At IU, where can I find information about IRB requirements for research that involves HIPAA-regulated PHI?

To help Indiana University researchers comply with all applicable laws, regulations, and institutional policies, the IU Human Subjects Office (HSO) and the Institutional Review Board (IRB) Executive Committee established standard operating procedures that specify the requirements for research involving protected health information (PHI) regulated by the Health Insurance Portability and Accountability Act (HIPAA). To view these requirements, as well as details regarding the circumstances under which data containing PHI may (and may not) be used or disclosed in connection with research activities at IU, see Guidance on the conduct of human subjects research.

Note:
IU researchers must use the Kuali Coeus (KC) IRB services in One.IU to enter and manage all IRB submissions, including new protocols, renewals, amendments, personnel updates, and reports. (Submissions are no longer accepted via email.) To launch any of KC IRB services, you must log in with your IU Network ID username and passphrase. If you do not have an IU Network ID account, submit this form to have the Human Subjects Office request an Affiliate account on your behalf; the HSO will follow up with additional instructions once your account is created. If you have an IU username but forgot your passphrase, see Reset your IU passphrase.

For more about KC IRB services, including links to training resources and answers to frequently asked questions, see the KC IRB page. For more about preparing to submit a study to the IRB, see Human Subjects and Institutional Review Boards. If you need help, have a question, or want to provide feedback regarding KC IRB services, contact KC IRB system support.

UITS provides consulting and online help for Indiana University researchers, faculty, and staff who need help securely processing, storing, and sharing data containing protected health information (PHI). If you have questions about managing HIPAA-regulated data at IU, contact UITS HIPAA Consulting. To learn more about properly ensuring the safe handling of PHI on UITS systems, see the UITS IT Training video Securing HIPAA Workflows on UITS Systems. For additional details about HIPAA compliance at IU, see HIPAA Privacy & Security on the University Compliance website.

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Last modified on 2018-10-10 18:26:03.

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