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2017-01-10 发布于湖南
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到 b waiverof authorizationor a m 的笔和（ applicationfor i r b waiverof authorizationor- a o m a）.doc

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Application for IRB Waiver of Authorization or Altered Authorization under the HIPAA Privacy Rule Purpose of this form This form was created to facilitate the submission and review of a request to use/disclose protected health information (PHI) under an IRB approved waiver of or altered authorization. Instructions ? Waiver If you are applying for approval of a new minimal risk initial review or exemption application (such as retrospective medical record review), and you believe it would be impracticable to obtain a signed authorization from some or all of the research subjects; you may apply to the IRB for a waiver of authorization to use/disclose their PHI. This application may be to use/disclose PHI located in either a medical record or in a database. ? Altered Authorization If you are applying for approval of a new minimal risk initial review or exemption application, and you are seeking either a waiver of some of the required elements of informed consent or a waiver of documentation of informed consent from the IRB (such as for survey or interview research), you may request an altered authorization, which asks the IRB to waive some of the elements of a full HIPAA Authorization required under the Privacy Rule for research subject authorization to use/disclose PHI. APPLICATION: A. This application is to request the following (check all that apply): [ ] Waiver of authorization (for all uses of PHI) [ ] Partial waiver of authorization (for some uses of PHI-describe the parts of the protocol for which you are requesting a waiver) [ ] Altered authorization. (Attach 2 copies of your altered authorization form proposed for use with subjects) B. Required Information The regulations require that the protocol present minimal risks to research subjects in order to qualify for a waiver of or altered authorization. Note that risks to research subjects can be physical or psychosocial. The answers to questions 1-5 below will help the IRB determine if th