Institutional Approval Form for Research

Ethical Review & Assessment:

Guidance Notes

Authored by Research Office

Date Oct-2019
Approved Research & Enterprise Committee
Version 2

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Part I

The guidance notes provided here accompany the form: Institutional Approval Form for Research
Ethical Review & Assessment. 1 Following that structure, this document is also divided by the relevant
part, with accompanying notes enclosed that are pertinent to that section.

1. Researcher details

1.1 Section 1 of the form requests the completion of information pertaining to the researcher:
name, department, title of research project.

1.2 A text box is provided so the researcher may provide a short, succinct summary about the
nature of their proposed research. The word limit is set to 250 words so as to avoid
unnecessary narrative. If required, a separate one-page addition can be provided.

1.3 Status indication is to delineate at what level the researcher is: be that a member of staff,
a doctoral researcher, or those on a taught programme.

1.4 Funding. Worktribe will remain the primary research management portal for externally
funded research projects. As such, this box will not appear in the portal. For non-
externally funded research (including those undertaking taught programmes at
undergraduate/postgraduate level), a no answer should be recorded.

2. Formal Approval

2.1 As outlined in the form as well as the Procedural guidance, there are certain areas of
research that invariably raise ethical issues that must be given the appropriate level of
consideration and scrutiny.

2.2 Any research proposal that falls within the remit of Table 1 will be referred on to the
Research Ethics Panel (REP) for consideration and approval.

2.3 The researcher must consider whether their proposed research falls within any of the
areas that are listed in Table 1 (attached as Annex A in this document). Broadly, these are
considered to potentially carry the highest risk and must therefore undergo the necessary
scrutiny to ensure that research is undertaken within the parameters of the Schools ethics
policy; any requirements as set out in law, and both the School and its individual
researchers are not placed in any jeopardy.

2.4 If applicable, against the relevant numbered area of research, the researcher shall be
required to detail:
i. The relevant research area (e.g. No. 2. Culturally Sensitive)
ii. Provide a brief synopsis of the potential issue(s) involved

1
A downloadable Word docx version of the form is also available via the Research Ethics webpage:
http://www.soas.ac.uk/research/ethics/ethics/file143534.docx

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 2.5 The remainder of the Toolkit for assessment will still be required to be completed, even
though the research topic may fall within the remit of Table 1, thereby requiring automatic
referral to the REP.

2.6 While the nature of the areas / topics listed is self-explanatory, some additional guidance
has been set out below.

Security Sensitive

2.7 Aside from the ethical issues involved, terrorism-related research does have the
propensity to entail risks to the individual researcher and the School. These can range
from accessing sensitive or restricted materials, to complex legal questions and is not
limited to simply participant interviews. Researchers, at all levels, should seek to highlight
any particular areas of research that may entail sensitive security issues and / or require
particular protocols, where appropriate, to be put in place.

Culturally Sensitive

2.8 Invariably, international disputes (such as involving ownership) can arise relating to
culturally sensitive objects and artefacts. Researchers need to be alert to any request
made upon them of entering into a written agreement (for example by a museum)
regarding access.

2.9 Moreover, with the increase in illegal activities relating to the trade in antiquities
becoming more commonplace (for example because of regional conflicts), researchers
will need to pay specific attention to any additional legal issues that could arise or even
potentially impact their research.

Vulnerable participant groups

2.10 Where a Researcher indicates that their research project relates to potentially
vulnerable participant groups (listed as category 3) a copy of the forms (including the
referral form) together with the completed risk assessment section will also be referred
to the Designated Safeguarding Lead (DSL) or equivalent deputy. This is in addition to the
project requiring formal ethical approval from the REP. Please also refer to the additional
notes contained in Part V below.

2.11 Researchers must also familiarise themselves with the School’s Safeguarding Policy.
If there are any accompanying training requirements, these can also be listed in the risk
assessment section as appropriate mitigation, if required.

2.12 In order for the School to discharge its legal obligations, Researchers should also be
aware that they may be required to undergo a Disclosure & Barring Service (DBS) check
prior to undertaking any research project involving vulnerable participant groups.
Sufficient time should be factored in so that this can be obtained.

3. Ethics Training

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 3.1 Completion of the Epigeum Research Integrity Course has been made mandatory from
academic year 2017/2018. This is for academic members of staff with an externally
funded research project and postgraduate researchers. Students on taught programmes
are encouraged to complete this course.

3.2 Researchers will therefore be asked to provide confirmation that they have successfully
completed this course.

3.3 The Research Office will check the accuracy of the date / certification provided and revert
to the researcher if required.

