TITLE 22. SOCIAL SERVICES

STATE BOARD OF SOCIAL SERVICES

Fast-Track Regulation

Title of Regulation: 22VAC40-890. Human Subject Research Regulations (amending 22VAC40-890-10 through 22VAC40-890-90).

Statutory Authority: §§ 63.2-217 and 63.2-218 Code of Virginia.

Public Hearing Information: No public hearing is currently scheduled.

Public Comment Deadline: January 29, 2025.

Effective Date: February 13, 2025.

Agency Contact: Gail Jennings, Policy and Planning Specialist, Department of Social Services, 801 East Main Street, Richmond, VA 23219, telephone (804) 726-7490, FAX (804) 726-7946, or email gail.jennings@dss.virginia.gov.

Basis: The State Board of Social Services is authorized by § 63.2-217 of the Code of Virginia to adopt regulations necessary to carry out Title 63.2 of the Code of Virginia. The board is authorized by § 63.2-218 of the Code of Virginia to adopt regulations related to human research in order to effectuate the provisions of Chapter 5.1 (§ 32.1-162.16 et seq.) of Title 32.1 of the Code of Virginia. 45 CFR 46, which sets the federal standard for regulations related to human research, governs requirements for Institutional Review Boards (IRBs).

Purpose: The amendments are needed to (i) provide congruence of language between § 63.2-218 Code of Virginia and the regulation; (ii) ensure that the provisions contained in the Code of Virginia for the health, safety, and welfare of citizens are aligned with those provisions in the regulation; and (iii) prevent any confusion in the execution of the regulations as they relate to statute.

Rationale for Using Fast-Track Rulemaking Process: This action aligns the regulation with federal regulation and state statute, updates citations, and makes technical changes for clarity. Those subject to the regulation will not be substantively impacted by the changes. The amendments are not expected to be controversial and are therefore appropriate for the fast-track rulemaking process.

Substance: The amendments include:

1. Clarifying definitions of local departments of social services, facilities, and contractors for congruence with language of the Code of Virginia. Definitions of "human research," "informed consent," and "legally authorized representative" are expanded to align with definitions of these key terms contained in § 32.1-162.19 of the Code of Virginia.

2. Revising 22VAC40-890-30 regarding categories of research that are exempt from review, as the section is outdated. In addition to categories listed in this section, 45 CFR 46.104(d) adds to the list of categories of research that may be exempt from IRB review.

3. Revising 22VAC40-890-50 regarding informed consent to align with § 32.1-162.18 A of the Code of Virginia, which includes the requirement of a witness for signatures of informed consent by the research participant, or the participant's legally authorized representative. Exceptions to this chapter apply to provisions in both 22VAC40-890-50 B and C.

4. Revising 22VAC40-890-60 regarding the Human Research Review Committee (also known as IRB) to clarify the minimum number of members as stated in departmental guidance. The number is changed from seven to "at least five members" to be congruent with 45 CFR 46.107.

5. Revising 22VAC40-890-70 regarding the review and approval process that refers to annual review of ongoing research. Low-risk research that was eligible for expedited review pursuant to 22VAC40-890-80 no longer requires a continuing review.

6. Revising 22VAC40-890-80 regarding categories of research that are eligible for expedited review, as the provision is outdated. The proposed revision reflects the appropriate, current reference to 45 CFR 46.110. 45 CFR 46.110 currently expands the list of categories of research that may be eligible for expedited review. The list of exempt research categories is approved by the U.S. Secretary of Health and Human Resources and is subject to review and revision every eight years.

7. Revising 22VAC40-890-90 regarding annual reporting on IRB activities, which will now require additional information about IRB approvals of research conducted by local agencies, affiliated facilities, and contractors on behalf of the department, including the manner in which research findings will be disseminated.

Issues: The primary advantages to the public and the Commonwealth include greater clarity in the regulation to adhere to the language used in the Code of Virginia and, for researchers, congruence with updated federal regulations in regard to human subject research, which will prevent any confusion when executing the regulation or developing guidance. The primary advantage to the agency is that the changes will reduce the administrative burden for the department's IRB. There are no foreseen disadvantages to the public, the Commonwealth, or the agency.

