Research ethics approval process

City Research Ethics Online will automatically establish the risk level of your application and route it to the correct Research Ethics Committee based on the risk. City has three levels of risk: low, medium and high. The applications are reviewed proportionately based on the level of risk of the project.

You should read the guidelines thoroughly in order to prevent unnecessary delay to the approval of your application. The guidelines will provide you with useful tools and processes to consider when you are completing the application form and to point out areas and issues that you should think about, and information you may need to include in the documentation.

You may establish the likely risk of your project before completing your application by following this checklist

This is so that you can plan your project as some Research Ethics Committees meet less frequently than other Committees (for instance Senate Research Ethics Committee). You can also contact the Chair of the Research Ethics Committee in your School/Department at the bottom of this page. For Senate Research Ethics Committee, please refer to the guidance further down this page.

Note that Research Ethics Committees may have different processes for dealing with applications, deadlines and timelines for responding to applications. Please contact the Chair or Secretary of the REC you are submitting to for information. Alternatively, you can see the Research Ethics Committee’s online guidance.

Applications which are deemed low risk will be reviewed by a proportionate REC in your Department. There is some variation across the institution. Please refer to the guidance provided by your department on how this is dealt with by a local research ethics committee.

For students:

Note that when you submit your application on the system, it will first be sent to your supervisor for comment/review (you may share it with your supervisor before this for comment – to find out how please see the user guide for information).

You can find information of your local REC contact at the bottom of this page.

Applications deemed medium risk will be reviewed at a full research ethics committee meeting within the applicant’s Department/School. For submission deadlines, turnaround times and local procedures, please refer to the local research ethics committee guidance.

You can find information of your local REC contact at the bottom of this page.

Regardless of if the applicant is student or staff, or which School /Department the applicant is from, all applications which are deemed high risk will be submitted to Senate Research Ethics Committee. Senate Research Ethics Committee meets 6 times/year (see table to the right).

Applications must be received 10 working days before the meeting date.

Emails outlining the outcome of the applications are sent within 10 working days of the Committee meeting.

You can find information of your local REC contact at the bottom of this page.

If you have obtained ethics approval from another institution, for example if you are transferring a project from a previous place of work/study, you will usually not be required to reapply for ethics approval, but a simpler process ratifying the approval from the other institution will take place. Please note that this is not the same as ethical approval – your response will not be submitted for additional review.

To have an approval from another institution ratified you will need to submit the following information:

• A copy of the approved application from the other institution.
• Evidence that the study has ethics approval (i.e. the approval letter).
• The approved participant information sheet and consent form (note that these may need to be updated to City branding/headed paper should City now be the sponsor of the study).
• You may also have to submit information about the committee that approved the study, especially if it has been approved by a non-UK institution.

You should normally submit your application to the Chair and/or Secretary of your local Research Ethics Committee. However, in cases of high risk/sensitive research where Senate Research Ethics Committee would normally be responsible for reviewing the application you should submit the documentation to researchethics@city.ac.uk.

Note that City does reserve the right not to accept an approval from another institution and you may be asked to submit a new application to one of City’s research ethics committees.

Depending on who your participants are and the setting of your research project, you may need to apply for ethics approval from an external research ethics committee. Below is some information about instances when City research ethics committees are unable to review your study.

If your research project does require external approval you will not need to get ethical approval from City. However, you are required to register your project on Research Ethics Online. The registration will also ensure that your study is covered by City’s insurance policy.

Note that only authorised signatories are able to sign off applications to external research ethics committees. Students should note that, in most instances, this does not include their supervisor.

The following are authorised to sign off applications on behalf of City:

• Heads of Departments
• Associate Deans for Research
• Deans of Schools.

You will also need to include a letter from the Sponsor (City) with your application that confirms that City is willing to accept the responsibility of the study. The letter is automatically generated in REO when you register your project and will grant you provisional indemnity. When you have the ethics approval you will need to upload the approval letter. This will generate the final indemnity.

There may be some local variations on the processes outlined above, including authorised signatories.

Contact your local REC for further information.

Retrospective approval of research protocols cannot be given. If you collect data before you have gain approval, you will not be able to use that data. Additionally, you will not be covered by City’s indemnity insurance. Failure to obtain approval may also result in disciplinary procedures being instigated.

A personal or commercial interest may include, but not limited to:

• Financial gain
• Professional recognition
• Advancing the career or the education or the personal life of a family or friend member, or/and other members of staff or students.

