The final rule requires the following information [see 21 CFR 56.106(b)]:
- The name, mailing address, and street address (if different from the mailing address) of
the institution operating the IRB and the name, mailing address, phone number, facsimile
number, and electronic mail address of the senior officer of that institution who is
responsible for overseeing activities performed by the IRB; - The IRB’s name, mailing address, street address (if different from mailing address),
phone number, facsimile number, and electronic mail address; each IRB chairperson’s
name, phone number, and electronic mail address; and the name, mailing address, phone
number, facsimile number, and electronic mail address of the contact person providing
the registration information; - The approximate number of active protocols involving FDA-regulated products
reviewed. For purposes of this rule, an “active protocol” is any protocol for which an
IRB conducted an initial review or a continuing review at a convened meeting or under
an expedited review procedure during the preceding 12 months; and - A description of the types of FDA-regulated products (such as biological products, color
additives, food additives, human drugs, or medical devices) involved in the protocols that the
IRB reviews.
