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IRB-118 / Non-Human Subjects Research Assessment Form

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IRB Administration provides an official assessment of projects to determine whether they constitute human subjects' research (in part or whole). If you would like an assessment of your project, please complete the Non-Human Subjects Research (NHSR) Request Form (also known at Rush as a "Form 118") below.

If you are a student, please ensure that you have obtained prior permission from your faculty advisor to submit this form. Forms submitted without prior permission from faculty advisors will not be reviewed.

Please note, once a determination has been made by IRB Administration on a project, no further changes to that project may occur in REDCap (Amendments are not an option). If you make changes to your project that has already received a determination, you must submit it as a new project and obtain a new determination.

Once this form has been submitted and a final determination has been made, an e-mail notifying you of the determination will be sent using the e-mail(s) provided in the form. If this study is deemed to be human subjects research, then you will need to submit the project via the Rush Research Portal.

Title of Study

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First Name

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Middle Initial

Last Name

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Degree(s) or Profession(s)

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PhD

DNP

Pharmacist

Other

Job Title

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Secondary/Co-Investigator(s) Name
If there are no secondary investigators, enter "NA"

Department or School/College

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Affiliation

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Medical Staff

Faculty

Staff

Fellow

Resident

Student

None of the above

Campus or Department Address

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Contact Phone Number

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Faculty Sponsor Contact Phone Number (this field is required if you are a student, fellow, or resident)

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Primary Contact Rush Email Address: (NOTE: Please use an e-mail address that is checked frequently)

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Secondary Contact Email Address: (NOTE: We strongly advise providing an additional email address that will receive the notification of revisions, acknowledgement, or denial).

If you are a student, fellow, or resident, you are required to add your faculty sponsor's e-mail address to this field. If you do not, your submission will not be reviewed.

* must provide value

Per Policy RA-IRB-118, activities that the Rush IRB may determine do not represent human subjects' research and do not require submission in the Rush Research Portal (RRP) include the following categories. Please select the category that applies to your project. If it is determined that your project does not fit any of these categories, you will be required to submit the project through the Rush Research Portal. Please see Rush RA-IRB-118 policy, 118 FAQs, and 118 guidance document which can all be found within the Rush Research Portal.

* must provide value

Research involving only the use/analysis of deceased individuals' information or specimens (cadaveric studies).
*** NOTE: A completed HIPAA Use/Disclosure without Authorization form must be uploaded under item #2.

Course-related activities designated specifically for educational or teaching purposes, where data is collected from and about human subjects as part of a class exercise or assignment but are not intended for use outside of the classroom (not intended to develop or contribute to generalizable knowledge).

Case report(s) involving the observation of a patient or patients whose novel condition or response to treatment was guided by the care provider's judgment regarding the best interest of the individual and no comparison of data is taking place. Please note that Rush HIPAA policies must be followed.
Case Reports: If an author develops a case report with no prior research intent, Rush University Medical Center IRB does not require review if the report does not meet the regulatory definition of research. In many instances, case reports do involve a human subject(s) by definition and may contribute to generalized knowledge by presentation or publication. A case report (3 or fewer patients) generally does not meet the definition of a systematic investigation. A case report describes an interesting treatment, presentation, or outcome. A critical component is that nothing was done to the patient(s) with prior "research" intent. Please note that Rush HIPAA policies must be followed. NOTE: The case report should not involve more than 3 patients. If it involves more than 3 patients, then you would need to submit an IRB application through the Rush Research Portal.

Collection of data with the sole purpose to conduct a quality improvement/quality assurance project for internal use only. This also applies to students of Rush University who are employed at another medical center, when the work is part of their class requirements and the employer institution has certified the activities do not constitute human subjects research.

Other research that is not human subjects or animal research, but does not fit the criteria above (e.g., publicly available de-identified data).

If you chose Other from the question immediately above, please explain:

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Once this form has been submitted and a final determination has been made, an e-mail notifying you of the determination will be sent using the e-mail(s) provided in the form. If this study is deemed to be human subject research, you will need to submit the project via the Rush Research Portal.

1. A description of project/case study and an abstract of the project including goals and methods.

* must provide value

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2. If the project involves the use/analysis of deceased individuals' information or specimens, a completed "HIPAA Use/Disclosure without Authorization" form and;

-explain where and how you plan to obtain the information/specimens. Discuss if your activity or investigation involves identifiable private information. If applicable, please address your access to secondary data by means listed below.

If the project involves the sharing of Rush specimens (material) or data with another institution, then a signed and fully executed Rush Material Transfer Agreement or a RUMC Data Transfer Agreement (Basic Science Data) must be submitted.

• A Data Transfer Agreement (DTA) for basic science data is used when Rush researchers are transferring basic science data (i.e., no human subject data) to another institution. A DTA is a legal contract governing the transfer of non-human subject data or completely de-identified human subject data.

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* A material/data transfer agreement (when applicable). A Material Transfer Agreement (MTA) is required when Rush is transferring material to another institution. An MTA is a contract that governs the transfer of tangible research materials between two organizations when the recipient intends to use it for his or her own research purposes. The MTA defines the rights of the provider and the rights and obligations of the recipient with respect to the materials and any progeny, derivatives, or modifications.

NOTE: Please contact Rush Office of Legal Affairs if you have any questions about the MTA/DUA.

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Will this project be conducted at Rush?

* must provide value

Yes

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If the project will be conducted at an outside institution, a determination letter or other documentation of review must be included from the institution where the activities will occur that indicates the institution does not consider the activities to be human subjects' research and/or require IRB review.

Please Note: The determination letter from the outside institution should be written on the other institution's letterhead and should be signed by the authorized signatory. The letter should specifically state that their institution does not consider the activities of your project to be human subjects research and/or requires IRB review.

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COVID-19 Project

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Yes

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If your study involves chart/database reviews, please upload a copy of your data collection tool (DCT) for this study.
NOTE: A data collection tool is a simple list of aggregate data points that will be retrieved from each chart/file/database.

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Additional Document #2 (optional)

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Additional Document #3 (optional)

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Investigator Attestation:
By typing my full name below, I hereby affirm that the above information, is true and complete to the best of my knowledge.

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Date Form Completed and Submitted

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M-D-Y

IMPORTANT: Submission of this form constitutes a request for a determination to be made by Rush IRB/Administration.

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