Source: https://law.lis.virginia.gov/admincodeexpand/title22/agency30/chapter40/
Timestamp: 2020-07-02 19:52:04
Document Index: 735033737

Matched Legal Cases: ['§ 1', 'art 160', 'art 164', '§ 208', '§ 3501', '§ 552', '§ 3501', '§ 2', '§ 32']

"Agent" means an individual performing department-designated activities or exercising department-delegated authority or responsibility.
"Assent" means a child's affirmative agreement to participate in research. Mere failure to object, absent affirmative agreement, shall not be construed as assent.
"Commissioner" means the Commissioner of the Department for Aging and Rehabilitative Services or the commissioner's designee.
"Human participant" or "human subject" means a living individual about whom an investigator, whether professional or student, conducting research obtains:
"Human subject research" means a systematic investigation, experiment, study, evaluation, demonstration, or survey designed to develop or contribute to general knowledge (basic research) or specific knowledge (applied research) in which a living individual about whom an investigator, whether professional or student, conducting research obtains data through intervention or interaction with the individual or obtains identifiable private information.
"Identifiable private information" means private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information.
"Informed consent" means a process by which the investigator fully explains the research activities and ensures that the prospective subject has sufficient opportunity to ask questions and has sufficient time to make a decision whether or not to participate in the research prior to signing the HRRC-approved written consent document. Informed consent shall be prospectively obtained without coercion and in accordance with 22VAC30-40-100.
"Institution" means any public or private entity or agency, including federal, state, and other agencies.
"Intervention" means both physical procedures by which data are gathered (e.g., venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes.
"IRB" means an institutional review board.
6. A parent of the prospective subject, when the subject is an adult;
7. An adult sibling of the prospective subject; or
8. Any person or judicial or other body authorized by law or regulation to consent on behalf of a prospective subject to the subject's participation in the particular human research.
For the purposes of this definition, any person authorized by law or regulation to consent on behalf of a prospective subject to the subject's participation in the particular human research shall include an attorney-in-fact appointed under a durable power of attorney, to the extent the power grants the authority to make such a decision. The attorney-in-fact shall not be employed by the person, institution, or agency conducting the human research. No official or employee of the institution or agency conducting or authorizing the research shall be qualified to act as a legally authorized representative.
"Minor," as defined in § 1-207 of the Code of Virginia, means an individual who is younger than 18 years of age.
"Permission" means the agreement of a parent or parents or a legally authorized representative to the participation of their minor or ward in research.
"Private information" means information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, or information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g., a medical record).
"Sheltered workshop" means a program that (i) provides directly or facilitates the provision of one or more vocational rehabilitation services enumerated in 34 CFR 361.5(c)(7)(i) to individuals with disabilities to enable them to maximize their opportunities for employment, including career advancement; (ii) has a vendor relationship with the department; and (iii) is not operated by a community services board.
"Written" or "in writing" means text or other human communication on a tangible medium (e.g., paper) or in an electronic format.
Derived from Virginia Register Volume 16, Issue 10, eff. March 1, 2000; amended, Virginia Register Volume 25, Issue 21, eff. July 22, 2009; Volume 36, Issue 17, eff. May 14, 2020.
Derived from Virginia Register Volume 16, Issue 10, eff. March 1, 2000.
Derived from Virginia Register Volume 16, Issue 10, eff. March 1, 2000; amended, Virginia Register Volume 25, Issue 21, eff. July 22, 2009; Volume 28, Issue 24, eff. August 30, 2012; Volume 31, Issue 21, eff. July 15, 2015.
D. The HRRC shall have authority to suspend or terminate approval of research that is not being conducted in accordance with the HRRC's requirements or that has been associated with unexpected serious harm to subjects. Any suspension or termination of approval shall include a statement of the reasons for the HRRC's action and shall be reported promptly to the research investigator, the commissioner, the heads of other appropriate covered entities, and in the case of cooperative research, the institutional officials responsible for human subjects research.
E. Research covered by this chapter that has been approved by the HRRC may be subject to further appropriate review and approval or disapproval by officials of the covered entities. However, those officials shall not approve the research if the research has not been approved by the HRRC.
Derived from Virginia Register Volume 16, Issue 10, eff. March 1, 2000; amended, Virginia Register Volume 25, Issue 21, eff. July 22, 2009; Volume 31, Issue 21, eff. July 15, 2015; Volume 36, Issue 17, eff. May 14, 2020.
