Applying for ethical approval

The School requires all research involving human participation or sensitive data conducted by its staff, research degree candidates and other students to be subjected to ethical scrutiny. This means that most researchers within the School are required to apply for ethical approval from the School Research Ethics and Integrity Committee (SREIC), using an SREIC form, before beginning data collection. There are a couple of exceptions to this outlined below where (i) SREIC delegates ethical scrutiny for research conducted as part of a taught postgraduate or undergraduate course to a Course Approval Panel or (ii) where staff research is undergoing external ethical scrutiny.

What counts as ‘research’?
A project is defined as ‘research’ if it seeks to systematically generate knowledge to share with others including the academic community, external partners such as funding organisations and/or the wider public. This includes all conventional academic research projects as well as work towards a research degree, whether or not the research is supported by a recognised research funder. It may also include many evaluation studies, for example, evaluations of new services in health and/or social care, education and criminal justice. However, evaluations which are part of routine monitoring of services or systems, which use familiar tools, and do not produce data that could be published in academic journals (or similar) may be excluded from SREIC scrutiny. Inevitably there will be grey areas regarding the status of evaluation studies. If in doubt, contact the SREIC administrator at hhs_srep@hud.ac.uk for advice.

What counts as ‘human participation’ in research?
Any study which meets the definition of research and involves collecting data directly from individuals or organisations will require ethical approval from SREIC and/or an external committee or Course Approval Panel. Data may be qualitative, including that obtained via interviews, focus groups, diaries, online methods and participant observation, or quantitative, including data obtained from experiments, surveys and structured observation. Research which involves only the analysis of data already in the public domain still needs to be submitted to SREIC but is likely to only require “low risk” assessment. It is good practice to have all research activity reviewed by an independent ethics panel as this is helpful in demonstrating ethical principals and also a requirement to publish in peer reviewed journals.

 

What counts as research using sensitive data?

Sensitive data includes data which may pose a legal or reputational risk to you or the University if your use of this data is misconstrued (for example, obtaining data relating to child abuse). It also includes data used in security-sensitive research. UUK guidelines class this as research that:

• Is commissioned by or on behalf of the military or the intelligence services
• Is commissioned under an EU security call
• Involves acquisition of security clearances
• Concerns terrorist or extreme groups

Further guidance on this is contained in the UUK guidance on security-sensitive research.

Requirements for different applicants

The circumstances in which you need to apply to SREIC for your study differ according to whether you are a member of staff, a postgraduate research degree candidate, or a student (postgraduate or undergraduate) on a taught degree course. If you are a member of staff undertaking a piece of research as part of a research degree, you will be treated as a postgraduate research degree candidate for the purposes of SREIC approval. Further details are provided below:

Members of staff

You need to apply to SREIC for approval for all research meeting the criteria above, unless your research project is being scrutinised by another external ethics committee, for example a Health Research Authority Research Ethics Committee (REC) via IRAS (Integrated Research Application System) or an ethics committee at another university. If your project is being scrutinised by an external committee, you must notify SREIC of your external application by sending a SREIC-Notification-of-external-ethical-review-Rev2-Jul19 to hhs_srep@hud.ac.uk before you apply. This form asks you to confirm that you have met University requirements for sponsorship of your research and to clarify whether your research is security-sensitive. Once you receive approval from the external ethical review body you will also need to send a copy of the approval to SREIC.‌

Research degree candidates

You must submit an SREIC application for all research before you commence any recruitment or data collection, even if it is being submitted to an external ethics committee as well. SREIC can advise you on your external application and should approve the external application before it is submitted if you want the University to act as sponsor of your research. Please note that each postgraduate researcher (PGR) should complete an individual SREIC application even if the research is linked to other research as part of a larger collaborative project. The application should clarify the unique part of the collaborative project that the PGR is designing and conducting. Where several PGRs are submitting applications which are linked, they should be submitted together where possible. A covering letter should also be provided explaining the relationship between the applications and identifying any shared procedures and documents.

Students on taught postgraduate or undergraduate degrees

Normally your research will be approved by a Course Approval Panel for your degree. You will be informed about the procedures for this by the leader of your project/dissertation module or equivalent. However, if your project fits into either of the following categories you should apply to SREIC:

• Research requiring external ethics committee approval where you want the University to act as sponsor of your research.  SREIC will need to approve your external application form before you submit it.
• Research which uses sensitive data, according to the criteria above.

