ࡱ> ] bjbj++ vI'bI'b qJ008h{\j^ttt~!~!~!@{B{B{B{B{B{B{$~Ӏf{~!\!"~!~!~!f{00tt{{"""~!v08tt@{"~!@{""xnhvt }<!v8qL,{{0{qYj"FYvYv$~!~!"~!~!~!~!~!f{f{"~!~!~!{~!~!~!~!Y~!~!~!~!~!~!~!~!~!B :  Office use only: Protocol #: _____________ Date: _______ Appendix A IRB Request for Oral Consent or Waiver/Alteration of Consent Process Please read the IRB Informed Consent Process policy online prior to beginning this form to determine whether your request meets the Federal and SU criteria for waiver or alteration. (Note: Inconvenience or expense does not satisfy the criterion for waiver or alteration.) Email this typed form with your initial protocol application as a separate file titled: LASTNAME.Appendix A.Waiver.DATE to  HYPERLINK "mailto:irb@seattleu.edu" irb@seattleu.edu. Research Study Information Principal Investigator (Last name, First)Project Title *Are any subjects minors (children)? FORMCHECKBOX  Yes FORMCHECKBOX  No **Indicate the nature of the request by checking the appropriate box below: FORMCHECKBOX  Use of oral consent (waiver of written documentation) > Complete only Section I  FORMCHECKBOX  Waiver or alteration of consent (e.g.: request to waive parental permission) > Complete only Section II Section I: Use of oral consent Briefly explain why you propose to obtain consent without standard written documentation (e.g., oral consent). >> Is the existence of a signed consent document the only document or record that would link the subject to the research (i.e., data and specimens will not be recorded or stored with identifiers or links to identifiers)? If so, explain why use of alternative consent is preferable to a signed consent document.>> Section II: Waiver or alteration of consent Note: If the research involves a product regulated by FDA or the results of the research may be submitted to FDA as part of a marketing application, consent cannot be waived. This request is for (check one) FORMCHECKBOX  A waiver of parental permission.  FORMCHECKBOX  A partial waiver or alteration of consent.  FORMCHECKBOX  A waiver of the requirement to obtain adult consent. Briefly explain why a waiver or other alteration of consent is requested for this research study.>> ( Note: Either Condition 1 (#3) or Condition 2 (#4) below must apply to the research to receive approval for waiver, partial waiver, or alteration of consent. CONDITION 1: Minimal Risk Does your research involve greater than minimal risk to the subjects? If YES, a waiver cannot be granted under this condition. Continue to Question #4. If NO, explain how the research involves no more than minimal risk.>> Will or could a waiver of consent adversely affect the rights and welfare of the subjects? If YES, a waiver cannot be granted under this condition. If NO, explain why the rights and welfare of the subjects will not be adversely affected. >> 4. CONDITION 2: State or Local Public Benefit or Service Programs Is the research to be conducted by, or subject to the approval of, state or local government officials? If NO, a waiver cannot be granted under this condition. If YES, explain what the research is designed to study, evaluate, or otherwise examine.>>     IRB Request for Informed Consent Waiver or Alteration: Page  PAGE 1 Last Revised: May 2018 SU Institutional Review Board Admin 201, 206-296-2585 irb@seattleu.edu  -57>?@JͿueUE5hEsh#$Q5CJOJQJaJ hrh:5CJOJQJaJ hEshEs5OJQJ\aJh.hNW>*OJQJ\aJh.hEs>*OJQJ\aJhEs5OJQJ\aJh.hNW>*OJQJhNWOJQJhNWhNW5OJQJhZ95OJQJ\aJhZ95>*OJQJ\aJ!h|hZ95>*OJQJ\aJhZ9hZ95OJQJ\aJ"jhZ9OJQJUmHnHu.?@ Z  & Fh<P$If^h`gdc  & Fhd$If^h`gdaW gd; <<gdZ9 <xgdZ9JQ]mstG H I J ²q`QBQBhc hp0w5OJQJ\]hc hNW5OJQJ\] *hc h [q5OJQJ\] *hc hp0w5OJQJ\] *hc h^5OJQJ\]hc h^5OJQJ\]hrh8Y5CJOJQJaJ hwDhh5CJOJQJaJ hEshm5CJOJQJaJ h-j5CJOJQJaJ hEshp0w5CJOJQJaJ hEsh [q5CJOJQJaJ J K P Q  ! 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