News & Announcements
April 28, 2017
The HRPP office has received questions regarding ClinicalTrial.gov disclosure requirements. To assist in better understanding of the ClinicalTrials.gov registration and reporting requirements, please refer to HRPP Policy 1000, Clinical Trial Registration and Results Reporting Requirement. See also the 04/27/2017 Office of Research Administration notice.
Principal Investigators may contact the Yale Center for Clinical Investigation (YCCI) for assistance with ClinicalTrials.gov registration and reporting for more information.
Principal Investigators who are unsure as to whether a clinical trial is subject to ClinicalTrial.gov disclosure requirements should contact Yale.CTgov@yale.edu or HRPP@yale.edu for assistance.
Monday, April 3, 2017
A revised HRPP procedure 920 PR.4 titled ‘Use of External IRBs for Review and Oversight of Research Involving Human Subjects’ went into effect Monday, April 3, 2017.
The revised procedure allows the HRPP to consider and allow the use of external (commercial) IRBs for a broader range of research studies. The procedure delineates the process in which Yale investigators can request review by an external IRB and describes the responsibilities of Yale, the investigator, and the external IRB after the study is approved for external IRB review.
Currently, Yale maintains agreements with Western IRB (WIRB) and Quorum Review. Agreements with additional IRBs including BRANY, Chesapeake, Hummingbird, and Schulman will be finalized soon. Each of the IRBs will be invited to provide live training to the Yale research community regarding the use of their electronic portals, protocol submission processes, reporting requirements, and other aspects of their operations and review capabilities. Announcements with training dates will be emailed later this month.
A quick guide on requesting review by an external IRB is available in the Help Center section in IRES IRB. Questions regarding the revised procedure can be sent to HRPP@yale.edu.
Good Clinical Practice Training Requirement
January 2, 2017
The requirement for Good Clinical Practice training for all investigators and staff involved in the conduct, oversight, or management of clinical trials was announced to the research community on December 22, 2016. The details regarding the training are available in the memo from Pamela Caudill, Senior Associate Provost for Research Administration.
New IRES IRB Electronic Protocol Submission System
January 2, 2017
The HRPP is pleased to announce a new IRES IRB electronic protocol submission system is LIVE for our research community!
The first group of researchers to migrate over to the new system was in July 2016. Other departments migrated over in the weeks/months after with all departments migrated in December 2016. Training sessions have been offered prior to each department going live.
Many hours have been dedicated to making this new system user friendly, reliable and efficient. We strived to provide Principal Investigators and study personnel with a system that aids in a smoother protocol submission, review and approval process.
Thank you for working with us throughout this exciting transition period! Any questions please contact IRB.Support@yale.edu.
August 26, 2016
The Yale IRB staff is available to meet with research coordinators, Principal Investigators, and consenting personnel to help create a consent process checklist and practice obtaining consent from subjects using a study approved consent form. Individual appointments will be held in the offices at 55 College Street and will last between 45 minutes and an hour. For more information and to schedule an appointment, contact Michele Antisdel at email@example.com or Jennifer Reese at firstname.lastname@example.org.