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Guidance Documents

Decision Charts -
Human Subject Regulations Decision Charts

NYU SoM IRB Guidelines for Writing a Research Protocol

Guidance of Required Elements of a Protocol

Guidance on Determining Human Subjects Research

Guidance on Submitting a New Application

Guidance on Using an FDA Regulated Product

Guidance for the Investigator as a Sponsor

Guidance for Data Monitoring Plans

Guidance for Emergency Use of an IND

Guidance for Emergency Use of an IND-IDE

Guidelines for Research in Pregnant Women, Human Fetuses and Neonates

Guidance on Research with Prisoners

Guidelines for Involving Children in Research

Guidance for Cognitively Impaired

Guidance for Students and Employees in Research

Guidelines for Recruitment of Research Subjects

Guidelines for Advertisements for Research Subjects

Guidance on Genetic Research

Guidelines on Protocol Development for Genetic Research

Guidance on the Consent Process and Documentation

Guidelines of Requests for Waiver of Consent

Guidance on Assent of A Minor

Guidance for Non-English Speaking Subjects

Guidance on Verbal Consent

Guidance on Waiver of Parental Permission

Guidelines for Amending a Protocol

Guidance on Continuing Review and Final Closures

Essential Documents

Guidelines to Investigator Responsibilities

Letter for Sponsors - Reportable Events Policy

Guidance for Reportable Events and Reporting Unanticipated Problems

Reviews Preparatory to Research

Research Data Compilations

How many copies do I submit?

The NYU SoM IRB Guidance documents provide information to assist the research community in the new and ongoing development of research protocols. To view the documents click on the topics listed in the navigation bar to the left of this screen.

IRB Resources
	HRPP Accreditation Tutorial
	IRB Online Tutorials
	IRB Online Tutorials Completion Search+Certificate Tool
	IRB CITI Tutorials
	Decision Charts - Human Subject Regulations Decision Charts
	IRB Newsletter
	IRB Course Calendar
	Policies and Procedures
	HELP Downloading Forms
	Lay Glossary
	Useful Web Links
	Sponsored Programs Administration (SPA)
	Office of Clinical Trials (OCT)
	Email a Suggestion or Comment to the IRB
	Contact the IRB
	GCRC Web Page
	Instructions for Research Conducted at Bellevue
	Printer-Friendly Version
	Email this to a friend

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