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Join TrialNet | OHRP Assurance

Obtaining OHRP Assurance Number

“If your institution is engaged in human subjects research (not otherwise exempt) that is conducted or supported by any agency of the U.S. Department of Health and Human Services (HHS), then your institution must have an OHRP-approved assurance of compliance with the HHS regulations (45 CFR 46.103) for the protection of human subjects.”

The OHRP Assurance option you need is the Federalwide Assurance (FWA).

To submit an FWA to obtain OHRP-approved assurance:

Step 1:

The first step in getting the OHRP-approved Assurance is to be sure that your institution’s IRB is registered with OHRP. If you think your IRB is registered it will be listed under Institutional Review Board Registry on the OHRP website: http://ohrp.cit.nih.gov/search/irbsearch.aspx?styp=bsc. You can search domestic or international Institutional Review Boards.

If you need to register your IRB, you can do this online: http://www.hhs.gov/ohrp/assurances/index.html#registernew.

Step 2:

To apply for your assurance online, go to http://www.hhs.gov/ohrp/assurances/assurances_index.html, select: New Federal Wide Assurance – Domestic (US only) or International (non-US). Next you will see the steps for a paper or electronic FWA submission.

Next Step: Complete New Affiliate Packet [.pdf]

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