LIS

Administrative Code

Creating a Report: Check the sections you'd like to appear in the report, then use the "Create Report" button at the bottom of the page to generate your report. Once the report is generated you'll then have the option to download it as a pdf, print or email the report.

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
11/23/2024

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.

Website addresses provided in the Virginia Administrative Code to documents incorporated by reference are for the reader's convenience only, may not necessarily be active or current, and should not be relied upon. To ensure the information incorporated by reference is accurate, the reader is encouraged to use the source document described in the regulation.

As a service to the public, the Virginia Administrative Code is provided online by the Virginia General Assembly. We are unable to answer legal questions or respond to requests for legal advice, including application of law to specific fact. To understand and protect your legal rights, you should consult an attorney.