Human Subjects Research Requirements (EDGAR Part 97)

1. Human Subjects Research Requirements(EDGAR Part 97) • General Rule When federally-supported research involves human subjects, it must be approved by an Institutional Review Board (IRB). • Purpose To ensure that the rights and welfare of the human subjects are protected. • Finding an IRB Most universities and colleges have IRBs. Contact your IHE partner to identify an IRB for your project.

2. Research “in established…educational settings, involving normal educational practices, such as…research on the effectiveness of … instructional techniques…” Section 97.101(b)(1) Research “involving the use of educational tests…unless: …information is recorded in such a manner that human subjects can be identified…” Section 97.101(b)(2) EXCEPTIONS TO THE IRB REQUIREMENTThere are several exceptions. Here are the two most relevant.

3. Special Scrutiny Under Subpart DED has adopted this subpart, which give special protection to research involving children. In the case of surveys involving children, the exceptions stated in the previous slide don’t apply.

4. Family Educational Rights and Privacy Act of 1974 (FERPA)Part 99 of EDGAR • This law gives parents access to their children’s education records at educational institutions. • This law also limits the circumstances under which educational records may be shared with others inside or outside the institution. • The parents’ rights transfer to the student when the student turns 18 years old or attends a postsecondary institution at any age.

5. FERPA (con’t)Access to Records • Parents have the right to inspect and review their children’s education records and to seek to amend them if the records are inaccurate or misleading. • The educational institution must supply notice of this right.

6. Educational institutions must not disclose personally identifiable information from a student’s education records without the signed and dated written consent of the parent. EXCEPTIONS (examples): Disclosure is permitted to: persons within the educational institution determined to have a “legitimate educational interest.” organizations conducting studies on behalf of the school. federal, state, and local educational authorities conducting an audit. FERPA (con’t)Disclosure Limited Without Prior Consent

7. Equitable ParticipationRequired by Section 9501 of ESEA • MSP Projects must provide private school teachers with an opportunity to participate in Title II, Part B activities equivalent to the opportunity provided public school teachers. • Projects should assess, address, and evaluate the needs and progress of both groups of teachers in the same manner.

8. Consultation must begin prior to submitting an application. Consultation must continue once the award has been made. The consultation should address: How to identify needs of children and teachers. What services will be offered. What program assessments will be conducted. Equitable Participation:Projects Must Consult with Private School Officials

9. Equitable Participation:State Responsibilities • Address Equitable Participation in the RFP • For example, require applicants to provide assurances about consultation in their applications. • Provide models of letters,logs, and other tools that projects can use to document consultation. • Monitor projects for evidence of appropriate consultation