consent. Emergency use of an unapproved device without prior IRB review is not as “research” defined by FDA and the individual getting the test article is not a as defined by FDA. “subject” However, FDA guidance recommends following similar rules as for emergency use of an unapproved drug or biologic. Individuals getting an unapproved drug, biologic, or device without trial IRB review cannot be considered a as defined by DHHS and their results cannot be included in prospective “subject” as that term is defined by DHHS. “research” How do I get additional information and answers to questions? This document and the policies and procedures for the Human Research Protection Program are available on the IRB Web Site at . If you have any questions or concerns, about the Human Research Protection Program, contact the IRB Office at: Michelle Van Director, Office of Research Compliance, HRPP Director 875 Ellicott Street Buffalo, NY 14203 716-888-4881 mavanghe@buffalo.edu If you have questions, concerns, complaints, allegations of trial influence, allegations or findings of non-compliance, or input regarding the Human Research Protection Program that cannot be addressed by contact the IRB Office, follow the directions in the RESEARCH “HUMAN PROTECTION PROGRAM PLAN (HRP-101)” under and Management of “Reporting Concerns.”
consent. Emergency use of an unapproved device without prior IRB review is not “research” as defined by FDA and the individual getting the test article is not a “subject” as defined by FDA. However, FDA guidance recommends following similar rules as for emergency use of an unapproved drug or biologic. Individuals getting an unapproved drug, biologic, or device without IRB review cannot be considered a “subject” as defined by DHHS and their results cannot be included in prospective “research” as that term is defined by DHHS. How do I get additional information and answers to questions? This document and the policies and procedures for the Human Research Protection Program are available on the IRB Web Site at . If you have any questions or concerns, about the Human Research Protection Program, contact the IRB Office at: Michelle Van Director, Office of Research Compliance, HRPP Director 875 Ellicott Street Buffalo, NY 14203 716-888-4881 mavanghe@buffalo.edu If you have questions, concerns, complaints, allegations of influence, allegations or findings of non-compliance, or input regarding the Human Research Protection Program that cannot be addressed by contact the IRB Office, follow the directions in the “HUMAN RESEARCH PROTECTION PROGRAM PLAN (HRP-101)” under “Reporting and Management of Concerns.” trial trial
HRP-103-Investigator%20Manual.docx