Department of Planning and Budget Economic Impact Analysis:

The Department of Planning and Budget (DPB) has analyzed the economic impact of this proposed regulation in accordance with § 2.2-4007.04 of the Code of Virginia and Executive Order 19. The analysis presented represents DPB's best estimate of the potential economic impacts as of the date of this analysis.¹

Summary of the Proposed Amendments to Regulation. As the result of a periodic review,² the Board of Social Services (board) seeks to conform this regulation to the Code of Virginia and the Code of Federal Regulations (CFR), and to make clarifying changes.

Background. This regulation requires that the Department of Social Services (DSS) Institutional Review Board (IRB) reviews and approves any research sponsored by DSS, local departments of social services, DSS-licensed facilities, and DSS-authorized contractors.³ According to the Code of Virginia, human research is "any systematic investigation, including research development, testing and evaluation, utilizing human subjects, that is designed to develop or contribute to generalized knowledge."⁴ The objective of this regulation is to "ensure the protection of the rights, welfare, and wellbeing of clients, staff or others who volunteer to participate in research."⁵ Federal regulations for the Protection of Human Subjects (45 CFR Part 46; also known as the Common Rule) were significantly revised in 2018.⁶ The revised Common Rule expanded the types of research that qualify for either an exemption from IRB review or an expedited review, wherein only the IRB chair or one appointed member reviews the application, on the basis that the research poses minimal risk to human subjects. The revised Common Rule also eliminated the need for a continuing review for ongoing research initially approved under an expedited review process. Continuing review requirements were also waived for research that had progressed to the data analysis stage, where no further contact with human subjects would be necessary, or where any additional clinical follow-up data could be collected as part of patient routine follow-up care. Other changes affect IRB reporting requirements and the required minimum number of IRB members."⁷ Besides clarifying changes, updating citations to the Code of Virginia and the CFR, and reorganizing some provisions, the most substantive proposed changes are summarized as follows:

22VAC40-890-10: Definitions that would be updated to be consistent with the Code of Virginia include "facility," "human research," "informed consent," and "legally authorized representative."

22VAC40-890-30: This section would be aligned with federal regulation in 45 CFR 46.104(d) that was updated in 2018 to broaden the categories of research that would be eligible for exemption from IRB review "because they pose no more than minimal risk to subjects" and reduce the burden on the IRB as well as researchers.

22VAC40-890-50: An amendment would newly require that the voluntary informed consent must be witnessed. This change would align the regulation with 45 CFR 46.117. The agency reports that in practice, the IRB and researchers have already been complying with this federal regulation for some time.

22VAC40-890-60: The committee composition would be changed to "consist of at least five members" in order to align with 45 CFR 46.107. Currently, the regulation states the IRB must have at least seven members.⁸

22VAC40-890-70: A new provision would add to the regulation the circumstances in which continuing review of research is not required. This includes (i) research eligible for expedited review in accordance with 22VAC40-890-80 and (ii) research that has progressed to the point that it involves only one or both of the following, which are part of the IRB-approved study: (a) data analysis, including analysis of identifiable private information or identifiable biospecimens, or (b) accessing follow-up clinical data from procedures that subjects would undergo as part of clinical care.

22VAC40-890-80: New subsections that align with 45 CFR 46.110 have been added, resulting in the addition of new subsections B, C, D and F. Subsections B and C refer to a list of Department of Health and Human Services-approved categories of research that qualify for expedited review.⁹ Subsection D states who may conduct the expedited review and what their authority is to disapprove research. Research may only be disapproved under a non-expedited (full board) review. (The IRB has already implemented this provision in practice.) Subsection F states that research where identification of subjects and/or their responses would potentially place them at risk or be damaging to their financial standing, employability, reputation, etc. would only qualify for expedited review if reasonable and appropriate measures are taken to minimize risk of invasion of privacy and breach of confidentiality of data.

22VAC40-890-90: More detail would be added about the content required to be in a report submitted by a local department, facility, or contractor participating in a human subject research project reviewed by another research review committee to the department research review committee by December 1 of each year.

