Is All Human Research Regulated?

Some Research is Outside of OHRP's Oversight

Even when research is not required to follow the Common Rule, there may be other regulations that provide protections.

For example, pharmaceutical companies that do research on new drugs that they plan to sell in the U.S. must comply with the U.S. Food and Drug Administration (FDA) rules to protect humans in research. The FDA’s rules are very similar to the Common Rule. The FDA protects public health by ensuring the safety and efficacy of drugs, biological products, and medical devices such as artificial heart valves. It is also responsible for advancing public health by helping the public get the accurate, science-based information they need to use medical products to maintain and improve their health.

Many institutions also voluntarily apply the protections laid out in the Common Rule, even if their research does not fall under OHRP oversight.

There are many research activities that do not come under the Common Rule. An example is research funded by private money such as certain research paid for by private companies, charitable foundations, or wealthy individuals that are conducted in private institutions. Some state or even federally funded research may not come under the Common Rule as well.

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