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Authorizations are required unless the proposed use meets one of the exceptions listed in the HIPAA regulation. It is never at the researcher's discretion. When they are required, authorizations must be:

a) Only in electronic form
b) In "plain language" so that individuals can understand the information contained in the form, and thus able to make an informed decision.
c) Signed by the researcher
d) Executed orally

1 Answer

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Final answer:

HIPAA requires authorizations for the use of private health information unless an exception applies, which must be in plain language for the subject's comprehension and signed, establishing the individual's informed consent and the protection of their privacy.

Step-by-step explanation:

Authorizations are indeed required under the Health Insurance Portability and Accountability Act (HIPAA) unless the proposed use or disclosure falls within one of the exceptions provided by the regulation. These authorizations must be in writing and composed in "plain language" to ensure that individuals can comprehend the information, thereby making an informed decision. As part of ethical research practices and legal compliance, it's important to have such authorizations to protect participant confidentiality, uphold their rights to privacy and dignity, and secure informed consent from research participants or, in the case of minors, their legal guardians. It's also crucial for the research plan to clearly outline any potential risks and benefits, and specify guidelines on data archiving or destruction. Furthermore, research collaborators are typically offered the right to review and potentially edit research reports, and the preservation of confidentiality is a key mandate.

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