Can HHS Form 690 be submitted in lieu of filling out all the assurances and certifications required under Section G of Form PHS 398?
If your institution has completed a Form 690 and filed it with the Office of Civil Rights, HHS, then the signature of the official identified in Block 13 of the Face page signifies that the institution has already complied. However, the portions of the Research Plan that deals with Human Subjects Research and Vertebrate Animals address project-specific requirements. These sections must be completed, as appropriate for your project. Question 45: If the Applicant Organization is a non-profit that does not have an in-house Institutional Review Board (IRB), and the proposed project involves intervention at the hospital level rather than with individual patients, is IRB approval required? Answer: If the project involves human subjects as defined by HHS regulations, you will need an IRB approval, as well as institutional assurance of intent to comply with all applicable regulations, before an award can be made. You do not need an in-house IRB. There are for-profit companies with whom the App
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