Note: For FDA-regulated clinical trials (see definition in Section 2), the following statement must be provided: Reliance agreements are signed by the Institutional Official or Designee. If the protocol meets all expedited examination requirements, the following information must be submitted electronically: all investigations involving faculties, staff or university students must be submitted to the Research and Compliance Support Office (CSR), even if another IRB is called an IRB audit. The RSC will conduct a compliance check on the submission to ensure that the study procedures and documents are in line with higher education guidelines. Compliance control includes: The purpose of the written presentation of the information in the consent form is to document the basis of the consent and to refer to the person concerned in the future. The consent document should be reviewed where deficiencies are identified or when additional information improves the consent process. All revisions must be verified and approved by the IRB before a revised authorization form can be used to register a subject. Authorization means the consent of parents or legal guardians to the child`s participation in research or clinical examination. /ohrp/ regulations-and-policy/guidance/faq/assurance-process/index.html Links to FWA submission instructions and forms are available on the OHRP website under iRB Registration Process FAQs. Researchers using e-mail surveys should add to their message the following information: all non-discriminatory efforts must be made to ensure that the IRB is not exclusively made up of men or women. No IRB can be made up exclusively of members of a profession. Each MEMBRE has at least one member whose main concerns are in scientific fields and at least one member whose main concerns are in non-scientific areas. Each MEMBRE includes at least one member who has no other connection to the institution and is not part of the immediate family of a person connected to the institution. a researcher must complete a protocol deviation or non-compliance report and submit it to the Office of Research Support and Compliance (RSC).

Researchers and researchers are expected to report protocol anomalies or non-compliance in a timely manner, whether they are minor, sporadic, serious or ongoing incidents. If non-compliance is reported or found, the AUTHORITY is informed in writing of the declaration of non-compliance.