The code block below illustrates how one might use # and // as comments in your logic and calculations.

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Do I need Institutional Review Board (IRB) review for a project that will use existing data?

The following instrument is adapted from the Self-Certification Form created by the NYU Langone Health Institutional Review Board.

For more detailed information or to view other decision charts, visit the following online resources from the Health and Human Services Office for Human Research Protections: Human Subjects Research and Private Information and Biospecimens.

To provide feedback on this tool, contact the NYU Health Sciences Library Data Services team at hsl.dataservices@nyulangone.org.

Does it involve a "systematic investigation"?

* must provide value

Yes

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"Systematic investigation" is an activity that involves a prospective research plan that incorporates data collection, either quantitative or qualitative, and data analysis to answer a research question. The systematic investigation will involve a predetermined method for studying a specific topic, answering a specific question(s), testing a specific hypothesis(es), or developing theory. Examples of systematic investigations include, but are not limited to, observational studies, interview (including those that are open-ended) or survey studies, group comparison studies, test development, program evaluation, interventional research.

Is it intended to contribute to generalizable knowledge?

* must provide value

Yes

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Investigations designed to develop or contribute to generalizable knowledge are those designed to draw general conclusions (i.e., knowledge gained from a study which may be applied to populations outside of the specific study population), inform policy, or generalize findings. To develop or contribute to generalizable knowledge requires that the results (or conclusions) of the activity are intended to be extended beyond a single individual or an internal program.

Your project is not considered "research" as defined by the Common Rule and does not require IRB review.

Will your project involve human subjects?

* must provide value

Yes

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Your project is not considered "human subjects research" as defined by the Common Rule and does not require IRB review.

If the project involves existing data: Is the data available in the public domain?

If the project involves existing biospecimens only: Are the biospecimens from a commercial provider, human cell lines where all information has been published, or unidentifiable and obtained from a provider who is prohibited from releasing identifiers by established regulations or policies?

* must provide value

Yes

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Will there be any further interaction with the living individuals?

* must provide value

Yes

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Can you (the data recipient) link the data directly or indirectly to identifiable, living individuals?

* must provide value

Yes

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Can the data provider link the data directly or indirectly to identifiable, living individuals?

* must provide value

Yes

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Will the data provider be an investigator or collaborator in your research?

* must provide value

Yes

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Your proposed project is not research that involves human subjects as described by US federal regulations governing human subject research. IRB review is not required.

Researchers at NYU Langone Health may verify with the IRB by phone at 212-263-4110 or via email to irb-info@nyulangone.org. A Self-Certification Form is also available through the NYU Human Research Protections Template Library.

You must submit an application to your IRB before starting your project. Researchers at NYU Langone Health can submit projects for IRB review through Research Navigator.

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