs receive training, guidance, standard operating procedures and quality assurance (including
p.000025: accreditation) in order to support them to identify the relevant issues and consider them appropriately.
p.000025: 5.4.2 RECs should receive guidance on the wider regulatory and governance environment for research and its
...
p.000025: responsible for the management, governance and monitoring of the research they host. Other standards assurance
p.000025: processes, such as inspection or accreditation of sites by regulators, may also be adequate for the REC to be assured
p.000025: about the suitability of those sites.
p.000025: c. Where others have a regulatory responsibility, a REC can expect to rely on them to fulfil it. If the law gives
p.000025: another body duties that are normally the responsibility of a REC according to this document, RECs do not duplicate
p.000025: them. For example, the Medicines and Healthcare products Regulatory Agency has the primary legal responsibility for
p.000025: considering the safety of the research it regulates.
p.000025: 5.5 Expedited review
p.000025: 5.5.1 Some research requiring REC review in accordance with Section 2 may be suitable for expedited review, e.g.
p.000025: because of a public health emergency or because the proposal presents no material issues of research ethics.
p.000025: 5.5.2 Standard operating procedures for expedited review of research proposals should specify each of the
p.000025: following:
p.000025: a. the nature of the applications, amendments or other considerations that are eligible for expedited review
p.000025: b. the application and review process
p.000025:
p.000025: c. the quorum requirements
p.000025:
p.000025: d. the status of decisions (e.g. whether they require ratification in full committee).
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p.000026:
p.000026: 5.6 Transparency
p.000026: 5.6.1 RECs should publish a summary of the research they have reviewed, together with their opinion, whether
p.000026: favourable or otherwise21 (See www.hra.nhs.uk for published summaries).
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p.000027:
p.000027: 6 Standard operating procedures
p.000027:
p.000027: 6.1 Summary
p.000027: 6.1.1 Common working practices promote efficiency and enable research ethics committees (RECs) to work together as
p.000027: part of a consistent Research Ethics Service. Published standards allow researchers and the public to expect
p.000027: transparent accountability.
p.000027: 6.2 Purpose
p.000027: 6.2.1 Standard operating procedures for RECs are essential to an efficient, consistent and accountable Research
p.000027: Ethics Service.
p.000027: 6.3 Content
p.000027: 6.3.1 Standard operating procedures take account of applicable laws and national guidance, advice and exemplars.
p.000027: They also reflect relevant internationally recognised principles and standards.
p.000027: 6.3.2 Standard operating procedures provide the operational detail for meeting the principles, requirements and
p.000027: standards set out in this document.
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p.000028:
p.000028:
p.000028: anonymised HSC
p.000028: intrusive research
p.000028: Anonymised in accordance with the Information Commissioner’s Office anonymisation code of practice
p.000028: Health and Social Care, the name for health and personal social services in Northern Ireland
p.000028: Section 30 of the Mental Capacity Act in England and Wales defines ‘intrusive research’ as research that (a) is carried
p.000028: out on, or in relation to, a person who lacks capacity to consent to it and (b) would be unlawful if it were carried
p.000028: out on, or in relation to, a person who had capacity to consent to it, but without his or her consent.
p.000028:
p.000028: Section 132 of the Mental Capacity Act (Northern Ireland) 2016 defines ‘intrusive research’ as research which is of a
p.000028: kind that would be unlawful if it were carried out:
p.000028:
p.000028: (a)on or in relation to a person who had capacity to consent to it; but (b)without that person’s consent.
p.000028: Intrusive research involving people who lack the capacity to consent to it requires a favourable REC opinion before it
p.000028: may begin. CTIMPs involving people who lack the capacity to consent are covered separately by the Clinical Trials
p.000028: Regulations.
p.000028:
p.000028:
p.000028: IR(ME)R MoDREC NHS
p.000028:
p.000028:
p.000028: REC
p.000028:
p.000028:
p.000028:
p.000028: relevant material
p.000028:
p.000028:
p.000028:
p.000028:
p.000028: UKECA
p.000028: Ionising Radiation (Medical Exposure) Regulations Ministry of Defence Research Ethics Committee
p.000028: National Health Service, the name for health services in England, health and social care services in Scotland and
p.000028: health services in Wales
p.000028: Research ethics committee, specifically one within the UK Research Ethics Service. NB the term ‘REC’ in this document
p.000028: should not be interpreted as referring to any other body that reviews the ethics of research.
p.000028: Section 53 of the Human Tissue Act defines ‘relevant material’ as any material consisting of or including human cells,
p.000028: apart from (a) hair and nails from living people, (b) embryos outside the human body and (c) gametes (i.e. sperm and
p.000028: unfertilised egg cells). NB Embryos and gametes are covered separately by the Human Fertilisation and Embryology Act.
p.000028: UK Ethics Committee Authority, which is the statutory body that, among other functions (see Annex F), recognises
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p.000013: quality, rigour and promptness of REC review and the efficiency of their decision-making processes. A REC should give
p.000013: its opinion within sixty calendar days of receipt of a valid application12 (Except where (a) the application relates to
p.000013: a clinical trial of an investigational medicinal product (CTIMP) for gene therapy or somatic cell therapy or the
p.000013: product contains a genetically modified organism, in which case the REC must give an opinion within 90 days, or 180
p.000013: days if a specialist group or committee is consulted; or (b) the application relates to a CTIMP for xenogeneic cell
p.000013: therapy, in which case no time limit applies.) The sixty-day period excludes the time an applicant may
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p.000014: take to supply additional information requested by the REC. RECs may make a request for additional information only
p.000014: once, which must be in writing.
p.000014: 3.2.10 RECs must operate according to the law in the conduct of their business, for example by following due process
p.000014: and complying with their own standard operating procedures. They must also have regard to statutory provisions for
p.000014: ethical review of particular types of research, e.g. the requirements for a favourable opinion of a clinical trial
p.000014: under the Medicines for Human Use (Clinical Trials) Regulations or for approving research involving adults lacking
p.000014: capacity under the Mental Capacity Acts or the Adults with Incapacity (Scotland) Act. Guidance on the application of
p.000014: this legislation to ethical review and REC operating procedures is provided by the Research Ethics Service head
p.000014: offices.
p.000014: 3.2.11 A REC must not give a favourable opinion where it knows the research will break the law. However, it is not
p.000014: the role of the REC to offer a legal opinion on research proposals, although it may advise the researcher, sponsor or
p.000014: host organisation whenever it considers that legal advice might be helpful to them. Researchers, sponsors and
p.000014: organisations where research is carried out remain responsible for making sure the research is conducted in accordance
p.000014: with the requirements of law, relevant regulators and guidance, e.g. the UK Policy Framework for Health and Social Care
p.000014: Research (or other recognised standards of good practice, as applicable), the Data Protection Act and the Codes of
p.000014: Practice issued under the Mental Capacity Acts and Human Tissue Act.
p.000014: Compliance and enforcement
p.000014:
p.000014: 3.2.12 If REC review is required (see Section 2), organisations providing care must ensure that the research they
p.000014: host has a favourable REC opinion. The research may not begin until a favourable REC opinion has been given.
p.000014: 3.2.13 If REC review is required, sponsors may not allow any research they are sponsoring to begin without a
p.000014: favourable REC opinion.
