Institutional Approval Form for Research Ethical Review & Assessment: Guidance Notes. Page Oct-2018 Research & Enterprise Committee Version 1.

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1 Institutional Approval Form for Research Ethical Review & Assessment: Guidance Notes Authored by Research Office (K Hasan) Date 10 Oct-2018 Approved Research & Enterprise Committee Version 1.0 Page 1

2 Part I The guidance notes provided here accompany the form: Institutional Approval Form for Research Ethical Review & Assessment. 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 abstract about the nature of their proposed research. 1.3 Status indication is to indicate 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 nonexternally 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 to the guidance notes for ease of reference). 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 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. Page 2

3 2.6 While the nature of the areas / topics listed as 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 access to sensitive or restricted materials, to complex legal questions. 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 no. 3) a copy of the forms (including the referral form) together with the completed risk assessment section will also be provided to the School / departmental Safeguarding Officer. This is in addition to the project requiring formal ethical approval from the REP 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 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. 3. Ethics Training 3.1 Completion of the Epigeum Research Integrity Course has been made mandatory from academic year 2017/ Researchers will therefore be asked to provide confirmation that they have successfully completed this course. Page 3

4 3.3 The Research Office will check the accuracy of the date / certification provided and revert to the researcher if required. 3.4 Where the Researcher hasn t yet completed the required training, they will be asked to provide an explanation and a reasonable timeframe of when they expect to complete the course. The Research Office will be contacting individually all researchers (staff/students) regarding their course completion. 3.5 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. 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 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 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 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. Page 4

5 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, 1 a Researcher is now required to identify and record the lawful basis upon which they are processing Personal Data and Special Category Data. 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, the School takes the view that the lawful basis for processing is: i. GDPR Article 6(1) (e) [public task] 3. Where a researcher answers yes to Part B, Q.2 or Q3, the School takes the view that the lawful basis for processing is: i. GDPR Article 9(2) (j) [scientific or historical research purposes or statistical purposes] ii. Data Protection Act (DPA) 2018 Schedule 1, Part 1 (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 of the guidance 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: 1 The General Data Protection Regulation (GDPR) and Data Protection Act 2018 came into force in May Page 5

6 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. 2 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). 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 laws, 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. 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 Again, Researchers must seek to document and retain any special permission or access rights that are granted in this regard. 2 The wording here is taken from UKRI. For additional information concerning Conflicts of Interest, the UKRI has additional guidance available. Page 6

7 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 biomedical / 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. 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 item 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. Page 7

8 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. 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. Part IV Declaration and Approval 1. For Taught programmes (postgraduate, undergraduate) only one resubmission following refusal is permitted. 2. Researchers should refer to the Procedure document for the process mapping and timelines of reporting. 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. Part V 1. Researcher details 1.1 The first part of the form replicates the section detailed in Part 1, paragraphs 1.1 to 1.4 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. Page 8

9 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 vulnerable participant group(s), that it should be referred to the School Safeguarding Officer. In the absence of that specific request, the Researcher should then complete the form and send a copy to their departmental Local Safeguarding Officer. 2.3 Following on from this, the Safeguarding Officer may further make a determination as to whether a DBS check is required. Page 9

10 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] 3 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 circumstances Where research plans have changed materially (e.g. research methodology has substantially changed) (9. Approval sought) (Self-referral: potential/likely significant ethical issues arising) 3 An enhanced DBS check may be required before any research project can be undertaken. Page 10

11 Annex B Key Data Protection Definitions Term Definition Reference 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. DPA 2018 Part 1 section 3 (Preliminary) (2), (3) GDPR Article 4 (1) 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. Data Protection Act (DPA) 2018 Part 1 section 3 (Preliminary) (4) GDPR Article 4 (2) 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. [Criminal offences and convictions] DPA 2018 Part 2 chapter 2 (10) GDPR Article 9 (1) DPA Act 2018 Schedule 1 Part 3 (29), (32) GDPR Article 10 Lawful basis for the processing of Personal Data Processing is necessary for the performance of a task carried out in the public interest. GDPR Article 6(1) (e) [public task] Lawful basis for the processing of Special Category Data Processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes DPA 2018, Schedule 1, Part 1 (4) GDPR Article 9(2) (j) 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. GDPR Recital 26 Page 11

12 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. GDPR Article 4 (5) Security Principle (Security of processing) Each controller and each processor must implement appropriate technical and organisational measures to ensure a level of security appropriate to the risks arising from the processing of personal data. DPA 2018 Part 3, chapter 4, (66) Data Protection by design / default Each controller must implement appropriate technical and organisational measures which are designed to implement the data protection principles in an effective manner, and to integrate into the processing itself the safeguards necessary for that purpose. DPA 2018, Part 3, chapter 4 (57) Page 12

13 Annex C List of Documents referred to 1. SOAS Research Ethics Policy 2. SOAS Safeguarding Policy 3. Code of Practice for SOAS staff and students: Using Personal Data in Research 4. PhD Full Embargo Request Form 5. Institutional Approval Form for Research Ethical Review & Assessment. 6. Epigeum Research Integrity Course 7. SOAS Research Data Management Page 13