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Large Language Models for IRB Protocol Generation

Large Language Models for IRB Protocol Generation

Thank you for your interest in participating in our research project (IRB-SBS #7515) on leveraging large language models (LLMs) for IRB protocol generation.
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    Dr. Mona Sloane and Dr. Chirag Agarwal at the University of Virginia (UVA) are developing an LLM-based open-source AI chatbot to help researchers draft IRB protocols (IRB-SBS #7515). This project is a collaboration with the National Institute for Standards and Technology Research Protections Office (NIST RPO).

    🤖 What does the chatbot do? It supports researchers as they work through questions asked as part of creating IRB protocols, engages them in principled reasoning about research ethics, and helps generate IRB protocol language as well as materials like consent forms, study information sheets, and recruitment language.

    📄 How is the chatbot developed? To fine-tune a set of LLMs for the chatbot, the research team requires PIs to donate training data in the form of already approved IRB protocols and supplementary documents (active or expired).

    🏛️ Where will the chatbot be hosted? Once the chatbot launches, it will be hosted and maintained by the National Institute for Standards and Technology’s (NIST) Research Protections Office. NIST’s Research Protections Office adheres to the same ethical principles as all IRB offices across the United States. 

    By donating your approved protocols, you help build an open-source tool that can make IRB protocol generation less time-consuming for empirical researchers everywhere.

    If you would like to donate your IRB protocol(s) and supplementary documents (such as consent forms or study information sheets), please use this form to submit a PDF version of your previously approved protocol(s) and any supplementary document(s). Please ensure that you do not submit any IRB protocol(s) or supplementary documents that are considered "sensitive" studies (i.e. any research that is classified, contains proprietary information, etc.).

    To ensure data privacy, all personally identifiable information (name, email, phone number, institution name, group leader, department chair, etc.) must be redacted from the documents prior to training. You may choose to redact this information yourself, or request that our research team does so for you. You will be asked for your preference during the donation process.

    If you choose to not redact personally identifiable information from your documents, the research team will strip or mask any identifying information in the documents as well as strip any non-essential metadata from the donated materials, such as embedded geolocation information or file paths related to the donated documents. Once the donated materials are de-identified, they will be stored in a secure, IRB-compliant environment that is encrypted and password-protected, ensuring that no one but members of the research team have access to the donated materials.

    Participants must be 18 or older, and all documents must be in English. The information that you give in the study will be handled confidentially per our approved IRB (IRB-SBS #7515).

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    Data Management & Privacy

    Confidentiality: The information that you give in the study will be handled confidentially. Any personally identifiable information included in the IRB protocol and its associated documents will be be de-identified or, if applicable, replaced with synthetic information so that none of your personal information will be included in the data used for fine-tuning. If you choose to redact your data yourself, we will still manually double-check to ensure the redaction was successful. Additionally, your name or the names of any members of your research team will be redacted, too. 


    Withdrawal: You have the right to withdraw from the study at any time. If you decide to withdraw, please contact either Dr. Mona Sloane (gbz9xx@virginia.edu) or Dr. Chirag Agarwal (qze3wn@virginia.edu), and your IRB protocol(s) and associated document(s) will be removed. 


    Storage: Your survey submission will be stored automatically in UVA Box, the university’s encrypted cloud storage system. After the research team confirms your uploaded files are in Box, your original Jotform submission will be permanently deleted. Only the research team will have access to your data. 


    Questions/Concerns: You are welcome to ask questions or request clarifications at any time. For any concerns regarding data donation, please reach out to Dr. Sloane at gbz9xx@virginia.edu or Dr. Agarwal at qze3wn@virginia.edu.


    If you would like to continue with the data donation process, continue to the next page to begin uploading your IRB protocol(s) and any supplementary documents.

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    Note: Please do not upload any IRB protocol(s) or supplementary documents that are considered "sensitive" studies (i.e. any research that is classified, contains proprietary information, etc.). If your protocol spans multiple files, please ensure that you upload all of the files. There is no limit to the number or size of files you can upload. 
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    Note: Your name and email will only be used to contact you if we cannot access the PDF you uploaded or if there are issues with reading the PDF. Once the documents are properly redacted and uploaded to Box storage, all records linking your name and email to the PDFs you provided, including your survey response, will be permanently destroyed.
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