Estimated Benefits and Costs: The proposed changes would primarily benefit the DSS IRB and researchers who conduct human subject research or program evaluations involving DSS clients or client data. In particular, research activities that fall under the now-broadened criteria for exemption and for expedited review could be started sooner. Secondly, research subject to expedited review, along with research that has progressed to the data analysis or follow-up data collection stages, would not be subject to annual (or more frequent) continuing review requirements. These changes would also reduce the administrative burden for the DSS IRB chair and IRB coordinator. The change reducing the number of required IRB members from seven to five could lower IRB administrative costs but may not have any practical effect since the IRB already has nine members when only seven are required.¹⁰

Businesses and Other Entities Affected. The proposed changes would primarily affect researchers at public and private universities and research institutions in the Commonwealth that conduct human subject research or program evaluations involving DSS clients or client data. DSS reports that there are roughly 10 research organizations per year that conduct human subject research, authorized by DSS, local departments, or their contractors. The Code of Virginia requires DPB to assess whether an adverse impact may result from the proposed regulation.¹¹ An adverse impact is indicated if there is any increase in net cost or reduction in net revenue for any entity, even if the benefits exceed the costs for all entities combined. As noted above, the new requirements would reduce the requirements for some categories of low-risk research activities, and thus reduce the administrative burden for DSS IRB and researchers. Thus, an adverse impact is not indicated.

Small Businesses¹² Affected.¹³ Some private universities or research institutions affected by the proposed changes may be small businesses. However, DSS does not collect information on whether the research entities that apply for IRB approval are small businesses.¹⁴ Nonetheless, the proposed amendments would not create new costs for any entities, including any small businesses, and could reduce their costs depending on the type of research they conduct.

Localities¹⁵ Affected.¹⁶ The proposed amendments would not impact localities or local governments.

Projected Impact on Employment. The proposed amendments would not affect total employment.

Effects on the Use and Value of Private Property. The proposed amendment would not affect the value of any private property or real estate development costs.

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¹ Section 2.2-4007.04 of the Code of Virginia requires that such economic impact analyses determine the public benefits and costs of the proposed amendments. Further the analysis should include but not be limited to: (1) the projected number of businesses or other entities to whom the proposed regulatory action would apply, (2) the identity of any localities and types of businesses or other entities particularly affected, (3) the projected number of persons and employment positions to be affected, (4) the projected costs to affected businesses or entities to implement or comply with the regulation, and (5) the impact on the use and value of private property.

² See https://townhall.virginia.gov/l/ViewPReview.cfm?PRid=1788.

³ See https://www.dss.virginia.gov/about/irb.cgi.

⁴ See https://law.lis.virginia.gov/vacode/32.1-162.16/.

⁵ See https://www.dss.virginia.gov/about/irb.cgi.

⁶ See https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-46.

⁷ See page 1 of the Agency Background Document (ABD) here: https://townhall.virginia.gov/l/GetFile.cfm?File=73\6126\9845\AgencyStatement_DSS_9845_v2.pdf.

⁸ See https://www.dss.virginia.gov/files/about/irb/about/SFY_2022-2024_VDSS_IRB_Members_Roster.pdf. The current IRB has nine members.

⁹ See https://www.hhs.gov/ohrp/regulations-and-policy/guidance/categories-of-research-expedited-review-procedure-1998/index.html.

¹⁰ DSS may want to maintain more members than are strictly necessary in order to ensure that the IRB adequately represents the needs and interests of DSS clients.

¹¹ Pursuant to § 2.2-4007.04 D: In the event this economic impact analysis reveals that the proposed regulation would have an adverse economic impact on businesses or would impose a significant adverse economic impact on a locality, business, or entity particularly affected, the Department of Planning and Budget shall advise the Joint Commission on Administrative Rules, the House Committee on Appropriations, and the Senate Committee on Finance. Statute does not define "adverse impact," state whether only Virginia entities should be considered, nor indicate whether an adverse impact results from regulatory requirements mandated by legislation.

¹² Pursuant to § 2.2-4007.04, small business is defined as "a business entity, including its affiliates, that (i) is independently owned and operated and (ii) employs fewer than 500 full-time employees or has gross annual sales of less than $6 million."

