Get the free OU HRPP Program- HSC Campus CONTINUING REVIEW REVIEWER CHECKLIST - ouhsc
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This document serves as a checklist for reviewers to assess various aspects of continuing research studies for compliance with ethical standards and regulations, particularly for studies involving
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How to fill out ou hrpp program- hsc
How to fill out OU HRPP Program- HSC Campus CONTINUING REVIEW REVIEWER CHECKLIST
01
Review the guidelines for the OU HRPP Program to understand the purpose of the checklist.
02
Obtain the Continuing Review Reviewer Checklist from the OU HRPP website or designated office.
03
Fill in the project title, principal investigator, and protocol number at the top of the checklist.
04
Go through each item on the checklist carefully, ensuring all required documents are attached and up to date.
05
Answer each question in the checklist, providing clear and concise information regarding the continuing review.
06
Attach any required additional documentation, such as progress reports or consent forms, as specified in the checklist.
07
Submit the completed checklist and all associated documents to the appropriate OU HRPP office by the required deadline.
Who needs OU HRPP Program- HSC Campus CONTINUING REVIEW REVIEWER CHECKLIST?
01
Researchers conducting studies that require ongoing review.
02
Institutional Review Board (IRB) members reviewing ongoing research protocols.
03
Compliance officers ensuring that research is conducted in accordance with regulatory and ethical standards.
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People Also Ask about
What is the common rule for continuing review?
A. Under the Revised Common Rule, the regulations no longer require annual continuing review for minimal risk (expedited) research studies. The IRB may; 1) still require a continuing review, 2) require submission of a progress report at periodic intervals, or 3) not require additional reporting on the study's progress.
What are the three types of IRB review?
There are three major types of review: Exempt, Expedited, and Full.
What is the purpose of the IRB review?
The purpose of IRB review is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research.
What is a continuing review IRB?
Continuing Review is a federally mandated re-evaluation of an approved study that is required to be conducted at least once per year. For most new non-exempt, minimal risk, and non-FDA regulated research projects, there will no longer be an expiration date and therefore, no requirement for annual continuing review.
What is IRB continuing review?
The HRPP Administrator reviews submissions; updates policies/practices based on current regulations, best practices in ethical human participant research, and input from the IRB Chair and Board; conducts educational outreach on research ethics for the campus community; and manages all office processing.
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What is OU HRPP Program- HSC Campus CONTINUING REVIEW REVIEWER CHECKLIST?
The OU HRPP Program- HSC Campus CONTINUING REVIEW REVIEWER CHECKLIST is a tool used by reviewers to ensure that research studies involving human subjects continue to meet ethical standards and regulatory requirements during their ongoing review process.
Who is required to file OU HRPP Program- HSC Campus CONTINUING REVIEW REVIEWER CHECKLIST?
Anyone responsible for overseeing research studies involving human subjects at the HSC Campus is required to file the checklist as part of the continuing review process.
How to fill out OU HRPP Program- HSC Campus CONTINUING REVIEW REVIEWER CHECKLIST?
To fill out the checklist, reviewers should carefully review the study materials, assess compliance with ethical standards, provide necessary documentation, and answer each question in the checklist according to the study's current status and activities.
What is the purpose of OU HRPP Program- HSC Campus CONTINUING REVIEW REVIEWER CHECKLIST?
The purpose of the checklist is to systematically evaluate ongoing research projects to ensure that they comply with federal regulations and institutional policies regarding the protection of human subjects.
What information must be reported on OU HRPP Program- HSC Campus CONTINUING REVIEW REVIEWER CHECKLIST?
The checklist requires information on study progress, any adverse events, changes to the protocol, informed consent processes, and the overall risk-benefit assessment of the research.
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