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U.S. Department of Education

U.S. Department of Education

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**I. Introduction**

The Department of Education's regulations for the protection of human subjects, 34 CFR, Part 97, require that each institution (footnote 1) engaged in the conduct of covered research activities have an approved Assurance of Compliance (footnote 2) on file and provide Certification (footnote 3) that the Institutional Review Board (IRB) (footnote 4) designated in the Assurance has reviewed and approved the proposed research activities before they are initiated.  This section provides a brief overview of the requirements for applicants and contract offerors for assurances and certifications at the application/proposal stage, and after award.  *(This section does not address all the requirements and, is, therefore, not a substitute for the regulations.  Interested persons should read the regulations as well.)*

**II. What information must a grant applicant or contract offeror provide the Department (ED) at the application/proposal stage regarding research activities involving human subjects?**

*Grant applicants:* The application form that applicants use to apply for a grant from ED includes a "human subjects research" item.  Every applicant must respond to the item to indicate whether or not research activities involving human subjects are planned at any time during the project period.  If human subjects research activities are planned, the applicant must indicate if these activities are exempt or covered (nonexempt) and provide detailed information about covered research activities.

*Contract offerors:* If the Contracting Officer determines that a procurement is likely to include research activities involving human subjects, the Request for Proposals (RFP) includes detailed instructions requesting contract offerors to provide information in their proposals that is similar to the information requested of grant applicants when human subjects research is planned.

**III. Is an applicant or offeror required to have an Assurance on file and to submit certification of IRB approval at the time of application/proposal?**

No. ED does not require an applicant or offeror to have an Assurance on file or to provide certification that an IRB has reviewed and approved the research at the application/proposal stage.

When a grant applicant is selected or recommended for an award and the project will include nonexempt research, an ED official will contact the applicant and request that the applicant comply with the requirements for the Assurance and IRB approval prior to an award. If the applicant does not have an Assurance, the ED official will ask that the applicant apply for it. The ED official will also request that the applicant obtain and send to ED certification of IRB approval.  In unusual circumstances, e.g., end of fiscal year, ED may make the award before the applicant meets the requirements.

Successful offerors will also be contacted and asked to comply with the requirements for the assurance and IRB approval for research that will be conducted under the contract.

**IV. What is an IRB and should an applicant or offeror do if it does not have an IRB at the time of application/proposal?**

An IRB is a group of five or more individuals whose primary responsibility is to protect the rights and welfare of research subjects.  IRBs review proposed research and have the authority to approve, require modification in, or disapprove research activities subject to the regulations.  

Many institutions, e.g., universities and evaluation firms, have their own IRB.  Some institutions do not.   ED does not require that an applicant or offeror have an IRB at the application/proposal stage or that they identify in the proposal the IRB that will review and approve the research.  However, we encourage an institution that does not have an IRB to look into the available options.

When requested by ED to comply with the requirement for the Assurance and IRB approval for an ED-funded project, an institution that does not have an IRB has three options.  It can form its own IRB, it can "borrow" the IRB of an institution that has one, e.g., the IRB of an institution that will collaborate in the research project, or it can use the services of a commercial, independent IRB.

**V.  What should be done when institutions in addition to the applicant or offeror institution will be engaged in the research activities?**

Each legally separate institution that will be conducting nonexempt research under the ED-funded project is subject to the requirement for Assurances and IRB approvals.  At the application or proposal stage, the applicant or offeror must identify the collaborating institutions (if known) and their role in the human subjects research activities.

Once the applicant or offeror is selected or recommended for an award, they will be responsible for ensuring collaborating institutions comply with the requirements in a timely manner.

**VI. What is expected of grantees and contractors?**
Grantees and contractors are required to comply with the requirements for assurances and IRB approvals for research activities that will be conducted in the ED-funded projects.  They will be responsible for ensuring that the requirements are met before any covered research activity is initiated.   This may include submitting IRB certifications for any covered research activities that were indefinite at the time of award, i.e., definite plans for the involvement of human subjects were not set forth in the application or proposal.

Grantees and contractors also are required to submit periodic certifications of IRB review of covered activities, in accordance with 34 CFR 97.109, which requires that an IRB conduct continuing periodic review of covered research, at intervals appropriate to the degree of risk, but not less than once a year.

Grantees and contractors are also responsible for ensuring that the collaborating institutions comply with the requirements.

August 1998 (revised February 2006)

This document is available on the Department of Education's Protection of Human Subjects in Research Web Site at: http://www.ed.gov/about/offices/list/ocfo/humansub.html

Footnotes:

- The regulations define an institution as "any public or private entity or agency (including federal, state, and other agencies)."
- An Assurance is a document or statement that formally acknowledges an organization's intent to comply with the Federal Policy for the Protection of Human Subjects, including ED's regulations for the protection of human subjects, and other applicable regulations.  The assurance most commonly used is the Federal Wide Assurance (FWA).  The Office for Human Research Protections in the Department of Health and Human Services issues the FWA.  The FWA is good for three-year periods, can be renewed, and is good for studies funded by any of the 17+ Federal agencies that have adopted the human subjects protections regulations.
- "Certification" is the official notification to ED by an institution, in accordance with the requirements of 34 CFR Part 97, that a covered research activity involving human subjects has been reviewed and approved by an IRB in accordance with an approved Assurance.  The certification of IRB review is accomplished by filing the HHS Protection of Human Subjects Assurance Identification/IRB Certification form (formerly the HHS Optional Form 310), or the equivalent, e.g., a letter from the IRB chair approving the research.
- An IRB is a group of five or more individuals whose primary responsibility is to protect the rights and welfare of research subjects.  IRBs review proposed research and have the authority to approve, require modification in, or disapprove research activities subject to the regulations.

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