Yale New Haven Health System (YNHHS) Research

    Yale Human Research Protection Program provides support to Yale New Haven Health System (YNHHS) researchers. Yale IRB is the designated IRB of record for YNHHS research. Researchers wishing to utilize external (non-Yale IRBs) must submit requests to use an external IRB in IRES IRB system to obtain prior authorization.

    Researchers must obtain Yale netID and email address in order to access IRES IRB system. See below for steps to prepare a submission to Yale IRB.

    Obtaining Yale netID and email address

    Yale netID and email address are needed to submit applications in IRES IRB system. Request the netID by completing the online form below. You will receive an email with instructions on how to activate the netID within 7 days. Important: All emails from the IRES IRB system will go to your Yale email address. Check your Yale email address frequently OR forward your Yale emails to your primary email address, so you do not miss notifications from IRES IRB.

    Request for Yale Net ID and Email

    Training Requirements

    Before submitting your research documents, ensure all research team members have completed Human Subjects Protection Training within the last 3 years and are up to date with their HIPAA training. In addition, if your research is considered a clinical trial (using NIH definition), all study team members must also complete Good Clinical Practice. See the Education page for options of how to satisfy these requirements.

    Documents for Submission

    Templates of documents needed for submission are available in IRES IRB Library or the documents page. Protocols can also be built using Protocol Builder. At a minimum, the following documents will be required:

    Research Requiring IRB Review – Submission to Yale IRB

    Document Purpose
    Protocol Describes the background, rationale, objectives, design, methodology, statistical considerations, etc., uploaded in the Basic Information page in IRES IRB
    IRB Submission Form Describes how research is conducted at a specific site, e.g., how consent process is conducted, provides information for requests for consent waivers, details about confidentiality, etc.; uploaded in the Local Documents page in IRES IRB
    COI Disclosure Asks questions about significant interest related to the study for any of the key personnel; uploaded in the Local Documents page in IRES IRB
    Other Research Documents: Consent, consent scripts, recruitment materials, etc. Additional research related documents; uploaded in the Local Documents page in IRES IRB

    Exempt Determination Request – Submission to Yale IRB

    Document Purpose
    Exemption Request Replaces Protocol and IRB Submission form; complete only the sections for the specific exemption category applicable to your research
    COI Disclosure Asks questions about significant interest related to the study for any of the key personnel; uploaded in the Local Documents page in IRES IRB
    Other Research Documents: Consent, consent scripts, recruitment materials, etc. Additional research related documents; uploaded in the Local Documents page in IRES IRB

    Research Requiring IRB Review – Reqest to Use External (non-Yale) IRB

    Document Purpose
    Requests to Use External IRB Describes how research is conducted locally to ensure the institutional requirements for human subjects research are met;
    Protocol Describes the background, rationale, objectives, design, methodology, statistical considerations, etc., uploaded in the Basic Information page in IRES IRB
    COI Disclosure Asks questions about significant interest related to the study for any of the key personnel; uploaded in the Local Documents page in IRES IRB
    Other Research Documents: Consent, consent scripts, recruitment materials, etc. Additional research related documents: for consent forms, submit the template consent forms (if received from the coordinating center or reviewing IRB) and the tracked version of the consent forms proposed for use locally; uploaded in the Local Documents page in IRES IRB

    IRES IRB Submission

    • Once in your IRES Dashboard, click the “Create New Study” button on the lefthand side of the webpage.
    • Complete each page of the study application.
    • Once you complete the application and upload all applicable documents, click “Finish” on the last page of the application. You will then navigate to the main study webpage, and you will need to click the “Submit” button on the lefthand side of the page. This action submits your study to the IRB for review. You will be notified via email if the IRB has any questions for you. You will be assigned a Regulatory Analyst once you submit your study, who will guide you through the IRB review and approval process, and who you can contact directly with questions.

    Where to Get Help

    For general IRB questions, you can also contact HRPP@yale.edu or OneIRB@yale.edu.

    Review “Frequently Asked Questions” guide for researchers. You should also familiarize yourself with the HRPP Policy and Standard Operating Procedure Manual and Investigator Manual, as these documents contain a lot of helpful information.

    Finally, there are several upcoming training sessions where learners are taught how to navigate IRES IRB. You can login to Yale’s Workday Learning with your Yale NetID to sign up for one of our Training on IRES-IRB System (Yale IRBs) courses (for studies where Yale will serve as the IRB of record), or one of our Training on IRES-IRB System (External IRBs) courses (for studies where an external IRB will serve as the IRB of record).