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Virginia Administrative Code
Title 12. Health
Agency 35. Department of Behavioral Health And Developmental Services
Chapter 180. Regulations to Ensure the Protection of Subjects in Human Research
5/24/2024

12VAC35-180-80. Kinds of human research exempt from committee review.

Human research activities in which the involvement of individuals as subjects is limited to one or more of the following categories are exempt from this chapter unless the human research is covered by other sections of this chapter:

1. Human research conducted in established or commonly accepted educational settings, involving commonly used educational practices, such as:

a. Research on regular and special education instructional strategies;

b. Research on the effectiveness of or the comparison among instructional techniques, curriculum, or classroom management methods; or

c. Research involving solely the use and analysis of the results of educational tests, whether cognitive, diagnostic, aptitude, or achievement, if the data from such tests are recorded in such a manner so that individuals cannot be identified, directly or through identifiers linked to the individuals.

2. Human research involving survey or interview procedures, unless responses are recorded in such a manner that the individuals can be identified, directly or through identifiers linked to the individuals, and either:

a. The individual's responses, if they became known outside the human research, could reasonably place the subject at risk of criminal or civil liability or be damaging to the individual's financial standing, employability, or reputation; or

b. The human research deals with sensitive aspects of the individual's own behavior, such as sexual behavior, drug or alcohol use, or illegal conduct.

3. Human research involving solely the observation (including observation by individuals who are the subjects of human research) of public behavior, unless observations are recorded in such a manner that individuals can be identified, directly or through identifiers linked to the individuals, and either:

a. The observations recorded about the individual, if they became known outside the human research, could reasonably place the individual at risk of criminal or civil liability or be damaging to the individual's financial standing, employability, or reputation; or

b. The human research deals with sensitive aspects of the individual's own behavior such as sexual behavior, drug or alcohol use, or illegal conduct.

4. Human research involving solely the collection or study of existing data, documents, records, or pathological or diagnostic specimens, if these sources are publicly available or if the information taken from these sources is recorded in such a manner that individuals cannot be identified, directly or through identifiers linked to the individuals.

5. Human research involving solely a combination of any of the activities described in this section.

Statutory Authority

§§ 37.2-203 and 37.2-402 of the Code of Virginia.

Historical Notes

Derived from VR470-06-01:1 § 8, eff. May 15, 1993; amended, Virginia Register Volume 20, Issue 9, eff. February 11, 2004; Volume 26, Issue 2, eff. November 12, 2009; Volume 36, Issue 11, eff. March 15, 2020.

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