Action:
Update Human Subject Research Chapter
Action 6126
General Information
Action Summary |
The Virginia Department of Social Services follows federal regulations (Title 45 CFR Part 46; also known as the Common Rule) for the Protection of Human Subjects to ensure protection of all human subjects participating in research conducted or sponsored by the Department. In addition to updating certain definitions and terms to be congruent with those that appear in other state Code (e.g., § 32.1-162.16), the Department will amend the 22 VAC 40-890-30 and 22 VAC 40-890-80 to be congruent with recent revisions to the Common Rule. The Revised Common Rule expands the list of types of research posing minimal risk to human subjects that qualify for either an exemption from IRB review or an expedited review in which only the Chair (or one other IRB member) conducts the review. The Common Rule eliminates the need for a continuing review for ongoing research initially approved under an expedited review process. Other changes affect IRB reporting requirements and the required minimum number of IRB members. Amendments to the existing chapter are to provide language aligned with § 63.2-218 of the Code of Virginia.
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Chapters Affected |
Only affects this chapter.
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Executive Branch Review |
This action will go through the normal Executive Branch Review process.
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RIS Project |
Yes [6069] |
Result of Prior Periodic Review Filed |
5/3/2019
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New Periodic Review |
This action will not be used to conduct a new periodic review.
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Stages
Stages associated with this regulatory action.
Stage ID |
Stage Type |
Status |
9845
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Fast-Track
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Comment period is underway and will end on 01/29/2025. |
Contact Information
Name / Title:
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Gail Jennings
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Policy & Planning Specialist
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Address:
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801 E. Main Street
Richmond, VA 23219
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Email Address:
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gail.jennings@dss.virginia.gov
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Phone:
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(804)726-7490
FAX: (804)726-7946
TDD: ()-
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This person is the primary contact for this chapter.