Guidance on Ethical Approval for Research

When is external approval necessary?

External Approvals: Research involving Human Tissue

The Human Tissue Act 2004 regulates the storage and use of human tissue for research purposes. It applies to human tissue whether or not it is sourced from the NHS. Human tissue includes blood and other material, other than gametes, which consists of or includes human cells (for further information on what constitutes human tissue, see the Human Tissue Authority’s list of relevant material). Failure to comply with the Act can lead to imprisonment and/or a fine.

The legislation requires that the storage of human tissue for research purposes must be done either under a licence issued by the Human Tissue Authority or as part of a project which has received ethical approval from an NHS Research Ethics Committee (NHS REC). Storage includes storage for any length of time. University research ethics committees like Greenwich’s University Research Ethics Board (UREB) are not authorised to approve the storage of human tissue for research purposes.

Because the University of Greenwich does not hold an HTA licence, you must submit an application to an NHS REC if your project will involve the storage of human tissue for research purposes. NHS RECs can approve applications for research involving human tissue irrespective of whether it is sourced from NHS patients. Applications should be submitted via the Integrated Research Application System (IRAS). Once your application has been approved by the NHS REC, you should submit a copy to UREB for information.

Where human tissue is stored under approval from an NHS REC, you must ensure that the material is stored for no longer than the duration of your project’s approval or apply in good time to the NHS REC to extend the approval.

There are some exceptions to the requirement that human tissue must be stored under an HTA licence or under NHS REC approval, where it may be possible for UREB to grant approval:

• Where the storage is incidental to transport to another organisation (the transportation should take place in a matter of hours or days and in less than a week);
• Where the human tissue has been received from an HTA-licenced tissue bank with generic NHS REC approval.
• Where the human tissue is stored with the intention of rendering it acellular. This should take place in a matter of hours or days and in less than a week. NB this exemption does not cover using human tissue for research purposes prior to rendering it acellular;
• Blood samples which are taken and analysed immediately before being disposed of on the same day;
• If your project involves the taking of blood samples, please see the Policy on the Collection of Blood Samples for Research or Teaching for further guidance.

Please contact the University Research Ethics Board for advice relating to the use of human tissue in research (see ‘Useful Contacts’ below).

External Approvals: Research Requiring Health Research Authority Approval

Some types of research require approval from the Health Research Authority (HRA). Researchers are responsible for identifying whether their project requires HRA approval (which may include approval from an NHS Research Ethics Committee) and for obtaining the necessary approvals and are advised to review the HRA’s guidance on when approval is required. Applications for this type of research will need to be made through the Integrated Research Application System (IRAS). Evidence of approval from the relevant body/bodies is required to be provided to UREB.

Types of research requiring HRA approval include:

• Research involving NHS patients, staff, data or facilities
• Research involving exposure of participants to Ionising Radiation
• Clinical trials of Investigational Medicinal Products
• Clinical investigations or studies of Medical Devices

Please contact the University Research Ethics Board for advice if your research falls into any of these categories (see ‘Useful Contacts’ below).

External Approvals: Research involving Animals

The University is not licenced to carry out research which falls within the scope of the Animals (Scientific Procedures) Act 1986. This Act regulates the use of protected animals in any experimental or other scientific procedure which may cause pain, suffering, distress, or lasting harm to the animal.

A protected animal according to the Act is “any living vertebrate other than man and any living cephalopod. Fish and amphibia are protected once they can feed independently”.

Any research involving vertebrates or cephalopods which falls outside the scope of the Act (e.g. studies of animals in a natural setting) must be submitted to the University Research Ethics Board for approval. Please contact the University Research Ethics Board for advice if your project involves animals (see ‘Useful Contacts’ below).

What approvals do I need if my project involves external universities?

The four most common situations for staff projects are:

• You are involved in a project where Greenwich is the lead partner and other universities are also involved. In this scenario, we would normally expect ethical approval to be sought from Greenwich covering the entire project.
• You are involved in a project where another university is the lead partner and has obtained ethical approval for the project. Unless the project involves recruiting Greenwich students or staff as participants (see below), approval does not need to be sought from the University Research Ethics Board (UREB) but you must provide UREB with evidence of the external approval (e.g. approval letter and ethics application including any appendices) so this can be noted.
• You are involved in a project where another university is the lead partner and has obtained ethical approval for the project, and the project will be seeking to recruit Greenwich students or staff as participants. You must submit an ethics application to UREB for approval. Your application should include evidence of the external approval (e.g. approval letter and ethics application including any appendices).
• You are involved in a project with other universities where each partner is expected to seek its own ethical approval. Your ethics application to UREB should explain clearly what aspects of the project UREB’s approval is intended to cover.

