If you choose to participate in a clinical study, you will receive educational and informed consent materials.
Our staff will assist you in understanding and completing all required paperwork. Any question you have about
the study and your participation will be answered. Clinical research conducted by Orthopedic Spine Associates
is conducted according to governing agencies, bodies, and regulations. In general, our research is governed by
The Food and Drug Administration (FDA) is a public health agency, charged with protecting American consumers by
enforcing the Federal Food, Drug, and Cosmetic Act and several related public health laws.
The FDA is responsible for the oversight of all clinical trials--drug and device. The FDA was founded in 1906 and
has regulated medical devices since 1938. The FDA uses science to make regulatory decisions to make devices safe
and effective. Ultimately, the burden of proof is on the FDA. All entities involved in a clinical trial are overseen
by the FDA, including the study sponsor (manufacturer of the device), the Insitutional Review Board, and the clinical
trial investigator. From time to time, the FDA may audit a study site to make sure that the investigator and his staff
are in compliance with all FDA regulations.
Under U.S. regulations, an Institutional Review Board (IRB) is an appropriately constituted group that has been formally
designated to review and monitor biomedical research involving human participants. In accordance with FDA regulations, an
IRB has the authority to approve, require modifications in order to secure approval, or disapprove research. Members of
the IRB who have a conflicting interest in any proposal under review may not participate in that review except to give
information as requested to the committee. An IRB may invite individuals with competence in special areas to assit in the
review of complex proposals, but these individuals may not vote.
Good Clinical Practies (GCP) is a standard of design, conduct, performance, monitoring, auditing, recording, analyses, and
reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that
the rights, integrity, and confidentiality of trial subjects are protected. Many of these practices are based on the World
Medical Association Declaration of Helsinki, adopted by the 18th World Medical Assembly in Helsinki, Finland in 1964 and
subsequently revised by the World Medical Assembly in 1975, 1983, and 1989.