Welcome! OHRP’s Division of Policy and assurances provided this tutorial to help explain some
of the requirements relating to institutional Review Board (or IRB) Registrations and step
by step instructions for the IRB registration process. Let’s get started!
All IRBs that review non-exempt human subjects research, conducted or supported by the U.S.
Department of Health and Human Services referred to as HHS, must register with the Office for
Human Research Protections (OHRP). You will need the following information to
register an IRB: Name and Address of the Organization that
operates the IRB Contact information for the Organization’s
Senior or Head Official and the Contact Person providing the registration
information Each IRB name and location
Each IRB chairperson’s name and contact information
Approximate number of all active protocols and approximate number of active protocols
that are conducted or supported by HHS Number of full time equivalent positions (or
FTEs) devoted to the IRB Administrative activities IRBs who must submit IRB membership information,
should include their voting and alternate IRB members', name, sex, earned degree, whether
he/she is a scientist or non-scientist, his or her primary specialty and if she or he
is affiliated with the IRB institution or organization
Institutions must register an IRB using the electronic submission system.
An IRB registration is active for 3 years; An update must be submitted within 90 days
after a change occurs in the information provider or an IRB chairperson.
After processing the initial registration, any update or renewal to the registration
information on your organization's IRB, also must be done electronically through the electronic
submission system. At this point, we are going to talk about
the process of registering a new IRB Using this web page, your organization can
register an IRB, if it has never been assigned an IORG number by OHRP, and never registered
an IRB. You can view the instructions for registering a new IRB, at www.hhs.gov/ohrp/assurances/irb/register/index.html
Obtaining a submission number is the first step in registering an IRB.
Once you initiate a submission number request, your submission number will remain valid for
30 days. Please do not request multiple submission
numbers for one institution. In order to obtain an electronic submission
number, please follow the instructions below: Go to: ohrp.cit.nih.gov/efile/IrbStart.aspx
Then Scroll down to the bottom of the webpage and select:“I need a submission number”
A new page will open, in this page enter the following in the appropriate fields:
Your e-mail address A password that contains:
at least (1) uppercase letter at least (1) lowercase letter
at least (1) number or special character (ex. !@#$&) and
a minimum of 7 characters, and a maximum of 15 characters
A password hint that cannot be the same as the password
Check your email for an automated message from the system. This email will contain your
submission number. Once your submission number request is processed
you will receive an automatically generated email with a submission number within 24-48
hours from the Electronic Submission System (ESS).
If you do not receive the automatically generated e-mail by then, contact OHRP for assistance.
If you lose your submission number, please return to the IRB section of the Electronic
Submission System. Scroll down to “Forgot Your Submission Number and/or Password”
and enter your email address, and click submit. You will receive your submission number via
email.
If you lose your submission number, please return to the IRB section of the Electronic
Submission System. Scroll down to “Forgot Your Submission Number and/or Password”
and enter your email address, and click submit. You will receive your submission number via
email. Go back to the home page of the Electronic
Submission System ohrp.cit.nih.gov/efile/IrbStart.aspx
Please be sure to select “New IRB” Then scroll down to the bottom of the webpage
and select: “I Have a Submission Number”
to file a new IRB registration: log in using the submission number that the
ESS sent to you, and -The password that you have created.
You may begin entering information for an electronic submission and then find that you
are not ready to "Submit" it to OHRP for review. In this case, you may save the data entered
and return at a later time to complete the submission.
Once you get to the “Register IRB” tab in the section called: “Register IRB for
the Following Institution or Organization”, select the “Add IRB” button.
The rest of the application, is, straight-forward. You will need to be sure all required asterisk
fields are completed. Once you have entered information on each
screen and proofread all data fields, click on the "Save and Continue" button to move
to the next section. When all entries are made, please proofread
all fields of the IRB registration form, and roster (if applicable) to ensure the accuracy
of the data, and then click "Submit and Print IRB Registration."
After you select "Submit", your application will be reviewed by OHRP within 7-10 business
days - Once OHRP accepts your registration, the
following people will receive an email: -the Organization's Head Official,
-the organization’s information provider -and the I R B Chairperson.
Of course, this is dependent upon correct e-mail addresses being provided for each of
these individuals. - This concludes steps for registering a new
IRB. In closing, the process for updating IRB registrations-
is -similar. to view the update or renewal instructions,
please visit: www.hhs.gov/ohrp/register-irbs-and-obtain-fwas/irb-registration/update-renew-registration/index.html
The submission number is valid until OHRP processes the IRB registration associated
with that submission number. After processing of an electronically submitted
IRB registration, you must request a new submission number for subsequent updates or renewals.
Also, please do not attempt to update or renew an IRB registration when there is a pending
electronic submission for your organization. The changes you request with each electronic
submission, are not effective until the IRB registration, has been processed.
When the IRB registration is processed, you will receive an e-mail notification.
That concludes our review of the I R B Registration process. We hope you found it helpful. Visit
OHRP’s website, www.hhs.gov/ohrp for additional information.
Thank You