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How To Determine IRB Level of Review for Secondary use of Data and/or Specimens

This tool is designed to assist in understanding what level of Institutional Review Board (IRB) review may be required for studies in which the only research procedure(s) is secondary use of data and/or specimens. The data/specimens must have already been collected for some other purpose (e.g. clinical care, quality improvement, or another research study) prior to being reviewed and obtained for use in the current study.

Once you have completed the survey, please click the "Submit" button for the option to download a copy of your responses and the corresponding guidance or to have a copy emailed to you.

To get started, please enter your email here:

* must provide value

Does this project involve an FDA regulated product; and data from the activity will be submitted to, or held for inspection by, the FDA in support of a marketing or research application for an FDA -regulated product?

* must provide value

Yes

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Since the FDA has a definition of "human subjects" that differs from that of DHHS, this tool cannot be used to make a review level determination for studies that are FDA regulated.

If you require assistance with your project, please consider submitting a "Human Subjects Regulatory Consultation" request with the SCTR SUCCESS Center at sparc.musc.edu. Information on how to submit that request can be found here: https://research.musc.edu/resources/c/about/success/regulatory. Thank you!

Is the analysis of data and/or specimens the ONLY study procedure(s) included this project?

* must provide value

Yes

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This tool is not designed for studies that involve research procedures outside of the analysis of existing data/specimens. If you require assistance with your project, please consider submitting a "Human Subjects Regulatory Consultation" request with the SCTR SUCCESS Center at sparc.musc.edu. Information on how to submit that request can be found here: https://research.musc.edu/resources/c/about/success/regulatory. Thank you!

Are ANY of the humans to whom the data and/or specimens belong currently living?

* must provide value

Yes/Unknown

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If none of the people from whom the data/specimens you are utilizing are living, the project DOES NOT meet the definition of Human Subjects Research. Federal regulations define a human subject as "a living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information." (45 CFR 46.102(e)(i)(ii)).

The MUSC IRB only reviews and approves projects that meet the definition of human subjects research. Consequently, your project does not require MUSC IRB review. The MUSC eIRB system does provide a pathway that allows an investigator to provide information about their project and receive a "Not Human Subjects Research" designation letter. This letter is sometimes required by honest brokers, biorepositories, or labs prior to providing you with requested data/specimens.

MUSC's IRB policy ("IRB HRPP 3.1 Human and Not Human Research") regarding Not Human Subjects Research including basic guidance on how to obtain a Not Human Subjects designation in eIRB can be found here: https://musc.policytech.com/dotNet/documents/?docid=3821&public=true. Not Human Subjects Research applications do NOT require a fully executed scientific protocol. When providing the justification for why the study does not meet the requirements for human subjects research, it is imperative to include enough details about the project for the IRB to confirm that. In this case, be extremely clear that ALL data/specimens will come from deceased patients.

If you require assistance with your project, please consider submitting a "Human Subjects Regulatory Consultation" request with the SCTR SUCCESS Center at sparc.musc.edu. Information on how to submit that request can be found here: https://research.musc.edu/resources/c/about/success/regulatory.

Do you plan to collect any identifiable information on the people/specimens and store it as part of your research data? Identifiable data includes ANY of the 18 HIPAA identifiers or any other unique identifier or characteristic that would allow the research team to ascertain the identity of the person. (https://research.musc.edu/-/sm/research/resources/ori/irb/policies/policies-files/hrpp-guide-section-4-13-privacy-and-confidentiality.ashx?la=en)

* must provide value

Yes

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Will your project utilize a method of receiving already de-identified data and/or specimens? Examples of this include:

Utilizing an honest broker (someone completely independent of your research project whose job duty includes the authority to review/provide data and specimens to various groups or individuals) who will provide the data and/or specimens to your study team. (For more information on honest broker services, you can visit MUSC's Biomedical Informatics website: https://medicine.musc.edu/departments/centers/bmic/data-request)
Receiving de-identified data sets from colleagues NOT listed on your study team (internal or external to MUSC)
Publicly available datasets and/or specimen samples
Biobanks/Tissue Banks that will provide de-identified specimens

* must provide value

Yes

No-Members of the study team will be accessing and reviewing/collecting the data.

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Will anyone on your study team perform a manual chart review at any time during the course of the project (this means accessing a patient's medical record to collect data for research purposes)?

* must provide value

Yes

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Will any member of your study team view, use, or have access to any of the 18 HIPAA identifiers (IRB HRPP 4.13 Privacy and Confidentiality v.3 (policytech.com) or have any other way of identifying the person from whom the data/specimens came at any point during the project?

* must provide value

Yes

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If MUSC's role in this project does not include the use of any identifiable data/specimens nor will your study team ever have access to patient identifiers, then this project DOES NOT meet the definition of Human Subjects Research at MUSC. Federal regulations define a human subject as "a living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information." 45 CFR 46.102(e)(i)(ii)).

MUSC's IRB policy ("IRB HRPP 3.1 Human and Not Human Research") regarding Not Human Subjects Research, including basic guidance on how to obtain a Not Human Subjects designation in eIRB, can be found here: https://musc.policytech.com/dotNet/documents/?docid=3821&public=true. Not Human Subjects Research Applications DO NOT require a fully executed scientific protocol. Draft and upload a brief attachment that includes:

A statement that ALL data/specimens will be received or provided in a completely de-identified fashion and that no member of the study team will ever have access to any of the 18 HIPAA identifiers or have any other way of identifying the person from whom the data/specimens came at any point during the project.
A brief description of the source of the data/specimens to be used. Example data sources that often constitute NHSR include:
- Utilizing an honest broker (someone completely independent of your research project whose job duty includes the authority to review/provide data and specimens to various groups or individuals) who will provide the data and/or specimens to your study team. (For more information on honest broker services, you can visit MUSC's Biomedical Informatics website: https://medicine.musc.edu/departments/centers/bmic/data-request)
- Receiving de-identified data sets from colleagues NOT listed on your study team (internal or external to MUSC)
- Publicly available datasets and/or specimen samples
- Biobanks/Tissue Banks that will provide de-identified specimens

Please select from one of the options below:

* must provide value

The project ONLY involves the use of clinical data

The project ONLY involves the use of specimens

The project involves the use of BOTH data and specimens

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Based on the information provided, this study appears to meet the definition of Human Subjects Research. Federal regulations define a human subject as "a living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information." (45 CFR 46.102(e)(i)(ii)). Since members of the study team will either have access to personal identifiers for the purpose of performing the data review or will be collecting identifiable information on living individuals for research purposes, this study will need to undergo human subjects research review by the IRB.

The project should meet the criteria for exempt review, given that the only study procedure involved in this project is data review and analysis. MUSC's policy on exempt research (IRB HRPP 3.2 Exempt Research Review) can be found here: https://musc.policytech.com/dotNet/documents/?docid=12605&public=true. Exempt applications do not require fully executed protocol documents. A guidance document entitled "Guidance for Exempt Review - Categories 2 and 4 (DOC)" is available that outlines the information the IRB expects to see in the justification can be found on the IRB's "Forms" page of their website: https://research.musc.edu/resources/ori/irb/forms.

Research involving identifiable specimens does not meet the criteria for Exemption (unless they are publically available) and, therefore, must be reviewed at a higher level. Expedited and Full Board applications require fully executed scientific protocols. The MUSC IRB provides a protocol template on the "Forms" page of their website, which can be found here: https://research.musc.edu/resources/ori/irb/forms.

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