The FDA has, over the years of its growth, been enacting laws that seek to ensure that all aspects that it covers are ethical. The FDA has been aware of the need to formulate rules and laws governing ethics. In fact, its forerunner, the Pure Food and Drug Act, enacted in 1906, more than three decades before the FDA came into existence, had a provision on ethics.
With the passage of time, even as the FDA’s reach and power expanded, ethics was one area it never compromised on. Laws governing ethics went on getting strengthened as the FDA evolved. Successive years of research and effort have given place to a number of well-defined, clearly stated laws on ethics that have to be complied with. The result is that today, any clinical trial or a product that is a result of it will never get approved by the FDA unless it has passed the test of ethics standards prescribed by this regulatory body.
Today, ethics laws are enacted to cover the following areas:
Human Participation (Institutional Review Board or IRB): Formulated with the intention of ensuring that any institution or organization that carries out clinical research involving humans complies with FDA regulations;
Animal Subjects (Institutional Animal Care & Use Committee (IACUC): Tasked with overseeing the welfare of animals and ensuring that there is compliance with all aspects of rules governing clinical trials on animal subjects;
Conflict of interests: The FDA lists out clear benchmarks by which its employees should comply when interacting with individuals or institutions or companies in which research is being carried out;
Scientific misconduct: There are clearly defined parameters by which to ensure that scientists and other staff participating in research should comply with;
Public access: To ensure that only designated staff get access to valuable scientific material; the FDA has regulation that state clearly the nature of disclosure to the public of records relating to medical research.
How does the FDA ensure compliance?
The FDA ensures compliance with set ethics regulations by carrying out what are called Ethics Committee Inspections. It performs, on average, 200 such inspections a year on clinical research sites. Each inspection lasts two to five days.