PGR School Research Ethics and Integrity Committee (SREIC) Applications are allocated for review during a Panel Week.  PGRs will be required to attend a short Panel Meeting remotely in order to discuss their Application. Panel schedule available here: PGR panel week 23-24.

Staff SREIC Applicants will continue to submit as they are ready throughout the year.

SREIC Applications to be submitted by e-mail to: hhs_srep@hud.ac.uk.

The following documents must be completed and submitted to the SREIC administrator:

• A completed application form - an‌ application form with explanatory notes is also made available and it is strongly recommended that you read this alongside subject-specific and professional ethical guidelines. Additional SREIC guidance is provided for guidance on researchers obligations to disclose unreported crimes.
• A University Risk Analysis and Management form‌ (RAM form) - an example of a completed RAM form is also made available.
• Where the application is submitted by a research degree candidate, a completed and signed Supervisor Report to confirm that the Supervisor has read all documents, fully supports the submission to SREIC and confirms that the application is of a suitable standard for review (SREIC retains the right to return any application deemed not to be of a suitable standard).
• Consent Form (see example Consent Form)
• Information sheet (see example information sheet)

The following supporting documentation must also be supplied if relevant:

• Evidence of management or other necessary permission to gain access to the research participants or database.
• Letters of invitation.
• Additional debrief sheet if full information is not provided prior to the research
• Questionnaires and/or interview guides.

All documents which will be provided to participants should indicate a version number and date, as a header or footer.  Any revisions to the documentation following SREIC approval should be resubmitted to SREIC for further approval.  These new documents should then carry a new version number and date.  The consent form should refer to the version number and date of the information sheet, so that it is clear what the participant has agreed to.

The examples of completed documents provided through the links given above will not be suitable for all projects. The Health Research Authority provides further guidance on producing information leaflets and consent forms. When planning the research methods you will use and developing your supporting documentation, you are also advised to consult (i) relevant subject-specific ethical codes and professional guidelines and (ii) the University Code of Practice for Research Ethics and Integrity Framework. This website provides an index of links to these external and internal codes of practice, and to guidance on the legal framework for research.

Security-sensitive research

If you are conducting/planning to conduct research that includes security-sensitive data, you will be asked to declare this on the SREIC application form and provide extra information about collection and storage of data. Security-sensitive research includes research that is:

• Commissioned by or on behalf of the military or the intelligence services
• Commissioned under an EU security call
• Involves acquisition of security clearances
• Concerns terrorist or extreme groups 

If your research concerns terrorist or extreme groups you will also be asked to complete and submit an additional Security Sensitive Information-Declaration-Rev2-Jul19.

Please read the UK guidance on security-sensitive research before completing your application.

PGR Applicants:

Your application will be allocated for review at the next PGR Panel Week.  You will be required to attend (remotely) a short panel meeting during the Panel Week in order to discuss your application with the panel reviewers.  You will receive verbal feedback at the meeting, followed by written feedback shortly after.  There are four possible decisions:

1. Approve outright / with minor amendments: this may offer suggestions for minor change and will not require another review. 
2. Approve with amendments to be resubmitted for panel reviewers’ approval. 
3. Resubmission required, application to be re-examined by panel reviewers. 
4. Reject.

Staff Applicants: 

Your application will be sent to two reviewers for their comments and you will be sent their feedback / decision by email. You should receive the decision within four weeks from submission of your application. There are four possible decisions: 

1. Approve outright / with minor amendments: This may offer suggestions for minor changes and will not require another review. 
2. Approve with amendments to be re-submitted for the reviewers’ approval. 
3. Resubmission required, application to be re-examined by reviewers. 
4. Reject. 

Resubmission

• If your application requires resubmission, you must resubmit the amended documents within four weeks, otherwise your application will be removed from the SREIC process. If you no longer wish to continue with your application please inform the SREIC administrator.
• Should your application receive approval but subject to amendments to be re-submitted for approval, you should receive a decision within two weeks of receipt of the amendments you have made and any required updates to your documentation.
• Should your application require resubmission, the application will be sent out for a second review and you should receive a decision within four weeks.
• The SREIC administrator will maintain a record of proposals submitted and outcomes from the review process.

