Framework for Research Ethics
https://esrc.ukri.org/files/funding/guidance-for-applicants/esrc-framework-for-research-ethics-2015/

Examining the file media/Synopses/5A71EB3B079C385D77612EE96779F088.html:

This file was generated: 2020-02-01 15:37:44

                                                                                                           Trigger
Indicators in focus are Peer Indicators (that share the same "Outside" Indicators (those that do NOT share
                                                                                                           Words/Phrases are
typically shown         Vulnerability association) are shown the same Vulnerability association) are shown
                                                                                                           shown highlighted in
highlighted in yellow;  highlighted in pink;                 highlighted in green;
                                                                                                           gray.

Link to Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay, Document Map)


Economic / Economic/Poverty
Searching for indicator economic:

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...
000031 p.000033: Appendix E: Example of ethical information in ESRC proposal 50
000032 p.000033: Example of a completed Ethical Information section on ESRC proposal 50
000033 p.000001: 1
000034 p.000001:
000035 p.000001: Introduction
000036 p.000001: The Economic and Social Research Council (ESRC), in facilitating innovative and high quality research, expects that
the
000037 p.000001: research we support will be carried out to a high ethical standard. By establishing the Framework for Research Ethics
000038 p.000001: (FRE) we confirm our commitment to a process of regular review through consultation with the research community
and
000039 p.000001: stakeholders, to ensure ethical standards reflect changing scientific agendas and policy developments.
000040 p.000001:
...

...
000649 p.000016: dimensions of the research that their REC reviews; adequate administrative and clerical support, and adequate
000650 p.000016: resources, including recognition in workload planning and the allocation of academic responsibilities, to carry out
000651 p.000016: reviews with due care and attention; and to attend meetings of the REC. Any additional resourcing for these
000652 p.000016: requirements should fall within a RO’s own budget. However, it should be remembered that the additional costs
incurred
000653 p.000016: by the host RO in carrying out ethics review specifically for ESRC-funded research are eligible costs under the
000654 p.000016: arrangements for Research Councils to meet a proportion of the full economic costs of research.
000655 p.000016:
000656 p.000016: Successful implementation of the FRE relies in a large part on the degree to which individual ROs have built
000657 p.000016: appropriate structures and a culture that recognises the central place that engaging in ethical reflection occupies in
000658 p.000016: good research practice. Encouraging a mindset towards a robust ethics culture and provision of training plays a
central
...

...
001130 p.000027:
001131 p.000027: Is it legitimate to expose some research participants/organisations to risk?
001132 p.000027: This might arise for two reasons. First, as is recognised elsewhere (see Tri-Council of Canada, 2002
001133 p.000027: (http://www.pre.ethics.gc.ca/English/policystatement/introduction.cfm)) research may be ‘deliberately and
legitimately
001134 p.000027: opposed to the interests of the research participants or organisations’ in cases where the objectives of the
research
001135 p.000027: are to reveal and critique fundamental economic, political or cultural disadvantage or exploitation. Much social
001136 p.000027: science research has a critical role to play in exploring and questioning social, cultural and economic structures and
001137 p.000027: processes (for example relating to patterns of power and social inequality, and institutional dynamics and regimes that
001138 p.000027: disadvantage some social groups over others, intentionally or not). Such research results may have a negative impact
on
001139 p.000027: some of the research participants/organisations. Principles of justice should, however, mean that researchers would
001140 p.000027: seek to minimise any personal harm to individuals. Secondly, researchers should also consider how to balance the
...

...
001896 p.000045: • International Visual Sociology Association (2009). Code of Research Ethics and Guidelines
001897 p.000045: http://visualsociology.org/about/ethics-and-guidelines.html
001898 p.000045: • Market Research Society (2014). Code of Conduct https://www.mrs.org.uk/standards/code_of_conduct/
001899 p.000045: • Nuffield Council on Bioethics (2009). Dementia: Ethical Issues
001900 p.000045: http://nuffieldbioethics.org/wp-content/uploads/2014/07/Dementia-report-Oct-09.pdf
001901 p.000045: • Respect Project (2004). An EU code of Ethics for socio-economic research
www.respectproject.org/code/index.php
001902 p.000045: • Social Research Association (2003). Ethics Guidelines http://the-sra.org.uk/research- ethics/ethics-guidelines/
001903 p.000045: • UK Data Service ethics advice: http://ukdataservice.ac.uk/manage-data/legal-ethical.aspx
001904 p.000045: • UKRIO Code of Practice for Research www.ukrio.org/what-we-do/code-of-practice- for-research
001905 p.000045: • Universities and Colleges Employer Association (2011). Guidance on Health and Safety in Fieldwork
...

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002093 p.000050: confidentially is afforded. Where necessary, the project information sheet will be translated, although it is
002094 p.000050: anticipated that English will be the lingua franca. Participation in the research will be voluntary, and informed
002095 p.000050: consent will be discussed with all participants. However, it is anticipated, particularly in the street surveys, that
002096 p.000050: verbal as opposed to signed consent, will be more readily obtainable.
002097 p.000050:
002098 p.000050: The first stage of data collection involves a socio-economic and spatial survey of a multi- ethnic street in each
002099 p.000050: respective city. Each shop unit is given a tracking code to relate the GIS spatial position to the survey material.
002100 p.000050: Personal identifiers are removed and the anonymity of participants will be secured through both research unit codes
and
002101 p.000050: pseudonyms. The raw data of each street survey will be collated in password protected computers and accessed by
the
002102 p.000050: principal investigator and the two research assistants. The data will then be systematised and stored in two
...

Searching for indicator poor:

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000725 p.000018: available should we wish to see them.
000726 p.000018:
000727 p.000018: 1.6 Complaints, appeals and conflict of interest procedures should be in place
000728 p.000018: Complaints - ROs should publish procedures and mechanisms for receiving and addressing, in a timely manner,
complaints
000729 p.000018: or expressions of concern about the conduct of research carried out under their auspices. Such complaints would
000730 p.000018: normally be regarded as allegations of either poor performance or unethical conduct and would appropriately be
000731 p.000018: addressed through the RO’s procedures for dealing with such allegations. Such mechanisms might include
providing
000732 p.000018: research participants with the contact details of a responsible officer within the RO who is independent of specific
000733 p.000018: research projects and is empowered to instigate appropriate investigation of any complaints in a timely manner.
000734 p.000018:
...

Economic / Welfare Recipient
Searching for indicator welfare:

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000537 p.000013: competent and timely. In some circumstances RECs may authorise other sub-committees or their chair to conduct
reviews
000538 p.000013: on research involving minimal risk on their behalf. These sub-committees and chair will have no conflicts of interest
000539 p.000013: with the project and will be accountable to the REC and through it to the appropriate organisational authorities for
000540 p.000013: the decisions they make.
000541 p.000013:
000542 p.000013: The primary role of a REC is to protect the dignity, rights and welfare of research participants. RECs should also give
000543 p.000013: due regard to the consequences of the proposed research for others directly affected by it, and to the interests of
000544 p.000013: those who do not take part in the research but who might benefit or suffer from its outcomes in the future. RECs also
000545 p.000013: need to consider the safety of researchers, especially where they are working in covert situations and/or conducting
000546 p.000013: lone fieldwork in settings that may pose risk to their safety, nationally and internationally.
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...
000704 p.000017: Where a REC or a designated sub-committee considers that a monitoring report or ad hoc audit has raised significant
000705 p.000017: concerns about the ethics in the conduct of the study, it should request a full and detailed account of the research
000706 p.000017: for full ethics review by the responsible REC.
000707 p.000017:
000708 p.000017: Where a REC or designated sub-committee considers that a study is being conducted in a way which is not in accord
with
000709 p.000017: the conditions of its review or in a way which does not appropriately protect the rights, dignity and welfare of
000710 p.000017: research participants, it should initially bring together a meeting of all those concerned with a view to resolving the
000711 p.000017: difficulties. In an extreme situation, the REC may withdraw its support, and require that the research be suspended or
000712 p.000017: discontinued. The ESRC should be informed of this decision and reserves the right to recoup its grant funding in
000713 p.000017: extreme cases of ethics and research misconduct, pending further investigation.
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001316 p.000032: 32
001317 p.000032:
001318 p.000032: who knows the person well who lacks capacity to make a decision, but is not a professional or paid care worker; this
001319 p.000032: does not include family members receiving some of the person’s pension or other benefits as a payment towards
their
001320 p.000032: share of the household expenses. The guidance states that it should be someone whom the person who lacks
capacity to
001321 p.000032: make a decision would trust with important decisions about their welfare.
001322 p.000032: Thus, a personal consultee could be a family member or close friend of the person.
001323 p.000032:
001324 p.000032: If no personal consultee can be identified, a nominated consultee should be proposed by the researcher. This is
someone
001325 p.000032: who is prepared to be consulted by the researcher, but has no connection with the research project - for example,
...

...
001329 p.000032:
001330 p.000032: 2.3 Medical research
001331 p.000032: The Adults with Incapacity (Scotland) Act (http://www.legislation.gov.uk/asp/2000/4/contents) states that any medical
001332 p.000032: research or treatment should benefit the individual and such benefit will not be reasonably achieved without the
001333 p.000032: intervention. The past and present wishes of the individual should be taken into account (by any methods of
001334 p.000032: communication), and consent should be obtained by the closest relative or person with relevant powers (egwelfare
001335 p.000032: attorney).
001336 p.000032:
001337 p.000032: What happens when research involves tissue samples (including blood)?
001338 p.000032: UK research involving human tissue (including blood) is subject to the Human Tissue Act 2004, or The Human Tissue
...

...
001801 p.000042: exchange and impact activities after the research has been published.
001802 p.000042:
001803 p.000043: 43
001804 p.000043:
001805 p.000043: Research Ethics Committee: A Research Ethics Committee (REC) is defined as a multidisciplinary, independent body
001806 p.000043: charged with reviewing research involving human participants to ensure that their dignity, rights and welfare are
001807 p.000043: protected. The independence of a REC is founded on its membership, on strict rules regarding conflict of interests, and
001808 p.000043: on regular monitoring of and accountability for its decisions.
001809 p.000043:
001810 p.000043: Research project lifecycle: includes the planning stage, the period of funding for the project and all activities that
...

General/Other / Cultural Differences
Searching for indicator cultural:

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000839 p.000020: developing and undertaking the research. Legal and ethical requirements for all the partner countries must be
ensured.
000840 p.000020:
000841 p.000020: There are several considerations here:
000842 p.000020:
000843 p.000020: • inequities in regard to access to research resources
000844 p.000020: • political and cultural considerations with regard to professional training and oversight; differingethics
000845 p.000020: traditions in research
000846 p.000020: • increased risk to researchers and participants where they are working remotely
000847 p.000021: 21
000848 p.000021:
...

...
001130 p.000027:
001131 p.000027: Is it legitimate to expose some research participants/organisations to risk?
001132 p.000027: This might arise for two reasons. First, as is recognised elsewhere (see Tri-Council of Canada, 2002
001133 p.000027: (http://www.pre.ethics.gc.ca/English/policystatement/introduction.cfm)) research may be ‘deliberately and
legitimately
001134 p.000027: opposed to the interests of the research participants or organisations’ in cases where the objectives of the
research
001135 p.000027: are to reveal and critique fundamental economic, political or cultural disadvantage or exploitation. Much social
001136 p.000027: science research has a critical role to play in exploring and questioning social, cultural and economic structures and
001137 p.000027: processes (for example relating to patterns of power and social inequality, and institutional dynamics and regimes that
001138 p.000027: disadvantage some social groups over others, intentionally or not). Such research results may have a negative impact
on
001139 p.000027: some of the research participants/organisations. Principles of justice should, however, mean that researchers would
001140 p.000027: seek to minimise any personal harm to individuals. Secondly, researchers should also consider how to balance the
...

Searching for indicator culture:

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000652 p.000016: requirements should fall within a RO’s own budget. However, it should be remembered that the additional costs
incurred
000653 p.000016: by the host RO in carrying out ethics review specifically for ESRC-funded research are eligible costs under the
000654 p.000016: arrangements for Research Councils to meet a proportion of the full economic costs of research.
000655 p.000016:
000656 p.000016: Successful implementation of the FRE relies in a large part on the degree to which individual ROs have built
000657 p.000016: appropriate structures and a culture that recognises the central place that engaging in ethical reflection occupies in
000658 p.000016: good research practice. Encouraging a mindset towards a robust ethics culture and provision of training plays a
central
000659 p.000016: role in this process. Such training should be ongoing and become an integral part of research practice, given the
000660 p.000016: changing ethics environment (see section 1.7)
000661 p.000016:
000662 p.000016: ROs should build a programme of support and provide resources to aid staff in understanding and implementing the
FRE,
...

...
000684 p.000016:
000685 p.000017: 17
000686 p.000017:
000687 p.000017: 1.5 ROs should establish procedures for monitoring research
000688 p.000017: ROs should establish and publish working practices and procedures for monitoring research which encourage a
grassroots
000689 p.000017: culture of robust collective governance.
000690 p.000017:
000691 p.000017: Where a study design is emergent, the REC should agree procedures for ongoing ethics review (for example through
a
000692 p.000017: Project Advisory Group) with the researchers. Where the study design is largely fixed in advance, procedures for
000693 p.000017: reporting to the REC or a designated sub-committee any unforeseen events that might challenge the ethics conduct of
the
...

...
000804 p.000019: (http://www.esrc.ac.uk/funding-and-guidance/postgraduates/esrc-students/index.aspx). These guidelines include
reference
000805 p.000019: to training in ethics and legal matters. ROs should ensure that training programmes they provide incorporate the range
000806 p.000019: of issues addressed in
000807 p.000020: 20
000808 p.000020:
000809 p.000020: the main framework document so that students embrace an ethics culture from the start of their research careers.
000810 p.000020: Doctoral Training Centres should detail the ethics training that they provide for their students.
000811 p.000020:
000812 p.000020: 1.9 Arrangements should be made for collaborative research
000813 p.000020: The FRE guidelines should be drawn to the attention of all proposed collaborators or project partners, providing
...

General/Other / Dependent
Searching for indicator dependent:

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000307 p.000007:
000308 p.000007: Research potentially requiring a full ethics review
000309 p.000007: Research involving:
000310 p.000007:
000311 p.000007: • Potentially vulnerable people, for example children and young people, those with a learning disability or
000312 p.000007: cognitive impairment, or potentially vulnerable individuals in a dependent or unequal relationship.
000313 p.000007:
000314 p.000007: • People who lack capacity to make decisions or who during the research project come to lackcapacity. Such
research
000315 p.000007: should be reviewed by an appropriate body operating under the Mental Capacity Act 2005
000316 p.000007:
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...
000345 p.000008:
000346 p.000008: • Individuals or groups where permission of a gatekeeper is normally required for initial or continued access to
000347 p.000008: participants. This includes research involving gatekeepers such as adult professionals (eg those working with children
000348 p.000008: or the elderly), or research in communities (in the UK or overseas) whereaccess to research participants is not
000349 p.000008: possible without the permission of another adult, such as another family member (eg the parent or husband of the
000350 p.000008: participant) or a community leader, and research where participants are in a dependent relationship with the
gatekeeper
000351 p.000008: (eg employees recruited through their workplace). Permission for access to other groups, for example participants in a
000352 p.000008: long term cohort study, may also need to be requested from a data producer who controls access to the group.
000353 p.000008:
000354 p.000008: • Justified deception or research conducted without participants’ valid and informed consent at the time the
study
...

...
001184 p.000028: involvement. Information should be provided in a form that is comprehensible and accessible to participants, typically
001185 p.000028: in written form (or in a form that participants can access after the end of the research interaction), and time should
001186 p.000028: be allowed for the participants to consider their choices and to discuss their decision with others if appropriate. The
001187 p.000028: consent forms should be signed off by the research participants to indicateconsent.
001188 p.000028:
001189 p.000028: Where participants are in a potentially vulnerable or dependent position (eg children) it is important to ensure that
001190 p.000028: they have the time and opportunity to access support in their decision-making, for example by discussing their choice
001191 p.000028: with a trusted adult. Where consent is sought from children it is normally good practice to secure permission from a
001192 p.000029: 29
001193 p.000029:
...

...
002112 p.000050: the workshops, to meet with relevant authorities and associations to develop appropriate workshop forums, and to
review
002113 p.000050: approaches to participation, confidentiality and dissemination. Feedback on workshop findings will be offered to local
002114 p.000050: authorities and associations through a summary report. More generally, participants will be able to view project
002115 p.000050: information and findings on the 'Superdiverse streets' online project pages.
002116 p.000050:
002117 p.000050: In sum, for all stages of research dependent on research participants, I will submit anEthics Review Questionnaire
for
002118 p.000050: Researchers to the LSE Research Ethics Committee, which operates in accordance with the ESRC ResearchEthics
Framework.
002119 p.000050:
002120 p.000050:
002121 p.000050:
...

General/Other / Diminished Autonomy
Searching for indicator age:

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000944 p.000023: Proxy consent
000945 p.000023: Proxy consent can be obtained by a person authorised to act on behalf of avulnerable person. Where proxy consent
for
000946 p.000023: research participants is necessary, the best interests of the vulnerable person should be of the highest importance.
000947 p.000023: Proxy consent should only be used when participants are unable toconsent themselves or where it is legally
necessary.
000948 p.000023: Care should be taken when consent cannot be sought from the participants, and it should not be assumed that
agreement
000949 p.000023: cannot be sought from children because of their age.
000950 p.000023: When proxy consent is used agreed criteria should be provided to confirm participants fully understands to what they
000951 p.000023: are participating, and criteria identifying signs of participants’ unwillingness to take part or wishing to terminate
000952 p.000023: the research interaction.
000953 p.000023:
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...
001488 p.000035: Yes No
001489 p.000035: Research that may need to be reviewed by NHS Research Ethics Committee or another external ethics committee (if
yes,
001490 p.000035: please give brief details as an annex)
001491 p.000035: Will the study involve recruitment of patients or staff through the NHS or the use of NHS data or premises and/or
001492 p.000035: equipment?
001493 p.000035: Does the study involve participants age 16 or over who are unable to give informedconsent? (eg people with learning
001494 p.000035: disabilities: see Mental Capacity Act 2005/ Adults with Incapacity (Scotland) Act 2000. All research that falls under
001495 p.000035: the auspices MCA/AWI should be reviewed by a recognised and appropriate REC operating under GAfREC or
Scotland ‘A’
001496 p.000035: REC).
001497 p.000035: Research that may need a full review
...

General/Other / Impaired Autonomy
Searching for indicator autonomy:

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...
000128 p.000003:
000129 p.000003: Our principles and expectations for ethical research
000130 p.000003: There are six key principles of ethical research that we expect to be addressed:
000131 p.000003:
000132 p.000003: • Research participants should take part voluntarily, free from any coercion or undue influence, and their rights,
000133 p.000003: dignity and (when possible) autonomy should be respected and appropriately protected.
000134 p.000003:
000135 p.000003: • Research should be worthwhile and provide value that outweighs any risk or harm. Researchers should aim to
000136 p.000003: maximise the benefit of the research and minimise potential risk of harm to participants and researchers. All potential
000137 p.000003: risk and harm should be mitigated by robust precautions.
...

...
000164 p.000003:
000165 p.000003: • ROs should have clear, transparent and effective procedures for ethics review and governance and appropriate
000166 p.000003: mechanisms for monitoring.
000167 p.000004: 4
000168 p.000004:
000169 p.000004: • Research should be designed in such a way that the dignity and (when possible) the autonomy of research
000170 p.000004: participants is respected and appropriately protected.
000171 p.000004:
000172 p.000004: • Ethics review should always be proportionate to the potentialrisk. Where possible, risks should be minimised; for
000173 p.000004: example, whether the research involves primary data collection or the re-use of existing data.
...

General/Other / Incapacitated
Searching for indicator incapacity:

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...
000317 p.000007: • (http://www.legislation.gov.uk/ukpga/2005/9/contents ). Normally this will be a REC recognised by the Secretary of
000318 p.000007: State and Welsh Ministers and operating under the Health Research Authority (HRA) Governance Arrangements for
Research
000319 p.000007: Ethics Committees (GAfREC) (http://www.hra.nhs.uk/resources/research-legislation-and-
000320 p.000007: governance/governance-arrangements-for-research-ethics- committees/#sthash.rH7OVRVy.dpuf). Research
conducted in
000321 p.000007: Scotland should be reviewed by the Scotland ‘A’ REC
(http://www.nhsresearchscotland.org.uk/226_Research+Ethics.html)
000322 p.000007: which is operating under The Adults with Incapacity (Scotland) Act 2000
000323 p.000008: 8
000324 p.000008:
000325 p.000008: (http://www.legislation.gov.uk/asp/2000/4/section/10).
000326 p.000008: • Potentially sensitive topics, for example participants’ sexual behaviour, illegal or political behaviour,
...

...
000885 p.000021: arrangements-for-research-ethics-committees/)apply to research involving research participants recruited through the
000886 p.000021: NHS or Social Care services, and such research should be reviewed by a recognised and appropriate REC (see
Appendix D).
000887 p.000022: 22
000888 p.000022:
000889 p.000022: In addition, research involving adults who come under the remit of the Mental Capacity Act 2005
000890 p.000022: (http://www.legislation.gov.uk/ukpga/2005/9/contents) or the Adults with Incapacity (Scotland) Act 2000
000891 p.000022: (http://www.legislation.gov.uk/asp/2000/4/contents) requires review by a recognised and appropriate REC operating
under
000892 p.000022: the GAfREC (http://www.hra.nhs.uk/resources/research-legislation-and-governance/governance-
000893 p.000022: arrangements-for-research-ethics-committees/) or Scotland ‘A’ REC. For a full list of the research which
requires
000894 p.000022: HRA/NRES REC approval see the HRA approval decision tool (http://www.hra-decisiontools.org.uk/ethics/). The HRA
and NHS
000895 p.000022: Scotland research ethics service (http://www.nhsresearchscotland.org.uk/226_Research+Ethics.html) also provide
guidance
000896 p.000022: on the scope of the research provisions under the Mental Capacity Act 2005
000897 p.000022: (http://www.hra.nhs.uk/resources/research-legislation-and-governance/questions-and- answers-mental-capacity-act-
2005/)
000898 p.000022: and Adults with Incapacity (Scotland) Act 2000 (http://www.legislation.gov.uk/asp/2000/4/contents).
000899 p.000022:
000900 p.000022: 1.11 Legal and data protection requirements should be met
000901 p.000022: Data requirements
000902 p.000022: ROs should ensure that appropriate practical arrangements are in place to maintain the integrity and security of
...

...
001107 p.000026: able to use reasoned judgment to decide whether or not they wish to participate. There is also therefore the need to
001108 p.000026: ensure that potential participants have the capacity to understand the consequences (and risks) of
001109 p.000027: 27
001110 p.000027:
001111 p.000027: participating in order to give valid consent. ‘Capacity’ is legally defined under the terms of the MentalCapacity
Act
001112 p.000027: 2005 and the Adults with Incapacity (Scotland) Act 2000, and any projects that involve participants who fall under
001113 p.000027: these Acts must be reviewed by a ‘recognised’ REC operating under the GAfREC
(http://www.ukbiobank.ac.uk/ethics/) or
001114 p.000027: Scotland ‘A’ REC. The Mental Capacity Act 2005 applies to 16-17 year olds and adults (18 years and over)
who lack
001115 p.000027: capacity to make decisions because of an impairment, mental disorder or ‘disturbance in the functioning of the
mind and
001116 p.000027: brain’. Guidance on the Mental Capacity Act notes that lack of capacity to make a decision may be permanent or
001117 p.000027: temporary. It could be state-related (eg due to drug or alcohol use, or because of the person’s emotional state at
the
001118 p.000027: time). ‘Intrusive’ research involving people without capacity to consent should comply with the specific
provisions for
001119 p.000027: research (Sections 30-33 of the Mental Capacity Act 2005) in order to be lawful. Intrusive procedures are defined as
001120 p.000027: the ones requiring consent in law, including the use of personal information. Code of Practice under the Adults with
001121 p.000027: Incapacity Act clarifies that ‘an adult does not have impaired capacity simply by virtue of having an addiction,
001122 p.000027: psychotic illness or learning difficulties and disabilities’ (p.6). The Scottish Act states that the wishes of the
001123 p.000027: individual should be taken into account and any intervention should benefit the individual (Section 51 of the Adults
001124 p.000027: with Incapacity (Scotland) Act 2000). The key point for both Acts is that valid consent can only be secured if the
001125 p.000027: participant has capacity to make a decision at the timeconsent is sought. (see Department of Health, Mental
Capacity
001126 p.000027: Act 2005 and consent for research
001127 p.000027: (http://www.wales.gov.uk/dhss/publications/health/mentalhealth/mentalcapacityact/2117019
001128 p.000027: /mcaconsente.pdf?lang=en) and Adults with Incapacity Act 2000- Code of Practice, Part 5
001129 p.000027: (http://www.scotland.gov.uk/Publications/2010/10/20153801/4)).
001130 p.000027:
001131 p.000027: Is it legitimate to expose some research participants/organisations to risk?
001132 p.000027: This might arise for two reasons. First, as is recognised elsewhere (see Tri-Council of Canada, 2002
...

...
001282 p.000031: gatekeepers where necessary to undertake the research, for example from the relevant public sector organisation to
001283 p.000031: undertake research on public sector property.
001284 p.000031:
001285 p.000031: How do you obtain consent from potentially vulnerable people?
001286 p.000031: In cases where research involves potentially vulnerable groups, for example children, older persons or adults with
001287 p.000031: learning disabilities (for those who fall under the remit of the Mental Capacity Act 2005/ Adults with Incapacity
001288 p.000031: (Scotland) Act 2000 see below), every effort should be made to secure actively given informed consent from individual
001289 p.000031: participants. Passive assent, including group assent (with consent given by a gatekeeper) should be avoided wherever
001290 p.000031: possible, and every effort should be made to develop methods of seeking consent that are appropriate to the groups
001291 p.000031: being studied, using expert advice, support and training where necessary.
...

...
001295 p.000031: legal equivalent). Researchers should consider whether mature children can confirm consent without adult approval,
for
001296 p.000031: example there may be circumstances where seeking consent from parents could jeopardise the research (for
example, in
001297 p.000031: research into teenage sexuality or alcohol use). In such circumstances, researchers will need to regard the potential
001298 p.000031: risk to the principal participants of the research as a priority.
001299 p.000031:
001300 p.000031: How do you obtain consent from participants who fall under the MentalCapacity Act 2005/ Adults with Incapacity
001301 p.000031: (Scotland) Act 2000?
001302 p.000031: In the case of research with adults who lack capacity to make a decision under the terms of the MentalCapacity Act
001303 p.000031: 2005 (http://www.legislation.gov.uk/ukpga/2005/9/contents) and Adults with Incapacity (Scotland) Act 2000
001304 p.000031: (http://www.legislation.gov.uk/asp/2000/4/contents), these projects must be reviewed by a ‘recognised’ REC or
Scotland
001305 p.000031: ‘A’ REC (Code of practice Mental Capacity Act 2005
(www.opsi.gov.uk/acts/acts2005/related/ukpgacop_20050009_en.pdf) and
001306 p.000031: Adults with Incapacity (Scotland) Act 2000 (http://www.scotland.gov.uk/Publications/2010/10/20153801/0)).
001307 p.000031:
001308 p.000031: The Mental Capacity Act states that researchers should assume that a person has capacity to make a decision;
unless
001309 p.000031: there is proof that they do not have capacity to make a specific decision, and that a potential participant must
001310 p.000031: receive support to try to help them make their own decision. The potential participant has the right to disagree with
...

...
001326 p.000032: someone from a relevant organisation (such as a local church or charity); but they could also be a professional care
001327 p.000032: worker (and thus could not be a personal consultee), such as the person’s GP, social worker or carer, providing
they
001328 p.000032: have no connection with the research project.
001329 p.000032:
001330 p.000032: 2.3 Medical research
001331 p.000032: The Adults with Incapacity (Scotland) Act (http://www.legislation.gov.uk/asp/2000/4/contents) states that any medical
001332 p.000032: research or treatment should benefit the individual and such benefit will not be reasonably achieved without the
001333 p.000032: intervention. The past and present wishes of the individual should be taken into account (by any methods of
001334 p.000032: communication), and consent should be obtained by the closest relative or person with relevant powers (egwelfare
001335 p.000032: attorney).
...

...
001489 p.000035: Research that may need to be reviewed by NHS Research Ethics Committee or another external ethics committee (if
yes,
001490 p.000035: please give brief details as an annex)
001491 p.000035: Will the study involve recruitment of patients or staff through the NHS or the use of NHS data or premises and/or
001492 p.000035: equipment?
001493 p.000035: Does the study involve participants age 16 or over who are unable to give informedconsent? (eg people with learning
001494 p.000035: disabilities: see Mental Capacity Act 2005/ Adults with Incapacity (Scotland) Act 2000. All research that falls under
001495 p.000035: the auspices MCA/AWI should be reviewed by a recognised and appropriate REC operating under GAfREC or
Scotland ‘A’
001496 p.000035: REC).
001497 p.000035: Research that may need a full review
001498 p.000035: Does the research involve other potentially vulnerable groups: children, those with cognitive impairment, or those in
...

