The use or disclosure of protected health information involves no more than a minimal risk to the privacy of individuals; The research could not practicably be conducted without the waiver or alteration; and The research could not practicably be conducted without access to and use of the protected health information Are any local laws or customs regarding the protection of health information? No Yes If yes, are local laws or customs comparable to the HIPAA Privacy Rule? No Yes Summarize the laws or customs regarding the protection of health information (include in your response an explanation of how these local laws/customs compare to the protections offered by the HIPAA Privacy Rule). If available, also provide web links to English-language copies. Is a waiver of HIPAA Authorization being requested? No Yes If yes, why is the waiver appropriate in the given local context? Complete the appropriate Waiver of HIPAA Authorization section in the standard application, or complete a separate waiver form and attach to application Is an alteration of HIPAA Authorization being requested? No Yes Will HIPAA forms (standard or altered) be written in a language other than English? No Yes Attach copy of HIPAA forms. If translated copies will be used, attach both English and translated versions and documentation of verification of translations. Altered HIPAA If a request for alteration of HIPAA Authorization is NOT being requested, continue to Section G now. If a request for alteration of Authorization IS being requested, explain why the alteration is needed and why it is appropriate in the given local context. If a request for alteration of HIPAA Authorization is being requested, describe how each of the following criteria are being met: The use or disclosure of protected health information involved no more than a minimal risk to the privacy of individuals:
The use or disclosure of protected health information involves no more than a minimal risk to the privacy of individuals; The research could not practicably be conducted without the waiver or alteration; and The research could not practicably be conducted without access to and use of the protected health information Are any local laws or customs regarding the protection of health information? No Yes If yes, are local laws or customs comparable to the HIPAA Privacy Rule? No Yes Summarize the laws or customs regarding the protection of health information (include in your response an explanation of how these local laws/customs compare to the protections offered by the HIPAA Privacy Rule). If available, also provide web links to English-language copies. Is a waiver of HIPAA Authorization being requested? No Yes If yes, why is the waiver appropriate in the given local context? Complete the appropriate Waiver of HIPAA Authorization section in the standard application, or complete a separate waiver form and attach to application Is an alteration of HIPAA Authorization being requested? No Yes Will HIPAA forms (standard or altered) be written in a language other than English? No Yes Attach copy of HIPAA forms. If translated copies will be used, attach both English and translated versions and documentation of verification of translations. Altered HIPAA If a request for alteration of HIPAA Authorization is NOT being requested, continue to Section G now. If a request for alteration of Authorization IS being requested, explain why the alteration is needed and why it is appropriate in the given local context. If a request for alteration of HIPAA Authorization is being requested, describe how each of the following criteria are being met: The use or disclosure of protected health information involved no more than a minimal risk to the privacy of individuals: