Policy Updates Now Effective - NEW Policy on New Protocol Submission Requirements

Notice of New DF/HCC Policy and Policy Updates
Effective August 1, 2023

The DF/HCC Policies for Human Subject Research listed below have been approved by DF/HCC leadership in accordance with ADM-100 and are effective as of August 1, 2023.

Updated versions of these policies have been posted to the DF/HCC Policy and Operation Library. A summary of updates and tracked changes are still available for review on the Policy Updates Page.

Additional Education for New Policy RCO-104:

To facilitate review and comprehension of new policy RCO-104: New Protocol Submission Requirements, we held two educational live webinar sessions in July. Please find a recording and slides below. Any research personnel who were not able to attend a live session should review these materials:

• Webinar Recording – New DF/HCC Policy RCO-104 – Overview of Requirements
• View Slides Only

Policy Updates

NEW RCO-104: New Protocol Submission Requirements

• This is a new policy outlining:
  • • Requirements for submission of a new research study to DF/HCC
    • Expectations for responding to conditions in a timely manner and escalation steps that may be taken when condition responses are not received
    • Criteria for the withdrawal of new research studies that do not move forward

RCO-100: Investigator-Sponsored Research

• Section 5.1.5.1. Updated to align with requirements in new policy RCO-104. When a DF/HCC investigator will hold an IND, FDA approval must be obtained before the new research study is submitted to DF/HCC for review.

Please contact ODQEducation@dfci.harvard.edu with any questions regarding this announcement.