...
001653 p.000039: review by department REC
001654 p.000039:
001655 p.000039:
001656 p.000039:
001657 p.000039: Does the research involve NHS patients, records, equipment, premises or vulnerable people under the Mental
Capacity Act
001658 p.000039: 2005 and Adults with Incapacity (Scotland) Act 2000?
001659 p.000039:
001660 p.000039:
001661 p.000039:
001662 p.000039:
...

...
001816 p.000043: research), this is especially important.
001817 p.000043:
001818 p.000043: Valid consent: Consent is valid if it meets three conditions: participant has capacity to make a decision; the process
001819 p.000043: is free from coercion; and the consent is informed. For consent to be ‘valid’ the participant must be capable of
001820 p.000043: understanding all the potential risks involved. Where this may be in doubt, the Mental Capacity Act 2005 and Adults
001821 p.000043: with Incapacity (Scotland) Act 2000 may apply (see Appendix D).
001822 p.000043:
001823 p.000043:
001824 p.000043:
001825 p.000043:
...
...
001974 p.000047: https://www.gov.uk/government/publications/mental-capacity-act-code-of-practice
001975 p.000047: • HRA Mental Capacity Act 2005-Questions and Answers
001976 p.000047: www.hra.nhs.uk/resources/research-legislation-and-governance/questions-and-answers- mental-capacity-act-2005/
001977 p.000047: • Department of Health Mental Capacity Act and consent for research
001978 p.000047: http://wales.gov.uk/dhss/publications/health/mentalhealth/mentalcapacityact/2117019/m caconsente.pdf?lang=en
001979 p.000047: • Adults with Incapacity (Scotland) Act 2000 www.legislation.gov.uk/asp/2000/4/section/10
001980 p.000047: • Adults with Incapacity Act 2000: Code of practice (2010) For practitioners authorised to carry out medical
001981 p.000047: treatment or research under Part 5 of the Act www.scotland.gov.uk/Publications/2010/10/20153801/0
001982 p.000047: • Adults with Incapacity (Ethics Committee) Scotland Regulations 2002
001983 p.000047: www.legislation.gov.uk/ssi/2002/190/contents/made
001984 p.000047: • Rehabilitation of Offenders Act 1974 www.legislation.gov.uk/ukpga/1974/53
001985 p.000047: • Rehabilitation of Offenders Act 1974 (Exceptions Order 1975)
www.legislation.gov.uk/uksi/2013/1198/contents/made
001986 p.000047: • The Rehabilitation of Offenders Act 1974 (Exceptions) Order 1975 (Amendment) (England and Wales) Order 2013.
...

General/Other / Laboratory Staff
Searching for indicator usage:

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...
001704 p.000040: framework is ethics review of each specific research project by an independentethics committee as well as strategies
001705 p.000040: to update regularly the biobank donor and ongoing withdrawal opportunities. If anything in the framework changes, the
001706 p.000040: participant should re-consent.
001707 p.000040:
001708 p.000040: Controlled data: are data which may be identifiable and thus potentially disclosive but to which access may be granted
001709 p.000040: to users who have been accredited and their data usage has been approved by a relevant Data Access Committee.
Data
001710 p.000040: service providers may provide details of their policies regarding access to controlled data, for example the UK Data
001711 p.000040: Service (http://ukdataservice.ac.uk/get-data/data-access-policy/controlled-data.aspx).
001712 p.000040:
001713 p.000040: Data Custodian (Data Controller): is a person who determines the purposes for which and manner in which any
personal
...

General/Other / Presence of Coercion
Searching for indicator coercion:

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...
000127 p.000003: 3
000128 p.000003:
000129 p.000003: Our principles and expectations for ethical research
000130 p.000003: There are six key principles of ethical research that we expect to be addressed:
000131 p.000003:
000132 p.000003: • Research participants should take part voluntarily, free from any coercion or undue influence, and their rights,
000133 p.000003: dignity and (when possible) autonomy should be respected and appropriately protected.
000134 p.000003:
000135 p.000003: • Research should be worthwhile and provide value that outweighs any risk or harm. Researchers should aim to
000136 p.000003: maximise the benefit of the research and minimise potential risk of harm to participants and researchers. All potential
...

...
001178 p.000028: should be particularly careful in publishing and using information about third parties.
001179 p.000028:
001180 p.000028: 2.2 Consent
001181 p.000028: What is informed consent?
001182 p.000028: Informed consent entails giving sufficient information about the research and ensuring that there is no explicit or
001183 p.000028: implicit coercion (see below) so that prospective participants can make an informed and free decision on their possible
001184 p.000028: involvement. Information should be provided in a form that is comprehensible and accessible to participants, typically
001185 p.000028: in written form (or in a form that participants can access after the end of the research interaction), and time should
001186 p.000028: be allowed for the participants to consider their choices and to discuss their decision with others if appropriate. The
001187 p.000028: consent forms should be signed off by the research participants to indicateconsent.
...

...
001209 p.000029:
001210 p.000029: In some areas of research, particularly in facilitating biobank research, participants are asked to provide broad
001211 p.000029: consent. This approach means that participants consent to a framework for future research of certain types, not just to
001212 p.000029: consent for a particular project.
001213 p.000029:
001214 p.000029: What does it mean that research participants should participate voluntarily, free from any coercion?
001215 p.000029: In all cases of research, researchers should inform participants of their right to refuse to participate or withdraw
001216 p.000029: from the investigation whenever and for whatever reason they wish. There should be no coercion or undue influence
of
001217 p.000029: research participants to take part in the research.
001218 p.000029:
001219 p.000029: Research participants, however, may be given small monetary reimbursement for their time and expenses involved.
Payment
001220 p.000029: should not override the principles of freely given and fully informed consent. Participants should know before they
...

...
001226 p.000029: money. If you are planning to use this approach the Market Research Society
001227 p.000029: (https://www.mrs.org.uk/standards/downloads/2008-01-
001228 p.000029: 18%20Incentives%20and%20Free%20Prize%20Draws.pdf?SESSID=hbt5j57mhnb2vrs0pfsrs2 hma0) has published
useful guidelines on
001229 p.000029: using free prize draws. Where children are involved, it is often appropriate to acknowledge their help with personal
001230 p.000029: gifts, for example gift vouchers or gifts to participating schools. Incentives may be permissible, but anything which
001231 p.000029: implies coercion is not.
001232 p.000029:
001233 p.000029:
001234 p.000030: 30
001235 p.000030:
...

...
001753 p.000041: died (cadavers, human remains and body parts), embryos and fetuses, human tissue and bodily fluids, and human
data and
001754 p.000041: records (such as, but not restricted to medical, genetic, financial, personnel, criminal or administrative records and
001755 p.000041: test results including scholastic achievements).
001756 p.000041:
001757 p.000041: Freely-given informed consent: Informed consent entails giving sufficient information about the research and ensuring
001758 p.000041: that there is no explicit or implicit coercion so that prospective participants can make an informed and free decision
001759 p.000041: on their possible involvement. Typically, the information should be provided in written form, time should be allowed
001760 p.000041: for the participants to consider their choices and the forms should be signed off by the research participants to
001761 p.000041: indicate consent. Where participants are not literate, verbal consent may be obtained but this should wherever
possible
001762 p.000041: be witnessed and
...

...
001814 p.000043: Transparency in research ethics: The full, accurate, and open disclosure of relevant information is always important.
001815 p.000043: Where the research involves new and innovative methodologies which raise distinctive considerations (eg online
001816 p.000043: research), this is especially important.
001817 p.000043:
001818 p.000043: Valid consent: Consent is valid if it meets three conditions: participant has capacity to make a decision; the process
001819 p.000043: is free from coercion; and the consent is informed. For consent to be ‘valid’ the participant must be capable of
001820 p.000043: understanding all the potential risks involved. Where this may be in doubt, the Mental Capacity Act 2005 and Adults
001821 p.000043: with Incapacity (Scotland) Act 2000 may apply (see Appendix D).
001822 p.000043:
001823 p.000043:
...

General/Other / Relationship to Authority
Searching for indicator authority:

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...
000267 p.000006:
000268 p.000006: RO policies and procedures for light-touch, expedited and full review should include a clear statement that addresses
000269 p.000006: the following issues:
000270 p.000006:
000271 p.000006: • criteria for identifying research that involves more than minimal risks (see example descriptions below)
000272 p.000006: • the system of review for such research, including the scope of the authority of those to whom responsibility for
000273 p.000006: review has been ‘delegated’
000274 p.000006: • forms and procedures for submitting applications for light-touch, expedited and full review
000275 p.000006: • procedures for reporting decisions to the principal REC
000276 p.000006: • procedures for periodic ad-hoc audit (of light-touch, full and expedited reviews by the principal REC)
...

...
000313 p.000007:
000314 p.000007: • People who lack capacity to make decisions or who during the research project come to lackcapacity. Such
research
000315 p.000007: should be reviewed by an appropriate body operating under the Mental Capacity Act 2005
000316 p.000007:
000317 p.000007: • (http://www.legislation.gov.uk/ukpga/2005/9/contents ). Normally this will be a REC recognised by the Secretary of
000318 p.000007: State and Welsh Ministers and operating under the Health Research Authority (HRA) Governance Arrangements for
Research
000319 p.000007: Ethics Committees (GAfREC) (http://www.hra.nhs.uk/resources/research-legislation-and-
000320 p.000007: governance/governance-arrangements-for-research-ethics- committees/#sthash.rH7OVRVy.dpuf). Research
conducted in
000321 p.000007: Scotland should be reviewed by the Scotland ‘A’ REC
(http://www.nhsresearchscotland.org.uk/226_Research+Ethics.html)
000322 p.000007: which is operating under The Adults with Incapacity (Scotland) Act 2000
...

...
000490 p.000012: applications per se. Wherever they are located, RECs should meet the requirements of this FRE, even at department
level
000491 p.000012: if this is where the decision to review a project is to be taken. If checklists are used to identify the type of review
000492 p.000012: required, the checklists may, if necessary, be overseen by an independent review body at faculty, school or department
000493 p.000012: level.
000494 p.000012:
000495 p.000012: The authority of a REC should be delegated through the RO’s usual governance mechanisms. It should report to
the
000496 p.000012: appropriate RO authority. In defining a REC’s mandate and authority, the organisation should make clear the
000497 p.000012: jurisdiction of a REC and its relationship to other relevant bodies or authorities both within and outside the RO.
000498 p.000012:
000499 p.000012: ROs are expected to monitor the operation of RECs for which they are responsible and the decisions they take in
000500 p.000012: relation to social science proposals, according to the standards and guidelines set out here.
...

...
000531 p.000013: Remit and responsibilities of Research Ethics Committees
000532 p.000013: RECs should provide supportive, reflexive governance to researchers and operate a system of ongoing monitoring and
000533 p.000013: supportive reflection that promotes mutual learning for researchers and REC members. RECs are responsible for
reviewing
000534 p.000013: all research involving human participants and personal data conducted under their auspices and undertaken by
000535 p.000013: individuals employed by the organisation that does not come under the remit of the UK Health Departments and
Health
000536 p.000013: Research Authority (http://www.hra.nhs.uk/). RECs should review research proposals in a way that is independent,
000537 p.000013: competent and timely. In some circumstances RECs may authorise other sub-committees or their chair to conduct
reviews
000538 p.000013: on research involving minimal risk on their behalf. These sub-committees and chair will have no conflicts of interest
000539 p.000013: with the project and will be accountable to the REC and through it to the appropriate organisational authorities for
000540 p.000013: the decisions they make.
...

...
001334 p.000032: communication), and consent should be obtained by the closest relative or person with relevant powers (egwelfare
001335 p.000032: attorney).
001336 p.000032:
001337 p.000032: What happens when research involves tissue samples (including blood)?
001338 p.000032: UK research involving human tissue (including blood) is subject to the Human Tissue Act 2004, or The Human Tissue
001339 p.000032: (Scotland) Act 2006, and should adhere to the Codes of Practice issued by the Human Tissue Authority. Ethics
review
001340 p.000032: should be obtained from a REC operating to the standards set out in the governance arrangements issued by the UK
Health
001341 p.000032: Departments or other ethics committees for clinical trials of investigational medicinal products recognised by the
001342 p.000032: United Kingdom Ethics Committee Authority (UKECA).
001343 p.000032:
001344 p.000032: Where research involves the need to secure tissue samples (including blood), participants should be informed of their
001345 p.000032: rights over such samples and data derived from them, especially whether they have or do not have the right to retrieve
001346 p.000032: such samples.
...

...
001890 p.000045: • Department for Business, Innovation and Skills– Universal ethical code for scientists (2007)
001891 p.000045: www.gov.uk/government/publications/universal-ethical-code-for-scientists
001892 p.000045: • Ethical Research Involving Children (ERIC) www.childethics.com/
001893 p.000045: • European Science Foundation (2011). European code of Conduct for Research Integrity
001894 p.000045: www.esf.org/fileadmin/Public_documents/Publications/Code_Conduct_ResearchIntegri ty.pdf
001895 p.000045: • Human Tissue Authority (2014). Code of Practice
www.hta.gov.uk/policiesandcodesofpractice/codesofpractice.cfm
001896 p.000045: • International Visual Sociology Association (2009). Code of Research Ethics and Guidelines
001897 p.000045: http://visualsociology.org/about/ethics-and-guidelines.html
001898 p.000045: • Market Research Society (2014). Code of Conduct https://www.mrs.org.uk/standards/code_of_conduct/
001899 p.000045: • Nuffield Council on Bioethics (2009). Dementia: Ethical Issues
...

...
001906 p.000045: www.ucea.ac.uk/en/publications/index.cfm/guidance-on-health-and-safety- in-fieldwork
001907 p.000045: • University of Durham and National Co-ordinating Centre for Public Engagement (NCCP) (2012) Community-based
001908 p.000045: participatory research. A guide to ethical principles and practice.
001909 p.000045: https://www.dur.ac.uk/resources/beacon/CBPREthicsGuidewebNovember20121.pdf
001910 p.000045:
001911 p.000045: Health research authority and NHS Research
001912 p.000045: • Health Research Authority (HRA) www.hra.nhs.uk/
001913 p.000045: • HRA guidance for applicants and research community www.hra.nhs.uk/research- community/
001914 p.000045: • HRA decision tool (MRC/HRA): www.hra-decisiontools.org.uk/ethics
001915 p.000045: • HRA Application process Flowchart www.hra.nhs.uk/documents/2014/05/rec-
001916 p.000045: application-process-flowchart-v6-0-19-may-2014.pdf
...

...
001925 p.000046: membership/12-11-13-framework-complete.pdf
001926 p.000046: • Department of Health (2011). Governance arrangements for research ethics committees: a harmonised edition
(updated
001927 p.000046: April 2012) www.gov.uk/government/publications/health-research-ethics-committees-governance- arrangements
001928 p.000046: • UK Health Departments, Research Governance Frameworks
001929 p.000046: www.hra.nhs.uk/resources/research-legislation-and-governance/research-governance- frameworks/
001930 p.000046: • Health Research Authority, Standard Operating Procedures for Research Ethics Committees (2015)
001931 p.000046: http://www.hra.nhs.uk/resources/research-legislation-and- governance/standard-operating-procedures/
001932 p.000046: • The Ministry of Defense Research Ethics Committees (MODREC)
www.science.mod.uk/engagement/modrec/modrec.aspx
001933 p.000046: • Social Care Research Ethics Committee www.screc.org.uk
001934 p.000046: • Wellcome Trust Biobank Ethics and Governance Framework
...

...
002078 p.000049: Ethical Considerations
002079 p.000049: This research project will be conducted with full compliance of research ethics norms, and more specifically the codes
002080 p.000049: and practices established in the British Sociological Association's Statement of Ethical Practice and the LSE Research
002081 p.000049: Ethics Policy. The research will involve human participants, commencing with a face-to-face/ door-to-door survey of
the
002082 p.000049: proprietors of each of the streets. In the second year of study, focus group workshops will be held with local
002083 p.000049: authority officers and members, and trade associations and relevant local organisations associated with each street.
As
002084 p.000049: principal investigator I will take core responsibility to explain, in appropriate detail, what the research is about to
002085 p.000049: participants. Every research participant will be given a one-page 'project information sheet' that outlines the purpose
002086 p.000049: of the study, who is undertaking and financing the study, and
002087 p.000050: 50
...

General/Other / Undue Influence
Searching for indicator undue influence:

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...
000127 p.000003: 3
000128 p.000003:
000129 p.000003: Our principles and expectations for ethical research
000130 p.000003: There are six key principles of ethical research that we expect to be addressed:
000131 p.000003:
000132 p.000003: • Research participants should take part voluntarily, free from any coercion or undue influence, and their rights,
000133 p.000003: dignity and (when possible) autonomy should be respected and appropriately protected.
000134 p.000003:
000135 p.000003: • Research should be worthwhile and provide value that outweighs any risk or harm. Researchers should aim to
000136 p.000003: maximise the benefit of the research and minimise potential risk of harm to participants and researchers. All potential
...

...
000499 p.000012: ROs are expected to monitor the operation of RECs for which they are responsible and the decisions they take in
000500 p.000012: relation to social science proposals, according to the standards and guidelines set out here.
000501 p.000012:
000502 p.000012: Independence of Research Ethics Committees
000503 p.000012: ROs are responsible for ensuring that the RECs within their organisation act independently. They should be free from
000504 p.000012: bias and undue influence from the RO in which they are located, from the researchers whose proposals they consider
and
000505 p.000012: from the personal or financial interests of their members. The independence of a REC is founded on their membership,
on
000506 p.000012: strict rules regarding conflict of interests and on regular monitoring of and accountability for their decisions.
000507 p.000012:
000508 p.000012: Composition of Research Ethics Committees
...

...
001211 p.000029: consent. This approach means that participants consent to a framework for future research of certain types, not just to
001212 p.000029: consent for a particular project.
001213 p.000029:
001214 p.000029: What does it mean that research participants should participate voluntarily, free from any coercion?
001215 p.000029: In all cases of research, researchers should inform participants of their right to refuse to participate or withdraw
001216 p.000029: from the investigation whenever and for whatever reason they wish. There should be no coercion or undue influence
of
001217 p.000029: research participants to take part in the research.
001218 p.000029:
001219 p.000029: Research participants, however, may be given small monetary reimbursement for their time and expenses involved.
Payment
001220 p.000029: should not override the principles of freely given and fully informed consent. Participants should know before they
...

Health / Cadavers
Searching for indicator cadavers:

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...
001748 p.000041: Expedited review: In exceptional circumstances, it may be necessary for a proposal involving possible risk of harm to
001749 p.000041: receive a full review at short notice. An expedited review is carried out by one or more members of a Research Ethics
001750 p.000041: Committee (REC), commonly its chair, and not by a member of the department due to carry out the research.
001751 p.000041:
001752 p.000041: Human participants: Human participants are defined as including living human beings, human beings who have
recently
001753 p.000041: died (cadavers, human remains and body parts), embryos and fetuses, human tissue and bodily fluids, and human
data and
001754 p.000041: records (such as, but not restricted to medical, genetic, financial, personnel, criminal or administrative records and
001755 p.000041: test results including scholastic achievements).
001756 p.000041:
001757 p.000041: Freely-given informed consent: Informed consent entails giving sufficient information about the research and ensuring
...

Health / Cognitive Impairment
Searching for indicator cognitive:

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...
000307 p.000007:
000308 p.000007: Research potentially requiring a full ethics review
000309 p.000007: Research involving:
000310 p.000007:
000311 p.000007: • Potentially vulnerable people, for example children and young people, those with a learning disability or
000312 p.000007: cognitive impairment, or potentially vulnerable individuals in a dependent or unequal relationship.
000313 p.000007:
000314 p.000007: • People who lack capacity to make decisions or who during the research project come to lackcapacity. Such
research
000315 p.000007: should be reviewed by an appropriate body operating under the Mental Capacity Act 2005
000316 p.000007:
...

...
001493 p.000035: Does the study involve participants age 16 or over who are unable to give informedconsent? (eg people with learning
001494 p.000035: disabilities: see Mental Capacity Act 2005/ Adults with Incapacity (Scotland) Act 2000. All research that falls under
001495 p.000035: the auspices MCA/AWI should be reviewed by a recognised and appropriate REC operating under GAfREC or
Scotland ‘A’
001496 p.000035: REC).
001497 p.000035: Research that may need a full review
001498 p.000035: Does the research involve other potentially vulnerable groups: children, those with cognitive impairment, or those in
001499 p.000035: unequal relationships? (eg your own students)
001500 p.000035: Will the study require the co-operation of a gatekeeper for initial
001501 p.000036: 36
001502 p.000036:
...

Searching for indicator cognitive impairment:

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...
000307 p.000007:
000308 p.000007: Research potentially requiring a full ethics review
000309 p.000007: Research involving:
000310 p.000007:
000311 p.000007: • Potentially vulnerable people, for example children and young people, those with a learning disability or
000312 p.000007: cognitive impairment, or potentially vulnerable individuals in a dependent or unequal relationship.
000313 p.000007:
000314 p.000007: • People who lack capacity to make decisions or who during the research project come to lackcapacity. Such
research
000315 p.000007: should be reviewed by an appropriate body operating under the Mental Capacity Act 2005
000316 p.000007:
...

...
001493 p.000035: Does the study involve participants age 16 or over who are unable to give informedconsent? (eg people with learning
001494 p.000035: disabilities: see Mental Capacity Act 2005/ Adults with Incapacity (Scotland) Act 2000. All research that falls under
001495 p.000035: the auspices MCA/AWI should be reviewed by a recognised and appropriate REC operating under GAfREC or
Scotland ‘A’
001496 p.000035: REC).
001497 p.000035: Research that may need a full review
001498 p.000035: Does the research involve other potentially vulnerable groups: children, those with cognitive impairment, or those in
001499 p.000035: unequal relationships? (eg your own students)
001500 p.000035: Will the study require the co-operation of a gatekeeper for initial
001501 p.000036: 36
001502 p.000036:
...

Searching for indicator impaired:

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...
001116 p.000027: brain’. Guidance on the Mental Capacity Act notes that lack of capacity to make a decision may be permanent or
001117 p.000027: temporary. It could be state-related (eg due to drug or alcohol use, or because of the person’s emotional state at
the
001118 p.000027: time). ‘Intrusive’ research involving people without capacity to consent should comply with the specific
provisions for
001119 p.000027: research (Sections 30-33 of the Mental Capacity Act 2005) in order to be lawful. Intrusive procedures are defined as
001120 p.000027: the ones requiring consent in law, including the use of personal information. Code of Practice under the Adults with
001121 p.000027: Incapacity Act clarifies that ‘an adult does not have impaired capacity simply by virtue of having an addiction,
001122 p.000027: psychotic illness or learning difficulties and disabilities’ (p.6). The Scottish Act states that the wishes of the
001123 p.000027: individual should be taken into account and any intervention should benefit the individual (Section 51 of the Adults
001124 p.000027: with Incapacity (Scotland) Act 2000). The key point for both Acts is that valid consent can only be secured if the
001125 p.000027: participant has capacity to make a decision at the timeconsent is sought. (see Department of Health, Mental
Capacity
...

Searching for indicator impairment:

(return to top)
...
000307 p.000007:
000308 p.000007: Research potentially requiring a full ethics review
000309 p.000007: Research involving:
000310 p.000007:
000311 p.000007: • Potentially vulnerable people, for example children and young people, those with a learning disability or
000312 p.000007: cognitive impairment, or potentially vulnerable individuals in a dependent or unequal relationship.
000313 p.000007:
000314 p.000007: • People who lack capacity to make decisions or who during the research project come to lackcapacity. Such
research
000315 p.000007: should be reviewed by an appropriate body operating under the Mental Capacity Act 2005
000316 p.000007:
...

...
001110 p.000027:
001111 p.000027: participating in order to give valid consent. ‘Capacity’ is legally defined under the terms of the MentalCapacity
Act
001112 p.000027: 2005 and the Adults with Incapacity (Scotland) Act 2000, and any projects that involve participants who fall under
001113 p.000027: these Acts must be reviewed by a ‘recognised’ REC operating under the GAfREC
(http://www.ukbiobank.ac.uk/ethics/) or
001114 p.000027: Scotland ‘A’ REC. The Mental Capacity Act 2005 applies to 16-17 year olds and adults (18 years and over)
who lack
001115 p.000027: capacity to make decisions because of an impairment, mental disorder or ‘disturbance in the functioning of the
mind and
001116 p.000027: brain’. Guidance on the Mental Capacity Act notes that lack of capacity to make a decision may be permanent or
001117 p.000027: temporary. It could be state-related (eg due to drug or alcohol use, or because of the person’s emotional state at
the
001118 p.000027: time). ‘Intrusive’ research involving people without capacity to consent should comply with the specific
provisions for
001119 p.000027: research (Sections 30-33 of the Mental Capacity Act 2005) in order to be lawful. Intrusive procedures are defined as
...

...
001493 p.000035: Does the study involve participants age 16 or over who are unable to give informedconsent? (eg people with learning
001494 p.000035: disabilities: see Mental Capacity Act 2005/ Adults with Incapacity (Scotland) Act 2000. All research that falls under
001495 p.000035: the auspices MCA/AWI should be reviewed by a recognised and appropriate REC operating under GAfREC or
Scotland ‘A’
001496 p.000035: REC).
001497 p.000035: Research that may need a full review
001498 p.000035: Does the research involve other potentially vulnerable groups: children, those with cognitive impairment, or those in
001499 p.000035: unequal relationships? (eg your own students)
001500 p.000035: Will the study require the co-operation of a gatekeeper for initial
001501 p.000036: 36
001502 p.000036:
...

Health / Drug Dependence
Searching for indicator dependence:

(return to top)
...
000294 p.000007: a short lead time and are commissioned in response to a demand of pressing importance. Most RECs only permit
expedited
000295 p.000007: review in exceptional and clearly justified cases. Such exceptions may include external drivers which are beyond the
000296 p.000007: control of the researchers (eg access to a sample) which mean that ethics clearance is required within a short
000297 p.000007: timescale, or when perhaps fieldwork is linked to a particular event or period that is outside the researcher’s
000298 p.000007: control. An expedited review should meet the criteria required for a full review and should not be carried out by REC
000299 p.000007: members who are in a position of dependence with the applicant which could be perceived as a conflict of interest.
000300 p.000007:
000301 p.000007: It is the responsibility of the researcher or research team, guided by standards set by their professional societies,
000302 p.000007: disciplinary bodies and ROs to determine whether their project should be subject to a light-touch or full review.
000303 p.000007: However, the REC is expected to ensure that the appropriate ethics review is undertaken. The following section
provides
...

Health / Drug Usage
Searching for indicator drug:

(return to top)
...
001112 p.000027: 2005 and the Adults with Incapacity (Scotland) Act 2000, and any projects that involve participants who fall under
001113 p.000027: these Acts must be reviewed by a ‘recognised’ REC operating under the GAfREC
(http://www.ukbiobank.ac.uk/ethics/) or
001114 p.000027: Scotland ‘A’ REC. The Mental Capacity Act 2005 applies to 16-17 year olds and adults (18 years and over)
who lack
001115 p.000027: capacity to make decisions because of an impairment, mental disorder or ‘disturbance in the functioning of the
mind and
001116 p.000027: brain’. Guidance on the Mental Capacity Act notes that lack of capacity to make a decision may be permanent or
001117 p.000027: temporary. It could be state-related (eg due to drug or alcohol use, or because of the person’s emotional state at
the
001118 p.000027: time). ‘Intrusive’ research involving people without capacity to consent should comply with the specific
provisions for
001119 p.000027: research (Sections 30-33 of the Mental Capacity Act 2005) in order to be lawful. Intrusive procedures are defined as
001120 p.000027: the ones requiring consent in law, including the use of personal information. Code of Practice under the Adults with
001121 p.000027: Incapacity Act clarifies that ‘an adult does not have impaired capacity simply by virtue of having an addiction,
...

...
001502 p.000036:
001503 p.000036: access to the groups or individuals to be recruited? (eg employees, students at school, members of self- help group,
001504 p.000036: residents of nursing home?)
001505 p.000036: Will it be necessary for participants to take part in the study without their knowledge and consent at the time? (eg
001506 p.000036: covert observation of people in non- public places, use of deception in experimental studies)
001507 p.000036: Will the study involve discussion of sensitive or potentially sensitive topics? (eg sexual activity, drug use, personal
001508 p.000036: lives)
001509 p.000036: Are drugs, placebos or other substances (eg food substances, vitamins) to be administered to the study participants,
or
001510 p.000036: will the study involve invasive, intrusive or potentially harmful procedures of any kind?
001511 p.000036: Will tissue samples (including blood or saliva) be obtained from participants?
...