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p.000019: interest is not health- or care-related research. At least a third of each REC’s membership should be lay.
p.000019: 4.2.8 The Research Ethics Service head offices should adopt and publish operational definitions of expert and lay
p.000019: members, taking into account other applicable requirements (see paragraph 4.2.12), and support RECs and their
p.000019: appointing authorities to ensure an appropriate balance of members.
p.000019: Affiliations
p.000019:
p.000019: 4.2.9 RECs are constituted, and operate, independently of organisations that sponsor, conduct or host research.
p.000019: Members absent themselves during consideration of research proposals that could be seen to create a conflict of
p.000019: interest. REC meetings should be attended so as to accommodate these absences while remaining quorate.
p.000019: Quorum
p.000019:
p.000019: 4.2.10 For the purpose of effective debate, a REC normally has no more than 18 members in total. A quorate meeting is
p.000019: one attended by no fewer than seven members, including:
p.000019: a. the chair or other officer
p.000019:
p.000019: b. at least one expert member
p.000019:
p.000019: c. at least one lay member.
p.000019:
p.000019: 4.2.11 Each REC should be constituted so that it can function quorately for the duration of its scheduled meetings.
p.000019: 4.2.12 Where other membership, composition or attendance criteria are specified, e.g. in law, for RECs reviewing
p.000019: certain types of research proposal18 (For instance, the REC
p.000019:
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p.000020:
p.000020: constituted by regulations made under the Adults with Incapacity (Scotland) Act 2000 and associated statutory
p.000020: instruments, RECs that review clinical trials of investigational medicinal products or research funded by the US
p.000020: government.), guidance enabling RECs to convene in accordance with the requirements set out in this document as well as
p.000020: the additional specifications is available from the Health Research Authority website, www.hra.nhs.uk19 (Standard
p.000020: Operating Procedures for Research Ethics Committees. www.hra.nhs.uk).
p.000020: Officers
p.000020:
p.000020: 4.2.13 Each REC has a chair, a vice-chair and an alternate vice-chair. These officers are appointed from among the
p.000020: REC’s members by the relevant appointing authority, after consulting the REC. If all three are unavailable, another
p.000020: member or an appointed officer from a different REC will be acting chair.
p.000020: 4.2.14 Candidates for office are expected to have at least one year’s experience as a member of a REC. Appointees
p.000020: should receive any necessary supplementary training (e.g. in chairing skills) prior to taking office.
p.000020: 4.2.15 Officers are appointed for a specified period not exceeding five years. Officer appointments may be renewed
p.000020: (and exceptionally extended) in the same way as member appointments (see paragraph 4.3.2). An acting chair’s
p.000020: appointment ceases when one of the other officers becomes available again or when his or her term as a member expires,
p.000020: whichever is sooner.
p.000020: 4.2.16 Officers may resign from office at any time. They may continue as members of the REC, subject to the
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p.000028: health services in Wales
p.000028: Research ethics committee, specifically one within the UK Research Ethics Service. NB the term ‘REC’ in this document
p.000028: should not be interpreted as referring to any other body that reviews the ethics of research.
p.000028: Section 53 of the Human Tissue Act defines ‘relevant material’ as any material consisting of or including human cells,
p.000028: apart from (a) hair and nails from living people, (b) embryos outside the human body and (c) gametes (i.e. sperm and
p.000028: unfertilised egg cells). NB Embryos and gametes are covered separately by the Human Fertilisation and Embryology Act.
p.000028: UK Ethics Committee Authority, which is the statutory body that, among other functions (see Annex F), recognises
p.000028: research ethics committees for the review of clinical trials of investigational medicinal products and approves their
p.000028: standard operating procedures for that review.
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p.000029:
p.000029: Annex A: Legal requirements for research ethics committee review
p.000029: Any updates to this list will be published at www.hra.nhs.uk
p.000029: Extent of legal requirement for research ethics committee review
p.000029:
p.000029:
p.000029: Legislation England Northern Ireland
p.000029: Scotland Wales
p.000029:
p.000029: Adults with Incapacity (Scotland) Act 2000 §51
p.000029: Adults with Incapacity (Ethics Committee) (Scotland) Regulations 2002, as amended 2007
p.000029: Health Service (Control of Patient Information) Regulations 2002, as amended 2016
p.000029: Human Fertilisation and Embryology (Disclosure of Information for Research Purposes) Regulation 2010
p.000029: No No Yes No
p.000029:
p.000029: No No Yes No
p.000029:
p.000029:
p.000029: Yes No No Yes
p.000029:
p.000029:
p.000029: Yes Yes Yes Yes
p.000029: Human Tissue Act 2004 Yes Yes Yes (§45) Yes
p.000029:
p.000029: Human Tissue Act 2004 (Ethical Approval, Exceptions from Licensing and Supply of Information about Transplants)
p.000029: Regulations 2006
p.000029: Human Tissue Act 2004 (Persons who Lack Capacity to Consent and Transplants) Regulations 2006
p.000029: Human Tissue (Scotland) Act 2006
p.000029: §40, 48
p.000029: Yes Yes No Yes
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p.000029: Yes Yes Yes Yes
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p.000029: No No Yes No
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p.000030: Extent of legal requirement for research ethics committee review
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p.000030: Legislation
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p.000025: 5.4.2 RECs should receive guidance on the wider regulatory and governance environment for research and its
p.000025: reliability so that they can assess the assurances they receive. RECs will accept credible assurances that others will
p.000025: do what is expected of them.
p.000025: a. A REC need not reconsider the quality of the science, as this is the responsibility of the sponsor and will have
p.000025: been subject to review by one or more experts in the field (known as ‘peer review’). The REC will be satisfied with
p.000025: credible assurances that the research has an identified sponsor and that it takes account of appropriate scientific
p.000025: peer review.
p.000025: b. A REC can expect to rely on established mechanisms for ensuring the proper conduct of the research at individual
p.000025: sites. Organisations providing care that are subject to the UK Policy Framework for Health and Social Care Research are
p.000025: responsible for the management, governance and monitoring of the research they host. Other standards assurance
p.000025: processes, such as inspection or accreditation of sites by regulators, may also be adequate for the REC to be assured
p.000025: about the suitability of those sites.
p.000025: c. Where others have a regulatory responsibility, a REC can expect to rely on them to fulfil it. If the law gives
p.000025: another body duties that are normally the responsibility of a REC according to this document, RECs do not duplicate
p.000025: them. For example, the Medicines and Healthcare products Regulatory Agency has the primary legal responsibility for
p.000025: considering the safety of the research it regulates.
p.000025: 5.5 Expedited review
p.000025: 5.5.1 Some research requiring REC review in accordance with Section 2 may be suitable for expedited review, e.g.
p.000025: because of a public health emergency or because the proposal presents no material issues of research ethics.
p.000025: 5.5.2 Standard operating procedures for expedited review of research proposals should specify each of the
p.000025: following:
p.000025: a. the nature of the applications, amendments or other considerations that are eligible for expedited review
p.000025: b. the application and review process
p.000025:
p.000025: c. the quorum requirements
p.000025:
p.000025: d. the status of decisions (e.g. whether they require ratification in full committee).
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p.000026:
p.000026: 5.6 Transparency
p.000026: 5.6.1 RECs should publish a summary of the research they have reviewed, together with their opinion, whether
p.000026: favourable or otherwise21 (See www.hra.nhs.uk for published summaries).
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p.000027:
p.000027: 6 Standard operating procedures
p.000027:
p.000027: 6.1 Summary
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p.000003: Governance arrangements for research ethics committees: 2020 edition
p.000003:
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p.000003:
p.000003: V2.0 FINAL 26.03.2020
p.000003:
p.000003: Contents
p.000003:
p.000003: 1 Introduction
p.000003: 3
p.000003: 2 Purpose and scope
p.000006: 6
p.000006: 3 Role and remit
p.000013: 13
p.000013: 4 Composition and membership 19
p.000013: 5 Requirements of research ethics committee review 25
p.000013: 6 Standard operating procedures 28
p.000013: Glossary
p.000029: 29
p.000029: Annex A: Legal requirements for research ethics committee review 30
p.000029: Annex B: Enforcement authorities 33
p.000029: Annex C: Research Ethics Service head office functions 34
p.000029: Annex D: Functions of appointing authorities 35
p.000029: Annex E: Health Research Authority functions related to the UK Research Ethics Service
p.000037: 37
p.000037: Annex F: Functions of the UK Ethics Committee Authority 38
p.000037: Annex G: Management information about research ethics committees 39
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p.000002: 2
p.000002:
p.000002: 1 Introduction
p.000002:
p.000002: 1.1 What are research ethics committees and what do they do?
p.000002: 1.1.1 A research ethics committee is a group of people appointed to review research proposals to assess formally if
p.000002: the research is ethical. This means the research must conform to recognised ethical standards, which includes
p.000002: respecting the dignity, rights, safety and well-being of the people who take part.
p.000002: 1.1.2 The Devolved Administrations and the Health Research Authority provide a Research Ethics Service so that
p.000002: research proposals relating to their areas of responsibility can be reviewed by a research ethics committee. The
p.000002: Research Ethics Service consists of research ethics committees, as well as head offices that co-ordinate the
p.000002: development and management of their operations.
p.000002: 1.1.3 Each of the research ethics committees within the Research Ethics Service is made up of members of the
p.000002: public, as well as people with specific knowledge that can help the committee understand particular aspects of research
p.000002: proposals. All the committee members are given training to understand research ethics.
p.000002: 1.1.4 When they review research proposals, these research ethics committees are independent of the researchers, the
p.000002: organisations funding the research and the organisations where the research will take place.
p.000002: 1.2 Why are research ethics committees needed?
