Professional ethics

Research and clinical trials

My question is which government agency at the federal level deals with unethically conducted research and clinic trials involving our universities. Mainly the consent and adverse events and injury that results from such ..

Nathan’s Answer

In the US, the FDA (Department of Health and Human Services) is tasked with oversight by virtue of the fact they can conduct audits. This is why many American Pharmaceutical companies have moved some of their research overseas where the FDA conducts less audits than stateside.

The DEA (Department of Justice) can be implicated also, along with the following: United States Department of Agriculture; Department of Energy; National Aeronautics and Space Administration; Department of Commerce; Consumer Product Safety Commission; International Development Cooperation Agency, Agency for International Development; Department of Housing and Urban Development; Department of Defense; Department of Education; Department of Veterans Affairs; Environmental Protection Agency; National Science Foundation; Department of Transportation.

For specifics, Title 21 of the Federal Code of Regulations, Chapter 1 is a good starting point.

Protection of Human Subjects (Informed Consent) (21 CFR Part 50)

Additional Safeguards for Children in Clinical Investigations of Food and Drug Administration-Regulated Products (21 CFR Parts 50 and 56)

Informed Consent Elements (21 CFR 50.25(c))

Exception From General Requirements for Informed Consent (21 CFR 50.23(e))

Financial Disclosure by Clinical Investigators (21 CFR Part 54)