Health and Life Sciences procedures

All HLS Faculty staff and students who wish to undertake research (academic or commercial) must apply for ethical approval before commencing their research. Primary data collection may not begin until the correct ethics approval procedures have been completed and written authorisation of the proposed study has been obtained.

Note: some projects will require a Data Protection Impact Assessment (DPIA) to be completed and agreed before data collection can begin., This is a separate process from obtaining ethics approval.

To obtain ethical approval, please ensure that the study-appropriate procedures are followed (as detailed below).

Worktribe

All ethics applications must be submitted on Worktribe. You will be able to access the system through the website and will be asked for your DMU single sign-on details. The new system asks a more comprehensive set of questions on your ethics application, while still being user-friendly.

Training on using the new system, in the form of videos and user guide are be available under the help menu on Worktribe and in the Digital Skills area of Blackboard.

If you have any questions please contact the team via email at worktribe.ethics@dmu.ac.uk.

All Postgraduate Research (PGR) student (MPhil, PhD) and Staff ethics submissions are reviewed by the Faculty Research Ethics Committee (FREC) review panel (reviewed by two reviewers, and moderated by the Chair or Deputy Chair).

Individual student Undergraduate/Taught Postgraduate (UG/PGT) student level studies(BA, BSc, MA, MSc) ethics submissions are reviewed at programme-level (but are escalated to FREC for medium-risk). Please refer to the ‘Guidance on Low Risk Research for UG and PGT Students’ below.

For UG/PGT Exceptional Approval Block Applications please refer to the ‘Module-level Exceptional Block Approval process’ section below.

If you believe there are no ethical implications to your research please complete a Research Ethics Screen Questions form. If you are a member of staff, please lodge your form with the HLS FREC at hlsfro@dmu.ac.uk. If you are a PGR student, please ask your supervisor email it to hlsfro@dmu.ac.uk, and also to researchstudents@dmu.ac.uk.

Please note that this screening form is under review by Research Governance.

The university’s Research Ethics Code of Practice must be read and referred to by all applicants, supervisors, module/programme leaders and reviewers when completing/assessing an ethics application.

Helpful documents

• HLS UG and PGT Ethics Submission Requirement and Guide
• HLS Ethics Resource Links
• HLS FREC Guidance for Reviewers

Video guides

• PGR: How to apply (18 minutes)
• How to apply (15 minutes)
• How to review (7 minutes)

• DMU policies (including our Ethical Considerations for Research with Children and Young People)
• Research Integrity and Ethics Resources

  NHS Research

  Research that recruits NHS patients and service users, NHS staff or takes place on an NHS site, is likely to require external approval by the Health Research Authority. Please see the Research Services pages on NHS Research.

  Researchers considering research with the NHS should first contact ethics@dmu.ac.uk to discuss what approvals may be required.

  policies, requirements, NHS, external, ethical, ethics, young people

• Sensitive research guidance
• Sensitive research form

If you have completed a full ethics application and received ethical approval but now wish to make amendments to your study, they will need approval. Please amend your authorised application on the Worktribe system in all sections that are impacted by your proposed changes, including updated documentation. We also expect to see a Word document uploaded into your Documents section bulleting the changes.

If you are unsure of whether the changes you wish to implement make a substantive difference to the ethics of your study, please contact the FREC Chair or Deputy for advice. This matters because substantive changes may require a re-review. Minor amendments will be assessed by the Chair or Deputy Chair of FREC.

Please note: For NHS HRA approvals, the differences between types of amendment are described on the NHS HRA website.

To amend a project (where the application was started or completed befoe re 30 March 2021), please use the amendment application forms below (replace # with your 4-digit reference number):

• FREC # Ethical Amendments Application Form
• FREC # Amendment Reviewer Form

If your study involves human participants, Participant Information Sheet and Consent forms may need to be uploaded to the Documents section of the Worktribe application, as part of your ethics submission. Approved templates are immediately below.

• Participant Information Sheet
• Participant Consent Form
• Research Proposal

When conducting research, it is possible that you will be collecting personal data as defined by the UK’s implementation of the GDPR. Further information on the meaning of personal data in this context can be found on the Information Commissioner’s Office website. If you are processing personal data, you are highly likely to require a completed Data Protection Impact Assessment (DPIA).

Please note that the DPIA process is managed by the Data Protection Team within the University, and not the FREC. Guidance on completing a DPIA can be found on DMU Connect.

• Read the DPIA template and guidance
• Read DMU's policies and external requirements

Please note that while ethical approval is granted on the understanding that you will follow all legal obligations, including those relating to data protection, we do not assess this as part of the ethics process. In some situations, it may be helpful for researchers to gain ethical approval before completing a DPIA (notwithstanding that if a DPIA is required this must be completed before data collection can begin).

In line with university policy, UG/PGT research (approved at a programme level) should be low-risk. In exceptional circumstances, medium-risk research can be approved after consultation with the FREC. The University states that UG/PGT students should not undertake high risk research.

Please note that an overview of medium risk projects should be emailed to the FREC using the mitigations spreadsheet, by giving enough detail under each heading to enable mitigations to be discussed.

Our focus is upon the intersection of the sensitivity of the research, the potential vulnerabilities of participants, and the potential for harm. Some mitigations include a focus upon the ways in which methods/questions are developed and implemented, the possibility for exclusion criteria, amending the research cohort, ensuring documentation is sufficiently detailed to explain risks, and providing appropriate debrief material.

For medium- to high-risk criteria, please refer to the university’s DMU Research Ethics Code of Practice (Appendix 2: Framework for Identifying Research Ethics Risk) available on the DMU policies and external requirements web page.

Note that in UG/PGT projects, as in all applications, where identifiable data are being collected about individuals (which might include the intersection of demographic data like age, gender, race and ethnicity, religious belief and so on), a DPIA screening checklist is recommended, and should be sent to Information Governance. It is possible to curate umbrella DPIA applications for programme-level UG/PGT research, where a full DPIA is required.

All research, except for those exclusively based on publicly available secondary data and published literature, requires ethical review.

Whilst normally this review is done on a project‐by‐project basis, it is recognised that for UG/PGT level (BA, BSc, MA, MSc) there are occasions where students may complete very similar or identical projects that are low-risk. In such cases, it may be proportionate to approve research at a programme or module level, rather than individually for each student, for instance based on a consistency in research processes and methods.

Read more: Block Ethics Approval: Taught students only

Block Approval is not judged appropriate for standard year long Dissertation Modules. Block approval may be suitable for dissertations in programmes which are delivering Dissertations in ED2030 Block teaching but please see section below on ED2030 teaching and then speak to the FREC in the first instance to discuss.

In the first instance, the module leader or the programme leader should have a discussion with the FREC to determine if the study meets the criteria for Exceptional Block Approval.

If the project is deemed suitable for block approval, all documentation must be included with the application, including the completed block approval form, the participant facing materials (if appropriate) and all the data collection tools as they plan to be used. We cannot approve applications for Block approval where the materials will be developed during the project. Any block approval applications require provision annually of all the students who have completed projects under the block approval- these must be submitted as an amendment to your block approval application on Worktribe via the amendments process. Approval of this amendment will indicate FREC approval of your data submission. The form for submission is at the back of the block approval form.

Exceptional Block Approval Applications must be submitted by the module leader or programme leader via the Worktribe System. Please note, you must not submit block approval applications for module level Worktribe approval, they must be assigned to the HLS Ethics officer group for approval via the FREC.

For Education 2030 modules that require students to conduct research we expect all non-dissertation modules to use block ethics approval. This is a system that allows module leaders to define the research projects that students will be conducting, ensure that these projects are at a suitable risk level, and complete a single application for the entire module for a period of up to 3 years.

Students need to be informed about the ethics of the research project and what are and are not permitted to do under the authorisation granted. Under the block ethics system students do not have to complete an ethics application themselves. As such this approach saves a significant amount of time while still allowing you to ensure that the students meet their module learning outcomes.

To apply, the module leader will need to complete the Block Ethics Approval form. This form, along with an application detailing the projects that will take place under the application, should be submitted by the module leader via WorkTribe.

Please note that applications for Block Approval must be reviewed by members of the Faculty Research Ethics Committee and so in practice review and approval can be slower than normal.

While this is the default expectation for Education 2030 modules, if you wish to consider Block Approval for a non-Education 2030 module, please do get in touch; it is a useful system for supporting our students. Similarly, if you believe that there are professional standards reasons why you cannot use Block Approval on an Education 2030 module, please also get in touch.