p.000002: 1.2.1 Research is a core part of the NHS1 (Where NHS is referenced, this refers to Health and Social Care (HSC) in
p.000002: Northern Ireland.) and other care services. Research enables these services to improve the current and future health
p.000002: and well-being of the people they serve. However, research sometimes involves a degree of risk because researchers
...
p.000002: worthwhile. The committee has to be assured that any anticipated risks, burdens or intrusions will be minimised for the
p.000002: people taking part in the research and are justified by the expected benefits for the participants or for science and
p.000002: society.
p.000002: 1.2.3 In this way, research ethics committees aim to protect people who take part in research. This helps promote
p.000002: public confidence about the conduct of researchers and the dignity, rights, safety and well-being of research
p.000002: participants. As a result, more
p.000002:
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p.000002:
p.000003: 3
p.000003:
p.000003: people will be encouraged to take part in research. This in turn leads to more, better and quicker improvements in
p.000003: health and social care.
p.000003: 1.2.4 The Research Ethics Service enables ethical research in partnership with researchers and their sponsors. The
p.000003: research ethics committee’s review complements the researcher’s own consideration of the ethical issues raised by their
p.000003: research and their involvement of service users, care professionals, methodologists and statisticians, academic
p.000003: supervisors, data protection officers etc, at the design stage.
p.000003: 1.3 What is the purpose of this document?
p.000003: 1.3.1 Governance arrangements for research ethics committees is a policy document of the Devolved Administrations,
p.000003: the Health Research Authority and the UK Ethics Committee Authority. It describes what is expected from the research
p.000003: ethics committees that review research proposals relating to areas of responsibility of the Devolved Administrations
p.000003: and the Health Research Authority. It also explains when review by these committees is required.
p.000003: 1.3.2 This policy covers the principles, requirements and standards for research ethics committees, including their
p.000003: remit, composition, functions, management and accountability. It also describes the Research Ethics Service in which
p.000003: the research ethics committees operate and the review they provide.
p.000003: 1.3.3 This document revises and replaces the previous edition.
p.000003:
p.000003: 1.3.4 In the light of feedback, we also clarified that the following types of research were excluded:
p.000003: a. Research undertaken independently of the NHS but where participants have been identified because they have a
p.000003: condition that was diagnosed by the NHS (e.g.
p.000003: patients on a disease charity’s list) – see paragraph 2.3.5(a) and footnote 6.
p.000003:
p.000003: b. research involving information anonymised2 (Anonymisation: managing data protection risk – code of practice.
p.000003: Information Commissioner’s Office, Nov 2012. https://ico.org.uk/ ) by an intermediary (such as NHS Digital) before its
p.000003: onward release to the researchers (provided there is a legal basis for the anonymisation) – see paragraph 2.3.5(c).
p.000003:
p.000003: c. research involving anonymised information released to researchers who work in an organisation that might
p.000003: separately hold other information, which if combined could identify the individual, but where there is no likelihood of
p.000003: doing so – see paragraph 2.3.5(c).
p.000003: 1.3.5 This edition has effect throughout the UK from 26th March 2020.
p.000003: 1.3.6 Where a research study does not require review by a research ethics committee within the Research Ethics
p.000003: Service under this document, review may be undertaken by research ethics committees established by universities or
p.000003: other institutions. The
p.000003:
p.000003:
p.000003:
p.000003:
p.000004: 4
p.000004:
p.000004: Economic and Social Research Council’s Framework for Research Ethics sets out principles, requirements and standards
p.000004: for university committees that are compatible with those set out in this document.
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p.000005: 5
p.000005:
p.000005: 2 Purpose and scope
p.000005: 2.1 Summary
p.000005: 2.1.1 The principles, requirements and standards set out in this document apply to research ethics committees
p.000005: (RECs) reviewing research that relates to areas of responsibility of the Devolved Administrations and the Health
p.000005: Research Authority. This includes research involving users of services for which the UK Health Departments are
p.000005: responsible. It also applies where the law requires review by a REC and the Devolved Administrations and the Health
p.000005: Research Authority provide for that review. The research sponsor has overall responsibility for ensuring that the
p.000005: research has REC approval, if needed, before the research begins. For a definitive decision about whether a project is
p.000005: research3 (Research is defined in section 3 of the UK Policy Framework for Health and Social Care Research.) and
p.000005: whether it needs REC review, see the on-line decision tools at www.hra.nhs.uk
p.000005: 2.2 Purpose
p.000005: 2.2.1 The Devolved Administrations and the Health Research Authority are committed to enhancing the contribution
p.000005: research can make. Research is essential for protecting and improving health and well-being, as well as for achieving
p.000005: modern, effective care services. At the same time, research can sometimes involve an element of risk, because research
p.000005: can involve trying something new. It is important that any risks are minimised and do not compromise the dignity,
p.000005: rights, safety and well-being of the people who take part. Proper governance arrangements are essential to ensure that
p.000005: service users and the public can have confidence in, and benefit from, high-quality, ethical research.
p.000005: 2.2.2 The public has a right to expect the highest scientific, ethical and financial standards, transparent
p.000005: decision-making processes, clear allocation of responsibilities and robust monitoring arrangements. The UK Policy
p.000005: Framework for Health and Social Care Research sets out principles of good practice in the management and conduct of
p.000005: research and the responsibilities for satisfying them. Governance arrangements for research ethics committees sets out
p.000005: principles, requirements and standards for RECs that review research proposals relating to responsibilities of the
p.000005: Devolved Administrations and the Health Research Authority.
p.000005: 2.3 Scope
p.000005: Legal requirements for research ethics committee review
p.000005:
p.000005: 2.3.1 Irrespective of whether the research involves the health and social care services for which the UK Health
p.000005: Departments are responsible, this document applies where the law requires review by a REC and the Devolved
p.000005: Administrations and the Health
p.000005:
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p.000005:
p.000006: 6
p.000006:
p.000006: Research Authority provide for that review. The relevant legislation is listed in Annex A.
p.000006: 2.3.2 Broadly speaking, this legislation requires REC review of research proposals involving any of the following:
p.000006: a. people who lack the capacity to give informed consent to take part (or to keep taking part) in the research
p.000006: b. processing of confidential patient information4 (‘Patient information’ means information, or any derivation
p.000006: thereof, however recorded, which relates to the physical or mental health or condition of an individual, to the
p.000006: diagnosis of his or her condition or to his or her care or treatment. ‘Confidential patient information’ is patient
p.000006: information where the identity of the individual is ascertainable from the information (or from it and other
p.000006: information in, or likely to come into, the possession of the person processing it) and the information was obtained or
p.000006: generated by someone who, in the circumstances, owed an obligation of confidence to the individual.) without consent
p.000006: where this would otherwise breach confidentiality
p.000006: c. material consisting of or including human cells, which has been taken from the living or the deceased (see
p.000006: paragraph 2.3.3 for details)
p.000006: d. in Northern Ireland and Wales, patients (or information about them) in independent hospitals or clinics (e.g.
p.000006: hospices with overnight beds).
p.000006: e. in Northern Ireland, residents or patients (or information about them) in private or voluntary sector nursing
p.000006: homes, care homes, dental practices, general practices, healthcare establishments and agencies or the fire authority
p.000006: f. exposure to ionising radiation as part of medical, biomedical, diagnostic or therapeutic research
p.000006: g. medical devices that are not CE-marked (i.e. not compliant with European Directives) or CE-marked medical devices
p.000006: that have been modified or are being used outside of their intended purpose.
p.000006: h. investigational medicinal products
p.000006:
p.000006: i. protected information from the Human Fertilisation and Embryology Authority register.
p.000006: 2.3.3 REC review is required by law for research, where it involves any of the following:
p.000006:
p.000006: a. storage or use of relevant material from the living, collected on or after 1 September 2006, where appropriate
p.000006: consent for the research is not in place from or on behalf of the donor; the researcher must not be in possession of,
p.000006: or likely to come into possession of, information from which the donor can be identified (England, Northern Ireland and
p.000006: Wales only)
p.000006:
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p.000007: 7
p.000007:
p.000007: b. relevant material from the living or the deceased that is not held on premises with a licence from the Human Tissue
p.000007: Authority for research (England, Northern Ireland and Wales only)
p.000007: c. organs retained from a post-mortem examination carried out on the instructions of the Procurator Fiscal (Scotland
p.000007: only)
p.000007: d. organs, tissue blocks or slides retained from a hospital post-mortem examination, or tissue blocks or slides
p.000007: retained from a post-mortem examination carried out on the instructions of the Procurator Fiscal, unless lawful
p.000007: authorisation has been given for use in research (Scotland only)
p.000007: e. analysis of human DNA in cellular material, where appropriate consent for the research is not in place from or on
p.000007: behalf of the person whose body manufactured the DNA. The researcher must not be in possession of, or likely to come
p.000007: into possession of, information from which the person whose body manufactured the DNA can be identified (UK-wide).
