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Amendments


 

To request an amendment, please complete this amendment request form and email to ethics@rhul.ac.uk. This document should clearly detail each proposed change and why these changes have been proposed.


Should you require changes to any supplementary documents (information sheets, consent forms, debrief sheets) please provide a copy of each document in .docx format with track changes enabled. This will make it much easier for the reviewer to identify the amendments being requested and how they change the documents.

Approval must be received prior to the commencement or continuation of the project. Amendments are distinguished between Minor and Major Amendments. Minor amendments are reviewed approved by the Research Ethics Officer and can take up to a week. If the Research Ethics Officer decides that an amendment request constitutes a Major Amendment, it will need to be reviewed and approved by the Chair of the REC, who are given three weeks to review.

Minor Amendments (Approved by Research Ethics Officer within Three Working-Days Timeframe)

  • Amendment to research methods that mean that the project operates at the same or lower level of risk
  • Minor textual errors, e.g. correcting errors, updating contact points, minor clarifications
  • changes in funding arrangements
  • changes to contact details for the chief/principal investigator or other study staff
  • extension of the study beyond the period specified in the application form
  • changes to the research team (excluding the Principal Investigator), subject to confirmation of additional researchers having undertaken appropriate training in research ethics

Major Amendments (Approved by Committee within Three Week Timeframe)

  • changes to the design or methodology of the study, or to background information affecting its academic value (including addition of participants);
  • changes to the procedures undertaken by, or other requirements expected of, participants (including any change relating to the safety or physical or mental integrity of participants, or to the risk/benefit assessment for the study)
  • significant changes to study documentation such as protocol, participant information sheets, consent forms, questionnaires, letters of invitation, information sheets for relatives or carers
  • appointment of a new chief/principal investigator
  • change of territory for international studies
  • temporary halt of a study to protect participants from harm (or resulting from a concern or complaint made), and the planned restart of a study following a temporary halt
  • any other significant change to the terms of the REC application

Please submit your amendment request by emailing it to ethics@rhul.ac.uk.

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