IRB Guidance and Exemplars

Human Research Guidance

The following guidance documents provide detailed instructions and best practices to support researchers in conducting compliant, ethical research involving human subjects. These resources cover various aspects of research, from study design to data management and multi-site collaboration:

• International Research: This guidance document is relevant to research involving data and/or study populations located outside of the United States. Considerations for submitting international research to the VU IRB are included in this guidance document.
• Community-Based Participatory Research (CBPR): For research involving community partners, this guidance document offers researchers examples and considerations when submitting to the VU IRB.
• Requesting a .118 Determination: The VU IRB can certify that certain grants or agreements have been awarded with a human subjects research component, but plans for the involvement of human participants are not yet definite. Refer to this guidance document for .118 determination considerations and how to submit the request to the VU HRPP.
• Personal Information Protection Law (China) Guidance: Effective November 2021, China’s Personal Information Protection Law (PIPL) sets strict regulations on the collection, storage, use, and transfer of personal information of Chinese citizens. If conducting research involving Chinese citizens, refer to this guidance.
• VU Office of Cybersecurity Data Classification Guide

COMING SOON

• IRB Authorization Agreement (IAA)(also known as Reliance Agreement): This guidance is for multi-site studies that will be reviewed by a single IRB. An IAA is an agreement that documents respective authorities, roles, responsibilities, and communication between an FWA institution/organization providing the ethical review and a participating institution relying on the ethical review.
• Individual Investigator Agreement (IIA): This guidance is for research collaborators, such as community partners, not affiliated with an FWA institution. An IIA is a formal contract between Vanderbilt University, a Federalwide Assured (FWA) organization, and an individual investigator who is not affiliated with an FWA organization or institutional research collaborator who is not acting as an agent of an FWA assured organization.
• Guidance for Secondary Analysis of Data and/or Biospecimens: This guidance document outlines definitions, best practices and considerations for those conducting research involving secondary analysis of identifiable, private information or biospecimens.
• Guidance for HIPAA-Regulated Research: This guidance document provides VU researchers with information regarding accessing/obtaining/using/sharing of protected health information from a covered entity for research purposes
• Guidance for working with the VUMC Synthetic Derivative, bioVU, Genetics Research, Using Biospecimens with FDA Regulated Articles, or Serving as the Coordinating Site for a Multi-site, Federally Funded Study