ࡱ> z|y (ibjbj$$ 4nF|F|Z**8'... (HHHJTY :-<-<-<-<-<-<-$U/2\`-"]^""`-**HH-***"P*lHH:-*":-**2,,~,HPˍ %jJ,&--0'.R,,c2w%Jc2~,c2~,!>C!,*o!$!*!!!`-`-'D!!!'.""""c2!!!!!!!!! :  Preparatory to Research Review Application HIPAA Research Agreement  IRB # ____________ (If this request is related to an existing IRB submission)   This Health Insurance Portability and Accountability Act (HIPAA) Research Agreement is made this  FORMTEXT       day of  FORMTEXT      , 201 FORMTEXT   by and between Saint Louis University and its members and healthcare providers and  FORMTEXT       (Principal Investigator). HIPAA sets forth a rule (the Privacy Rule) governing the privacy of a patients identifiable health information (referred to in the Privacy Rule as protected health information or PHI). The Privacy Rule sets forth guidelines intended to preserve the integrity and confidentiality of PHI. The Privacy Rule can be found at 45 CFR, Part 164, Subpart E or at: HYPERLINK "http://www.hhs.gov/ocr/hipaa/finalreg.html"http://www.hhs.gov/ocr/hipaa/finalreg.html. Section 164.512(i) of the Privacy Rule titled Standard: Uses and Disclosures for Research Purposes provides that a covered entity may disclose a patient's PHI to the Researcher for reviews preparatory to research based on the following representations from the Researcher, to which Researcher agrees to comply: Such use or disclosure is solely for purposes of reviewing the PHI as necessary to prepare a research protocol or for similar purposes preparatory to research (e.g., to design a study or to assess the feasibility of conducting a study). Describe the purpose of your PHI review: The PHI being sought to be used or disclosed is limited to the minimum necessary to achieve the purpose(s) of the review. Describe the specific nature of the PHI that you are requesting for review, where that PHI is located, and indicate why each of the data elements being requested is necessary to achieve the purpose(s) of the review: What type of record/chart/database will be reviewed for research? Please check all appropriate boxes:  FORMCHECKBOX  Medical Record/Chart Review  FORMCHECKBOX  Films/X-rays  FORMCHECKBOX  Computer/Database  FORMCHECKBOX  Billing records  FORMCHECKBOX  Quality Improvement Records  FORMCHECKBOX  Other types of records (please specify):  The PHI being sought to be used or disclosed is necessary for the research project. Explain why the requested PHI review is necessary to prepare your research protocol: The Researcher(s) will not remove any PHI from the source, either physically or through disclosure to a third party, in the course of the research review. The Researcher(s) will comply with IRB requirements for all research studies that result from this review performed preparatory to research. The Researcher(s) will not contact any individual whose record has been reviewed as part of this preparatory work. I agree that only the following individuals will query medical records/charts and/or databases under my direction, for the above stated purpose: (They must be employees of the Saint ֱοƵ University.) NameDepartment/FacilityStatus (i.e., investigator, fellow, coordinator, etc.) FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT        FORMCHECKBOX  I have attached a copy of my data collection form (if applicable). 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This agreement is to be completed by the principal investigator and submitted to the Institutional Review Board (IRB) for review if it relates to an existing IRB sX X XXXXXfXhXjXlXnXXXXXXXXYYYRYZYϾϕyhV<Ϧ2j+hb[ hxn>*CJOJQJU^JaJ#hb[ h >*CJOJQJ^JaJ hwuh CJOJQJ^JaJhCJOJQJ^JaJhb[ h >*OJQJ^J hb[ h CJOJQJ^JaJ/jhb[ h >*CJU^JaJmHnHu h>*CJ^JaJmHnHu,jhb[ hxn>*CJOJQJU^JaJ2jX+hb[ hxn>*CJOJQJU^JaJZY\Y`YpYYYYYYYYYZZ Z ZbZdZfZzZض養rarF9hb[ h OJQJ^J4jhxnhxnCJOJQJU^JaJmHnHu h>*CJ^JaJmHnHu/jhb[ h >*CJU^JaJmHnHu2jD,hb[ hxn>*CJOJQJU^JaJ#hb[ h >*CJOJQJ^JaJhCJOJQJ^JaJ&hb[ h 5CJOJQJ\^JaJ hb[ h CJOJQJ^JaJ,jhb[ hxn>*CJOJQJU^JaJnX^Y`YZ ZbZdZj[l[ \\\\\\\\\$\%\&\1\e\f\g\rhgd h]h&`#$@&gd gd zZ|Z~ZZZZZZ[[j[l[[[[[ \\\\\\\\\ϷϘucuuQuIEIEIEIEh0jh0U#hwuh 6CJOJQJ^JaJ#hb[ h >*CJOJQJ^JaJ hb[ h CJOJQJ^JaJ#hwuh6CJOJQJ^JaJhCJOJQJ^JaJ h>*CJ^JaJmHnHu/jhb[ h >*CJU^JaJmHnHu,jhb[ hxn>*CJOJQJU^JaJ2j,hb[ hxn>*CJOJQJU^JaJ\\ \!\"\#\$\%\&\'\-\.\/\0\1\4\[\_\b\e\f\g\]hqhrhŲŝŲ~p~lYWYGh.56OJQJ\]^JU$hwEh.56OJQJ\]^Jh0h#CJOJQJ^JaJh.CJOJQJ^JaJ hh.CJOJQJ^JaJ)h.0JCJOJQJ^JaJmHnHu$hh.0JCJOJQJ^JaJ-jhhxn0JCJOJQJU^JaJh-h.h.0JmHnHu h.0Jjhxn0JUubmission; otherwise it should be forwarded for review and approval by the Research Privacy Officer or designee. 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