Please contact UREB for advice if you’re not sure which of these situations applies to you (see ‘Useful Contacts’ below).

When does the use of secondary data require ethical approval?

Secondary data is information which has been collected by others for purposes other than the researcher’s current investigation (e.g. from a data archive or another project, including a previous project by the same researcher).

The main thing to consider is whether the secondary data is anonymised. If the data is fully anonymised (i.e. it is not possible to identify individuals in any way), you shouldn’t need ethical approval. However, if the data is not fully anonymised (e.g. individuals are identified in the dataset, or the data has been pseudonymised to remove identifiers, but it would still be possible to identify an individual by linking information), you will be using personal data and this may be considered as research indirectly involving human participants, so ethical approval will be required. If you are unsure, contact your Faculty Research Ethics Committee or the University Research Ethics Board for advice (see ‘Useful Contacts’ below).  For guidance on anonymisation and pseudonymisation, see the University’s Code of Practice on the Anonymisation of Data.

What is the UoG ethical approval process for staff applications?

What is the UoG ethical approval process for taught student applications?

Where can I find the research ethics application form?

The website includes the University Research Ethics Board’s research ethics application form. Please download and use the online version of the form (rather than one which you have saved previously) as it is regularly updated.

Alongside the application form, we also provide templates for a consent form and a participant information sheet which we strongly encourage applicants to use.

What are the ‘low risk’ and ‘higher risk’ categories?

Research ethics applications are classified as ‘higher risk’ by the University Research Ethics Board (UREB) if they involve one or more of the following:

• Vulnerable groups or individuals (children, the elderly, physically or mentally ill individuals, people with cognitive impairments, people in care, bereaved people, people in prison, people with experience of crime or abuse, and adults who may be considered vulnerable for other reasons).
• Research involving animals (vertebrates or cephalopods) where the research falls outside the scope of the Animals (Scientific Procedures) Act (e.g. observational studies of animals in a natural setting).
• Physically invasive/intrusive procedures (e.g. blood sampling).
• Harmful, criminal, sensitive, extremist or terrorist subject matters.
• Research where the nature of collaboration (e.g. the source of funding) raises concerns that it may be inconsistent with the University of Greenwich values – see the Ethical Research Collaboration Policy for more details.

Applications which do not fall into any of these categories are considered by UREB to be ‘low risk’.

The implications of your application being categorised as ‘low risk’ or ‘higher risk’ depend on whether you are a staff member or a student:

Staff members: ‘low risk' applications are reviewed by UREB by an expedited process, while ‘higher risk’ applications are reviewed by UREB by circulation or at a Board meeting (see ‘UREB approval by circulation, by Board meeting and low risk approval’ below). For an overview of the process, see our flowchart for the staff ethical approval process.

Students: ‘low risk’ applications should normally be approved by the Faculty Research Ethics Committee (FREC) or School Research Ethics Panel (SREP); ‘higher risk’ applications should be referred following review by the FREC/SREP for approval. There are some exceptions where approval of ‘higher risk’ applications is delegated to faculty ethics committees for approval (e.g. where a teacher training programme typically involves students carrying out projects in school settings with children as participants). For an overview of the process, see our flowchart for the student ethical approval process.

What is low risk approval, approval via circulation or board meeting?

Low Risk Approval: if your application is categorised as Low Risk by the University Research Ethics Board (UREB) then it will be reviewed in an expedited process and approved outside the UREB meeting cycle by the Chair or Vice-Chair of UREB.

Approval by Circulation: your application has been categorised as ‘higher risk’ by UREB and will be circulated to UREB members outside of the UREB meeting cycle, meaning you will not have to wait for a Board meeting to take place. Normally, your application will be reviewed by a group of UREB members rather than the full Board.

