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What is an IRB determination?

The IRB makes the determination if a study is Exempt, Expedited, Greater Than Minimal Risk, or Not Human Subjects Research. This determination is dependent on the nature of the study and the level of risk present to study participants.

What is PHS in NIH?

The PHS Human Subjects and Clinical Trials Information form is used to collect information on human subjects research, clinical research, and/or clinical trials, including study population characteristics, protection and monitoring plans, and a protocol synopsis.

What is an IRB form?

An institutional review board is a committee that has been formally designated to approve, monitor, and review research involving humans with the aim to protect the rights and welfare of the research subjects. Additional resources related to Institutional Review Boards:

What is a PHS form?

Completion and submittal of a Personal History Statement (PHS) is the first step of the Background Investigation. The PHS requires compilation of extensive biographical information, fingerprinting, and an interview with a background investigator.

What is the human subject research determination form?

This form is made available so that individuals can self-determine whether IRB review is necessary for a proposed activity/project that does not involve the use of a drug, device or biologic and that is not intended to be submitted to the FDA in support of a marketing application.

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