Title of Regulation: 22VAC30-40. Protections of Participants in Human Research (amending 22VAC30-40-10, 22VAC30-40-40 through 22VAC30-40-110, 22VAC30-40-130, 22VAC30-40-160).

Statutory Authority: §§ 51.5-131 and 51.5-132 of the Code of Virginia.

Effective Date: May 14, 2020.

Agency Contact: Charlotte Arbogast, Policy Advisor, Department for Aging and Rehabilitative Services, 8004 Franklin Farms Drive, Richmond, VA 23229, telephone (804) 662-7093, FAX (804) 662-7663, TTY (800) 464-9950, or email charlotte.arbogast@dars.virginia.gov.

Summary:

The amendments, which are necessary to comport with federal regulatory changes, (i) update the list of types of vulnerable human subjects; (ii) establish new requirements regarding the information that must be given to prospective research subjects as part of the informed consent process; (iii) allow the use of broad consent (i.e., seeking prospective consent to unspecified future research) from a subject for storage, maintenance, and secondary research use of identifiable private information, as an optional alternative that an investigator may choose instead of conducting the research on nonidentified information, having the department's human research review committee (HRRC) waive the requirement for informed consent, or obtaining consent for a specific study; (iv) clarify current exempt categories for research involving minors and establish new exempt categories of research based on a human subject's risk profile, under some of which exempt research would be required to undergo HRRC limited review to ensure that there are adequate privacy safeguards for identifiable private information; (v) create a requirement for institutions based in the United States that are engaged in cooperative research to use a single institutional review board for that portion of the research that takes place within the United States, with certain exceptions; (vi) remove the requirement to conduct continuing review of ongoing research for studies that undergo expedited review by the HRRC and for studies that have completed study interventions and are merely analyzing study data or involve only observational follow up in conjunction with standard clinical care; (vii) update the role of the commissioner with regard to terminating or suspending projects; and (viii) make other minor changes for clarity and accuracy.

22VAC30-40-10. Definitions.

The following words and terms when used in this chapter shall have the following meanings unless the context clearly indicates otherwise:

"Affiliated with the covered entity" means employed by the covered entity or a member of a household containing an employee of the covered entity.

"Agent" means any 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 should not, 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.

"Covered entity" means the Department for Aging and Rehabilitative Services, the Wilson Workforce and Rehabilitation Center, sheltered workshops, or independent living centers.

"Department" means the Department for Aging and Rehabilitative Services.

"Guardian" means an individual who is authorized under applicable state or local law to consent on behalf of a minor to general medical care.

"Human Research Review Committee" or "HRRC" means the committee established in accordance with and for the purposes expressed in this chapter.

"HRRC approval" means the determination of the HRRC that the research has been reviewed and may be conducted within the constraints set forth by the HRRC and by other department, state, and federal requirements.

"Human participant" or "human subject" means a living individual about whom an investigator (whether, whether professional or student) student, conducting research obtains:

1. Data through intervention or interaction with the individual; or

2. Identifiable private information.

"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, whether professional or student) student, conducting research obtains data through intervention or interaction with the individual or obtains identifiable private information.

"Identifiable 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, and 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 or social security number). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) to constitute research involving human subjects private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information.

"Independent living center" means a consumer-controlled, community-based, cross disability, nonresidential private nonprofit agency that:

1. Is designed and operated within a local community by individuals with disabilities; and

2. Provides an array of independent living services.

"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 must shall be prospectively obtained without coercion, include all of the basic elements of informed consent as specified in 22VAC30-40-100 B, be legally effective, contain no exculpatory language, and as required, include the additional elements of informed consent specified in 22VAC30-40-100 C and in accordance with 22VAC30-40-100.

"Institution" means any public or private entity or agency (including, including federal, state, and other agencies) agencies.

"Interaction" means communication or interpersonal contact between investigator and subject.

"Intervention" means both physical procedures by which data are gathered (e.g., venipuncture) and manipulations of the subject or subject's environment that are performed for research purposes.

"Investigator" means the person, whether professional or student, who conducts the research.

"IRB" means an institutional review board.

