Important Research Support and Governance Considerations

Human Subjects Research

Researchers must include how they plan to use these tools in their Human Subjects Research projects and adhere to information security policies. For questions related to the IRB submission process, email the IRB.  For the latest policy updates, please visit the Human Research Protection Program (HRPP) and Institutional Review Board (IRB) web-page and the RASCAL IRB Library, which can be accessed once logged into RASCAL.

• Any language within the protocol consideration section of each tool/vendor provides an example of language regarding the inclusion of each tool in your protocol and is not required or templated language. Please do not copy/paste this information to your own protocol without reviewing to ensure it applies to your study and specific use of the tool. 

• All written or verbal communication used along with these tools must be IRB approved prior to implementation. English-language items should be submitted to the IRB, and translations can be submitted in a modification after the initial project approval. This includes but is not limited to: scripts, templates for text messages, MyChart messages, consent forms, etc.  

Evaluation, Quality Improvement, and other Exempt Projects

These types of projects can also use the tools listed in the Digital Toolkit. Contact the tool owner/administrator for specific access requirements.

Intellectual Property

Any newly created content, such as apps, websites, or other creative works, may be governed by Lurie Children's intellectual property policies. You are encouraged to reach out to the Innovate2Impact team before making any product publicly available. Please contact the Innovate2Impact Team early in your work to set up a collaborative meeting. Note: At this time, recruitment materials and informational flyers do not require review.  

Digital Health Ethics

For guidance on ethical and just research practices, explore the Clinical Research Ethics Consultation: Northwestern University Clinical & Translational Sciences Institute (CREC). The CREC team can support you by ensuring that research opportunities are offered fairly and ethically, especially when involving the provision or inclusion of digital tools. This consultation service is available to Lurie Children's, Shirley Ryan AbilityLab, and Northwestern University faculty conducting clinical research.

New Technology Request

Researchers are strongly encouraged to use existing reviewed and approved tools to conduct your work whenever possible. If your research needs a new software or platform, please visit New Research Technology Requests to initiate the process for review and approval of tools that would align with your project’s requirements.

Research Security

If you have questions on research information security policies and regulations, visit Research Security. Resources on compliant use of AI, and processes for electronic information system attestations and survey requests may be found there as well.

• Data Sharing: The Shared Documents Guidance provides researchers with essential information on external data-sharing options for academic and research collaborations outside of Lurie Children’s and Manne Research Institute.

External Project Partners

For guidance on external document sharing, please refer to the General File Sharing Guidance. Note: Lurie Children’s permits external content sharing with certain restrictions. External users can collaborate, edit, and upload content within the Lurie Children’s environment but are not allowed to download or print content on non-Lurie Children's devices.  

Statistical Platforms and Project Management

This guide focuses on participant-facing tools and content creation. There are many approved tools available to conduct statistical and qualitative analyses to manage and organize your research project. If you are interested in learning about the statistical platforms and project management tools available, researchers are encouraged to review the Quantitative Science Resource Directory and to reach out to the Quantitative Science team with questions.