When working with certain governmental entities, there are additional steps and protections that PIs and IRBs must be aware of and execute, or risk complications with their funding.
ED Research applies to research conducted, supported or otherwise subject to regulation by the ED. These additional requirements would be applied to studies conducted at K-12 schools as well as colleges and universities that receive ED funds. It also includes research conducted, supported, or otherwise subject to regulation by ED outside the United States.
ED is one of the Common Rule agencies and has its own set of regulations found in 34 CFR 97. As described in this document, human participants research (HSR) is any research that collects (1) Data through intervention or interaction with the individual, or (2) Identifiable private information from or about a living individual as part of a systematic investigation.
ED outlines additional protections for students whenever researchers plan to study the following:
As outlined in 34 CFR 98 ( .4) and 20 U.S.C. 1232h , no student shall be required to submit without prior consent to psychiatric examination, testing, or treatment, or psychological examination, testing, physical examinations, or treatment, in which the primary purpose is to reveal information concerning one or more of the above.
Additional protections to student privacy as outlined by ED policies may apply. PIs should consult the resources found in Section VIII to verify their protocol includes all necessary component protections.
Parental access to study materials: surveys concerning any of the information topics found above must be made available at the school for review by parents within a reasonable period to time after the request is recieved. Likewise, parents or guardians must be allowed to inspect materials relating to novel or unproven teaching methods or techniques before the survey is administered or distributed by a school to a student.
Parental notification: activities involving the collection, disclosure, or use of personal information collected from students for the purpose of marketing or for selling that information (or otherwise providing that information to others for that purpose).
Researchers should consult these statues when scheduling their study events, as most procedures require notification and parental consent well in advance of the activity.
20 USC 1232h also describes how parents must be given the opportunity to opt their student out of participation of certain activities.
Education records are defined under FERPA as records that directly relate to a student and that are maintained by an educational agency or institution, or a third party on the institution's or agency's behalf. Education records generally do not include the following: records maintained by law enforcement units; employment records related to students in their capacity as employees; medical records made by a physician, psychiatrist, psychologist, or other health professional for treatment of the student and disclosed only to individuals providing the treatment; and records created or received by an institution or agency after an individual is no longer a student at the institution and that are not directly related to the individual's attendance as a student.
When researchers need to obtain consent under FERPA (34 CFR 99.30): FERPA generally requires consent before personally identifiable information from a student's education records can be disclosed. Personally identifiable information includes, but is not limited to:
(Note: because this is not an exhaustive list, researchers should consult with the IRB when determining whether consent is need.)
Under FERPA, for consent to be valid, it must be written, signed, and dated, and must specify the records to be disclosed, the purpose of the disclosure, and the person or class of persons to whom the disclosure may be made. The FERPA regulations permit electronic consents, as long as they are in a form that identifies and authenticates a particular person as the source of the electronic consent.
When researchers do not need to obtain consent under FERPA (34 CFR 99.31): There are certain conditions described in 34 CFR 99.31 where personally identifiable information from a school or educational institution can be disclosed without prior consent from parents, current students, and/or former students. Researchers should familiarize themselves with the scope of information that can be collected, as well as the conditions (i.e. the creation of a written agreement between the researcher and the educational institution) that must be satisfied before data collection can begin.
If a school or educational institution has given public notice to parents and affected students that directory information will be released for the purpose of research (and they have been given the right to opt out), no consent is necessary. Directory information means information contained in an education record of a student that would not generally be considered harmful or an invasion of privacy if disclosed.
When UW IRBs initially review research protocols that require the inclusion of children with disabilities or individuals
with mental disabilities as research participants, the IRB must include at least one person primarily concerned with the
welfare of these research participants, per
34 CFR 350.4 (c)(2)
34 CFR 356.3. For purposes of IRB review, children are persons enrolled in research not above the elementary or secondary education level, who have not reached the age of majority as determined under state law.
There are categories of research supported by ED that may be reviewed by the IRB through an expedited review procedure.
There are no additional funding requirements for ED studies. Refer to the UW department of Research and Sponsored Programs website for guidance: https://www.rsp.wisc.edu/
Per UW policy, researchers are expected to complete a financial conflict of interest report on an annual basis while the study is active. Researchers may be required to submit a COI management plan if a conflict is identified. Refer to the UW COI website for guidance: https://research.wisc.edu/respolcomp/coioar/
There is no additional training required for ED studies. Researchers and their study staff are expected to take human participants research training as required by the UW, and maintain this certification while participating on an ED trial. The UW uses the CITI program for this training. The NIH has a FAQ that discusses who on the researcher's study team is required to have human participants training, and what programs satisfy this requirement.
ED requires researchers to report any unanticipated risks in research or serious or continuing noncompliance the ED Protection of Human Subjects in Research Coordinator. (There is additional information on how to report unanticipated incidents (adverse events, serious or continuing noncompliance, etc.) to ED.)
Researchers and their study staff are expected to follow UW policy on reporting adverse events, continuing reviews, etc.
There are no additional requirements for retention of ED study materials. Refer to UW IRB for recordkeeping guidance here:
34 CFR 97, ED Protection of Human Subjects
Overview of the Protection of Human Subjects in Research Supported by ED
Links for ED Human Subjects Research
ED Requirements at the Application/Proposal Stage and After Award
Expedited Review of Social and Behavioral Research Activities , Social and Behavioral Research Working Group, Human Subjects Research Subcommittee, Committee on Science, National Science and Technology Council (June 2008)
34 CFR 350.4 (c)(2) , Representation for Vulnerable Subjects on the IRB
Family Educational Rights and Privacy Act (FERPA)
Protection of Pupil Rights (PPRA)