Approval via Board meeting: your application has been categorised as ‘higher risk’ by UREB and will be added to the UREB meeting agenda ready to be discussed by all Board members at the next scheduled meeting. This is sometimes to ensure that applications which may be particularly sensitive, contentious or precedent setting are discussed in a formal environment.

What types of approvals are granted?

The following decisions are granted by our ethics committees – approved, approved subject to amendments, and rejected. Please note it is not often that applications are rejected but it can happen if there is insufficient information to enable an ethical decision to be reached, or if there are felt to be fundamental flaws in an application.

If your application is approved, you can commence your research. Please ensure that you abide by any conditions in your approval letter.

If your application is approved subject to amendments, you need to amend your application to reflect the feedback from the Faculty Research Ethics Committee (FREC) or the University Research Ethics Board (UREB) and send it back for approval by chair’s action. Please track/highlight any changes. You must not commence any data gathering until final approval has been received.

If your application is rejected, you will receive feedback which you should use to amend your application and resubmit it for consideration.

How long does it take for an ethical approval decision to be made?

Application Guidance: what risks do I need to consider?

Section 4 of UREB's application form asks researchers to identify potential ethical risks or issues relating to their project and explain how these will be addressed.

Areas of ethical risks to consider include, but are not limited to:

Risks to participants:

• Physical risks (e.g. arising from invasive procedures).
• Participants finding the research triggering or experiencing stress or distress (consider sources of support that could be provided).
• Risks that could arise if participants are identified (explain how results and data will be anonymised).
• Risks to participants who are children or drawn from other vulnerable groups (e.g. the elderly, disabled people, prisoners).

Risks to voluntary informed consent:

• Is there a risk of coercion (e.g. students believing that they have no choice to participate because the research is conducted by a University staff member)? For guidance on pedagogical research, see ‘What if my project involves Greenwich students as participants?’ below.
• Does the project involve deception (e.g. not explaining fully to participants at the outset what the research is about)? If so, the reasons for deception need to be explained in the application and how you will mitigate the risk (e.g. providing participants with a debrief sheet after participation which provides the missing information and the ability to opt out).
• Does the research involve covert observation/filming?

Safeguarding risks:

• Participants disclosing that they have broken the law or providing information which indicates that they or a third party may be at risk. Consider when it may be necessary to break confidentiality, how that will be explained to participants and how you will report safeguarding concerns.

Risks to the researcher/research team:

• Are there risks related to the location where the research will take place (e.g. armed conflict, crime, disease)?
• Lone working risks to the researcher. Measures to mitigate these risks can include: holding interviews online/in offices/in public places; having a safety protocol in place if in-person interviews have to be conducted in participants’ homes.

Risks related to the research collaboration:

• Whether the nature of the collaboration (e.g. the source of the funding) raises concerns that it may be inconsistent with the University's values (see the Ethical Research Collaboration Policy for further details).

Risks related to the subject matter:

• Is the subject matter of the research particularly sensitive, contentious or controversial?

Risks to research data:

• Consider how you will keep personal data secure in line with data protection legislation (see ‘Personal data and data security’, below).

If your project involves gathering data in person (e.g. in person interviews or focus groups), a health and safety risk assessment must be completed and approved through the normal faculty/directorate health and safety process (see Health and Safety Services’ guidance on risk assessments). UREB will require confirmation that a risk assessment has been/will be carried out, but we don’t require you to provide the risk assessment. Research which is carried out wholly online / remotely does not require a risk assessment.

Application Guidance: personal data and data protection

Section 5 of UREB's application form asks researchers to indicate whether they are gathering personal data (including ‘special category’ personal data) and the steps they will take to ensure compliance with data protection legislation (the UK General Data Protection Regulation (UK GDPR).

Personal data is data on a living individual who is identified or identifiable – i.e. who can be identified from the data or from other information in combination with the data.

‘Special category’ personal data is personal data revealing racial or ethnic origin; political opinions; religious or philosophical beliefs; trade union membership; genetic data; biometric data (where used for identification purposes); data concerning health; data concerning a person’s sex life; and data concerning a person’s sexual orientation. This data is seen as particularly sensitive and is given additional protection under the UK GDPR.

