Upcoming DF/HCC Policy Updates - Effective 2/28/2022

December 01, 2021

 Notice of Upcoming DF/HCC Policy Updates
Effective February 28, 2022 

DF/HCC Research Community, 

 The DF/HCC Policies for Human Subject Research listed below have been revised and will go into effect on February 28, 2022. Research teams may start implementing the updated version 12 of RCO-204 as early as January 1, 2022. 

Tracked changes have been posted to the DF/HCC website to facilitate notification and review: DF/HCC Policy Updates Page 

DF/HCC leadership has determined that no formal documentation of training is required. However, we strongly encourage Principal Investigators of FDA-regulated research studies to view the 9-minute e-learning that accompanies the RCO-204 revisions.

Summary of Policy Updates

RCO-204: Safety and Event Reporting

  • Significant updates to section 5.3. IND Safety Reports received from external sponsors, including:
    • Removal of the different process for IND/IDE Safety Report (INDSR) Review for phase I and I/II studies. Consistent policy language now applies to studies of all phases.
    • PIs may delegate review of INDSRs to an appropriately qualified subinvestigator.
    • Documentation of INDSR review and receipt can occur either per institutional practice or via a sponsor- or CRO-provided online portal/system.

Rolling Implementation

  • Researchers may begin implementing the updated version 12 of RCO-204: Safety and Event Reporting as early as January 1, 2022.
  • Investigators and teams that choose to implement prior to February 28, 2022 should retain this Note-to-File with their regulatory documents.

Educational Resources

  • Program leaders are asked to share this information with all research personnel who work on FDA-regulated research.

Password: ODQ

CON-100: Informed Consent Process

  • Clarification only: When additional documents are required to be given to subjects as part of the consent process (e.g., conflict of interest information sheets), the consent process documentation must indicate whether they were provided.

RCL-101: Record Retention for Completed Research

  • Revised to indicate that institutional record retention requirement timelines may be longer than otherwise required under DF/HCC policy.

ADM-100: Creation and Maintenance of DF/HCC Policies and Operations
Version 12.1 effective as of 12/1/2021

  • Administrative update to remove the title of DF/HCC Associate Director of Administration from the responsible personnel.