Which entity is responsible for protecting the rights and welfare of human research subjects in clinical trials?

Which entity is responsible for protecting the rights and welfare of human research subjects in clinical trials?

• A. Board of Pharmacy
• B. Institutional Review Board
• C. Medical Review Board
• D. Clinical Trials Board

Answer: (B)

Independent oversight of research involving people comes through an Institutional Review Board that reviews every clinical study before it begins and continues monitoring it as it proceeds. The IRB assesses the study plan to ensure risks are minimized and reasonable in relation to potential benefits, confirms that participants are selected fairly, and ensures informed consent is obtained and kept up to date. It also protects participant privacy and data, and monitors ongoing safety and regulatory compliance. Because of these duties, the IRB is the entity responsible for safeguarding the rights and welfare of human research subjects in clinical trials. The other bodies described don’t perform this ethical oversight: they handle pharmacy practice and medication-related issues, and there isn’t a standard, recognized role called a Medical Review Board or a generic Clinical Trials Board for protecting research participants.

Independent oversight of research involving people comes through an Institutional Review Board that reviews every clinical study before it begins and continues monitoring it as it proceeds. The IRB assesses the study plan to ensure risks are minimized and reasonable in relation to potential benefits, confirms that participants are selected fairly, and ensures informed consent is obtained and kept up to date. It also protects participant privacy and data, and monitors ongoing safety and regulatory compliance. Because of these duties, the IRB is the entity responsible for safeguarding the rights and welfare of human research subjects in clinical trials. The other bodies described don’t perform this ethical oversight: they handle pharmacy practice and medication-related issues, and there isn’t a standard, recognized role called a Medical Review Board or a generic Clinical Trials Board for protecting research participants.