"Legally authorized representative," as defined in § 32.1-162.16 of the Code of Virginia, means, in the following specified order of priority:

1. The parent or parents having custody of a prospective subject who is a minor;

2. The agent appointed under an advance directive, as defined in § 54.1-2982 of the Code of Virginia, executed by the prospective subject, provided the advance directive authorizes the agent to make decisions regarding the prospective subject's participation in human research;

3. The legal guardian of a prospective subject;

4. The spouse of the prospective subject, except where a suit for divorce has been filed and the divorce decree is not yet final;

5. An adult child of the prospective subject;

6. A parent of the prospective subject, when the subject is an adult;

7. An adult brother or sister 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 such 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 such 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.

"Minimal risk" means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

"Minor," as defined in § 1-207 of the Code of Virginia, means an individual who is less younger than 18 years of age.

"Nontherapeutic research" means human subject research in which there is no reasonable expectation of direct benefit to the physical or mental condition of the subject.

"Parent" means a minor's biological or adoptive parent.

"Permission" means the agreement of parent(s) 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). Private information must be individually identifiable (i.e., the identity of the human participant is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human participants.

"Research" means a systematic investigation designed to develop or contribute to generalizable knowledge (basic research) or specific knowledge (applied research). Activities that meet this definition constitute research for purposes of this chapter, whether or not they are supported or funded under a program that is considered research for other purposes. For example, some "demonstration" and "service" programs may include research activities.

"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(b)(9)(i) 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.

22VAC30-40-40. General provisions for conducting human subjects research.

A. No human subjects research may shall be conducted by a covered entity without the informed consent of the subject or the subject's legally authorized representative. The required elements of informed consent are provided in 22VAC30-40-100. The consent of the human subject or the human subject's legally authorized representative to participate in the research must shall be documented in writing and supported by the signature of a witness not involved in the conduct of the research, except as provided for in 22VAC30-40-100 J L. The investigator shall ensure that a knowledgeable member of the research team signs and provides human subjects of a research project with a copy of the written, informed consent document as defined in 22VAC30-40-100 B. The investigator shall make arrangements for those who need special assistance in understanding the consequences of participating in the research.

B. Each human subjects research project shall be approved by the department's HRRC as provided by this chapter.

C. Nontherapeutic research is shall be prohibited unless the HRRC determines that such nontherapeutic research will not present greater than minimal risk to human subjects.

D. The investigator shall be required to notify all human subjects of the risks caused by the research that are discovered after the research has concluded.

E. 22VAC30-40-160 applies shall apply to all research involving minors as subjects conducted or supported by the covered entity. In addition to other responsibilities assigned to the HRRC under 22VAC30-40-160, the HRRC shall review research covered by 22VAC30-40-160 and approve only research that satisfies the conditions of all applicable sections of this chapter. Exemptions in subdivisions 1 and 3 through 6 of 22VAC30-40-80 are applicable to 22VAC30-40-160. The exemption in subdivision 2 of 22VAC30-40-80 regarding educational tests is also applicable to 22VAC30-40-160. However, the exemption in subdivision 2 of 22VAC30-40-80 for research involving survey or interview procedures or observations of public behavior does not apply to research covered by 22VAC30-40-160, except for research involving observation of public behavior when the investigator or investigators do not participate in the activities being observed. Notwithstanding this subsection, some projects involving minors may qualify as exempt research as outlined in 22VAC30-40-80 and as approved by the HRRC. Such qualifications are described in the following table:

Exempt Category	Potential Qualification
Category 1	May qualify as exempt
Category 2 and the project involves observation of public behavior when the investigators do not participate in the activities being observed	May qualify as exempt
Category 2 and the project involves: (i) Surveys or interviews; (ii) The investigator's participation in the activities being observed; or (iii) Educational testing, sensitive information, and identifiers collected with responses	Cannot qualify as exempt
Category 3	Cannot qualify as exempt
Category 4	May qualify as exempt
Category 5	May qualify as exempt
Category 6	May qualify as exempt
Category 7	May qualify as exempt
Category 8	May qualify as exempt

F. Cooperative research projects are shall be those projects covered by this chapter that involve a covered entity in conjunction with an institution(s) institution. In the conduct of cooperative research projects, the covered entity and each institution are shall be responsible for safeguarding the rights and welfare of human subjects and for complying with this chapter. With the approval of the commissioner, a covered entity participating in a cooperative project may enter into a joint review arrangement, rely upon the review of another qualified institutional review board (IRB) IRB, or make similar arrangements for avoiding duplication of effort.

