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Any institution is eligible to file a federalwide assurance (FWA) with the Office for Human Research Protections (OHRP). Each legally separate institution must now obtain an FWA. IRBs currently designated only under Cooperative Protocol Agreements or Single Protocol Agreements will have to submit registration materials through the new system. Joint Assurances and Interinstitutional Amendments have been eliminated.
Remember, after Feb. 28, 2001, OHRP will no longer routinely accept assurances limited to Health and Human Services-supported research, to special categories of research, or to individual research projects.
1. First, complete an IRB registration with OHRP. (See "How to register your IRB using the new process," in this issue.)
2. Go to the OHRP FWA link on the OHRP Web site, or use the form provided in this issue: ohrp.osophs.dhhs.gov/humansubjects/assurance/filasuri.htm.
3. Download the form onto your computer, complete, and forward the registration form to the OHRP offices through one of the mailing addresses listed in "How to register your IRB using the new process."
4. Update your information as changes occur or once every 36 months — even if there are no changes — to maintain an active FWA on file.
If you have any questions or need additional information, please call (301) 496-7005.
During the three-month implementation phase, OHRP will accept comments and suggestions about the registration process and filing assurances. Based on the feedback, an on-line version of the submission process will be launched to provide instantaneous updating of materials.
Source: Office for Human Research Protections, Rockville, MD.