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HIPAA Research Policy 4 Reviews Preparatory to Research Form
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People also ask
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What is the preparatory to research provision of HIPAA?
Under the "preparatory to research" provision, no PHI may leave the covered entity. Under the "preparatory to research" provision, covered entities may use and disclose PHI to researchers to aid in study recruitment. They may allow a researcher to identify, but not contact, potential study participants.
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What is research use disclosure without authorization?
A covered entity may use or disclose protected health information without individuals' authorizations for the creation of a research database, provided the covered entity obtains documentation that an IRB or Privacy Board has determined that the specified waiver criteria were satisfied.
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What is the HIPAA policy for research?
Under the HIPAA Privacy Rule, covered entities may use or disclose protected health information from existing databases or repositories for research purposes either with individual authorization as required at 45 CFR 164.508, or with a waiver of individual authorization as permitted at 45 CFR 164.512(i).
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Under which circumstances can you disclose PHI?
In a situation that poses a serious and imminent threat to the safety of a person or the public, you can disclose a patient's PHI to law enforcement, family members, and anyone else you believe can lessen or prevent the threat.
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Can researchers use and disclose PHI without authorization when preparing a research protocol and examining trial feasibility?
Investigators may use or disclose PHI for reviews preparatory to research without written authorization, provided CHLA receives from the investigator: 1) representation that the use and disclosure is sought solely to review PHI as necessary to prepare a research protocol or for similar purposes preparatory to research, ...
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Is it permissible to disclose PHI without authorization?
A covered entity is permitted, but not required, to use and disclose protected health information, without an individual's authorization, for the following purposes or situations: (1) To the Individual (unless required for access or accounting of disclosures); (2) Treatment, Payment, and Health Care Operations; (3) ...
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Can PHI be disclosed for research?
A: Under the Privacy Rule at section 164.512(i), a covered entity may use or disclose PHI for a research study without Authorization (or with an altered Authorization) from the research participant if the covered entity obtains proper documentation that an IRB or Privacy Board has granted a waiver (or alteration) of ...
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What is preparatory research?
Preparatory research (or simply “prep research”) often includes digging deeper into the client's perspective of what the research problem is, their context, perceptions, internal conflicts, or interplays that may emerge during the project, and so on.
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