G. In the event research is undertaken without the intention of involving human subjects, but it is later proposed to involve human subjects in the research, the research shall first shall be reviewed and approved by the HRRC, as provided in this chapter, a certification submitted by the covered entity to the commissioner, and final approval given to of the proposed change shall be given by the commissioner.

H. With respect to any research project or any class of research projects, the commissioner may impose additional conditions prior to or at the time of approval when, in the judgment of the commissioner, additional conditions are necessary for the protection of human subjects.

I. In reviewing proposed research projects, the HRRC shall consider the requirements of review stated in 22VAC30-40-70.

22VAC30-40-50. Certification process.

A. No later than 45 days after the end of each state fiscal year, the Wilson Workforce and Rehabilitation Center, sheltered workshops, and independent living centers shall send a written report to the commissioner giving assurance that either all human subjects research conducted during the fiscal year was reviewed and approved by the department's HRRC prior to implementation of that research or that no human subjects research was conducted during that state fiscal year.

B. At the time that the research is approved by the HRRC, the HRRC chairperson shall send to the commissioner a description of the research project to be undertaken, which shall include a statement of the criteria for inclusion of prospective human subjects in the research project, a description of what will be done to prospective human subjects, and the type of review performed by the HRRC.

C. The commissioner may inspect the records of the department's HRRC.

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 head(s) 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 may shall not approve the research if it the research has not been approved by the HRRC.

22VAC30-40-60. Composition of the HRRC.

A. The HRRC shall have at least five members, appointed by the commissioner, with varying backgrounds to promote complete and adequate review of research projects commonly conducted by covered entities. The HRRC shall be sufficiently qualified through the experience and expertise of its members, and the diversity of the members, including consideration of race, gender, and cultural background, and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects. In addition to possessing the professional competence necessary to review specific research projects, the HRRC shall be able to ascertain the acceptability of proposed research in terms of the department's commitments and regulations, applicable law, standards of professional conduct and practice, and community attitudes. If the HRRC regularly reviews research that involves a vulnerable category of subjects, such as children, pregnant women, or persons with mental disabilities prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons, consideration shall be given to the inclusion of one or more individuals who are knowledgeable about and experienced in working with these subjects. Additional membership requirements may be imposed on the HRRC by 34 CFR 350.4(c) and 356.3(c) for research sponsored by the National Institute on Disability and Rehabilitation Research. When minors with disabilities or persons with mental disabilities intellectual or developmental disabilities are purposefully included as research subjects, the HRRC's membership must shall include at least one person who is primarily concerned with the welfare of these research subjects.

B. Every nondiscriminatory effort will shall be made to ensure that the HRRC does not consist entirely of men or entirely of women, including the department's consideration of qualified persons of both sexes, so long as no selection is made to the HRRC on the basis of gender. The HRRC may shall not consist entirely of members of one profession.

C. The HRRC shall include:

1. At least one member whose primary concerns are in nonscientific areas;

2. At least one member who is not otherwise affiliated with any a covered entity and who is not part of the immediate family of a person who is affiliated with the a covered entity; and

3. At least one member whose primary concerns are in the scientific areas.

D. The HRRC shall not have a member participate in the HRRC's initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the HRRC. The HRRC has responsibility for determining whether a member has a conflicting interest. The HRRC member shall be replaced in the case of conflicting interest resulting in a decrease of the HRRC below to fewer than five members.

E. The HRRC may, at its discretion, may invite individuals with competence in special areas to assist in the review of complex issues which that require expertise beyond or in addition to that available on the HRRC. These individuals may not vote.

F. A quorum of the HRRC shall consist of a majority of its members, including at least one member whose primary concerns are in nonscientific areas. Except when exempt or expedited review procedures are used, proposed research shall be reviewed at convened meetings at which a majority of members is present, including at least one member whose primary concerns are in nonscientific areas. In order for the research to be approved, it shall receive the approval of a majority of those members present at the meeting.

G. The HRRC and the department shall establish procedures and rules of operation necessary to fulfill the requirements of these regulations this chapter.

22VAC30-40-70. Elements of the HRRC's review process.

A. The HRRC shall review and have authority to approve, require modifications in, or disapprove all research activities covered by this chapter.

