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HfSjKbAf2AoferpbJAS4aBdcoDUQyVsGqV26RBoNPryDye9LngIkvQMeYdjdVp5oRYYmYGSGdV7JvpZyd4

Honest Broker Intake

Please fill out the form below to the best of your ability to start the process for an honest broker review.

Contact for Honest Broker request
First Name
Last Name
Email

What's the official title of this study or project?

* must provide value

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What's the corresponding shorthand title?

This is for ease of use in future communications regarding this request. This doesn't have to be the official title. Pick a short title that makes sense to you.

* must provide value

Are you (the contact person) also the Prinicipal Investigator (PI) for this study?

* must provide value

Yes

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Prinicple Investigator for Honest Broker request
First name
Last name
Email

Please select which method you want to use to extract clinical data:

* must provide value

Slicer/Dicer

Data export from DAWG

Large Language Model (LLM)

Curated Clinical Research Database

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Is your LLM dataset going to be 'identified' or 'de-identified'? *

The rapid evolution of artificial intelligence (AI), and specifically machine learning, introduces new questions and considerations concerning the privacy and confidentiality of research participants. To further aid the Research Access to Patient Data (RAPiD) Committee in its review and oversight of this research, UW Medicine is requiring a security risk review of research involving the use of UW Medicine patient data (whether identified or de-identified) for machine learning.

*UW Medicine is in the process of developing a comprehensive institutional approach to the responsible use of generative artificial intelligence ( commonly known as AI or generative AI), including large language models (LLMs), in the healthcare setting. Your responses and intake request in general may be shared with the LLM Workgroup, to inform the group of the type of LLM-related requests that are being submitted, to ultimately aid them in advising on the development of our institutional approach including, but not limited to, policy and procedures, guidance and governance.

* must provide value

Identified

De-identified

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Will the data be analyzed using machine learning tools, such as ChatGPT or other external language models?

* must provide value

Yes

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Will any part of the modeling or processing be executed outside of UW IT Systems?

* must provide value

Yes

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How many individuals will have access to the data generated during this research?

* must provide value

Approximately how many unique patient records will be used?

* must provide value

What type of data will be shared and what will the level of de-identification be?

* must provide value

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Is there a plan in place to delete/destroy any sensitive data when it is no longer being used?

* must provide value

Yes

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Is the work going to produce a new or modified model based on the project data?

* must provide value

Yes

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What does that model produce and how is that model going to be used moving forward?

* must provide value

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Please select your current IRB status.

* must provide value

I have an approved IRB from the University of Washington

I have an approved IRB from another institution

I want to request a "Prep to Research" Honest Broker request

I received an exemption from the University of Washington's HSD department

My IRB application is currently under review

I don't have an approved IRB and I don't believe that I need one (Uncommon)

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Please upload a copy (.pdf) of your UW's IRB letter of approval:

For all external IRB approvals, we require that UW's IRB (Human Subjects Division) vet the validity of the external IRB.

* must provide value

Upload file

Please upload a copy (.pdf) of your IRB application:

This document should be your main guide for scoping out any data pull and should be provided by the researcher to you.
NOTE: This should be in the application format of the IRB. Whole sale protocols will not be accepted.

* must provide value

Upload file

Does your IRB application detail which variables you want to extract or is that detailed elsewhere?

* must provide value

Within the IRB application

External file

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Please upload any supporting documentation that might detail your desired data variables:

Occassionaly, studies will reference an additional document in their IRB application detailing all the data variables.
We need that document to evaluate your request.

* must provide value

Upload file

Please upload a copy (.pdf) of your IRB exemption:

Note: We require both the exemption document and the application.
If either is missing we can't complete your Honest Broker review.

* must provide value

Upload file

Please upload a copy (.pdf) of your IRB approval:

Note: We require both the approval document and the application.
If either is missing we can't complete your Honest Broker review.

* must provide value

Upload file

If your IRB application is still in review, we can't move forward with your Honest Broker request.
Please fill out this form again when you have completed IRB documentation and approval.

We won't be able to process your Honest Broker request without a valid IRB approval
or a proper declaration that your export will only be used for "prep to research" purposes.

