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Joint Research Management Office

Breadcrumb

  1. JRMO
  2. Performing research
  3. Conducting research with human participants (outside the NHS)
  4. How do I apply?
  5. Post approval responsibilities

Post approval responsibilities

Amendments 

Changes to studies must be submitted as an amendment prior to the implementation. Implementation can only occur once ethics approval for the amendment is in place. Amendments are classified as either major or minor.

Examples of Major amendments: 

  • Changes likely to have a significant impact on the safety or physical or mental integrity of participants, or to the risk/benefit assessment for the study.
  • Changes to the design or methodology of the study, or to background information likely to have a significant impact on its scientific value.
  • A change of sponsor or the insurance or indemnity arrangements for the study.

Examples of Minor amendments: 

  • Minor changes to the protocol or other study documentation, e.g. correcting errors, updating contact points, minor clarifications.
  • Short time extensions; and
  • Changes to the research team. 

Please contact the team in case of any unexpected events or deviations from the proposed protocol as per the original application

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For applications on QM Ethics please complete the form online. For all other applications please complete an Annual Progress Report [DOC 52KB] form on the 12-month anniversary of the QMERC’s approval letter and every year after that until study closure. Only applicable for studies with a duration of more than one year.  

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For applications on QM Ethics please complete the form online. For all other applications please complete the End of Study Notification [DOC 52KB] within three months of the end of a study.

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