¹³ If the proposed regulatory action may have an adverse effect on small businesses, § 2.2-4007.04 requires that such economic impact analyses include: (1) an identification and estimate of the number of small businesses subject to the proposed regulation, (2) the projected reporting, recordkeeping, and other administrative costs required for small businesses to comply with the proposed regulation, including the type of professional skills necessary for preparing required reports and other documents, (3) a statement of the probable effect of the proposed regulation on affected small businesses, and (4) a description of any less intrusive or less costly alternative methods of achieving the purpose of the proposed regulation. Additionally, pursuant to § 2.2-4007.1 of the Code of Virginia, if there is a finding that a proposed regulation may have an adverse impact on small business, the Joint Commission on Administrative Rules shall be notified.

¹⁴ See ABD, page 6.

¹⁵ "Locality" can refer to either local governments or the locations in the Commonwealth where the activities relevant to the regulatory change are most likely to occur.

¹⁶ Section 2.2-4007.04 defines "particularly affected" as bearing disproportionate material impact.

Agency Response to Economic Impact Analysis: The Department of Social Services has reviewed the economic impact analysis prepared by the Department of Planning and Budget and concurs.

Summary:

Pursuant to a periodic review, the amendments (i) align the regulation to the 2018 Common Rule (45 CFR 46 Subpart A); (ii) expand the list of types of research posing minimal risk to human subjects that qualify for either an exemption from Institutional Review Board (IRB) review or an expedited review in which only the chair or one other IRB member conducts the review; (iii) eliminate the need for a continuing review for ongoing research initially approved under an expedited review process; (iv) revise IRB reporting requirements; and (v) revise the required number of IRB members.

22VAC40-890-10. 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 department" means any individual employed, either on a paid or volunteer basis, by the Virginia Department of Social Services, by a local department of social services, or by an agency a facility licensed by the Virginia Department of Social Services.

"Authorized" means to permit the implementation or conducting of research.

"Board" means the Virginia State Board of Social Services.

"Commissioner" means the Commissioner of the Virginia Department of Social Services or his the commissioner's designee.

"Committee" means the human research review committee, also known as the Institutional Review Board (IRB), which reviews and approves human research activities related to this chapter.

"Contractor" means agencies, organizations, or individuals providing goods or services, receiving funds, or under contract with the department or a local agency department, including, but not limited to, foster homes and day-care homes.

"Department" means the Virginia Department of Social Services.

"Discomforts, risks, and benefits" means the expected advantages and disadvantages to the participant for participating in the research.

"Facility" means any agency person, as defined in § 63.2-1701 A of the Code of Virginia, licensed by the department including, but not limited to, adult and child day and residential facilities.

"Human participant" or "participant" means any individual, customer, volunteer, or employee who is the subject of research conducted or authorized by the department, facility, local agency department, or contractor.

"Human research" or "research" means any formal and structured evaluation involving individuals in a special project, program, or study systematic investigation, including research development, testing, and evaluation, utilizing human subjects that is designed to develop or contribute to generalized knowledge. Human research does not include research exempt from federal research regulations in accordance with 45 CFR § 46.104(d), as determined by the U.S. Secretary of Health and Human Services (HHS) and published as a notice in the Federal Register.

"Informed consent" means the knowing and voluntary agreement of the participant exercising free choice, without undue inducement or any element of force, fraud, deceit, duress, or other form of constraint or coercion, of a person who is capable of exercising free power of choice. For the purposes of human research, the basic elements of information necessary to such consent include:

1. A reasonable and comprehensible explanation to the person of the proposed procedures or protocols to be followed, the purpose of those procedures or protocols, including descriptions of any attendant discomforts, and the risks and benefits reasonably to be expected;

2. A disclosure of any appropriate alternative procedures or therapies that might be advantageous for the person;

3. An instruction that the person may withdraw consent and discontinue participation in the human research at any time without prejudice to the person;

4. An explanation of any costs or compensation that may accrue to the person and, if applicable, the availability of third-party reimbursement for the proposed procedures or protocols; and

