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

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

The HCC Policies for Human Subject Research listed below have been approved by 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 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 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 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 HCC investigator will hold an IND, FDA approval must be obtained before the new research study is submitted to HCC for review.

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