Health and Life Sciences Procedures

 

  1. Ethics Application Procedures

  2. Worktribe Ethics Pre-screening Form 

  3. Guidance and Training Resources 

  4. DMU Policies and External Requirements (including NHS Research)

  5. Sensitive Research 

  6. Amending applications 

  7. Faculty supporting document templates for all study levels and individual research 

  8. Being compliant with the Data Protection regulations when undertaking research  

  9. Faculty Guidance on Low Risk Research for UG and PGT Students 

  10. Module-Level Exceptional Block Approval Applications 

  11. Student Ethics for Education 2030 modules 

  12. Contact 

Ethics Application Procedures 

All Health and Life Sciences (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: 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. 

 

Worktribe Ethics Pre-screening Form 

“I’m unsure my project requires an ethical review” 

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.

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

 

Guidance and Training Resources 

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. 

HLS Ethics Resource Links 

HLS FREC Guidance for Reviewers 

 

Videos 

PGR-How to Apply (18mins)  

How to Apply (15mins) 

How to Review (7mins) 

 

DMU Policies and External Requirements 

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.

 

Sensitive Research 

Sensitive Research Guidance 

Sensitive Research Form 

 

Amending applications 

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 whether 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.

Note: For NHS HRA approvals, the differences between types of amendments.

To amend a project (application started/completed pre 30/03/21) please use the amendment application form below 

Replace # with your 4-digit reference number 

FREC # Ethical Amendments Application Form

 

Faculty supporting document templates for all study levels and individual research 

If your study involves human participants, Participant Information Sheet/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 Form

 

Being compliant with the Data Protection regulations when undertaking research 

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). 

Note: 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). 

 

Faculty Guidance on Low Risk Research for UG and PGT Students 

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. 

Note: 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/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.

 

Module-Level Exceptional Block Approval Applications 

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.

See the material at: Block Ethics Approval: Taught Students Only 

Note: 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.

 

Student Ethics for Education 2030 modules 

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.  

 

Contact 

Faculty Research Ethics Committee 
Faculty of Health and Life Sciences 
De Montfort University 
Research and Innovation Office 
2.14 Heritage House 
The Gateway, Leicester
LE1 9BH 

+44 (0) 116 207 8228 / +44 (0) 116 257 7864 

hlsfro@dmu.ac.uk 

 

Committee Chair/Deputy 

Professor Richard Hall – Chair 

Dr Esmée Hanna - Deputy Chair