3.4 Completing the Epigeum Research Integrity Course does not detract from any additional
ethics training a Researcher may have undertaken or be required to take departmentally.

4. Travel

4.1 The online Risk assessment, travel safety and security form is to be completed where
overseas travel is due to occur, for example on fieldwork.

4.2 Researchers must check whether a research visa or a research permit is required for the
country or countries they are proposing to travel to. In tandem with this, researchers
should also check whether they are required to obtain local authorisation from either a
national ethics committee or university in the country they are travelling to. The
International Compilation of Human Research Standards is a useful starting resource in
this regard.

5. Impact Assessment

5.1 Essentially, a Data Protection Impact Assessment would be required if a ‘yes’ answer is
recorded in the Screening Evaluation contained in Appendix 1. If a researcher thinks that
this may be the case, or they are unsure, then they should contact the Research Ethics
officer in the first instance to have a preliminary discussion.

Part II

Ethics Review and Assessment

The assessment toolkit is not designed as being an all-encompassing ethics framework. Rather, it is
crafted to help a Researcher think-through, be reflexive and document accordingly, the various ethical
aspects or implications that may arise for their research project.

The assessment toolkit is made up of six-broad areas, namely:

i. Part A: Nature of Proposed Research
ii. Part B: Research Participants: Personal Data
iii. Part C: Consent and Compliance
iv. Part D: Data Management
v. Part E: Transparency and Publication

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 vi. Part F: Specialised Risk

In general, the assessment undertaken by the researcher here (bar A1) is considered to be of a lower
risk and will not require a mandatory referral to the Research Ethics Panel. The assessment can
therefore be approved by the relevant reviewer.

Where a ‘Yes’ response (marked with , no marked as ) is detailed against any of the areas in Parts
A to F, a separate section has been provided (Part III) to detail the particulars of that area of risk and
the various appropriate mitigating steps. It can also be utilised to provide further information or
details as required. In relation to Worktribe, the online version already has a drop-down box each
time a ‘yes’ answer is indicated so that a researcher may provide the requisite detail and response. A
completed version may also be uploaded to the documents section.

The guidance notes here for Parts A to F are intended to directly mirror the questions outlined on the
form: Institutional Approval Form for Research Ethical Review & Assessment.

Part A: Nature of Proposed Research

1. Areas that require formal approval if they fall within Table 1 – also detailed at Annex A.

2. These broad questions enable the Researcher to think through any ethical issues that
potentially could arise in relation to: Research Objective(s), Methodology and Impact.

Part B: Research Participants: Personal Data

Following changes to Data Protection laws, 2 there is now a requirement to identify and record the
lawful basis upon which the processing Personal Data and Special Category Data occurs. Where a
researcher is working with Personal Data and / or Special Category Data, they must also have
completed the requisite Information Governance training, including any refresher training (if required
to do so).

1. Where a researcher is working with Personal Data they must identify the lawful basis for
processing that data. Researchers must familiarise themselves with the Code of Practice as it
relates to the use of personal data in research. Annex B contains a list of relevant data
protection terms and associated definitions.

2. Where a researcher answers ‘yes’ to Part B, Q.1, SOAS takes the view that the lawful basis for
processing is:
i. processing is necessary for the performance of a task carried out in the public
interest. 3

3. Where a researcher answers ‘yes’ to Part B, Q.2 or Q3, SOAS takes the view that the lawful
basis for processing is:

2 The General Data Protection Regulation (GDPR) and Data Protection Act 2018 came into force in May 2018.
3 GDPR Article 6 (1) (e)

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 i. processing is necessary for archiving purposes in the public interest, scientific or
historical research purposes or statistical purposes. 4

Part C: Consent and Compliance

1. Where a researcher is working with living human research participants, obtaining informed
consent is an important ethical consideration.

2. Section 4 of the Code of Practice contains detailed guidance in relation to obtaining informed
consent, including where it may not be possible to do so. Contained within the appendices is
the Model Consent Form which can be used and adapted by SOAS researchers, where
appropriate.

3. Please refer to the Code of Practice for additional guidance in relation to anonymisation.

4. Funders of external research projects are increasingly seeking to ensure value for money and
may specify additional or follow up requests for monitoring / compliance. The Research Office
will also be conducting assurance activities in relation to research projects to ensure that SOAS
remains compliant with any legal or contractual obligations.

5. SOAS has a clear view on potential conflicts of interest that may arise in relation to research.
As the Research Ethics Policy states:

Conflict of Interest: Researchers must disclose any financial and / or other conflicts of
interest that could (potentially) compromise the trustworthiness of their work in research
proposals, publications and public communications, as well as in all review activities.