Searching for indicator influence:

(return to top)
...
000127 p.000003: 3
000128 p.000003:
000129 p.000003: Our principles and expectations for ethical research
000130 p.000003: There are six key principles of ethical research that we expect to be addressed:
000131 p.000003:
000132 p.000003: • Research participants should take part voluntarily, free from any coercion or undue influence, and their rights,
000133 p.000003: dignity and (when possible) autonomy should be respected and appropriately protected.
000134 p.000003:
000135 p.000003: • Research should be worthwhile and provide value that outweighs any risk or harm. Researchers should aim to
000136 p.000003: maximise the benefit of the research and minimise potential risk of harm to participants and researchers. All potential
...

...
000499 p.000012: ROs are expected to monitor the operation of RECs for which they are responsible and the decisions they take in
000500 p.000012: relation to social science proposals, according to the standards and guidelines set out here.
000501 p.000012:
000502 p.000012: Independence of Research Ethics Committees
000503 p.000012: ROs are responsible for ensuring that the RECs within their organisation act independently. They should be free from
000504 p.000012: bias and undue influence from the RO in which they are located, from the researchers whose proposals they consider
and
000505 p.000012: from the personal or financial interests of their members. The independence of a REC is founded on their membership,
on
000506 p.000012: strict rules regarding conflict of interests and on regular monitoring of and accountability for their decisions.
000507 p.000012:
000508 p.000012: Composition of Research Ethics Committees
...

...
001211 p.000029: consent. This approach means that participants consent to a framework for future research of certain types, not just to
001212 p.000029: consent for a particular project.
001213 p.000029:
001214 p.000029: What does it mean that research participants should participate voluntarily, free from any coercion?
001215 p.000029: In all cases of research, researchers should inform participants of their right to refuse to participate or withdraw
001216 p.000029: from the investigation whenever and for whatever reason they wish. There should be no coercion or undue influence
of
001217 p.000029: research participants to take part in the research.
001218 p.000029:
001219 p.000029: Research participants, however, may be given small monetary reimbursement for their time and expenses involved.
Payment
001220 p.000029: should not override the principles of freely given and fully informed consent. Participants should know before they
...

Health / HIV/AIDS
Searching for indicator hiv:

(return to top)
...
001078 p.000026: generate. This is especially pertinent in the context of health-related research. But, in addition, social science
001079 p.000026: raises a wider range of risks that needs to be considered by RECs. These include risk to a participant’s personal
001080 p.000026: social standing, privacy, personal values and beliefs, their links tofamily and the wider community, and their
001081 p.000026: position within occupational settings, as well as the adverse effects of revealing information that relates to illegal,
001082 p.000026: sexual or deviant behaviour. Research, though it may carry no physical risk, can be disruptive and damaging to
research
001083 p.000026: participants as individuals or to whole communities or categories of people, such as those with HIV infection.
001084 p.000026:
001085 p.000026: Can all risks be avoided?
001086 p.000026: Not all risks can, or in some cases should, be avoided, but it is important that researchers and RECs develop
awareness
001087 p.000026: of potential risks. Such risks may be difficult or impossible to quantify or anticipate in full prior to the start of a
...

Health / Health
Searching for indicator health:

(return to top)
...
000313 p.000007:
000314 p.000007: • People who lack capacity to make decisions or who during the research project come to lackcapacity. Such
research
000315 p.000007: should be reviewed by an appropriate body operating under the Mental Capacity Act 2005
000316 p.000007:
000317 p.000007: • (http://www.legislation.gov.uk/ukpga/2005/9/contents ). Normally this will be a REC recognised by the Secretary of
000318 p.000007: State and Welsh Ministers and operating under the Health Research Authority (HRA) Governance Arrangements for
Research
000319 p.000007: Ethics Committees (GAfREC) (http://www.hra.nhs.uk/resources/research-legislation-and-
000320 p.000007: governance/governance-arrangements-for-research-ethics- committees/#sthash.rH7OVRVy.dpuf). Research
conducted in
000321 p.000007: Scotland should be reviewed by the Scotland ‘A’ REC
(http://www.nhsresearchscotland.org.uk/226_Research+Ethics.html)
000322 p.000007: which is operating under The Adults with Incapacity (Scotland) Act 2000
000323 p.000008: 8
000324 p.000008:
000325 p.000008: (http://www.legislation.gov.uk/asp/2000/4/section/10).
000326 p.000008: • Potentially sensitive topics, for example participants’ sexual behaviour, illegal or political behaviour,
000327 p.000008: experience of violence, abuse or exploitation, mental health, their personal or family lives, or their gender or ethnic
000328 p.000008: status. Elite interviews may also fall into this category.
000329 p.000008:
000330 p.000008: • Deceased persons. Researchers should adhere to relevant legislation ie Human Tissue Act 2004
000331 p.000008: (http://www.legislation.gov.uk/ukpga/2004/30/contents), Human Tissue (Sc) Act 2006
...

...
000513 p.000012: of the community and wider society as well as the researchers and funders of research.
000514 p.000012:
000515 p.000012: RECs should be multidisciplinary and comprised of both men and women. They should include at least one lay
member with
000516 p.000012: no affiliation to the RO in question. There should be a chairperson and members who have broad experience and
expertise
000517 p.000012: in the areas of research regularly reviewed by the REC and members who have the confidence and esteem of the
research
000518 p.000012: community. RECs would also benefit from including individuals who reflect ethnic diversity, users of specialist health,
000519 p.000012: education or social services (where these are the focus of research activities), individuals with experience of
000520 p.000012: professional care or counselling, and individuals with specific methodological expertise (for example, quantitative or
000521 p.000012: qualitative methods) relevant to the research they review. A REC should include among its membership people who
are
000522 p.000012: collectively familiar with a range of
...

...
000530 p.000013:
000531 p.000013: Remit and responsibilities of Research Ethics Committees
000532 p.000013: RECs should provide supportive, reflexive governance to researchers and operate a system of ongoing monitoring and
000533 p.000013: supportive reflection that promotes mutual learning for researchers and REC members. RECs are responsible for
reviewing
000534 p.000013: all research involving human participants and personal data conducted under their auspices and undertaken by
000535 p.000013: individuals employed by the organisation that does not come under the remit of the UK Health Departments and
Health
000536 p.000013: Research Authority (http://www.hra.nhs.uk/). RECs should review research proposals in a way that is independent,
000537 p.000013: competent and timely. In some circumstances RECs may authorise other sub-committees or their chair to conduct
reviews
000538 p.000013: on research involving minimal risk on their behalf. These sub-committees and chair will have no conflicts of interest
000539 p.000013: with the project and will be accountable to the REC and through it to the appropriate organisational authorities for
...
...
000919 p.000022: protection (https://ico.org.uk/for-organisations/guide-to-data- protection/).
000920 p.000022:
000921 p.000022: Legal requirements
000922 p.000022: ROs should comply with all relevant legal requirements and with the requirements of data custodians. The regulatory
000923 p.000022: requirements which apply may vary depending on the locus of data collection, the location of the subjects of the
000924 p.000022: research, where data are held, and the nature of the research involved. Privacy, health and safety, and intellectual
000925 p.000022: property are especially likely to arise as ethics concerns in research, but all legal requirements should be met. In
000926 p.000022: addition, careful consideration is needed in regard to the ethics implications that might be associated with the re-use
000927 p.000022: and re-purposing of data. Where a principal investigator confirms that a full ethics review is not required, the
000928 p.000022: research will still need to
...

...
000985 p.000024: • Data protected by legislation, for example personal data which includes census data and personal data provided
for
000986 p.000024: administrative purposes. Here, the data producer and data custodian has a strong interest in how researchers will
000987 p.000024: access the data, and may control access. This category of data may only be available via ‘safe settings’, see
for
000988 p.000024: example ESRC’s Administrative Data Research Network (http://www.adrn.ac.uk/) and the Safe Haven Farr
Institute
000989 p.000024: (http://www.ed.ac.uk/schools-departments/molecular-
000990 p.000024: clinical-medicine/health-services-research-unit/projects/safe-haven) collaboration, which have been set up,
000991 p.000024: respectively, to ensure the safe use of administrative data and patient and research data for medical research across
000992 p.000024: all diseases.
000993 p.000024: • Data such as the National Child Development Study (NCDS), where the inclusion of information such as a birth
date
000994 p.000024: or postcode makes disclosure possible, perhaps via a link to other datasets. This means that such data are ethically
...

...
001005 p.000024: issues arising over its re-use. Data which have been anonymised may have a residual risk of disclosure, or may
become
001006 p.000024: disclosive when linked with other data within the public domain. The licensing regime provided by ESRC’s Data
Service
001007 p.000024: Providers mitigates this risk considerably.
001008 p.000024:
001009 p.000024: There are also specific ethics issues relating to large-scale and longitudinal surveys, such as the Millennium Cohort
001010 p.000024: Study, where social and other health or medical data is secured.
001011 p.000024: The REC should consider issues such as the relation between opting in and out of the study and consent, data
security
001012 p.000024: of named files and data and the anonymisation of individual respondents. It should ensure that proposals involving
001013 p.000024: third parties such as
001014 p.000025: 25
...

...
001073 p.000026: What is the meaning of risk?
001074 p.000026: Proposals should be considered in the context of the risks of the project. Ethics scrutiny should be proportionate to
001075 p.000026: the level of risk and appetite for risk in the specific context of the research proposed and its potential benefits.
001076 p.000026: Risk is often defined by reference to the potential physical or psychologicalharm, discomfort, stress or reputational
001077 p.000026: risk to human participants (and participating groups, organisations and funders) that a research project might
001078 p.000026: generate. This is especially pertinent in the context of health-related research. But, in addition, social science
001079 p.000026: raises a wider range of risks that needs to be considered by RECs. These include risk to a participant’s personal
001080 p.000026: social standing, privacy, personal values and beliefs, their links tofamily and the wider community, and their
001081 p.000026: position within occupational settings, as well as the adverse effects of revealing information that relates to illegal,
001082 p.000026: sexual or deviant behaviour. Research, though it may carry no physical risk, can be disruptive and damaging to
research
...

...
001120 p.000027: the ones requiring consent in law, including the use of personal information. Code of Practice under the Adults with
001121 p.000027: Incapacity Act clarifies that ‘an adult does not have impaired capacity simply by virtue of having an addiction,
001122 p.000027: psychotic illness or learning difficulties and disabilities’ (p.6). The Scottish Act states that the wishes of the
001123 p.000027: individual should be taken into account and any intervention should benefit the individual (Section 51 of the Adults
001124 p.000027: with Incapacity (Scotland) Act 2000). The key point for both Acts is that valid consent can only be secured if the
001125 p.000027: participant has capacity to make a decision at the timeconsent is sought. (see Department of Health, Mental
Capacity
001126 p.000027: Act 2005 and consent for research
001127 p.000027: (http://www.wales.gov.uk/dhss/publications/health/mentalhealth/mentalcapacityact/2117019
001128 p.000027: /mcaconsente.pdf?lang=en) and Adults with Incapacity Act 2000- Code of Practice, Part 5
001129 p.000027: (http://www.scotland.gov.uk/Publications/2010/10/20153801/4)).
001130 p.000027:
001131 p.000027: Is it legitimate to expose some research participants/organisations to risk?
...

...
001335 p.000032: attorney).
001336 p.000032:
001337 p.000032: What happens when research involves tissue samples (including blood)?
001338 p.000032: UK research involving human tissue (including blood) is subject to the Human Tissue Act 2004, or The Human Tissue
001339 p.000032: (Scotland) Act 2006, and should adhere to the Codes of Practice issued by the Human Tissue Authority. Ethics
review
001340 p.000032: should be obtained from a REC operating to the standards set out in the governance arrangements issued by the UK
Health
001341 p.000032: Departments or other ethics committees for clinical trials of investigational medicinal products recognised by the
001342 p.000032: United Kingdom Ethics Committee Authority (UKECA).
001343 p.000032:
001344 p.000032: Where research involves the need to secure tissue samples (including blood), participants should be informed of their
...

...
001367 p.000033: (http://www.hra-decisiontools.org.uk/ethics/).
001368 p.000033:
001369 p.000033: It is expected that a light-touch review by a REC will be able to provide an effective filter for projects that might
001370 p.000033: otherwise have been inappropriately sent to an NHS REC, including those that while involving a physically invasive
001371 p.000033: technique do not do so for clinical purposes. Similarly, the framework provides for review by a REC of large-scale,
001372 p.000033: longitudinal social science studies that may seek information relating to respondents’ personalhealth profile.
001373 p.000033:
001374 p.000033: 2.4 Internet-mediated research
001375 p.000033: Why should internet research receive full ethics review?
001376 p.000033: In a fast developing area RECs may need to involve an independent expert in assessing research proposals that
break new
...

...
001787 p.000042: individual.
001788 p.000042:
001789 p.000042: Under this act, personal data consists of information as to (a) the racial or ethnic origin of the data subject, (b)
001790 p.000042: his/her political opinions, (c) his/her religious beliefs or other beliefs of a similar nature, (d) whether he/she is
001791 p.000042: a member of a trade union (within the meaning of the [1992 c. 52.] TradeUnion and Labour Relations (Consolidation)
Act
001792 p.000042: 1992), (e) his/her physical or mental health or condition, (f) his/her sexual life, (g) the commission or alleged
001793 p.000042: commission by him/her of any offence, or (h) any proceedings for any offence committed or alleged to have been
001794 p.000042: committed by him/her, the disposal of such proceedings or the sentence of any court in such proceedings.
001795 p.000042:
001796 p.000042: Research: Research is defined as any form of disciplined inquiry that aims to contribute to a body of knowledge or
...

...
001900 p.000045: http://nuffieldbioethics.org/wp-content/uploads/2014/07/Dementia-report-Oct-09.pdf
001901 p.000045: • Respect Project (2004). An EU code of Ethics for socio-economic research
www.respectproject.org/code/index.php
001902 p.000045: • Social Research Association (2003). Ethics Guidelines http://the-sra.org.uk/research- ethics/ethics-guidelines/
001903 p.000045: • UK Data Service ethics advice: http://ukdataservice.ac.uk/manage-data/legal-ethical.aspx
001904 p.000045: • UKRIO Code of Practice for Research www.ukrio.org/what-we-do/code-of-practice- for-research
001905 p.000045: • Universities and Colleges Employer Association (2011). Guidance on Health and Safety in Fieldwork
001906 p.000045: www.ucea.ac.uk/en/publications/index.cfm/guidance-on-health-and-safety- in-fieldwork
001907 p.000045: • University of Durham and National Co-ordinating Centre for Public Engagement (NCCP) (2012) Community-based
001908 p.000045: participatory research. A guide to ethical principles and practice.
001909 p.000045: https://www.dur.ac.uk/resources/beacon/CBPREthicsGuidewebNovember20121.pdf
001910 p.000045:
001911 p.000045: Health research authority and NHS Research
001912 p.000045: • Health Research Authority (HRA) www.hra.nhs.uk/
001913 p.000045: • HRA guidance for applicants and research community www.hra.nhs.uk/research- community/
001914 p.000045: • HRA decision tool (MRC/HRA): www.hra-decisiontools.org.uk/ethics
001915 p.000045: • HRA Application process Flowchart www.hra.nhs.uk/documents/2014/05/rec-
001916 p.000045: application-process-flowchart-v6-0-19-may-2014.pdf
...

...
001921 p.000045: • AREC (2013). A Framework of Policies and Procedures for University Research Ethics Committees
001922 p.000045: http://s3.spanglefish.com/s/21217/documents/independent-
001923 p.000046: 46
001924 p.000046:
001925 p.000046: membership/12-11-13-framework-complete.pdf
001926 p.000046: • Department of Health (2011). Governance arrangements for research ethics committees: a harmonised edition
(updated
001927 p.000046: April 2012) www.gov.uk/government/publications/health-research-ethics-committees-governance- arrangements
001928 p.000046: • UK Health Departments, Research Governance Frameworks
001929 p.000046: www.hra.nhs.uk/resources/research-legislation-and-governance/research-governance- frameworks/
001930 p.000046: • Health Research Authority, Standard Operating Procedures for Research Ethics Committees (2015)
001931 p.000046: http://www.hra.nhs.uk/resources/research-legislation-and- governance/standard-operating-procedures/
001932 p.000046: • The Ministry of Defense Research Ethics Committees (MODREC)
www.science.mod.uk/engagement/modrec/modrec.aspx
001933 p.000046: • Social Care Research Ethics Committee www.screc.org.uk
001934 p.000046: • Wellcome Trust Biobank Ethics and Governance Framework
...

...
001959 p.000046: • The National Archives. Making a freedom of information request
001960 p.000046: http://apps.nationalarchives.gov.uk/foi/requests.htm
001961 p.000047: 47
001962 p.000047:
001963 p.000047: • Freedom of Information (Scotland) Act 2002 www.legislation.gov.uk/asp/2002/13/contents
001964 p.000047: • Health and Social Care Act 2008 www.legislation.gov.uk/ukpga/2008/14/contents
001965 p.000047: • Health and Social Care Act 2012 www.legislation.gov.uk/ukpga/2012/7/contents
001966 p.000047: • Human Rights Act 1998 www.legislation.gov.uk/ukpga/1998/42/contents
001967 p.000047: • Human Tissue Act 2004 www.legislation.gov.uk/ukpga/2004/30/contents
001968 p.000047: • HRA Human Tissue Act 2004-Questions and Answers
001969 p.000047: www.hra.nhs.uk/resources/research-legislation-and-governance/questions-and-answers- the-human-tissue-act-2004/
...

...
001972 p.000047: • Mental Capacity Act 2005 www.legislation.gov.uk/ukpga/2005/9/contents
001973 p.000047: • Office of the Public Guardian (2014) Mental Capacity Act 2005: Code of Practice
001974 p.000047: https://www.gov.uk/government/publications/mental-capacity-act-code-of-practice
001975 p.000047: • HRA Mental Capacity Act 2005-Questions and Answers
001976 p.000047: www.hra.nhs.uk/resources/research-legislation-and-governance/questions-and-answers- mental-capacity-act-2005/
001977 p.000047: • Department of Health Mental Capacity Act and consent for research
001978 p.000047: http://wales.gov.uk/dhss/publications/health/mentalhealth/mentalcapacityact/2117019/m caconsente.pdf?lang=en
001979 p.000047: • Adults with Incapacity (Scotland) Act 2000 www.legislation.gov.uk/asp/2000/4/section/10
001980 p.000047: • Adults with Incapacity Act 2000: Code of practice (2010) For practitioners authorised to carry out medical
001981 p.000047: treatment or research under Part 5 of the Act www.scotland.gov.uk/Publications/2010/10/20153801/0
001982 p.000047: • Adults with Incapacity (Ethics Committee) Scotland Regulations 2002
...

Health / Mentally Disabled
Searching for indicator disability:

(return to top)
...
000306 p.000007: are not necessarily exempt from full review.
000307 p.000007:
000308 p.000007: Research potentially requiring a full ethics review
000309 p.000007: Research involving:
000310 p.000007:
000311 p.000007: • Potentially vulnerable people, for example children and young people, those with a learning disability or
000312 p.000007: cognitive impairment, or potentially vulnerable individuals in a dependent or unequal relationship.
000313 p.000007:
000314 p.000007: • People who lack capacity to make decisions or who during the research project come to lackcapacity. Such
research
000315 p.000007: should be reviewed by an appropriate body operating under the Mental Capacity Act 2005
...

Health / Motherhood/Family
Searching for indicator family:

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...
000322 p.000007: which is operating under The Adults with Incapacity (Scotland) Act 2000
000323 p.000008: 8
000324 p.000008:
000325 p.000008: (http://www.legislation.gov.uk/asp/2000/4/section/10).
000326 p.000008: • Potentially sensitive topics, for example participants’ sexual behaviour, illegal or political behaviour,
000327 p.000008: experience of violence, abuse or exploitation, mental health, their personal or family lives, or their gender or ethnic
000328 p.000008: status. Elite interviews may also fall into this category.
000329 p.000008:
000330 p.000008: • Deceased persons. Researchers should adhere to relevant legislation ie Human Tissue Act 2004
000331 p.000008: (http://www.legislation.gov.uk/ukpga/2004/30/contents), Human Tissue (Sc) Act 2006
...

...
000344 p.000008: sufficient. Issues however may arise when data are linked and where it may be possible to identify participants.
000345 p.000008:
000346 p.000008: • Individuals or groups where permission of a gatekeeper is normally required for initial or continued access to
000347 p.000008: participants. This includes research involving gatekeepers such as adult professionals (eg those working with children
000348 p.000008: or the elderly), or research in communities (in the UK or overseas) whereaccess to research participants is not
000349 p.000008: possible without the permission of another adult, such as another family member (eg the parent or husband of the
000350 p.000008: participant) or a community leader, and research where participants are in a dependent relationship with the
gatekeeper
000351 p.000008: (eg employees recruited through their workplace). Permission for access to other groups, for example participants in a
000352 p.000008: long term cohort study, may also need to be requested from a data producer who controls access to the group.
000353 p.000008:
...

...
001075 p.000026: the level of risk and appetite for risk in the specific context of the research proposed and its potential benefits.
001076 p.000026: Risk is often defined by reference to the potential physical or psychologicalharm, discomfort, stress or reputational
001077 p.000026: risk to human participants (and participating groups, organisations and funders) that a research project might
001078 p.000026: generate. This is especially pertinent in the context of health-related research. But, in addition, social science
001079 p.000026: raises a wider range of risks that needs to be considered by RECs. These include risk to a participant’s personal
001080 p.000026: social standing, privacy, personal values and beliefs, their links tofamily and the wider community, and their
001081 p.000026: position within occupational settings, as well as the adverse effects of revealing information that relates to illegal,
001082 p.000026: sexual or deviant behaviour. Research, though it may carry no physical risk, can be disruptive and damaging to
research
001083 p.000026: participants as individuals or to whole communities or categories of people, such as those with HIV infection.
001084 p.000026:
...

...
001314 p.000031: 2005 requires that the researcher must consult with a specified consultee as set out in the Guidance to the Act (2008).
001315 p.000031: If possible, this should be a personal consultee. The researcher should take reasonable steps to identify someone
001316 p.000032: 32
001317 p.000032:
001318 p.000032: who knows the person well who lacks capacity to make a decision, but is not a professional or paid care worker; this
001319 p.000032: does not include family members receiving some of the person’s pension or other benefits as a payment towards
their
001320 p.000032: share of the household expenses. The guidance states that it should be someone whom the person who lacks
capacity to
001321 p.000032: make a decision would trust with important decisions about their welfare.
001322 p.000032: Thus, a personal consultee could be a family member or close friend of the person.
001323 p.000032:
001324 p.000032: If no personal consultee can be identified, a nominated consultee should be proposed by the researcher. This is
someone
001325 p.000032: who is prepared to be consulted by the researcher, but has no connection with the research project - for example,
001326 p.000032: someone from a relevant organisation (such as a local church or charity); but they could also be a professional care
...

Health / Physically Ill
Searching for indicator illness:

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...
001117 p.000027: temporary. It could be state-related (eg due to drug or alcohol use, or because of the person’s emotional state at
the
001118 p.000027: time). ‘Intrusive’ research involving people without capacity to consent should comply with the specific
provisions for
001119 p.000027: research (Sections 30-33 of the Mental Capacity Act 2005) in order to be lawful. Intrusive procedures are defined as
001120 p.000027: the ones requiring consent in law, including the use of personal information. Code of Practice under the Adults with
001121 p.000027: Incapacity Act clarifies that ‘an adult does not have impaired capacity simply by virtue of having an addiction,
001122 p.000027: psychotic illness or learning difficulties and disabilities’ (p.6). The Scottish Act states that the wishes of the
001123 p.000027: individual should be taken into account and any intervention should benefit the individual (Section 51 of the Adults
001124 p.000027: with Incapacity (Scotland) Act 2000). The key point for both Acts is that valid consent can only be secured if the
001125 p.000027: participant has capacity to make a decision at the timeconsent is sought. (see Department of Health, Mental
Capacity
001126 p.000027: Act 2005 and consent for research
...
Political / Illegal Activity
Searching for indicator illegal:

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...
000321 p.000007: Scotland should be reviewed by the Scotland ‘A’ REC
(http://www.nhsresearchscotland.org.uk/226_Research+Ethics.html)
000322 p.000007: which is operating under The Adults with Incapacity (Scotland) Act 2000
000323 p.000008: 8
000324 p.000008:
000325 p.000008: (http://www.legislation.gov.uk/asp/2000/4/section/10).
000326 p.000008: • Potentially sensitive topics, for example participants’ sexual behaviour, illegal or political behaviour,
000327 p.000008: experience of violence, abuse or exploitation, mental health, their personal or family lives, or their gender or ethnic
000328 p.000008: status. Elite interviews may also fall into this category.
000329 p.000008:
000330 p.000008: • Deceased persons. Researchers should adhere to relevant legislation ie Human Tissue Act 2004
...

...
000464 p.000011: media, researchers will also need to abide by the regulations set by the data producers subject to such regulations
000465 p.000011: being consistent with legal and ethical guidelines (see also internet-mediated research in FAQs). The potential for
000466 p.000011: identifiabilty of online sources, as well as ethical debates about how privacy is constituted in digital contexts,
000467 p.000011: means that full ethics review may be appropriate for research involving these communities. For example, people often
000468 p.000011: assume that social media sources are public domain, but it is quite likely that some service users – including
children
000469 p.000011: – may not understand the implications of what they are doing, and those harvesting data may also uncover illegal
images
000470 p.000011: or activities.
000471 p.000011:
000472 p.000011: Research that involves anonymised records and datasets that exist in the public domain may only require a light-touch
000473 p.000011: review. This includes, for example, datasets available through the Office for National Statistics or ESRC’s data
...

...
000952 p.000023: the research interaction.
000953 p.000023:
000954 p.000023: Limits to confidentiality
000955 p.000023: Researchers should, when eliciting consent, make clear the limits to confidentiality, particularly when working with
000956 p.000023: potentially vulnerable individuals or groups - for example when undertaking research withchildren, families and
000957 p.000023: vulnerable populations, or individuals involved in illegal activities. If for example an interview reveals that a
000958 p.000023: participant or another person identified in the interview is in significant danger, the researcher will be obliged to
000959 p.000023: take action in response to that disclosure. Researchers should have established procedures, necessary systems and
000960 p.000023: appropriate contacts in place to activate help and support in the event of a disclosure. If the researcher feels it is
000961 p.000023: necessary to break confidentiality, the participant should normally be informed what action is being taken by the
...

...
001076 p.000026: Risk is often defined by reference to the potential physical or psychologicalharm, discomfort, stress or reputational
001077 p.000026: risk to human participants (and participating groups, organisations and funders) that a research project might
001078 p.000026: generate. This is especially pertinent in the context of health-related research. But, in addition, social science
001079 p.000026: raises a wider range of risks that needs to be considered by RECs. These include risk to a participant’s personal
001080 p.000026: social standing, privacy, personal values and beliefs, their links tofamily and the wider community, and their
001081 p.000026: position within occupational settings, as well as the adverse effects of revealing information that relates to illegal,
001082 p.000026: sexual or deviant behaviour. Research, though it may carry no physical risk, can be disruptive and damaging to
research
001083 p.000026: participants as individuals or to whole communities or categories of people, such as those with HIV infection.
001084 p.000026:
001085 p.000026: Can all risks be avoided?
...

...
001254 p.000030: data, but this should be discussed with an appropriate ESRC data service provider, for example the UK Data Service.
001255 p.000030:
001256 p.000030: What if it is not possible to obtain informed consent?
001257 p.000030: Informed consent may be impracticable or meaningless in some research, such as research on crowd behaviour, or
may be
001258 p.000030: contrary to the research design, as is sometimes the case in psychological experiments where fully informed consent
001259 p.000030: would compromise the objective of the research. In some circumstances (such as when users of illegal drugs and
illegal
001260 p.000030: groups are involved) written consent might also create unnecessary risks for research participants. Even in this last
001261 p.000030: case a researcher should seek informed consent where possible to secure the trust and confidence of those involved,
but
001262 p.000030: care must be taken to ensure than consent processes (eg asking for written signatures) do not pose risks to
001263 p.000030: participants. Such circumstances may encourage the researcher to seek valid consent from participants, which
ensures
...

Political / Political
Searching for indicator party:

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...
001589 p.000038: • Who will benefit from this research?
001590 p.000038: • Have you considered anonymity and confidentiality?
001591 p.000038: • How will you store your collected data?
001592 p.000038: • How will data be disposed of and after how long?
001593 p.000038: • Are there any conflicts of interest in undertaking this research, eg financial reward for outcomes?
001594 p.000038: • Will you be collecting information through a third party?
001595 p.000038: • Have you considered consent?
001596 p.000038: o If using secondary data, does the consent from the primary data cover further analysis?
001597 p.000038: o Can participants opt out?
001598 p.000038: o Does your information sheet (or equivalent) contain all the information participants need?
...

