Which of the following is a requirement for waiving informed consent for minimal risk research according to FDA guidance?

Which of the following is a requirement for waiving informed consent for minimal risk research according to FDA guidance?

• A. The clinical investigation must involve more than minimal risk
• B. The waiver must adversely affect the rights of subjects
• C. The study could not be practically conducted without the waiver
• D. Subjects must not receive any information post-participation

Answer: (C)

The requirement that a waiver of informed consent for minimal risk research is justified if the study could not be practically conducted without the waiver is significant because it emphasizes the balance between ethical considerations and the feasibility of conducting certain research. In minimal risk research, obtaining informed consent might impose undue burdens that could hinder the research's effectiveness or viability. For instance, if the research involves a large population or aims to explore sensitive issues, obtaining individual consent might be logistically challenging and could result in insufficient participation, thereby compromising the study's objectives. Therefore, providing a waiver under these conditions is seen as a necessary practice to enable valuable research to move forward while still protecting the rights of participants in contexts where traditional consent processes may not be practical. This principle aligns with the FDA's aim to promote ethical research that advances medical knowledge while considering the practical limitations researchers may face. The other options present conditions that either do not align with the criteria for a waiver or misinterpret the regulatory framework meant to protect participants in research settings.

The requirement that a waiver of informed consent for minimal risk research is justified if the study could not be practically conducted without the waiver is significant because it emphasizes the balance between ethical considerations and the feasibility of conducting certain research. In minimal risk research, obtaining informed consent might impose undue burdens that could hinder the research's effectiveness or viability.

For instance, if the research involves a large population or aims to explore sensitive issues, obtaining individual consent might be logistically challenging and could result in insufficient participation, thereby compromising the study's objectives. Therefore, providing a waiver under these conditions is seen as a necessary practice to enable valuable research to move forward while still protecting the rights of participants in contexts where traditional consent processes may not be practical.

This principle aligns with the FDA's aim to promote ethical research that advances medical knowledge while considering the practical limitations researchers may face. The other options present conditions that either do not align with the criteria for a waiver or misinterpret the regulatory framework meant to protect participants in research settings.