Overall conflict of interest could arise if the researcher has commitment and obligations to another person or body that may appear to act as a potential influence over their independent conduct of research. A conflict of interest could be actual or perceived. They are both equally damaging to the outcome of a decision, therefore treated equal.

Conflict of interest must be declared before the researcher engages in any activity. If that is not possible, any potential conflict of interest must be declared as soon as the researcher becomes aware of such conflict. Applicants must declare any real or perceived conflicts of interest that are relevant to the research project on their application form.

Once the conflict of interest has been declared, each incident must be recorded including a description of how the researcher intends to manage the conflict of interest. The documents must be stored in the departmental shared drive where files can be encrypted with a password. Please note that the Research Ethics Committee may ask you to submit the documentation that shows how you plan to manage the conflict of interest.

A conflict of interest, openly declared and with an agreed process for managing the conflict, is unlikely to be a barrier to receiving ethical approval, provided that you have followed the conflict of interest policy.

Failure to declare a conflict of interest may lead to the refusal of ethical approval. If identified after approval has been given, the Committee must be notified as soon as possible; otherwise ethical approval will be withdrawn.

Please note that conflicts of interest should also be declared in any publications according to the journal’s and publisher’s policy.

Read City's policy on Conflict of Interest for Academic and Research Staff.

Projects which involve the recruitment of School staff and/or students require approval by the School you intend to recruit from. This ensures that the same group of staff or students are not repeatedly contacted to become involved in research projects.

Principal investigators should not contact students or staff directly. Approval should be sought from the relevant Dean(s) of School(s), Head(s) of Department(s) and/or Programme Director from which you are recruiting.

Your request should include a brief summary outlining which students or staff you wish to recruit, information of which REC has approved the study and why you are seeking to recruit this particular population, including details of the particular recruitment method.

Note that in some areas of City, permission to recruit staff/students is not needed. For information about the arrangements in your School/Department, please contact your local research ethics committee.

Learn how to appropriately recruit participants for a research project. Discover guidelines and templates for participant information forms.

You will need to apply for an amendment approval if you wish to:

• Change or add a new category of participants;
• Change in the researchers involved in the project, including PI, adding someone on to the project or change of supervisor for student projects;
• Change to the sponsorship/collaboration;
• Add a new or change a territory for international studies;
• Request an extension to your current ethics approval (note that, unless otherwise specified, approval is given for a maximum 3 years, with the possibly to extend the approval for 1 year, twice).
• Change the procedures undertaken by participants, including any change relating to the safety or physical or mental integrity of research participants, or to the risk/benefit assessment for the study or collecting additional types of data from your research participants;
• Change the design and/or methodology of the study, including changing or adding a new research method and/or research instrument;
• Change study documentation such as protocol, participant information sheets, consent forms, questionnaires, letters of invitation, information sheets for relatives or carers;
• Change to the insurance or indemnity arrangements for the study;
• Temporary halt of a study to protect participants from harm or resulting from a concern or complaint made, and the planned restart of a study following a temporary halt (note that this may also require you to complete a Reporting Adverse Events form.

Should you wish to make an amendment to an approved study, you will need submit a completed an 'amendment to protocol' form on Research Ethics Online

The changes may not be initiated without prior review and approval, except where necessary to eliminate apparent immediate hazards to the participants.

Please note that major amendments that alter previous ethical consideration of your project may require submission of a new application to ensure full consideration of the ethical implications of your amendment.

If you wish to amend a project which has ethical approval from an NHS REC you can seek minor amendments from the Chair of the NHS REC that you submitted your application to. Major amendments are likely to require a resubmission. See the Health Research Authority's guidance.

You will need to submit a form on Research Ethics Online to report any adverse events or untoward incidents occurring during your study in the event of one of the following incidents:

(a) Adverse events

(b) Breaches of confidentiality and/or inappropriate disclosure of personal data under GDPR

(c) Safeguarding issues relating to children and vulnerable adults

(d) Incidents that affect the personal safety of a participant or researcher

Issue (a) should be reported as soon as possible and no later than 5 days after the event. Issues (b), (c) and (d) should be reported immediately.

Where appropriate the researcher should also report adverse events to other relevant institutions such as the police or social services.

Note that in cases of externally approved application (e.g. applications approved by an NHS REC) you are also required to complete and submit this report.

If the adverse effect involves the loss or inappropriate disclosure of personal data, please report immediately as a data breach to the Information Compliance Team via the Information Compliance section of the Service Catalogue.

Under the General Data Protection Regulation (GDPR), City has a statutory obligation to report data breaches to the Information Commissioner’s Office (ICO) within 72 hours.

Further information regarding data breaches is available on the Staff hub.