Per UW Medicine Compliance Policy: Comp.103-

Activities that are sometimes categorized as "preparatory to research" are considered to be research by the Human Subjects Division, which makes such determinations on behalf of the University. These include but are not limited to: screening activities such as review of PHI to identify possible research subjects, feasibility studies and/or pilot studies. Such activities may involve the use of human subjects directly or indirectly (through individually identifiable health records, the collection or review of other data such as samples, specimens or autopsy materials).

Link to full policy

Preparatory to Research is IDENTIFIED patient data. If you need simple feasibility counts, answer "no" below.The "Preparatory to Research" designation is typically only used for the purpose of preparing a research protocol or planning the research activity.

Is any of the information you plan to access for your project preparatory to research?

You've indicated that you are not requesting a Prep to Research Honest Broker request.Please start over or select another option in the 'IRB Status' question.

Please select your institution

* must provide value

Fred Hutch Cancer Research Center

Seattle Children's Hospital

University of Washington

Other

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Please note that per Fred Hutch Compliance, identifiable data for preparatory to research is not allowed. You have indicated that you are with ______ , therefore are unfortunately unable to move forward with your request at this time.

If you would like more information, please refer to the Fred Hutch Preparatory to Research Policy. You will need to use your FH credentials to login and view this policy.

Please note that per UW Medicine Compliance, identifiable data for preparatory to research is not allowed. You have indicated that you are with ______ , which is outside of the UW Medicine HIPAA Coverage. We are unfortunately unable to move forward with your request at this time.

Please note that per UW Medicine Compliance, identifiable data for preparatory to research is not allowed. You have indicated that you are with ______, which is outside of the UW Medicine HIPAA Coverage. We are unfortunately unable to move forward with your request at this time.

Use or disclosure of PHI is sought solely to review it for the purpose of preparing a research protocol or planning the research activity.
For example, a researcher may review PHI to design a research study or to assess whether a sufficient number or type of records exist to conduct the research)

* must provide value

I agree to this condition

I do not agree to this condition

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No PHI will be removed from the UW Medicine covered entity by the researcher in the course of the review.

* must provide value

I agree to this condition

I do not agree to this condition

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The PHI for which use or disclosure is sought is necessary for research purposes.

* must provide value

I agree to this condition

I do not agree to this condition

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You have indicated that you do not agree to one or more of the preparatory to research statements. Please note that per UW Medicine Compliance, identifiable data for preparatory to research is only allowed with agreement the the above statements. We are unfortunately unable to move forward with your request at this time. If you find that you have made a selection in error, please correct it before moving forward.

To complete the 'Preparatory to Research' attestation, please sign using your mouse or finger.

This electronic signature will be considered the same as an inked signature

* must provide value

Add signature

Are you or someone on behalf of the study planning to share the requested data with any party outside of the University of Washington Medicine?

* must provide value

Yes

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Do you have Data Use Agreements (DUA) in place with the other parties you intend to share this data with?

* must provide value

Yes

We are working on it

I don't believe I need a DUA for sharing this data (Uncommon)

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Please upload a copy (.pdf) of the relevant DUA.

* must provide value

Upload file

Due to the sensitive nature of Personal Health Information (PHI),
we require DUA's to be in place with all involved external parties.
Without a DUA, we WILL NOT be able to sign off on your Honest Broker review.

The rapid evolution of artificial intelligence (AI), and specifically machine learning, introduces new questions and considerations concerning the privacy and confidentiality of research participants.

To further aid the RAPiD Committee in its review and oversight of this research, UW Medicine is requiring a security risk review of research involving the use of UW Medicine patient data (whether identified or de-identified) for machine learning.

For identified LLM requests, we will first verify your documentation for completion and accuracy before performing a security review.

For de-identified LLM requets, we will perform a security review immediately.

If you supplied all required documentation and see the 'submit' button below, that means we can move forward with the Honest Broker process.

Upon submitting this form, our team will review your supplied documentation for accuracy and completeness.

If we find any issues with the documentation or form, we will reject your request and supply you a justification to the email provided in the form.

Once received, please correct any identified issues and submit another request.

If documentation is accurate and complete, we will email follow up instructions for your selected extraction method (______).

You have selected an option that triggers this survey to end right now.

To save your responses and end the survey, click the 'End Survey' button below. If you have selected the wrong option by accident and/or wish to return to the survey, click the 'Return and Edit Response' button.