Section 90. Exemptions from the requirements governing human research

In accordance with § 32.1-162.17 of the Code of Virginia, the following categories of human research are not subject to this regulation's provisions governing human research. Except when provided for by law or regulation, these activities may be subject to the nonhuman research review and approval process established by the department.

1. Activities of the Virginia Department of Health conducted pursuant to § 32.1-39 of the Code of Virginia.

2. 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 subject.

3. Research involving solely the observation of public behavior, including observation by participants, or research involving survey or interview procedures unless subjects can be identified from the data either directly or through identifiers linked to the subjects, and either:

a. The information about the subject, if it become known outside the research, could reasonably place the subject at risk of criminal or civil liability or be damaging to the subject's financial standing or employability; or

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

4. The collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the subjects cannot be identified from the information either directly or through identifiers linked to the subjects.

5. Medical treatment of an experimental nature intended to save or prolong the life of the subject in danger of death, to prevent the subject from becoming disfigured, physically or mentally incapacitated, or to improve the quality of the subject's life.

Historical Notes

Derived from Volume 21, Issue 09, eff. February 9, 2005.

Statutory Authority

§ 66-10.1 of the Code of Virginia.