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Initial IRB Registration

An institution or organization that has not registered any IRB must do so on-line, unless it lacks the ability to register its IRB online. If an institution or organization believes it lacks the ability to register its IRB online, it should contact OHRP by telephone or email (see here) and explain why it is unable to register its IRB online). 

  • Obtaining a submission number is the first step.
  • Please follow the instructions below:
  1. Go to http://ohrp.cit.nih.gov/efile/IrbStart.aspx
  2. Scroll down to the bottom of the screen and click on “I need a submission number”
  3. Enter the following in the appropriate fields
    1. Your e-mail address
    2. A password with a mix of upper and lower case letters and numbers or special characters
    3. A password hint that cannot be the same as the password
  4. Click on the “Submit” button
  5. Once you receive the submission number:
    1. Repeat step 1 above
    2. Then scroll down to the bottom of the screen and click “I have a submission number”.
    3. Enter the submission number
    4. Enter the password
  6. Click on the “Submit” button
  7. The IRB Registration fields will be presented to complete.

 

Frequently Asked Questions (FAQs) on the IRB Registration Process are at http://answers.hhs.gov/ohrp/categories/1565.

  • FDA’s “Guidance for Institutional Review Boards (IRBs) - Frequently Asked Questions - IRB Registration” is available here.

 

  • If an IORG lacks the ability to register an IRB electronically using the Web page, after consulting with OHRP it must send the IRB registration information in writing:

 

  • If the IRB reviews research regulated by OHRP only or reviews research regulated by FDA and OHRP, send the IRB registration information to OHRP by:

FAX: 240-453-8202,

By email as a pdf scanned document,
or mail it to
Division of Policy and Assurances
Office for Human Research Protections
The Tower Building
1101 Wootton Parkway, Suite 200
Rockville, MD 20852

  • If the IRB reviews research regulated by FDA only, send the IRB registration information to FDA to:

The Good Clinical Practice Program (HF-34)
Office of Science and Health Coordination
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857