The RA Application Process
An organization is ready to submit an application to become a Yale RA once it has identified individuals to serve in the positions that support a human subjects protection program, has adopted policies that provide the framework for such a program, and completed all required training. Please note that an incomplete application could delay the review and decisionmaking process.
Step 1 – Contact the IRB
The Yale principal investigator who is working with the potential RA should contact the Yale IRB most likely to review the research and describe the proposed research project(s) and the potential RA. The IRB personnel at the cognizant IRB(s) are available to answer questions and to provide additional information. Contact information for the Yale IRBs:
- Yale University's School of Medicine IRBs (Human Investigation Committee I and II ) 203-785-4688
- Yale University Faculty of Arts and Sciences IRB (Human
Subjects Committee)
203-436-3650, human.subjects@yale.edu - Yale University School of Nursing IRB: contact the Office of Research Affairs 203-737-2420.
Step 2 - Complete the Application
The application to become a Yale RA is called the "Request for Permission to Designate Yale University's Institutional Review Board(s) (IRB) as IRB of Record for Research Involving Human Subjects." This form is located in the Forms and Templates section of this website.
Step 3 – Attach the Required Documentation to the Application
Submit the following documentation with the application:
- The signed DRAFT version of the organization's Federalwide Assurance (FWA) application
- All of the organization's human subjects protection policies (including both its standard policies and practices as well as appropriate special topic policies).
- Proof of training (training certificates) for the organization's Signatory Official (SO) and the Human Protections Administrator (HPA) in the following areas:
- Human subjects protection training (NIH);
- HIPAA Privacy Rule as it pertains to research, if applicable; and
- OHRP FWA training.
Step 4 – Submit the Application
Submit the application to become a Yale RA, with the required documentation, to the Yale IRB most likely to review the organization's research.
Step 5 – Application Review
Yale will review the application and decide whether to approve or disapprove it. Yale will notify the organization of the decision. If the application is approved, Yale will prepare an IRB Authorization Agreement (IAA) and provide the IAA to the organization for review.
OHRP requires an organization that wishes to use another organization's IRB as its IRB of record to sign an IAA. The IAA is the agreement between Yale and the RA. The IAA typically describes the relationship between the RA and Yale including (a) the authority of the Yale IRB(s); (b) the responsibilities of the RA regarding human subjects protection education, training, policies, and reporting; (c) HIPAA (if applicable); and (d) the term of the IAA and the types of protocols to be reviewed.
The RA application process and approval process are complete when the following have occurred:
- Yale has notified the organization that its application to become an RA has been approved;
- Yale and the organization have signed the IAA; and
- The organization has submitted, and OHRP has approved, the organization's FWA.
Step 6 – Submit Research Protocol(s) to a Yale IRB
A Yale IRB will review a research protocol from an organization only after the RA process is completed. Each Yale IRB has its own set of policies and procedures that will govern the review process for all submitted protocols. The RA should therefore review the website and/or guidance for the specific Yale IRB that will review the research protocol before submitting it for review. Researchers should direct all questions about the IRB review process to the IRB reviewing their protocols.