5. An offer to answer and answers to any inquiries by the person concerning the procedures and protocols.

"Legally authorized representative" means a person with authority to consent on behalf of a prospective participant to include, in the following specified order of priority, (i) the parent or parents having custody, of a prospective subject who is a minor; (ii) 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; (iii) the legal guardian, or (iii) of a prospective subject; (iv) the spouse of a prospective subject, except where a suit for divorce has been filed and the divorce decree is not yet final; (v) the adult child of a prospective subject; (vi) the parent of a prospective subject when the subject is an adult; (vii) the adult brother or sister of a prospective subject; or (viii) any person or judicial or other person or body authorized by law or regulation, including to consent on behalf of a prospective subject to such subject's participation in the particular human research. For the purposes of this chapter, any person authorized by law or regulation to consent on behalf of a prospective subject to such subject's participation in the particular human research includes an attorney in fact appointed under a durable power of attorney, to the extent the power grants the authority to make a decision related to human research. The attorney in fact shall not be employed by the person or department entity conducting the human research. No official or employee of the department, facility or local agency entity conducting or authorizing the research shall be qualified to act as a legally authorized representative.

"Local department" means the local department of social services of any county or city in this the Commonwealth.

"Minimal risk" means that the risks of harm to the prospective participant anticipated in the proposed research are not greater, considering probability and magnitude, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

22VAC40-890-20. Applicability.

This chapter shall apply to the Virginia Department of Social Services, to local departments of social services or departments of welfare, to facilities licensed by the department, and to contractors that authorize, conduct, or propose to conduct or authorize any human research.

22VAC40-890-30. Research exempt from chapter.

Research activities in which the only involvement of human participants will be in one or more of the following categories are exempt from this chapter unless the research is covered by other sections of this chapter:

1. Human research which that is subject to policies and regulations for the protection of human subjects promulgated by any agency of the federal government, except for the provisions in 22VAC40-890-40 C and 22VAC40-890-90 B.

2. Research conducted in established or commonly accepted educational settings involving commonly used educational practices, provided that participants cannot be identified, directly or through identifiers, for:

a. Regular and special education instructional strategies;

b. The effectiveness of or the comparison among instructional techniques, curriculum or classroom management methods; or

c. Educational tests.

3. 2. Research involving solely the observation of public behavior or survey or interview procedures, except when observations or responses are recorded in such a manner that participants can be identified directly or through identifiers linked to the participants, and when either (i) the participant's responses, if they the responses became known outside the research, could reasonably place the participant at risk of criminal or civil liability or be damaging to the participant's financial standing or employability; or (ii) the research deals with sensitive aspects of the participant's own behavior, such as sexual behavior, drug or alcohol use, or illegal conduct.

4. Research involving survey or interview procedures, when the respondents are elected or appointed public officials or candidates for public office.

5. Research involving solely the collection or study of existing data, documents, or records, if these sources are publicly available or if the information taken from these sources is recorded in such a manner that participants cannot be identified directly or through identifiers linked to the participants.

6. Research and demonstration projects covered under 45 CFR 46.101(b)(5) which are conducted by or subject to the approval of the commissioner, and which are designed to study, evaluate, or otherwise examine (i) public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs.

3. Research that is exempt in accordance with 45 CFR § 46.104(d).

22VAC40-890-40. Policy.

A. Each human research activity, as well as significant changes to approved research proposals, shall be submitted to and approved by a committee composed of representatives of varied backgrounds prior to implementation of the research. The committee shall ensure the competent, complete, and professional review of human research activities conducted, authorized, or proposed to be conducted or authorized by the department, local agencies departments, facilities, or contractor contractors. The committee shall ensure the participants' participant's rights to privacy are maintained.

B. Every person engaged in the conduct of human research or proposing to conduct human research shall report to an agency having a research review committee, and the human research which he that the person conducts or proposes to conduct shall be subject to review and approval by such committee in the manner set forth in this chapter.

C. Every person or organization engaged in a human research project that requires an allowable variance or other approval related to department regulations must obtain approval for such from the department prior to requesting the committee's review and approval of the proposed research.

