We are writing to update you on the status of the clinical research support processes in the DF/HCC Office for Human Research Studies (OHRS). While we all recognize the mission-critical importance of reviewing clinical research submissions in a timely manner, recent personnel shifts in OHRS have resulted in understaffing after the implementation of the iRIS system. The administrative leadership is working to fill these open positions, and please know that the entire OHRS team is working diligently to process all submissions. We appreciate your patience during this temporary period as we work to bring OHRS up to full staffing for optimal review and activation of our clinical research studies. Our faculty and staff involved in scientific, ethical, and logistical reviews of studies are all adding extra SRC and IRB meetings as well as taking on extra review tasks to facilitate throughput during these staffing challenges.
OHRS is prioritizing highly time-sensitive requests (such as ensuring that active research interventions can continue without lapses, processing continuing reviews with impending expiration dates, clearing out any remaining studies that had been submitted in the legacy p360 system, and iRIS submissions of new protocols, continuing reviews and amendments based on dates of submission. Other submissions are being handled according to the expected timelines announced earlier. To avoid patient rescheduling and missed expectations, we do not recommend scheduling protocol visits for new potential participants on research studies until formal IRB approval has been received.
If your submission is critical for the ongoing care of existing research participants and was submitted within the expected timelines, please bring this to our attention by sending a high priority email to OHRS@dfci.harvard.edu. Senior staff at OHRS will be monitoring this mailbox and will assist in prioritizing all requests.
Here are some things that might be helpful for faculty, staff, and study teams to know:
- Study teams can view the real-time status of every submission in iRIS by going to Submissions History and clicking on Track Location. More information can be found in the iRIS WIKI instructions for navigating the Study Assistant workspace
- IRB review dates can only be assigned after any new submissions have been approved by Scientific Review committee (SRC), if needed and Feasibility Screening (e.g., Nursing, Pharmacy, Office of Data Quality). The iRIS system allows everyone to track the status of these reviews and assess timelines, for which we have strict performance targets.
- The phrase “Process Administratively” means that a Human Research Coordinator (HRC) staff analyst has been assigned to perform a pre-review of the submission to determine the correct review path (e.g., expedited vs full board). These are handled in the order of receipt
- Submissions scheduled for Full Board review will display a meeting date as soon as it is assigned. We are increasing our dockets for review in order to maximize efficient review times.
Due to the current short staffing in OHRS, we are opening opportunities for current staff in other departments to assist with HRC tasks outside of normal work hours. If any research staff are interested in learning more about OHRS processes and working in the office to provide temporary and additional support, please email us at OHRS@dfci.harvard.edu.
Thank you for your patience during this time.
Senior Vice President for Research Administration, Dana-Farber Cancer Institute
Associate Director for Administration, Dana-Farber/Harvard Cancer Center
Vice President for Clinical Trials Operations, Dana-Farber/Harvard Cancer Center and Dana-Farber Cancer Institute