IRB Guidance and Exemplars

Guidance  and exemplars provide VU researchers with key considerations, best practices, and examples relating to a specific topic in order to facilitate compliant and ethical human research.

How to use VERA

To submit your research project for VU IRB review and approval, log in to VERA, the VU IRB electronic management system, using your VUNetID and password. For step-by-step instructions, please refer to the VERA Guide: How to Submit a New Study. 

As a PhD student serving as the Principal Investigator (PI) for your research project, you are required to designate your faculty advisor as your Proxy PI in VERA. For step-by-step instructions, please refer to the VERA Guide: How to Assign a PI Proxy.

A Department Chair or a Department Chair Designated Reviewer's ancillary review is required for all studies being submitted to the VU IRB in VERA. For step-by-step instructions, please refer to the VERA Guide for Department Chairs: How to submit an Ancillary Review.

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. If a formal Local Ethics Committee review is not required in the country(ies) where your study is taking place, the International Research Consultant Form must be completed by a local context reviewer and uploaded in VERA as part of the IRB submission process for non-exempt studies.
  • 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

Tips and Exemplars

Examples of completed research submissions are currently in development and will be available soon.

In the meantime, we have compiled a list of practical tips for VU researchers to effectively navigate the SBER IRB ethical considerations, avoid common pitfalls in the IRB submission process, meet regulatory requirements, and streamline the review process for both researchers and IRB reviewers. Consider the following practical tips when submitting to the VU IRB:

  • Know if your research meets the regulatory definition of human subjects research
  • Ensure all research personnel have completed the required training
  • Ensure all permissions and additional ethical reviews are obtained prior to the study start
  • Identify a qualified Principal Investigator (PI)
  • Determine if external research collaborators are engaged in human subjects research
  • Determine if anyone on the research team has a conflict of interest
  • Review the Investigator Manual and relevant policies/guidance documents
  • Identify if additional regulations apply to your research
  • Submit your research in a timely manner
  • Use VU HRPP templates and label documents clearly
  • Maintain consistency and transparency within research study submission materials
  • Provide a detailed description of research procedures in lay terms
  • Directly answer the questions that are being asked
  • Ensure the submission is complete
  • Expect revisions or clarification questions from the VU IRB during the study review

For more details, please review the practical tips guide that includes best IRB submission practices.