D. Prior to the initiation of any human research, each participant or legally authorized representative must be informed in writing of the following:

1. Procedure or procedures to be utilized, their the procedure's purposes, and any expected discomforts, risks, and benefits;

2. Instruction that the participant may withdraw his consent and discontinue participation in the human research at any time without loss of services or benefits to which the participant is otherwise entitled;

3. Explanation of any costs or benefits which that may accrue to the participant or the participant's family;

4. An offer to answer any inquiries by the participant concerning the procedures and use of the results;

5. Statement assuring confidentiality of records and describing the extent to which confidentiality of records identifying the participant will be maintained; and

6. Expected duration of participation.

E. Where the human research activity exposes to risk others not participating, all parties must give their signed voluntary informed consent.

F. The committee may suspend or terminate research that is in violation of the research protocol.

22VAC40-890-50. Informed consent.

A. No human research may be conducted without voluntary informed consent signed by the participant or by the participant's legally authorized representative and witnessed, except as provided for in subsection subsections B and C of this section. If the participant is a minor otherwise capable of rendering voluntary informed consent, the consent shall be signed by both the minor and his the minor's legally authorized representative. A researcher shall seek such consent only under circumstances that provide the prospective participant or the 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 participant or the representative shall be in language understandable to the participant or the representative.

B. The committee may approve a consent procedure which that omits or alters basic elements of informed consent or may waive the requirements to obtain informed consent, provided the committee finds and documents that:

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

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

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

4. Whenever appropriate, the participants will be provided with additional pertinent information after participation.

C. The committee may waive the requirement for the researcher to obtain a signed consent form for some or all participants if it finds that the only record linking the participant and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. The committee may require the investigator to provide participants with a written statement explaining the research. Each participant shall be asked whether he the participant wants documentation linking him the participant to the research and the subject's wishes shall govern.

22VAC40-890-60. Human research review committee.

A. The department shall establish a department committee, consisting of seven at least five members, appointed by the commissioner. The department committee is authorized to (i) to determine if a proposed project is human subject research; and (ii) to review and approve any human research proposed, authorized, or conducted by the department, or by any local agency department, by any facility, or by any contractor.

B. All human research conducted or authorized by the department, or any local agency department, facility, or contractor must be reviewed and approved by the department committee, except local agencies departments, facilities, or contractors collaborating with another organization on a research project may instead elect to utilize that organization's research review committee.

C. Members of the committee will be appointed to ensure the competent, complete, and professional review of human research. No member of the committee shall be directly involved in the proposed human research project or have administrative approval authority over the proposed research, except in connection with his the member's responsibilities as a member of the committee. At least two members of the committee must be individuals whose primary concerns are in nonscientific or ethical areas (e.g., the clergy, lawyers).

D. The committee shall include at least two members who are not affiliated with and are not immediate family members of persons who are affiliated with the department.

E. No member of the committee shall participate in the committee's initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the committee. The committee has responsibility for determining whether a member has a conflict of interest. If necessary, the committee size shall be maintained by the appointment of a substitute representative to review a project where a member has a conflicting interest.

F. A committee may, at its discretion, 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 committee. These individuals may not vote with the committee.

G. A quorum of the committee shall consist of a majority of its members.

H. The committee shall establish procedures and rules of operations necessary to fulfill the requirements of this chapter.

22VAC40-890-70. Review and approval process.

A. Prior to the initiation of a human research project, a description of the proposed human research project shall be submitted to the department committee for review and approval, except for projects which that are exempt or those reviewed by another organization's committee. The description shall include a statement of the purpose of the proposed project and justification of it the project, the criteria for inclusion of a participant in the research project, a description of what will be done to the participants, and the proposed informed consent statement.

B. No human research shall be conducted or authorized by the department unless the department committee has reviewed and approved the proposed human research project, giving consideration to:

1. The necessity and utility of the research;

2. The adequacy of the description of potential benefits and risks involved and the appropriateness of the research methodology;

3. Whether the research presents more than a minimal risk to the subject;

4. Whether the risks to the participants are outweighed by the potential benefits to them the participants;

5. Whether the rights and welfare of the participants involved are adequately protected;

6. Whether the voluntary informed consent is obtained by methods (, including the written consent form), that are adequate and appropriate considering the participants' participant's educational level and language of greatest fluency;

7. Whether the people proposing to supervise or conduct the research are competent and qualified; and

8. Whether the criteria for selection of participants is are equitable.

C. Except for the research referenced in 22VAC40-890-80, the committee shall consider research proposals within 30 days after submission to the committee. 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 committee shall notify investigators in writing of its the committee's decision to approve or disapprove the proposed research activity or of modifications required to secure committee approval.

