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Question: OHRP is an oversight body primarily concerned with:
Quick answer: Protection of human research subjects.
This question is a part of GCP Audits And Inspections Of Clinical Trials Of Drugs And Biologics.
The Office for Human Research Protections (OHRP) is primarily concerned with the protection of human research subjects. It is responsible for ensuring that human subjects involved in research are treated with respect and that their rights and welfare are protected.
The OHRP provides leadership and oversight on all matters related to the protection of human subjects in research that is conducted or supported by the U.S. Department of Health and Human Services (HHS). It ensures that such research is carried out ethically and in compliance with U.S. regulations.
The main functions of the OHRP include:
- Providing guidance and clarification on regulations and ethical issues related to human research protections.
- Developing educational programs and materials to enhance understanding of human research protections.
- Maintaining regulatory oversight of research involving human subjects.
- Providing advice on ethical and regulatory issues in biomedical and behavioral research.
- Supporting the Secretary’s Advisory Committee on Human Research Protections (SACHRP), which provides expert advice and recommendations to the Secretary of HHS on issues and topics pertaining to the protection of human research subjects.
In summary, the OHRP plays a crucial role in ensuring that the rights, welfare, and wellbeing of human subjects involved in research are adequately protected.
Source: Office for Human Research Protections