Conflicts of interest can arise from:

i. A direct or indirect financial interest
ii. Non-financial or personal interests
iii. Competing loyalties between an organisation they owe a primary duty to and/or
some other person or entity. 5

Researchers should also consult the professional code of their relevant discipline where
required or mandated to do so.

Part D: Data Management

1. Please refer to the table of definitions in Annex B for additional clarification upon the meaning
of anonymisation and pseudonymisation. An example of a pre-existing data set(s) are those
produced by the Office for National Statistics (ONS).

4 GDPR Article 9(2) (j). In line with GDPR Article 89 (1), this type of personal data that is processed for research
purposes must be accompanied with appropriate safeguards, by way of technical and organisational measures to
ensure that the processing is necessary for that research purpose and broadly in line with the principle of data
minimisation. The Data Protection Act 2018 [Part 2, Chapter 2, sec. 10] further specifies that the processing would
meet the requirement of Article 9(2) (j) if it meets a condition in Part 1 of Schedule 1 of the Act. In this instance,
section 4 on research.
5 The wording here is taken from UKRI. For additional information concerning Conflicts of Interest, the UKRI has

additional guidance available.

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 2. The Code of Practice contains detailed guidance in relation to Data Management and where
appropriate, if additional measures need to be put in place, a researcher should seek
additional clarification / training upon this matter.

3. Under the current data protection regulations, the School and its researchers are by law
required to ensure that there are the appropriate technical measures in place to safeguard
individuals’ rights where their personal data is being utilised for research purposes. As such,
‘data protection by design and by default’ is a necessary feature of the data management
questions to consider.

4. Additional guidance in relation to data management planning has been included in the list of
relevant links accompanying this document at Annex C. Researchers should though be
factoring in appropriate time / adequate resources for the organisation of research data,
particular where it is voluminous.

5. Researchers must seek to document and retain any special permission or access that is
granted in this regard.

6. Sample data management plans are available, for example at DMP online which can be
accessed using SOAS login details. Research funders may have their own specifications in
relation to this and researchers should be particularly alert to any requirements in this regard.

Part E: Transparency and Publication

1. Any concerns regarding the possible or potential embargoing of PhD theses must be raised at
the earliest opportunity to the relevant supervisor / Research Tutor. The PhD Full Embargo
Request Form must be completed if a yes answer is recorded for Q.1.

2. Again, Researchers must seek to document and retain any special permission or access rights
that are granted in this regard.

3. The School has several legal obligations that it must fulfil as required by statutory and
regulatory authorities, funders and other relevant stakeholders. It is therefore essential that
research is conducted according to appropriate ethical, legal and professional frameworks,
obligations and standards.

4. The question allows the Researcher to document and outline any financial remuneration that
may be offered to research participants.

5. The last question under this section allows the Researcher to comment and document any
other ethical issue that may arise for the research project.

Part F: Specialised Risks

1. Although SOAS is not an institution that undertakes primary research in the area of bio-
medical / behavioural sciences, this section (and the associated questions) has been included
for the Researcher to consider. There is occasion where Researchers from SOAS may be
partnering with other institutions that are undertaking such work thereby potentially giving
rise to such issues.

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Part III

Documenting / Managing Risk(s)

1. The risk assessment table has been integrated into the Ethical Review & Assessment process,
rather than having this as a separate form.

2. The assessment table should be cross-referenced to the earlier parts of the assessment toolkit
where a ‘yes’ answer is recorded for any of the questions outlined in Parts A through to E.

3. For research that is externally funded, Worktribe has this functionality built-in.

Issue
4. This section can be referenced with the Part-letter and relevant question number, for example:
Part E, Q.4.

Risk
5. The (anticipated) individual risk or issue can be detailed in column two.

Risk Rating
6. The standard Risk rating used is RAG: Red / Amber / Green. Red representing the highest level
of risk. These may either be recorded as Red / Amber / Green in the column or with the
corresponding number, for example 1 (Red) / 2 (Amber) / 3 (Green).

Mitigation
7. The section here requires outlining the steps the Researcher is taking in order to address the
risk or item that has been identified. In other words, the proposed action seeks to eliminate,
substantially reduce or render the risk tolerable in relation to the project purpose and aims.

Evaluation
8. The section allows the Researcher to think through and document how the final impact(s)
arising from the proposed mitigation will be in line with the overall aims and objectives of the
research project.

Mitigation Approval
9. The researcher is given the layer of assurance here that the mitigating steps they are outlining
/ implementing have been approved and have received the requisite sign-off by the
appropriate reviewer. Where referred to the Research Ethics Panel, this can be detailed.

