Final answer:
The statement is false due to the aligned international guidelines governing IRBs, which focus on protecting human research participants and are consistent across institutions and countries.
Step-by-step explanation:
True or False: There are or are not several differences between the FDA and ICH regarding the responsibilities and duties of the IRB?
This statement is False. The management and oversight of human trials are often guided by similar ethical principles globally, which are designed to protect human participants in research studies. While Institutional Review Boards (IRB) are specific committees that operate within research institutions to oversee studies involving human subjects, their duties and responsibilities are in line with international guidelines provided by organizations such as the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). These are harmonized across different regulatory agencies, including the U.S. Food and Drug Administration (FDA), to ensure global standards are met.
IRBs are crucial in maintaining ethical oversight in human subjects research. They review research proposals to ensure the safety and well-being of participants. This process includes evaluating risks and benefits, informing consent, and safeguarding participants' rights. The role of the IRB conforms with the principles set forth in notable ethical frameworks, such as the Nuremberg Code, and adheres to federal regulations that mandate such committees for research institutions receiving federal support.