Clinical Research Staff Council

Regulatory Authorities

 Guidance and Regulatory Departments


                     i.            Food and Drug Administration (FDA) The FDA is the main legislative body in the U.S. regarding clinical research regulations.  It maintains the Code of Federal Regulations (CFR), which is the overall regulatory document addressing all aspects of FDA policy.  The FDA protects public health by assuring the safety, and efficacy and security of human and veterinary drugs, biologic products, medical devices, the U.S.’s food supply, cosmetics, and products that emit radiation.  The FDA is the body that pharmaceutical marketing studies must be submitted to.


                   Human Subject Research Oversight

                   Human subject research supported or conducted by the Department of Health and Human Services (DHHS)must obtain an assurance of compliance, known as a Federal Wide Assurance (FWA) through the Office for Human Research Protections (OHRP).  An FWA is a formal written, bining committment that is sumitted to OHRP in which an institution promises to comply with applicable regulations governing research with human subjects and stipulates the procedures through which compliance will be achieved.

                   Vanderbilt University receives federal funding to conduct human subject research.  Therefore, VU has obtained a FWA through OHRP.  The FWA assures the government that the Institution and affiliated sites will follow all applicable federal regulations for the protection of human subjects participating in research.  Although an assurance is required for an institution receiving federal funds for human subjject research, Vanderbilt has committed to the government, through its FWA, to follow OHRP's human subject regulations for all human subject research, regardless of sponsorship.  Therefore, all human subject research conducted at Vanderbilt University and its affiliated sites is regulated by OHRP.


                        Human subject research involving drugs and devices are regulated by the Food and Drub Administration (FDA).  Therefore, drug and device research involving human subjects is regulated by both the FDA and OHRP regulations.

                   IRB (Institutional Review Board)

                   OHRP and the FDA regulations require all human subject research be reviewed and approved by an Institutional Review Board (IRB) ot Independant Ethics Committee(IEC).

                        Vanderbilt University IRB has established three Health Science Committees and one Behavioral Science Committee.  All human subject research sponsored by Vanderbilt University and conducted under the direction of any faculty, staff, student, or agent of Vanderbilt in connnection with his or her institutional responsibilities or using property or facility of Vanderbilt University or involving non-public information to identify or contact human research subjects must be reviewed and approved by the Vanderbilt University IRB. 

                   The IRB has the authority and responsibility to approve and montior for compliance with institutional policy all research involving humans conducted by Vanderbilt faculty, staff, students or agents.

                   The VU IRB website, www.mc.vanderbilt.edu/irb provides information to assist investigators and their research personnel in the conduct of human subject research under the jurisdiction of VU.  







                               ii.            International Conference on Harmonisation/Good Clinical Practice (ICH GCP) Good Clinical Practice (GCP) is an international ethical and quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects.  Compliance with this standard provides public assurance that the rights, safety, and wellbeing of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible.  ICH-GCP was officially adopted by the European Union in 1996 and by Japan and the USA in 1997.


                              iii.            National Institutes of Health (NIH) The National Institutes of Health (NIH), a part of the U.S. Department of Health and Human Services, is the primary Federal agency for conducting and supporting medical research. Helping to lead the way toward important medical discoveries that improve people’s health and save lives, NIH scientists investigate ways to prevent disease as well as the causes, treatments, and even cures for common and rare diseases. Composed of 27 Institutes and Centers, the NIH provides leadership and financial support to researchers in every state and throughout the world.


                             iv.            Office of Human Research Protection (OHRP) The OHRP supports, strengthens and provides leadership to the nation’s system for protecting volunteers in research that is conducted or supported by the U.S. Department of Health and Human Services (HHS).  OHRP provides clarification and guidance to research institutions, develops educational programs and materials, and promotes innovative approaches to enhancing human subject protections.  To carry out their mission, nearly 10,000 universities, hospitals, and other research institutions in the U.S. and abroad have formal agreements (“assurances”) with OHRP to comply with the regulations pertaining to human subject protections.


                               v.            Office of Research Integrity (ORI) The Office of Research Integrity (ORI) promotes integrity in biomedical and behavioral research supported by the U. S. Public Health Service (PHS) at about 4,000 institutions worldwide. ORI monitors institutional investigations of research misconduct and facilitates the responsible conduct of research (RCR) through educational, preventive, and regulatory activities. Organizationally, ORI is located in the Office of Public Health and Science (OPHS), within the Office of the Secretary of Health and Human Services (OS), in the U.S. Department of Health and Human Services (HHS).




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