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34958 Federal Register / Vol. 77, No. 113 / Tuesday, June 12, 2012 / Notices burden to be 25 hours per response, for a total burden of 250 hours. As noted, FDA estimates that all the future Forms

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What is guidance for institutional review?

Guidance for institutional review refers to a document or set of instructions that provides guidance on the process and requirements for conducting an institutional review. It outlines the steps that need to be followed, the information that needs to be collected, and the timeline for completion.

Who is required to file guidance for institutional review?

Any institution or organization that intends to conduct an institutional review is required to file guidance for institutional review. This includes research organizations, universities, hospitals, and other institutions involved in human subjects research.

How to fill out guidance for institutional review?

Filling out guidance for institutional review typically involves completing a standardized form or template provided by the governing body or ethical review board. The form will require information about the research project, its objectives, methods, study population, and any potential risks or benefits. It may also require supporting documents such as informed consent forms and study protocols.

What is the purpose of guidance for institutional review?

The purpose of guidance for institutional review is to ensure that research involving human subjects is conducted ethically and in compliance with relevant regulations and guidelines. It provides a framework for researchers and ethical review boards to assess the potential risks and benefits of a research project and make informed decisions about its approval.

What information must be reported on guidance for institutional review?

The information that must be reported on guidance for institutional review depends on the specific requirements set by the governing body or ethical review board. Typically, it includes details about the research project, such as its objectives, methodology, study population, and potential risks and benefits. It may also require information about the qualifications and experience of the research team, the adequacy of the proposed safeguards for participant welfare, and the plans for data management and confidentiality.

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