Searching for indicator political:

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...
000321 p.000007: Scotland should be reviewed by the Scotland ‘A’ REC
(http://www.nhsresearchscotland.org.uk/226_Research+Ethics.html)
000322 p.000007: which is operating under The Adults with Incapacity (Scotland) Act 2000
000323 p.000008: 8
000324 p.000008:
000325 p.000008: (http://www.legislation.gov.uk/asp/2000/4/section/10).
000326 p.000008: • Potentially sensitive topics, for example participants’ sexual behaviour, illegal or political behaviour,
000327 p.000008: experience of violence, abuse or exploitation, mental health, their personal or family lives, or their gender or ethnic
000328 p.000008: status. Elite interviews may also fall into this category.
000329 p.000008:
000330 p.000008: • Deceased persons. Researchers should adhere to relevant legislation ie Human Tissue Act 2004
...

...
000370 p.000009: assistants working outside the UK in their own community.
000371 p.000009:
000372 p.000009: • Members of the public in a research capacity in research data collection, eg participatory research.
000373 p.000009:
000374 p.000009: • International partners or research undertaken outside of the UK where there may be issues of local practice and
000375 p.000009: political sensitivities. In some cases partnership with a RO in the geographical area involved may prove helpful. It is
000376 p.000009: also necessary to act in accordance with the legal and ethics review requirements in the countries included in the
000377 p.000009: research. Researchers should also consider these issues when undertaking social media research, as most of this is
000378 p.000009: international in scope as data are often drawn from a range of international settings.
000379 p.000009:
...

...
000839 p.000020: developing and undertaking the research. Legal and ethical requirements for all the partner countries must be
ensured.
000840 p.000020:
000841 p.000020: There are several considerations here:
000842 p.000020:
000843 p.000020: • inequities in regard to access to research resources
000844 p.000020: • political and cultural considerations with regard to professional training and oversight; differingethics
000845 p.000020: traditions in research
000846 p.000020: • increased risk to researchers and participants where they are working remotely
000847 p.000021: 21
000848 p.000021:
...

...
000857 p.000021: regard to specific schemes involving international collaboration. In many cases it is good practice to collaborate with
000858 p.000021: a local RO or other relevant local experts (eg an NGO). Researchers should also consider these issues when
undertaking
000859 p.000021: social media research as most of this is international in scope, as data is often drawn from a range of international
000860 p.000021: settings.
000861 p.000021:
000862 p.000021: In addition, problems may occur where the research involves political sensitivities. Researchers may not be able to
000863 p.000021: obtain permission for further research from authorities in that country unless they respect such sensitivities. Again,
000864 p.000021: collaborating with a RO in the local area is good practice. RECs and researchers need to be alert to potential
000865 p.000021: difficulties while staying true to the principles of the FRE.
000866 p.000021:
...

...
001130 p.000027:
001131 p.000027: Is it legitimate to expose some research participants/organisations to risk?
001132 p.000027: This might arise for two reasons. First, as is recognised elsewhere (see Tri-Council of Canada, 2002
001133 p.000027: (http://www.pre.ethics.gc.ca/English/policystatement/introduction.cfm)) research may be ‘deliberately and
legitimately
001134 p.000027: opposed to the interests of the research participants or organisations’ in cases where the objectives of the
research
001135 p.000027: are to reveal and critique fundamental economic, political or cultural disadvantage or exploitation. Much social
001136 p.000027: science research has a critical role to play in exploring and questioning social, cultural and economic structures and
001137 p.000027: processes (for example relating to patterns of power and social inequality, and institutional dynamics and regimes that
001138 p.000027: disadvantage some social groups over others, intentionally or not). Such research results may have a negative impact
on
001139 p.000027: some of the research participants/organisations. Principles of justice should, however, mean that researchers would
...

...
001155 p.000028:
001156 p.000028: What are the risks in disseminating findings?
001157 p.000028: The media can be very helpful in disseminating findings, but the possible impact on research participants, their
001158 p.000028: families and organisations, and populations from which the sample is drawn needs to be thought through, particularly
001159 p.000028: where anonymity may be jeopardised or where there is potential for stigmatisation of individuals or groups or of misuse
001160 p.000028: or misrepresentations of research findings (eg to further political agendas).
001161 p.000028:
001162 p.000028: For example, descriptions of participants (eg in case studies) need to take care to ensure that they do not risk making
001163 p.000028: those who take part identifiable, particularly if sample sizes are small or participants have distinctive
001164 p.000028: characteristics that may make them recognisable. In some cases, for example in elite interviews, participants may wish
...

...
001168 p.000028: exemption cannot be claimed if data subjects will not be anonymous when findings are published (See Section 33 of
the
001169 p.000028: Data Protection Act- A practical note for researchers
001170 p.000028: (www.adls.ac.uk/wp-content/uploads/2011/04/Section-33-of-the-DPA-a-practical-note-for- researchers.pdf)).
001171 p.000028:
001172 p.000028: What is the impact on other areas of participants’ lives, such as their families and careers? Did they give
permission
001173 p.000028: for the material to be data archived or shared with other researchers? Political sensitivities may arise when findings
001174 p.000028: are contrary to local or national policy. It may be important to publish critical findings about policies and
001175 p.000028: organisations, but was this within the original remit of the research? Were participants aware that this could be a
001176 p.000028: consequence of their participation? When working with commercial and government organisations, principal
investigators
001177 p.000028: should look carefully at the forms they are asked to sign concerning possible publication of the findings. Researchers
...

...
001597 p.000038: o Can participants opt out?
001598 p.000038: o Does your information sheet (or equivalent) contain all the information participants need?
001599 p.000038: o If your research changes, how will consent be renegotiated?
001600 p.000038: • Have you considered ethics within your plans for dissemination/impact?
001601 p.000038: • Are you conducting research outside the UK? Are there any additional issues that need to be considered as a
001602 p.000038: result? eg local customs, local ‘gatekeepers’, political sensitivities?
001603 p.000038: • Which Ethics Committee is most appropriate for your research?
001604 p.000038: • Have you considered the time you need to gain ethics review?
001605 p.000038: • Have you considered what legal requirements your project will need to abide by? Eg Data Protection Act,
Freedom of
001606 p.000038: Information Act, Human Rights Act
...

...
001785 p.000042: possession of, or is likely to come into the possession of, the data controller, and includes any expression of opinion
001786 p.000042: about the individual and any indication of the intentions of the data controller or any other person in respect of the
001787 p.000042: individual.
001788 p.000042:
001789 p.000042: Under this act, personal data consists of information as to (a) the racial or ethnic origin of the data subject, (b)
001790 p.000042: his/her political opinions, (c) his/her religious beliefs or other beliefs of a similar nature, (d) whether he/she is
001791 p.000042: a member of a trade union (within the meaning of the [1992 c. 52.] TradeUnion and Labour Relations (Consolidation)
Act
001792 p.000042: 1992), (e) his/her physical or mental health or condition, (f) his/her sexual life, (g) the commission or alleged
001793 p.000042: commission by him/her of any offence, or (h) any proceedings for any offence committed or alleged to have been
001794 p.000042: committed by him/her, the disposal of such proceedings or the sentence of any court in such proceedings.
...

Political / Trade Union Membership
Searching for indicator union:

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...
000863 p.000021: obtain permission for further research from authorities in that country unless they respect such sensitivities. Again,
000864 p.000021: collaborating with a RO in the local area is good practice. RECs and researchers need to be alert to potential
000865 p.000021: difficulties while staying true to the principles of the FRE.
000866 p.000021:
000867 p.000021: Co-funded research may involve the ESRC in partnership with other Research Councils, business, other public sector
000868 p.000021: organisations, civil society sector or research funded under a European Union framework programme and involving
000869 p.000021: research teams from different EU member states. For co-funded research there may be conflicting national or
000870 p.000021: international review procedures. In each of these cases, co-funders will discuss and agree the ethics review
000871 p.000021: requirements. There should be a commitment of mutual recognition of ethical consideration between funders, where
000872 p.000021: possible, of common standards, and if not it should be made clear where researchers should go for advice.
...

...
001786 p.000042: about the individual and any indication of the intentions of the data controller or any other person in respect of the
001787 p.000042: individual.
001788 p.000042:
001789 p.000042: Under this act, personal data consists of information as to (a) the racial or ethnic origin of the data subject, (b)
001790 p.000042: his/her political opinions, (c) his/her religious beliefs or other beliefs of a similar nature, (d) whether he/she is
001791 p.000042: a member of a trade union (within the meaning of the [1992 c. 52.] TradeUnion and Labour Relations (Consolidation)
Act
001792 p.000042: 1992), (e) his/her physical or mental health or condition, (f) his/her sexual life, (g) the commission or alleged
001793 p.000042: commission by him/her of any offence, or (h) any proceedings for any offence committed or alleged to have been
001794 p.000042: committed by him/her, the disposal of such proceedings or the sentence of any court in such proceedings.
001795 p.000042:
...

...
001879 p.000044: www.bps.org.uk/publications/policy-and-guidelines/research-guidelines-policy- documents/research-guidelines-poli
001880 p.000044: • British Psychological Society Ethics Guidelines for internet-mediated research (2013)
001881 p.000044: www.bps.org.uk/publications/policy-and-guidelines/research-guidelines-policy- documents/research-guidelines-poli
001882 p.000044: • British Sociological Association ‘Statement of Ethical Practice’ (2002)
001883 p.000044: http://www.britsoc.co.uk/about/equality/statement-of-ethical-practice.aspx
001884 p.000044: • Charter of Fundamental Rights of the European Union (2000) www.europarl.europa.eu/charter/pdf/text_en.pdf
001885 p.000044: • Committee on Publication Ethics (COPE) guidelines - http://publicationethics.org/resources/guidelines
001886 p.000044: • Council of Europe (1953). Convention for the Protection of Human Rights and Fundamental Freedoms
001887 p.000045: 45
001888 p.000045:
...

Social / Access to Social Goods
Searching for indicator access:

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...
000291 p.000007: number of research proposals that need to go to a full ethics review.
000292 p.000007:
000293 p.000007: Expedited review may be appropriate in exceptional circumstances where research projects require a full review but
have
000294 p.000007: a short lead time and are commissioned in response to a demand of pressing importance. Most RECs only permit
expedited
000295 p.000007: review in exceptional and clearly justified cases. Such exceptions may include external drivers which are beyond the
000296 p.000007: control of the researchers (eg access to a sample) which mean that ethics clearance is required within a short
000297 p.000007: timescale, or when perhaps fieldwork is linked to a particular event or period that is outside the researcher’s
000298 p.000007: control. An expedited review should meet the criteria required for a full review and should not be carried out by REC
000299 p.000007: members who are in a position of dependence with the applicant which could be perceived as a conflict of interest.
000300 p.000007:
...
...
000341 p.000008:
000342 p.000008: • Administrative or controlled data. Appropriate approval within the relevant governance regime(s) is needed for use
000343 p.000008: of these datasets. In many cases a light-touch review confirming that researchers have met these requirements will be
000344 p.000008: sufficient. Issues however may arise when data are linked and where it may be possible to identify participants.
000345 p.000008:
000346 p.000008: • Individuals or groups where permission of a gatekeeper is normally required for initial or continued access to
000347 p.000008: participants. This includes research involving gatekeepers such as adult professionals (eg those working with children
000348 p.000008: or the elderly), or research in communities (in the UK or overseas) whereaccess to research participants is not
000349 p.000008: possible without the permission of another adult, such as another family member (eg the parent or husband of the
000350 p.000008: participant) or a community leader, and research where participants are in a dependent relationship with the
gatekeeper
000351 p.000008: (eg employees recruited through their workplace). Permission for access to other groups, for example participants in a
000352 p.000008: long term cohort study, may also need to be requested from a data producer who controls access to the group.
000353 p.000008:
000354 p.000008: • Justified deception or research conducted without participants’ valid and informed consent at the time the
study
000355 p.000008: is carried out. It is recognised that there are occasions when the use of covert research methods is necessary and
000356 p.000008: justifiable and consent may need to be managed at a point beyond the completion of research fieldwork (see
Frequently
000357 p.000008: Asked Questions).
000358 p.000008:
000359 p.000008: • Access to records of personal orsensitive confidential information, including genetic or other biological
000360 p.000008: information, concerning identifiable individuals. See the Data Protection Act 1998
000361 p.000008: (http://www.legislation.gov.uk/ukpga/1998/29/contents).
000362 p.000009: 9
000363 p.000009:
...

...
000471 p.000011:
000472 p.000011: Research that involves anonymised records and datasets that exist in the public domain may only require a light-touch
000473 p.000011: review. This includes, for example, datasets available through the Office for National Statistics or ESRC’s data
000474 p.000011: service providers where appropriate permissions have already been obtained and where the risk of identifying
000475 p.000011: individuals from the information provided is negligible. Specific regulations relate to the use of administrative and
000476 p.000011: controlled data (other data producers are likely to specify their own restrictions on the access to and use of their
000477 p.000011: data), which should be complied with. There may be some circumstances where ethics issues arise with the re-use of
000478 p.000011: data, as described in section 1.11
000479 p.000011:
000480 p.000011: ROs should ensure that there is a principal REC for their organisation, but may establish secondary RECs (for example
...

...
000576 p.000014: organisations that fund research to require that ethics review be completed before an application for funding is
000577 p.000014: submitted, as a significant proportion of applications are not funded. ROs and funding agencies should be flexible
000578 p.000014: about the point at which review by a REC is required. In the majority of cases this will be immediately after
000579 p.000014: notification of funding, but it could also be prior to a pilot study so that participants’ interests are protected;
000580 p.000014: prior to seeking the agreement of potential research sites and gatekeepers so they can be assured of its good
standing;
000581 p.000014: or prior to the main data collection when research instruments have been tested and access to participants agreed.
000582 p.000014:
000583 p.000014: • Identifying, documenting and dealing with conflicts of interests (see section1.6).
000584 p.000014:
000585 p.000014: • Methods of decision-making and recording decisions. ROs should record and make clear how they come to their
...

...
000673 p.000016: • The use of approved protocols for commonly occurring situations. It will be the responsibility of the local REC to
000674 p.000016: review the suggested protocol for the individual proposals.
000675 p.000016:
000676 p.000016: In order to facilitate greater transparency and the sharing of solutions to ethics dilemmas, ROs are encouraged to
000677 p.000016: publish their approved protocols on the web for use by others.
000678 p.000016: ROs giving access to their approved protocols cannot be expected to enter into any discussion on their use. Those
000679 p.000016: making use of such protocols will need to justify to their RO why the suggested protocol is appropriate to their
000680 p.000016: research.
000681 p.000016:
000682 p.000016:
...

...
000770 p.000019:
000771 p.000019: The aim of this training should be to build confidence in individuals to recognise the need for ethics scrutiny with
000772 p.000019: regard to social science research; throughout the lifecycle of the research, which includes the research activity,
000773 p.000019: knowledge exchange and impact activities and further ethical consideration required for potential re-use of data;
000774 p.000019: training should also help individuals understand the RO’s requirements and procedures for review; and to
understand how
000775 p.000019: to access additional help, both internal and external to the RO.
000776 p.000019:
000777 p.000019: In practical terms, training requirements are likely to include training for:
000778 p.000019:
000779 p.000019: • individual researchers
...

...
000838 p.000020: establish whether ethics review is required by the non- UK ROs, and how the principles of the FRE can be followed in
000839 p.000020: developing and undertaking the research. Legal and ethical requirements for all the partner countries must be
ensured.
000840 p.000020:
000841 p.000020: There are several considerations here:
000842 p.000020:
000843 p.000020: • inequities in regard to access to research resources
000844 p.000020: • political and cultural considerations with regard to professional training and oversight; differingethics
000845 p.000020: traditions in research
000846 p.000020: • increased risk to researchers and participants where they are working remotely
000847 p.000021: 21
000848 p.000021:
000849 p.000021: • issues about gatekeepers (for example in some societies, access to research participants may not be possible
000850 p.000021: without first obtaining permission from a community leader or female participant’s husband)
000851 p.000021: • considerable differences in power between the researcher and the participant.
000852 p.000021:
000853 p.000021: Moreover, research ethics in some societies raises issues about what is meant byethics, and therefore how we
...

...
000974 p.000024: collect the data should be aware that the ESRC expects that others will also re-use the data. The original researcher
000975 p.000024: should take into account the long- term use, including the potential for data linkage and preservation of data, when
000976 p.000024: obtaining consent. Further advice on securing consent for data re-use, as well as exemplar consent forms, are
available
000977 p.000024: at the UK Data Service’s website (http://ukdataservice.ac.uk/manage- data/plan.aspx). In some cases it may not
be
000978 p.000024: possible to sufficiently anonymise data in order for it to be available at the appropriate ESRC Data Service Provider
000979 p.000024: (for example the UK Data Service) through a standard End User License, but alternative secure access methods could
be
000980 p.000024: arranged.
000981 p.000024:
000982 p.000024: Data re-use falls into three categories:
000983 p.000024:
000984 p.000024: • Non-sensitive data or data where there is minimal risk of disclosure of the identity of individuals.
000985 p.000024: • Data protected by legislation, for example personal data which includes census data and personal data provided
for
000986 p.000024: administrative purposes. Here, the data producer and data custodian has a strong interest in how researchers will
000987 p.000024: access the data, and may control access. This category of data may only be available via ‘safe settings’, see
for
000988 p.000024: example ESRC’s Administrative Data Research Network (http://www.adrn.ac.uk/) and the Safe Haven Farr
Institute
000989 p.000024: (http://www.ed.ac.uk/schools-departments/molecular-
000990 p.000024: clinical-medicine/health-services-research-unit/projects/safe-haven) collaboration, which have been set up,
000991 p.000024: respectively, to ensure the safe use of administrative data and patient and research data for medical research across
...

...
000993 p.000024: • Data such as the National Child Development Study (NCDS), where the inclusion of information such as a birth
date
000994 p.000024: or postcode makes disclosure possible, perhaps via a link to other datasets. This means that such data are ethically
000995 p.000024: sensitive.
000996 p.000024:
000997 p.000024: A data producer such as the Office for National Statistics (ONS) or other government departments may also have
000998 p.000024: stringent requirements and restrictions relating to access and re-use of data that should be followed. Legal and data
000999 p.000024: producer access requirements on the re-use of datasets should be complied with, including provisions relating to
001000 p.000024: presumed consent and potential risk of disclosure of personal data. Appropriate ESRC Data Service Providers, for
001001 p.000024: example the UK Data Service, should be approached in the first instance for advice on current data producer
001002 p.000024: requirements. Researchers may also consult directly with data producers regarding project-specific issues.
001003 p.000024:
...

...
001015 p.000025:
001016 p.000025: polling companies contracted to secure data will do so according to the ethics principles set out here. These
001017 p.000025: organisations often operate according to codes of practice developed by bodies such as the Market Research Society
001018 p.000025: (https://www.mrs.org.uk/).
001019 p.000025:
001020 p.000025: Data access through technology
001021 p.000025: Researchers are now making greater use of datasets which have been generated through internet-mediated
technology and
001022 p.000025: social media. Researchers need to consider the ethical issues which arise; for example, the interpretation of
anonymity
001023 p.000025: and whether participants (eg social media users) would consider data in the public domain to be private, the meaning
of
001024 p.000025: informed consent in this context and the important issue of what permissions a researcher has over the data supplied
by
001025 p.000025: the data producer (eg Facebook or Twitter data).
001026 p.000025:
001027 p.000025: Data access through biobank
001028 p.000025: Social scientists are also making greater use of data held in a public or private biobank where broadconsent is often
001029 p.000025: utilised. The UK Biobank (http://www.ukbiobank.ac.uk/ethics/) is an example of broad consent and has stringent
measures
001030 p.000025: in place to ensure that participants are not identified.
001031 p.000025:
...

...
001180 p.000028: 2.2 Consent
001181 p.000028: What is informed consent?
001182 p.000028: Informed consent entails giving sufficient information about the research and ensuring that there is no explicit or
001183 p.000028: implicit coercion (see below) so that prospective participants can make an informed and free decision on their possible
001184 p.000028: involvement. Information should be provided in a form that is comprehensible and accessible to participants, typically
001185 p.000028: in written form (or in a form that participants can access after the end of the research interaction), and time should
001186 p.000028: be allowed for the participants to consider their choices and to discuss their decision with others if appropriate. The
001187 p.000028: consent forms should be signed off by the research participants to indicateconsent.
001188 p.000028:
001189 p.000028: Where participants are in a potentially vulnerable or dependent position (eg children) it is important to ensure that
001190 p.000028: they have the time and opportunity to access support in their decision-making, for example by discussing their choice
001191 p.000028: with a trusted adult. Where consent is sought from children it is normally good practice to secure permission from a
001192 p.000029: 29
001193 p.000029:
001194 p.000029: responsible adult in addition to child consent. Where participants are not literate verbal consent may be obtained, but
...

...
001498 p.000035: Does the research involve other potentially vulnerable groups: children, those with cognitive impairment, or those in
001499 p.000035: unequal relationships? (eg your own students)
001500 p.000035: Will the study require the co-operation of a gatekeeper for initial
001501 p.000036: 36
001502 p.000036:
001503 p.000036: access to the groups or individuals to be recruited? (eg employees, students at school, members of self- help group,
001504 p.000036: residents of nursing home?)
001505 p.000036: Will it be necessary for participants to take part in the study without their knowledge and consent at the time? (eg
001506 p.000036: covert observation of people in non- public places, use of deception in experimental studies)
001507 p.000036: Will the study involve discussion of sensitive or potentially sensitive topics? (eg sexual activity, drug use, personal
...

...
001703 p.000040: research. Broad consent means consenting to a framework for future research of certain types. Included in this
001704 p.000040: framework is ethics review of each specific research project by an independentethics committee as well as strategies
001705 p.000040: to update regularly the biobank donor and ongoing withdrawal opportunities. If anything in the framework changes, the
001706 p.000040: participant should re-consent.
001707 p.000040:
001708 p.000040: Controlled data: are data which may be identifiable and thus potentially disclosive but to which access may be granted
001709 p.000040: to users who have been accredited and their data usage has been approved by a relevant Data Access Committee.
Data
001710 p.000040: service providers may provide details of their policies regarding access to controlled data, for example the UK Data
001711 p.000040: Service (http://ukdataservice.ac.uk/get-data/data-access-policy/controlled-data.aspx).
001712 p.000040:
001713 p.000040: Data Custodian (Data Controller): is a person who determines the purposes for which and manner in which any
personal
001714 p.000040: data are to be processed in line with the Data Protection Act
001715 p.000040: (https://ico.org.uk//for-organisations/guide-to-data-protection/).
...
...
001729 p.000041: purpose and value and why the individual is being invited to take part. The person interviewed should be aware what
001730 p.000041: will happen to any findings, whether the data will be shared with others, and whether he/she will be identified.
001731 p.000041:
001732 p.000041: Enduring consent: This is where there is no time limit onconsent given unless consent is withdrawn. Human
participants
001733 p.000041: do not need to be re-contacted should any of their personal data be reused for further research. Securing enduring
001734 p.000041: consent may be essential in longitudinal studies. It may also be important for data for whichaccess is provided by the
001735 p.000041: UK Data Service. Principles of preserving confidentiality apply.
001736 p.000041:
001737 p.000041: ESRC data service providers: Organisations funded by ESRC to coordinate with data owners to provide access to
data.
001738 p.000041: This may be purchased, created or deposited for re-use (eg the UK Data Service (http://www.ukdataservice.ac.uk/)) or
001739 p.000041: obtained and linked for specific approved projects (eg the Administrative Data Research Network
001740 p.000041: (http://www.adrn.ac.uk/)). ESRC data service providers may also provide user support, training and strategic data
001741 p.000041: related advice.
...

...
001946 p.000046: • Information Commissioner’s Office (2014). Data Controllers and data processors: what the difference is and
what
001947 p.000046: the governance implications are https://ico.org.uk/media/for-organisations/documents/1546/data-controllers-and-data-
001948 p.000046: processors-dp-guidance.pdf
001949 p.000046: • Disclosure and Barring Service www.gov.uk/government/organisations/disclosure-and- barring-service
001950 p.000046: • Disclosure Scotland www.disclosurescotland.co.uk/index.htm
001951 p.000046: • Access Northern Ireland www.dojni.gov.uk/accessni
001952 p.000046: • Freedom of Information Act 2000 www.legislation.gov.uk/ukpga/2000/36/contents
001953 p.000046: • JISC FOI and Research Data
http://webarchive.nationalarchives.gov.uk/20140702233839/http://www.jisc.ac.uk/public
001954 p.000046: ations/programmerelated/2010/foiresearchdata.aspx#downloads
001955 p.000046: • Information Commissioner’s Office. How to access information from a public body
001956 p.000046: https://ico.org.uk/for-the-public/official-information/
001957 p.000046: • Information Commissioner’s Office. Guide to freedom of information
001958 p.000046: https://ico.org.uk/for-organisations/guide-to-freedom-of-information/
001959 p.000046: • The National Archives. Making a freedom of information request
...

...
002002 p.000048: www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1001328
002003 p.000048: • Observatory for Responsible Research and Innovation in ICT http://responsible- innovation.org.uk/torrii/
002004 p.000048: • Salway et al (2011) Ethnic diversity and inequality ethical and scientific rigour in social research. Joseph
002005 p.000048: Roundtree Foundation www.jrf.org.uk/publications/ethnic-diversity- social-research
002006 p.000048: • Stevens, Leslie A. and Laurie, Graeme, The Administrative Data Research Centre Scotland: A Scoping Report on
the
002007 p.000048: Legal & Ethical Issues Arising from Access & Linkage of Administrative Data (August 27, 2014). Edinburgh School of
Law
002008 p.000048: Research Paper No. 2014/35. Available at SSRN: http://ssrn.com/abstract=2487971 or
002009 p.000048: http://dx.doi.org/10.2139/ssrn.2487971
002010 p.000048:
002011 p.000048:
...

Social / Breastfeeding Children
Searching for indicator justice:

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...
001134 p.000027: opposed to the interests of the research participants or organisations’ in cases where the objectives of the
research
001135 p.000027: are to reveal and critique fundamental economic, political or cultural disadvantage or exploitation. Much social
001136 p.000027: science research has a critical role to play in exploring and questioning social, cultural and economic structures and
001137 p.000027: processes (for example relating to patterns of power and social inequality, and institutional dynamics and regimes that
001138 p.000027: disadvantage some social groups over others, intentionally or not). Such research results may have a negative impact
on
001139 p.000027: some of the research participants/organisations. Principles of justice should, however, mean that researchers would
001140 p.000027: seek to minimise any personal harm to individuals. Secondly, researchers should also consider how to balance the
001141 p.000027: potential of immediate or short-term risks to research participants against longer-term gains to future beneficiaries.
001142 p.000027: It is the responsibility of the research proposers to make such a case in detail to a REC. In making a decision RECs
001143 p.000027: may wish to consider safety issues and whether participants should have the right of protection.
...

Social / Child
Searching for indicator child:

(return to top)
...
000988 p.000024: example ESRC’s Administrative Data Research Network (http://www.adrn.ac.uk/) and the Safe Haven Farr
Institute
000989 p.000024: (http://www.ed.ac.uk/schools-departments/molecular-
000990 p.000024: clinical-medicine/health-services-research-unit/projects/safe-haven) collaboration, which have been set up,
000991 p.000024: respectively, to ensure the safe use of administrative data and patient and research data for medical research across
000992 p.000024: all diseases.
000993 p.000024: • Data such as the National Child Development Study (NCDS), where the inclusion of information such as a birth
date
000994 p.000024: or postcode makes disclosure possible, perhaps via a link to other datasets. This means that such data are ethically
000995 p.000024: sensitive.
000996 p.000024:
000997 p.000024: A data producer such as the Office for National Statistics (ONS) or other government departments may also have
...

...
001184 p.000028: involvement. Information should be provided in a form that is comprehensible and accessible to participants, typically
001185 p.000028: in written form (or in a form that participants can access after the end of the research interaction), and time should
001186 p.000028: be allowed for the participants to consider their choices and to discuss their decision with others if appropriate. The
001187 p.000028: consent forms should be signed off by the research participants to indicateconsent.
001188 p.000028:
001189 p.000028: Where participants are in a potentially vulnerable or dependent position (eg children) it is important to ensure that
001190 p.000028: they have the time and opportunity to access support in their decision-making, for example by discussing their choice
001191 p.000028: with a trusted adult. Where consent is sought from children it is normally good practice to secure permission from a
001192 p.000029: 29
001193 p.000029:
001194 p.000029: responsible adult in addition to child consent. Where participants are not literate verbal consent may be obtained, but
001195 p.000029: this should wherever possible include a recorded written witness sign-off. In other circumstances, for example
001196 p.000029: telephone interviews, this may not be possible. Where consent is not to be secured, a full statement justifying this
001197 p.000029: should be submitted to the REC for review. In longitudinal research and data archiving it may be necessary to explain
001198 p.000029: the need for (and limitations of) enduring consent (see Appendix C for a definition); it may also be necessary to
...

