Coventry University Ethics
Coventry University Ethics
Ethics at Coventry University
During the past 12 months, we have sought feedback in order to identify how to improve the procedure, speed up the peer review and approval process and at the same time empower Faculties/School to take more responsibility to ensure that good ethical practice becomes the mainstay of research activity.
As a result, a simplified ethics approval procedure has been introduced this academic year (Refer to Revised Ethics Procedure ). This will require the Faculty/School Ethics and Governance Leader to take the lead in creating and managing teams of ethics reviewers who would then be tasked with reviewing all low and medium risk ethics applications in each Faculty/School. Responsibility for ensuring compliance with the University’s policy on Principles and Standards of Conduct on the Governance of Applied Research (Refer to Revised Policy Document (2013)) will lie with the Faculty/School Ethics and Governance Leader. This will ensure that ethical approval is given at Faculty/School level where accountability will lie. Any applications dealt with in this way will therefore be subject to random audit to ensure compliance with good ethical practice and the University’s policy. The audit process will be managed by the Director of Postgraduate Research with assistance from the Faculty/School Ethics and Governance Leaders and the Registry Research Unit (RRU).
The Ethics Checklists
In order for your research project to receive ethical approval, you (the Principal Investigator) will be required to complete an ethics questionnaire. The questionnaire is used to identify the level of risk associated with your research project. You are advised to start by using the ‘Low Risk Research Ethics Checklist’ and answer the questions.
If you answer ‘No’ to all the questions, your research project is classified as low risk. All you then need to do is sign the checklist and get your supervisor to sign this as well. This is what is termed as Principal Investigator Certified. Please remember to keep a copy of this completed and signed checklist as you will be required to attach it as an Appendix to your dissertation or thesis.
If you answer ‘Yes’ to some of the questions in the Low Risk Research Ethics Checklist, you will be required to have your application reviewed by your Supervisor or Faculty Research Ethics Leader. A list of the Faculty Research Ethics Leaders is available (Refer to names of Faculty Research Ethics Leaders).
The Medium to High Risk Approval Procedure
If you find that you are mainly answering ‘Yes’ to the questions in the Low Risk Research Ethics Checklist, this is an indication that the risk associated with your research project is not low. You should then move to the next level checklist, the ‘Medium to High Risk Research Ethics Checklist’ (Refer to Medium to High Risk Checklist).
Your application will be sent for peer review within your Faculty/School. Once the review is completed any feedback and changes will be communicated back to the applicant using the Ethics Reviewer Feedback form (Refer to Ethics Reviewer Feedback form). The applicant will then be required to make the necessary amendments and forward the amended application back to the reviewer so that they can give approval to proceed. Please note that responsibility lies with the applicant to ensure that the reviewers recommendations are actioned and amended documentation provided in good time.
Once your application has been approved by the peer reviewer, your application is then forwarded to the Faculty/School Ethics & Governance Leader for final off. It is at this point that you can proceed to collect primary data as set out in your application.
Ethical Approval Procedures for External Organisations
Ethics applications made to external organisation e.g. Ministry of Defence etc will be dealt with using the following procedure (Refer to Ethical Approval Process – External Orgs). You should use the external organisations application form.
The application will be sent for peer review within your Faculty/School. Once the review is completed any feedback and changes will be communicated back to the applicant using the Ethics Reviewer Feedback form (Refer to Ethics Reviewer Feedback form). The applicant will then be required to make the necessary amendments and forward the amended application back to the reviewer so that they can give approval to proceed. Please note that responsibility lies with the applicant to ensure that the reviewers recommendations are actioned and amended documentation provided in good time.
Once your application has been approved by the peer reviewer, your application is then forwarded to the Faculty/School Ethics & Governance Leader for final off. It is at this point that you can proceed to submit your application to the external organisation in order for your application to be processed by them.