B. The HRRC shall require that information given to prospective subjects as part of the informed consent process is in accordance with 22VAC30-40-100. The HRRC may require that information, in addition to that specifically mentioned in 22VAC30-40-100, be given to prospective subjects when in the HRRC's judgment the information would meaningfully add to the protection of the rights and welfare of subjects.
C. The HRRC shall require documentation of informed consent or may waive documentation in accordance with 22VAC30-40-100 L.
D. The HRRC shall consider research proposals within 45 days after submission of a complete application to the HRRC's chairperson. The HRRC shall notify investigators and the covered entity in writing of its decision to approve or disapprove the research, or of modifications required to secure HRRC approval.
E. The HRRC shall develop written complaint procedures to be followed by a human subject who has a concern about a research project in which he is participating or has participated.
F. Any participant who has a complaint about a research project in which he is participating or has participated shall be referred to the chairperson of the HRRC, who shall refer the complaint to the HRRC to determine if there has been a violation of the research protocol as approved by the HRRC.
G. The HRRC shall require periodic reports, the frequency of which should reflect the nature and degree of risk of each research project.
H. If the HRRC decides to disapprove a research application, the HRRC shall include in its written notification a statement of the reasons for its decision and give the investigator an opportunity to respond in person or in writing.
I. The HRRC shall conduct continuing review of research covered by this chapter at intervals appropriate to the degree of risk, but not less often than once per year, and shall have authority to observe or have a third party observe the consent process and the research. Unless the HRRC determines otherwise, continuing review of research shall not be required in the following circumstances:
1. Research eligible for expedited review in accordance with 22VAC30-40-90;
2. Research reviewed by the HRRC in accordance with the limited IRB review described in 22VAC30-40-80 B 3, 22VAC30-40-80 C 1 c, and 22VAC30-40-80 G and H; or
3. Research that has progressed to the point that it involves only one or both of the following, which are part of the HRRC-approved study:
a. Data analysis, including analysis of identifiable private information; or
b. Accessing follow-up clinical data from procedures that subjects would undergo as part of clinical care.
2. Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the HRRC should consider only those risks and benefits that may result from the research as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research. The HRRC should not consider possible long-range effects of applying knowledge gained in the research (e.g., the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility.
3. Selection of subjects is equitable. In making this assessment, the HRRC should take into account the purposes of the research and the setting in which the research will be conducted. The HRRC should be particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons.
4. Informed consent is sought from each prospective subject or the subject's legally authorized representative in accordance with and to the extent required by 22VAC30-40-100.
5. Informed consent is appropriately documented in accordance with and to the extent required by 22VAC30-40-100.
K. For purposes of conducting the limited review required by 22VAC30-40-80-G, the HRRC need not make the determinations at subdivisions J 1 through J 7 of this section and shall make the following determinations:
1. Broad consent for storage, maintenance, and secondary research use of identifiable private information is obtained in accordance with the requirements of 22VAC30-40-100 A and D;
2. Broad consent is appropriately documented or waiver of documentation is appropriate, in accordance with 22VAC30-40-100 L; and
3. If there is a change made for research purposes in the way the identifiable private information is stored or maintained, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
L. When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons, there are additional safeguards in place to protect the rights and welfare of the human subjects.
Derived from Virginia Register Volume 16, Issue 10, eff. March 1, 2000; amended, Virginia Register Volume 21, Issue 16, eff. May 18, 2005; Volume 25, Issue 21, eff. July 22, 2009; Volume 36, Issue 17, eff. May 14, 2020.
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:
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:
6. Category 6. Taste and food quality evaluation and consumer acceptance studies:
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.
Derived from Virginia Register Volume 16, Issue 10, eff. March 1, 2000; amended, Virginia Register Volume 25, Issue 21, eff. July 22, 2009; Volume 30, Issue 4, eff. November 21, 2013; Volume 36, Issue 17, eff. May 14, 2020.
22VAC30-40-110. HRRC records.
