ࡱ> lok bjbj *F}c}cU 9Occcwww84w!V"|||UUUUUUU$WZUc|||||UccU6#6#6#|dccU6#|U6#6#bMQfT l| RVUU0!V`Re[\e[fTfTne[cT||6#|||||UU@!|||!V||||e[||||||||| : SAINT LOUIS UNIVERSITY Institutional Review Board Alteration of Consent, Principal Investigator (PI):IRB #:First Name / Last Name CredentialsTitle of Project: The research involves no more than minimal risk to the subjects.  The alteration will not adversely affect the rights and welfare of the subjects.  The research could not practicably be conducted without the requested alteration.  Whenever appropriate, the subjects or legally authorized representatives will be provided with additional pertinent information after participation.  If the research involves using identifiable private information or identifiable biospecimens, the research could not practicably be conducted without using such information or biospecimens in an identifiable format.  Indicate whether or not this study is a research or demonstration project to be conducted by or subject to the approval of state or local government officials. If yes, indicate what the research is designed to study, evaluate, or otherwise examine [a) Public benefit or service programs; b) Procedures for obtaining benefits or services under those programs; c) Possible changes in or alternatives to those programs or procedures; or d) Possible changes in methods or levels of payment for benefits or services under those programs.  The information listed in the alteration application is accurate and all research staff will comply with the consent regulations and the alteration criteria. I assure that the information I obtain as part of this research (including protected health information) will not be reused or disclosed to any other person or entity other than those listed on this form, except as required by law. If at any time I want to reuse this information for other purposes or disclose the information to other individuals or entity I will seek approval by the IRB. Signature of Principal Investigator (PI)Date First Name / Last Name CredentialsPrinted Name of Principal Investigator (PI) FOR IRB USE ONLY APPROVED ____________________________________________ IRB Authorized Representative Date   Federal Regulations: 45 CFR 46.116(d)(1-4); An IRB may alter the requirements to obtain informed consent provided that the IRB finds and documents that all four criteria listed above are justified.  Please note: If this research is associated with a product (biologic or device) regulated by the FDA, regulations 21 CFR Parts 50 and 56 do not allow for waiver/alteration of informed consent unless a circumstance described at 21 CFR 50.23 (Exception from General Requirements) or 21 CFR 50.24 (Exception for Emergency Research) applies. FDA regulations do allow for waiver of written consent if the research meets the required criteria outlined in Section B.  Note: Research staff is defined as ALL study personnel (including PI) that is involved in the research.     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