IRB - Getting Started

We want to help ensure a smooth integration into the Yale HRPP/IRB system and ask that you follow the steps in order as presented for the best outcome. We look forward to working with you! Please feel free to contact us at [email protected] or call 203-384-4549 should you have any questions. Or, if you have intranet access, contact research on the Bookings app in Microsoft Teams.

1. Getting Started: Yale NetID and email address
   • Please use our fillable form. Please complete all of the requested datapoints including work email addresses as well as your primary home institution. 
   • Please be advised that it will take at least five business days to receive your NetID and email address. 
   • The OneIRB platform (IRES) only connects with users via their @yale.edu email address. Please be sure to forward this address to your @bpthosp.org account or check @yale.edu regularly.
2. CITI Certifications:
   • Please complete your required CITI certification training as your next step. You will need to complete either: social behavioral or biomedical training for all studies. Please be sure that the training is marked IRB. No other training (GCP, RCR, etc) can be substituted for IRB training.
   • For those working in clinical trials, or FDA studies, you will need to complete a second training, Good Clinical Practice.
   • Please be sure to register and create an account using your Yale email address. You can transfer your active, existing CITI certifications through CITI to Yale IRB. However, the transfer must be made through the CITI platform. Please do not send CITI certifications to Yale IRB directly. 
   • Register with CITI and then affiliate with Yale. Should you already have a CITI account, you can affiliate with Yale University and have your information transferred to Yale. Or you can create an account with CITI and then affiliate with Yale.
3. HIPAA:
   • All YNNHS researchers must complete HIPAA training.
   • There are also training options available for clinicians, administrators, and those working at foundations. We are focused on researchers with this handout. Please complete the “researcher course” for research-related activities for persons working in the YNNHS.
4. BH IRB Contact:
   • Bridgeport Hospital does not have an active IRB. We offer support services for researchers preparing their IRB protocols or those interested in pursuing research activities. All protocols must be received and reviewed by Yale HRPP/IRB. Please contact [email protected] should you need support prior to submitting your research proposal.
     
     1. Education and Training:
        1. How to use the Yale IRES online HRPP platform
        2. Quick access to protocol templates:
           1. Medical Record Review Form (MMR or Chart Review)
           2. Exempt (No greater than minimal risk)
           3. Expedited studies and Full Board Studies (Yale IRB)
           4. Secondary Data Analysis (Existing Datasets)
     2. Protocol Builder:
        1. Yale School of Medicine and the HRPP have provided a tool to support protocol development.
        2. You will still need to provide additional information and modifications to your protocol after using the protocol development tool, although you will have a developed draft.
   • Faculty Advisor Agreement:
     1. All residents and fellows must have a faculty advisor supervise their research activities.
     2. Please complete the faculty advisor form and return with signatures.