ࡱ> orn bjbj *F}c}c 4U66}84R\" [[[[[[[$0^`[[  \j!j!j!d [j![j!j!RSZnyHpW\["\0R\WxaaSZSZa [j![[ R\a6 C: SAINT LOUIS UNIVERSITY Institutional Review Board Waiver of Written Consent Principal Investigator (PI):IRB #:First Name / Last Name CredentialsTitle of Project: When waiving written consent, the IRB requires that you submit (upload) a document/script/letter for participants that addresses the eight required elements of consent as stated in 45 CFR 46.116(a)(1-8). You may use or refer to the  HYPERLINK "http://www.slu.edu/Documents/provost/irb/model_recruitment_statement.doc" \t "_blank" ƵModel Recruitment Statement when preparing this document. In addition, please complete the items below. PLEASE JUSTIFY HOW YOUR RESEARCH MEETS AT LEAST ONE OF THE FOLLOWING CRITERIA * The consent document would be the only record linking the subject to the research, and the principal risk is the potential harm resulting from a breach of confidentiality.  The research involves no more than minimal risk and involves no procedures for which a written consent is normally required outside of research.  The subjects or legally authorized representatives are members of a distinct cultural group or community in which signing forms is not the norm, the research presents no more than minimal risk of harm to subjects, and there is an appropriate alternative mechanism for documenting that informed consent was obtained.  PLEASE INDICATE THE CONSENT PROCESS TO BE USED IN LIEU OF WRITTEN CONSENT. * VERBAL CONSENT: Verbal consent must be documented in the research record. IMPLIED CONSENT: Indicate how implied consent will be given by subjects. (e.g., by continuation of an interview over the telephone or return of questionnaire, etc.).  OTHER:  The information listed in the waiver application is accurate and all research staff will comply with the consent regulations and the waiver 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 approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth in this section.  Note: Research staff is defined as ALL study personnel (including PI) that is involved in the research.     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