Name of WU Principal Investigator (PI):
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Email of WU PI:
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Department of WU PI:
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Is WU PI filling out this form?
Yes
No
Name of person filling out this form:
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Email of person filling out this form:
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(optional) Name of additional WU Contact, if any:
(optional) Email of additional WU Contact:
Name of Collaborator/Other Party:
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Name of PI/technical contact at ______ :
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Name of contact for contracts/legal issues at ______ :
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Email of contact for contracts/legal issues at ______ :
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If the proposed agreement is a mulit-party agreement, please list those other parties here along with relevant contact information:
Is the Collaborator a non-profit or for-profit entity?
Non-Profit
For-Profit
Does ______ or any investigator participating in the study, or their spouse/partner/dependent child, have a financial interest in the Collaborator consisting of:
(select all that apply)
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Compensation for consulting, speaking fees, honorarium, service on advisory board
License agreement or royalty income
Equity interests, including stock, stock options, warrants, partnership or equitable ownership interest
External employment
External appointment
Board of Directors, Officer, Trustee, or other fiduciary role
Other personal fees/compensation
None
Compensation for consulting, speaking fees, honorarium, service on advisory board
License agreement or royalty income
Equity interests, including stock, stock options, warrants, partnership or equitable ownership interest
External employment
External appointment
Board of Directors, Officer, Trustee, or other fiduciary role
Other personal fees/compensation
None
Please list individual with financial interest.
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To your knowledge, does this study involve a technology developed at Washington University that is currently licensed to a commercial entity?
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Yes
No
Please describe. If known, please list the OTM technology number, the name of the technology, name of licensee, funding source for technology creation, and any other relevant information.
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Is the Collaborator a foreign entity?
* must provide value
Yes
No
WU is required to report certain transactions with foreign entities. To assist in our efforts, please provide the monetary value (or best estimate) of any material/equipment/ or other in-kind contribution received from the Collaborator.
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If ______ provided a template, then attach here:
Project Title:
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Duration of Project/Agreement
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Description of the Project/Scope of Work. This section should provide sufficient information such that each party understands the Project to be performed. If the Project is collaborative, include a description of each party's activities. Please include any material or equipment to be exchanged. You may also choose to attach the SOW as a file below.
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Who developed the protocol/SOW?
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WU PI
Collaborator
Both
If both, who initiated the idea?
WU PI
Collaborator
Will either party be providing funding to the other party under this agreement?
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Collaborator will pay WU
WU will pay Collaborator
Each party will cover its own costs
Collaborator will pay WU
WU will pay Collaborator
Each party will cover its own costs
Please describe all funding sources supporting this Project.
If department funds are supporting the costs please attach evidence of the Department Chair or the Department Chair's designee's approval.
If funded by the NIH and subject to a Data Sharing Plan, please attach the applicable data sharing plan with this form.
If funded by third party funding, please attach applicable funding agreements if available.
(Attachment field bellow with extra located at the end of this form.)
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Please provide (or attach below) a budget and preferred payment schedule if not included in the template provided by the other party.
Note: University overhead for corporate sponsored studies is 50% (Med. School), and 55.5% (Danforth), effective July 1, 2023. The Budget must incorporate the appropriate University overhead, any departmental overhead, and fees.
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If departmental funds are used, please attach department head or business manager approval here:
RMS PD#
(Please contact your department grant specialist for this)
Do you plan to publish the results of the Project?
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Yes
No
Do you anticipate publishing jointly with Collaborator?
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Yes
No
If you do not anticipate publishing jointly or decide not to publish jointly, do you require the right to publish first?
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Yes
No
Do you anticipate that you will make an independent discovery or invention in the performance of the Project or do you expect to make an improvement to or develop a new use for the Collaborator's product? (if applicable)
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Yes
No
Please describe.
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Do you have any issued or pending patents, or have you ever filed an invention disclosure related in any way to the Project?
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Yes
No
Please describe. If known, please list the OTM technology number, name of the technology, funding source for technology creation, whether the Intellectual Property has been licensed or is available for licensing, and any other relevant information.
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Please describe your expectations for use/ownership of Data/Results generated in the Project? For example, do you anticipate joint ownership, each party receiving a right to use the other's results for research purposes only, etc.?
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Will you be sending or receiving any proprietary materials (other than biospecimens)?
(select all that apply)
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Please describe the WU materials to be transferred.
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Please describe the Collaborator Materials to be received.
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Will proprietary materials (other than any material provided by the Collaborator) be used in the performance of the Project? (ex. cell lines, mouse models, software etc)
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Yes
No
Please describe, including the source of those other materials. (Please attach any related agreements/MTAs to the end of this form)
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Is WU sending or receiving individual level human data or bio-specimens?
(select all that apply)
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Please describe the bio-specimens to be transferred by WU.
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Are you aware of any obligations or restrictions associated with the data or biospecimens that JROC should be aware of? If so, then describe:
Please answer the following questions regarding the data that WU is sending.
Describe the data that WU is sending to ______ :
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If you have a list of data points to be transferred to the ______ , then attach it here.
Please select ALL data elements that WU will be sending to ______ .
