In lieu of a new Assurance, ED will accept a current Multiple Project Assurance on file with the Office for Protection from Research Risks, Department of Health and Human Services, if ED determines that the Multiple Project Assurance is appropriate to the proposed covered research activity. Offerors reasonably likely to receive an award and proposing to do research that is covered by the regulations will be contacted by ED and given detailed instructions on filing the Assurances and Certifications. The offeror is responsible for ensuring that it and the other entities submit the required documents to ED in a timely manner. Failure to submit the documents in a timely manner may result in deferral of an award or award to another offeror. The following clause will be inserted in any contract that will include, or is likely to include, nonexempt 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. Part 97 requires the contractor, subcontractors and any other entities involved in covered research activities to establish and maintain procedures for the protection of human subjects. The definitions in 34 CFR 97.102 apply to this clause. The requirements at Part 97 apply to all entities involved in covered research under this contract.