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Furthermore, it is the responsibility of the investigator to obtain written informed consent from each patient participating in the study or to withdraw from it any time, for any reason. The investigator must assure that patient’s anonymity will be maintained and that their identities are protected from unauthorized parties. Approval from Institutional Review Boards or Ethical Committees must be obtained before any study is started, and should be documented in a letter to the investigator specifying the date on which the Board met and grated the approval. When no local review board exists, the investigator is expected to submit the protocol to a regional Board.
