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Protection of Human Subjects

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Citation Edit

Protection of Human Subjects.

Overview Edit

There are two sets of regulations under the same name.

These regulations require consent of research subjects, subject to some exemptions, including research on records where if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects. Consent forms must include notice of adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
These regulations require consent of research subjects, subject to some exemptions, especially for research conducted on investigative new drugs (INDs). Consent forms must include notice of adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.

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