Study Completion or Termination

Investigators must report when they have finished conducting the research protocol.

Also, Goodwyn IRB has the authority to suspend or terminate approval of research that is not being conducted in accordance with the Board's decision, conditions and requirements, or that has been associated with unexpected serious harm to subjects. Serious or continuing noncompliance with the determinations of the IRB may result in the IRB withdrawing approval for a study. Failure to provide responses in a timely manner to notice of period or annual review is considered cause for suspension or termination of approval.

Final Report Form *   **

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Definitions:

Study Suspension: The temporary removal of approval to conduct the research study.

Study Termination: The permanent cessation of study conduct due either to completion of the protocol or to removal of approval to conduct the research study.

Non-compliance: Conduct of research in a manner that disregards or violates the study protocol or regulations governing such research. This can include, but is not limited to, failure to obtain IRB approval, inadequate or nonexistent process(es) for administering informed consent, inadequate supervision of research, failure to follow recommendations made by IRB to ensure the safety of subjects, failure to report adverse events or changes to the protocol and failure to provide ongoing progress reports when requested.