Fellowships and the Institutional Review Board (IRB)

What is the Institutional Review Board?

The Yale Human Research Protection Program provides administrative and regulatory support to 4 Institutional Review Boards (IRBs) for biomedical research known as Human Investigation Committee (HIC I, HIC II, HIC III, HIC IV) and one IRB for social, behavioral and educational research known as Human Subjects Committee (HSC).

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Why is the IRB necessary?

As explained on the Human Research website, Yale has made a commitment to ensure that all Yale research complies with federal and state regulations, University policy, and the highest ethical standards. You can also see this as an opportunity to reflect upon your research from different perspectives to make sure that you are being as ethical and responsible as possible in your methodology and approach.

How do I know if my research requires IRB review?

If you are applying for, or have been awarded a fellowship, this decision tree may help you determine whether your research requires IRB or exemption. Please note, you cannot determine exemption for yourself. Exemption must be applied for and can only be granted by the IRB.

Tip: Be sure to check the Human Research website for an overview on how to approach the IRB application process.

What does it mean if my research requires IRB review?

If your project requires IRB review, it means that you will need to go through the Institutional Review Board that is relevant to your project to seek approval or exemption, before you can start your research and before a fellowship check can be released to you. For CIPE fellowships, this is usually the Human Subjects Committee (HSC). If your research will involve animals, please go here for further details.

When should I submit my IRB application?

At certain times of the year, such as the spring semester, the IRB has to process lots of applications from all over Yale. Some CIPE fellowships (such as the Global Health fellowships and the CIPE Summer Research fellowships) ask in the application that you start your IRB application before you submit your fellowship award. If that is the case, please start your IRB application as soon as possible to avoid a delay in receiving your fellowship award as IRB review takes, on average, 25 days. For most other fellowships, you should not start your IRB application until you have been notified that you are the recipient of a fellowship award. Please refer to the instructions in your fellowship application for further details.

How can I prepare for the IRB application process?

You are strongly advised to read the "What is the IRB application process" section of this page before you begin.

Once you have read the information below, the Human Research website has some useful guidelines as to how you can prepare to submit an IRB application for review. Go to this page and scroll down to click on "General FAQs for Student Research" for information specific to undergraduate applications. Once you have started your IRB application, you will be able to access the forms you will need from within the IRES system. The verbal information sheet and written consent forms can be found on this page.

Tip: You must read and adhere to this checklist before submitting to avoid your application being returned or delayed.

Can anyone help me as I prepare my IRB application?

As a Yale student, your research will most likely be supervised by a Yale faculty member. You may need to collaborate with your supervisor, who will likely be familiar with the IRB process, as you submit your IRB application. Your faculty supervisor will also be required to sign your application protocol. The staff and committee members of the Yale IRBs are very understanding in their approach, and recognize that for many undergraduates the IRB process can sound daunting. The resources available on the Human Research website can help you be sure that your application is as complete as possible before you submit it. Once you have submitted your application, the Regulatory Analyst assigned to your application will be in touch with any changes or questions.

What is the role of my faculty supervisor/adviser in the IRB process?

Before you commit to carrying out research, you should make sure that the person who will be your faculty supervisor/adviser has agreed to work with you in that role, that they are aware of, and comfortable with, what that role entails (this may vary depending on the advising style of the faculty member, their department and your project) and that they will be present or, at least, easily reachable and available to you as you plan and carry out your research. Be sure to discuss your plans thoroughly with your faculty supervisor/advisor to reach a mutual understanding regarding the terms of your working relationship.

Your faculty superviser/adviser will also be a vital resource for discussing any ethical and practical concerns or questions you may have about your research and how it might impact your participants.

If I am carrying out research abroad, do I need to be in touch with a local IRB?

If you are carrying out human subjects research abroad, you will need to go through the Yale IRB process and you may also need to seek IRB approval in your host country. To locate an IRB for your host country, go to the OHRP IRB database and click on "Advanced Search" to search by country. When planning, be aware that the process of getting approval from an international IRB may take a long time and involve a cost. Contact Human.Subjects@yale.edu for further guidance.

What is the IRB application process?

Tip: IRB applications cannot be processed until the requirements of steps 1 and 2 have been met.

Step 1.

All students and faculty advisors need to complete Human Subjects Protection Training.

Step 2.

All students and faculty advisors need to submit a Conflict of Interest Disclosure.

Please contact the Conflict of Interest Office at conflicts@yale.edu so that an account can be created for you to complete the External Interests Disclosure form. To reach the form, click on “Access the External Interests Disclosure form” on the left side of the Conflict of Interest page. Please note: This is a university requirement and must be fulfilled, regardless of the funding source.

Tip: IRB applications for research funded by fellowships must be submittted via the IRES IRB Submission System.

    Important: Read and adhere to this checklist before submitting. Incomplete submissions will be returned and applications which have not been appropriately flagged as fellowships may be delayed.

Step 3.

Once you have completed steps 1 and 2, you will need to submit the following via the IRES IRB Submission System:

• A completed HSC application, along with survey questions and consent forms. These can be found within the IRES system - click "Library" in the menu bar and then click on the "Templates" tab.
• A completed International Research Checklist (if applicable)

Tip: Access to the IRES IRB Submission System requires your NetID and password.

To be able to log in to the IRES IRB Submission System using your NetID, you will need to be registered as a student worker. If you have applied for, or been awarded, a CIPE fellowship, this will be done on your behalf and may take up to 2 working days.

If you are unable to log in to the IRES IRB Submission System, contact irb.support@yale.edu