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How to write an irb protocol

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The following is a compilation of answers to questions asked of FDA regarding the protection of human subjects of research. For ease of reference, the numbers assigned to the questions are consecutive throughout this section. These questions and answers are organized as follows. Under FDA regulations, an IRB is an appropriately constituted group that has been formally designated to review and monitor biomedical research involving human subjects. In accordance with FDA regulations, an IRB has the authority to approve, require modifications in to secure approval , or disapprove research. This group review serves an important role in the protection of the rights and welfare of human research subjects.
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IRB Registration Instructions |

The following outlines the basic elements of a research protocol. The IRB templates will provide more specific requirements. Protocols coming from industry or protocols for multi-site studies typically include a table of contents. The introduction should indicate the specific reasons or rationale for performing the study, the hypotheses, study design e. If applicable, Principal Investigators should briefly describe the intervention, treatment, drugs, or devices to be used. A hypothesis is a tentative statement that proposes a possible explanation to some phenomenon or event. A useful hypothesis is a testable statement which may include a prediction.
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IRB Protocol Amendment Instructions

In accordance with 45 CFR Answer all questions. Amendments are reviewed as they are received and, according to the level of risk to subjects, may be reviewed by one reviewer or by the entire Board. You will be notified by email when the amendment has been approved and you may then begin your research. The new consent form, should one be required, will be stamped with the IRB approval stamp and sent to you by email.
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Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you cannot identify the appropriate OHRP or FDA staff, call the appropriate number listed on the second title page of this guidance. This guidance is intended for institutional review boards IRBs and institutions responsible for review and oversight of human subject research under the HHS or FDA regulations, or both.
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