Research ethics - what do I need to do?

For all funded staff projects being conducted on behalf of the University, the PI must submit an ethics checklist via Worktribe in the first instance.  This also acts, where relevant, as a request for sponsorship in line with the Department of Health's Research Governance Framework).

If you are not already aware of which ethics approval route you will need to go through, the responses submitted in the checklist will help to determine this. You will also receive an email confirmation from the Ethics Team that provides further guidance and your unique ERN reference number.

If you need to submit a University or HRA/NHS ethics application (see ‘second step’ below) your checklist will be returned to you with a message that from the new system that the application is ‘not approved’ and you will get confirmation that your application will be managed via the ethics or governance systems.

This also now acts, where relevant, as a request for sponsorship in line with the Department of Health's Research Governance Framework). It will indicate whether further ethics review is required, or whether no further action is necessary (likely in the case of very low risk projects).

 For all funded staff projects, once you have completed the ethics checklist in Worktribe, the next steps in the review process will depend upon the nature of the project. Some examples include:

• Projects requiring the ethics checklist only – the project involves no human participants and raises no other ethical issues.  No further action is needed in this instance.
• Studies involving healthy human participants, NHS members of staff or work deemed as ‘service evaluation’ by the NHS – ethical approval via one of the University’s central research ethics committees (for staff and postgraduate research projects). The Application for Ethics Review (AER) form should be used to apply for UoB ethics review.  For funded projects, ethics review should normally be sought after funded has been awarded unless the funding body requires it at application stage.   All AERs should be submitted by email to aer-ethics@contacts.bham.ac.uk.
• Studies involving NHS patients/carers, participants with mental incapacity, studies which involve storing human tissue, clinical trials, etc – ethical approval via the Health Research Authority (HRA)
• NHS REC Approved Tissue Banks/Research Databases
• Studies involving work with animals will require approval via the University's Animal Welfare and Ethical Review Body (AWERB), which is a University ethics committee which reviews applications involving animal work before it is sent to the Home Office for approval.
• Other specialist review processes, eg. MoDREC (Ministry of Defence).

As your research progresses, if the details of the project change from those originally provided to the University ethics committee you may need to submit an amendment for approval.

For all funded staff projects, if you wish to amend an Application for Ethical Review (AER) which has previously received ethical approval, please download and complete an Application for Amendments Form, and submit this to the Research Ethics Office via email to aer-ethics@contacts.bham.ac.uk. 

Amendments requiring approval may include, but are not limited to, additions to the research protocol, study population, recruitment of participants, access to personal records, research instruments, or participant information and consent documentation. Amendments must be approved by before they are implemented.

If the details of your project do not change (i.e. there are no changes that impact upon the ethical issues raised within the project) then your approval is valid until the completion of the project.

From 13^th June 2022, Ethics Review Manager (ERM) replaces both the previous online self-assessment form (SAF) and application for ethics review (AER) form for all PGR and unfunded staff projects. ERM acts as a one-stop online gateway for both new ethics applications and amendments to applications originally submitted via ERM.

Please be aware that if a SAF has already been submitted (prior to 13th June 2022) then if further review is required an AER should be used rather than mixing the old and new systems.

Early in 2023, ERM will be fully rolled out to include funded staff projects.  In the meantime, such projects should continue to use the Worktribe ethics checklist and the AER form, as detailed above.

For all projects, ethics approval should be obtained prior to the beginning of the proposed work.  In addition, for PGR student projects ethics approval should usually be sought within the first year of registration. 

For some projects, there may be requirements for ethics review from an external body (e.g. an NHS REC, MoDREC, etc).  ERM will identify and record this and you will be directed towards the appropriate review mechanism.  For projects with existing ethics approval (e.g. from another University) you will be asked to upload the relevant documentation into ERM.  

ERM can be accessed at https://applicants-erm.bham.ac.uk using your UoB log in details.  All research staff should automatically have an account; 

All University of Birmingham academics and postgraduate research students will automatically be given an account in the system. If you do not have access to ERM, you can request an account in IT Service now (https://universityofbirmingham.service-now.com/itportal/). When logged in, click ‘Make a Request’, then ‘Administrative Systems’, there will be a button called “Request access to Research Ethics” (please note it may take up to 24 hours to action).

For further information, please download our guidance document for applicants on how to use ERM.  You can also download a guidance document on how to answer specific questions within the system. 

A series of online Q&A sessions will take place shortly after rollout – if you have any questions about the new system you are encouraged to register to attend one of these.

As your research progresses, if the details of the project change from those originally provided to the University ethics committee you may need to submit an amendment for approval. 

Projects originally submitted via ERM should use ERM for amendments. Please download our guidance document for applicants on how to use ERM to submit amendments for further information.

Applications originally submitted via an AER can be amended by either submitting an amendment using an amendment form, or you can submit a full, new application via ERM.  When ERM is rolled out fully in early 2023, all amendments will be routed via ERM and the guidance will be updated to reflect this changeover.

Amendments requiring approval may include, but are not limited to, additions to the research protocol, study population, recruitment of participants, access to personal records, research instruments, or participant information and consent documentation.  If the details of your project do not change (i.e. there are no changes that impact upon the ethical issues raised within the project) then your approval is valid until the completion of the project. 

Please be aware that during a review of the pilot phase of ERM in March 2023, it has come to light that there was a period of time during which amendments may not have been automatically submitted once signed by the researchers.  If you have prepared an amendment application during this period, please check that it has been correctly submitted.  If you have any problems, you should contact the ethics team and any delayed amendments will be expedited.

University researchers may apply for ethical approval for a Programme of Work if they are undertaking a number of linked studies with common research objectives and methodology.  A guidance note on Programmes can be accessed here.  Programme Applications are intended to allow investigators to gain ‘umbrella’ ethical approval for interlinked studies without needing to submit a Full Application for ethical review to the Committee for each individual study.  Please contact the Ethics Team to discuss any plans to set up Programmes.

Undergraduate and taught postgraduate students are not subject to the University's central ethical review process. Instead, Schools/Colleges have a mechanism in place to identify Undergrad and Taught projects which may raise ethical issues.

As a minimum, ethics review should be carried out by at least 2 members of academic staff within the relevant School/College, one of whom may be the student’s supervisor.   It is understood that individual Schools/Colleges may choose to go beyond these requirements, and that implementation may differ in nature across different subject areas.  Please consult colleagues within your School/College to confirm your local arrangements for this. 

Under certain circumstances (e.g. particularly high risk or complex studies) applications for undergraduate or taught postgraduate student projects may be accepted by the University's central ethics committees on request. 

For those subject areas in which research is likely to require sponsorship in accordance with the Department of Health’s Research Governance Framework, additional work may be required to ensure that the ethics approval process meets regulatory requirements. 

Where ethics review is required, no project should commence until ethics approval has been granted.