ࡱ>    / ,!bjbjNN ,bh,bh#<$B8UUUVBXBXBXBXBXBXB$EG|B@U|B-B.8VBVB>Ab?"BBB0B@H RHDAHA`U^7L=UUU|B|B^LUUUBHUUUUUUUUUX J: 91Ϣ of Health Sciences Institutional Review Board 16200 E Amber Valley Drive Whittier, CA 90604 Phone: 562 947 8755 Fax: 562 947 5724  Request for Approval of HIPAA Privacy Rule Waiver/Alteration of Patient Authorization 45 CFR 164.512 Complete this form if you will access identifiable patient records without written authorization for any of the following: To collect identifiable information for research To create a limited data set To de-identify data for use in research (unless the data sources are limited to your own patients or research subjects). Data are identifiable unless fully de-identified according to the HIPAA standards and re-identification is no longer possible Do not submit this form if you will access or receive de-identified data only and will have no ability to re-identify data subjects. The IRB must approve a waiver or alteration of patient authorization for the use of disclosure of PHI. In order to grant this waiver, the IRB must review enough information, to be provided by the Applicant, to determine that the alteration or waiver of authorization satisfies all of the following criteria: That the use of disclosure of PHI involves no more than a minimal risk to the privacy of individuals based on criteria i iii below; and Adequate plan to protect the identifiers from improper use or disclosure; and Adequate plan to destroy the identifiers at the earliest opportunity, unless retention of identifiers is required by law or is justified by research or health issues; and Adequate written assurance that the PHI will not be used or disclosed to a third party except as required by law or permitted by an authorization signed by the research subject. That the research could not practicably be conducted without the waiver or alteration; and That the research could not practicably be conducted without access to and use of the protected health information. Section 1 Project Identification In applying for waiver of the HIPAA authorization requirement, you are assuring the IRB that the identifiers you request will not be used for any other purpose or disclosed to any other person or entity (apart from research team members listed in this application), except as required by law, for authorized oversight of the research study, or for use in future IRB-approved research. Table 1 Complete this table for principal investigator only NameTitle & DepartmentAcademic Degree(s)TelephoneAddressEmail Address Table 2 Submission DateTitle of Project In the space below, describe the expected duration of project through data analysis: Start Date: _________________ End Date:___________________ Table 3 Other Review Boards Involved (include copies of other IRB approvals/denials as an appendix to this application): InstitutionIRB Contact NamePhone NumberEmail (if applicable) Section 2 Description of Request to be completed by applicant Please select the waiver type you are requesting. Request for:SelectA. Full waiver of HIPAA authorizationB. Partial waiver or Alteration of HIPAA authorization Please complete the table below. ItemPlease provide a response in this columnDescribe why the study is of minimal risk:Describe why the study cannot be practicably conducted without this waiver or alteration of this waiver:Describe why this study cannot be practicably conducted without access to and use of PHI:List what data will be collected:List the categories of records will be accessed (patient charts, billing records, diagnostic studies, etc.)Describe the plan to protect identifiers:Describe the plan to destroy identifiers at the earliest opportunity: Section 3 Support Documents required for Waiver Applicant, please attach documentation to support the criteria if applicable. Definitions of HIPAA Terms for De-identified Data: To de-identify data under the Privacy Rule safe harbor, you must ensure the following: Each of the data elements listed below is removed from the data; AND You do not know that any recipient of the data could re-identify a data subject, using the information alone or in combination with other publicly-available information. Data elements that must be removed: Names Geographic subdivisions smaller than a state (including street, city county, precinct), except first three digits of the zip code if, according to current Bureau of Census data: The geographic unit formed by combining all ZIP codes with the same three initial digits contains more than 20,000 people, and The initial three digits of ZIP code for all such geographic units containing 20,000 or fewer people are changed to 000. All elements of dates (except year) for dates directly related to an individual, and all ages over 89 and elements of date (including year) indicative of such age, except that ages and elements may be aggregated into a single category of age 90 or older. Telephone numbers; Fax numbers; E-mail addresses; Social security numbers; Medical record numbers; Health plan beneficiary numbers; Account numbers; Certificate/license numbers; Vehicle identifiers and serial numbers, including license plate numbers; Device identifiers and serial numbers; Web Universal Resource Locators (URLs); Internet protocol address numbers; Biometric identifiers, including voice and finger prints; Full face photographic images and any comparable images; Any other unique, identifying number characteristic, or code, except for a unique code that meets the following criteria: Is not derived from any other code (e.g., MRN or SSN) and is not used for any other purpose; and Persons using the data for research have no access to the code key and the key is held by a source that is not part of the research team. An investigator (or her study team members) may not create the code for de-identified data that she will use in her own research. BOX FOR COMMITTEE USE ONLY 1) Minimal Risk ___ No. ___ Yes, based on: i. Security plan: ___ adequate ___ needs development ii. Destruction plan: ___ adequate ___ needs development iii. 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