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Review of Research

  1. The IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all research activities covered by this human subjects policy.

  2. The IRB shall require that information given to subjects as part of informed consent is in accordance with 45 CFR 46.

  3. The IRB shall require documentation of informed consent or may waive documentation in accordance with 45 CFR 46.

  4. The IRB shall notify investigators and the institution in writing of its decision to approve or disapprove the proposed research activity, or of modifications required to secure IRB approval of the research activity. If the IRB decides to disapprove a research activity, it shall include in its written notification a statement of the reasons for its decision and give the investigator an opportunity to respond in person or in writing.

  5. The IRB shall conduct continuing review of research covered by this policy (except protocols determined by the IRB to qualify for exempt status) at intervals appropriate to the degree of risk, but not less than once per year, and shall have authority to observe or have a third party observe the consent process and the research.