VCU Human Research Protection Program (HRPP) Blog

The VCU HRPP is dedicated to facilitating ethically and scientifically sound research through robust review of research projects and through effective education and outreach to the VCU research community.

Update to VCU IRB Policy Regarding Study Closure

by Susan Kimbrough

Update to VCU IRB Written Policy and Procedure (WPP) Regarding Study Closure

The IRB policy on study closure (WPP #X-4: Closure of Study from VCU IRB Oversight) has recently undergone a significant revision. All individuals with responsibility for IRB submissions, including principal investigators, study coordinators, and regulatory study staff,  should review this WPP in its entirety to ensure familiarity and compliance.

A major change involves the criteria that must be met in order to close a study with the VCU IRB. Per the newly updated policy:

VCU IRB oversight may end (following a request for closure) only when ALL the following conditions are met:

  1. The research is permanently closed to enrollment at the site(s) under the VCU IRB approval, and
  1. All interactions/interventions with subjects, or access to subjects identifiable private information (including identifiable biological specimens) for the purpose of research data collection is complete, and
  1. All use, study, and/or analysis of identifiable private information at the research site(s) under the VCU IRB approval is complete.  
  • Note: For multi-center studies: Continuing review of the research by the VCU IRB is no longer required once the above conditions are met (following a request for closure), even if (i) interactions or interventions with subjects may be occurring at study sites other than those under the VCU IRB approval; or (ii) data analysis of identifiable private information is ongoing at another central site (site other than those under the VCU IRB approval) that collects and analyzes data from all study sites. For studies closed with the VCU IRB under these conditions, investigators may still respond to queries from the statistical center at the other institution regarding previously collected data about subjects who were enrolled under the VCU IRB approval.

With this update, research data is not required to be de-identified prior to study closure. However, all use, study, and/or analysis of identifiable private information must be complete in order to close the study. Data security must be ensured, even after study closure, if identifiable information (including coded data) is retained.

The RAMS-IRB Continuing Review/Closure smartform as well as the Study Closure Form (for paper studies) have been revised to reflect the information in this updated policy.

This policy also addresses Lapse in Continuing Review as well as Principal Investigator Separation from VCU/VCUHS, and outlines the requirements associated with both circumstances.

The policy can be viewed in its entirety at: http://www.research.vcu.edu/human_research/irb_wpp/X-4.htm.  This policy pertains only to studies approved by the VCU IRB; for those studies reviewed by an external IRB (i.e. Western IRB, NCI Central IRB), investigators must follow that IRB’s policy for study closure.

 

Categories Announcements and Updates