Provision and Clause
If the Contracting Officer determines that a procurement is likely to include human subjects research activities, he/she must include the Protection of Human Subjects Provision in the solicitation. If the Contracting Officer determines that a contract will or is likely to include nonexempt human subjects research activities, he/she must include the Human Subjects Clause in the contract document.
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.
NOTICE ABOUT RESEARCH ACTIVITIES INVOLVING HUMAN SUBJECTS (MARCH 1999) (a) Applicable Regulations. Any research activities under this proposed contract involving human subjects are governed by Department of Education (ED) regulations for the protection of human subjects in research, Title 34, Code of Federal Regulations, Part 97 (hereafter, "the regulations"). The regulations require contractors and other entities involved in covered (nonexempt) research activities to establish and maintain procedures for the protection of human subjects. The regulations, and related information on the protection of human research subjects, can be found on ED's Protection of Human Subjects in Research Web Site:
(1) The regulations define research as "a systematic investigation, including research development, testing and evaluation designed to develop or contribute to generalizable knowledge." (If an activity follows a deliberate plan whose purpose is to develop or contribute to generalizable knowledge, such as an exploratory study or the collection of data to test a hypothesis, it is research.) It includes activities that meet this definition, whether or not they are conducted under a program considered "research" for other purposes [34 CFR 97.102(d)].
(2) The regulations define human subject as "a living individual about whom an investigator (whether professional or student)conducting research obtains data through intervention or interaction with the individual or obtains identifiable private information" [34 CFR 97.102(f)(1)]. The definition of human subjects is met if an activity involves obtaining--
(A) information about a living person by-- (i) manipulating that person's environment, as might occur when a new instructional technique is tested, or (ii) communicating or interacting with the individual, as occurs with surveys and interviews; or
(B) private information about a living person in such a way that the information can be linked to that individual (the identity of the subject is or may be readily determined by the investigator or associated with the information). [Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which an individual can reasonably expect will not be made public (for example, a school health record).]
(c) Exemptions. The regulations provide exemptions from coverage for activities in which the only involvement of human subjects will be in one or more of the categories set forth in 34 CFR 97.101(b)(1-6). However, if the research subjects are children, the exemption at 34 CFR 97.101(b)(2)(i.e., research involving use of educational tests, survey procedures, interview procedures or observation of public behavior) is modified by 34 CFR 97.401(b), as explained in paragraph (d) below. Many types of research conducted on behalf of ED's National Center for Education Statistics are exempt under 34 CFR 97.101(b)(3)(ii), since the National Education Statistics Act prohibits disclosure of any individually identifiable information.
(d) Children as research subjects. Paragraph 34 CFR 97.402(a) of the regulations defines children as "persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted." Paragraph 34 CFR 97.401(b) of the regulations provides that, if the research involves children as subjects--
(1) The exemption at 34 CFR 97.101(b)(2) does not apply to activities involving--(A) survey or interview procedures involving children as subjects, or(2) The exemption at 34 CFR 97.101(b)(2) continues to apply, unmodified by 34 CFR 97.401(b), to--
(B) observations of public behavior of children in which the investigator(s) will participate in the activities being observed.(A) educational tests, and
(B) observations of public behavior in which the investigator(s) will not participate in the activities being observed.
(e) Proposal Instructions. 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. No specific page limitation applies to this requirement, but the offeror should be brief and to the point.
(1) For exempt research activities involving human subjects, the offeror should identify the exemption(s) that applies and provide sufficient information to allow ED to determine that the designated exemption(s) is appropriate.
(2) For covered research activities involving human subjects (whether conducted at the offeror's site or elsewhere), the offeror should identify the organizations (i.e., legally separate entities) that will be involved in the research activities to allow ED to:(A) Determine the identity of the entities that need to submit Assurances and Certifications;(3) If a reasonable potential exists that a need to conduct research involving human subjects may be identified after award of the contract and the offeror's proposal contains no definite plans for such research:
(B) Evaluate the adequacy of the proposed Institutional Review Board(s) in light of the research subjects likely to be involved; and
(C) Evaluate the appropriateness of the initial and continuing Institutional Review Board review procedures in consideration of the risks to subjects.(A) The offeror should briefly describe the circumstances and nature of the potential research involving human subjects.
(B) If the offeror believes that an exemption is likely to apply, the offeror should identify the exemption and explain why it would apply.
(C) The offeror's proposal should allow adequate time to obtain and submit an Assurance of Compliance and a Certification of Institutional Review Board (IRB) review for any potential covered research that may be identified after award. Offerors are cautioned that no human subjects may be involved in covered research until the research has been reviewed and approved by the IRB and the contractor has submitted to ED an acceptable Assurance and a Certification of IRB review.
(f) Assurances and Certifications.
(1) For an offeror reasonably likely to receive an award, if ED determines that proposed research activities involving human subjects are covered (i.e., not exempt) under the regulations, the contracting officer will request the offeror to file an acceptable Assurance of Compliance with the regulations and provide Certification of IRB review and approval of the proposed project. In lieu of a new Assurance, ED will accept a current Federal Wide Assurance on file with the Office for Protection from Research Risks, Department of Health and Human Services, if ED determines that the Federal Wide 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.
