iRIS serves oncology trials at Beth Israel Deaconess Medical Center, Boston Children's Hospital, Brigham and Women's Hospital, Dana-Farber Cancer Institute, Massachusetts General Hospital, and other affiliated institutions. 

Visit the iRIS Wiki for more details.
ANNOUNCEMENT
Dear DF/HCC Research Community,
 
iRIS has undergone several updates today, Friday, October 1st. The primary update is a change to the New Project Application to support the OHRS requirement that consent forms be included upon initial submission of a study. Several other minor changes are listed in the Summary of Changes below.
The Details
What is changing?

  • Initial Submission Review Packet Form: The “Pending” option for Consents was removed.
  • Initial Submission Review Packet Form: Language clarifications for Consent-related documents and “Pending” diaries.
  • DFHCC OHRS Application - New Project Application: Accrual goal header and eConsent language updated for clarity.
  • Amendment: When attaching consents, a reminder was added that the last approved consent document in IRIS should be revised to make necessary changes. Do not attempt to edit the documents posted to OncPro.
  • Amendment: A new guidance document is linked in the Amendment form to clarify what are considered to be Therapy changes.
  • Operational Readiness Checklist (DFCI Only): Two new items were added regarding flowsheets and Chestnut Hill.
Wiki Friendly Reminders

  • The applicable Wiki documents have been updated with all changes accompanying this release.
  • The iRIS Updates section, found on the iRIS Wiki landing page, provides a table of all iRIS updates and the date of their release.
Oncology trials in Boston are a collaborative effort involving many from many institutions. iRIS represents an opportunity to streamline all of the processes involved, and move trials from submission to activation, and to our patients, more quickly. Please take advantage of all of the provided information and resources to help us make this system as efficient to use as possible.

Sincerely,
Jeffrey Meyerhardt, MD, MPH
Associate Director for Clinical Trials,
Dana-Farber/Harvard Cancer Center
Erica Woulf
Senior Director for Research Informatics Operations,
Dana-Farber/Harvard Cancer Center
Previously sent on 9/9/2021
9 September 2021
 
To: Investigators and Research Teams Participating in Human Subject Research at DF/HCC:
 
Please see below for four important updates from OHRS.
 
Consent Forms Required at Time of Submission 
 
Beginning October 1st, OHRS will ask research teams to submit the Informed Consent Form (ICF) at the time of the original New Protocol Application (NPA). This new requirement is needed to prevent the current delays caused by the 37% of NPAs that sit in the IRB queue awaiting an IRB meeting date, while OHRS staff reaches out to study teams to request these forms. 
 
Beginning next month, the Initial Review Submission Packet in iRIS will now require the ICF to be attached in order to be accepted for submission and routed to SRC and feasibility reviews. Alternatively, a confirmation of a request to waive the consent documentation may be included in the application. For any questions regarding this change, or concerns with the implementation, please contact OHRS directly.
 
sIRB Website and Concierge Service
 
OHRS has recently updated the sIRB page on the OHRS website. The new website now contains updated information regarding the sIRB process, new guidance for study teams, FAQs regarding submission to WIRB, as well as guidance regarding other sIRB platforms. The website also provides easy access to consent templates and other pertinent documents. Please stay tuned for more helpful content to be added to this site shortly.
 
In addition, OHRS is now providing a concierge service for sIRB studies. For any study that has ceded review to an external IRB, OHRS staff will monitor the progress and reach out to contacts at partner IRBs to ensure a timely review process. Please contact OHRS for further information
 
Welcome to New ORHS Staff
OHRS is pleased to introduce two new staff members.
 
Dr. Jiale Dai will be joining OHRS as an Associate Director, Medical Reviewer. Dr. Dai was most recently the Director of the Research Pharmacy at DFCI and served on the IRB both here at DFCI as well at MD Anderson and other academic medical centers. Dr. Dai brings an extensive knowledge of pharmaceutical science, IRB panel member experience, as well as institutional knowledge at DFCI. We are very excited to have him join OHRS.
 
In addition, Allen Li will be joining as a new Human Research Coordinator. Allen has his Master’s degree in Biostatistics and will be helping both in the prereview of IRB protocols as well as extensive work with our Scientific Review Committees. We are so pleased to have him join our team.
 
Please contact OHRS, OHRS@dfci.harvard.edu with any questions regarding the information presented here.