...
001984 p.000047: • Rehabilitation of Offenders Act 1974 www.legislation.gov.uk/ukpga/1974/53
001985 p.000047: • Rehabilitation of Offenders Act 1974 (Exceptions Order 1975)
www.legislation.gov.uk/uksi/2013/1198/contents/made
001986 p.000047: • The Rehabilitation of Offenders Act 1974 (Exceptions) Order 1975 (Amendment) (England and Wales) Order 2013.
001987 p.000047: www.legislation.gov.uk/uksi/2013/1198/contents/made
001988 p.000047: • Safeguarding Vulnerable Groups Act 2006 www.legislation.gov.uk/ukpga/2006/47/contents
001989 p.000047: • Protecting of Vulnerable Groups (Scotland) Act 2007 www.legislation.gov.uk/asp/2007/14/contents
001990 p.000047:
001991 p.000047: Other links
001992 p.000047: • Academy of social sciences (2013) Professional Briefings 3: Developing Generic Ethics Principles in Social
Science
001993 p.000047: Research http://acss.wpengine.com/wp- content/uploads/2013/11/pb3_genericethicsprinciples.pdf
001994 p.000047: • Dockett, S., Perry, B. (2011). Researching with young children: seeking assent. Child Indicators Research,
001995 p.000047: 4(2):231-247, DOI: 10.1007/s12187-010-9084-0 www.victoria.ac.nz/education/pdf/ethics/Docket-Perry-2011.pdf
001996 p.000048: 48
001997 p.000048:
001998 p.000048: • Ipsos-MORI Social Research Institute (2014). Dialogue on data
...

Searching for indicator children:

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...
000282 p.000006: Many student projects may require only a light-touch review. However, this cannot be assumed; projects, including
000283 p.000006: student projects, which involve more than minimal risk, should receive a full REC review. Some RECs have facilitated
000284 p.000006: ethics approval for research
000285 p.000007: 7
000286 p.000007:
000287 p.000007: with potentially vulnerable people by establishing ethics protocols for commonly occurring situations, such as research
000288 p.000007: undertaken with typically-developing children in mainstream school settings. If the researcher can confirm that they
000289 p.000007: are abiding by the established protocol and that this is appropriate for their research, a light-touch review may be
000290 p.000007: justified. The use of individual RO-approved research ethics protocols for commonly occurring situations may limit the
000291 p.000007: number of research proposals that need to go to a full ethics review.
000292 p.000007:
...

...
000306 p.000007: are not necessarily exempt from full review.
000307 p.000007:
000308 p.000007: Research potentially requiring a full ethics review
000309 p.000007: Research involving:
000310 p.000007:
000311 p.000007: • Potentially vulnerable people, for example children and young people, those with a learning disability or
000312 p.000007: cognitive impairment, or potentially vulnerable individuals in a dependent or unequal relationship.
000313 p.000007:
000314 p.000007: • People who lack capacity to make decisions or who during the research project come to lackcapacity. Such
research
000315 p.000007: should be reviewed by an appropriate body operating under the Mental Capacity Act 2005
000316 p.000007:
...

...
000342 p.000008: • Administrative or controlled data. Appropriate approval within the relevant governance regime(s) is needed for use
000343 p.000008: of these datasets. In many cases a light-touch review confirming that researchers have met these requirements will be
000344 p.000008: sufficient. Issues however may arise when data are linked and where it may be possible to identify participants.
000345 p.000008:
000346 p.000008: • Individuals or groups where permission of a gatekeeper is normally required for initial or continued access to
000347 p.000008: participants. This includes research involving gatekeepers such as adult professionals (eg those working with children
000348 p.000008: or the elderly), or research in communities (in the UK or overseas) whereaccess to research participants is not
000349 p.000008: possible without the permission of another adult, such as another family member (eg the parent or husband of the
000350 p.000008: participant) or a community leader, and research where participants are in a dependent relationship with the
gatekeeper
000351 p.000008: (eg employees recruited through their workplace). Permission for access to other groups, for example participants in a
...

...
000463 p.000011: critical to the research, such as in statements by public officials. For research that involves the use of social
000464 p.000011: media, researchers will also need to abide by the regulations set by the data producers subject to such regulations
000465 p.000011: being consistent with legal and ethical guidelines (see also internet-mediated research in FAQs). The potential for
000466 p.000011: identifiabilty of online sources, as well as ethical debates about how privacy is constituted in digital contexts,
000467 p.000011: means that full ethics review may be appropriate for research involving these communities. For example, people often
000468 p.000011: assume that social media sources are public domain, but it is quite likely that some service users – including
children
000469 p.000011: – may not understand the implications of what they are doing, and those harvesting data may also uncover illegal
images
000470 p.000011: or activities.
000471 p.000011:
000472 p.000011: Research that involves anonymised records and datasets that exist in the public domain may only require a light-touch
...

...
000928 p.000022: research will still need to
000929 p.000023: 23
000930 p.000023:
000931 p.000023: adhere to professional codes of practice, legal requirements and compliance with the Data Protection Act, 1998.
000932 p.000023:
000933 p.000023: Work with potentially vulnerable groups
000934 p.000023: In most cases, researchers working with vulnerable people will need to secure Disclosure and Barring Service (DBS)
000935 p.000023: clearance (https://www.gov.uk/government/organisations/disclosure-and-barring-service). The DBS offers
organisations a
000936 p.000023: means to check the criminal record of researchers to ensure that they do not have a history that would make them
000937 p.000023: unsuitable for work involving children and vulnerable adults. The responsibility for ensuring that applicants are
000938 p.000023: suitable to work with such groups ultimately rests with individual employers. In some cases other individuals (such as
000939 p.000023: a head teacher or social services manager) may be better placed to provide information on necessary disclosures (see
000940 p.000023: the Safeguarding Vulnerable Groups Act 2006 (http://www.legislation.gov.uk/ukpga/2006/47/contents); Rehabilitation
of
000941 p.000023: Offenders Act 1974 (http://www.legislation.gov.uk/ukpga/1974/53); the Rehabilitation of Offenders Act 1974
(Exceptions
000942 p.000023: Order 1975 (http://www.legislation.gov.uk/uksi/2013/1198/contents/made)).
000943 p.000023:
000944 p.000023: Proxy consent
000945 p.000023: Proxy consent can be obtained by a person authorised to act on behalf of avulnerable person. Where proxy consent
for
000946 p.000023: research participants is necessary, the best interests of the vulnerable person should be of the highest importance.
000947 p.000023: Proxy consent should only be used when participants are unable toconsent themselves or where it is legally
necessary.
000948 p.000023: Care should be taken when consent cannot be sought from the participants, and it should not be assumed that
agreement
000949 p.000023: cannot be sought from children because of their age.
000950 p.000023: When proxy consent is used agreed criteria should be provided to confirm participants fully understands to what they
000951 p.000023: are participating, and criteria identifying signs of participants’ unwillingness to take part or wishing to terminate
000952 p.000023: the research interaction.
000953 p.000023:
000954 p.000023: Limits to confidentiality
000955 p.000023: Researchers should, when eliciting consent, make clear the limits to confidentiality, particularly when working with
000956 p.000023: potentially vulnerable individuals or groups - for example when undertaking research withchildren, families and
000957 p.000023: vulnerable populations, or individuals involved in illegal activities. If for example an interview reveals that a
000958 p.000023: participant or another person identified in the interview is in significant danger, the researcher will be obliged to
000959 p.000023: take action in response to that disclosure. Researchers should have established procedures, necessary systems and
000960 p.000023: appropriate contacts in place to activate help and support in the event of a disclosure. If the researcher feels it is
000961 p.000023: necessary to break confidentiality, the participant should normally be informed what action is being taken by the
...

...
001184 p.000028: involvement. Information should be provided in a form that is comprehensible and accessible to participants, typically
001185 p.000028: in written form (or in a form that participants can access after the end of the research interaction), and time should
001186 p.000028: be allowed for the participants to consider their choices and to discuss their decision with others if appropriate. The
001187 p.000028: consent forms should be signed off by the research participants to indicateconsent.
001188 p.000028:
001189 p.000028: Where participants are in a potentially vulnerable or dependent position (eg children) it is important to ensure that
001190 p.000028: they have the time and opportunity to access support in their decision-making, for example by discussing their choice
001191 p.000028: with a trusted adult. Where consent is sought from children it is normally good practice to secure permission from a
001192 p.000029: 29
001193 p.000029:
001194 p.000029: responsible adult in addition to child consent. Where participants are not literate verbal consent may be obtained, but
001195 p.000029: this should wherever possible include a recorded written witness sign-off. In other circumstances, for example
001196 p.000029: telephone interviews, this may not be possible. Where consent is not to be secured, a full statement justifying this
001197 p.000029: should be submitted to the REC for review. In longitudinal research and data archiving it may be necessary to explain
001198 p.000029: the need for (and limitations of) enduring consent (see Appendix C for a definition); it may also be necessary to
...

...
001224 p.000029: eligible to a free prize draw; it should be clear that potential participants can enter the prize draw even if they
001225 p.000029: don’t answer the questions in the survey, and incentives should not be offered that require the respondent to
spend
001226 p.000029: money. If you are planning to use this approach the Market Research Society
001227 p.000029: (https://www.mrs.org.uk/standards/downloads/2008-01-
001228 p.000029: 18%20Incentives%20and%20Free%20Prize%20Draws.pdf?SESSID=hbt5j57mhnb2vrs0pfsrs2 hma0) has published
useful guidelines on
001229 p.000029: using free prize draws. Where children are involved, it is often appropriate to acknowledge their help with personal
001230 p.000029: gifts, for example gift vouchers or gifts to participating schools. Incentives may be permissible, but anything which
001231 p.000029: implies coercion is not.
001232 p.000029:
001233 p.000029:
...

...
001280 p.000031: aims and objectives of the research and given the opportunity to withdraw their data from the study (eg experimental
001281 p.000031: studies involving deception). Researchers should also ensure they have received the relevant permission from
001282 p.000031: gatekeepers where necessary to undertake the research, for example from the relevant public sector organisation to
001283 p.000031: undertake research on public sector property.
001284 p.000031:
001285 p.000031: How do you obtain consent from potentially vulnerable people?
001286 p.000031: In cases where research involves potentially vulnerable groups, for example children, older persons or adults with
001287 p.000031: learning disabilities (for those who fall under the remit of the Mental Capacity Act 2005/ Adults with Incapacity
001288 p.000031: (Scotland) Act 2000 see below), every effort should be made to secure actively given informed consent from individual
001289 p.000031: participants. Passive assent, including group assent (with consent given by a gatekeeper) should be avoided wherever
001290 p.000031: possible, and every effort should be made to develop methods of seeking consent that are appropriate to the groups
001291 p.000031: being studied, using expert advice, support and training where necessary.
001292 p.000031:
001293 p.000031: In the case of research on children, one cannot expect parents alone to provide approval on theirchildren’s
behalf. In
001294 p.000031: such cases, every effort should be made to deal with consent through dialogue with both children and their parents
(or
001295 p.000031: legal equivalent). Researchers should consider whether mature children can confirm consent without adult approval,
for
001296 p.000031: example there may be circumstances where seeking consent from parents could jeopardise the research (for
example, in
001297 p.000031: research into teenage sexuality or alcohol use). In such circumstances, researchers will need to regard the potential
001298 p.000031: risk to the principal participants of the research as a priority.
001299 p.000031:
...
...
001493 p.000035: Does the study involve participants age 16 or over who are unable to give informedconsent? (eg people with learning
001494 p.000035: disabilities: see Mental Capacity Act 2005/ Adults with Incapacity (Scotland) Act 2000. All research that falls under
001495 p.000035: the auspices MCA/AWI should be reviewed by a recognised and appropriate REC operating under GAfREC or
Scotland ‘A’
001496 p.000035: REC).
001497 p.000035: Research that may need a full review
001498 p.000035: Does the research involve other potentially vulnerable groups: children, those with cognitive impairment, or those in
001499 p.000035: unequal relationships? (eg your own students)
001500 p.000035: Will the study require the co-operation of a gatekeeper for initial
001501 p.000036: 36
001502 p.000036:
...

...
001575 p.000037: o anyone else be put at risk as a consequence of this research
001576 p.000037: • What might these risks be?
001577 p.000037: • How can these risks be addressed?
001578 p.000037: • How will you protect your data at the research site and away from the research site?
001579 p.000037: • Details and recruitment of participants:
001580 p.000037: o What types of people will be recruited? Eg students, children, people with learning disabilities, elderly
001581 p.000037: o How will the competence of participants to give informed consent be determined?
001582 p.000038: 38
001583 p.000038:
001584 p.000038: o How, where, and by whom participants will be identified, approached, and recruited?
...

...
001739 p.000041: obtained and linked for specific approved projects (eg the Administrative Data Research Network
001740 p.000041: (http://www.adrn.ac.uk/)). ESRC data service providers may also provide user support, training and strategic data
001741 p.000041: related advice.
001742 p.000041:
001743 p.000041: Ethics protocols: The use of approved protocols for commonly occurring situations such as research with normally
001744 p.000041: developing children in schools. These can expedite ethics review as principal investigators can confirm in a
001745 p.000041: light-touch review to their REC that there is an approved protocol that appropriately covers the ethics issues raise by
001746 p.000041: their research. It will be the responsibility of the local REC to approve the suggested protocol for the work.
001747 p.000041:
001748 p.000041: Expedited review: In exceptional circumstances, it may be necessary for a proposal involving possible risk of harm to
...

...
001887 p.000045: 45
001888 p.000045:
001889 p.000045: http://conventions.coe.int/Treaty/Commun/QueVoulezVous.asp?NT=005&CM=7&DF= 16/01/2015&CL=ENG
001890 p.000045: • Department for Business, Innovation and Skills– Universal ethical code for scientists (2007)
001891 p.000045: www.gov.uk/government/publications/universal-ethical-code-for-scientists
001892 p.000045: • Ethical Research Involving Children (ERIC) www.childethics.com/
001893 p.000045: • European Science Foundation (2011). European code of Conduct for Research Integrity
001894 p.000045: www.esf.org/fileadmin/Public_documents/Publications/Code_Conduct_ResearchIntegri ty.pdf
001895 p.000045: • Human Tissue Authority (2014). Code of Practice
www.hta.gov.uk/policiesandcodesofpractice/codesofpractice.cfm
001896 p.000045: • International Visual Sociology Association (2009). Code of Research Ethics and Guidelines
...

...
001984 p.000047: • Rehabilitation of Offenders Act 1974 www.legislation.gov.uk/ukpga/1974/53
001985 p.000047: • Rehabilitation of Offenders Act 1974 (Exceptions Order 1975)
www.legislation.gov.uk/uksi/2013/1198/contents/made
001986 p.000047: • The Rehabilitation of Offenders Act 1974 (Exceptions) Order 1975 (Amendment) (England and Wales) Order 2013.
001987 p.000047: www.legislation.gov.uk/uksi/2013/1198/contents/made
001988 p.000047: • Safeguarding Vulnerable Groups Act 2006 www.legislation.gov.uk/ukpga/2006/47/contents
001989 p.000047: • Protecting of Vulnerable Groups (Scotland) Act 2007 www.legislation.gov.uk/asp/2007/14/contents
001990 p.000047:
001991 p.000047: Other links
001992 p.000047: • Academy of social sciences (2013) Professional Briefings 3: Developing Generic Ethics Principles in Social
Science
001993 p.000047: Research http://acss.wpengine.com/wp- content/uploads/2013/11/pb3_genericethicsprinciples.pdf
001994 p.000047: • Dockett, S., Perry, B. (2011). Researching with young children: seeking assent. Child Indicators Research,
001995 p.000047: 4(2):231-247, DOI: 10.1007/s12187-010-9084-0 www.victoria.ac.nz/education/pdf/ethics/Docket-Perry-2011.pdf
001996 p.000048: 48
001997 p.000048:
001998 p.000048: • Ipsos-MORI Social Research Institute (2014). Dialogue on data
...
Searching for indicator vulnerable:

(return to top)
...
000282 p.000006: Many student projects may require only a light-touch review. However, this cannot be assumed; projects, including
000283 p.000006: student projects, which involve more than minimal risk, should receive a full REC review. Some RECs have facilitated
000284 p.000006: ethics approval for research
000285 p.000007: 7
000286 p.000007:
000287 p.000007: with potentially vulnerable people by establishing ethics protocols for commonly occurring situations, such as research
000288 p.000007: undertaken with typically-developing children in mainstream school settings. If the researcher can confirm that they
000289 p.000007: are abiding by the established protocol and that this is appropriate for their research, a light-touch review may be
000290 p.000007: justified. The use of individual RO-approved research ethics protocols for commonly occurring situations may limit the
000291 p.000007: number of research proposals that need to go to a full ethics review.
000292 p.000007:
...

...
000306 p.000007: are not necessarily exempt from full review.
000307 p.000007:
000308 p.000007: Research potentially requiring a full ethics review
000309 p.000007: Research involving:
000310 p.000007:
000311 p.000007: • Potentially vulnerable people, for example children and young people, those with a learning disability or
000312 p.000007: cognitive impairment, or potentially vulnerable individuals in a dependent or unequal relationship.
000313 p.000007:
000314 p.000007: • People who lack capacity to make decisions or who during the research project come to lackcapacity. Such
research
000315 p.000007: should be reviewed by an appropriate body operating under the Mental Capacity Act 2005
000316 p.000007:
...

...
000608 p.000015:
000609 p.000015: • Aims of the research and scientific background of the research.
000610 p.000015: • Study design.
000611 p.000015: • Participants – who (inclusion and exclusion criteria), how many, how potential participants are identified and
000612 p.000015: recruited.
000613 p.000015: • Potentially vulnerable individuals or groups.
000614 p.000015: • Methods of data collection and analysis.
000615 p.000015: • Response to any conditions of use set by data custodians and data producers.
000616 p.000015: • Principal investigator’s summary of potential ethics issues and how they will be addressed. For projects that
000617 p.000015: include non-academic or international collaborators, this summary should be agreed by all parties.
...

...
000928 p.000022: research will still need to
000929 p.000023: 23
000930 p.000023:
000931 p.000023: adhere to professional codes of practice, legal requirements and compliance with the Data Protection Act, 1998.
000932 p.000023:
000933 p.000023: Work with potentially vulnerable groups
000934 p.000023: In most cases, researchers working with vulnerable people will need to secure Disclosure and Barring Service (DBS)
000935 p.000023: clearance (https://www.gov.uk/government/organisations/disclosure-and-barring-service). The DBS offers
organisations a
000936 p.000023: means to check the criminal record of researchers to ensure that they do not have a history that would make them
000937 p.000023: unsuitable for work involving children and vulnerable adults. The responsibility for ensuring that applicants are
000938 p.000023: suitable to work with such groups ultimately rests with individual employers. In some cases other individuals (such as
000939 p.000023: a head teacher or social services manager) may be better placed to provide information on necessary disclosures (see
000940 p.000023: the Safeguarding Vulnerable Groups Act 2006 (http://www.legislation.gov.uk/ukpga/2006/47/contents); Rehabilitation
of
000941 p.000023: Offenders Act 1974 (http://www.legislation.gov.uk/ukpga/1974/53); the Rehabilitation of Offenders Act 1974
(Exceptions
000942 p.000023: Order 1975 (http://www.legislation.gov.uk/uksi/2013/1198/contents/made)).
000943 p.000023:
000944 p.000023: Proxy consent
000945 p.000023: Proxy consent can be obtained by a person authorised to act on behalf of avulnerable person. Where proxy consent
for
000946 p.000023: research participants is necessary, the best interests of the vulnerable person should be of the highest importance.
000947 p.000023: Proxy consent should only be used when participants are unable toconsent themselves or where it is legally
necessary.
000948 p.000023: Care should be taken when consent cannot be sought from the participants, and it should not be assumed that
agreement
000949 p.000023: cannot be sought from children because of their age.
000950 p.000023: When proxy consent is used agreed criteria should be provided to confirm participants fully understands to what they
000951 p.000023: are participating, and criteria identifying signs of participants’ unwillingness to take part or wishing to terminate
000952 p.000023: the research interaction.
000953 p.000023:
000954 p.000023: Limits to confidentiality
000955 p.000023: Researchers should, when eliciting consent, make clear the limits to confidentiality, particularly when working with
000956 p.000023: potentially vulnerable individuals or groups - for example when undertaking research withchildren, families and
000957 p.000023: vulnerable populations, or individuals involved in illegal activities. If for example an interview reveals that a
000958 p.000023: participant or another person identified in the interview is in significant danger, the researcher will be obliged to
000959 p.000023: take action in response to that disclosure. Researchers should have established procedures, necessary systems and
000960 p.000023: appropriate contacts in place to activate help and support in the event of a disclosure. If the researcher feels it is
000961 p.000023: necessary to break confidentiality, the participant should normally be informed what action is being taken by the
...

...
001184 p.000028: involvement. Information should be provided in a form that is comprehensible and accessible to participants, typically
001185 p.000028: in written form (or in a form that participants can access after the end of the research interaction), and time should
001186 p.000028: be allowed for the participants to consider their choices and to discuss their decision with others if appropriate. The
001187 p.000028: consent forms should be signed off by the research participants to indicateconsent.
001188 p.000028:
001189 p.000028: Where participants are in a potentially vulnerable or dependent position (eg children) it is important to ensure that
001190 p.000028: they have the time and opportunity to access support in their decision-making, for example by discussing their choice
001191 p.000028: with a trusted adult. Where consent is sought from children it is normally good practice to secure permission from a
001192 p.000029: 29
001193 p.000029:
001194 p.000029: responsible adult in addition to child consent. Where participants are not literate verbal consent may be obtained, but
001195 p.000029: this should wherever possible include a recorded written witness sign-off. In other circumstances, for example
...

...
001280 p.000031: aims and objectives of the research and given the opportunity to withdraw their data from the study (eg experimental
001281 p.000031: studies involving deception). Researchers should also ensure they have received the relevant permission from
001282 p.000031: gatekeepers where necessary to undertake the research, for example from the relevant public sector organisation to
001283 p.000031: undertake research on public sector property.
001284 p.000031:
001285 p.000031: How do you obtain consent from potentially vulnerable people?
001286 p.000031: In cases where research involves potentially vulnerable groups, for example children, older persons or adults with
001287 p.000031: learning disabilities (for those who fall under the remit of the Mental Capacity Act 2005/ Adults with Incapacity
001288 p.000031: (Scotland) Act 2000 see below), every effort should be made to secure actively given informed consent from individual
001289 p.000031: participants. Passive assent, including group assent (with consent given by a gatekeeper) should be avoided wherever
001290 p.000031: possible, and every effort should be made to develop methods of seeking consent that are appropriate to the groups
...

...
001493 p.000035: Does the study involve participants age 16 or over who are unable to give informedconsent? (eg people with learning
001494 p.000035: disabilities: see Mental Capacity Act 2005/ Adults with Incapacity (Scotland) Act 2000. All research that falls under
001495 p.000035: the auspices MCA/AWI should be reviewed by a recognised and appropriate REC operating under GAfREC or
Scotland ‘A’
001496 p.000035: REC).
001497 p.000035: Research that may need a full review
001498 p.000035: Does the research involve other potentially vulnerable groups: children, those with cognitive impairment, or those in
001499 p.000035: unequal relationships? (eg your own students)
001500 p.000035: Will the study require the co-operation of a gatekeeper for initial
001501 p.000036: 36
001502 p.000036:
...

...
001605 p.000038: • Have you considered what legal requirements your project will need to abide by? Eg Data Protection Act,
Freedom of
001606 p.000038: Information Act, Human Rights Act
001607 p.000038: • How will the ethics aspects of the project be monitored throughout its course?
001608 p.000038: • Is there an approved research ethics protocol that would be appropriate to use?
001609 p.000038: • How will unforeseen or adverse events in the course of research be managed? Eg do you have procedures to deal
with
001610 p.000038: any disclosures from vulnerable participants?
001611 p.000038: • Have you considered data management and curation? What measures have been taken to ensure confidentiality,
privacy
001612 p.000038: and data protection during and beyond the end of the project and to encourage data sharing and linkage? See the
ESRC
001613 p.000038: Research Data Policy.
001614 p.000038:
...
...
001652 p.000039: Yes No Light-touch
001653 p.000039: review by department REC
001654 p.000039:
001655 p.000039:
001656 p.000039:
001657 p.000039: Does the research involve NHS patients, records, equipment, premises or vulnerable people under the Mental
Capacity Act
001658 p.000039: 2005 and Adults with Incapacity (Scotland) Act 2000?
001659 p.000039:
001660 p.000039:
001661 p.000039:
...

...
001983 p.000047: www.legislation.gov.uk/ssi/2002/190/contents/made
001984 p.000047: • Rehabilitation of Offenders Act 1974 www.legislation.gov.uk/ukpga/1974/53
001985 p.000047: • Rehabilitation of Offenders Act 1974 (Exceptions Order 1975)
www.legislation.gov.uk/uksi/2013/1198/contents/made
001986 p.000047: • The Rehabilitation of Offenders Act 1974 (Exceptions) Order 1975 (Amendment) (England and Wales) Order 2013.
001987 p.000047: www.legislation.gov.uk/uksi/2013/1198/contents/made
001988 p.000047: • Safeguarding Vulnerable Groups Act 2006 www.legislation.gov.uk/ukpga/2006/47/contents
001989 p.000047: • Protecting of Vulnerable Groups (Scotland) Act 2007 www.legislation.gov.uk/asp/2007/14/contents
001990 p.000047:
001991 p.000047: Other links
001992 p.000047: • Academy of social sciences (2013) Professional Briefings 3: Developing Generic Ethics Principles in Social
Science
001993 p.000047: Research http://acss.wpengine.com/wp- content/uploads/2013/11/pb3_genericethicsprinciples.pdf
...

Social / Educational
Searching for indicator education:

(return to top)
...
000447 p.000011: activities below:
000448 p.000011:
000449 p.000011: • Routine audit
000450 p.000011: • Performance reviews
000451 p.000011: • Quality assurance studies
000452 p.000011: • Testing within normal education requirements
000453 p.000011: • Literary or artistic criticism.
000454 p.000011:
000455 p.000011: While data collected and stored as a record at an individual level are considered personal data, material already in
000456 p.000011: the public domain are not. For example, published biographies, newspaper accounts of an individual’s activities
and
...

...
000514 p.000012:
000515 p.000012: RECs should be multidisciplinary and comprised of both men and women. They should include at least one lay
member with
000516 p.000012: no affiliation to the RO in question. There should be a chairperson and members who have broad experience and
expertise
000517 p.000012: in the areas of research regularly reviewed by the REC and members who have the confidence and esteem of the
research
000518 p.000012: community. RECs would also benefit from including individuals who reflect ethnic diversity, users of specialist health,
000519 p.000012: education or social services (where these are the focus of research activities), individuals with experience of
000520 p.000012: professional care or counselling, and individuals with specific methodological expertise (for example, quantitative or
000521 p.000012: qualitative methods) relevant to the research they review. A REC should include among its membership people who
are
000522 p.000012: collectively familiar with a range of
000523 p.000013: 13
...

...
001990 p.000047:
001991 p.000047: Other links
001992 p.000047: • Academy of social sciences (2013) Professional Briefings 3: Developing Generic Ethics Principles in Social
Science
001993 p.000047: Research http://acss.wpengine.com/wp- content/uploads/2013/11/pb3_genericethicsprinciples.pdf
001994 p.000047: • Dockett, S., Perry, B. (2011). Researching with young children: seeking assent. Child Indicators Research,
001995 p.000047: 4(2):231-247, DOI: 10.1007/s12187-010-9084-0 www.victoria.ac.nz/education/pdf/ethics/Docket-Perry-2011.pdf
001996 p.000048: 48
001997 p.000048:
001998 p.000048: • Ipsos-MORI Social Research Institute (2014). Dialogue on data
001999 p.000048: www.esrc.ac.uk/_images/Dialogue_on_Data_report_tcm8-30270.pdf
...

Searching for indicator educational:

(return to top)
...
001871 p.000044: • Association of Internet Researchers (2012). Ethical decision-making and internet research 2.0
001872 p.000044: http://aoir.org/ethics/
001873 p.000044: • Association of Internet Researchers, Ethics guide http://ethics.aoir.org/index.php?title=Main_Page
001874 p.000044: • Association of Social Anthropologists of the UK and the Commonwealth (ASA) 2011. Ethical Guidelines for good
001875 p.000044: research practice www.theasa.org/ethics.shtml
001876 p.000044: • British Educational Research Association (2012) Ethics and Educational Research
001877 p.000044: www.bera.ac.uk/resources/ethics-and-educational-research
001878 p.000044: • British Psychological Society (2014) Code of Human Research Ethics
001879 p.000044: www.bps.org.uk/publications/policy-and-guidelines/research-guidelines-policy- documents/research-guidelines-poli
001880 p.000044: • British Psychological Society Ethics Guidelines for internet-mediated research (2013)
001881 p.000044: www.bps.org.uk/publications/policy-and-guidelines/research-guidelines-policy- documents/research-guidelines-poli
...