A. The HRRC shall prepare and maintain adequate documentation of HRRC activities, including the following:
1. Copies of all research applications reviewed, scientific evaluations, if any, that accompany the applications, approved consent documents, progress reports submitted by investigators, and reports of injuries to subjects;
2. Minutes of HRRC meetings which shall be in sufficient detail to show attendance at the meetings; actions taken by the HRRC; the vote on these actions including the number of members voting for, against, and abstaining; the basis for requiring changes in or disapproving research; and a written summary of the discussion of controverted issues and their resolution;
4. Copies of all correspondence between the HRRC and the investigators;
5. A list of all HRRC members identified by name; earned degrees; representative capacity; indications of experience such as board certifications, licenses, etc., sufficient to describe each member's chief anticipated contributions to HRRC deliberations; and any employment or other relationship between each member and the covered entity, for example: full-time employee, part-time employee, member of governing panel or board, or paid or unpaid consultant;
6. Statements of significant new findings provided to participants; and
7. Written procedures for the HRRC that shall include:
a. Conducting its initial and continuing review of research and for reporting its findings and actions to the investigator and the department;
b. Determining which projects require review more often than annually and which projects need verification from sources other than the investigators that no material changes have occurred since previous HRRC review;
c. Ensuring prompt reporting to the HRRC of proposed changes in a research activity, and for ensuring that such changes in approved research, during the period for which HRRC approval has already been given, may not be initiated without HRRC review and approval except when necessary to eliminate apparent immediate hazards to the subject; and
d. Ensuring prompt reporting to the HRRC and the commissioner of (i) any unanticipated problems involving risks to subjects or others or any serious or continuing noncompliance with this policy or the requirements or determinations of the HRRC and (ii) any suspension or termination of HRRC approval.
8. The rationale for an expedited reviewer's determination under 22VAC30-40-90 A 1 that research appearing on the expedited review list described in 63 FR 30364-60367 is more than minimal risk.
9. As applicable, documentation specifying the responsibilities that the covered entity and another qualified IRB other than the HRRC, each shall undertake to ensure compliance with the requirements of this chapter when (i) nonexempt research involving human subjects or (ii) exempt research with a limited review is overseen by another qualified IRB other than the HRRC. Such documentation may include:
a. A written agreement between the covered entity and the qualified IRB that is not the HRRC;
b. Implementation of an institution-wide policy directive providing the allocation of responsibilities between the covered entity and the qualified IRB that is not the HRRC; or
c. A research protocol.
B. The records required by this chapter shall be retained for at least three years, and records relating to research which is conducted shall be retained for at least three years after completion of the research. All records may be maintained in printed or electronic form and shall be accessible for inspection and copying by authorized employees or agents of the department or federal agency at reasonable times and in a reasonable manner.
C. The HRRC shall ensure that an overview of approved human subject research projects and the results of such projects are made public on the department's website unless otherwise exempt from disclosure under the Virginia Freedom of Information Act (§ 2.2-3700 et seq. of the Code of Virginia).
D. The HRRC shall have access to meeting space and sufficient staff to support the HRRC's review and recordkeeping duties.
Derived from Virginia Register Volume 16, Issue 10, eff. March 1, 2000; amended, Virginia Register Volume 25, Issue 21, eff. July 22, 2009.
B. The commissioner shall review communications from the HRRC reporting violations of research protocols that led to suspension or termination of the research to ensure that appropriate steps have been taken for the protection of the rights of human subjects.
C. The commissioner shall arrange for printing and dissemination of copies of this chapter.
D. The commissioner may require that support for a project be terminated or suspended in the manner prescribed in applicable program requirements when the commissioner finds a covered entity has materially failed to comply with the terms of this chapter.
E. In making decisions about supporting or approving applications or proposals covered by this chapter, the commissioner may take into account, in addition to all other eligibility requirements and program criteria, factors such as whether the applicant has been subject to a termination or suspension under subsection D of this section and whether the applicant or the person who would direct or has directed the scientific and technical aspects of an activity has, in the judgment of the commissioner, materially failed to discharge responsibility for the protection of the rights and welfare of human subjects (whether or not the research was subject to federal regulation).
22VAC30-40-140. Applicability of state policies.
Nothing in this chapter shall be construed as limiting in any way the rights of human subjects in research under regulations promulgated in response to Chapter 5.1 (§ 32.1-162.16 et seq.) of Title 32.1 of the Code of Virginia.
Derived from Virginia Register Volume 16, Issue 10, eff. March 1, 2000; amended, Virginia Register Volume 21, Issue 16, eff. May 18, 2005; Volume 25, Issue 21, eff. July 22, 2009.
22VAC30-40-150. Applicability of federal policies.
The conduct of human subjects research that is subject to policies and regulations for the protection of human subjects promulgated by any agency of the federal government shall be exempt from requirements of this chapter. When the HRRC reviews or approves federally funded or sponsored human research proposals, the HRRC shall notify the commissioner at least annually of its compliance with federal policies and regulations for the protection of human research subjects.
Derived from Virginia Register Volume 25, Issue 21, eff. July 22, 2009; amended, Virginia Register Volume 36, Issue 17, eff. May 14, 2020.