(2) In accordance with 34 CFR 97, all subcontractors and any other legally separate entity (neither owned nor operated by the offeror) that will be engaged in covered research activities shall be required to have an Assurance on file and to provide to ED Certification of IRB review and approval.
(3) The offeror is responsible for ensuring that it and the other entities submit the required documents to ED in a timely manner. Although an offeror does not need to submit an Assurance of Compliance or a Certification of Institutional Review Board (IRB) review with its initial proposal, the offeror should be prepared to obtain and provide these documents promptly upon request. Failure to submit the documents in a timely manner may result in deferral of an award or award to another offeror.
(g) Offerors may contact the following office to obtain information about the regulations for the protection of human subjects and related policies and guidelines.
Office of the Chief Financial Officer
Grants Policy and Oversight Staff
Washington, D.C. 20202-4250
Telephone: (202) 245-6120
This information is also available on the ED website at:
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.
RESEARCH ACTIVITIES INVOLVING HUMAN SUBJECTS (March 1999) (a) Any research activities under this contract involving human subjects are governed by Department of Education (ED) regulations for the protection of human subjects in research, Title 34, Code of Federal Regulations, 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. As used in this clause, "covered research" means research involving human subjects that is not exempt under 34 CFR 97.101(b) and 34 CFR 97.401(b). The requirements at Part 97 apply to all entities involved in covered research under this contract. The requirements of this clause apply to the Contractor, regardless of which entity performs the covered research. The contractor shall comply with Part 97 and shall ensure that each entity involved in covered research activities complies with Part 97.
(b) The Contractor agrees that the rights and welfare of human subjects involved in research under this contract shall be protected in accordance with 34 CFR Part 97 and with the Contractor's current Assurance of Compliance on file with ED or the Office for Protection from Research Risks, Department of Health and Human Services.
(c) Under no condition shall the Contractor conduct, or allow to be conducted, any covered research activity involving human subjects prior to the Department's receipt of the Certification that the research has been reviewed and approved by the Institutional Review Board (IRB) [34 CFR 97.103(f)]. No covered research involving human subjects shall be initiated under this contract until the Contractor has provided the Contracting Officer (or the Contracting Officer's designee) a properly completed Certification form certifying IRB review and approval of the research activity, and the Contracting Officer or designee has received the Certification. This restriction applies to the activities of each participating entity.
(d) In accordance with 34 CFR 97.109(e), an IRB must conduct continuing reviews of covered research activities at intervals appropriate to the degree of risk, but no less than once a year. Covered research activities that are expected to last one year or more are therefore subject to review by an IRB at least once a year.
(1) For each covered activity under this contract that requires continuing review, the contractor shall submit an annual written representation to the Contracting Officer (or the Contracting Officer's designee) stating whether covered research activities have been reviewed and approved by an IRB within the previous 12 months. The contractor may use Optional Form 310 for this representation. For multi- institutional projects, the contractor shall provide this information on its behalf and on behalf of any other entity engaged in covered research activities for which continuing IRB reviews are required.
(2) If the IRB disapproves, suspends, terminates or requires modification of any covered research activities under this contract, the Contractor shall immediately notify the Contracting Officer in writing of the IRB's action.
(e) The Contractor shall bear full responsibility for performing as safely as is feasible all activities under this contract involving the use of human subjects and for complying with all applicable regulations and requirements concerning human subjects. No one (neither the Contractor, nor any subcontractor, agent or employee of the Contractor, nor any other person or organization, institution, or group of any kind whatsoever) involved in the performance of such activities shall be deemed to constitute an agent or employee of the Department or Education or of the Federal Government with respect to such activities. The Contractor agrees to discharge its obligations, duties, and undertakings and the work pursuant thereto, whether requiring professional judgement or otherwise, as an independent Contractor without imputing liability on the part of the Government for the acts of the Contractor and its employees.
(f) Upon discovery of any noncompliance with any of the requirements or standards stated in paragraphs (b), (c) and (d) above, the Contractor shall immediately correct the deficiency. If at any time during performance of this contract, the Contracting Officer determines, in consultation with the Protection of Human Subjects Coordinator, Office of the Chief Financial and Chief Information Officer, or the sponsoring office, that the Contractor is not in compliance with any of the requirements or standards stated in paragraphs (b), (c) and (d) above, the Contracting Officer may immediately suspend, in whole or in part, work and further payments under this contract until the Contractor corrects such noncompliance. Notice of the suspension may be communicated by telephone and confirmed in writing.
(g) The Government may terminate this contract, in full or in part, for failure to fully comply with any regulation or requirement related to human subjects involved in research. Such termination may be in lieu of or in addition to suspension of work or payment. Nothing herein shall be construed to limit the Government's right to terminate the contract for failure to fully comply with such requirements.
(End of clause)
Additional information is available at the Department's Protection of Human Subjects in Research page.