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This document outlines the procedures the North Shore Medical Center Institutional Review Board (NSMC IRB) follows to ensure prompt reporting and review of proposed changes in approved non-exempt
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How to fill out amendments to approved research
How to fill out Amendments to Approved Research
01
Obtain the Amendment form from your research institution's website or office.
02
Review the original approved research proposal to identify the changes that need to be amended.
03
Fill out the Amendment form by providing detailed descriptions of the proposed changes.
04
Include any supporting documents or data that justify the amendments.
05
Ensure compliance with institutional guidelines and ethical standards relevant to the amendments.
06
Submit the completed Amendment form and supporting materials to the appropriate review board or authority for evaluation.
07
Wait for feedback or approval from the review board before implementing changes in the research.
Who needs Amendments to Approved Research?
01
Researchers who are modifying their previously approved research protocols.
02
Principal investigators who need to update their eligibility criteria, objectives, or methodologies.
03
Institutions requiring compliance updates for funding or regulatory purposes.
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What is Amendments to Approved Research?
Amendments to Approved Research refer to changes or modifications made to a research study that has already received approval from an Institutional Review Board (IRB) or ethics committee. These amendments could involve changes in research procedures, participant eligibility, or study duration.
Who is required to file Amendments to Approved Research?
Researchers or principal investigators who have ongoing approved research studies are required to file Amendments to Approved Research whenever there are changes that affect the study's conduct or its ethical considerations.
How to fill out Amendments to Approved Research?
To fill out Amendments to Approved Research, one must provide detailed descriptions of the proposed changes, the rationale for each change, and any impact these changes might have on the study's integrity or participant safety. A standardized form provided by the IRB is typically used.
What is the purpose of Amendments to Approved Research?
The purpose of Amendments to Approved Research is to ensure that any changes to a study are reviewed for ethical compliance and participant safety, maintaining the integrity of the research process and aligning with regulatory requirements.
What information must be reported on Amendments to Approved Research?
Information that must be reported includes descriptions of the proposed amendments, rationale for the changes, any new risks to participants, changes in informed consent processes, and updated study protocols.
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