OBJECTIVE:

To describe the applicability of state law for research conducted in- and outside of Virginia by a VCU investigator(s).

DESCRIPTION:

This Written Policy and Procedure (WPP) will describe circumstances in which the state law in Virginia places protections and/or restrictions on the conduct of the research, in addition to federal regulations.  IRB chairs and vice-chairs and Directors of OECO and ORSP have 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.   The VCU Federal-Wide Assurance states that Common Rule at HHS regulations 45CFR46 and Subparts B, C, and D will be applied to all research regardless of the source of funding support, except for research that is covered under a separate Assurance.  Virginia law provides definitions of applicability and additional protections as listed in Section A below.

A.     Applicability of State Law (for Certain Research Considerations):

1.       Informed Consent Process – Refer to:

a)      The Code of Virginia § 32.1-162.18.  

b)      VCU IRB WPP XI-1: Consent Process, Elements, Waiver of Element(s), and Modification; 

c)      VCU IRB WPP XI-2: Informed Consent Documentation, Waiver of Documentation, and Required Signatures

2.       Legally Authorized Representative – Refer to:

a)      Code of Virginia § 32.1-162.16. Definitions “Legally Authorized Representative”;

b)      VCU IRB WPP XI-3: Legally Authorized Representative (Inclusion in Consent Process); and

c)      VCU IRB WPP XVII-7: Evaluating Consent / Persons with Limited Decision-Making Capacity  

3.       Child/Minor –Refer to:

a)      The Code of Virginia § 1-207.  Definition. “Child; juvenile; minor; infant or any combination thereof means a person less than 18 years of age.”

b)      VCU IRB WPP XV-1: Children as Research Subjects (Permissible categories); and

c)      VCU IRB WPP XV-2: Assent and Parental/Guardian Permission Considerations.

d)      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:

a)      The Code of Virginia § 32.1-162.16. Definitions (“Legally authorized representative”);

b)      VCU IRB WPP XV-2: Assent and Parental/Guardian Permission Considerations;  and

c)      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.

B.     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 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.

RESPONSIBILITY:

It is the responsibility of the principal investigator to be aware of state law in the location where research will be conducted.  To emphasize, IRB Chairs/Vice-Chairs, OECO and ORSP Directors have open access to General Counsel for advice and assistance in applying Virginia state law to questions about research involving human subjects.  The principal investigator is expected to consider implications for the application of state law outside of Virginia in the planning and conduct of research at non-VCU sites.  

The IRB is to determine the need for consultation regarding knowledge of local research context for non-VCU site research.  Applicable state law considerations at the out-of-state research location may require such consultation.  

REFERENCES:

Cited in text.