Social / Elderly
Searching for indicator elderly:

(return to top)
...
000343 p.000008: of these datasets. In many cases a light-touch review confirming that researchers have met these requirements will be
000344 p.000008: sufficient. Issues however may arise when data are linked and where it may be possible to identify participants.
000345 p.000008:
000346 p.000008: • Individuals or groups where permission of a gatekeeper is normally required for initial or continued access to
000347 p.000008: participants. This includes research involving gatekeepers such as adult professionals (eg those working with children
000348 p.000008: or the elderly), or research in communities (in the UK or overseas) whereaccess to research participants is not
000349 p.000008: possible without the permission of another adult, such as another family member (eg the parent or husband of the
000350 p.000008: participant) or a community leader, and research where participants are in a dependent relationship with the
gatekeeper
000351 p.000008: (eg employees recruited through their workplace). Permission for access to other groups, for example participants in a
000352 p.000008: long term cohort study, may also need to be requested from a data producer who controls access to the group.
...

...
001575 p.000037: o anyone else be put at risk as a consequence of this research
001576 p.000037: • What might these risks be?
001577 p.000037: • How can these risks be addressed?
001578 p.000037: • How will you protect your data at the research site and away from the research site?
001579 p.000037: • Details and recruitment of participants:
001580 p.000037: o What types of people will be recruited? Eg students, children, people with learning disabilities, elderly
001581 p.000037: o How will the competence of participants to give informed consent be determined?
001582 p.000038: 38
001583 p.000038:
001584 p.000038: o How, where, and by whom participants will be identified, approached, and recruited?
...

Social / Ethnicity
Searching for indicator ethnic:

(return to top)
...
000322 p.000007: which is operating under The Adults with Incapacity (Scotland) Act 2000
000323 p.000008: 8
000324 p.000008:
000325 p.000008: (http://www.legislation.gov.uk/asp/2000/4/section/10).
000326 p.000008: • Potentially sensitive topics, for example participants’ sexual behaviour, illegal or political behaviour,
000327 p.000008: experience of violence, abuse or exploitation, mental health, their personal or family lives, or their gender or ethnic
000328 p.000008: status. Elite interviews may also fall into this category.
000329 p.000008:
000330 p.000008: • Deceased persons. Researchers should adhere to relevant legislation ie Human Tissue Act 2004
000331 p.000008: (http://www.legislation.gov.uk/ukpga/2004/30/contents), Human Tissue (Sc) Act 2006
...

...
000513 p.000012: of the community and wider society as well as the researchers and funders of research.
000514 p.000012:
000515 p.000012: RECs should be multidisciplinary and comprised of both men and women. They should include at least one lay
member with
000516 p.000012: no affiliation to the RO in question. There should be a chairperson and members who have broad experience and
expertise
000517 p.000012: in the areas of research regularly reviewed by the REC and members who have the confidence and esteem of the
research
000518 p.000012: community. RECs would also benefit from including individuals who reflect ethnic diversity, users of specialist health,
000519 p.000012: education or social services (where these are the focus of research activities), individuals with experience of
000520 p.000012: professional care or counselling, and individuals with specific methodological expertise (for example, quantitative or
000521 p.000012: qualitative methods) relevant to the research they review. A REC should include among its membership people who
are
000522 p.000012: collectively familiar with a range of
...

...
001784 p.000042: individual who can be identified a) from those data or, b) from those data and other information which is in the
001785 p.000042: possession of, or is likely to come into the possession of, the data controller, and includes any expression of opinion
001786 p.000042: about the individual and any indication of the intentions of the data controller or any other person in respect of the
001787 p.000042: individual.
001788 p.000042:
001789 p.000042: Under this act, personal data consists of information as to (a) the racial or ethnic origin of the data subject, (b)
001790 p.000042: his/her political opinions, (c) his/her religious beliefs or other beliefs of a similar nature, (d) whether he/she is
001791 p.000042: a member of a trade union (within the meaning of the [1992 c. 52.] TradeUnion and Labour Relations (Consolidation)
Act
001792 p.000042: 1992), (e) his/her physical or mental health or condition, (f) his/her sexual life, (g) the commission or alleged
001793 p.000042: commission by him/her of any offence, or (h) any proceedings for any offence committed or alleged to have been
...

...
001999 p.000048: www.esrc.ac.uk/_images/Dialogue_on_Data_report_tcm8-30270.pdf
002000 p.000048: • Janssens ACJW, Kraft P (2012) Research Conducted Using Data Obtained through Online Communities: Ethical
002001 p.000048: Implications of Methodological Limitations. PLoS Med 9(10): e1001328. doi:10.1371/journal.pmed.1001328
002002 p.000048: www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1001328
002003 p.000048: • Observatory for Responsible Research and Innovation in ICT http://responsible- innovation.org.uk/torrii/
002004 p.000048: • Salway et al (2011) Ethnic diversity and inequality ethical and scientific rigour in social research. Joseph
002005 p.000048: Roundtree Foundation www.jrf.org.uk/publications/ethnic-diversity- social-research
002006 p.000048: • Stevens, Leslie A. and Laurie, Graeme, The Administrative Data Research Centre Scotland: A Scoping Report on
the
002007 p.000048: Legal & Ethical Issues Arising from Access & Linkage of Administrative Data (August 27, 2014). Edinburgh School of
Law
002008 p.000048: Research Paper No. 2014/35. Available at SSRN: http://ssrn.com/abstract=2487971 or
002009 p.000048: http://dx.doi.org/10.2139/ssrn.2487971
...

...
002093 p.000050: confidentially is afforded. Where necessary, the project information sheet will be translated, although it is
002094 p.000050: anticipated that English will be the lingua franca. Participation in the research will be voluntary, and informed
002095 p.000050: consent will be discussed with all participants. However, it is anticipated, particularly in the street surveys, that
002096 p.000050: verbal as opposed to signed consent, will be more readily obtainable.
002097 p.000050:
002098 p.000050: The first stage of data collection involves a socio-economic and spatial survey of a multi- ethnic street in each
002099 p.000050: respective city. Each shop unit is given a tracking code to relate the GIS spatial position to the survey material.
002100 p.000050: Personal identifiers are removed and the anonymity of participants will be secured through both research unit codes
and
002101 p.000050: pseudonyms. The raw data of each street survey will be collated in password protected computers and accessed by
the
002102 p.000050: principal investigator and the two research assistants. The data will then be systematised and stored in two
...

Social / Fetus/Neonate
Searching for indicator capacity:

(return to top)
...
000309 p.000007: Research involving:
000310 p.000007:
000311 p.000007: • Potentially vulnerable people, for example children and young people, those with a learning disability or
000312 p.000007: cognitive impairment, or potentially vulnerable individuals in a dependent or unequal relationship.
000313 p.000007:
000314 p.000007: • People who lack capacity to make decisions or who during the research project come to lackcapacity. Such
research
000315 p.000007: should be reviewed by an appropriate body operating under the Mental Capacity Act 2005
000316 p.000007:
000317 p.000007: • (http://www.legislation.gov.uk/ukpga/2005/9/contents ). Normally this will be a REC recognised by the Secretary of
000318 p.000007: State and Welsh Ministers and operating under the Health Research Authority (HRA) Governance Arrangements for
Research
000319 p.000007: Ethics Committees (GAfREC) (http://www.hra.nhs.uk/resources/research-legislation-and-
...

...
000367 p.000009: humiliation, or cause more than minimal distress.
000368 p.000009:
000369 p.000009: • Risk to the safety of the researcher, for example researchers working in the field and international research
000370 p.000009: assistants working outside the UK in their own community.
000371 p.000009:
000372 p.000009: • Members of the public in a research capacity in research data collection, eg participatory research.
000373 p.000009:
000374 p.000009: • International partners or research undertaken outside of the UK where there may be issues of local practice and
000375 p.000009: political sensitivities. In some cases partnership with a RO in the geographical area involved may prove helpful. It is
000376 p.000009: also necessary to act in accordance with the legal and ethics review requirements in the countries included in the
...

...
000884 p.000021: (http://www.hra.nhs.uk/resources/research-legislation-and-governance/governance-
000885 p.000021: arrangements-for-research-ethics-committees/)apply to research involving research participants recruited through the
000886 p.000021: NHS or Social Care services, and such research should be reviewed by a recognised and appropriate REC (see
Appendix D).
000887 p.000022: 22
000888 p.000022:
000889 p.000022: In addition, research involving adults who come under the remit of the Mental Capacity Act 2005
000890 p.000022: (http://www.legislation.gov.uk/ukpga/2005/9/contents) or the Adults with Incapacity (Scotland) Act 2000
000891 p.000022: (http://www.legislation.gov.uk/asp/2000/4/contents) requires review by a recognised and appropriate REC operating
under
000892 p.000022: the GAfREC (http://www.hra.nhs.uk/resources/research-legislation-and-governance/governance-
000893 p.000022: arrangements-for-research-ethics-committees/) or Scotland ‘A’ REC. For a full list of the research which
requires
000894 p.000022: HRA/NRES REC approval see the HRA approval decision tool (http://www.hra-decisiontools.org.uk/ethics/). The HRA
and NHS
000895 p.000022: Scotland research ethics service (http://www.nhsresearchscotland.org.uk/226_Research+Ethics.html) also provide
guidance
000896 p.000022: on the scope of the research provisions under the Mental Capacity Act 2005
000897 p.000022: (http://www.hra.nhs.uk/resources/research-legislation-and-governance/questions-and- answers-mental-capacity-act-
2005/)
000898 p.000022: and Adults with Incapacity (Scotland) Act 2000 (http://www.legislation.gov.uk/asp/2000/4/contents).
000899 p.000022:
000900 p.000022: 1.11 Legal and data protection requirements should be met
000901 p.000022: Data requirements
...

...
001103 p.000026:
001104 p.000026: How do you inform participants of potential risks?
001105 p.000026: Once potential risks have been identified, researchers should ensure that these are discussed with research
001106 p.000026: participants in order to secure valid consent. When presented with sufficient information individuals will usually be
001107 p.000026: able to use reasoned judgment to decide whether or not they wish to participate. There is also therefore the need to
001108 p.000026: ensure that potential participants have the capacity to understand the consequences (and risks) of
001109 p.000027: 27
001110 p.000027:
001111 p.000027: participating in order to give valid consent. ‘Capacity’ is legally defined under the terms of the MentalCapacity
Act
001112 p.000027: 2005 and the Adults with Incapacity (Scotland) Act 2000, and any projects that involve participants who fall under
001113 p.000027: these Acts must be reviewed by a ‘recognised’ REC operating under the GAfREC
(http://www.ukbiobank.ac.uk/ethics/) or
001114 p.000027: Scotland ‘A’ REC. The Mental Capacity Act 2005 applies to 16-17 year olds and adults (18 years and over)
who lack
001115 p.000027: capacity to make decisions because of an impairment, mental disorder or ‘disturbance in the functioning of the
mind and
001116 p.000027: brain’. Guidance on the Mental Capacity Act notes that lack of capacity to make a decision may be permanent or
001117 p.000027: temporary. It could be state-related (eg due to drug or alcohol use, or because of the person’s emotional state at
the
001118 p.000027: time). ‘Intrusive’ research involving people without capacity to consent should comply with the specific
provisions for
001119 p.000027: research (Sections 30-33 of the Mental Capacity Act 2005) in order to be lawful. Intrusive procedures are defined as
001120 p.000027: the ones requiring consent in law, including the use of personal information. Code of Practice under the Adults with
001121 p.000027: Incapacity Act clarifies that ‘an adult does not have impaired capacity simply by virtue of having an addiction,
001122 p.000027: psychotic illness or learning difficulties and disabilities’ (p.6). The Scottish Act states that the wishes of the
001123 p.000027: individual should be taken into account and any intervention should benefit the individual (Section 51 of the Adults
001124 p.000027: with Incapacity (Scotland) Act 2000). The key point for both Acts is that valid consent can only be secured if the
001125 p.000027: participant has capacity to make a decision at the timeconsent is sought. (see Department of Health, Mental
Capacity
001126 p.000027: Act 2005 and consent for research
001127 p.000027: (http://www.wales.gov.uk/dhss/publications/health/mentalhealth/mentalcapacityact/2117019
001128 p.000027: /mcaconsente.pdf?lang=en) and Adults with Incapacity Act 2000- Code of Practice, Part 5
001129 p.000027: (http://www.scotland.gov.uk/Publications/2010/10/20153801/4)).
...

...
001282 p.000031: gatekeepers where necessary to undertake the research, for example from the relevant public sector organisation to
001283 p.000031: undertake research on public sector property.
001284 p.000031:
001285 p.000031: How do you obtain consent from potentially vulnerable people?
001286 p.000031: In cases where research involves potentially vulnerable groups, for example children, older persons or adults with
001287 p.000031: learning disabilities (for those who fall under the remit of the Mental Capacity Act 2005/ Adults with Incapacity
001288 p.000031: (Scotland) Act 2000 see below), every effort should be made to secure actively given informed consent from individual
001289 p.000031: participants. Passive assent, including group assent (with consent given by a gatekeeper) should be avoided wherever
001290 p.000031: possible, and every effort should be made to develop methods of seeking consent that are appropriate to the groups
001291 p.000031: being studied, using expert advice, support and training where necessary.
...

...
001295 p.000031: legal equivalent). Researchers should consider whether mature children can confirm consent without adult approval,
for
001296 p.000031: example there may be circumstances where seeking consent from parents could jeopardise the research (for
example, in
001297 p.000031: research into teenage sexuality or alcohol use). In such circumstances, researchers will need to regard the potential
001298 p.000031: risk to the principal participants of the research as a priority.
001299 p.000031:
001300 p.000031: How do you obtain consent from participants who fall under the MentalCapacity Act 2005/ Adults with Incapacity
001301 p.000031: (Scotland) Act 2000?
001302 p.000031: In the case of research with adults who lack capacity to make a decision under the terms of the MentalCapacity Act
001303 p.000031: 2005 (http://www.legislation.gov.uk/ukpga/2005/9/contents) and Adults with Incapacity (Scotland) Act 2000
001304 p.000031: (http://www.legislation.gov.uk/asp/2000/4/contents), these projects must be reviewed by a ‘recognised’ REC or
Scotland
001305 p.000031: ‘A’ REC (Code of practice Mental Capacity Act 2005
(www.opsi.gov.uk/acts/acts2005/related/ukpgacop_20050009_en.pdf) and
001306 p.000031: Adults with Incapacity (Scotland) Act 2000 (http://www.scotland.gov.uk/Publications/2010/10/20153801/0)).
001307 p.000031:
001308 p.000031: The Mental Capacity Act states that researchers should assume that a person has capacity to make a decision;
unless
001309 p.000031: there is proof that they do not have capacity to make a specific decision, and that a potential participant must
001310 p.000031: receive support to try to help them make their own decision. The potential participant has the right to disagree with
001311 p.000031: the decisions that others (such as relatives or carers) might make.
001312 p.000031:
001313 p.000031: If it is established that an adult does not have the capacity to decide whether to participate, the MentalCapacity Act
001314 p.000031: 2005 requires that the researcher must consult with a specified consultee as set out in the Guidance to the Act (2008).
001315 p.000031: If possible, this should be a personal consultee. The researcher should take reasonable steps to identify someone
001316 p.000032: 32
001317 p.000032:
001318 p.000032: who knows the person well who lacks capacity to make a decision, but is not a professional or paid care worker; this
001319 p.000032: does not include family members receiving some of the person’s pension or other benefits as a payment towards
their
001320 p.000032: share of the household expenses. The guidance states that it should be someone whom the person who lacks
capacity to
001321 p.000032: make a decision would trust with important decisions about their welfare.
001322 p.000032: Thus, a personal consultee could be a family member or close friend of the person.
001323 p.000032:
001324 p.000032: If no personal consultee can be identified, a nominated consultee should be proposed by the researcher. This is
someone
...

...
001489 p.000035: Research that may need to be reviewed by NHS Research Ethics Committee or another external ethics committee (if
yes,
001490 p.000035: please give brief details as an annex)
001491 p.000035: Will the study involve recruitment of patients or staff through the NHS or the use of NHS data or premises and/or
001492 p.000035: equipment?
001493 p.000035: Does the study involve participants age 16 or over who are unable to give informedconsent? (eg people with learning
001494 p.000035: disabilities: see Mental Capacity Act 2005/ Adults with Incapacity (Scotland) Act 2000. All research that falls under
001495 p.000035: the auspices MCA/AWI should be reviewed by a recognised and appropriate REC operating under GAfREC or
Scotland ‘A’
001496 p.000035: REC).
001497 p.000035: Research that may need a full review
001498 p.000035: Does the research involve other potentially vulnerable groups: children, those with cognitive impairment, or those in
...

...
001515 p.000036: Will the study involve prolonged or repetitive testing?
001516 p.000036: Will the research involve administrative or secure data that requires permission from the appropriate authorities
001517 p.000036: before use?
001518 p.000036: Is there a possibility that the safety of the researcher may be in question? (eg lone working in international
001519 p.000036: research)
001520 p.000036: Does the research involve members of the public in a research capacity (participant research)?
001521 p.000036: Will the research take place outside the UK?
001522 p.000036: Will the research involve internet participants or other visual/vocal methods where participants may be identified?
001523 p.000036: Will research involve the sharing of data or confidential information beyond the initial consent given?
001524 p.000036: Will financial inducements (other than reasonable expenses and compensation for time) be offered to participants?
...

...
001652 p.000039: Yes No Light-touch
001653 p.000039: review by department REC
001654 p.000039:
001655 p.000039:
001656 p.000039:
001657 p.000039: Does the research involve NHS patients, records, equipment, premises or vulnerable people under the Mental
Capacity Act
001658 p.000039: 2005 and Adults with Incapacity (Scotland) Act 2000?
001659 p.000039:
001660 p.000039:
001661 p.000039:
...

...
001813 p.000043:
001814 p.000043: Transparency in research ethics: The full, accurate, and open disclosure of relevant information is always important.
001815 p.000043: Where the research involves new and innovative methodologies which raise distinctive considerations (eg online
001816 p.000043: research), this is especially important.
001817 p.000043:
001818 p.000043: Valid consent: Consent is valid if it meets three conditions: participant has capacity to make a decision; the process
001819 p.000043: is free from coercion; and the consent is informed. For consent to be ‘valid’ the participant must be capable of
001820 p.000043: understanding all the potential risks involved. Where this may be in doubt, the Mental Capacity Act 2005 and Adults
001821 p.000043: with Incapacity (Scotland) Act 2000 may apply (see Appendix D).
001822 p.000043:
001823 p.000043:
001824 p.000043:
...

...
001967 p.000047: • Human Tissue Act 2004 www.legislation.gov.uk/ukpga/2004/30/contents
001968 p.000047: • HRA Human Tissue Act 2004-Questions and Answers
001969 p.000047: www.hra.nhs.uk/resources/research-legislation-and-governance/questions-and-answers- the-human-tissue-act-2004/
001970 p.000047: • Human Tissue (Scotland) Act 2006 www.legislation.gov.uk/asp/2006/4/introduction
001971 p.000047: • The Medicines for Human Use (Clinical Trials) Regulations 2004
www.legislation.gov.uk/uksi/2004/1031/contents/made
001972 p.000047: • Mental Capacity Act 2005 www.legislation.gov.uk/ukpga/2005/9/contents
001973 p.000047: • Office of the Public Guardian (2014) Mental Capacity Act 2005: Code of Practice
001974 p.000047: https://www.gov.uk/government/publications/mental-capacity-act-code-of-practice
001975 p.000047: • HRA Mental Capacity Act 2005-Questions and Answers
001976 p.000047: www.hra.nhs.uk/resources/research-legislation-and-governance/questions-and-answers- mental-capacity-act-2005/
001977 p.000047: • Department of Health Mental Capacity Act and consent for research
001978 p.000047: http://wales.gov.uk/dhss/publications/health/mentalhealth/mentalcapacityact/2117019/m caconsente.pdf?lang=en
001979 p.000047: • Adults with Incapacity (Scotland) Act 2000 www.legislation.gov.uk/asp/2000/4/section/10
001980 p.000047: • Adults with Incapacity Act 2000: Code of practice (2010) For practitioners authorised to carry out medical
001981 p.000047: treatment or research under Part 5 of the Act www.scotland.gov.uk/Publications/2010/10/20153801/0
...
Social / Gender
Searching for indicator gender:

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...
000322 p.000007: which is operating under The Adults with Incapacity (Scotland) Act 2000
000323 p.000008: 8
000324 p.000008:
000325 p.000008: (http://www.legislation.gov.uk/asp/2000/4/section/10).
000326 p.000008: • Potentially sensitive topics, for example participants’ sexual behaviour, illegal or political behaviour,
000327 p.000008: experience of violence, abuse or exploitation, mental health, their personal or family lives, or their gender or ethnic
000328 p.000008: status. Elite interviews may also fall into this category.
000329 p.000008:
000330 p.000008: • Deceased persons. Researchers should adhere to relevant legislation ie Human Tissue Act 2004
000331 p.000008: (http://www.legislation.gov.uk/ukpga/2004/30/contents), Human Tissue (Sc) Act 2006
...

Social / In Nursing Home
Searching for indicator nursing home:

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...
001499 p.000035: unequal relationships? (eg your own students)
001500 p.000035: Will the study require the co-operation of a gatekeeper for initial
001501 p.000036: 36
001502 p.000036:
001503 p.000036: access to the groups or individuals to be recruited? (eg employees, students at school, members of self- help group,
001504 p.000036: residents of nursing home?)
001505 p.000036: Will it be necessary for participants to take part in the study without their knowledge and consent at the time? (eg
001506 p.000036: covert observation of people in non- public places, use of deception in experimental studies)
001507 p.000036: Will the study involve discussion of sensitive or potentially sensitive topics? (eg sexual activity, drug use, personal
001508 p.000036: lives)
...

Social / Incarcerated
Searching for indicator restricted:

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...
001749 p.000041: receive a full review at short notice. An expedited review is carried out by one or more members of a Research Ethics
001750 p.000041: Committee (REC), commonly its chair, and not by a member of the department due to carry out the research.
001751 p.000041:
001752 p.000041: Human participants: Human participants are defined as including living human beings, human beings who have
recently
001753 p.000041: died (cadavers, human remains and body parts), embryos and fetuses, human tissue and bodily fluids, and human
data and
001754 p.000041: records (such as, but not restricted to medical, genetic, financial, personnel, criminal or administrative records and
001755 p.000041: test results including scholastic achievements).
001756 p.000041:
001757 p.000041: Freely-given informed consent: Informed consent entails giving sufficient information about the research and ensuring
001758 p.000041: that there is no explicit or implicit coercion so that prospective participants can make an informed and free decision
...

Social / LGBTQ+ Status
Searching for indicator physically:

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...
001365 p.000033: care staff who are recruited as research participants by virtue of their professional role may require NHS REC review
001366 p.000033: only if they raise significant ethical issues. Please see the HRA approval decision tool
001367 p.000033: (http://www.hra-decisiontools.org.uk/ethics/).
001368 p.000033:
001369 p.000033: It is expected that a light-touch review by a REC will be able to provide an effective filter for projects that might
001370 p.000033: otherwise have been inappropriately sent to an NHS REC, including those that while involving a physically invasive
001371 p.000033: technique do not do so for clinical purposes. Similarly, the framework provides for review by a REC of large-scale,
001372 p.000033: longitudinal social science studies that may seek information relating to respondents’ personalhealth profile.
001373 p.000033:
001374 p.000033: 2.4 Internet-mediated research
...

Social / Linguistic Proficiency
Searching for indicator deceased:

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...
000325 p.000008: (http://www.legislation.gov.uk/asp/2000/4/section/10).
000326 p.000008: • Potentially sensitive topics, for example participants’ sexual behaviour, illegal or political behaviour,
000327 p.000008: experience of violence, abuse or exploitation, mental health, their personal or family lives, or their gender or ethnic
000328 p.000008: status. Elite interviews may also fall into this category.
000329 p.000008:
000330 p.000008: • Deceased persons. Researchers should adhere to relevant legislation ie Human Tissue Act 2004
000331 p.000008: (http://www.legislation.gov.uk/ukpga/2004/30/contents), Human Tissue (Sc) Act 2006
000332 p.000008: (http://www.legislation.gov.uk/asp/2006/4/contents) and to the relevant NHS policy requirements for REC reviews. See
000333 p.000008: also HTA Code of Practice (http://www.hta.gov.uk/legislationpoliciesandcodesofpractice/codesofpractice.cfm), NHS
000334 p.000008: Research Scotland (NRS) (http://www.nhsresearchscotland.org.uk/).
...

Social / Literacy
Searching for indicator literate:

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...
001189 p.000028: Where participants are in a potentially vulnerable or dependent position (eg children) it is important to ensure that
001190 p.000028: they have the time and opportunity to access support in their decision-making, for example by discussing their choice
001191 p.000028: with a trusted adult. Where consent is sought from children it is normally good practice to secure permission from a
001192 p.000029: 29
001193 p.000029:
001194 p.000029: responsible adult in addition to child consent. Where participants are not literate verbal consent may be obtained, but
001195 p.000029: this should wherever possible include a recorded written witness sign-off. In other circumstances, for example
001196 p.000029: telephone interviews, this may not be possible. Where consent is not to be secured, a full statement justifying this
001197 p.000029: should be submitted to the REC for review. In longitudinal research and data archiving it may be necessary to explain
001198 p.000029: the need for (and limitations of) enduring consent (see Appendix C for a definition); it may also be necessary to
...

...
001756 p.000041:
001757 p.000041: Freely-given informed consent: Informed consent entails giving sufficient information about the research and ensuring
001758 p.000041: that there is no explicit or implicit coercion so that prospective participants can make an informed and free decision
001759 p.000041: on their possible involvement. Typically, the information should be provided in written form, time should be allowed
001760 p.000041: for the participants to consider their choices and the forms should be signed off by the research participants to
001761 p.000041: indicate consent. Where participants are not literate, verbal consent may be obtained but this should wherever
possible
001762 p.000041: be witnessed and
001763 p.000042: 42
001764 p.000042:
001765 p.000042: recorded. In other circumstances, for example telephone interviews, written or witnessed consent may not be
possible,
...

Social / Marital Status
Searching for indicator engaged:

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...
000441 p.000010:
000442 p.000011: 11
000443 p.000011:
000444 p.000011: Within the definition of research, all data collection and analysis involving human participants and/or personal data
000445 p.000011: should undergo ethics review prior to the research commencing, with the exception of the following, which are not
000446 p.000011: considered ‘research’. However, ESRC would not usually provide funding to support a project engaged in only
these
000447 p.000011: activities below:
000448 p.000011:
000449 p.000011: • Routine audit
000450 p.000011: • Performance reviews
...
...
000811 p.000020:
000812 p.000020: 1.9 Arrangements should be made for collaborative research
000813 p.000020: The FRE guidelines should be drawn to the attention of all proposed collaborators or project partners, providing
000814 p.000020: co-funding or in-kind contribution, prior to a submission for funding. In many cases requirements can be satisfied by
000815 p.000020: the research being conducted in a FRE-compliant RO. If this is not the case, proposals submitted to ESRC should
confirm
000816 p.000020: that the research will adhere to our requirements. ROs engaged in collaborative research may agree to use the
services
000817 p.000020: of one of their RECs to review a joint project on behalf of all participants.
000818 p.000020:
000819 p.000020: Projects involving researchers from more than one RO can create complications for formal ethics review procedures.
ROs
000820 p.000020: and other partners engaged in collaborative research may agree to use the REC of the RO where the principal
000821 p.000020: investigator is based to review the project on behalf of all participants. A single review process should be agreed by
000822 p.000020: all researchers, the standards of which should at least satisfy the ESRC minimum ethics requirements. Researchers
and
000823 p.000020: their co-producing partners also need to agree to an iterative and shared process of ethics review as the project
000824 p.000020: develops. Each RO needs to be satisfied that the research proposal has been properly scrutinised by the appropriate
000825 p.000020: REC, for example the principal investigator’s REC, and that regular monitoring of the conduct of the research is
taking
...

Searching for indicator single:

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...
000154 p.000003: rests with the principal investigator and the administering RO. However all researchers are expected to take personal
000155 p.000003: responsibility for undertaking research to the highest ethical standards.
000156 p.000003:
000157 p.000003: • Responsibility for determining the appropriate ethics review required lies with the principal investigator and the
000158 p.000003: research team. Ensuring that research is subject to appropriate ethics review and monitoring lies with the RO seeking
000159 p.000003: or administering an ESRC grant. A single review process should be agreed in collaborative research involving more
than
000160 p.000003: one organisation or multi-discipline research. The applicant should ensure that participating organisations and
000161 p.000003: collaborative researchers are satisfied that the research proposal has received adequate ethics review, and that
000162 p.000003: regular monitoring of the conduct of the research takes place and is promptly reported to all organisations or
000163 p.000003: multi-discipline researchers involved.
...

