Question:

Do the FDA and federal regulations apply to activities such as process development activities that are privately funded? For federally funded research, if the sponsor purchases human cells or specimens from a supplier and the purchase agreement specifies that that identifiable information will never be disclosed to the sponsor, is the sponsor required to follow the federal regulations?
– Biotechnology company

Response:

Part 1: Do the regulations apply?

Let’s begin by defining the scope of the FDA and federal regulations on human research protections.

If activity is privately funded and not FDA regulated, the regulations do not apply unless the organization has elected apply the regulations to all research regardless of funding source.

For federally funded research, the regulations apply only to those activities that meet the definition of research requiring IRB review. Activities aimed at assessing or improving laboratory operations and efficiencies within your organization, may not meet the definition of research; and, the regulations would not apply.

FDA regulations apply when the activity involves FDA regulated products including drugs, biologicals, and in vitro devices. For example, activities used to develop an in vitro diagnostic device require compliance with FDA regulations.

Part 2: Is informed consent required?

Informed consent is not required when:

  • the specimens are de-identified or anonymous;
  • the specimens are publicly available.
  • the specimens are coded, and the investigator and the holder of the key enter into an agreement prohibiting the release of identifiable information. Refer to OHRP guidance for details on coded private information or specimens used for research.