Loughborough University
Leicestershire, UK
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Loughborough University

University Committees

Ethics Approvals (Human Participants) Sub-Committee

Additional Information

Making a Submission to the Ethics Approvals (Human Participants) Sub-Committee 

1. Do I need to obtain approval from the Ethics Approvals (Human Participants) Sub-Committee?

If you are conducting ANY investigation involving human participants, you will need to obtain approval from the Ethics Approvals (Human Participants) Sub-Committee. The type of approval required depends on the extent of any physical, sociological or emotional risks to participants.

2. How do I know which type of approval I need to obtain?

The first step is to complete the Ethical Clearance Checklist.  If you do not select 'yes' to any of the questions the checklist can be approved by the School.  If you select 'yes' to any of the questions you should follow the next steps as described on the checklist.  

If your research is being conducted off campus and ethical approval for your study has been granted by an external Ethics Committee (e.g. a different University or the NHS), you may not need to seek full approval from the University Ethics Approvals (Human Participants) Sub-Committee. However, you will be expected to provide evidence of approval from the external Ethics Committee and the terms on which this approval has been granted.
If you believe this statement applies to your research, please contact the Secretary of the Sub-Committee for confirmation.

If your research is transferring into Loughborough University and approval was obtained from your originating institution, there is a requirement on the University to ensure that appropriate approvals are in place.
If you believe this statement applies to your research, please contact the Secretary of the Sub-Committee with evidence of former approval and the terms on which this approval has been granted.

3. Guidance on Completing a Research Proposal.

If you need to submit a full Research Proposal Application Form you should use the Ethical Clearance Checklist as a guide, assess which areas/aspects of your proposed methodology have prompted the need for a full proposal to be completed, this means that you can provide the most detail about those aspects. The more detailed your proposal is the less likely it is that you will be requested to provide extra clarification from the Sub-Committee, therefore speeding up the approval process.

It is also very important that any accompanying documents required for your application are also completed fully and carefully. Some ideas and suggestions of relevant information for each of the documents is listed below.

3.1 Informed Consent Forms

3.2 Participant Information Sheets

3.3 Health Screen Questionnaires

3.4 Other Documents

4. What does the Ethics Approvals (Human Participants) Sub-Committee consider when deciding whether to issue approval?

4.1 The Ethics Approvals (Human Participants) Sub-Committee considers individual research proposals in detail, before issuing a decision on the proposal. The Sub-Committee may refer proposals which raise new or contentious ethical issues to the Loughborough University Ethics Committee for further consideration. When considering proposals, the Sub-Committee is broadly concerned with:

It is important, therefore, that investigators use the Research Proposal Application Form to demonstrate that the issues above have been carefully thought through.

4.2 More specifically, members of the Ethics Approvals (Human Participants) Sub-Committee check proposals against a number of criteria and will either issue 'approval', 'approval with conditions' or will 'decline' to approve the study.  

5. Generic Protocols

The Ethics Approvals (Human Participants) Sub-Committee also considers the establishment of generic protocols for procedures/techniques involving human participants that are used on a regular basis, and which form all or part of subsequent research projects or taught modules. This facility for the establishment of generic protocols is intended to allow investigators to use the same set of procedures/techniques involving human participants as part of a number of different research projects, without needing to submit a full Research Proposal Application Form to the Sub-Committee on each occasion.

The procedure for the initial approval of generic protocols is similar to that used for research proposals, but there is a different form that must be completed and submitted to the Sub-Committee - the Generic Protocol Application Form. This form should not be used for one-off research projects.

Each approved generic protocol is reviewed, and updated as necessary, every three years. An archive of approved generic protocols is available on request. This also indicates when the last update took place and when the proposal is next due for update, at this time please contact the Secretary of the Sub-Committee to confirm whether there have been any changes to the protocol and whether it is still needed. There are forms for requesting amendments or adding investigators which must be completed and signed by the relevant Head of School/Department, then sent to the Secretary of the Sub-Committee.

Further details, and a list of approved Generic Protocols, are available in the section on Generic Protocols under Additional Information.

6. How do I submit my completed proposal? 

Completed applications should be submitted, prior to the relevant submission deadline, to: Jacqueline Green, Secretary to the Ethics Approvals (Human Participants) Sub-Committee, Research Office, Hazlerigg Building.  You should ensure that you allow sufficient time for the application to be approved by the School prior to submission.

7. Amendments

If your study is approved via a checklist and your methodology changes once you have started your investigations in relation to the human participants, it is very important that you once again complete the Ethical Clearance Checklist to confirm that your new procedures still conform to the basic ethical principles.  

Amendments to studies which required a full Research Proposal should be submitted to the Secretary.

8. Any further questions?

If you have any other questions or problems or are not sure if you need to complete a form then please contact Jacqueline Green

Contact

Jacqueline Green

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