- Outline a viable plan to secure signed authorizations* from the study participants (inclusive of family members) and/or guardians or legal custodians as applicable; or
- Outline a viable plan to ensure de-identification (anything, including DOBs, SSNs and case DCNs, that can be tied back to an individual to identify that individual with personal health information) of PHI associated to study participants.
- Data received for a specified research study must be used only for the purpose outlined in the application and not for any other or future studies
- *It is preferable that the Department’s “Authorization for Disclosure of Health Information” form http://dssweb/dpl/adman/POLICIES/5-103ex2.pdf (Employee Access Only) be used where authorizations are required. Otherwise, it must be ascertained that forms supplied by a researcher are “Privacy Rule”-compliant. It is permissible under the Privacy Rule that valid authorizations be combined with informed consents (if the authorization is valid and the consent adequately informs what a participant can expect from being involved).
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