LOUGHBOROUGH UNIVERSITY
Ethical Advisory Committee

Guidance on Making a Submission to the Ethical Advisory Committee

1. Do I need to obtain approval from the Ethical Advisory Committee?

If you are conducting ANY research involving human participants, you will need to obtain approval from the Ethical Advisory 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?

Please see the flow chart for a quick guide to the process for obtaining ethical approval.

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 Ethical Advisory 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 Ethical Advisory 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 Ethical Advisory Committee with evidence of former approval and the terms on which this approval has been granted.

3. What does the Ethical Advisory Committee consider when deciding whether to issue approval?

3.1 The Ethical Advisory Committee (and Sub-Committee) considers individual research proposals in detail, before issuing clearance to proceed, or offering advice to investigators on certain aspects of their proposals. The Sub-Committee may refer proposals which raise new or contentious ethical issues to the main Committee for further consideration. When considering proposals, the Committee is broadly concerned with:

  • Whether the research has clear objectives,
  • Whether there is a risk of harm (physical or emotional) to those involved (participants and investigators), and
  • The need/justification for the research, including whether any risk of harm is necessary in order to achieve the objectives of the research.

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

3.2 More specifically, members of the Ethical Advisory Committee check proposals against a number of criteria, including those listed on this Checklist for Evaluating EAC Proposals.

4. Generic Protocols

The Ethical Advisory 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 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 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 here. 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 Ethical Advisory committee to confirm whether there have been any changes to the protocol and whether it is still needed. There is also a form available to add new investigators must be completed and signed by the relevant Head of Department, then sent to the Secretary of the Ethical Advisory Committee.

5. Guidance on Completing a Research Proposal.

Using 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 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.

5.1 Informed Consent Forms

  • Please use the template provided as a starting point for your consent form but consider carefully what information can be removed from this and what information needs to be added,
  • Please make sure that details of the complaints procedures are made available to all participants, either by providing the web address or contact details of the Secretary to the Informed Consent form,
  • Please make two copies of the Informed Consent form for all participants, one which you retain and one for them to keep, make sure that you, as the investigator sign the participants copy,

5.2 Participant Information Sheets

  • Please use the template provided as a starting point for your information sheet but consider carefully what information can be removed from this and what information needs to be added,
  • Please make sure that you include the contact details (telephone and email) of all the investigators,
  • Consider who will need to read and understand the participant information sheet, and alter the literacy level and style accordingly,
  • Consider adding pictures, this may be a good way of introducing equipment etc to the participants early so they are more familiar with it at the start of the investigations,
  • Include details of any sponsors of the project, unless this is not possible due to the contract
  • Do include the academic background to the study and what it is that you hope their tests will tell you, but be careful of using too much technical information which the participants may not be able to understand.

5.3 Health Screen Questionnaires

  • Please use the template provided as a starting point for your Health Screen Questionaire but consider carefully what information can be removed from this and what information needs to be added,
  • Make sure that only relevant questions are included, for example, if you are only testing male participants then remove the questions which are only for females,
  • Make sure that any additional questions are included, for example, if your investigations include dietary supplements ask for details of all allergies

5.4 Other Documents

  • If participants are under the age of 18 the consent form has to be completed by their parent or guardian, however it is also good practice to include a Willingness to Participate Form,
  • If your investigation includes a questionnaire please ensure that this is also included,
  • Also include any other information sheets or letter that you are likely to send out as a part of the study, this can include advertisement materials, letters to schools etc

If once you have started your investigations your methodology changes 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.

6. How do I submit my completed proposal?

Completed applications should be submitted, prior to the relevant submission deadline, to: Zoe Stockdale, Secretary to the Ethical Advisory Committee, Research Office, 2.01 Rutland Building.

7. 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 Zoe Stockdale. Alternatively there are regular advice sessions run about the Universities Ethical policies, details of which can be found through Professional Development.

Back to Main EAC page

Back to EAC - Additional Information and Resources page

Ethical Advisory Committee
Last updated December 2008
Copyright © Loughborough University. All rights reserved.