What is OHRP primarily concerned with in the realm of clinical research?

What is OHRP primarily concerned with in the realm of clinical research?

• A. Compliance with ICH guidelines
• B. Adherence to FDA regulations
• C. Protection of human research subjects
• D. Approval of new drugs

Answer: (C)

The Office for Human Research Protections (OHRP) plays a vital role in overseeing ethical standards in clinical research, with a primary focus on the protection of human research subjects. This duty entails ensuring that individuals participating in research are treated ethically and that their rights, safety, and well-being are prioritized. OHRP accomplishes this by enforcing regulations and providing guidance that establishes how research should be conducted in a manner that respects participant autonomy and minimizes risk. The emphasis on human subject protection includes the review and oversight of Institutional Review Boards (IRBs), informed consent processes, and compliance with ethical guidelines such as the Belmont Report. These efforts are crucial for building trust between researchers and participants, which is foundational for the integrity and success of clinical research. Other choices, while related, focus on different aspects of clinical research governance. Compliance with ICH guidelines and adherence to FDA regulations are important for ensuring rigorous scientific and regulatory standards, but they do not directly address the protection of the individuals involved in the research. Approval of new drugs is a function typically conducted by the FDA, which assesses the safety and efficacy of medications rather than directly addressing the ethical considerations related to human subjects. In summary, the central mission of OHRP aligns closely with ensuring that the

The Office for Human Research Protections (OHRP) plays a vital role in overseeing ethical standards in clinical research, with a primary focus on the protection of human research subjects. This duty entails ensuring that individuals participating in research are treated ethically and that their rights, safety, and well-being are prioritized. OHRP accomplishes this by enforcing regulations and providing guidance that establishes how research should be conducted in a manner that respects participant autonomy and minimizes risk.

The emphasis on human subject protection includes the review and oversight of Institutional Review Boards (IRBs), informed consent processes, and compliance with ethical guidelines such as the Belmont Report. These efforts are crucial for building trust between researchers and participants, which is foundational for the integrity and success of clinical research.

Other choices, while related, focus on different aspects of clinical research governance. Compliance with ICH guidelines and adherence to FDA regulations are important for ensuring rigorous scientific and regulatory standards, but they do not directly address the protection of the individuals involved in the research. Approval of new drugs is a function typically conducted by the FDA, which assesses the safety and efficacy of medications rather than directly addressing the ethical considerations related to human subjects.

In summary, the central mission of OHRP aligns closely with ensuring that the