Human Subjects Research Determination Form

Fill this form out to determine whether the research project fits the federal definition of human subjects research.

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Determination of Research

A systematic investigation is a plan which incorprates the collection of data or specimens, either qualitative or quantitative, and analyzes to answer a question.

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A clinical investigation is any study that involves a test article (e.g. drug, device, biologic) and one or more human subjects and the study is subject to FDA or results intended to be submitted later or hold for inspection by FDA as part of an application for research or marketing permit.

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Generalizable knowledge is considered knowledge gained from a study that may be applied to a population beyond the specific study population.

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The results of the activity will be disseminated beyond the University of North Texas

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To provide more context to our analysts, please explain your intention for the results of the project you plan to conduct. Examples: Presentations, Publications, classroom use only, quality improvement activities.

NOTE: Data gathered without obtaining informed consent may not be used for academic presentations at a later date.


Determination of Human Subject

The activity involves obtaining information about living individuals

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The activity involves INTERVENTION with individuals

Intervention includes both physical procedures by which information or biospecimens are collected and manipulation of the research subject or their environment, performed for research purposes.

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The activity involved INTERACTION with individuals.

Interaction includes communication or interpersonal contact between the researcher and the participant.

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  1. FDA Approved Drugs
  2. Unapproved use of approved drugs
  3. Investigational drugs or biologics
  4. Other compounds intended to affect the structure or function of the human body
  5. Dietary supplements, botanicals, foods, neutraceuticals or substances used to diagnose, cure, mitigate, treat, or prevent disease.
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Data are being collected specifically for the research study

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Data are being collected from individuals known to the researcher

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Activity involves collaborators in which researchers will have access to identifiers or the code to link data to participants

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The activities involve collaborators and/or co-authors who will have access to identifiers or the code to link data to individuals.

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Data will be coded in a way that a link exists that could allow the source of the data to be re-identified.

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Data is being received from a neutral third-party that has no interaction with the researchers beyond providing the data.

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Specimens are being collected specifically for this research study and not for an alternative purpose.

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The researcher will know the individuals from whom the specimens were collected

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The research study involves collaboration with a researcher who will have access to identifiers

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Specimens are coded such that a link exists that could allow the specimens to be re-identified.

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The specimens will be DEIDENTIFIED

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Specimens will be obtained from a neutral third party that has no interaction with the researchers beyond providing the specimens.

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What information/data will be included with the specimens?

Number of Specimens that will be collected and/or used.


Other Regulatory Considerations

The activity is supported by a federal agency such as HHS, NSF, DoD, DoED, DoE, DoJ, etc.

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Briefly list the study objective(s)

Briefly describe the participant population or type of data/specimens that will be studied.

Briefly describe how the data or specimens will be obtained.

Examples:

Funding documentation

Statements of work

Protocols

Explanations of data to be collected

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I include my full name below to attest that the above information is true and complete to the best of my knowledge and I am aware that misstatements or omissions may result in the conduct of noncompliant research activity, for which I accept responsibility.