Section II:

VCU Human Research Protection Program

WPP #: II-5

Title 5:

State Law Applicability for Research Conducted In and Outside of Virginia 

Effective Date:

06-23-15

Revision History:

10-15-07; 1-30-14; 02-25-14

Policy Statement

The conduct of human research within the Commonwealth of Virginia must comply with the Code of Virginia unless the Code is superseded by federal regulations. The conduct of human research outside of Virginia is subject to relevant law for the jurisdiction in which the research is being conducted.

Description

This Written Policy and Procedure (WPP) describes circumstances in which the state law in Virginia places protections and/or restrictions on the conduct of the research, in addition to federal regulations. The IRB Leadership and Enhancement Committee (ILEC) and the Director of ORSP has open access to VCU General Counsel for advice and assistance in applying state law to questions about research involving human subjects.

The excerpt below from the Code of Virginia § 32.1-162.20, articulates the applicability of federal regulations to human research conducted in Virginia.

§ 32.1-162.20. Applicability of federal policies.

“Human research which is subject to policies and regulations for the protection of human subjects promulgated by any agency of the federal government shall be exempt from the provisions of this chapter.

In lieu of promulgating regulations pursuant to the requirements of this chapter, an institution or agency may comply with this chapter by promulgating regulations under the provisions of the Administrative Process Act (§ 2.2-4000 et seq.) governing human research projects which incorporate, explicitly or by reference, federal policies and regulations for the protection of human subjects. However, in the case of projects which are not required, by reason of their nature, the source of their funding, or the lack thereof, to comply with federal policies and regulations, the institution or agency may enforce compliance by filing a petition for an injunction in the appropriate circuit court. This section shall not preclude any other enforcement action available to the institution or agency.”

The VCU Federal-Wide Assurance states that the Common Rule at HHS regulations 45CFR46 and Subparts B, C, and D will be applied to all research, regardless of funding source.

  1. Applicability of State Law (for Certain Research Considerations):
    1. Informed Consent Process Refer to:
      1. The Code of Virginia 32.1-162.18.
      2. VCU IRB WPP XI-1: Consent Process, Elements, Waiver of Element(s), and Modification;
      3. VCU IRB WPP XI-2: Informed Consent Documentation, Waiver of Documentation, and Required Signatures
    2. Legally Authorized Representative – Refer to:
      1. Code of Virginia 32.1-162.16. Definitions Legally Authorized Representative;
      2. VCU IRB WPP XI-3: Legally Authorized Representative (Inclusion in Consent Process); and
      3. VCU IRB WPP XVII-7: Evaluating Consent / Persons with Limited Decision-Making Capacity
    3. Child/Minor – Refer to:
      1. The Code of Virginia § 1-207. Definition. Child; juvenile; minor; infant or any combination thereof means a person less than 18 years of age.
      2. VCU IRB WPP XV-1: Children as Research Subjects (Permissible categories); and
      3. VCU IRB WPP XV-2: Assent and Parental/Guardian Permission Considerations.
      4. NOTE: Certain sponsors have definitions of "child" that differ or serve different purposes (e.g. the National Institutes of Health Grants Policy Statement notes that "For the purpose of addressing the NIH policy requirement for inclusion, a child is defined as an individual under the age of 21 years.")

    4. Parent/Guardian Permission and/or Court-Appointed Custody of Minor – Refer to:
      1. The Code of Virginia 32.1-162.16. Definitions (Legally authorized representative);
      2. VCU IRB WPP XV-2: Assent and Parental/Guardian Permission Considerations; and
      3. VCU IRB WPP XV-3: Children in Court-Appointed or State Custody and Emancipated Minors
    5. State-Mandated Reporting (of Issues that may arise in the Context of the Research) In accordance with state law, health care practitioners are required by the Commonwealth of Virginia to report suspected child and adult abuse, HIV testing results, and other incidences of certain diseases to designated authorities. Research subjects are included in this reporting requirement. This reporting requirement must appear in the informed consent, assent, and/or permission form as applicable to the context of the research.
  2. Research Conducted Outside the State of Virginia:

    In all cases, applicability of state law for research conducted outside of Virginia is based on the relevant law for the jurisdiction in which the research is being conducted. The considerations listed above are generally provided for in the law of other states. Every state also has a federal applicability law, similar to that of Virginia. In addition, other states may have laws (as does Virginia) that afford additional protections or requirements and are relevant to the research. The PI is responsible for being aware of state law in the location where research will be conducted, must understand the implications of state laws for the proposed research, and describe how differing state requirements will be met in the research. For additional guidance on research involving non-VCU facilities or institutions, refer to: VCU IRB WPP XVII-6: Involving Non-VCU Institution in Human Subjects Research.

References

None listed