D. During the committee review of research projects, no personal identifiers of present or potential participants shall be presented or discussed.

E. The committee shall require a written description of the procedure to be followed when a participant has a complaint about a research project in which he the complainant is participating or has participated. All complaints shall be referred to the committee to determine if there has been a violation of the established protocol.

F. The committee shall require reports from approved research projects at least annually to ensure conformity with the approved proposal. The frequency of such reports shall be consistent with the nature and degree of risk of each research project. The committee shall also require a report from the research project at the conclusion of the project. Continuing review of research is not required in the following circumstances:

1. Research eligible for expedited review in accordance with 22VAC40-890-80; or

2. Research that has progressed to the point that it involves only one or both of the following, which are part of the Institutional Review Board-approved study:

a. Data analysis, including analysis of identifiable private information or identifiable biospecimens; or

b. Accessing follow-up clinical data from procedures that subjects would undergo as part of clinical care.

22VAC40-890-80. Expedited review of human research participants.

A. The committee is authorized to conduct an expedited review of a human research project which that involves no more than minimal risk to the participants if: 1. The the research review committee affiliated with another state department, local agency department, licensed facility, or institution has reviewed and approved the project; or

2. The review involves only minor changes in previously approved research and the changes occur during the approved project period.

B. In accordance with 45 CFR 46.110, as determined by the U.S. Secretary of Health and Human Services (HHS) and published as a notice in the Federal Register, certain categories of research may be reviewed by the Institutional Review Board (IRB) through an expedited review procedure. The Secretary of HHS will evaluate the list at least every eight years and amend the list, as appropriate. A copy of the list is available from the Office for Human Research Protections, HHS, or any successor office.

C. The IRB may use the expedited review procedure to review the following:

1. Some or all of the research appearing on the list described in subsection B of this section, unless the reviewer determines that the study involves more than minimal risk; or

2. Minor changes in previously approved research during the period for which approval is authorized.

D. Under an expedited review procedure, the review may be carried out by the IRB chairperson or by one or more experienced reviewers designated by the chairperson from among members of the IRB. In reviewing the research, the reviewers may exercise all of the authorities of the IRB, except that the reviewers may not disapprove the research. A research activity may be disapproved only after review in accordance with the nonexpedited procedure set forth in 22VAC40-890-70.

E. The committee shall adopt a method for keeping all members advised of research proposals which that have been approved under the procedure.

F. The expedited review procedure may not be used where identification of a subject or a subject's responses would reasonably place the subject at risk of criminal or civil liability or be damaging to the subject's financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal.

22VAC40-890-90. Reporting.

A. The department's research review committee shall report by December 15 of each year to the commissioner on activities of the committee during the year. The report shall include:

1. A description of each human research project reviewed and whether the project was approved or disapproved;

2. Any significant changes from research proposals as approved by the committee;

3. A list of committee members, their qualifications for service on the committee, and their affiliation with the department, local agency, or facility;

4. A copy of the minutes of each committee meeting; and

5. Results of the research after its conclusion.

B. A local agency department, facility, or contractor participating in a human subject research project reviewed by another agency's research review committee shall report to the department research review committee by December 1 of each year on such participation. The report shall include:

1. A description of each human research project in which the agency local department, facility, or contractor participated, including the name and contact information for the approving research review committee; and

2. Results of the research after its conclusion, including a description of how the research will be shared beyond the local department, facility, or contractor.

C. The chairperson of the department's committee shall report as soon as possible to the commissioner any violation of the research protocol that may lead the committee to either suspend or terminate the research.

D. The commissioner shall report at least annually to the Governor and General Assembly on the human research projects authorized or conducted by the department, local agency department, facility, or contractor.

E. Other reports may be required by the committee, as indicated in 22VAC40-890-70 F.