Which of the following is true regarding changes in research protocols under FDA regulations?

Which of the following is true regarding changes in research protocols under FDA regulations?

• A. IRB review of deviations is explicitly required
• B. IRB must approve all amendments to the protocol
• C. Investigators have total freedom to modify protocols
• D. Only serious deviations must be reported to the IRB

Answer: (B)

The statement that the Institutional Review Board (IRB) must approve all amendments to the protocol is accurate under FDA regulations. This requirement underscores the necessity of safeguarding the rights and welfare of research participants. When a research protocol undergoes any changes, whether they pertain to the study design, objectives, methodology, or even participant eligibility, these amendments must be reviewed and approved by the IRB before implementation. This process ensures that any modifications are ethically sound and that they adequately protect study subjects. The need for IRB approval for protocol amendments is part of the broader framework-regulated environment in which research is conducted, ensuring that all changes are justified and align with the ethical principles laid out in the regulations. It helps maintain the integrity of the research process and the trust of the participants involved. In contrast, the other statements suggest practices that are either overly permissive or misinterpret the responsibilities of investigators and the IRB. For example, while some deviations may not require prior IRB review, all significant changes should be vetted to uphold ethical standards.

The statement that the Institutional Review Board (IRB) must approve all amendments to the protocol is accurate under FDA regulations. This requirement underscores the necessity of safeguarding the rights and welfare of research participants. When a research protocol undergoes any changes, whether they pertain to the study design, objectives, methodology, or even participant eligibility, these amendments must be reviewed and approved by the IRB before implementation. This process ensures that any modifications are ethically sound and that they adequately protect study subjects.

The need for IRB approval for protocol amendments is part of the broader framework-regulated environment in which research is conducted, ensuring that all changes are justified and align with the ethical principles laid out in the regulations. It helps maintain the integrity of the research process and the trust of the participants involved.

In contrast, the other statements suggest practices that are either overly permissive or misinterpret the responsibilities of investigators and the IRB. For example, while some deviations may not require prior IRB review, all significant changes should be vetted to uphold ethical standards.