For an IRB to grant a waiver for informed consent, which condition must be met?

Study for the CITI Program Biomedical Research Exam. Utilize our resources with flashcards and multiple-choice questions, complete with hints and explanations. Prepare with confidence!

To grant a waiver for informed consent, one of the primary conditions that must be met is that conducting the research without a waiver would be impractical. This means that the research could not feasibly be conducted if consent were required from all participants. In such situations, the IRB may determine that the potential benefits of the research, and the importance of the information to be gathered, outweigh the necessity of obtaining informed consent from each individual. This condition is designed to facilitate valuable research that may otherwise be hindered by consent requirements while still ensuring that the rights and welfare of participants are considered.

The other conditions listed do not specifically relate to the criteria for waiving informed consent. Benefits to participating subjects are important but do not justify a waiver in themselves. Additionally, the presence of a data safety monitoring board is not a prerequisite for consent waivers; rather, it's a separate consideration related to the oversight of a research study's safety. Lastly, the involvement of individuals no longer living pertains to a different context, such as research on deceased persons, and does not directly relate to the conditions for waiving informed consent for living participants.

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