Personal data gathered in the course of a research project must be collected, held and disposed of securely in line with the University’s Data Protection Policy. Detailed advice and guidance are available on the information compliance webpages, from the information compliance team (compliance@greenwich.ac.uk) and by contacting Information and Library Services (ILS). If a project involves gathering personal data, UREB would expect researchers to consider the following in their ethics application and participant facing materials:

• Data minimisation: the data collected should be proportionate to the needs of the project and no more than necessary (e.g. don’t gather demographic information if you have no plans to use it).
• Data use: personal data gathered for a research project should be used solely for the purposes of the project, unless participants have consented to further use (NB this does not prevent the long-term archiving of data or the submission of anonymised datasets to data archives).
• Data security: data must be stored securely during and after data collection. Any mobile devices used to collect/store data (e.g. laptops) must be encrypted. Wherever possible, data should be stored in the University’s secure cloud storage (OneDrive) with access limited to those who need access for the purposes of the project. Hard copy data (e.g. consent forms) should also be stored securely (e.g. in a locked cabinet until scanned and stored on OneDrive, with the hard copies then securely disposed of as confidential waste).
• Anonymisation: wherever possible, personal data should be anonymised to remove the risk of identification and a possible data breach. Please note the difference between anonymisation (where there ceases to be any possibility of identification) and pseudonymisation (where identifiers are removed, but the possibility of identification remains): see the University’s Code of Practice on the Anonymisation of Data for further information. Anonymised data ceases to be personal data, but pseudonymised data remains personal data.
• Data transfers/data sharing: secure methods (e.g. Teams sites, encryption) should be used when transferring/sharing personal data between members of the research team and with any third parties (e.g. transcription services). Any contractors used in the project must be University approved. If you will be transferring personal data from the UK/European Economic Area (EEA) to a country outside the UK/EEA, contact the information compliance team (compliance@greenwich.ac.uk) for advice as additional measures may need to be put in place to comply with the UK GDPR.
• Software: any software used in the project must be University approved; otherwise, approval will need to be sought from ILS.
• Data retention: specify in your application and your participant facing materials how long data gathered in the project will be kept for and how data will be securely disposed of at the end of that period.
• Data archiving: specify in your application and your participant facing materials whether you intend to submit data to a data archive (only anonymised datasets should be submitted to public data archives).

Application Guidance: Data Retention, Archiving and Publishing

All data needs to be retained, archived and published in accordance with university procedures for the purpose of research data integrity. Please see below for information on the types of data management. You will be asked to provide information on data retention, archiving and publication on the UREB application form.

Funders’ requirements: in all cases, any requirements by research funders for the retention, archiving and publication of research data must be met. These requirements may be different from the university’s requirements. Researchers are responsible for ensuring that they understand and can implement research funders’ requirements for data retention, archiving and publication.

Non-anonymised data sets collected during the research project: subject to funders’ requirements, in line with the recommendations of the JISC and UK Research and Innovation, the following retention periods are recommended for non-anonymised research data and related records (e.g. records of informed consent by participants):

• Population health and clinical studies – at least 20 years after study completion.
• Other studies - at least 10 years after study completion.

Non-anonymised data must be stored securely (see ‘Personal data ad data protection’). At the end of the retention period, research data must be permanently deleted or otherwise securely disposed of (e.g. shredding/confidential waste for hard copy data).

Publishing and archiving anonymised research data: in line with the University’s Statement on Scholarly Communication research projects are expected to take an open access approach when publishing the results and data. The following principles are outlined:

• “In accordance with the principles laid out in the Concordat on Open Research Data, all appropriate data generated by projects supported or led by University of Greenwich Staff, as appropriate, shall be made openly available with as few restrictions as possible.”
• “Data should be retained for a minimum of 10 years from the end of the project, or from publication of an output relating to the research, whichever comes first.”
• “Researchers should avoid retaining data solely using methods that might not persist for 10 years, such as on project websites, personal computing equipment or in formats limited to proprietary software. Researchers are permitted to have an embargo period on their research data to complete their work, publications, or intellectual property filing on that data, before release.”

Research data that must be retained include:

a. Data that support research findings.

b. Data that are of potential long term value.

c. Data that support patent applications.

d. Data which are subject to other legal requirements for data retention.

