Ethics Review Committee Application Form

Ethical review application

• What projects require ethical review and approval

  All research involving human participants, their data or samples, requires ethical review and approval before the research starts. This includes observation-based research.

  The term 'research' refers toa process of investigation leading to new insights.

  For projects with multiple phases, it is recommended that each phase is submitted for review as and when it arises, unless another organisation such as a research funder or collaborator requires otherwise.

  Exemptions from ethical approval

  The following types of workdo not require ethical approval:

  • Service evaluation. This is work to monitor, improve or test a service being delivered, where a 'service provider' (or someone acting on their behalf) collects information from a 'service user'. For example, a module coordinator seeking feedback on a module from their students, or an employer seeking feedback on its support activities from its staff.
  • Audit. This is work to ascertain whether an activity was undertaken as it should have been.
  • Research involving only deceased subjects. If the subjects are deceased, and the information collected will not contain sensitive information about the living, then ethical approval is not normally required. However,research involving the use of health and census information that is less than 100 years old does require ethical approval.
  • Literature reviews. Literature reviews, including systematic reviews and meta-analyses, do not require ethical review unless:
    • The review includes analysis of the underpinning raw data or of a dataset attached to a publication (for which researchers should follow the guidance on using secondary data).
    • The review will raise ethical issues such as around social profiling, data management issues such as managing sensitive personal data, or access issues that are best addressed by completion of the ethical review process.

  If you are unsure whether your project is research or one of the above, contact your School ethics committeefor guidance.

• Why ethical review and approval is required

  Ethical review is a peer-review process to help researchers fulfil their personal responsibility to act in accordance with the Universitys Principles of Good Research Conduct (Policy) (PDF) and fully account for ethical issues related to research involving humans. Thisminimises risk to the project, the researcher, the participants and the University.

  Failure to obtain and adhere to ethical approvals is defined as research misconduct.

• Who should complete the application

  Thelead researcher, whether that is a member of staff or student,should complete the ethical review application form (Word). For student projects, supervisors must check and countersign the application form. Failure to do so may delay approval.

  The form should name all researchers associated with the project so that ethical approval covers everyone involved.

  The same applies to an ethical amendment application.

• Which documents to complete

  More detail is available on the template documentspage.

  All applications should normally include:

  • ethical review application form (Word)
  • participant information sheet (PIS) (Word)
  • consent form (Word).

  You may also need to include copies or drafts of:

  • participant advertisement (Word): when an advert (electronic or hardcopy) will be used to recruit participants
  • participant debrief (Word): when participants may need referral to support services or additional information about the purpose of a project following completion
  • surveys or questionnaires: when using surveys or questionnaires to collect data, append copies to the application - for online surveys or questionnaires, append screenshots of the initial and final pages, and the list of questions.
  • interview or focus group schedules or topic guides: when usinginterviews or focus groups to collect data, append copies to the application

  Depending on the nature of your research project, there are otheradditional documents related to policies and procedures outwith the ethical approval process, which may need to be obtained prior to research commencing and might need to be appended to your application.

  Some School ethics committees (SECs) require their own forms to be submitted alongside the ethical application form. For more information,contact yourSEC.

  Research involving child participants

  If the research involves child participants or is taking place in educational establishments (schools) you should include the appropriate documents:

  • Letter to schools: when research is within an educational establishment. There is an initial letter to school - agreement in principle (Word) and a follow-up letter to school - study commencing (Word)
  • letter to parent or guardian (Word): when research is with child participants
  • Age-appropriate documents: when research is with child participants. There are age-appropriate versions of the template PIS and consent forms (on the templates page under 'PIS and consent for child participants').

• Where to submit your application

  Following the completion of the form, most Schools require that you email it to your School ethics committee(SEC), howeveryou should check with your SEC ifthey have specific instructions for submission.

  You should submit your application as far in advance of needing to start research as possible to ensure it can be reviewed in time for your project.

  Take care in completing your application form - application forms which are poorly completed, incomplete or unsigned will be returned and may delay approval. Student applications should be checked and countersigned by their supervisor.

  Research involving child participants

  If yourresearchwill involve child participants you shouldseek guidance from the Child Panel Representative (Dr Barbara Dritschel, email) before submitting the application to your SEC.