p.000007: Good practice requirements for research ethics committee review
p.000007:
p.000007: 2.3.4 This document applies, and REC review is required, where research relates to the following areas of the UK
p.000007: Health Departments’ responsibility:
p.000007: Nation Health Department Services
p.000007:
p.000007: England
p.000007: Department of Health and Social Care (England)
p.000007: NHS and adult Social Care
p.000007:
p.000007:
p.000007: Northern Ireland
p.000007: Department of health (Northern Ireland)
p.000007: Health and Social Care
p.000007:
p.000007:
p.000007: Scotland
p.000007: Scottish Government Health and Social Care Directorate
p.000007: NHS and adult Social Care
p.000007:
p.000007:
p.000007: Wales
p.000007: Department for Health and Social Services
...
p.000008:
p.000008: unless any of the exceptions or other exclusions described in paragraph 2.3.9–2.3.17 apply.
p.000008: 2.3.6 REC review under this document is also required for:
p.000008:
p.000008: a. xenotransplantation (i.e. putting living cells, tissue or organs from animals into people), which, as a matter of
p.000008: Government policy7 (New interventional procedures are overseen and scrutinised by the National Institute for Health and
p.000008: Care Excellence (NICE). In addition to xenotransplantation, RECs may need to consider studies of other new procedures
p.000008: as advised by NICE.)8 (Xenotransplantation Guidance. Department of Health (England), Dec 2006. ), is recommended to
p.000008: take place in a controlled research context, carried out with a research protocol approved by a REC within the UK
p.000008: Research Ethics Service.
p.000008: b. health-related research involving offenders, for which Her Majesty’s Prison and Probation Service, Scottish Prison
p.000008: Service and Northern Ireland Prison Service are responsible require review by a REC as well as compliance with their
p.000008: own approval procedures
p.000008: c. social care research projects funded by the Department of Health and Social Care (England) involving adult social
p.000008: care service users as participants, which must always be reviewed by a REC within the Research Ethics Service for
p.000008: England
p.000008: d. research involving analysis of human DNA in acellular material9 (See paragraphs 70– 79 of the Human Tissue
p.000008: Authority’s Code of Practice E at www.hta.gov.uk ) (e.g. serum, processed plasma and processed semen) where appropriate
p.000008: consent for the research is not in place from or on behalf of the person whose body manufactured
p.000008:
p.000008:
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p.000009: 9
p.000009:
p.000009: the DNA. The researcher must not be in possession of, or likely to come into possession of, information from which the
p.000009: person whose body manufactured the DNA can be identified.
p.000009: Other provisions for research ethics committee review
p.000009:
p.000009: 2.3.7 RECs may agree to consider applications in respect of activities preparatory to research (e.g. the
p.000009: establishment of research databases or tissue banks, or pre-trial advertising and screening for healthy volunteers) and
p.000009: research proposals which fall outside the normal scope described above, capacity permitting. When they do this, they
p.000009: must follow the relevant standard operating procedures.
p.000009: 2.3.8 REC review is always available to applicants in respect of research funded by any of the UK Health
p.000009: Departments.
p.000009: Exceptions
p.000009:
p.000009: 2.3.9 This document does not apply in England and Wales if social care research proposals are reviewed by a
p.000009: committee operating in accordance with the Economic and Social Research Council’s Framework for Research Ethics10(
p.000009: Framework for Research Ethics. Economic and Social Research Council, Jan 2015. https://esrc.ukri.org/ ), unless any of
p.000009: the following apply:
...
p.000009: (MoDREC). Where research approved by MoDREC continues within the services for which the UK Health Departments are
p.000009: responsible, following transfer of participants into their care, it does not then require separate REC review under
p.000009: this document. MoDREC operates to standards set out separately by the Ministry of Defence, which are compatible with
p.000009: those in this document.
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p.000010: 2.3.11 REC review involving previously collected material consisting of or including human cells is only required
p.000010: where;
p.000010: a. it is required by law under paragraph 2.3.3(a)–(e) above,
p.000010: b. the research also involves use of identifiable information about patients or service users under paragraph 2.3.5 (c
p.000010: & d),
p.000010: c. consent for research has not been given by the donors or the research is outside the terms of consent for
p.000010: research.
p.000010: Using anonymous material with due consent presents no outstanding issues of research ethics.
p.000010: 2.3.12 REC review under this document is not required for research involving human biological material not consisting
p.000010: of or including cells11 (Guidance on identifying ‘relevant material’ for the purposes of the Human Tissue Act 2004,
p.000010: i.e. material consisting of or including human cells, is published by the Human Tissue Authority at www.hta.gov.uk.),
p.000010: unless it is required by law under paragraph 2.3.3(e) above, or where the research involves analysis of human DNA in
p.000010: acellular material where it is not within the terms of consent for research from the person whose body manufactured the
p.000010: DNA under paragraph 2.3.6(d), or where the research also involves use of identifiable information about patients or
p.000010: service users under paragraph 2.3.5 (c & d).
p.000010: Other exclusions
p.000010:
p.000010: 2.3.13 Care providers owe a duty of care to users of their services. They are responsible for ensuring that ethical
p.000010: issues and risks in the course of the care they provide are considered. RECs are not expected to consider applications
p.000010: in respect of activities that are not research, for example clinical or other non-financial audit, service evaluation
p.000010: and public health surveillance. Guidance on differentiating research from such activities is available from the Health
p.000010: Research Authority’s on-line decision tools (www.hra.nhs.uk) REC members who give advice on the ethics of such
p.000010: activities should make it clear that they are not doing so in their capacity as a REC member.
p.000010: 2.3.14 Employers owe a duty of care to their employees that is different from the duty of care that care providers
p.000010: owe to users of their services. RECs are not expected to assume employers’ responsibilities or liabilities, or to act
p.000010: as a substitute for employers’ proper management of health and safety in the workplace. It is for employers to ensure
p.000010: that they are fulfilling their duties as employers when their employees take part in research. Research involving staff
p.000010: of the services listed in paragraph 2.3.4, who are recruited by virtue of their professional role, does not therefore
p.000010: require REC review except where it would otherwise require REC review under this document (for example, because there
p.000010: is a legal requirement for REC review, or because the research also involves patients or service users as research
p.000010: participants).
p.000010: 2.3.15 Market research may be undertaken by professional market researchers, e.g. for public health research or on
p.000010: behalf of pharmaceutical or medical device companies.
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p.000011:
p.000011: Where such research is conducted by professional market researchers in accordance with the principles set out in the
p.000011: Market Research Society Code of Conduct or with the Legal and Ethical Guidelines issued by the British Healthcare
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p.000014: researchers’ employer and sponsor and with the care organisations where the research takes place (or through which the
p.000014: researchers have access to participants, or their tissue or information) or where the researchers have contracts.
p.000014: Statutory enforcement authorities are listed in Annex B.
p.000014: 3.2.16 The Research Ethics Service should agree channels of communication with the relevant bodies in order to
p.000014: exchange advice. RECs should use these channels to alert
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p.000015: the bodies responsible for enforcement if they have grounds to suspect that enforcement action is warranted.
p.000015: 3.2.17 RECs receive annual reports about the progress of the research they have reviewed. These reports reflect any
p.000015: developments affecting participants' dignity, rights, safety or well-being.
p.000015:
p.000015: 3.2.18 A REC should reconsider its favourable opinion in light of pertinent information13 (RECs are not expected to
p.000015: duplicate the ongoing checks for which others are responsible (see paragraph 5.4.2). For instance, safety reports in
p.000015: respect of research that is subject to Clinical Trials Regulations or Medical Devices Regulations are received and
p.000015: reviewed by the Medicines and Healthcare products Regulatory Agency.) that comes to its attention. If the REC consider
p.000015: that it would not have reached a favourable opinion had it been given that information during its initial review, it
p.000015: should notify the relevant statutory enforcement authority. Where the law does not specify the responsibility for
p.000015: enforcement, the REC should notify the chief investigator and the sponsor that its opinion is no longer favourable.
