The Department of Education (ED) regulations at 34 CFR 97.103(a) require that each institution "engaged" in human subjects research provide an assurance to comply with the regulations and obtain Institutional Review Board (IRB) approval, unless the research is exempt under 34 CFR 97.101(b). The assurance can be the Federal Wide Assurance on file with the Department of Health and Human Services (HHS) (note 1).
An institution becomes "engaged" in human subjects research when its employees or agents (i) intervene or interact with living individuals for research purposes; or (ii) obtain individually identifiable private information for research purposes [34 CFR 97.102(d), (f). When the institution is engaged in a covered activity, i.e., an activity that is not exempt, the institution must have an Assurance and IRB approval.
The purpose of this guidance is to elaborate on the general definition of "engagement" by providing examples to clarify when institutions involved in an ED awarded project would or would not be engaged in research and need Assurances and IRB approval. The list is not meant to be exhaustive by any means, and we will add to it from time to time, as appropriate, in response to the need for additional guidance.
Institutions would be considered "engaged" in human subjects research (and would need an Assurance and IRB approval) if their involvement includes the following:
An institution receives an ED award to support research, and a sub-contractor or collaborating institution carries out all the research activities involving human subjects. The awardee institution bears ultimate responsibility for protecting the research subjects under the award. If the research activities of the sub-contractor or the collaborating institution are covered, the ED awardee must have an Assurance and IRB approval. (The sub-contractor and the collaborating institution that are engaged in nonexempt research also must have an assurance and IRB approval.)
An institution, e.g., an elementary school, that is not the grantee under an ED award collaborates with the grantee by performing research activities involving human subjects. If the school's research activities are covered (e.g.,the school staff administer surveys to fourth graders as part of the research initiative), the school must have an Assurance and IRB approval even though it is not the grantee.
An institution's employees or agents act as authoritative representatives of the researchers and/or obtain the informed consent of research subjects on behalf of the researchers. The institution is engaged in research. However, see Example (B) (1) below regarding informational activities that would not constitute engagement in research.
An institution's employees or agents obtain, receive, or possess "coded" private information for research purposes. Coded data are identifiable data if the institution that holds the data is able to link the information to individuals through the coding system. The institution is engaged in covered research and needs an Assurance and IRB approval. However, see Example (B) (4) below when coded information would not be identifiable and the receipt of such information would not constitute engagement in research.
An institution's employees or agents utilize identifiable private information in circumstances where the institution originally obtained the data for purposes other than the research. The institution is engaged in research.
Institutions would not be considered "engaged in human subjects research (and would not need an Assurance and IRB approval) if their involvement is limited to the following:
An institution's employees or agents
- inform prospective subjects about the availability of research;
- provide prospective subjects with written information about research (which may include a copy of the relevant informed consent document and other IRB-approved materials) but do not obtain subjects' consent or act as authoritative representatives of the researchers;
- provide prospective subjects with information about contacting researchers for information or enrollment (e.g., a school psychologist provides parents with literature about a research study and tells them how to contact the investigator if they want to enroll their child in the research);
- obtain and appropriately document prospective subjects' permission for investigators to contact them (e.g., a school psychologist provides investigators with contact information about potential subjects after receiving explicit permission from each potential subject/parent; the school provides the researchers only parent contact information that is included in the school's student directory) (note 2).
The institution is not engaged in research and does not need an Assurance and IRB approval.
An institution (e.g., school, nursing home, business) permits use of its facilities for intervention or interaction with subjects by research investigators (e.g., a school permits researchers to test students whose parents have provided written permission for their participation; a business permits investigators to solicit research volunteers at the worksite). The institution is not engaged in research.
An institution's employees or agents release identifiable private information to researchers without the explicit prior permission of the research subjects. The institution discloses the information in compliance with its policies and with any applicable pertinent Federal, state, and local laws and regulations for the release of the information, including the Family Educational Rights and Privacy Act (note 3). The institution does not need an Assurance and IRB approval. However, the research institution to which the information is disclosed is engaged in research and needs an Assurance and IRB approval.
An institution receives "coded" data from another institution. Coded data are identifiable data as long as the institution that holds the data is able to link the information to individuals through the coding system. The institution that receives the coded data is not engaged in human subjects research, however, and does not need an Assurance and IRB approval if
- the institution whose employees or agents release the coded data provides a statement, satisfactory to ED, that it will not release the identifying codes to the research institution and that the data are not otherwise identifiable and
- the institution that receives the coded data provides a written signed statement, satisfactory to ED, that it will not attempt to identify the individuals.
(In lieu of separate signed statements, the institutions may provide ED with a written signed agreement between the institutions.) With the written and signed statements or agreements, ED would determine that the identities of the research subjects are not "reasonably ascertainable" under 102(f)(2), so human subjects are not involved.
Under the circumstances, ED would not require the institutions to have assurances or IRB approvals for this aspect of the research because the institutions would not be engaged in human subjects research.
Information about the Federal Wide Assurance can be found at http://www.hhs.gov/ohrp/assurances/assurances_index.html
Another ED regulation, The Family Educational Rights and Privacy Act (FERPA), 34 CFR Part 99, allows schools to disclose "student directory information" without consent as long as the school has informed the parents about the directory information and given them the opportunity to opt out of having directory information disclosed.
FERPA does not allow schools to disclose information from student records without parental or student consent if the disclosure does not meet one of several exceptions outlined in the FERPA regulations. Additional information about FERPA is available from the Family Policy Compliance Office at http://www.ed.gov/policy/gen/guid/fpco/index.html