TITLE 6. CRIMINAL JUSTICE AND CORRECTIONS
Title of Regulation: 6VAC15-26. Regulations for Human Subject Research (repealing 6VAC15-26-10 through 6VAC15-26-130).
Statutory Authority: § 53.1-5 of the Code of Virginia.
Public Hearing Information: No public hearing is currently scheduled.
Public Comment Deadline: February 1, 2023.
Effective Date: March 1, 2023.
Agency Contact: Colleen Maxwell, Policy Analyst, Department of Corrections, 6900 Atmore Drive, Richmond, VA 23225, telephone (804) 887-8445, or email colleen.maxwell@vadoc.virginia.gov.
Basis: Section 53.1-5.1 of the Code of Virginia authorizes the State Board of Local and Regional Jails to make, adopt, and promulgate such rules and regulations as may be necessary to carry out the provisions of Title 53.1 of the Code of Virginia. However, Chapter 759 of the 2020 Acts of Assembly moved authority to regulate human subject research from the board to the Department of Corrections.
Purpose: The regulation directly impacts the health, safety, and welfare of citizens who may be subject to research projects. It is essential to their protection that the Virginia Administrative Code accurately reflects the appropriate promulgating authority. Therefore, 6VAC15-26 must be repealed as the regulation is being adopted by the Department of Corrections at 6VAC16-20.
Rationale for Using Fast-Track Rulemaking Process: The regulation is for the protection of a group of individuals who may be part of a research project. These projects are prevalent in agencies responsible for services and supervision, as well as universities. The regulation protects those involved in the research and provides those conducting the research with clarity and guidance. Having the regulation at 6VAC15-26 under the State Board of Local and Regional Jails, which no longer has regulatory authority to enforce the regulation, creates a problem for the public seeking to conduct research and for the individuals who may be subject to such research. To place the regulation under the Department of Corrections at 6VAC16-20 requires 6VAC15-26 be repealed.
Due to the changes in the Code of Virginia pursuant to Chapter 759 of the 2020 Acts of Assembly regarding regulatory authority for certain Department of Corrections responsibilities, the regulation must be repealed under 6VAC15-26 and promulgated under 6VAC16-20. As there will be no substantive changes to the content of the regulation, and the agency has no discretion in the action, the regulatory action will likely be noncontroversial.
Substance: This action repeals 6VAC15-26 in entirety so that the regulation may be promulgated under the Department of Corrections at 6VAC16-20.
Issues: The regulation is for the protection of a group of individuals who may be part of a research project. These projects are prevalent in agencies responsible for services and supervision, as well as universities. The regulation protects those involved in the research and provides those conducting the research with clarity and guidance. The primary advantage to the public of the amendments is that users will be able to find the regulation easily because having this regulation under 6VAC15, with no regulatory authority for the board to issues them, creates a problem for the public seeking to conduct research, and for the individuals who may be subject to such research. There is no disadvantage to the public.
The primary advantage of this regulatory change to for the agency is that it accurately reflects the appropriate promulgating authority. There is no disadvantage to the agency or Commonwealth.
Department of Planning and Budget's 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 (Code) and Executive Order 19. The analysis presented represents DPB's best estimate of these economic impacts.1
Summary of the Proposed Amendments to Regulation. The State Board of Local and Regional Jails (Board) proposes to repeal this regulation, which has become obsolete following a legislative change in the authority for the regulation.
Background. This action would repeal rules governing human research for the Board. Chapter 759 of the 2020 Acts of Assembly, renamed the Board of Corrections as the State Board of Local and Regional Jails and changed the authority for this regulation from the prior Board of Corrections to the Director of the Department of Corrections (DOC).2 Hence, the Registrar assigned a new location for DOC regulations within Title 6 of the VAC (6VAC16). Consequently, the Director proposed to establish substantially the same human research rules for replacement under the new Virginia Administrative Code 6VAC16 for DOC in a separate regulatory action.3 This action would repeal this regulation which has become obsolete after the enactment of Chapter 759 by operation of law.
Estimated Benefits and Costs. The primary effect of this action is to repeal regulatory language that has become obsolete. As a result, no economic impact is expected other than improving the accuracy of the administrative code.
Businesses and Other Entities Affected. No businesses or other entities are expected to be affected as this regulation is obsolete.
The Code of Virginia requires DPB to assess whether an adverse impact may result from the proposed regulation.4 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. Repealing obsolete regulatory language with this action does not indicate an adverse impact on any entity.
Small Businesses5 Affected.6 The proposed repeal does not adversely affect small businesses.
Localities7 Affected.8 The proposed repeal does not disproportionally affect any particular localities or introduce costs for local governments.
Projected Impact on Employment. The proposed repeal does not affect total employment.
Effects on the Use and Value of Private Property. The proposed repeal does not affect the use and value of private property or the real estate development costs.
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1Section 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.
4Pursuant 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.
5Pursuant 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."
6If 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.
7"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.
8Section 2.2-4007.04 defines "particularly affected" as bearing disproportionate material impact.
Agency's Response to the Economic Impact Analysis: The State Board of Local and Regional Jails concurs with the economic impact analysis performed by the Department of Planning and Budget.
Summary:
The amendments repeal Regulations for Human Subject Research (6VAC15-26) under the State Board of Local and Regional Jails, which no longer has regulatory authority over human subject research pursuant to Chapter 759 of the 2020 Acts of Assembly, so that the regulation can be added at 6VAC16-20 under the Department of Corrections.
VA.R. Doc. No. R22-7154; Filed December 07, 2022