News & Announcements
Notice of Changes to NIH Policy for Issuing Certificates of Confidentiality
Effective October 1, 2017, all NIH-funded research that was commenced or ongoing on or after December 13, 2016 and collects or uses identifiable, sensitive information is deemed to be issued a Certificate of Confidentiality, and is therefore required to protect the privacy of individuals who are subjects of such research in accordance with subsection 301(d) of the Public Health Service Act.
- “Identifiable, sensitive information” means information about an individual that is gathered or used during the course of biomedical, behavioral, clinical, or other research, where the following may occur:
- An individual is identified; or
- For which there is at least a very small risk, that some combination of the information, a request for the information, and other available data sources could be used to deduce the identity of an individual.
- The NIH will continue to consider request for Certificates for non-federally funded research in which identifiable, sensitive information is collected or used.
- For more information, please visit the Notice of Changes to NIH Policy for Issuing Certificates of Confidentiality website
- Visit the National Institutes of Health’s internet site on Certificates of Confidentiality website
- Visit CoC Contacts at NIH and Other DHHS Agencies that Issue Certificate website
- Please contact the Yale HRPP Office (email@example.com) with any questions. Training materials on CoCs are being developed.
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.