Loughborough University
Leicestershire, UK
LE11 3TU
+44 (0)1509 222222
Loughborough University

University Committees

Ethics Approvals (Human Participants) Sub-Committee

Additional Information

Application Forms

Ethical Clearance Checklist  (NEW VERSION) - to be completed for ALL investigations involving human participants.

The revised Ethical Clearance Checklist (above) has been approved and replaces the previous version.  This should be completed in future for studies involving human participants.  Please contact the Secretary if you have any queries.

If you select any 'yes' answers in Section A a Research Proposal submission is required.  If you select 'yes' to any question in Section B (but none in section A) the approved checklist should be sent to the Secretary for approval.  If you select 'no' to all questions then the checklist can be approved in the School/Department and submission is not required.

Guidance on Completion of Ethical Clearance Checklist ‌

Research Proposal Application Form 

Generic Protocol Application Form

Templates for Download

Participant Information Sheet Template (Participants should be allowed a reasonable amount of time to consider their participation.  For studies involving invasive procedures or physical activity it is good practice to allow participants at least 24 hours to consider the information sheet before they are asked to consent.)

Informed Consent Template (Two copies should be signed by each participant - one signed copy should be retained by the participant and one kept by the investigator.)

Child Assent Template

Health Screen Questionnaire Template (This data should be considered sensitive personal data and should be stored appropriately.)

Repeat Visits Template

Materials Transfer Agreement (HTA relevant material)

This template should be used for Materials Transfer Agreements for Human Tissue Act relevant material.  Once completed it should be signed by the Principle Investigator and HTA Designated Individual and then sent to the Research Office for institutional approval.  If any of the terms are changed please advise the Research Office of the changes so that they can be approved.

Materials Transfer Agreement (HTA relevant material)

Risk Assessment Templates

Risk Assessments should be completed for all projects.  Please find below some templates which can be used.  These should be revised so that they are relevant to your study.

Guidance on completion of risk assessments is available here.

If your School has existing templates these can be used instead and are acceptable.

Risk Assessment Template

Risk Assessment Template: Interview/Questionnaire

Risk Assessment Template: Online Questionnaire

Risk Assessment Template: Public Activities

SSEHS Risk Assessment Template

Insurance Form

Insurance Questionnaire

Contact

Jacqueline Green

University Governance

The University's statutory documents, regulations and governance processes.

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