Federal and state regulations mandate that research involving human participants must be reviewed and approved by an Institutional Review Board (IRB). The IRB is responsible for providing guidance and oversight for the human participant protection program and for helping to maintain compliance with applicable laws, regulations, and policies. The IRB is responsible for the following oversight functions:
- Determine what activities constitute human participant research.
- Review, approve, require modifications in (to secure approval), or disapprove all research activities covered by this policy prior to the commencement of the research.
- Require that information given to participants as part of informed consent is in accordance with appropriate laws, regulations, and standards. The IRB may require that additional information be given to the participants when, in the IRB's judgment, the information would meaningfully add to the protection of the rights and welfare of participants.
- Require documentation of informed consent or waive documentation in accordance with federal and Kentucky laws and regulations. If research activities are being proposed to be conducted in other states and/or countries by Union faculty, staff, and/or students, the research activities will be approved in compliance with the regulations for those specific research locations.
- 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.
- Conduct continuing review of research covered by this policy at intervals appropriate to the degree of risk, but not less than once per year, (unless the research has been classified as "Exempt") and have authority to observe or have a third party observe the consent process and the research.
- Suspend or terminate approval of research that is not being conducted in accordance with the IRB's requirements or that has been associated with unexpected serious harm to participants. Any suspension or termination of approval shall include a statement of the reasons for the IRB's action and shall be reported promptly to the investigator, appropriate institutional official and the department chair .