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Human Research

AAHRPP Accreditation SealThe 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.

2018 Common Rule Information

On January 21, 2019, revisions to the Federal Policy for the Protection of Human Subjects go 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 RAMS-IRB is patched in January 2019, all currently approved studies will 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 Resources

 

Overview of the RAMS-IRB Smartform changes

Overview of the 2018 Common Rule changes

List of new questions added to the main pages of the RAMS-IRB Smartform
Note: Other new questions that are specific to only certain types of studies that are not included.

Organization of pages in the updated RAMS-IRB Smartform

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.