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 J L.

D. The HRRC shall consider research proposals within 45 days after submission of a complete application to the HRRC's chairperson. In order for the research to be approved, it shall receive the approval of a majority of those members present at a meeting in which a quorum exists. 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(s) 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 it the complaint to the HRRC to determine if there has been a violation of the research protocol as approved by the HRRC.

G. The committee HRRC shall require periodic reports. The, the frequency of such reports which should reflect the nature and degree of risk of each research project.

H. If the HRRC decides to disapprove a research application, it 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.

J. In order to approve research covered by this chapter, the HRRC shall determine that all of the following requirements are satisfied:

1. Risks to subjects are minimized:

a. By using procedures that are consistent with sound research design and that do not unnecessarily expose subjects to risk; and

b. Whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.

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 as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research) research. The HRRC should not consider possible long-range effects of applying knowledge gained in the research (for example (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 and. The HRRC should be particularly cognizant of the special problems of research involving vulnerable populations, such as children, pregnant women, persons with mental disabilities, or economically or educationally disadvantaged persons prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons.

4. Informed consent will be 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 will be is appropriately documented in accordance with and to the extent required by 22VAC30-40-100.

6. When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.

7. When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.

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.

8. L. When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, pregnant women, persons with mental disabilities prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons, there are additional safeguards have been included in the project place to protect the rights and welfare of these the human subjects.

22VAC30-40-80. Kinds of research exempt from committee review.

Research activities in which the only involvement of human participants will shall be in limited to one or more of the following categories are shall be exempt from these regulations 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 category categories in this section before the research can 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; and

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. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under subdivision 2 of 22VAC30-40-80 if:

a. The human subjects are elected or appointed public officials or candidates for public office; or

b. Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.

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:

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

b. The information is recorded by the investigator in such 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 that are conducted by or subject to the approval of the commissioner, and that 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.

22VAC30-40-90. Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research.

A. The HRRC may use the expedited review procedure for categories of research that are listed in 63 FR 60364-60367 where either or both one or more of the following apply:

1. Some or all of the research appearing on the list and found by the reviewer(s) reviewer to involve no more than minimal risk.

2. Minor changes in previously approved research during the period (of of one year or less) less for which approval is authorized; or

3. Research for which limited review is a condition of exemption under 22VAC30-40-80 B 3, 22VAC30-40-80 C 1 c, and 22VAC30-40-80 G and H.

Under an expedited review procedure, the review may be carried out by the HRRC chairperson or by one or more experienced reviewers designated by the chairperson from among members of the HRRC. In reviewing the research, reviewers may exercise all of the authorities of the HRRC except that reviewers may not disapprove the research. A research proposal may be disapproved only after review by a convened meeting of the HRRC in which a quorum is present and in accordance with procedure set forth in 22VAC30-40-70.

B. When an expedited review procedure is used, the HRRC shall adopt a method for keeping all members advised of research proposals which have been approved under the expedited review procedure.

C. The commissioner may restrict, suspend, terminate, or choose not to authorize the HRRC's use of the expedited review procedure.

22VAC30-40-100. Informed consent.

A. Except as provided elsewhere in this chapter, no investigator may involve a human being as a subject in research covered by this chapter unless the investigator has obtained the legally effective informed consent of the prospective human subject or the prospective human subject's legally authorized representative in accordance with this chapter. The investigator shall seek such consent only under circumstances that provide the prospective human participant subject or the prospective human participant's subject's legally authorized representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence. The information that is given to the prospective human participant subject or the prospective human participant's subject's legally authorized representative shall be in language understandable to the prospective human participant subject or the prospective human participant's subject's legally authorized representative. The prospective human subject or the prospective human subject's legally authorized representative shall be provided with the information that a reasonable person would want to have in order to make an informed decision about whether to participate, and an opportunity to discuss that information. No informed consent, whether oral or written, may include any exculpatory language through which the human subject or the human subject's legally authorized representative is made to waive or appear to waive any of the human subject's legal rights, or releases or appears to release the investigator, the sponsor, the covered entity, or its agents from liability for negligence.

