MODIFICATION REQUEST FORM FOR APPROVED RESEARCH ETHICS APPLICATIONS Applicants should submit this form together with accompanying documents to the administrator of the approving committee/panel for review. Students who obtained approval using the Low Risk application procedure will need to submit their modification request form as per the submission process for the low risk procedure. Such applicants should use this form to outline the changes to be made, and ensure to include all relevant appended documents. TITLE OF STUDY RESEARCH ETHICS REFERENCE NUMBER NAME OF LEAD RESEARCHER CONTACT DETAILS FOR CORRESPONDENCE CONCERNING THIS MODIFICATION Name: Full postal address: Telephone number: Email: TYPE OF MODIFICATION/S (tick as appropriate) Research procedure/protocol (including research instruments) Participant group Sponsorship/collaborators Extension to approval needed (extensions are given for one year) Information Sheet/s Consent form/s Lead researcher/medical supervisor* Other recruitment documents Other *Additions to the research team other than the lead researcher, student supervisor and medical supervisor do not need to be submitted as amendments but a complete list should be available upon request. DETAILS OF MODIFICATION/S (provide full details of each amendment requested, state where the changes have been made and attach all amended and new documentation) JUSTIFICATION (give the reasons why the amendment/s are needed) ETHICAL CONSIDERATIONS (insert details of any ethical issues raised by the proposed modification/s. In addition to general issues, detail any items on your original Risk Checklist and associated responses that are affected, and also indicate any additional items that should now be included on the Risk Checklist) OTHER INFORMATION (provide any other information which you believe should be taken into account during ethical review of the proposed changes) 1 King’s College London - Research Ethics 2012/2013/2 LIST OF SUPPORTING DOCUMENTS (please list all attachments submitted with this form) DECLARATION (to be signed by the lead researcher) I confirm that the information in this form is accurate to the best of my knowledge and I take full responsibility for it. I consider that it would be reasonable for the proposed modification to be implemented. For student projects I confirm that my supervisor has approved my proposed modifications. Signature………………………………………………… Date………………………………. 2 King’s College London - Research Ethics 2012/2013/2