...
000811 p.000020:
000812 p.000020: 1.9 Arrangements should be made for collaborative research
000813 p.000020: The FRE guidelines should be drawn to the attention of all proposed collaborators or project partners, providing
000814 p.000020: co-funding or in-kind contribution, prior to a submission for funding. In many cases requirements can be satisfied by
000815 p.000020: the research being conducted in a FRE-compliant RO. If this is not the case, proposals submitted to ESRC should
confirm
000816 p.000020: that the research will adhere to our requirements. ROs engaged in collaborative research may agree to use the
services
000817 p.000020: of one of their RECs to review a joint project on behalf of all participants.
000818 p.000020:
000819 p.000020: Projects involving researchers from more than one RO can create complications for formal ethics review procedures.
ROs
000820 p.000020: and other partners engaged in collaborative research may agree to use the REC of the RO where the principal
000821 p.000020: investigator is based to review the project on behalf of all participants. A single review process should be agreed by
000822 p.000020: all researchers, the standards of which should at least satisfy the ESRC minimum ethics requirements. Researchers
and
000823 p.000020: their co-producing partners also need to agree to an iterative and shared process of ethics review as the project
000824 p.000020: develops. Each RO needs to be satisfied that the research proposal has been properly scrutinised by the appropriate
000825 p.000020: REC, for example the principal investigator’s REC, and that regular monitoring of the conduct of the research is
taking
...

...
000872 p.000021: possible, of common standards, and if not it should be made clear where researchers should go for advice.
000873 p.000021:
000874 p.000021: 1.10 Duplication of submission should be avoided
000875 p.000021: Researchers and ROs should avoid duplication of ethics review. The appropriate review body will be determined by
the
000876 p.000021: issues raised by the research, the nature of the data to be obtained and the population of participants to be included
000877 p.000021: in the study. This will apply to both single-discipline research and interdisciplinary research, especially where
000878 p.000021: social and biomedical scientists are working together. For a full review ESRC does not require an organisational REC
000879 p.000021: and a NHS REC to be involved. Researchers should submit proposals either to the REC of their RO or to HRA
000880 p.000021: (http://www.hra.nhs.uk/) for review by NHS RECs across the UK, including the Gene Therapy Advisory Committee
(GTAC),
000881 p.000021: and to the Social Care REC.
...

Social / Philosophical Differences/Difference of Opinion
Searching for indicator opinion:

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...
001780 p.000042: example), should be completed for all social science research projects. RECs need to confirm that only a light-touch
001781 p.000042: review is justified.
001782 p.000042:
001783 p.000042: Personal data: Under the Data Protection Act 1998 ‘personal data’ is defined as data which relates to a living
001784 p.000042: individual who can be identified a) from those data or, b) from those data and other information which is in the
001785 p.000042: possession of, or is likely to come into the possession of, the data controller, and includes any expression of opinion
001786 p.000042: about the individual and any indication of the intentions of the data controller or any other person in respect of the
001787 p.000042: individual.
001788 p.000042:
001789 p.000042: Under this act, personal data consists of information as to (a) the racial or ethnic origin of the data subject, (b)
...

Social / Police Officer
Searching for indicator officer:

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...
000204 p.000004: • Funded proposals should normally commence no sooner than three months after the formal notification of funding
to
000205 p.000004: allow for recruitment of staff and ethics review. If an ethics review is required at a later stage in the project, this
000206 p.000004: should be discussed with us when confirmation of funding is received, and funding arrangements will need to be
000207 p.000005: 5
000208 p.000005:
000209 p.000005: agreed with the lead ESRC officer. At a minimum we expect that ethics review will be carried out prior to the stage in
000210 p.000005: the project that the research will be undertaken. In those cases where it is agreed that ethics review is to be
000211 p.000005: undertaken after the project funding has commenced, funds will be made available to cover the period through to the
000212 p.000005: completion of the review, and continued funding will be conditional on the outcome of the ethics review.
000213 p.000005:
...

...
000418 p.000010: As research progresses, further ethical issues may arise. Principal investigators should check through the implications
000419 p.000010: of the issues and have these reviewed by the appropriate REC. Non-conflicting advisory bodies, independent experts
and
000420 p.000010: mentors may also assist in this process. Ongoing monitoring should be proportionate to the nature and degree of risk
000421 p.000010: and harm entailed in the research. If ongoing review by a REC shows that a project requires major changes in the
000422 p.000010: lifetime of the research, which will alter it so much that it can no longer attract ESRC support, this should be
000423 p.000010: referred to the lead ESRC officer.
000424 p.000010:
000425 p.000010: Pathways to impact and dissemination
000426 p.000010: Risk to researchers, participants and others (eg potentially stigmatised or marginalised groups) as a result of
000427 p.000010: potential impact, knowledge exchange and dissemination activity should be considered as part of the ethical
information
...

...
000727 p.000018: 1.6 Complaints, appeals and conflict of interest procedures should be in place
000728 p.000018: Complaints - ROs should publish procedures and mechanisms for receiving and addressing, in a timely manner,
complaints
000729 p.000018: or expressions of concern about the conduct of research carried out under their auspices. Such complaints would
000730 p.000018: normally be regarded as allegations of either poor performance or unethical conduct and would appropriately be
000731 p.000018: addressed through the RO’s procedures for dealing with such allegations. Such mechanisms might include
providing
000732 p.000018: research participants with the contact details of a responsible officer within the RO who is independent of specific
000733 p.000018: research projects and is empowered to instigate appropriate investigation of any complaints in a timely manner.
000734 p.000018:
000735 p.000018: Appeals – ROs should publish procedures and mechanisms for receiving and addressing, in a timely manner,
appeals from
000736 p.000018: researchers. Where a decision has gone against a proposal or has required significant revisions to its conduct, the
...

...
001544 p.000037: Faculty/School Ethics Committee for their records.
001545 p.000037:
001546 p.000037: If you have answered ‘yes’ to any of the other questions in the Research checklist, you will need to describe
more
001547 p.000037: fully how you plan to deal with the ethics issues raised by your research. Your proposal will need to be reviewed by
001548 p.000037: the REC. You should submit your plans for addressing the ethics issues raised by your proposal using an ethics
review
001549 p.000037: application form, which should be sent to the Faculty/School/ Department Research Ethics Officer. Forms can be
obtained
001550 p.000037: from the Faculty/School/Department/University website.
001551 p.000037:
001552 p.000037: Please note that it is your responsibility to follow the RO’s Code of Practice on Ethical Standards and any relevant
001553 p.000037: academic or professional guidelines in the conduct of your study. This includes providing appropriate information
001554 p.000037: sheets and consent forms, and ensuring confidentiality in the storage and use of data. Any significant change in the
001555 p.000037: question, design or conduct over the course of the research should be notified to the Faculty/School Research Ethics
001556 p.000037: Officer and may require a new application for ethics review.
001557 p.000037:
001558 p.000037: Points to consider when planning research
001559 p.000037:
001560 p.000037: This section aims to facilitate the process of considering ethics around social science research: it is not intended to
...

Social / Property Ownership
Searching for indicator home:

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...
001499 p.000035: unequal relationships? (eg your own students)
001500 p.000035: Will the study require the co-operation of a gatekeeper for initial
001501 p.000036: 36
001502 p.000036:
001503 p.000036: access to the groups or individuals to be recruited? (eg employees, students at school, members of self- help group,
001504 p.000036: residents of nursing home?)
001505 p.000036: Will it be necessary for participants to take part in the study without their knowledge and consent at the time? (eg
001506 p.000036: covert observation of people in non- public places, use of deception in experimental studies)
001507 p.000036: Will the study involve discussion of sensitive or potentially sensitive topics? (eg sexual activity, drug use, personal
001508 p.000036: lives)
...

Social / Racial Minority
Searching for indicator racial:

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...
001784 p.000042: individual who can be identified a) from those data or, b) from those data and other information which is in the
001785 p.000042: possession of, or is likely to come into the possession of, the data controller, and includes any expression of opinion
001786 p.000042: about the individual and any indication of the intentions of the data controller or any other person in respect of the
001787 p.000042: individual.
001788 p.000042:
001789 p.000042: Under this act, personal data consists of information as to (a) the racial or ethnic origin of the data subject, (b)
001790 p.000042: his/her political opinions, (c) his/her religious beliefs or other beliefs of a similar nature, (d) whether he/she is
001791 p.000042: a member of a trade union (within the meaning of the [1992 c. 52.] TradeUnion and Labour Relations (Consolidation)
Act
001792 p.000042: 1992), (e) his/her physical or mental health or condition, (f) his/her sexual life, (g) the commission or alleged
001793 p.000042: commission by him/her of any offence, or (h) any proceedings for any offence committed or alleged to have been
...

Social / Religion
Searching for indicator religious:

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...
001785 p.000042: possession of, or is likely to come into the possession of, the data controller, and includes any expression of opinion
001786 p.000042: about the individual and any indication of the intentions of the data controller or any other person in respect of the
001787 p.000042: individual.
001788 p.000042:
001789 p.000042: Under this act, personal data consists of information as to (a) the racial or ethnic origin of the data subject, (b)
001790 p.000042: his/her political opinions, (c) his/her religious beliefs or other beliefs of a similar nature, (d) whether he/she is
001791 p.000042: a member of a trade union (within the meaning of the [1992 c. 52.] TradeUnion and Labour Relations (Consolidation)
Act
001792 p.000042: 1992), (e) his/her physical or mental health or condition, (f) his/her sexual life, (g) the commission or alleged
001793 p.000042: commission by him/her of any offence, or (h) any proceedings for any offence committed or alleged to have been
001794 p.000042: committed by him/her, the disposal of such proceedings or the sentence of any court in such proceedings.
...

Searching for indicator special:

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...
000696 p.000017: ROs should undertake occasional ad hoc audits of ESRC-funded research. How often this is done will depend on the
amount
000697 p.000017: of ESRC research undertaken in the RO. In major ROs it is anticipated that a REC should undertake an audit of at
least
000698 p.000017: one ESRC research project per year, randomly chosen, or in the case of a large centre, part of a project.
000699 p.000017: Principal investigators and supervisors of students need to know that they should keep good records of their ethics
000700 p.000017: procedures in case they are called to account. This could be a desk-based exercise, asking to see the consent
000701 p.000017: documents, other special permissions and relevant paperwork, information on data storage and data sharing, as well
as a
000702 p.000017: note from the principal investigator on changes that have been made, and highlighting specific problems.
000703 p.000017:
000704 p.000017: Where a REC or a designated sub-committee considers that a monitoring report or ad hoc audit has raised significant
000705 p.000017: concerns about the ethics in the conduct of the study, it should request a full and detailed account of the research
...

Social / Social
Searching for indicator social:

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...
000031 p.000033: Appendix E: Example of ethical information in ESRC proposal 50
000032 p.000033: Example of a completed Ethical Information section on ESRC proposal 50
000033 p.000001: 1
000034 p.000001:
000035 p.000001: Introduction
000036 p.000001: The Economic and Social Research Council (ESRC), in facilitating innovative and high quality research, expects that
the
000037 p.000001: research we support will be carried out to a high ethical standard. By establishing the Framework for Research Ethics
000038 p.000001: (FRE) we confirm our commitment to a process of regular review through consultation with the research community
and
000039 p.000001: stakeholders, to ensure ethical standards reflect changing scientific agendas and policy developments.
000040 p.000001:
000041 p.000001: This document establishes key principles and minimum requirements and confirms what we regard as good practice for
all
000042 p.000001: social science research. It also identifies requirements for ethics review for the research we are asked to support.
000043 p.000001: Whilst adherence to these requirements is mandatory for ESRC-funded research, the guidance is also a useful tool to
000044 p.000001: other audiences including other funders, research organisations (ROs), Research Ethics Committees (RECs),
individual
000045 p.000001: researchers, research teams (including teams with non- academic researchers) and research participants.
000046 p.000001:
...

...
000372 p.000009: • Members of the public in a research capacity in research data collection, eg participatory research.
000373 p.000009:
000374 p.000009: • International partners or research undertaken outside of the UK where there may be issues of local practice and
000375 p.000009: political sensitivities. In some cases partnership with a RO in the geographical area involved may prove helpful. It is
000376 p.000009: also necessary to act in accordance with the legal and ethics review requirements in the countries included in the
000377 p.000009: research. Researchers should also consider these issues when undertaking social media research, as most of this is
000378 p.000009: international in scope as data are often drawn from a range of international settings.
000379 p.000009:
000380 p.000009: • Social media and participants recruited or identified through the internet, in particular when the understanding
000381 p.000009: of privacy in these settings is contentious where sensitive issues are discussed - for example in ‘closed’
discussion
000382 p.000009: groups where there is potential for quotes to be identifiable and including where visual images are used.
000383 p.000009:
000384 p.000009: • Other visual / vocal methods, particularly where participants or other individuals may be identifiable in the
...

...
000456 p.000011: the public domain are not. For example, published biographies, newspaper accounts of an individual’s activities
and
000457 p.000011: published minutes of a meeting would not be considered ‘personal data’ requiring ethics review, nor would
interviews
000458 p.000011: broadcast on radio or television or online, nor diaries or letters in the public domain.
000459 p.000011:
000460 p.000011: Information provided in forums or spaces on the internet that are intentionally public would be considered ‘in the
000461 p.000011: public domain’, but the public nature of any communication or information on the internet or through social media
000462 p.000011: should always be critically examined, and the identity of individuals protected, wherever possible, unless it is
000463 p.000011: critical to the research, such as in statements by public officials. For research that involves the use of social
000464 p.000011: media, researchers will also need to abide by the regulations set by the data producers subject to such regulations
000465 p.000011: being consistent with legal and ethical guidelines (see also internet-mediated research in FAQs). The potential for
000466 p.000011: identifiabilty of online sources, as well as ethical debates about how privacy is constituted in digital contexts,
000467 p.000011: means that full ethics review may be appropriate for research involving these communities. For example, people often
000468 p.000011: assume that social media sources are public domain, but it is quite likely that some service users – including
children
000469 p.000011: – may not understand the implications of what they are doing, and those harvesting data may also uncover illegal
images
000470 p.000011: or activities.
000471 p.000011:
000472 p.000011: Research that involves anonymised records and datasets that exist in the public domain may only require a light-touch
...

...
000495 p.000012: The authority of a REC should be delegated through the RO’s usual governance mechanisms. It should report to
the
000496 p.000012: appropriate RO authority. In defining a REC’s mandate and authority, the organisation should make clear the
000497 p.000012: jurisdiction of a REC and its relationship to other relevant bodies or authorities both within and outside the RO.
000498 p.000012:
000499 p.000012: ROs are expected to monitor the operation of RECs for which they are responsible and the decisions they take in
000500 p.000012: relation to social science proposals, according to the standards and guidelines set out here.
000501 p.000012:
000502 p.000012: Independence of Research Ethics Committees
000503 p.000012: ROs are responsible for ensuring that the RECs within their organisation act independently. They should be free from
000504 p.000012: bias and undue influence from the RO in which they are located, from the researchers whose proposals they consider
and
...

...
000514 p.000012:
000515 p.000012: RECs should be multidisciplinary and comprised of both men and women. They should include at least one lay
member with
000516 p.000012: no affiliation to the RO in question. There should be a chairperson and members who have broad experience and
expertise
000517 p.000012: in the areas of research regularly reviewed by the REC and members who have the confidence and esteem of the
research
000518 p.000012: community. RECs would also benefit from including individuals who reflect ethnic diversity, users of specialist health,
000519 p.000012: education or social services (where these are the focus of research activities), individuals with experience of
000520 p.000012: professional care or counselling, and individuals with specific methodological expertise (for example, quantitative or
000521 p.000012: qualitative methods) relevant to the research they review. A REC should include among its membership people who
are
000522 p.000012: collectively familiar with a range of
000523 p.000013: 13
...

...
000762 p.000018: ethics issues within the research lifecycle). These minimum standards may be achieved
000763 p.000019: 19
000764 p.000019:
000765 p.000019: through programmes at organisational, faculty, departmental, research centre or unit level.
000766 p.000019:
000767 p.000019: We expect social scientists to engage with ethics issues from the start of their research careers. ROs should ensure
000768 p.000019: that social science postgraduate training programmes in the doctoral centres incorporate the range of issues in this
000769 p.000019: framework.
000770 p.000019:
000771 p.000019: The aim of this training should be to build confidence in individuals to recognise the need for ethics scrutiny with
000772 p.000019: regard to social science research; throughout the lifecycle of the research, which includes the research activity,
000773 p.000019: knowledge exchange and impact activities and further ethical consideration required for potential re-use of data;
000774 p.000019: training should also help individuals understand the RO’s requirements and procedures for review; and to
understand how
000775 p.000019: to access additional help, both internal and external to the RO.
000776 p.000019:
...

...
000854 p.000021: conceptualise notions of rights (for example: consent, choice, volition or self-determination) and the handling of
000855 p.000021: personal data or linking and sharing of data in an international context where data handling may not be subject to the
000856 p.000021: UK Data Protection Act (http://www.legislation.gov.uk/ukpga/1998/29/contents). These issues need to be borne in
mind in
000857 p.000021: regard to specific schemes involving international collaboration. In many cases it is good practice to collaborate with
000858 p.000021: a local RO or other relevant local experts (eg an NGO). Researchers should also consider these issues when
undertaking
000859 p.000021: social media research as most of this is international in scope, as data is often drawn from a range of international
000860 p.000021: settings.
000861 p.000021:
000862 p.000021: In addition, problems may occur where the research involves political sensitivities. Researchers may not be able to
000863 p.000021: obtain permission for further research from authorities in that country unless they respect such sensitivities. Again,
...

...
000873 p.000021:
000874 p.000021: 1.10 Duplication of submission should be avoided
000875 p.000021: Researchers and ROs should avoid duplication of ethics review. The appropriate review body will be determined by
the
000876 p.000021: issues raised by the research, the nature of the data to be obtained and the population of participants to be included
000877 p.000021: in the study. This will apply to both single-discipline research and interdisciplinary research, especially where
000878 p.000021: social and biomedical scientists are working together. For a full review ESRC does not require an organisational REC
000879 p.000021: and a NHS REC to be involved. Researchers should submit proposals either to the REC of their RO or to HRA
000880 p.000021: (http://www.hra.nhs.uk/) for review by NHS RECs across the UK, including the Gene Therapy Advisory Committee
(GTAC),
000881 p.000021: and to the Social Care REC.
000882 p.000021:
000883 p.000021: The Governance Arrangements for Research Ethics Committees (GAfREC)
000884 p.000021: (http://www.hra.nhs.uk/resources/research-legislation-and-governance/governance-
000885 p.000021: arrangements-for-research-ethics-committees/)apply to research involving research participants recruited through the
000886 p.000021: NHS or Social Care services, and such research should be reviewed by a recognised and appropriate REC (see
Appendix D).
000887 p.000022: 22
000888 p.000022:
000889 p.000022: In addition, research involving adults who come under the remit of the Mental Capacity Act 2005
000890 p.000022: (http://www.legislation.gov.uk/ukpga/2005/9/contents) or the Adults with Incapacity (Scotland) Act 2000
...

...
000910 p.000022: ROs should be aware of the limits of the original consent given by participants. Transferring personal data to others
000911 p.000022: in which the original participants are identifiable may violate privacy and the original consent given.
000912 p.000022:
000913 p.000022: UK Data Protection Act 1998 (DPA)
000914 p.000022: It is important that those undertaking research are aware that the Data Protection Principles embodied in the DPA
apply
000915 p.000022: to their work. Social science research often involves the processing of personal data. Researchers should be aware
that
000916 p.000022: the processing of any information relating to an identifiable living individual constitutes ‘personal data
processing’
000917 p.000022: and is subject to the provisions of the Data Protection Act 1998
000918 p.000022: (http://www.legislation.gov.uk/ukpga/1998/29/contents). Helpful guidance can be found at the ICO guide to data
000919 p.000022: protection (https://ico.org.uk/for-organisations/guide-to-data- protection/).
...

...
000934 p.000023: In most cases, researchers working with vulnerable people will need to secure Disclosure and Barring Service (DBS)
000935 p.000023: clearance (https://www.gov.uk/government/organisations/disclosure-and-barring-service). The DBS offers
organisations a
000936 p.000023: means to check the criminal record of researchers to ensure that they do not have a history that would make them
000937 p.000023: unsuitable for work involving children and vulnerable adults. The responsibility for ensuring that applicants are
000938 p.000023: suitable to work with such groups ultimately rests with individual employers. In some cases other individuals (such as
000939 p.000023: a head teacher or social services manager) may be better placed to provide information on necessary disclosures (see
000940 p.000023: the Safeguarding Vulnerable Groups Act 2006 (http://www.legislation.gov.uk/ukpga/2006/47/contents); Rehabilitation
of
000941 p.000023: Offenders Act 1974 (http://www.legislation.gov.uk/ukpga/1974/53); the Rehabilitation of Offenders Act 1974
(Exceptions
000942 p.000023: Order 1975 (http://www.legislation.gov.uk/uksi/2013/1198/contents/made)).
000943 p.000023:
...

...
001005 p.000024: issues arising over its re-use. Data which have been anonymised may have a residual risk of disclosure, or may
become
001006 p.000024: disclosive when linked with other data within the public domain. The licensing regime provided by ESRC’s Data
Service
001007 p.000024: Providers mitigates this risk considerably.
001008 p.000024:
001009 p.000024: There are also specific ethics issues relating to large-scale and longitudinal surveys, such as the Millennium Cohort
001010 p.000024: Study, where social and other health or medical data is secured.
001011 p.000024: The REC should consider issues such as the relation between opting in and out of the study and consent, data
security
001012 p.000024: of named files and data and the anonymisation of individual respondents. It should ensure that proposals involving
001013 p.000024: third parties such as
001014 p.000025: 25
...

...
001017 p.000025: organisations often operate according to codes of practice developed by bodies such as the Market Research Society
001018 p.000025: (https://www.mrs.org.uk/).
001019 p.000025:
001020 p.000025: Data access through technology
001021 p.000025: Researchers are now making greater use of datasets which have been generated through internet-mediated
technology and
001022 p.000025: social media. Researchers need to consider the ethical issues which arise; for example, the interpretation of
anonymity
001023 p.000025: and whether participants (eg social media users) would consider data in the public domain to be private, the meaning
of
001024 p.000025: informed consent in this context and the important issue of what permissions a researcher has over the data supplied
by
001025 p.000025: the data producer (eg Facebook or Twitter data).
001026 p.000025:
001027 p.000025: Data access through biobank
001028 p.000025: Social scientists are also making greater use of data held in a public or private biobank where broadconsent is often
001029 p.000025: utilised. The UK Biobank (http://www.ukbiobank.ac.uk/ethics/) is an example of broad consent and has stringent
measures
001030 p.000025: in place to ensure that participants are not identified.
001031 p.000025:
001032 p.000025:
...

...
001073 p.000026: What is the meaning of risk?
001074 p.000026: Proposals should be considered in the context of the risks of the project. Ethics scrutiny should be proportionate to
001075 p.000026: the level of risk and appetite for risk in the specific context of the research proposed and its potential benefits.
001076 p.000026: Risk is often defined by reference to the potential physical or psychologicalharm, discomfort, stress or reputational
001077 p.000026: risk to human participants (and participating groups, organisations and funders) that a research project might
001078 p.000026: generate. This is especially pertinent in the context of health-related research. But, in addition, social science
001079 p.000026: raises a wider range of risks that needs to be considered by RECs. These include risk to a participant’s personal
001080 p.000026: social standing, privacy, personal values and beliefs, their links tofamily and the wider community, and their
001081 p.000026: position within occupational settings, as well as the adverse effects of revealing information that relates to illegal,
001082 p.000026: sexual or deviant behaviour. Research, though it may carry no physical risk, can be disruptive and damaging to
research
001083 p.000026: participants as individuals or to whole communities or categories of people, such as those with HIV infection.
001084 p.000026:
...

...
001091 p.000026: ethics review. The FRE case studies (http://www.esrc.ac.uk/about-esrc/information/research-ethics.aspx) illustrate
how
001092 p.000026: different projects carry potentially different risks, and how these can be usefully identified through questions that
001093 p.000026: help anticipate ethics difficulties.
001094 p.000026:
001095 p.000026: Research projects that involve researchers from more than one discipline can include further risk, especially where the
001096 p.000026: research team includes researchers from non-social science areas or non-academic research organisations. For
example,
001097 p.000026: social science researchers working with medical researchers who undertake qualitative research as part of a
001098 p.000026: non-clinical trial should be aware of potential risks when working in interdisciplinary research. The form of vigilance
001099 p.000026: required for the management of physical risk used in medical or biomedical research is inappropriate for the
management
001100 p.000026: of the social risks that may be present in social science research. RECs should provide guidance and advice to
001101 p.000026: researchers about ways in which risks can be minimised and participants protected from harm, while at the same time
001102 p.000026: offering advice on the prioritisation and different degrees of risk.
001103 p.000026:
001104 p.000026: How do you inform participants of potential risks?
...
...
001130 p.000027:
001131 p.000027: Is it legitimate to expose some research participants/organisations to risk?
001132 p.000027: This might arise for two reasons. First, as is recognised elsewhere (see Tri-Council of Canada, 2002
001133 p.000027: (http://www.pre.ethics.gc.ca/English/policystatement/introduction.cfm)) research may be ‘deliberately and
legitimately
001134 p.000027: opposed to the interests of the research participants or organisations’ in cases where the objectives of the
research
001135 p.000027: are to reveal and critique fundamental economic, political or cultural disadvantage or exploitation. Much social
001136 p.000027: science research has a critical role to play in exploring and questioning social, cultural and economic structures and
001137 p.000027: processes (for example relating to patterns of power and social inequality, and institutional dynamics and regimes that
001138 p.000027: disadvantage some social groups over others, intentionally or not). Such research results may have a negative impact
on
001139 p.000027: some of the research participants/organisations. Principles of justice should, however, mean that researchers would
001140 p.000027: seek to minimise any personal harm to individuals. Secondly, researchers should also consider how to balance the
001141 p.000027: potential of immediate or short-term risks to research participants against longer-term gains to future beneficiaries.
001142 p.000027: It is the responsibility of the research proposers to make such a case in detail to a REC. In making a decision RECs
...

...
001234 p.000030: 30
001235 p.000030:
001236 p.000030: How do you obtain consent in multi-disciplinary projects?
001237 p.000030: In cases of multi or inter-disciplinary research the definition of informed consent should be given very careful
001238 p.000030: consideration. The relationship between researchers and participants may vary between disciplines or in projects using
001239 p.000030: diverse methodologies. In the case of participatory social science research, consent to participate is seen as an
001240 p.000030: ongoing and
001241 p.000030: open- ended process. Consent here is not simply resolved through the formal signing of aconsent document at the
start
001242 p.000030: of research. Instead it is continually open to revision and questioning. Highly formalised or bureaucratic ways of
001243 p.000030: securing consent should be avoided in favour of fostering relationships in which ongoingethics regard for participants
...

...
001266 p.000030: and warranted.
001267 p.000030:
001268 p.000030: Covert research may be undertaken when it may provide unique forms of evidence that are crucial to the research
001269 p.000030: objectives and methodology or where overt observation might alter the phenomenon being studied. The broad principle
001270 p.000030: should be that covert research should not be undertaken lightly or routinely. It is only justified if important issues
001271 p.000030: are being addressed and if matters of social significance which cannot be uncovered in other ways are likely to be
001272 p.000030: discovered. Normally, social scientists should ensure that research participants are aware of and consent to
001273 p.000030: arrangements made with regard to the management and security of data, the preservation of anonymity, and any risk
that
001274 p.000030: might arise during or beyond the project itself, and how these might be minimised or avoided.
001275 p.000030: Disciplinary professional ethics codes may be helpful here. Where the research design is
001276 p.000031: 31
...

...
001322 p.000032: Thus, a personal consultee could be a family member or close friend of the person.
001323 p.000032:
001324 p.000032: If no personal consultee can be identified, a nominated consultee should be proposed by the researcher. This is
someone
001325 p.000032: who is prepared to be consulted by the researcher, but has no connection with the research project - for example,
001326 p.000032: someone from a relevant organisation (such as a local church or charity); but they could also be a professional care
001327 p.000032: worker (and thus could not be a personal consultee), such as the person’s GP, social worker or carer, providing
they
001328 p.000032: have no connection with the research project.
001329 p.000032:
001330 p.000032: 2.3 Medical research
001331 p.000032: The Adults with Incapacity (Scotland) Act (http://www.legislation.gov.uk/asp/2000/4/contents) states that any medical
...