B. In seeking informed consent, the following basic elements shall be provided to each prospective human subject or prospective human subject's legally authorized representative:

1. A statement that the project involves research, an explanation of the purposes of the research and the expected duration of the human subject's participation, a description of the procedures to be followed, and identification of any procedures that are experimental;

2. A description of any reasonably foreseeable risks or discomforts to the human subject;

3. A description of any benefits to the human subject or to others that may reasonably be expected from the research;

4. A disclosure of appropriate alternative procedures or courses of treatment, if any, that might may be advantageous to the human subject;

5. A statement describing the extent, if any, to which confidentiality of records identifying the human subject will be maintained;

6. For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained;

7. An explanation of who to contact for answers to pertinent questions about the research and research the human subject's rights, and who to contact in the event of a research-related injury to the subject; and

8. A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the human subject is otherwise entitled, and the human subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled; and

9. One of the following statements about research that involves the collection of identifiable private information:

a. A statement that identifiers may be removed from the identifiable private information and that, after such removal, the information could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from the human subject or the human subject's legally authorized representative, if this may be a possibility; or

b. A statement that the human subject's information collected as part of the research, even if identifiers are removed, shall not be used or distributed for future research studies.

C. When the HRRC determines that it is appropriate, one or more of the following additional elements of informed consent shall also shall be provided to each subject:

1. A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) that are currently unforeseeable;

2. Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent;

3. Any additional costs to the subject that may result from participation in the research;

4. The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject;

5. A statement that significant new findings developed during the course of the research that may relate to the subject's willingness to continue participation will be provided to the subject; and

6. The approximate number of subjects involved in the project; and

7. A statement regarding whether clinically relevant research results, including individual research results, shall be disclosed to subjects, and if so, under what conditions.

D. Broad consent for the storage, maintenance, and secondary research use of identifiable private information (collected for either research studies other than the proposed research or nonresearch purposes) is permitted as an alternative to the informed consent requirements in subsections B and C of this section. If the subject or the subject's legally authorized representative is asked to provide broad consent, the following shall be provided to each subject or the subject's legally authorized representative:

1. The information required in subdivisions B 2, B 3, B 5, and B 8 of this section;

2. A general description of the types of research that may be conducted with the identifiable private information. This description shall include sufficient information such that a reasonable person would expect that the broad consent would permit the types of research conducted;

3. A description of the identifiable private information that may be used in research, whether sharing of identifiable private information may occur, and the types of institutions or researchers that may conduct research with the identifiable private information;

4. A description of the period of time that the identifiable private information may be stored and maintained, which period of time could be indefinite, and a description of the period of time that the identifiable private information may be used for research purposes, which period of time could be indefinite;

5. Unless the subject or legally authorized representative will be provided details about specific research studies, a statement that they will not be informed of the details of any specific research studies that may be conducted using the subject's identifiable private information, including the purposes of the research, and that they may have chosen not to consent to some of those specific research studies;

6. Unless it is known that clinically relevant research results, including individual research results, will be disclosed to the subject in all circumstances, a statement that such results may not be disclosed to the subject; and

7. An explanation of whom to contact for answers to questions about the subject's rights and about storage and use of the subject's identifiable private information, and whom to contact in the event of a research-related harm.

D. E. The HRRC may approve a consent procedure that does not include or which that alters some or all of the elements of informed consent set forth in subsection B of this section, or waive waives the requirement to obtain informed consent provided the HRRC finds and documents that:

1. The research or demonstration project is to be conducted by or subject to the approval of state or local government officials and is 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; and

2. The research could not practicably be carried out without the waiver or alteration.

E. F. The HRRC may approve a consent procedure that does not include or that alters some or all of the elements of informed consent set forth in subsection B of this section, or waive the requirements to obtain informed consent provided the HRRC finds and documents that:

1. The research involves no more than minimal risk to the subject;

2. The waiver or alteration will not adversely affect the rights and welfare of the subjects;

3. The research could not practicably be carried out without the waiver or alteration; and

4. If the research involves using identifiable private information, the research could not practicably be carried out without using such information in an identifiable format; and

5. Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

F. G. The HRRC may approve a research proposal in which an investigator will obtain information for the purpose of screening, recruiting, or determining the eligibility of prospective subjects without the informed consent of the prospective subject or the subject's legally authorized representative if either of the following conditions are met:

1. The investigator will obtain information through oral or written communication with the prospective subject or the prospective subject's legally authorized representative; or

2. The investigator will obtain identifiable private information by accessing records.

H. The informed consent requirements in this chapter are shall not intended to preempt any applicable federal, state, or local laws that require additional information to be disclosed in order for informed consent to be legally effective.