p.000015: 3.3 Remit
p.000015: 3.3.1 RECs established and operating in accordance with the principles, requirements and standards set out in this
p.000015: document are recognised by the Department of Health (Northern Ireland), the Scottish Ministers, the Secretary of State
p.000015: for Health and Social Care and the Welsh Ministers.
p.000015: 3.3.2 Together, these RECs – as well as head offices that co-ordinate the development and management of their
p.000015: operations – form the UK Research Ethics Service.
p.000015: 3.3.3 In general, any REC anywhere in the Research Ethics Service may carry out the review required by Section 2.
p.000015: Specific RECs within the Research Ethics Service may be recognised, or otherwise designated, for review of certain
p.000015: types of research proposal, according to legal, policy or operational requirements.
p.000015: 3.3.4 Each head office within the Research Ethics Service is accountable to the relevant Health Department:
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p.000016: Head office
p.000016: Remit
p.000016: Accountability
p.000016:
p.000016:
p.000016: Chief Scientist Office
p.000016: RECs in Scotland
p.000016: Scottish Government Health and Social Care Directorate
p.000016:
p.000016:
p.000016: Health and Care Research Wales Ethics Service
p.000016: RECs in Wales
p.000016: Department for Health and Social Services
p.000016:
p.000016:
p.000016: Health Research Authority
p.000016: Recs in England14 (the HRA performs some functions relating to management of the UK research ethics service outside of
p.000016: England (see paragraphs 3.3.7, 3.3.8, glossary and annex E)
p.000016: Department for Health and Social Care (England)
p.000016:
p.000016:
p.000016: Office for Research Ethics Committees Northern Ireland
p.000016: RECs in Northern Ireland
p.000016: Department of Health (Northern Ireland)
p.000016:
p.000016:
p.000016: 3.3.5 The head offices work with each other to maintain a consistent approach, on behalf of appointing authorities,
p.000016: to the operations of all RECs within the UK Research Ethics Service. The responsibilities and functions of the head
p.000016: offices are listed in Annex C.
p.000016: 3.3.6 Appointing authorities are the bodies that establish RECs, appoint and indemnify their members, seek their
p.000016: recognition if the law requires it and monitor their performance15 (The relevant head office is responsible for
p.000016: day-to-day and ad hoc management of the operation and performance of RECs). Each appointing authority identifies a
p.000016: named senior person, who is not otherwise directly involved in the management of Research Ethics Service staff, who has
p.000016: responsibility for governance of the RECs on behalf of the chief executive (unless the named officer is the chief
p.000016: executive). The chief executive has overall accountability. The responsibilities and functions of appointing
p.000016: authorities are listed in Annex D.
p.000016: 3.3.7 The head office of the Research Ethics Service for England, the Health Research Authority, performs some
p.000016: functions on behalf of the other head offices. It also acts in respect of some UK-wide functions and for the Devolved
p.000016: Administrations and the UK Ethics Committee Authority (UKECA), which is the statutory body that recognises RECs for the
p.000016: review of clinical trials of investigational medicinal products. Functions performed by the Health Research Authority
p.000016: are listed in Annex E. Functions performed by UKECA are listed in Annex F.
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p.000017: 3.3.8 The Health Research Authority has established a National Research and Ethics Advisers’ Panel to provide it
p.000017: with a transparent source of advice and expertise to enable it to fulfil its statutory functions within an overall
p.000017: UK-wide framework for research ethics and broader research governance16 (For further details, see the panel’s terms of
p.000017: reference at www.hra.nhs.uk). The panel is a resource available to the UK Research Ethics Service and to the appointing
p.000017: authorities of the RECs within that service.
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p.000018:
p.000018: 4 Composition and membership
p.000018:
p.000018: 4.1 Summary
p.000018: 4.1.1 Research ethics committees (RECs) harmonise public and professional opinion in reaching decisions about
p.000018: proposed research. Their members reflect the diversity of society and do not represent vested interests.
p.000018: 4.2 Composition of research ethics committees
p.000018: Nature of membership
p.000018:
...
p.000019: appointing authorities to ensure an appropriate balance of members.
p.000019: Affiliations
p.000019:
p.000019: 4.2.9 RECs are constituted, and operate, independently of organisations that sponsor, conduct or host research.
p.000019: Members absent themselves during consideration of research proposals that could be seen to create a conflict of
p.000019: interest. REC meetings should be attended so as to accommodate these absences while remaining quorate.
p.000019: Quorum
p.000019:
p.000019: 4.2.10 For the purpose of effective debate, a REC normally has no more than 18 members in total. A quorate meeting is
p.000019: one attended by no fewer than seven members, including:
p.000019: a. the chair or other officer
p.000019:
p.000019: b. at least one expert member
p.000019:
p.000019: c. at least one lay member.
p.000019:
p.000019: 4.2.11 Each REC should be constituted so that it can function quorately for the duration of its scheduled meetings.
p.000019: 4.2.12 Where other membership, composition or attendance criteria are specified, e.g. in law, for RECs reviewing
p.000019: certain types of research proposal18 (For instance, the REC
p.000019:
p.000019:
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p.000020: 20
p.000020:
p.000020: constituted by regulations made under the Adults with Incapacity (Scotland) Act 2000 and associated statutory
p.000020: instruments, RECs that review clinical trials of investigational medicinal products or research funded by the US
p.000020: government.), guidance enabling RECs to convene in accordance with the requirements set out in this document as well as
p.000020: the additional specifications is available from the Health Research Authority website, www.hra.nhs.uk19 (Standard
p.000020: Operating Procedures for Research Ethics Committees. www.hra.nhs.uk).
p.000020: Officers
p.000020:
p.000020: 4.2.13 Each REC has a chair, a vice-chair and an alternate vice-chair. These officers are appointed from among the
p.000020: REC’s members by the relevant appointing authority, after consulting the REC. If all three are unavailable, another
p.000020: member or an appointed officer from a different REC will be acting chair.
p.000020: 4.2.14 Candidates for office are expected to have at least one year’s experience as a member of a REC. Appointees
p.000020: should receive any necessary supplementary training (e.g. in chairing skills) prior to taking office.
p.000020: 4.2.15 Officers are appointed for a specified period not exceeding five years. Officer appointments may be renewed
p.000020: (and exceptionally extended) in the same way as member appointments (see paragraph 4.3.2). An acting chair’s
p.000020: appointment ceases when one of the other officers becomes available again or when his or her term as a member expires,
p.000020: whichever is sooner.
p.000020: 4.2.16 Officers may resign from office at any time. They may continue as members of the REC, subject to the
p.000020: disqualification and resignation procedures of its appointing authority.
p.000020: Deputies
p.000020:
p.000020: 4.2.17 REC members may have deputies to enable the REC to perform its duties and meet quorately, while accommodating
p.000020: absences.
p.000020: 4.2.18 Deputies of expert members must be eligible for appointment in their own right as expert members. Deputies of
p.000020: lay members must be eligible for appointment in their own right as lay members. Deputies are appointed by the REC’s
p.000020: appointing authority.
p.000020: 4.2.19 Deputies do not count towards the quorum or vote on decisions unless the members for whom they deputise are
p.000020: absent.
p.000020: Referees
p.000020:
p.000020: 4.2.20 RECs may seek advice from specialist referees on any aspects of a research proposal that fall beyond the
p.000020: members’ expertise. RECs may seek referees’ advice at their discretion or because the law requires them to do so.
p.000020: Referees’ advice should only be sought on issues material to the REC’s review of the research proposal, i.e. issues of
p.000020: research ethics.
