News & Announcements

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. The transfer of currently approved and ongoing studies from the Bridgeport Hospital IRB to the Yale IRB will likely commence by fall 2024. Additional information on the transfer of those studies will be provided soon (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).

YNHHS investigators, research staff, and other stakeholders are highly encouraged view the One IRB Overview video, for information on the purpose of OneIRB and an overview of the Yale HRPP and Yale IRB, including relevant policies, procedures, and next steps. A copy of the presentation is also available for your review. We also plan to schedule live Zoom trainings.

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.

Stay tuned for more information, including the schedule for live trainings!

February 16, 2024

Orientation to Yale IRBs for Yale New Haven Health System Researchers

In preparation for a transition of oversight of Yale New Haven Health research to Yale Human Research Protection Program and Yale IRBs, Yale New Haven Health researchers, staff, and individuals with oversight responsibilities are invited to attend any one of the orientation sessions on navigating Yale IRBs. The session will cover the process for getting access to the Yale IRB system, IRB review of initial submissions, and transfer of existing studies. All sessions will be recorded.

If needed, additional sessions may be added. If you cannot attend any of the sessions and would like to schedule an individual orientation for your research team, please, contact Gina Larsen at gina.larsen@yale.edu and OneIRB@yale.edu.

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.

May 25, 2023

Effective May 25, 2023, the “Supplement Safety during Pandemic” form will no longer be required as part of the IRB application for research being conducted within the United States. The Supplement remains a requirement for studies conducted outside the United States, except for studies limited to secondary data analysis or research that does not involve in-person interaction (for example, online surveys).

IRB guidance and IRB requirements have been updated accordingly and the revised Supplement is now available to investigators via the Other Forms tab in the IRES IRB Library and the Other Forms and Templates webpage on the Yale HRPP website.