...
001359 p.000033:
001360 p.000033: What happens when research is undertaken with medical clinicians?
001361 p.000033: Initially, a light-touch review by the RO’s REC should identify those projects that need to be reviewed by an NHS
REC
001362 p.000033: (through HRA (http://www.hra.nhs.uk/resources/applying-to- recs/nhs-rec-central-booking-service-cbs/)) regardless of
001363 p.000033: the level of risk. Such projects will involve any of the following groups: NHS patients and service users and their
001364 p.000033: families (including carers and past patients, if identified through NHS records). Research involving NHS and social
001365 p.000033: care staff who are recruited as research participants by virtue of their professional role may require NHS REC review
001366 p.000033: only if they raise significant ethical issues. Please see the HRA approval decision tool
001367 p.000033: (http://www.hra-decisiontools.org.uk/ethics/).
001368 p.000033:
001369 p.000033: It is expected that a light-touch review by a REC will be able to provide an effective filter for projects that might
001370 p.000033: otherwise have been inappropriately sent to an NHS REC, including those that while involving a physically invasive
001371 p.000033: technique do not do so for clinical purposes. Similarly, the framework provides for review by a REC of large-scale,
001372 p.000033: longitudinal social science studies that may seek information relating to respondents’ personalhealth profile.
001373 p.000033:
001374 p.000033: 2.4 Internet-mediated research
001375 p.000033: Why should internet research receive full ethics review?
001376 p.000033: In a fast developing area RECs may need to involve an independent expert in assessing research proposals that
break new
001377 p.000033: ground. Internet research can take place in a range of settings, for example email, chat rooms, web pages, social
media
001378 p.000033: and various forms of ‘instant messaging’. These can pose specific ethical dilemmas.
001379 p.000033:
001380 p.000033: For example, what constitutes ‘privacy’ in an online environment? How easy is it to get informed consent from
the
001381 p.000033: participants in the community being researched? What does informed consent entail in that context? How certain is
the
...

...
001555 p.000037: question, design or conduct over the course of the research should be notified to the Faculty/School Research Ethics
001556 p.000037: Officer and may require a new application for ethics review.
001557 p.000037:
001558 p.000037: Points to consider when planning research
001559 p.000037:
001560 p.000037: This section aims to facilitate the process of considering ethics around social science research: it is not intended to
001561 p.000037: be definitive but may help to highlight potential issues to researchers.
001562 p.000037:
001563 p.000037: Further information on the issues raised in this list can be found in the main body of the framework as well as in
001564 p.000037: ethics guidelines from Learned Societies and subject-specific guides. Please see Appendix D for links to websites that
...

...
001694 p.000040: Biobank (research tissue bank (http://www.nres.nhs.uk/applications/approval-
001695 p.000040: requirements/ethical-review-requirements/research-tissue-banks-biobanks/)): A collection of human tissue or other
001696 p.000040: biological material, which is stored for potential research use beyond the life of a specific project.
001697 p.000040:
001698 p.000040: Biosocial Research: The interdisciplinary interplay between biology, experiences and behaviours over the course of
001699 p.000040: life. This encompasses multi-disciplinary science from the fields of biological, medical and social sciences.
001700 p.000040:
001701 p.000040: Broad consent: has been seen as essential to facilitating biobank research. Participants are asked toconsent to the
001702 p.000040: use of samples and data within a biobank, at the time of collection rather than to a specific project or types of
001703 p.000040: research. Broad consent means consenting to a framework for future research of certain types. Included in this
...

...
001775 p.000042: provide the perspective of the research participant to the REC.
001776 p.000042:
001777 p.000042: Light-touch review: All ESRC-funded research should undergo at least a light-touch review. Light-touch reviews identify
001778 p.000042: those projects where the potential for risk of harm to participants and others affected by the proposed research is
001779 p.000042: minimal. In many cases this is the only ethics review necessary. An RO ethics checklist (see Appendix A for an
001780 p.000042: example), should be completed for all social science research projects. RECs need to confirm that only a light-touch
001781 p.000042: review is justified.
001782 p.000042:
001783 p.000042: Personal data: Under the Data Protection Act 1998 ‘personal data’ is defined as data which relates to a living
001784 p.000042: individual who can be identified a) from those data or, b) from those data and other information which is in the
...

...
001864 p.000044: • ESRC Research Funding Guide (2014) www.esrc.ac.uk/funding-and- guidance/applicants/research-funding-
guide.aspx
001865 p.000044: • ESRC Administrative Data Research Network – Protecting Privacy (2015) http://www.adrn.ac.uk/protecting-
privacy
001866 p.000044: • UK Data Service advice on managing and sharing data (2014) http://ukdataservice.ac.uk/manage-data.aspx
001867 p.000044:
001868 p.000044: Professional ethics codes and guidelines
001869 p.000044: • Academy of Social Sciences (2014). Developing Generic Ethics Principles in Social Science Research -
001870 p.000044: http://acss.org.uk/developing-generic-ethics-principles-social- science/
001871 p.000044: • Association of Internet Researchers (2012). Ethical decision-making and internet research 2.0
001872 p.000044: http://aoir.org/ethics/
001873 p.000044: • Association of Internet Researchers, Ethics guide http://ethics.aoir.org/index.php?title=Main_Page
001874 p.000044: • Association of Social Anthropologists of the UK and the Commonwealth (ASA) 2011. Ethical Guidelines for good
001875 p.000044: research practice www.theasa.org/ethics.shtml
001876 p.000044: • British Educational Research Association (2012) Ethics and Educational Research
001877 p.000044: www.bera.ac.uk/resources/ethics-and-educational-research
001878 p.000044: • British Psychological Society (2014) Code of Human Research Ethics
...

...
001897 p.000045: http://visualsociology.org/about/ethics-and-guidelines.html
001898 p.000045: • Market Research Society (2014). Code of Conduct https://www.mrs.org.uk/standards/code_of_conduct/
001899 p.000045: • Nuffield Council on Bioethics (2009). Dementia: Ethical Issues
001900 p.000045: http://nuffieldbioethics.org/wp-content/uploads/2014/07/Dementia-report-Oct-09.pdf
001901 p.000045: • Respect Project (2004). An EU code of Ethics for socio-economic research
www.respectproject.org/code/index.php
001902 p.000045: • Social Research Association (2003). Ethics Guidelines http://the-sra.org.uk/research- ethics/ethics-guidelines/
001903 p.000045: • UK Data Service ethics advice: http://ukdataservice.ac.uk/manage-data/legal-ethical.aspx
001904 p.000045: • UKRIO Code of Practice for Research www.ukrio.org/what-we-do/code-of-practice- for-research
001905 p.000045: • Universities and Colleges Employer Association (2011). Guidance on Health and Safety in Fieldwork
001906 p.000045: www.ucea.ac.uk/en/publications/index.cfm/guidance-on-health-and-safety- in-fieldwork
...

...
001928 p.000046: • UK Health Departments, Research Governance Frameworks
001929 p.000046: www.hra.nhs.uk/resources/research-legislation-and-governance/research-governance- frameworks/
001930 p.000046: • Health Research Authority, Standard Operating Procedures for Research Ethics Committees (2015)
001931 p.000046: http://www.hra.nhs.uk/resources/research-legislation-and- governance/standard-operating-procedures/
001932 p.000046: • The Ministry of Defense Research Ethics Committees (MODREC)
www.science.mod.uk/engagement/modrec/modrec.aspx
001933 p.000046: • Social Care Research Ethics Committee www.screc.org.uk
001934 p.000046: • Wellcome Trust Biobank Ethics and Governance Framework
001935 p.000046: www.wellcome.ac.uk/about-us/publications/reports/biomedical- ethics/wtd003284.htm
001936 p.000046:
001937 p.000046: Relevant legislation
001938 p.000046: • Data Protection Act 1998 www.legislation.gov.uk/ukpga/1998/29/contents
001939 p.000046: • Information Commissioner’s Office (2014). The Guide to Data Protection https://ico.org.uk/media/for-
001940 p.000046: organisations/documents/1607/the_guide_to_data_protection.pdf
001941 p.000046: • Information Commissioner’s Office (2014). Social Networking and online forums- When does the DPA apply?
001942 p.000046: https://ico.org.uk/media/for- organisations/documents/1600/social-networking-and-online-forums-dpa-guidance.pdf
001943 p.000046: • Information Commissioner’s Office (2014). Big Data and data protection
001944 p.000046: http://ico.org.uk/for_organisations/guidance_index/~/media/documents/library/Data_Pr
001945 p.000046: otection/Practical_application/big-data-and-data-protection.pdf
001946 p.000046: • Information Commissioner’s Office (2014). Data Controllers and data processors: what the difference is and
what
...

...
001959 p.000046: • The National Archives. Making a freedom of information request
001960 p.000046: http://apps.nationalarchives.gov.uk/foi/requests.htm
001961 p.000047: 47
001962 p.000047:
001963 p.000047: • Freedom of Information (Scotland) Act 2002 www.legislation.gov.uk/asp/2002/13/contents
001964 p.000047: • Health and Social Care Act 2008 www.legislation.gov.uk/ukpga/2008/14/contents
001965 p.000047: • Health and Social Care Act 2012 www.legislation.gov.uk/ukpga/2012/7/contents
001966 p.000047: • Human Rights Act 1998 www.legislation.gov.uk/ukpga/1998/42/contents
001967 p.000047: • Human Tissue Act 2004 www.legislation.gov.uk/ukpga/2004/30/contents
001968 p.000047: • HRA Human Tissue Act 2004-Questions and Answers
001969 p.000047: www.hra.nhs.uk/resources/research-legislation-and-governance/questions-and-answers- the-human-tissue-act-2004/
...

...
001987 p.000047: www.legislation.gov.uk/uksi/2013/1198/contents/made
001988 p.000047: • Safeguarding Vulnerable Groups Act 2006 www.legislation.gov.uk/ukpga/2006/47/contents
001989 p.000047: • Protecting of Vulnerable Groups (Scotland) Act 2007 www.legislation.gov.uk/asp/2007/14/contents
001990 p.000047:
001991 p.000047: Other links
001992 p.000047: • Academy of social sciences (2013) Professional Briefings 3: Developing Generic Ethics Principles in Social
Science
001993 p.000047: Research http://acss.wpengine.com/wp- content/uploads/2013/11/pb3_genericethicsprinciples.pdf
001994 p.000047: • Dockett, S., Perry, B. (2011). Researching with young children: seeking assent. Child Indicators Research,
001995 p.000047: 4(2):231-247, DOI: 10.1007/s12187-010-9084-0 www.victoria.ac.nz/education/pdf/ethics/Docket-Perry-2011.pdf
001996 p.000048: 48
001997 p.000048:
001998 p.000048: • Ipsos-MORI Social Research Institute (2014). Dialogue on data
001999 p.000048: www.esrc.ac.uk/_images/Dialogue_on_Data_report_tcm8-30270.pdf
002000 p.000048: • Janssens ACJW, Kraft P (2012) Research Conducted Using Data Obtained through Online Communities: Ethical
002001 p.000048: Implications of Methodological Limitations. PLoS Med 9(10): e1001328. doi:10.1371/journal.pmed.1001328
002002 p.000048: www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1001328
002003 p.000048: • Observatory for Responsible Research and Innovation in ICT http://responsible- innovation.org.uk/torrii/
002004 p.000048: • Salway et al (2011) Ethnic diversity and inequality ethical and scientific rigour in social research. Joseph
002005 p.000048: Roundtree Foundation www.jrf.org.uk/publications/ethnic-diversity- social-research
002006 p.000048: • Stevens, Leslie A. and Laurie, Graeme, The Administrative Data Research Centre Scotland: A Scoping Report on
the
002007 p.000048: Legal & Ethical Issues Arising from Access & Linkage of Administrative Data (August 27, 2014). Edinburgh School of
Law
002008 p.000048: Research Paper No. 2014/35. Available at SSRN: http://ssrn.com/abstract=2487971 or
002009 p.000048: http://dx.doi.org/10.2139/ssrn.2487971
...

...
002103 p.000050: password-protected external storage drives, since the digital and visual data generates large storage requirements.
002104 p.000050: Storage drives will be stored in the secure office of the principal investigator.
002105 p.000050:
002106 p.000050: The second stage of data collection involves focus group workshops related to two of the selected streets. The
002107 p.000050: workshops will be arranged with respective local authorities, traders and local organisations to understand how these
002108 p.000050: streets are organized, managed and imagined. For this stage of research I will work alongside 'Social Life', a social
002109 p.000050: enterprise created by the Young Foundation. We will establish a specific ethics protocol for this stage of research,
002110 p.000050: drawing on Social Life's extensive expertise in working with local authorities, community organisations and frontline
002111 p.000050: agencies, and submitting the protocol for review to the LSE Research Ethics Committee. Time has been allocated
prior to
002112 p.000050: the workshops, to meet with relevant authorities and associations to develop appropriate workshop forums, and to
review
002113 p.000050: approaches to participation, confidentiality and dissemination. Feedback on workshop findings will be offered to local
002114 p.000050: authorities and associations through a summary report. More generally, participants will be able to view project
...

Social / Student
Searching for indicator student:

(return to top)
...
000009 p.000011: 11
000010 p.000011: 1.5 ROs should establish procedures for monitoring research 18
000011 p.000011: 1.6 Complaints, appeals and conflict of interest procedures should be in place 19
000012 p.000011: 1.7 Arrangements should be made for training researchers, research students, supervisors and member of RECs
000013 p.000019: 19
000014 p.000019: 1.8 Student research and ethics review 20
000015 p.000019: 1.9 Arrangements should be made for collaborative research 21
000016 p.000019: 1.10 Duplication of submission should be avoided 22
000017 p.000019: 1.11 Legal and data protection requirements should be met 23
000018 p.000019: 2. Frequently asked questions 27
...

...
000277 p.000006: • a published timetable of the maximum time necessary for undertaking light-touch and full ethics reviews.
000278 p.000006:
000279 p.000006: Types of review
000280 p.000006: A light-touch review, when fully justified, identifies projects where the actual or potential risk of harm to
000281 p.000006: participants (and others affected by the proposed research) is minimal.
000282 p.000006: Many student projects may require only a light-touch review. However, this cannot be assumed; projects, including
000283 p.000006: student projects, which involve more than minimal risk, should receive a full REC review. Some RECs have facilitated
000284 p.000006: ethics approval for research
000285 p.000007: 7
000286 p.000007:
000287 p.000007: with potentially vulnerable people by establishing ethics protocols for commonly occurring situations, such as research
...

...
000600 p.000014:
000601 p.000014:
000602 p.000015: 15
000603 p.000015:
000604 p.000015: Ethics review application forms and protocols
000605 p.000015: Research proposals, including student proposals, submitted for review to a REC might be expected to include most,
but
000606 p.000015: not necessarily all, of the following information in a way that is understandable to a lay member, though the precise
000607 p.000015: way this is done is left to the discretion of the RO:
000608 p.000015:
000609 p.000015: • Aims of the research and scientific background of the research.
...

...
000781 p.000019: • research managers, and heads of research groups, centres or departments
000782 p.000019: • members of local and organisation-wide RECs, including lay members
000783 p.000019: • postgraduate students in local ethics review requirements (in addition to any more generalethics training)
000784 p.000019: • undergraduate students whose projects may require ethics review.
000785 p.000019:
000786 p.000019: 1.8 Student research and ethics review
000787 p.000019: The same principles should apply to student research as to all other research. The ESRC recommends that ROs
should
000788 p.000019: establish procedures specifically for reviewing research projects undertaken by undergraduate students and students
on
000789 p.000019: taught postgraduate courses. Student research poses particular challenges in relation toethics review because of the
000790 p.000019: large numbers, short timescales and limited scope of the projects involved.
000791 p.000019: Supervisors of research postgraduate students should work closely with their students in considering ethical aspects of
000792 p.000019: proposed research in keeping with this framework.
000793 p.000019:
000794 p.000019: The same high ethical standards should be expected in student research. It cannot be assumed that all students’
000795 p.000019: projects involve minimal risk. Student projects involving research potentially requiring a fullethics review may need
000796 p.000019: careful consideration.
000797 p.000019: However, in many cases student research may be managed at school/department level and overseen by a light-touch
000798 p.000019: departmental ethics committee using an initial checklist.
000799 p.000019: Established protocols for commonly occurring research, as mentioned previously, can expedite the review process. It
000800 p.000019: should be made clear to potential research participants that the study is a student project. ROs also need to ensure
000801 p.000019: that students are not exposed to undue risk in conducting their research.
000802 p.000019:
000803 p.000019: The ESRC already provides Guidance and information for ESRC-funded students
000804 p.000019: (http://www.esrc.ac.uk/funding-and-guidance/postgraduates/esrc-students/index.aspx). These guidelines include
reference
...

...
001461 p.000035: for ethics review needs to be submitted. Below is an example of anethics checklist for reference only. Research
001462 p.000035: Organisations (ROs) will have their own checklist and procedures in place for submitting proposals to their Research
001463 p.000035: Ethics Committees.
001464 p.000035:
001465 p.000035: Before completing a checklist please refer to the appropriate RO’s Code of Practice on ethical standards for
research
001466 p.000035: involving human participants. The principal investigator or (where the principal investigator is a student) the
001467 p.000035: supervisor, is responsible for exercising appropriate professional judgment in determining the ethics review required.
001468 p.000035:
001469 p.000035: An appropriate checklist should be completed before potential participants are approached to take part in any
research.
001470 p.000035:
...

Social / Threat of Stigma
Searching for indicator threat:

(return to top)
...
000899 p.000022:
000900 p.000022: 1.11 Legal and data protection requirements should be met
000901 p.000022: Data requirements
000902 p.000022: ROs should ensure that appropriate practical arrangements are in place to maintain the integrity and security of
000903 p.000022: research data. Clear direction should be provided on where responsibilities reside in all these areas. Researchers may
000904 p.000022: not appreciate the threat to data integrity and security presented by routinely-used collection and storage methods,
000905 p.000022: such as computer files on hard drives and similar devices, portable computing equipment and memory, email and
000906 p.000022: databases. Periodic audit of data storage arrangements at all levels is likely to be necessary to ensure compliance
000907 p.000022: with both legal obligations and good research practice. Regular staff training is another avenue for ensuring
000908 p.000022: appropriate practice.
...

Social / Threat of Violence
Searching for indicator violence:

(return to top)
...
000322 p.000007: which is operating under The Adults with Incapacity (Scotland) Act 2000
000323 p.000008: 8
000324 p.000008:
000325 p.000008: (http://www.legislation.gov.uk/asp/2000/4/section/10).
000326 p.000008: • Potentially sensitive topics, for example participants’ sexual behaviour, illegal or political behaviour,
000327 p.000008: experience of violence, abuse or exploitation, mental health, their personal or family lives, or their gender or ethnic
000328 p.000008: status. Elite interviews may also fall into this category.
000329 p.000008:
000330 p.000008: • Deceased persons. Researchers should adhere to relevant legislation ie Human Tissue Act 2004
000331 p.000008: (http://www.legislation.gov.uk/ukpga/2004/30/contents), Human Tissue (Sc) Act 2006
...

Social / Victim of Abuse
Searching for indicator abuse:

(return to top)
...
000322 p.000007: which is operating under The Adults with Incapacity (Scotland) Act 2000
000323 p.000008: 8
000324 p.000008:
000325 p.000008: (http://www.legislation.gov.uk/asp/2000/4/section/10).
000326 p.000008: • Potentially sensitive topics, for example participants’ sexual behaviour, illegal or political behaviour,
000327 p.000008: experience of violence, abuse or exploitation, mental health, their personal or family lives, or their gender or ethnic
000328 p.000008: status. Elite interviews may also fall into this category.
000329 p.000008:
000330 p.000008: • Deceased persons. Researchers should adhere to relevant legislation ie Human Tissue Act 2004
000331 p.000008: (http://www.legislation.gov.uk/ukpga/2004/30/contents), Human Tissue (Sc) Act 2006
...

Social / Women
Searching for indicator women:

(return to top)
...
000510 p.000012: necessary to provide competent and rigorous ethics review of the submitted research proposals, and to do so from a
000511 p.000012: position that is independent of both the researchers and the RO in which it is located. Its composition and
000512 p.000012: independence are important in establishing the legitimacy of the opinions expressed and the decisions made, in the
eyes
000513 p.000012: of the community and wider society as well as the researchers and funders of research.
000514 p.000012:
000515 p.000012: RECs should be multidisciplinary and comprised of both men and women. They should include at least one lay
member with
000516 p.000012: no affiliation to the RO in question. There should be a chairperson and members who have broad experience and
expertise
000517 p.000012: in the areas of research regularly reviewed by the REC and members who have the confidence and esteem of the
research
000518 p.000012: community. RECs would also benefit from including individuals who reflect ethnic diversity, users of specialist health,
000519 p.000012: education or social services (where these are the focus of research activities), individuals with experience of
...

Social / Youth/Minors
Searching for indicator minor:

(return to top)
...
000214 p.000005: • If review by the REC shows that a project requires major changes which will alter it substantially and the project
000215 p.000005: can no longer attract ESRC support, payments may be suspended and the grant terminated. This is likely to be an
000216 p.000005: extremely rare occurrence since the proposal will already have undergone external peer-review which should identify
000217 p.000005: such severe problems.
000218 p.000005:
000219 p.000005: • Approval for minor changes to a project following REC review is delegated to the RO. If ongoing review by a REC
000220 p.000005: shows that a project requires major changes in the lifetime of the research which will alter it so much that it can no
000221 p.000005: longer attract ESRC support, this should be referred to ESRC.
000222 p.000005:
000223 p.000005: • The ESRC’s guidance and information for ESRC-funded students
...
                                                        Appendix
Indicator List
      Indicator                     Vulnerability
          abuse                    Victim of Abuse
        access                Access to Social Goods
            age                Diminished Autonomy
       authority              Relationship to Authority
     autonomy                   Impaired Autonomy
      cadavers                         Cadavers
       capacity                    Fetus/Neonate
            child                         Child
        children                          Child
       coercion                Presence of Coercion
      cognitive                Cognitive Impairment
cognitive impairment           Cognitive Impairment
        cultural                Cultural Differences
         culture                Cultural Differences
     deceased                  Linguistic Proficiency
   dependence                    Drug Dependence
    dependent                         Dependent
       disability                Mentally Disabled
            drug                     Drug Usage
     economic                    Economic/Poverty
     education                        Educational
    educational                       Educational
         elderly                         Elderly
       engaged                      Marital Status
          ethnic                        Ethnicity
          family                Motherhood/Family
        gender                          Gender
          health                         Health
             hiv                       HIV/AIDS
           home                 Property Ownership
          illegal                   Illegal Activity
          illness                    Physically Ill
       impaired                Cognitive Impairment
    impairment                 Cognitive Impairment
     incapacity                     Incapacitated
      influence                      Drug Usage
         justice              Breastfeeding Children
         literate                       Literacy
           minor                    Youth/Minors
   nursing home                   In Nursing Home
          officer                   Police Officer
                       Philosophical Differences/Difference of
      opinion
                                        Opinion
        party                           Political
     physically                    LGBTQ+ Status
       political                        Political
         poor                    Economic/Poverty
        racial                      Racial Minority
      religious                         Religion
     restricted                      Incarcerated
        single                      Marital Status

       social                          Social
      special                         Religion
      student                         Student
       threat                     Threat of Stigma
   undue influence                   Undue Influence
        union                    Trade Union Membership
       usage                         Laboratory Staff
      violence                      Threat of Violence
     vulnerable                           Child
      welfare                       Welfare Recipient
      women                              Women


Indicator Peers (Indicators in Same Vulnerabilty)
     Indicator                                      Peers
          child                     ['children', 'vulnerable']
       children                        ['child', 'vulnerable']
      cognitive      ['cognitive impairment', 'impairment', 'impaired']
cognitive impairment        ['cognitive', 'impairment', 'impaired']
        cultural                                 ['culture']
        culture                                 ['cultural']
          drug                                ['influence']
     economic                                      ['poor']
     education                             ['educational']
    educational                              ['education']
      engaged                                     ['single']
                             ['cognitive', 'cognitive impairment',
      impaired
                                            'impairment']
    impairment         ['cognitive', 'cognitive impairment', 'impaired']
      influence                                    ['drug']
         party                                  ['political']
        political                                  ['party']
          poor                               ['economic']
       religious                                ['special']
         single                               ['engaged']
        special                                ['religious']
     vulnerable                          ['child', 'children']


Trigger Words
consent

developing

ethics

harm

protect

protection

risk

self-determination

sensitive

vulnerable


Applicable Type / Vulnerability / Indicator Overlay for this Input
   Vulnerability
                                      Vulnerability                        Indicator
      Type
    Economic                       Economic/Poverty                        economic
    Economic                       Economic/Poverty                          poor
    Economic                        Welfare Recipient                       welfare
   General/Other                   Cultural Differences                     cultural
 General/Other            Cultural Differences                   culture
 General/Other                  Dependent                      dependent
 General/Other           Diminished Autonomy                          age
 General/Other            Impaired Autonomy                     autonomy
 General/Other                Incapacitated                     incapacity
 General/Other               Laboratory Staff                       usage
 General/Other           Presence of Coercion                     coercion
 General/Other          Relationship to Authority                authority
 General/Other              Undue Influence                  undue influence
    Health                       Cadavers                        cadavers
    Health               Cognitive Impairment                    cognitive
    Health               Cognitive Impairment              cognitive impairment
    Health               Cognitive Impairment                    impaired
    Health               Cognitive Impairment                  impairment
    Health                 Drug Dependence                    dependence
    Health                     Drug Usage                             drug
    Health                     Drug Usage                        influence
    Health                       HIV/AIDS                              hiv
    Health                         Health                           health
    Health                 Mentally Disabled                     disability
    Health                Motherhood/Family                         family
    Health                     Physically Ill                       illness
   Political                  Illegal Activity                      illegal
   Political                      Political                          party
   Political                      Political                       political
   Political           Trade Union Membership                        union
    Social              Access to Social Goods                     access
    Social              Breastfeeding Children                     justice
    Social                          Child                             child
    Social                          Child                         children
    Social                          Child                       vulnerable
    Social                      Educational                     education
    Social                      Educational                    educational
    Social                         Elderly                         elderly
    Social                        Ethnicity                         ethnic
    Social                   Fetus/Neonate                        capacity
    Social                        Gender                           gender
    Social                  In Nursing Home                   nursing home
    Social                     Incarcerated                      restricted
    Social                   LGBTQ+ Status                      physically
    Social               Linguistic Proficiency                 deceased
    Social                        Literacy                         literate
    Social                    Marital Status                     engaged
    Social                    Marital Status                        single
                 Philosophical Differences/Difference of
    Social                                                       opinion
                                  Opinion
    Social                    Police Officer                      officer
    Social                Property Ownership                      home
    Social                    Racial Minority                     racial
    Social                        Religion                      religious
    Social                        Religion                       special
    Social                         Social                         social
    Social                        Student                        student
    Social                  Threat of Stigma                      threat
    Social                 Threat of Violence                   violence
    Social                   Victim of Abuse                      abuse
    Social                        Women                          women
    Social                    Youth/Minors                        minor


Document Match Map - Line Numbers where Indicators and Trigger Words Appear
Refer to 5A71EB3B079C385D77612EE96779F088

---- ....|...10....|...20....|...30....|...40....|...50....|...60....|...70....|...80....|...90....|..100

0000 _____________X__X__________________XX____X_X________________________________________________________

0100 _______________________________XX_XXX___________________XXX_X___X___X__X____________________________

0200 ____X___XX_X______X____________________________________________________X____X__X_XXX__XX_XX____X__X_

0300
__X____X__XX_XX__XXXXX___XX__X_______________XXXXXXX_X_X__XX________X__X__XXX__XX___________________

0400 ___________________XX_X__X__________________XX_____X____X___X_X___XXX____X_XX_________________XX___X

0500 _X_X___X_X____X__XX___________X___XX_X___X___X_____________________________X____X___________________

0600 ___XX_______X__X____________________________________XX__XX_X_______________X_X__________X_X_X_____XX

0700 X___XX__X___X________________X_X_____________________________X____XX__XX__X_______XX_XX_X____XX_XX_X

0800
X___X___XX_____X__XXXXX______________XX___XX_X__X___XX_X__X__X_____X_X____X_XX__X_X_XX__XX__XXXXXX_X

0900
___X_____XX_XXX_X_X____XXXX___X_XX__X_XX___XXXXXXX____XXX__________________X__X____X__X__X__X_X__XXX

1000
____X_X_XXX____X___X_XXX__XXX___________________________________________XXXXXXXXXXX_______X_X_XXX_XX

1100
XX___X_X__XXXXXXXXXXXX_XXXXX__X_X_XXXXXX__X________________X_X______X___X______XXXX_X_X_XXX__X_X_X__

1200
__________XX_X_X___X________X_X____XX_X_X_X____________XXXXXXXX_______XXX_X_________XXXXXX__XXXX_X_X

1300
_XX_XX_XX___X____XXXXX____X___X__X____XXXX____________________XX__X__X_X__XXX__XX___________________

1400 ____________________________________________________________X_X__XX_____________________X___XX___X__

1500 __XXX_X____________X__X____________________X__XXX____XXX___X___X__________X__X_XX____________XXX__XX

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XXX_XX____XX_X______X____XXX_X_XXXX__XX_XXX_X_____X___X________XX______XXXXXXXXX_X_____XX__X_XX__X__

2000 ___XX_X_______________________________________________________________________X_X_X___________XX_X__

2100 _______XXXX_____XX______________