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p.000021: 4.2.21 Referees do not count towards the quorum or vote on decisions. They are not involved in any REC business apart
p.000021: from advising on the issues put to them. Their advice is recorded in the minutes of the relevant REC meeting.
p.000021: Observers
p.000021:
p.000021: 4.2.22 REC meetings are not public meetings. External observers may attend following a written invitation which
p.000021: states the terms and conditions of their attendance. Attendance will be agreed by the REC and minuted accordingly.
p.000021: External observers play no part in the deliberations of the REC.
p.000021: 4.2.23 Representatives of the relevant Research Ethics Service head office may attend and observe meetings at any
p.000021: time, with prior notification.
p.000021: Advice to applicants
p.000021:
p.000021: 4.2.24 RECs should take steps to facilitate communication with their potential or actual applicants. A REC may
p.000021: designate a point of contact for more detailed discussion. This includes advice about whether a proposed activity
...
p.000021: determining its final opinion to the chair or other officer, or to a sub- committee of specified members.
p.000021: 4.2.27 Responsibilities of REC officers may be delegated to administrative staff where the matters are
p.000021: administrative, in accordance with standard operating procedures. In particular, administrative staff may check
p.000021: evidence provided by applicants in response to requests for further information and issue letters confirming the REC’s
p.000021: opinion.
p.000021: 4.3 Conditions of membership
p.000021: Terms of appointment
p.000021:
p.000021: 4.3.1 Written terms of appointment for REC members should include the following:
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p.000022:
p.000022: a. duration of appointment
p.000022:
p.000022: b. renewal policy
p.000022:
p.000022: c. disqualification and resignation procedures
p.000022:
p.000022: d. policy concerning declaration of interests
p.000022:
p.000022: e. details of allowable expenses.
p.000022:
p.000022: 4.3.2 REC members are appointed for fixed terms not exceeding five years. Appointments may be renewed. However,
p.000022: members should not normally serve more than two consecutive terms of five years on the same REC. Where a member is
p.000022: appointed as an officer during their second term, their membership may be extended until the completion of their term
p.000022: as an officer (see paragraph 4.2.15). Where the normal period of membership has expired, the appointing authority may
p.000022: exceptionally extend a member’s term while new members are appointed.
p.000022: 4.3.3 Former members may be reappointed to the same REC no sooner than two years after the end of their last term,
p.000022: or to another REC without interval.
p.000022: 4.3.4 Attendance at meetings of other RECs as a co-opted member, referee or observer is encouraged, in the
p.000022: interests of training and consistency.
p.000022: 4.3.5 Simultaneous membership of more than one REC is permitted with the approval of the appointing authorities
p.000022: concerned, as is deputy membership of other RECs. REC members are normally required to attend in full at least two
p.000022: thirds of all scheduled REC meetings in each year, barring exceptional circumstances. Attendance at scheduled
p.000022: sub-committee meetings should be taken into account. With the approval of the appointing authority, a REC member and
p.000022: his or her deputy may make arrangements to share responsibility for attendance. In this case, the REC member should
p.000022: attend at least as many scheduled meetings in each year as the deputy.
p.000022: 4.3.6 REC members may resign at any time.
p.000022:
p.000022: 4.3.7 REC members should normally allow publication of their full name and, if applicable, their profession and
p.000022: institutional affiliation. In the interests of transparency and probity, any potential conflict of interest should be
p.000022: recorded and published with these personal details.
p.000022: 4.3.8 REC members are unpaid volunteers. RECs may not charge an application fee or seek any other financial
p.000022: contribution or donation for or on considering a research proposal for which their review is required by Section 2.
p.000022: Members receive no payment for contributing to the review of applications at scheduled meetings or for attending such
p.000022: meetings.
p.000022: 4.3.9 Expenses incurred during the course of a REC member’s duties are reimbursed. These may cover travel,
p.000022: subsistence, domestic care and locum arrangements, but do not normally cover loss of earnings. Allowances may be
p.000022: offered to REC members for
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p.000023:
p.000023: additional activities, e.g. appointment as an officer, acting as a point of contact to advise applicants or providing
p.000023: expert critique of research proposals as a referee.
p.000023: Training
p.000023:
p.000023: 4.3.10 As a condition of appointment, REC members must agree to take part in initial and continual training
p.000023: appropriate to their role.
p.000023: Confidentiality
p.000023:
p.000023: 4.3.11 REC members must maintain confidentiality regarding applications, meeting deliberations, information about
p.000023: research participants and related matters.
p.000023: Indemnity
p.000023:
p.000023: 4.3.12 Each REC member must be supplied with a personal statement regarding the indemnity provided by the appointing
p.000023: authority and its conditions.
p.000023: Conduct
p.000023:
p.000023: 4.3.13 The meetings and proceedings of RECs and their sub-committees are conducted in accordance with standard
p.000023: operating procedures.
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p.000024:
p.000024: 5 Requirements of research ethics committee review
p.000024: Summary
p.000024: 5.1.1 There is a standard process for applying to a research ethics committee. Research ethics committees (RECs)
p.000024: also review applications in accordance with standards.
p.000024: 5.1 Applying for research ethics committee review
p.000024: 5.2.1 Applications to RECs should be made in accordance with a process set out in standard operating procedures for
p.000024: RECs and in written guidance for applicants. This process covers the application from submission to opinion and on to
p.000024: subsequent notification of substantial amendments, annual progress reporting etc.
p.000024: 5.2.2 The Research Ethics Service should be prepared to offer accurate advice and guidance to potential and actual
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p.000027:
p.000027: 6 Standard operating procedures
p.000027:
p.000027: 6.1 Summary
p.000027: 6.1.1 Common working practices promote efficiency and enable research ethics committees (RECs) to work together as
p.000027: part of a consistent Research Ethics Service. Published standards allow researchers and the public to expect
p.000027: transparent accountability.
p.000027: 6.2 Purpose
p.000027: 6.2.1 Standard operating procedures for RECs are essential to an efficient, consistent and accountable Research
p.000027: Ethics Service.
p.000027: 6.3 Content
p.000027: 6.3.1 Standard operating procedures take account of applicable laws and national guidance, advice and exemplars.
p.000027: They also reflect relevant internationally recognised principles and standards.
p.000027: 6.3.2 Standard operating procedures provide the operational detail for meeting the principles, requirements and
p.000027: standards set out in this document.
p.000027: 6.4 Compliance and accountability
p.000027: 6.4.1 Each REC must adopt standard operating procedures approved by or on behalf of its appointing authority, as
p.000027: well as by any other body whose approval is required by law. The head offices of the Research Ethics Service enable
p.000027: adoption by all RECs of standard operating procedures and other common working practices.
p.000027: 6.4.2 RECs act in accordance with their standard operating procedures and are ultimately accountable to their
p.000027: appointing authorities for their governance in this respect.
p.000027: 6.4.3 Standard operating procedures are publicly available from the Health Research Authority (www.hra.nhs.uk).
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p.000028:
p.000028: Glossary
p.000028:
p.000028:
p.000028: anonymised HSC
p.000028: intrusive research
p.000028: Anonymised in accordance with the Information Commissioner’s Office anonymisation code of practice
p.000028: Health and Social Care, the name for health and personal social services in Northern Ireland
p.000028: Section 30 of the Mental Capacity Act in England and Wales defines ‘intrusive research’ as research that (a) is carried
p.000028: out on, or in relation to, a person who lacks capacity to consent to it and (b) would be unlawful if it were carried
p.000028: out on, or in relation to, a person who had capacity to consent to it, but without his or her consent.
p.000028:
p.000028: Section 132 of the Mental Capacity Act (Northern Ireland) 2016 defines ‘intrusive research’ as research which is of a
p.000028: kind that would be unlawful if it were carried out:
p.000028:
p.000028: (a)on or in relation to a person who had capacity to consent to it; but (b)without that person’s consent.
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p.000028: may begin. CTIMPs involving people who lack the capacity to consent are covered separately by the Clinical Trials
p.000028: Regulations.
p.000028:
p.000028:
p.000028: IR(ME)R MoDREC NHS
p.000028:
p.000028:
p.000028: REC
p.000028:
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p.000028:
p.000028: relevant material
p.000028:
p.000028:
p.000028:
p.000028:
p.000028: UKECA
p.000028: Ionising Radiation (Medical Exposure) Regulations Ministry of Defence Research Ethics Committee
p.000028: National Health Service, the name for health services in England, health and social care services in Scotland and
p.000028: health services in Wales
p.000028: Research ethics committee, specifically one within the UK Research Ethics Service. NB the term ‘REC’ in this document
p.000028: should not be interpreted as referring to any other body that reviews the ethics of research.
p.000028: Section 53 of the Human Tissue Act defines ‘relevant material’ as any material consisting of or including human cells,
p.000028: apart from (a) hair and nails from living people, (b) embryos outside the human body and (c) gametes (i.e. sperm and
p.000028: unfertilised egg cells). NB Embryos and gametes are covered separately by the Human Fertilisation and Embryology Act.
p.000028: UK Ethics Committee Authority, which is the statutory body that, among other functions (see Annex F), recognises
p.000028: research ethics committees for the review of clinical trials of investigational medicinal products and approves their
p.000028: standard operating procedures for that review.
