Policy Updates Effective August 1, 2023 - NEW Policy on New Protocol Submission Requirements

June 20, 2023

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.

The approved new policy and policy updates will go into effect on August 1, 2023.

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

Applicable research staff are strongly encouraged to review and familiarize themselves with the new policy RCO-104: New Protocol Submission Requirements. Impacted research staff should attend one of the training sessions listed below; however, DF/HCC leadership has determined that no formal documentation of re-training is required.

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 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.

Additional education and Q&A opportunities for new policy RCO-104:

We will be holding two informational Office Hours webinars in anticipation of the August 1 effective date for RCO-104. All research staff responsible for or involved in new protocol submissions and responding to conditions should attend one of these sessions.* Please click below to register!


Session 1 – Thursday July 20, 9am-10am

Click here to register

Session 2 – Thursday, July 27, 3pm-4pm

Click here to register


Click here to submit a question ahead of time for our panelist Q&A!


*A recording will be available for those unable to attend either session.


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