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This document serves as a regulatory review form for human research projects conducted under the Yale University School of Medicine, addressing protocols, approvals, and compliance with federal and
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How to fill out Yale University School of Medicine/Human Investigation Committee Regulatory Review
01
Begin by gathering all necessary documents related to your research project, including protocols, consent forms, and funding details.
02
Access the Yale University School of Medicine's Human Investigation Committee (HIC) website to download the regulatory review forms.
03
Fill out the application form, ensuring that you provide detailed information about the purpose, methodology, and potential risks of your study.
04
Include information on participant recruitment and consent processes, specifying how you will protect participant confidentiality.
05
Review your completed form for accuracy and completeness before submission.
06
Submit your application through the designated online portal as instructed on the HIC website.
07
Check for any feedback or requests for additional information from the HIC, and respond promptly to ensure timely review.
Who needs Yale University School of Medicine/Human Investigation Committee Regulatory Review?
01
Researchers conducting studies involving human subjects at Yale University or affiliated institutions.
02
Faculty members seeking to obtain funding or publish their research that includes human participants.
03
Graduate students and postdoctoral fellows who are involved in research projects that require ethical review.
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People Also Ask about
What does expedited IRB review mean?
Expedited review is a procedure through which certain kinds of research may be reviewed and approved without convening a meeting of the IRB. The IRB regulations permit, but do not require, an IRB to review certain categories of research through an expedited procedure if the research involves no more than minimal risk.
What are the three types of IRB reviews?
There are three major types of review: Exempt, Expedited, and Full.
Who completes an expedited IRB review?
An expedited review must be performed by the IRB Chair or by an experienced IRB member designated by the IRB Chair, i.e. a member with demonstrated knowledge and application of research ethics in human subject protections of at least one year.
What qualifies for an expedited review?
In order to qualify for review via expedited procedures, the research must not be greater than minimal risk and fall into at least one of the expedited categories defined by the federal regulations.
What is an expedited review at Yale IRB?
Under the expedited review process, research proposals are assigned by the IRB regulatory analyst for primary review by the Chair, by one or more experienced members of the IRB or by a regulatory analyst who also serves as an IRB member, under the delegated authority of and oversight by the IRB Chair.
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What is Yale University School of Medicine/Human Investigation Committee Regulatory Review?
The Yale University School of Medicine/Human Investigation Committee Regulatory Review is a process to ensure that all research involving human subjects meets ethical and regulatory standards.
Who is required to file Yale University School of Medicine/Human Investigation Committee Regulatory Review?
All researchers and faculty members at Yale University who conduct studies involving human subjects are required to file for this review.
How to fill out Yale University School of Medicine/Human Investigation Committee Regulatory Review?
To fill out the review, researchers must complete a submission form detailing their study protocols, participant recruitment methods, informed consent processes, and potential risks associated with the research.
What is the purpose of Yale University School of Medicine/Human Investigation Committee Regulatory Review?
The purpose of the review is to protect the rights and welfare of human subjects involved in research by ensuring compliance with ethical guidelines and regulatory requirements.
What information must be reported on Yale University School of Medicine/Human Investigation Committee Regulatory Review?
Researchers must report information including the study's objectives, methodology, participant demographics, consent procedures, potential risks, and how data will be collected and stored.
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