Ethics approval process
The process of obtaining research ethical approval has been made as simple as possible across City and is consistent with ensuring the rights and safety of research participants and researchers.
In the first instance you will need to follow the guidelines and policies provided by your Department/ Division / School. Senate Research Ethics Committee (SREC) will only deal with applications from Schools without local Research Ethics Committees, instances where a local Research Ethics Committee refers an application to SREC in accordance with agreed local policies and procedures, or where the risk to the research participants and/or the researchers or the sensitivity of the project is particularly high.
Note that applications submitted to SREC for convenience (e.g. more suitable deadlines or missing a local deadline) will not be accepted.
If you have obtained ethics approval from another institution, for example if you re 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 the Secretary of Senate Research Ethics Committee.
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 still need to ensure that your study is covered by City’s insurance policy. Although you will not need to get ethical approval from City of such projects, you are required to register your project using the appropriate from.
Unless you are a member of staff or a student in the School of Health Sciences, this form must be submitted to firstname.lastname@example.org.
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. This letter should be written by the authorised signatory, unless that person is the same as the Principle Investigator.
There may be some local variations on the processes outlined above.
Retrospective approval of research protocols cannot be given. Any data collected before research ethics approval has been granted cannot be used.
Things to think about when applying for ethical review
Read information pertaining to possible conflicts of interest in research.
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.
Discover the possible outcomes of a research ethics application and how to begin the appeal process for a denied application.
You will need to apply for a modification approval if you wish to:
- 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, methodology and or procedure/protocol of the study, including adding a new research method and/or research instrument or removing a group of participants or a research method;
- 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 an Reporting Adverse Events form [link];
Should you wish to make an amendment to an approved study, you will need submit a completed Project Amendments/Modifications/Request for Extension form to the research ethics committee that approved the original application.
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. The Health Research Authority has guidance here
You will need to submit a form to report any adverse event 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.
Completed forms should be returned to the Research Ethics Committee that approved the original application. An electronic copy should at the same time also be emailed to the Research Governance & Integrity Manager, Anna Ramberg.
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. In such instances, the report should be submitted to the Principal Investigator’s School Research Ethics Committee and to the Research Governance & Integrity Manager, Anna Ramberg.
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