Virginia Law

Research activities in which the involvement of human participants shall be limited to one or more of the following categories shall be exempt from this chapter unless the research is covered by other sections of this chapter. The HRRC shall determine whether the proposed research project satisfies at least one of the following exemption categories in this section before the research may be conducted pursuant to the exemption provided under this section:

1. Category 1. Research conducted in established or commonly accepted educational settings, involving normal educational practices that are not likely to impact adversely student opportunity to learn required educational content or the assessment of educators who provide instruction, such as:

a. Research on regular and special education instructional strategies; or

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

2. Category 2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, or achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording), unless:

a. Information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects;

b. Any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation; or

c. The information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects and the HRRC conducts a limited review to make the determination required by 22VAC30-40-70 J 7.

3. Category 3. Research involving benign behavioral interventions.

a. Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses, including data entry, or audiovisual recording if the subject prospectively agrees to the intervention and information collection and at least one of the following criteria is met:

(1) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;

(2) Any disclosure of the human subjects' responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation; or

(3) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and the HRRC conducts a limited review to make the determination required by 22VAC30-40-70 J 7.

b. For the purpose of this subsection, benign behavioral interventions are brief in duration, harmless, painless, not physically invasive, and not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing. Provided all of these criteria are met, examples of benign behavioral interventions include having the subjects play an online game, having them solve puzzles under various noise conditions, or having them decide how to allocate a nominal amount of received cash between themselves and someone else.

c. If the research involves deceiving the subjects regarding the nature or purposes of the research, this exemption is not applicable unless a subject authorizes the deception through a prospective agreement to participate in research in circumstances in which a subject is informed that he will be unaware of or misled regarding the nature or purposes of the research.

4. Category 4. Secondary research for which consent is not required: Secondary research using identifiable private information, if at least one of the following criteria is met:

a. The research involves the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available;

b. The information is recorded by the investigator in a manner that subjects (i) cannot be identified, directly or through identifiers linked to the subjects; (ii) the investigator does not contact the subjects; and (iii) the investigator will not reidentify the subject;

c. The research involves only information collection and analysis involving the investigator's use of identifiable health information when that use is regulated under 45 CFR Part 160, General Administrative Requirements, and Part 164, Security and Privacy, Subparts A and E, for the purposes of "health care operations'' or "research'' as those terms are defined at 45 CFR 164.501 or for "public health activities and purposes'' as described under 45 CFR 164.512(b); or

d. The research is conducted by, or on behalf of, the department using department-generated or department-collected information obtained for nonresearch activities if the research generates identifiable private information that is or will be maintained on information technology that is subject to and in compliance with § 208(b) of the E-Government Act of 2002, 44 USC § 3501 note; if all of the identifiable private information collected, used, or generated as part of the activity will be maintained in systems of records subject to the Privacy Act of 1974, 5 USC § 552a; and if applicable, the information used in the research was collected subject to the Paperwork Reduction Act of 1995, 44 USC § 3501 et seq.

5. Category 5. Research and demonstration projects conducted by or subject to the approval of the commissioner, which are designed to study, evaluate, or otherwise examine:

a. Public benefit or service programs;

b. Procedures for obtaining benefits or services under those programs;

c. Possible changes in or alternatives to those programs or procedures; or

d. Possible changes in methods or levels of payment for benefits or services under those programs.

6. Category 6. Taste and food quality evaluation and consumer acceptance studies:

a. If wholesome foods without additives are consumed; or

b. If a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.

7. Category 7. Storage or maintenance for secondary research for which broad consent is required. Storage or maintenance of identifiable private information for potential secondary research use if the HRRC conducts a limited review and makes the determinations required by 22VAC30-40-70 J 8.

8. Category 8. Secondary research for which broad consent is required: Research involving the use of identifiable private information, if it meets the following criteria:

a. Broad consent for the storage, maintenance, and secondary research use of the identifiable private information is obtained in accordance with 22VAC30-40-100 A and D;

b. Documentation of informed consent or waiver of documentation of consent is obtained in accordance with 22VAC30-40-100 L;

c. The HRRC conducts a limited review and makes the determination required by 22VAC30-40-70 J 7 and makes the determination that the research to be conducted is within the scope of the broad consent referenced in subdivision 1 of this subsection; and

d. The investigator does not include returning individual research results to subjects as part of the study plan. The investigator shall not be prevented from abiding by any legal requirements to return individual research results.