Royal College of Surgeons in Ireland Coláiste Ríoga na Máinleá in Éirinn

Terms of ethical approval

Research Ethics Committee (REC) approval is always made on the basis of a number of important conditions

  • Research must not commence until the RCSI REC has granted full and final ethics approval.
  • The research must be conducted in compliance with the approved protocol and any deviation from the original protocol must not be implemented without prior approval from the REC.
  • Any unforeseen events that might affect the continued ethical acceptability of the research project must be reported immediately to the REC via the convenor.
  • The REC must be notified of, and approve, any changes to the original (approved) protocol.
  • The REC must be notified of any changes in names of the principal research team.
  • Research data arising from a research study must be held securely for a period of five years in line with best practice and data protection guidelines.
  • Information for participants must include the name and contact details for both the researcher and of the academic supervisor/principal investigator.
  • Approval is for the period stated on the letter of approval. Researchers must make a request for an extension should the collection of data exceed the study approval period.
  • Arrangements are in place to ensure that indemnity and/or compensation are available to cover all possible claims from participants.
  • Research is carried out in full compliance with all regulatory and legal requirements currently in existence and in accordance with the ethical principles that have been outlined in the Declaration of Helsinki.