Amendments involving changes to irb approved protocols do not need prior irb approval if: the investigator keeps careful records of all changes and includes them in the final report. They are eligible for review using expedited procedures. They only involve changes to the consent form. The changes must be immediately implemented for the health and well being of the subject.

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Davian Everett

8 June, 16:55

Amendments involving changes to irb approved protocols do not need prior irb approval if: the investigator keeps careful records of all changes and includes them in the final report. They are eligible for review using expedited procedures. They only involve changes to the consent form. The changes must be immediately implemented for the health and well being of the subject.

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Coleman Black · Answer 1

I guess the correct answer the changes must be immediately implemented for the health and well being of the subject

Amendments involving changes to IRB approved protocols do NOT need prior IRB approval if the changes must be immediately implemented for the health and well being of the subject.

An amendment is a formal or official change madè to a law, contract, constitution, or other lègal document. It is based on the vèrb to amend, which means to change for bètter. Amendments can add, remοve, or update parts of thèse agreements.