OHRP Is An Oversight Body Primarily Concerned With:
The Office for Human Research Protections (OHRP) is an oversight body within the Department of Health and Human Services (HHS). OHRP is primarily concerned with protecting human research subjects and ensuring that researchers are adhering to ethical standards in their experiments, studies, and clinical trials involving human participants. They are responsible for overseeing the research process in order to protect the rights, safety, and wellbeing of participants in research activities. OHRP also works to ensure that all data collected is accurately documented and securely stored.
OHRP works to ensure that research involving human subjects is conducted in accordance with the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH E6 GCP) and other applicable regulations. This involves monitoring the entire research process from the initial planning stage through the completion of the study. OHRP also reviews research protocols and the informed consent documents used for research involving human subjects. They conduct inspections of research sites and may suspend or terminate approval of research that does not meet the standards.
The regulations set by OHRP provide the framework for the ethical conduct of research involving human subjects. They are designed to protect the rights, safety, and wellbeing of participants in research activities. OHRP also works to ensure the accuracy of data collected and its secure storage. It is the responsibility of OHRP to ensure that research involving human subjects is conducted in accordance with regulatory requirements and ethical standards.
Data collected from research involving human subjects is an invaluable resource for the advancement of scientific knowledge and medical treatments. OHRP is dedicated to protecting human subjects while ensuring that the data collected from research involving human subjects is accurate, secure, and used appropriately.