Ethical Approval Procedures for NHS and Medical Risk research projects
This procedure applies to all projects that involve:
- Administration of Radioactive Substances Advisory Committee (ARSAC)
- Gene Therapy Advisory Committee (GTAC)
- Medicines and Healthcare products Regulatory Agency (MHRA)
- Ministry of Justice
- NHS / HSC R&D offices
- NRES/ NHS / HSC Research Ethics Committees
- National Information Governance Board (NIGB)
- The process is managed by the Integrated Research Approval System (IRAS) which acts as a single system for applying for the permissions and approvals for health and social care / community care research in the UK. IRAS: Enables you to enter the information about your project once instead of duplicating information in separate application forms and Uses filters to ensure that the data collected and collated is appropriate to the type of study, and consequently the permissions and approvals required
- Helps you to meet regulatory and governance requirements
- Retains familiar aspects of the NRES form system
If you are unsure whether you should complete an IRAS form please check with your supervisor in the first instance and then your Faculty/School Research Ethics Leader. This is a more detailed and thorough procedure as the risk associated with these projects is considered to be high or very high. Therefore, more care and attention is needed to ensure that the University complies with the Ethical Guidance of the Bodies/Organisations listed above but also any associated legislation (e.g. Human Tissue Act 2004 etc.)
The procedure is set out in this flowchart (Refer to Coventry University IRAS Ethical Approval Process).
As the Principal Investigator, you will be required to get ethical approval from the University before you submit your application to the Integrated Research Approval System (IRAS). This means that you will need to follow the following steps:
Log onto the IRAS website: https://www.myresearchproject.org.uk/ to begin the process. You will need to set up an account
Complete the form and transfer it via email to RRU ethics email address firstname.lastname@example.org
Your IRAS application will then be sent to an Ethics Reviewer for review. Any feedback and suggestions for amendments will be forwarded to the RRU to forward to you. You will be required to make the necessary amendments to your IRAS application. When this is done, save your work and email email@example.com to inform them that the changes have been addressed. Your form will then be forwarded again to the initial reviewer to check.
It is at this point that you can lock your application and download your IRAS reference number for sign off by the Principal Investigator and/or the supervisory team. You will then need to book an appointment with the Pro-Vice-Chancellor (Research) so that he can sign the official sponsorship and indemnity letter and your application.
The IRAS form can then be submitted to the appropriate Research Ethics Committee for approval.
|(i)||You are not allowed to begin collecting primary data before you have completed and signed off the Low Risk Research Ethics Checklist or completed the Medium to High Risk Research Ethics Checklist or IRAS application and received approval through the ethics approval procedures explained above. By ignoring this procedure or falsely self-certifying your ethics approval a student is liable to face disciplinary action and immediate failure of your project or module. As a member of staff you are liable to face disciplinary action and possible dismissal.|
|(ii)||The amendment and approval process as set out in the Coventry University and IRAS flowcharts may take some time. We approximate that the IRAS approval process may take up to three (3) months so please ensure that you submit your application in good time.|
|(iii)||In addition, just because you have received ethical approval by the University does not mean you will receive ethical approval by the Research Ethics Committee to which you are applying.|
Guidance to preparing Participant Information Sheet
If your research projects requires the use of a participant information sheet, the following guidance note is available for use (Refer to ‘How to prepare your essential documentation‘). Our thanks to Dr Clare Wood for preparing this guidance note.
In addition, we have prepared the following templates to assist with the application process:
If you research project is likely to progress in a multi-staged manner, it is possible to submit an ethical application for each stage of project e.g. if the initial stages of the project does not require collection of primary data, the Principal Investigator may chose to use the Low Risk Research Ethics Checklist. If the second stage of the project then requires the collection of primary date involving human subjects, a Medium to High Risk Research Ethics Checklist can then be used. If you are unsure about any aspect of this, please seek advice from the RRU using the email address firstname.lastname@example.org[/link.
If your project is being carried out as part of a collaboration, please check if the project has already been given ethical approval by any of the collaborating institutions. If ethical approval has already been given you may not need to seek Coventry University ethical approval. Please check with the RRU via the email address email@example.com in the first instance.
Major changes to research project
If you find that as a result of your initial research and literature review that you need to change your project substantially it may be necessary for you to repeat the ethics questionnaire so as to better assess the risk associated with your project.
In this case follow, complete the appropriate ethics questionnaire and seek approval again. Remember to attach all approved ethics application forms to your dissertation or thesis. This is to ensure that you can evidence that you have sought and received ethical approval for your project.
If you have any questions about any of the above processes, please contact the Registry Research Unit on firstname.lastname@example.org.