It is highly encouraged that University of Greenwich researchers adopt the approach of Open Access to support the research community to continue to progress, particularly as the UK is a leader in research data.

For more information and training, researchers can reach out to gala@gre.ac.uk with direct enquiries or visit the Library Guides. In addition, RETI Open Access training sessions, which can be found in the RETI training catalogue.

Application Guidance: how do I allow participants to withdraw?

Allowing participants to withdraw after completion is part of ensuring that you have voluntary informed consent. If a participant withdraws, their data should also be deleted. In most cases, it should be possible to enable withdrawal:

• You should explain clearly in your research ethics application and in the information provided to participants how they can withdraw (e.g. who to contact, what information to provide) and you should set a clear deadline for withdrawal.
• Anonymous surveys: it is good practice to allow the participant to provide a code which they can use to identify themselves if they subsequently wish to withdraw.
• Focus groups: while it may not be possible to delete the participant’s data from a recording of a focus group discussion, you can assure them that their data will not be used.

Application Guidance: what if my research involves UoG students as participants?

The main risks related to recruiting Greenwich students as participants are bias on the part of the researcher (if the researcher knows the students) and coercion (e.g. the student perceiving that they have no choice about participating because of the power imbalance between them and the staff member).  These risks are greater if you will be seeking to recruit your own students as participants.

To mitigate these risks, we recommend that you consider the following in your ethics application and participant facing information:

• Explain clearly to students that deciding not to participate or to withdraw after participation will have no negative consequences for them in terms of their studies or life at the University.
• Use anonymous data collection (e.g. an anonymous survey) where feasible.
• Create distance between yourself and participants, e.g. by getting someone who is not involved in teaching the students to gather the data / anonymise the data.
• Consider the timing of the research (e.g. scheduling it after marking has taken place may reduce the risk of coercion).
• If you intend to link data gathered in your project to other data which the University holds about students (e.g. their marks), this must be explained clearly to participants in the information provided to them.

Application Guidance: what software am I allowed to use in my research project?

UREB's application form will require you to indicate if you intend to use software in your project which has not been approved by Information and Library Services (ILS).

‘Approved software’ is software or platforms which are provided by ILS for University staff to use. This includes:

• Microsoft Forms, Microsoft Teams, OneDrive and other Microsoft 365 apps
• Qualtrics
• JISC Online Surveys
• SPSS
• Moodle
• Panopto
• Mentimeter
• Adobe Creative Cloud
• NVivo

Otherwise, you will need to seek approval of the software which you want to use from ILS (contact the IT service desk) and provide evidence of that approval to UREB. ILS will only grant approval exceptionally and on a project-by-project basis. An information security checklist will need to be approved by ILS for any non-approved software.

What research ethics training is offered at UoG?

RETI’s training catalogue provides details of the ethics training available to staff and postgraduate research students, including the University’s requirements for ethics training.

Please note that the University Research Ethics Board (UREB) will require evidence that the two online Epigeum ethics courses (‘Research Ethics in Practice’ and ‘Becoming an Ethical Researcher’) have been completed by the applicant for any project submitted to it for approval. This includes all staff research ethics applications and ‘higher risk’ student ones. For details of how to enrol on the Epigeum ethics courses, see RETI’s training catalogue.

In addition to the mandatory training, the Chair and Vice Chair of UREB hold a Research Ethics Training Workshop once a term where research staff or students are welcome to join and ask direct questions relating to process, or ethical risks in research. Details can be found in RETI’s training catalogue.

What are the dates of the committee and board meetings?

Useful Contacts

If you are a staff member and would like to speak with someone directly to ask questions or enquire about our University processes, please contact the University Research Ethics Board (researchethics@greenwich.ac.uk) or your Faculty Research Ethics Committee (see below).

If you are a student and would like to find out more about the student ethical approval process, please contact your Faculty Research Ethics Committee.

Faculty Research Ethics Committee contact details:

Faculty of Education, Health and Human Sciences FREC: feh-researchethics@greenwich.ac.uk

Faculty of Engineering and Science FREC: fes-ethics@greenwich.ac.uk.

Faculty of Liberal Arts and Sciences FREC: flas-ethics@greenwich.ac.uk

Greenwich Business School FREC:  gbs-researchethics@greenwich.ac.uk