G. I. Nothing in this chapter is intended to shall limit the authority of a physician to provide emergency medical care, to the extent the physician is permitted to do so under applicable federal or state law, or local ordinance.

H. J. Notwithstanding consent by a legally authorized representative, no person shall be forced to participate in any human subject research. Each human subject shall be given a copy of the signed consent form required by this section, except Except as provided for in subsection J L of this section, human subjects shall be given a copy of the signed consent form required by this section.

I. K. No legally authorized representative may consent to nontherapeutic research unless the HRRC determines that such nontherapeutic research will present no more than a minor increase over minimal risk to the prospective subject. No nontherapeutic research shall be performed without the consent of the human subject.

J. L. Documentation of informed consent.

1. Except as provided in subdivision 3 of this subsection, informed consent shall be documented by the use of a written consent form approved by the HRRC and signed by the subject or the subject's legally authorized representative. A copy shall be given to the person signing the form.

2. Except as provided in subdivision 3 of this subsection, the consent form may be either of the following:

a. A written consent document that embodies the elements of informed consent required in subsection B of this section. This form may be read to the subject or the subject's legally authorized representative, but in any event, the investigator shall give either the subject or the subject's legally authorized representative adequate opportunity to read it before it is signed; or

b. A short form written consent document stating that the elements of informed consent required in subsection B of this section have been presented orally to the subject or the subject's legally authorized representative. When this method is used, there shall be a witness to the oral presentation. Also, the HRRC shall approve a written summary of what is to be said to the subject or the representative. Only the short form itself is to be signed by the subject or the representative. However, the witness shall sign both the short form and a copy of the summary, and the person actually obtaining consent shall sign a copy of the summary. A copy of the summary shall be given to the subject or the legally authorized representative, in addition to a copy of the short form.

3. The HRRC may waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds either:

a. That the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern; or

b. That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context; or

c. If the subjects or subjects' legally authorized representatives are members of a distinct cultural group or community in which signing forms is not the norm, that the research presents no more than minimal risk of harm to subjects and provided there is an appropriate alternative mechanism for documenting that informed consent was obtained.

4. In cases in which the documentation requirement is waived, the HRRC may require the investigator to provide subjects with a written statement regarding the research.

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;

3. Records of continuing review activities;

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.

22VAC30-40-130. Role of the commissioner.

A. The commissioner shall maintain records of federal assurances, annual reports, and summary descriptions of research projects.

B. The commissioner shall review communications from the HRRC reporting violations of research protocols which 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 these regulations 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).

22VAC30-40-160. Additional protection for minors involved as subjects in research.

A. Research not involving greater than minimal risk. The covered entity may conduct or fund research in which the HRRC finds that no greater than minimal risk to minors is presented, only if the HRRC finds that adequate provisions are made for soliciting the assent of the minors and the permission of their parents or guardians, pursuant to subsection E of this section.

B. Research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects. The covered entity may conduct or fund research in which the HRRC finds that more than minimal risk to minors is presented by an intervention or procedure that holds out the prospect of direct benefit for the individual subject, or by a monitoring procedure that is likely to contribute to the subject's well-being, only if the HRRC finds that:

1. The risk is justified by the anticipated benefit to the subjects;

2. The relation of the anticipated benefit to the risk is at least as favorable to the subjects as that presented by available alternative approaches; and

3. Adequate provisions are made for soliciting the assent of the minors and permission of their parents or guardians, pursuant to subsection E of this section.

C. Research involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subject's disorder or condition. The covered entity may conduct or fund research in which the HRRC finds that more than minimal risk to minors is presented by an intervention or procedure that does not hold out the prospect of direct benefit for the individual subject, or by a monitoring procedure that is not likely to contribute to the well-being of the subject, only if the HRRC finds that:

1. The risk represents a minor increase over minimal risk;

2. The intervention or procedure presents experiences to subjects that are reasonably commensurate with those inherent in their actual or expected medical, dental, psychological, social, or educational situations;

3. The intervention or procedure is likely to yield generalizable knowledge about the subjects' subject's disorder or condition that is of vital importance for the understanding or amelioration of the subjects' subject's disorder or condition; and

4. Adequate provisions are made for soliciting assent of the minors and permission of their parents or guardians, pursuant to subsection E of this section.