Date for Reporting / Implementation

10. A date for tracking or reporting on any particular milestones can be utilised to indicate (for
example) a completion date for training or utilised as a milestone date.

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Part IV

Declaration and Approval

1. For Taught programmes (postgraduate, undergraduate) only one resubmission following a

refusal is permitted.

2. Researchers should refer to the Procedure document for the process mapping.

3. Where a matter is referred to the Research Ethics Panel and approved, Researchers will be
given an Approval Code (a reference number with lettering) that will be detailed on the
notification letter. Researchers must keep a copy of that letter for audit and monitoring
purposes.

4. Academic departments may require taught students to attach a copy of this section to the ISP
or Masters dissertation as an appendix. Students should seek clarification from their
supervisor and / the relevant departmental ethics officer (if appointed) to note any
requirements.

Part V

1. Researcher details

1.1 The first part of the form replicates the section detailed in Part 1 as detailed above.

1.2 An additional question asks the researcher where the research is to be conducted,
whether in the UK or overseas. A text box is provided for the researcher to outline any
necessary details (e.g. if it is overseas, precisely where).

1.3 Thereafter, the researcher is prompted to provide detail of the vulnerable participant
group(s) that the research project involves.

2. Authorisation

2.1 Once considered by the Research Ethics Panel, an authorisation code will be issued to the
researcher. This can be included in the approvals section together with the date of
consideration.

2.2 The Research Ethics Panel may further specify, depending upon the nature of the
participant group(s), that it should be referred to the Designated Safeguarding Lead (DSL)
or equivalent deputy.

2.3 Following on from this referral, there may some follow up actions requested, for example
by providing confirmation of a valid DBS.

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Annex A

Table 1: Areas of Research requiring formal approval from the Research Ethics Panel (REP)

Nature of Research Details

1. Security sensitive All terrorism related research.

2. Culturally sensitive Research involving culturally sensitive

objects and / or artefacts.

3. Participant sensitive Research involving potentially vulnerable

participant groups including but not limited
to: children, individuals lacking mental
capacity etc. [whether in the UK or
overseas] 6

4. Fieldwork security risks Proposed fieldwork that may potentially

give rise to adverse risks including
potential/actual physical harm to either the
researcher and/or research participant(s).

5. Gatekeeper A single authority figure, (domestically or

internationally), with the power or ability
to grant / deny access to research
participants and being remunerated
financially.

6. Conflict of Interest Including: direct/indirect financial interest;

non-financial personal interests

7. Embargoing Requests to embargo PhD thesis

8. Significant / material change of Where research plans have changed

circumstances materially (e.g. research methodology has
substantially changed)

(9. Approval sought) (Self-referral: potential/likely significant

ethical issues arising)

6An enhanced DBS (disclosure and barring service) check may be required before any research project can be
undertaken.

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Annex B

Term Definition

Personal Data Information relating to an identified or identifiable living

individual/natural person (data subject): one who can be identified
directly/indirectly by reference to an identifier (e.g. a name) or, one of
certain specific characteristics relating to the individual.

Special Category Data
Personal data revealing racial or ethnic origin, political opinions,
religious or philosophical beliefs, or trade union membership, and the
processing of genetic data, biometric data for the purpose of uniquely
identifying a natural person, data concerning health or data
concerning a natural person's sex life or sexual orientation.

Processing In relation to information, means an operation or set of operations

which is performed on information, or on sets of information, such as:
collection, recording, organisation, structuring or storage, etc.

Lawful basis for the Processing is necessary for the performance of a task carried out in the
processing of Personal Data public interest.

Lawful basis for the Processing is necessary for archiving purposes in the public interest,
processing of Special Category scientific or historical research purposes or statistical purposes.
Data

Anonymisation Anonymous information, namely: information which does not relate

to an identified or identifiable natural person or to personal data
rendered anonymous in such a manner that the data subject is not or
no longer identifiable.

Pseudonymisation Processing of personal data in such a manner that the personal data
can no longer be attributed to a specific data subject without the use
of additional information, provided that such additional information is
kept separately and is subject to technical and organisational
measures to ensure that the personal data are not attributed to an
identified or identifiable natural person.

Data minimisation (Personal data shall be): adequate, relevant and limited to what is
necessary in relation to the purposes for which they are processed.

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Annex C

List of Documents referred to

1. SOAS Research Ethics Policy

2. Procedure: Ethical Review of Research Projects

3. SOAS Safeguarding Policy

4. Code of Practice for SOAS staff and students: Using Personal Data in Research

5. Institutional Approval Form for Research Ethical Review & Assessment

6. Epigeum Research Integrity Course

7. SOAS Research Data Management

8. International Compilation of Human Research Standards

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