  Researchers from the Schools of Geography and Sustainable Development, Medicine and Psychology and Neuroscience may send their applications directly to their SEC as usual.

• The review process

  After you submit your fully completed and signed ethical review application, it is reviewed by yourSchool ethics committee (SEC). You can be invited to attend a meeting.

  Standard and proportionate review

  At the start of the ethical review application form there are a set of filterquestions to determine whether the research should undergo standard or proportionate review. This lets theSchool ethics committee (SEC)determinehow they should review the application:

  • Proportionatereview - this means that it can be reviewed and approved by a single SEC member without being taken to a full SEC meeting
  • Standard review - this means that it will be reviewed by three SEC members or taken to a full SEC meeting

  Filter criteria and why they are used

  The criteria are detailed in the filter form at the start of theethical review application form (Word)

  Research whichis complex or that brings more substantial ethical considerationscan be valuable and rewarding. However, it is important to consider whether theresearch is appropriate given the potential participants, nature of the project, experience of the researcher, and circumstances. Projects meetingthe filter criteria undergo standard review processes to ensure these aspects are fully considered, while more straightforward projects can often undergo a 'lighter touch' proportionate review.

  If an application reviewed under the proportionate review routeis found to involve substantial ethical considerations it may be escalated into the standard review route for consideration by the SEC in full.

  Developing a standardised protocol for research that is complex or which brings substantial ethical considerations

  Researchers, research groups or Schools that frequently conduct research projects that would normally come under the standard review route can choose to develop a proposal with a protocol or 'standard operating procedure' (SOP) that puts in place a standardised approach that mitigates the ethical issues.

  If approved, this meansany subsequent research projects which strictly follow that protocol or procedure can be reviewed through the proportionate review route.

  Protocols or SOPs should be submitted to theSchool ethics committeefor approval in principle. The SEC will then seek final sign off from theUniversity Teaching and Research Ethics Committee.

• Review process and outcomes

  AllSECsaim to give their decision on applications as soon as possible, though exact timings vary.

  The SEC can make three decisions following review:

  • Immediate approval: the SEC decides that your application meets the requisite standard and is approved. This is rare because, as a peer-review process, revisions (even if minor) are often requested.
  • Requires revisions: the SEC has identified a need for you to make revisions to your application. Make the required revisions, explicitly highlighting them in the application form, and resubmit the application asinstructedby your SEC. Substantial revisions may need to bereviewedat a SEC meeting.
  • Escalation to the University Teaching and Research Ethics committee (UTREC): sensitive or complex ethical applications may need to be referred to UTREC for further guidance and approval. For most SECs, applications involving childparticipants must be escalated to UTREC.

  If the SEC escalates your application to UTREC review and approval might take longer. If you anticipate that your project will require review by UTREC, please make sure that you submit your application to the SEC in good time so as not to delay the start of your project. Once reviewed at UTREC (at a meeting of the committee), you should be informed within three days of their decision. For information on UTREC and their meetings, refer to the UTREC web page.

  How to complain

  If you have evidence that your application has not been properly processed by the SEC, please refer to the guidance on concerns and complaints.

• Addressing a request for revisions

  If the outcome of your ethical application has been a request for revisions, the SEC may be concerned with two areas:

  • Statutory: the committee cannot approve anything that does not meet statutory requirements. For example, if the proposed project fails to comply with data protection legislation.
  • Discretionary: the committee exercisesjudgment overethical issues. For example, it may judge that the project entails risk out of proportion to the benefits it may bring or that the researcher has not adequately considered (or detailed in the application form) the ethical issues arising from the proposed research.

  Using the committees comments, you shouldrevise your application and address any issues. There is guidance available on the ethical issues to consider when planning your research or completing the application form.

  When resubmitting your application, make sure to explicitly highlight where you have dealt with the committees concerns.

  If you are unsure about how to revise or resubmit your application, contact your SEC.

• Once your application is approved

  You must wait for confirmation of approval from your SEC before you can start your research. This is normally in the form of an approval code, issued in a formal letter.Approval is valid for five years.

  Once you have received approval, if your research changes and no longer reflects that which you described in your original application then you should submit anamendment application.

  If you need to extend your approval then you should submit an extension application. Ensure you apply or an extension in good time, before your current approvl is due to expire.

  If any adverse events occur during your research you should contact your SECand any other relevant contacts.