Names
Any geocodes that identify an individual household such as a street address or Post Office Box Number
Telephone numbers
Fax numbers
Electronic mail (email) addresses
Social Security numbers
Health plan beneficiary identifiers
Account numbers
Certificate/license numbers
Vehicle identifiers and serial numbers, including license plate numbers
Medical device identifiers and serial numbers
Web universal resource locators (URL)
Internet Protocol (IP) address numbers
Biometric identifiers, including finger and voice prints
Full face photographic images
Geographic subdivision smaller than a state
5 or 9 digit ZIP codes
Any elements of dates (except year), including the date of service, date of birth, date of death, etc.
Specific age over 90 years
Any other unique identifying number, characteristic, or code that could be used by the researcher to identify the individual
Names
Any geocodes that identify an individual household such as a street address or Post Office Box Number
Telephone numbers
Fax numbers
Electronic mail (email) addresses
Social Security numbers
Health plan beneficiary identifiers
Account numbers
Certificate/license numbers
Vehicle identifiers and serial numbers, including license plate numbers
Medical device identifiers and serial numbers
Web universal resource locators (URL)
Internet Protocol (IP) address numbers
Biometric identifiers, including finger and voice prints
Full face photographic images
Geographic subdivision smaller than a state
5 or 9 digit ZIP codes
Any elements of dates (except year), including the date of service, date of birth, date of death, etc.
Specific age over 90 years
Any other unique identifying number, characteristic, or code that could be used by the researcher to identify the individual
Was any part of the data collected under NIH funding after November 2016 or is there a certificate of confidentiality applicable?
Yes
No
Data from how many individuals will be transferred by WU to the ______ ?
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Do you have (or are you seeking) IRB approval associated with the original collection of the data?
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What is the IRB number?
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What is the original source of the data?
(select all that apply)
* must provide value
Was the data collected or will it be collected under an informed consent or a waiver of consent?
(select all that apply)
* must provide value
Do you have any other requirements for ______ 's use of the data that WU is sending? If so, please explain:
For example: security standards, authorship expectations, publication embargo periods, ______ must acknowledge source of the data in any publications, ______ must share the results back with you?
Will ______ 's use of the data include the training of an algorithm, machine learning or any other AI development?
* must provide value
Yes
No
Describe the AI tool and any anticipated end product:
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Is the AI tool already established or is it currently being developed? Please describe the status of the AI tool.
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How will WU's data contribute to the development or validation of the tool, if at all?
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Please answer the following questions regarding the data that WU is receiving.
Describe the data that the WU is receiving from the ______ :
* must provide value
Please select ALL data elements that WU will be receiving from ______ .
Names
Any geocodes that identify an individual household such as a street address or Post Office Box Number
Telephone numbers
Fax numbers
Electronic mail (email) addresses
Social Security numbers
Health plan beneficiary identifiers
Account numbers
Certificate/license numbers
Vehicle identifiers and serial numbers, including license plate numbers
Medical device identifiers and serial numbers
Web universal resource locators (URL)
Internet Protocol (IP) address numbers
Biometric identifiers, including finger and voice prints
Full face photographic images
Geographic subdivision smaller than a state
5 or 9 digit ZIP codes
Any elements of dates (except year), including the date of service, date of birth, date of death, etc.
Specific age over 90 years
Any other unique identifying number, characteristic, or code that could be used by the researcher to identify the individual
Names
Any geocodes that identify an individual household such as a street address or Post Office Box Number
Telephone numbers
Fax numbers
Electronic mail (email) addresses
Social Security numbers
Health plan beneficiary identifiers
Account numbers
Certificate/license numbers
Vehicle identifiers and serial numbers, including license plate numbers
Medical device identifiers and serial numbers
Web universal resource locators (URL)
Internet Protocol (IP) address numbers
Biometric identifiers, including finger and voice prints
Full face photographic images
Geographic subdivision smaller than a state
5 or 9 digit ZIP codes
Any elements of dates (except year), including the date of service, date of birth, date of death, etc.
Specific age over 90 years
Any other unique identifying number, characteristic, or code that could be used by the researcher to identify the individual
Do you have (or are you seeking) IRB approval associated with WU's use of the data that you are receiving from ______ ?
* must provide value
What is the IRB number? If the same as an IRB number that was previously provided, then you can put same .
* must provide value
Will WU be sharing the data with any other third party entities collaborating on the project? (i.e. anyone who is not a WU employee). If so, please list out who.
Please attached any agreements associated with the bio-specimens (eg. funding, clinical trial, or material transfer agreements under which the bio-specimens were collected or received)
Will the Collaborator be performing any CLIA assays utilizing the bio-specimens?
* must provide value
Yes
No
Will the assay results be returned to the patient/subject?
* must provide value
Yes
No
Please describe the bio-specimens to be received from the Collaborator.
* must provide value
Are you planning on disclosing or receiving any confidential information?
(select all that apply)
* must provide value
Please describe confidential information to be disclosed.
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Are you doing any related research for another party including another private entity or a Government agency that could conflict or overlap with this study?
* must provide value
Yes
No
Please explain.
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Will there be any students or post-docs working on this project?
* must provide value
Yes
No
Will there be any Visiting Scholars or other non-employees working on this project or present in the lab during performance of the project?
* must provide value
Yes
No
Please provide name and employer of visitor and any additional information regarding the role of the visitor in the project.
* must provide value
Please describe the benefit the Collaborator will derive from the collaboration
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Is there any other information you think would be helpful for us to know?
Please attach the email chain with ______ regarding this project, if any. (eg. email receiving agreement template)
Please sign this form by typing your name here. If you are not the PI, then by typing your name here you certify that the PI has reviewed and approved the contents of this form:
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Please enter today's date:
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