October 9, 2025
Good Clinical Practice (GCP) Training Updates: FDA Adoption of ICH E6(R3) and Related CITI Course Updates.
September 9, 2024
The Yale Human Research Protection Program (HRPP), in partnership with the Yale School of Medicine (YSM) and Yale New Haven Health System (YNHHS), has recently updated the guidance document titled “Guidance 410 – Research Recruitment at Yale and YNHHS”.
Effective September 9, 2024, this document can be found in Part II of the HRPP Policy & Standard Operating Procedure Manual or as a standalone document. The purpose of the guidance is to provide investigators under the purview of the Yale HRPP (including Yale and YNHHS investigators) with an overview of the requirements regarding research recruitment of patients via direct interaction and/or secondary use of data from patients who have received care at Yale and YNHHS affiliated hospitals, clinics, care centers, or research centers.
Yale and YNHHS investigators, research staff, and other stakeholders are highly encouraged to view the Recruitment Guidance Overview Video or view this Research Recruitment Slide Deck. These resources provide a detailed overview of the guidance document, including a summary of recent changes surrounding research recruitment that investigators and stakeholders should be aware of.
Recent changes to the recruitment guidance include:
- Revision to allowable methods of using medical records to identify and contact potential participants;
- Revision to allowable recruitment involving direct interactions with participants;
- Added sections on using phone, mail, email, and text messaging to contact participants;
- Added MyChart recruitment templates and examples of other recruitment scripts;
- Revised generally throughout for formatting/clarity; &
- Web links updated.
For any questions related to research recruitment at Yale and/or YNHHS, please contact HRPP@yale.edu.
April 30, 2024
Beginning on May 8, 2024, Yale New Haven Health System (YNHHS) investigators will begin using the Yale University IRB for review of all new human subjects research. After May 7, 2024, the Bridgeport Hospital IRB will not accept any new submissions for review. Please note, studies with an exemption, Not Human Subjects Research, or Quality Improvement determination will not be transferred and that Modifications to existing projects affecting the level of IRB oversight will require submission for a new determination.
You can also contact OneIRB@yale.edu with any questions. Additionally, please review the Yale University HRPP section for information on training requirements, Yale HRPP/IRB policies and procedures, and Frequently Asked Questions related to conducting human subject research as an affiliate of Yale University.
July 24, 2023
The Yale Human Research Protection Program (HRPP) recently revised several public facing documents that our research community utilizes on a regular basis. Effective Monday, July 24, 2023, the following documents were minorly revised on our HRPP website and in the IRES IRB Library. Please ensure you are using the most recent version of the following documents:
- HRPP Policy & Standard Operating Procedure Manual
- HRPP Investigator Manual
- Consent/Assent/Parental Permission Templates
- HRP – 314 – WORKSHEET – Criteria for Approval
- IRB Submission Form
- Guideline-Quality Improvement Projects
Please note, the changes made are minor and should not substantially impact the development of research protocols nor the submission of IRES IRB applications.
Please see this high-level summary document that outlines the changes made to each public facing document. Please note, the Consent Glossary was also recently revised and is posted on the HRPP website and in the IRES IRB Library, with an effective date of June 26, 2023. The high-level summary document also details the Consent Glossary changes. For any questions, please contact HRPP@yale.edu.