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Human Research

AAHRPP Accreditation Seal [View Image]The Institutional Review Board (IRB) at VCU is charged with reviewing all research involving human participants to ensure research is conducted ethically and in compliance with federal, state, and local regulations. Guidance and resources for researchers, research participants, and IRB members are provided on this site.

COVID-19 UPDATES: For information, updates, and guidance related to the COVID-19 outbreak and its impact on human research, please monitor the VCU HRPP Blog, as well as the OVPRI COVID-19 webpage.

For guidance on VCU’s Phased Return to Research (R2R) plan, read the HRPP’s letter to the research community. You may also access written guidance on investigator responsibilities to the IRB during the R2R plan. This written guidance is also supplemented with a flowchart. Finally, there is also guidance available in video format.

New! IRB Education/Training Event Request Form

IRB Staff are available for consultations as well as education/training events, such as lectures, workshops, and presentations. To request a consultation or education/training event, please complete this request form, and someone from IRB Staff will follow up with you, generally within one business day.

2018 Common Rule Information

On January 21, 2019, revisions to the Federal Policy for the Protection of Human Subjects went into effect. This new version of the “Common Rule,” as it is typically known, represents the first revision to the rule since its publication in 1991.

  • The new rule is referenced as the “2018 Common Rule” by regulatory agencies and in the VCU IRB’s policies, resources, and forms.
  • The previously effective rule is referenced by the VCU IRB as the “Pre-2018 Common Rule.”

After the RAMS-IRB patch that occurred in January 2019, all currently approved studies must be converted. “Conversion” refers to:

  1. Conversion to the updated RAMS-IRB Smartform – a streamlined, protocol-like submission form, and, if eligible,
  2. Transition to the 2018 Common Rule to take advantage of the new, burden-reducing provisions

Click Here for Conversion Resourcespdf logo [View Image]

 

Overview of the RAMS-IRB Smartform changes

Overview of the 2018 Common Rule changes

To convert your consent documents, read and follow these instructions to avoid doing unnecessary work: Instructions on how to convert existing consent documents

Template language needed to convert existing consent documents

  1. Four new consent elements
  2. Key summary section for biomedical consent documents
  3. Key summary section for social-behavioral consent documents

If you have questions, contact the IRB Coordinator assigned to your study ‐ this will be the best person to assist you.

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