Revisions to previously approved applications

SREIC's approval is for the methods outlined in your SREIC application, and you will be required to confirm annually that your research has adhered to these methods and to the ethical conduct SREIC has approved.  If you wish to make any changes to your research you should seek SREIC approval for a revision, using the Revisions Form‌.  This should be sent to hhs_srep@hud.ac.uk.  SREIC aims to review revisions as quickly as possible, and may be able to do this via chair's action, though complex revisions may require fuller review.

Research in health and social care contexts

The ‘Governance Arrangements for Research Ethics Committees’ (GAfREC) defines the types of research that require approval by a Health Research Authority REC (Research Ethics Committee) via the Integrated Research Application System (IRAS). A summary of the research requiring REC approval is provided by the Health Research Authority (HRA), which also produces Defining research guide. Only studies that are defined as research and involve patients or informal/family carers require REC approval. Studies that involve staff only do not require REC approval. If a study requires REC approval but is low risk it may be eligible for proportionate review which is a simplified REC review process.

If a study is classed as research but does not need REC approval because it does not involve patients or informal carers (e.g. it just involves NHS staff), there is still a requirement for HRA approval and therefore an application will still need to be made via IRAS, though this will involve a shorter application form which will not be reviewed by a REC. If a study is classed as ‘service evaluation’ or ‘audit’ it does not need either REC or HRA approval and can be agreed by local NHS services.

All researchers conducting studies within the NHS (whether with staff or patients and whether classed as ‘research’ or ‘service evaluation/audit’) additionally need to confirm that there is the capability and capacity to conduct the research at the proposed NHS site/s and need to negotiate accesses. Therefore it is advised, in the first instance, for the lead researcher to contact the Research and Development Department at the relevant NHS site/s (or site offering NHS services e.g. social enterprise) before making an application via IRAS or to SREIC. Research and Development Departments welcome early contact by researchers and this avoids the need to redesign a study following ethical approval in order to meet local Trust requirements.

If you have questions about IRAS applications the School Research Ethics and Integrity Committee (SREIC) will try to help you if we can, though you should seek advice from the following sources in the first place:

• Integrated Research Application System
• NHS Health Research Authority’s advice pages on applying for REC and management (R&D) approval via IRAS
• Research and Development Department of the relevant NHS Trust
• E-learning on HRA/REC Permissions (aimed at students applying for NHS research permissions for the first time but would also suit any researcher new to the process) – https://www.hra.nhs.uk/about-us/news-updates/hra-releases-bite-size-elearning-modules-help-student-researchers-get-it-right-first-time/
• Student research toolkit – Health Research Authority (PGRs and their supervisors will need to use this toolkit before proceeding with their IRAS (Integrated Research Application System) application
• All researchers, students, supervisors, and sponsors are advised to refresh themselves with the UK Policy Agreement for Health and Social Care which sets out principles for good practice, management, and conduct of research in health and social care settings. The policy applies to all UK organisations and individuals conducting work in this setting.
• HR Good Practice Resource Pack - for information about the Research Passport about pre-engagement checks required for researchers undertaking their activities in the NHS

Training for applicants

Online Epigeum modules relating to Research Ethics can be accessed for free.  To access the material, users must register with their @hud.ac.uk email account.  Further detail including the link for registering: Epigeum - Researcher Environment (hud.ac.uk)

Details of the next ‘Ethical Review and External Governance’ training sessions can be found within the School 2021/22 PGR Training Schedule (in the Common Room in Brightspace (https://brightspace.hud.ac.uk/d2l/le/content/17267/Home)  Although the training sessions will be live-streamed and recorded, face-to-face attendance is likely to be a better learning experience.

E-learning on HRA/REC Permissions (aimed at students applying for NHS research permissions for the first time but would also suit any researcher new to the process) – https://www.hra.nhs.uk/about-us/news-updates/hra-releases-bite-size-elearning-modules-help-student-researchers-get-it-right-first-time/’

For further information about training sessions contact the SREIC Administrator (below)

Kirsty Thomson
E-mail: hhs_srep@hud.ac.uk