a professor at big state university is writing a biography about bill gates and conducting oral histories with all of bill gates’ friends, family members, and business acquaintances. the researcher submits the research proposal to the institution’s irb. what action can he expect by the irb?
a professor at big state university is writing a biography about bill gates and conducting oral histories with all of bill gates’ friends, family members, and business acquaintances. the researcher submits the research proposal to the institution’s irb. what action can he expect by the irb?
Answer:
In the scenario described, where a professor at a university is writing a biography about Bill Gates and conducting oral histories with Bill Gates’ friends, family members, and business acquaintances, the researcher submits the research proposal to the institution’s Institutional Review Board (IRB). The IRB will typically review the proposal to determine whether it falls under the purview of human subjects research and whether it requires IRB oversight. Here are some possible actions that the IRB can take:
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Exemption Determination: The IRB may review the proposal and determine that the research is exempt from full IRB review. Exemption is possible if the research involves minimal risk to participants, does not include sensitive or identifiable information, and falls under certain categories specified in federal regulations. If the research is exempt, the professor may still need to submit documentation to the IRB to confirm the exemption status.
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Full IRB Review: If the research does not qualify for exemption, the IRB will conduct a full review of the research proposal. During this review, the IRB will assess the ethical and regulatory aspects of the research, including issues related to informed consent, participant confidentiality, and potential risks to participants.
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Protocol Modifications: The IRB may require the researcher to make modifications to the research protocol to address ethical concerns or ensure the protection of participants. For example, the IRB may request changes to the informed consent process or require additional safeguards for participant confidentiality.
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Informed Consent: The IRB will evaluate how the researcher plans to obtain informed consent from participants. In oral history research, informed consent can be a complex issue, especially if the research involves sensitive or private information. The IRB may provide guidance on the informed consent process to ensure that participants fully understand the nature of the research and their participation.
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Continuing Oversight: If the IRB approves the research, it may also provide instructions for ongoing oversight and reporting. This may include periodic updates on the progress of the research, any adverse events or issues that arise during the study, and any changes to the research protocol.
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Monitoring and Compliance: The IRB may require the researcher to comply with specific ethical and regulatory standards throughout the research process. Failure to adhere to these standards can result in the suspension or termination of the research.
The specific actions taken by the IRB will depend on the nature of the research, the potential risks to participants, and the policies and procedures of the university or institution. It is essential for the researcher to work closely with the IRB and follow its guidance to ensure that the research is conducted ethically and in compliance with relevant regulations.