Ethics Procedure

Ethics Procedure (January 2019)

An umbrella ethics framework (Programme Proforma)  ERN_11-0429PA approved by the University of Birmingham Central Ethics Committee forms the basis of ethical coverage for volunteer studies on healthy participants at CHBH (amendment to BUIC Programme Proforma ERN_110429). In order for new CHBH MRI projects to use this ethics Programme, each investigator must prepare an Application to Use CHBH Ethics Programme Form. In situations where this is not the case, additional ethical approval will need to be sought and obtained before your project application can be approved by the Management Committee. BUIC projects transferring to CHBH will be covered under the new umbrella ethic framework, no new application required, however all relevant documents will need to be updated e.g., consent form, PIS etc.


Projects falling within the Umbrella Programme

The generic fMRI ethics programme ERN_11-0429PA can be used as the basis for research in healthy volunteers in non-invasive studies. If you plan to work under the generic program there are four steps to follow:

  1. First, register the project via the Self Assessment Form online at You will then receive an email from the Ethics office with an Ethics reference number. You will need this reference number when you submit the Ethics Application form.


  1. You then need to complete the Ethics Application to Use Form and submit this to the Ethics Programme Lead via along with any accompanying documents (e.g. project specific information sheets and consent forms) AND the reference number you obtained in Step 1 above. Please use the reference number in the subject line of the email so that the Ethics office can match the applications in their system.


  1. Your Application to Use will then be reviewed by the Programme Lead and, if there are no problems, forwarded to the University of Birmingham Ethics Committee for approval. For projects that make no changes to the approved programme ERN_11-0429PA this process should take a matter of days.


  1. You will be notified when the Ethics Committee has approved the project. The Ethics Committee will confirm your project-specific approval. In your CHBH project application you will be required to quote the approved Ethics reference number.


Note, however, there are many categories of subject or experiment that are not covered by this protocol. These include cases where there is an additional concern over informed consent, or where there are additional concerns over safety, such as:

  • Participants below the age of 14 years old
  • Participants with special learning difficulties
  • Participants selected because of their clinical history (i.e. not healthy volunteers)
  • Participants with increased risk factors (e.g. epilepsy, stroke)
  • Studies that involve invasive or clinical procedures (e.g. injection of drugs)
  • Studies that involve administration of deliberately painful stimuli
  • Studies that involve novel stimulus delivery procedures or MRI-untested equipment


Projects that are extensions of the Umbrella Programme

The intention is that, wherever possible, the standard ethics protocol be extended on a case-by-case basis by applying to the University Ethics Committee to cover those cases which are straightforward extensions of the standard protocol. You may still use the Application to Use Form to obtain ethical approval, but this may require full review by the Ethics Committee. This process is likely to take longer. For each of these extensions, the two areas of particular concern that would need to be addressed are (a) whether any special informed consent arrangements are needed (and if so, how they will be dealt with), and (b) whether there are any special safety issues arising (and if so, what steps will be taken to reduce the consequent risk). Example cases might include: 

  • Participants who are children younger than 14 years old
  • Participants who are selected for clinical reasons, such as epilepsy
  • Participants who are to be sleep deprived
  • Participants who are to have hypoxia
  • Combined TMS and fMRI experiments


Projects falling outside the Umbrella Programme

Those studies which are outside the competence of the University Ethics Committee, or which for other reasons clearly should involve outside scrutiny should go to an appropriate external clinical or research ethics committee. This would usually include studies on clinical populations (such as pre-surgical patients), drug or medical intervention studies, recruitment via the NHS, and studies on especially vulnerable groups. In this instance you should provide evidence of your external ethical approval on your CHBH Project Application.