p.000028:
p.000028:
p.000029: 29
p.000029:
p.000029: Annex A: Legal requirements for research ethics committee review
p.000029: Any updates to this list will be published at www.hra.nhs.uk
p.000029: Extent of legal requirement for research ethics committee review
p.000029:
p.000029:
p.000029: Legislation England Northern Ireland
p.000029: Scotland Wales
p.000029:
p.000029: Adults with Incapacity (Scotland) Act 2000 §51
p.000029: Adults with Incapacity (Ethics Committee) (Scotland) Regulations 2002, as amended 2007
p.000029: Health Service (Control of Patient Information) Regulations 2002, as amended 2016
p.000029: Human Fertilisation and Embryology (Disclosure of Information for Research Purposes) Regulation 2010
p.000029: No No Yes No
p.000029:
p.000029: No No Yes No
p.000029:
p.000029:
p.000029: Yes No No Yes
p.000029:
p.000029:
p.000029: Yes Yes Yes Yes
p.000029: Human Tissue Act 2004 Yes Yes Yes (§45) Yes
p.000029:
p.000029: Human Tissue Act 2004 (Ethical Approval, Exceptions from Licensing and Supply of Information about Transplants)
...
p.000031:
p.000031: Residential Care Homes Regulations (Northern Ireland) 2005
p.000031: No Yes No No
p.000031:
p.000031:
p.000031: No Yes No No
p.000031:
p.000031:
p.000031: Yes Yes Yes Yes
p.000031:
p.000031:
p.000031:
p.000031:
p.000031: No Yes No No
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000032: 32
p.000032:
p.000032: Annex B: Enforcement authorities
p.000032:
p.000032: Any updates to this list will be published at www.hra.nhs.uk.
p.000032:
p.000032:
p.000032: Jurisdiction
p.000032:
p.000032:
p.000032: Activity Relevant Body England Northern Ireland
p.000032: Scotland Wales
p.000032:
p.000032: Protection of service users from unsafe or inappropriate care
p.000032: Human Embryo Research
p.000032:
p.000032: Licensed storage of relevant materials for research purposes
p.000032: Research exposure to ionising radiation
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032: Clinical investigations of medical devices
p.000032:
p.000032: Clinical trial of investigational medicinal products
p.000032: Care Quality Commission
p.000032:
p.000032: Human Fertilisation and Embryology Authority
p.000032: Human Tissue Authority
p.000032:
p.000032: IR(ME)R
p.000032: Inspectorates23 (Each nation has its own IR(ME)R Inspectorate.
p.000032: This is a function of the Care Quality Commission in England and of the Department of Health (Northern Ireland), the
p.000032: Scottish Ministers and the Welsh Ministers in Northern Ireland, Scotland and Wales.)
p.000032: Medicines and Healthcare Products Regulatory Agency
p.000032: Medicines and Healthcare Products Regulatory Agency
p.000032: Yes No No No
p.000032:
p.000032:
p.000032: Yes Yes Yes Yes
p.000032:
p.000032:
p.000032: Yes Yes No Yes
p.000032:
p.000032:
p.000032: Yes Yes Yes Yes
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032: Yes Yes Yes Yes
p.000032:
p.000032:
p.000032: Yes Yes Yes Yes
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000032:
p.000033: 33
p.000033:
p.000033: Annex C: Research Ethics Service head office functions
p.000033:
p.000033: The head office of the Research Ethics Service in each nation:
p.000033:
p.000033: a. makes arrangements on behalf of appointing authorities for the appointment of such administrative and other staff
p.000033: for their research ethics committees (RECs) as it considers necessary to enable them to perform their functions;
...
p.000033: maintenance, cleaning and other services as it considers necessary);
p.000033: c. may fund RECs through, or on behalf of, their appointing authorities a sum in respect of each financial year equal
p.000033: to the amount of expenditure which it considers may be reasonably incurred by the RECs in that year for the purpose of
p.000033: performing their functions;
p.000033: d. may pay RECs through, or on behalf of, their appointing authorities such travelling and other allowances as it may
p.000033: determine;
p.000033: e. collaborates with appointing authorities on their behalf to establish sufficient provision for REC review,
p.000033: according to a common administrative structure so that applications are directed to an appropriate and convenient REC;
p.000033: f. ensures on behalf of appointing authorities that a rotation system (e.g. staggered tenure) is in place for REC
p.000033: members so as to achieve business continuity, the development and maintenance of expertise within each REC and the
p.000033: regular refreshment of debate;
p.000033: g. establishes and manages regional centres where appropriate to oversee the activity of RECs;
p.000033: h. supports appointing authorities in ensuring standard practice and a consistent approach, for the benefit of
p.000033: researchers and RECs alike; and
p.000033: i. handles appeals against the unfavourable opinions of RECs on behalf of their appointing authorities.
p.000033: The distribution of functions may vary between nations and some of these functions may be performed by appointing
p.000033: authorities (see Annex D).
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000034: 34
p.000034:
p.000034: Annex D: Functions of appointing authorities
p.000034: An appointing authority:
p.000034:
p.000034: a. establishes, on the advice of the relevant head office, research ethics committees
p.000034:
p.000034: a. (RECs) to act for the whole or part of their geographical area under its jurisdiction, ensuring there is sufficient
p.000034: provision to meet the local demand for REC review;
p.000034: b. establishes, on the advice of the relevant head office, RECs to act in relation to such descriptions or classes of
p.000034: research as are appropriate;
p.000034: c. varies, on the advice of the relevant head office, the extent to which its RECs may act under (a) and (b);
p.000034: d. seeks recognition of its RECs if the law requires it;
p.000034:
p.000034: e. on the advice of the relevant head office and in collaboration with other appointing authorities where appropriate,
p.000034: abolishes RECs it has established, merges them with other RECs and nominates, if required, successor RECs when RECs
p.000034: cease to operate or are abolished or varied under (c) or have their recognition revoked;
p.000034: f. appoints, with support from the relevant head office, the members of its RECs in accordance with Governance
p.000034: arrangements for research ethics committees and the law to ensure that its RECs have the required composition;
p.000034: g. indemnifies members of its RECs to relieve them of personal liability in respect of their opinions of the ethics of
p.000034: research;
p.000034: h. facilitates the provision of funds for the operation of its RECs and may recharge these costs to the relevant head
p.000034: office;
p.000034: i. on the advice of the relevant head office, may enter into legal agreements to secure the accommodation and
p.000034: facilities required to support the operation of its RECs
p.000034: j. appoints the officers of its RECs, extends their tenure of appointment and terminates their appointment in
p.000034: accordance with its disqualification and resignation procedures, the requirements of Governance arrangements for
p.000034: research ethics committees and the RECs’ standard operating procedures;
p.000034: k. approves, with advice from the relevant head office, standard operating procedures for the regulation of the
p.000034: proceedings and business of its RECs;
p.000034: l. approves, with advice from the relevant head office, variations to, or revocation or suspension of, the standard
p.000034: operating procedures of its RECs; and
p.000034:
p.000034:
p.000034:
p.000034:
p.000035: 35
p.000035:
p.000035: m. monitors the extent to which its RECs adequately perform their functions, through annual reports from its RECs,
p.000035: notification of their accreditation status and other mechanisms for quality assurance provided by the Research Ethics
p.000035: Service.
p.000035: The distribution of functions may vary between nations and some of these functions may be performed by Research Ethics
p.000035: Service head offices (see Annex C) on behalf or instead of appointing authorities.
p.000035: In Scotland, NHS Health Boards are the appointing authority and are accountable for the establishment, funding,
p.000035: support, training and monitoring of all NHS RECs within their wider NHS Research Scotland node. It is the
p.000035: responsibility of the appointing authority to set an annual budget for the adequate support of the RECs for which it is
p.000035: accountable and it must provide adequate administrative support for their business. Where an NHS Scotland Health Board
p.000035: is not a REC appointing authority, they must contribute proportionately to the running costs of their NHS Research
p.000035: Scotland nodal research ethics service.
