The following provision will be inserted in any solicitation where a resultant contract will include, or is likely to include, research activities involving human subjects covered under 34 CFR Part 97.
Research is a systematic investigation designed to develop or contribute to generalizable knowledge.
Research is considered to involve human subjects when a researcher obtains information about a living individual through intervention or interaction with the individual or obtains personally identifiable private information about an individual. Some categories of research are exempt under the regulations, and the exemptions are in 34 CFR Part 97. Copies of the regulations and related information on the protection of human research subjects are available on ED's Protection of Human Subjects in Research Web Site at and from the Department's Protection of Human Subjects Coordinator, at the address shown below. An offeror proposing to do research that involves human subjects must provide information to ED on the proposed exempt and nonexempt activities. The offeror should submit this information as an attachment to its technical proposal.