Question

The Case: A Full IRB Committee meeting is convened and one agenda item is a new research proposal to evaluate how mothers interact with their learning disabled child. The inclusion criteria require the children to be a minimum of five years of age. The protocol requires the mother of the child to look at the child without any expression and not to talk to the child for three minutes. The Question: The committee considers that the risks to the children could be more than minimal, but the proposal does not include adequate information to make a final determination regarding the risks. Which of the following best describes how the IRB should proceed? a. Table the protocol and ask the investigator to provide the needed information for review by the full board at the next convened meeting. b. Approve the protocol with the condition that the investigator provides additional information about the potential risks to the children before proceeding with the study. c. Reject the protocol outright due to the perceived risks involved for the children in the study. d. Approve the protocol without any additional conditions, trusting the investigator's judgment regarding the minimal risks associated with the study.

Answer 1

The best course of action for the IRB (Institutional Review Board) in this situation would be to choose option a. Table the protocol and ask the investigator to provide the needed information for review by the full board at the next convened meeting.

The IRB's primary responsibility is to protect the rights and welfare of human research participants. In this case, the committee recognizes that the risks to the children involved in the study may be more than minimal, but the proposal lacks sufficient information to make a final determination regarding these risks. It is crucial for the IRB to have a comprehensive understanding of the potential risks to the participants before making a decision.

By tabling the protocol and requesting the investigator to provide the necessary information, the IRB ensures that they have all the relevant details to assess the risks accurately. This information can then be thoroughly reviewed by the full board during the next convened meeting. This approach allows the IRB to make an informed decision based on complete information and uphold their responsibility to protect the participants' welfare.