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OHRP Guidance – FWA Instructions – U.S. Institutions
If your institution relies on the IRB of another institution or organization, this arrangement must be documented in writing between the two institutions/organizations. OHRP has a sample IRB Authorization Agreement on its website at http://www.hhs.gov/ohrp/humansubjects/assurance/iprotsup.rtf that may be used for this purpose, or the parties involved may develop their own agreement. The agreement must be kept on file at the institutions and available for review by OHRP upon request, but it should not be submitted with the FWA form.
If at any time your institution relies on an IRB not listed on your FWA to review research to which the FWA applies, you must update your FWA and list the additional IRB(s) (see the instructions for updating or renewing an FWA on the OHRP website at http://www.hhs.gov/ohrp/humansubjects/assurance/renwfwa.htm).
ITEM #6 - Human Protections Administrator (e.g., Human Subjects Administrator or Human Subjects Contact Person)
Designate the individual who will serve as the Human Protections Administrator (HPA) (i.e., the primary contact person for human subjects protection issues) for your institution. The HPA would exercise operational responsibility for your institution’s program for protecting human subjects in research. The HPA should have comprehensive knowledge of all aspects of your institution’s system of protections for human subjects, as well as be familiar with the institution’s commitments under the FWA, and play a key role in ensuring that the institution fulfills its responsibilities under the FWA. Please note that the HPA should be prepared to fulfill the responsibilities noted above for all research covered under the FWA.
Type or print the full name, degree(s) or suffix, institutional title (e.g., administrative title such as manager or director of a given office), institution name, telephone and fax numbers, e-mail address, and full mailing address for the HPA. The e-mail address is very important, as this will provide the means for effective communication from OHRP (e.g., sending of new information regarding the FWA or other guidance from OHRP). If any of these fields are not available, please indicate accordingly rather than leaving the field blank.
ITEM #7 - Signatory Official (i.e., Official Legally Authorized to Represent the Institution -- cannot be IRB Chairperson or IRB member)
The Signatory Official must be a senior institutional official who has the authority to commit the entire institution named in the FWA form, as well as all of the institutional components listed under Item #2, to a legally binding agreement. Entities that the Signatory Official is not legally authorized to represent may not be covered under the FWA. This individual must also have the authority to assure compliance of the institution and all of its components to the Terms of the FWA. Generally, this is someone at the level of President, Chief Executive Officer (CEO), of Vice President of a company, or at the level of President, Provost, Chancellor, Vice President, or Dean of an academic institution, unless another official has been specifically delegated with this authority. Typically, the Signatory Official is not a department chair, division director, or another official who only has authority over a portion of the institution. The IRB Chairperson and IRB members are not appropriate personnel to serve as the Signatory Official.
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