Research ethics - what do I need to do?

 From 15 January 2024, all new PGR and staff research projects should be submitted for review via Ethics Review Manager (ERM) which can be accessed at https://applicants-erm.bham.ac.uk.

All University of Birmingham academics and postgraduate research students should 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).

ERM replaces both the previous online self-assessment form (SAF) and application for ethics review (AER) form for all PGR and unfunded staff research projects, and acts as a one-stop online gateway for both new ethics applications and amendments.

Please note that if a SAF has been submitted prior to 15th January 2024 that indicated the need for a full research ethics application, then from 15th January 2024 this should be done via the ERM system.

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 pathways.  For projects with existing ethics approval (e.g. from another University) you will be asked to upload the relevant documentation into ERM.  

More information on how to answer the questions in ERM and further training materials including a video demo are available on our canvas course at https://canvas.bham.ac.uk/courses/62352. 

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

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. 

Both those projects originally submitted via ERM and those submitted via an old AER form should now use ERM for amendments, as follows: 

1. If you wish to amend an Application for Ethical Review which has previously received ethical approval in ERM (https://applicants-erm.bham.ac.uk), you can do this by creating a ‘subform’ to your existing project. For step-by-step details on how to do this, please see our amendments manual at: https://canvas.bham.ac.uk/courses/62352 
   
   
2. If your last approval was outside of ERM, you can apply for an amendment to this by creating a ‘new project’ in ERM.  These are termed ‘legacy amendments’. Please note that the form questions will ask you to re-enter some basic information about your original project, to ensure your project details are consistent with our new reporting processes.  Please note that to apply for a legacy amendment you will need to know the original reference number of the approval (in the format ERN_XX-XXXX).  More information on how to answer the legacy questions in available on our canvas course in the form questions manual at: https://canvas.bham.ac.uk/courses/62352

Note: Once you have had a legacy amendment approved, if you need to make further changes to the project, this can be done using the amendment route in point 1.

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.  You are encouraged to contact the Ethics Team to discuss any plans to set up Programmes.

Please be aware that the Programme of Work scheme will shortly be reviewed and the way it operates may change – please check back here for the latest news on this.

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 undergraduate and postgraduate taught student 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.