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USC COVID-19 Biospecimen Request Form

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This application is used to request samples from the USC COVID-19 Biorepository. Your responses to the questions below will determine the processes that are necessary to obtain the biospecimens. Requesting biospecimens for the sole purpose of laboratory test validation go through a separate process compared to other study types. In addition, different processes will apply regarding obtaining identifiable vs de-identified samples. Please complete the following form to request for biospecimens from the USC COVID-19 Biorepository. For general information on the COVID-19 Biorepository, click here.

If you have any questions regarding this form or the Biorepository, please contact Lily Jara at Liliacna.Jara@med.usc.edu.

Yes

Will the results of the specimen analysis be published?

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Will the results of the specimen analysis be disclosed outside of your laboratory, such as in a presentation in a scientific lecture?

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Will patient-identifying information related to the samples be required?

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Will you maintain records of the specimen analysis to be used in later studies?

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Are the samples being collected for any purpose other than validation of a laboratory test?

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If the answer to any question above is "yes" the study must be reported to the USC IRB at http://istar.usc.edu/
The IRB protocol is required before any specimens can be distributed.

Are you a USC Principal Investigator?

* must provide value

Yes

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USC Principal Investigator name

* must provide value

USC School and Department

* must provide value

USC Principal Investigator e-mail

* must provide value

USC Principal Investigator phone #

Non-USC Principal Investigator name

* must provide value

Entity you are affiliated with

* must provide value

Non-USC Principal Investigator e-mail

* must provide value

Non-USC Principal Investigator phone #

Collaborating USC Principal Investigator name
(A USC PI is required for these requests. Please list the name of the USC PI below.)

* must provide value

Collaborating USC Principal Investigator School and Department

* must provide value

Collaborating USC Principal Investigator e-mail

* must provide value

Collaborating USC Principal Investigator phone #

Name

Phone #

E-mail

Study title

* must provide value

Study description
Please include study purpose, hypothesis and how you intend to use the Biorepository samples
(max. 2,500 characters)

* must provide value

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Study protocol (optional)
If you have the study protocol available, please upload it here. This is optional.

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Primary funding source

* must provide value

Account #

* must provide value

Please download and fill out the biospecimen request form below. Once complete, please upload your completed biospecimen request form in the next field. To view the frequency of collection as per parent Biorepository protocol, click here.

Attachment:Biospecimen Request Form_110221.xlsx

Please upload your completed biospecimen request form here.

* must provide value

Upload file

Our database contains the following clinical information:

Name, MRN, Date of birth, Age, Sex, Race, Diagnosis, Date of diagnosis, Date(s) of specimen, Type(s) of specimen, Procedure(s), Co-morbidities, Onset of illness, Resolution of illness, Symptoms at presentation, Ventilator days, ICU days, Hospital days, Dialysis days, Pathology reports associated with Covid-19, Imaging study reports associated with Covid-19, Laboratory data associate with Covid-19, Medications - associated with Covid-19, and concomitant medications.

The processes for requesting identifiable vs de-identified specimens and data are different.

Definition of Identifiable Biospecimens and/or Data: Identifiable data are any data that contain any of the following elements of Protected Health Information (PHI):

Name, address (all geographic subdivisions smaller than state, including street address, city county, and zip code), all elements (except years) of dates related to an individual (including birthdate, admission date, discharge date, date of death, and exact age if over 89), telephone numbers, fax number, email address, social security number, medical record number, health plan beneficiary number, account number, certificate or license number, vehicle identifiers and serial numbers, including license plate numbers, device identifiers and serial numbers, web url, internet protocol (ip) address, finger or voice print, photographic image - photographic images are not limited to images of the face, any other characteristic that could uniquely identify the individual.

Requests for identifiable data require IRB approval. With the appropriate IRB approval, investigators can obtain additional clinical information linked to the specimens.

If you need help on your IRB application, please visit https://oprs.usc.edu/irb-review/istar/

For additional information regarding OPRS office hours, please visit https://oprs.usc.edu/virtual-office-hours/

If you do not have an approved IRB protocol and would like to see an example of IRB language requesting Biorepository samples, please see the attachment below.

Attachment:IRB Template Language_Requesting Biorepository Samples-Data_Identified.docx

Definition of de-identified Biospecimens and/or Data: does not contain PHI (must obtain IRB exemption status or expedited approval from the HSC IRB):

If you are seeking to obtain de-identifiable specimen, you need to apply exemption status from IRB. (Include in your IRB application the USC COVID-19 Biorepository IRB#HS-20-00322 for reference.)

If you need help on your IRB application, please visit https://oprs.usc.edu/irb-review/istar/

For additional information regarding OPRS office hours, please visit https://oprs.usc.edu/virtual-office-hours/

For more information regarding IRB guidance for exemption, please see https://oprs.usc.edu/irb-review/types-of-irb-review/exempt/

If you do not have an approved IRB protocol and would like to see an example of IRB language requesting Biorepository samples, please see the attachment below.

Attachment:IRB Template Language_Requesting Biorepository Samples-Data_De-identified.docx

Identifiable specimens and/or data

De-identified specimens and/or data

Please indicate whether the request is for "Identifiable" or "Deidentified" biospecimens and associated clinical information.

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Please contact cri@usc.edu to specify the type of clinical information you would like on these specimens.

Is this study IRB approved?

* must provide value

Yes

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Is this study IRB approved?

* must provide value

Yes

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HSC IRB approval #

* must provide value

HSC IRB approval #

* must provide value

Please attach evidence of IRB approval.

* must provide value

Upload file

Please attach evidence of IRB approval for exemption of obtaining de-identified data.

* must provide value

Upload file

Has this study been submitted to the IRB?

* must provide value

Yes

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Has this study been submitted to the IRB?

* must provide value

Yes

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IRB approval is required for this type of application. Please see IRB language template below for instructions.

Attachment:IRB Template Language_Requesting Biorepository Samples-Data_Identified.docx

IRB approval is required for this type of application. Please see IRB language template below for instructions.

Attachment:IRB Template Language_Requesting Biorepository Samples-Data_De-identified.docx

Please attach evidence of IRB submission.

* must provide value

Upload file

Please attach evidence of IRB submission for exemption of obtaining de-identified data.

* must provide value

Upload file

Please download and fill out the lab agreement form below. Once complete, please upload your completed lab form in the next field.

Attachment:LaboratoryAgreement10.18.2021_UPDATED.pdf

Please upload your completed lab agreement form here.

* must provide value

Upload file

A material transfer agreement is required for non-USC investigator requests. A material transfer agreement 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 recipient with respect to the materials and any derivatives. Please consult your University or Companies guidelines before submitting your USC MTA.

If you need infomation regarding the USC MTA, their website is https://stevens.usc.edu/researchers/mta-cda/. You can also call 213-821-0939 or email mta@stevens.usc.edu.

If you would like to see an example of a USC MTA, please see the attachment below.

Attachment:Download_USC_MTA_Template.docx

Please upload your completed USC MTA form here.

* must provide value

Upload file

The request will be evaluated for scientific merit, whether the request is consistent with the permissions granted by donors in the consent process, and whether the request is consistent with privacy regulations, by the Biorepository committee. The committee aims to make a decision within 2 weeks of the request.

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