Research ethics approval of Covid-19 projects not requiring HRA approval
20 Mar 2020
Details of the application process
This advice is correct at the time of publication of this news article.
For research to be conducted in the NHS, please seek advice from the Faculty Research Governance team, email FBMHethics@manchester.ac.uk. The following procedure is in relation to research that would require approval by the University Research Ethics Committee (UREC) or a Division/School Committee.
New Research Studies
Should staff or PGR students wish to conduct research projects with an exclusive focus on the COVID-19 outbreak and data collection has to start immediately, expedited UREC review can be obtained in the following way:
- You must prepare a full UREC application in the ERM system and ensure that all questions are answered and all supporting documents are appended to the application (i.e. participant information sheets, consent forms, recruitment materials, a risk assessment, etc).
- Once you have successfully submitted your ethics application in the ERM system, you must email firstname.lastname@example.org and provide a robust justification as to why your project requires urgent ethical review. You must also include the title, reference number and name of the PI/any Co-I’s in the body of the email.
- The subject header of your email must include: COVID-19: Request for urgent UREC review.
- Your request will be reviewed by a member of the research ethics team as well as the Chair of the Ethics Oversight Committee (or their nominated deputy) and a decision in relation to whether the project is eligible for urgent review will be confirmed via email within 48 working hours.
- If your request is approved, your application will be reviewed by experienced members of the UREC panel within the following 72 working hours, with the decision (provisional favourable or unfavourable) and any required revisions sent via the ERM system.
- If your request is denied, your application will be allocated to the next available full UREC meeting for consideration by the panel.
Please note that this expedited route is only for UREC projects focusing on specific COVID-19 related research questions.
Amendments to Approved Research Studies
If researchers want to add COVID-19 specific elements to an existing approved research project, (e.g. new questions in the interview guide, or new participant groups) please use the normal amendment process and in addition email email@example.com with the following information:
- The subject header of your email must include: COVID-19 – Amendment request
- You must make it clear in the body of the email why the amendment requires urgent review and specifically what element is in relation to COVID-19
- The normal timeframe for the review of amendments is 10 working days, but we will endeavour to make decisions on COVID-19 related amendments as quickly as possible.
All staff members and students who have obtained research ethics approval for their projects, either via the Division/School or University Research Ethics Committee (UREC) processes, should carefully consider whether the current COVID-19 outbreak will have any potential impact on their recruitment strategy or data collection methods. If this is the case, please ensure you seek an extension to your dates of data collection, as listed in your approved application or last approved amendment request, via the normal amendment process (details of which can be found here). Please ensure all requests are sought prior to the end date or within 3 months of this date.
If you are conducting research with a data collection methodology that involves face-to-face contact (i.e. interviews, focus groups, psychological experiments, tissue sampling, and any other research procedure requiring face-to-face contact) you must switch to data collection via Skype, telephone or an alternative digital platform.
Please note, you do not need to seek a formal amendment to your existing ethical approval to make these changes provided your consent procedures remain the same (i.e. if you are still obtaining written consent but the form is returned by post or email). If you are choosing an alternative consenting procedure, please submit a formal amendment to your ethical approval via the usual process.
If switching your data collection to digital or electronic means is not possible (i.e. human tissue studies) then you must suspend all research activity until further notice unless doing so will have critical impacts on research participants (i.e. affect their wellbeing or care).
Researchers who wish to continue with face-to-face data collection during this period will require specific approval from the Research Governance, Ethics and Integrity Team. Such approval will only be given if 1) the researcher is a member of staff or PGR, 2) the research is specifically related to the Covid-19 situation and data collection has to take place at the present time, or 2) there are exceptional reasons for the continuation of face-to-face data collection (i.e. critical impacts on the wellbeing or care of research participants).
The University will not approve continued face-to-face data collection with participants belonging to groups that are particularly vulnerable to Covid-19 infection.
Researchers who wish to request such approvals must email firstname.lastname@example.org ensuring the subject line reads“COVID-19 Permission to continue face to face data collection” The body of the email must clearly state the reasons why the continuation of face-to-face data collection is essential and must also include the title and reference number of the project.
Any request relating to PGR projects should be submitted by the project supervisor (unless this is not possible under the current circumstances) and any requests for staff projects should be submitted by the PI of the study.
We aim to process all requests within 48 working hours of receipt.
Meetings of the University Research Ethics Committees (UREC)
Meetings of the University Research Ethics Committees (UREC) will be held via Zoom during this period of closure. If you have already confirmed your attendance at a future UREC meeting, the Research Ethics team will be in touch with you to make the necessary arrangements for your attendance via Zoom.
- Zoom has both audio only and video options. Find out more about Zoom.