D. Research not otherwise approvable that presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of minors. The covered entity may conduct or fund research that the HRRC does not believe meets the requirements pursuant to subsection A, B, or C of this section only if:

1. The HRRC finds that the research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of minors; and

2. The Secretary of the United States Department of Education, after consultation with a panel of experts in pertinent disciplines (for example: (e.g., science, medicine, education, ethics, or law) and following opportunity for public review and comment, has determined either that:

a. The research in fact satisfies the conditions pursuant to subsection A, B, or C of this section, as applicable; or

b. (i) The research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of minors; (ii) the research will be conducted in accordance with sound ethical principles; and (iii) adequate provisions are made for soliciting the assent of minors and the permission of their parents or guardians, pursuant to subsection E of this section.

E. Requirements for permission by parents or guardians and for assent by minors.

1. In addition to the determinations required under other applicable subsections of this section, the HRRC shall determine that adequate provisions are made for soliciting the assent of the minors, if in the judgment of the HRRC the minors are capable of providing assent. In determining whether minors are capable of assenting, the HRRC shall take into account the ages, maturity, and psychological state of the minors involved. This judgment may be made for all minors to be involved in research under a particular protocol, or for each minor, as the HRRC deems appropriate. If the HRRC determines that the capability of some or all of the minors is so limited that they cannot reasonably be consulted or that the intervention or procedure involved in the research holds out a prospect of direct benefit that is important to the health or well-being of the minors and is available only in the context of the research, the assent of the minors is not a necessary condition for proceeding with the research. Even if the HRRC determines that the subjects are capable of assenting, the HRRC may still may waive the assent requirement under circumstances in which consent may be waived in accord with 22VAC30-40-100.

2. In addition to the determinations required under other applicable subsections of this section, the HRRC shall determine, in accordance with and to the extent that consent is required by 22VAC30-40-100, that adequate provisions are made for soliciting the permission of each minor's parent(s) parent or parents or guardian(s) guardian. If parental permission is to be obtained, the HRRC may find that the permission of one parent is sufficient for research to be conducted pursuant to subsection A or B of this section. If research is covered pursuant to subsections C and D of this section and permission is to be obtained from parents, both parents must shall give their permission unless one parent is deceased, unknown, incompetent, or not reasonably available, or if only one parent has legal responsibility for the care and custody of the minor. Only the legal custodial parent can is able to give informed consent.

3. In addition to the provisions for waiver contained in 22VAC30-40-100, if the HRRC determines that a research protocol is designed for conditions or for a subject population for which parental or guardian permission is not a reasonable requirement to protect the subjects (for example, neglected or abused minors), it may waive the consent requirements in 22VAC30-40-100 and subdivision 2 of this subsection, provided an appropriate mechanism for protecting the minors who will participate as subjects in the research is substituted, and provided further that the waiver is not inconsistent with federal, state, or local law. The choice of an appropriate mechanism depends upon the nature and purpose of the activities described in the protocol, the risk and anticipated benefit to the research subjects, and their age, maturity, status, and condition.

4. Permission by parents or guardians must shall be documented in accordance with and to the extent required by 22VAC30-40-100 J L.

5. If the HRRC determines that assent is required, it shall also determine whether and how assent must shall be documented.

F. Wards.

1. Minors who are wards of the state or any other agency, institution, or entity may be included in research approved under subsection C or D of this section only if that research is:

a. Related to their status as wards; or

b. Conducted in schools, camps, hospitals, institutions, or similar settings in which the majority of minors involved as subjects are not wards.

2. If research is approved under subdivision 1 of this subsection, the HRRC shall require appointment of an advocate for each minor who is a ward, in addition to any other individual acting on behalf of the minor as guardian or in loco parentis. One individual may serve as advocate for more than one minor. The advocate must shall be an individual who has the background and experience to act in, and agrees to act in, the best interest of the minor for the duration of the minor's participation in the research and who is not associated in any way (except, except in the role as advocate or member of the HRRC) HRRC, with the research, the investigator or investigators, or the guardian organization.