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000036: 36
p.000036:
p.000036: Annex E: Health Research Authority functions related to the UK Research Ethics Service
p.000036:
p.000036: In addition to its functions as the head office for the Research Ethics Service for England (see Annex C), the Health
p.000036: Research Authority:
p.000036: a. develops and manages a national training programme for research ethics committee (REC) members and administrative
p.000036: staff and provides resources to support this training;
p.000036: b. develops, implements and maintains standard operating procedures for RECs and provides advice and support to RECs
p.000036: on procedural issues;
p.000036: c. develops a quality assurance programme to encourage a consistently high level of service to applicants, including
p.000036: accreditation of RECs, based on regular monitoring and audit of their operation and performance;
p.000036: d. provides guidance and advice to assist RECs in their work and encourage consistency of approach to common issues in
p.000036: research ethics;
p.000036: e. provides advice to the UK Health Departments on the practical implications of implementing legislation, policy and
p.000036: guidance;
p.000036: f. appoints and supports the National Research and Ethics Advisers’ Panel;
p.000036:
p.000036: g. acts for the UK Ethics Committee Authority (UKECA) to provide a national mechanism for operational advice and
p.000036: assistance to RECs recognised for the purposes of Clinical Trials Regulations and to receive, on UKECA’s behalf, their
p.000036: annual reports (see Annex G);
p.000036: h. acts for UKECA to handle appeals against the unfavourable opinions of RECs in respect of clinical trials of
p.000036: investigational medicinal products;
p.000036: i. acts for UKECA to transfer to a successor REC the functions of a REC that has ceased to operate or that has been
p.000036: varied, abolished or had its recognition revoked; and
p.000036: j. acts for UKECA to reallocate to RECs applications made to the Gene Therapy Advisory Committee which do not
p.000036: require its review.
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000036:
p.000037: 37
p.000037:
p.000037: Annex F: Functions of the UK Ethics Committee Authority
p.000037:
p.000037:
p.000037: The Health Research Authority performs some functions on behalf of the UK Ethics Committee Authority (UKECA) (see Annex
p.000037: E). The following functions remain the responsibility of UKECA for the purposes of Clinical Trials Regulations:
p.000037: a. establishing or recognising research ethics committees (RECs) to act for the entirety of the geographical extent of
p.000037: its jurisdiction or such areas thereof as it considers appropriate;
p.000037: b. establishing or recognising RECs to act in relation to such descriptions or classes of research as it considers
p.000037: appropriate;
p.000037: c. varying the extent to or relation in which RECs act under (a) and (b);
p.000037:
p.000037: d. abolishing or revoking the recognition of RECs which it has established or recognised;
p.000037:
p.000037: e. monitoring the extent to which RECs adequately perform their functions, including through annual reports from RECs
p.000037: it has recognised;
p.000037: f. approving standing orders and standard operating procedures for the regulation of the proceedings and business of
p.000037: RECs; and
p.000037: g. approving variations to or revocation or suspension of orders or procedures made or adopted under (f).
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000038: 38
p.000038:
p.000038: Annex G: Management information about research ethics committees
p.000038:
p.000038: The head office should maintain information, at least on an annual basis, about the following:
p.000038:
p.000038: a. the REC’s name, address and other contact details;
p.000038:
p.000038: b. the type of REC, including details of any recognition by UKECA and/or designation by the Research Ethics Service
p.000038: for review of certain types of research proposal;
p.000038: c. details of the officers and staff of the REC;
p.000038:
p.000038: d. details of the membership of the REC, including for each member and deputy member their occupation, expert/lay
p.000038: status, initial date of appointment, and where applicable the date on which the term of membership expired or the
p.000038: member resigned;
p.000038: e. the current register of members’ interests;
p.000038:
p.000038: f. the attendance record of each member and deputy member during the year;
p.000038:
p.000038: g. a list of full meetings held during the year, including their dates and the number of members attending;
p.000038: h. the training record of each member and deputy member; and
p.000038:
p.000038: i. a list of the applications reviewed during the year, including the final decision reached on each application and
p.000038: the time taken to complete the review (or the current status of the review).
p.000038: In the case of clinical trials of investigational medicinal products, the REC must, within six months from the end of
p.000038: each financial year, prepare a report on its activities during that year, which shall include a list of the
p.000038: applications made to the REC in accordance with regulation 14 of the Medicines for Human Use (Clinical Trials)
p.000038: Regulations 2004 and the decisions made by the REC in relation to those applications. The REC must send a copy of the
p.000038: report to, on behalf of UKECA, the Health Research Authority.
p.000038:
p.000038:
p.000038:
p.000038:
p.000038:
p.000038:
p.000038:
p.000038:
p.000038:
p.000038:
p.000038:
p.000038:
...
General/Other / declaration of helsinki
Searching for indicator helsinki:
(return to top)
p.000024: 5.2.1 Applications to RECs should be made in accordance with a process set out in standard operating procedures for
p.000024: RECs and in written guidance for applicants. This process covers the application from submission to opinion and on to
p.000024: subsequent notification of substantial amendments, annual progress reporting etc.
p.000024: 5.2.2 The Research Ethics Service should be prepared to offer accurate advice and guidance to potential and actual
p.000024: applicants (see paragraphs 3.3.8 and 4.2.24). This includes being able to answer queries about whether REC review is
p.000024: required (see Section 2), the application process (including the requirements for a valid application) and the review
p.000024: process (including the issues RECs consider before reaching an opinion).
p.000024: 5.2.3 There is a managed process for allocating REC applications to an appropriate REC (see paragraph 3.3.3). As
p.000024: far as possible, it takes into account what will be convenient to the applicant.
p.000024: 5.2 Requirements for a favourable opinion
p.000024: 5.3.1 A REC gives a favourable opinion if it is assured about the ethical issues presented by the proposed
p.000024: research. These issues may vary, depending on the research in question. REC members receive training and guidance about
p.000024: the issues they should consider, both in general and in particular cases. The training and guidance reflect recognised
p.000024: standards for ethical research, such as the Declaration of Helsinki 20(World Medical Association Declaration of
p.000024: Helsinki: Ethical Principles for Medical Research Involving Human Subjects. World Medical Association, Oct 2013.
p.000024: www.wma.net/policies-post/wma-declaration- of-helsinki-ethical-principles-for-medical-research-involving-human-subjects
p.000024: The latest version of the Declaration should normally be used, insofar as it is compatible with UK law. NB: The Medical
p.000024: Devices Regulations 2002 implement Council Directive 93/42/EEC, which specifies the September 1989 version. The
p.000024: Medicines for Human Use (Clinical Trials) Regulations 2004 specify the October 1996 version.) and take account of
p.000024: applicable legal requirements.
p.000024:
p.000024:
p.000024:
p.000024:
p.000024:
p.000024:
p.000024:
p.000024:
p.000024:
p.000024:
p.000024:
p.000025: 25
p.000025:
p.000025: 5.4 Principles of research ethics committee review
p.000025: 5.4.1 RECs receive training, guidance, standard operating procedures and quality assurance (including
p.000025: accreditation) in order to support them to identify the relevant issues and consider them appropriately.
p.000025: 5.4.2 RECs should receive guidance on the wider regulatory and governance environment for research and its
p.000025: reliability so that they can assess the assurances they receive. RECs will accept credible assurances that others will
p.000025: do what is expected of them.
p.000025: a. A REC need not reconsider the quality of the science, as this is the responsibility of the sponsor and will have
p.000025: been subject to review by one or more experts in the field (known as ‘peer review’). The REC will be satisfied with
p.000025: credible assurances that the research has an identified sponsor and that it takes account of appropriate scientific
p.000025: peer review.
p.000025: b. A REC can expect to rely on established mechanisms for ensuring the proper conduct of the research at individual
p.000025: sites. Organisations providing care that are subject to the UK Policy Framework for Health and Social Care Research are
...
Orphaned Trigger Words
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| access | Access to Social Goods |
| age | Age |
| authority | Relationship to Authority |
| belief | Religion |
| disability | Mentally Disabled |
| embryo | embryo |
| emergency | Public Emergency |
| employees | employees |
| gender | gender |
| healthy volunteers | Healthy People |
| helsinki | declaration of helsinki |
| incapacity | Incapacitated |
| job | Occupation |
| liberty | Incarcerated |
| nation | stateless persons |
| not employed | Unemployment |
| occupation | Occupation |
| officer | Police Officer |
| opinion | philosophical differences/differences of opinion |
| party | political affiliation |
| political | political affiliation |
| prison | Incarcerated |
| race | Racial Minority |
| religion | Religion |
| union | Trade Union Membership |
| unlawful | Illegal Activity |
| volunteers | Healthy People |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| belief | ['religion'] |
| healthy volunteers | ['volunteers'] |
| job | ['occupation'] |
| liberty | ['prison'] |
| occupation | ['job'] |
| party | ['political'] |
| political | ['party'] |
| prison | ['liberty'] |
| religion | ['belief'] |
| volunteers | ['healthyXvolunteers'] |
Trigger Words
capacity
consent
ethics
protect
protection
risk
volunteer
Applicable Type / Vulnerability / Indicator Overlay for this Input