Administrative Code

Virginia Administrative Code
12/1/2021

Chapter 565. Regulations for the Protection of Students As Participants in Human Research

8VAC20-565-10. Definitions.

The terms in this chapter, except as otherwise defined herein, shall be in accord with the definitions contained in Chapter 5.1 (§ 32.1-162.16 et seq.) of Title 32.1 of the Code of Virginia entitled "Human Research."

Statutory Authority

§ 22.1-16.1 of the Code of Virginia.

Historical Notes

Derived from VR270-01-0055 § 1, eff. February 22, 1995.

8VAC20-565-20. Scope.

No human research involving students shall be conducted or authorized by the Virginia Department of Education or any public school of the Commonwealth, including the Virginia Schools for the Deaf and Blind, or any proprietary schools certified by the Board of Education, unless in compliance with this chapter and other applicable law, including 45 CFR 46.

Statutory Authority

§ 22.1-16.1 of the Code of Virginia.

Historical Notes

Derived from VR270-01-0055 § 2, eff. February 22, 1995.

8VAC20-565-30. Informed consent.

No such research shall be conducted or authorized unless the student and the student's parents or legally authorized representative give their informed consent. Such informed consent shall be evidenced by a signed and witnessed informed consent form. Such form shall comply with § 32.1-162.18 A of the Code of Virginia.

Statutory Authority

§ 22.1-16.1 of the Code of Virginia.

Historical Notes

Derived from VR270-01-0055 § 3, eff. February 22, 1995.

8VAC20-565-40. Research committee.

Any such research shall be approved and conducted under the review of a human research committee, which shall be established by the agency or school conducting or authorizing the research. Any such committee shall comply with the provisions of § 32.1-162.19 of the Code of Virginia. Each committee shall submit to the Governor, the General Assembly, and the Superintendent of Public Instruction or his designee at least annually a report on the student projects reviewed and approved by the committee, which shall state significant deviations from the proposals as approved.

Statutory Authority

§ 22.1-16.1 of the Code of Virginia.

Historical Notes

Derived from VR270-01-0055 § 4, eff. February 22, 1995.

8VAC20-565-50. Exemptions.

There shall be excluded from the operation of this chapter those categories of research as set forth in § 32.1-162.17 of the Code of Virginia which exempts "Research or student learning outcomes assessments conducted in educational settings involving regular or special education instructional strategies, the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods, or the use of educational tests, whether cognitive, diagnostic, aptitude, or achievement, if the data from such tests are recorded in a manner so that subjects cannot be identified, directly or through identifiers linked to the subjects. . . ."

Statutory Authority

§ 22.1-16.1 of the Code of Virginia.

Historical Notes

Derived from VR270-01-0055 § 5, eff. February 22, 1995.

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