Forms and Templates

These forms are subject to revision so always check the IRB library for the latest versions.

The IRB library has three institution-specific libraries:

  • Oak Ridge Associated Universities
  • Oak Ridge National Laboratory
  • Y-12 National Security Complex

Note: All institutions have the same documents, but institution-specific documents may be included as well (e.g., organization conflict of interest).

The library contains standard operating procedures (SOPs), general documents, worksheets, checklists, templates, and job aids. The library contains the documents that are needed to submit to the Oak Ridge Sitewide Institutional Review Board (ORSIRB).

The IRB library in the electronic IRB system:

Forms and Templates

Accessing the Library

  1. To access the library, log in to the IRB system.
  2. Click on “Library.”
  3. Click on the site name (e.g., Oak Ridge National Laboratory).
  4. The library will show tabs of various topics.

To access the job aids in the library, click on the PI Guides tab.

To access the templates in the library, click on the Template tab.

Templates Required for Submission

One or more of these templates are required for your submission to the IRB.

  • New Study – HRP-503 Protocol with Instructions
  • New Study – HRP-583 Data Application
  • New Study – HRP-584 Specimens Application
  • Consent Form – HRP-502 Consent Document
  • Continuing Review – HRP-585 Continuing Review Application

Which Protocol to Use?

Depending on your study, there are three different protocols that can be used. Review the information below to help you decide which one to use.

Human subject means a living individual about whom an investigator (whether professional or student) conducting research:

  • obtains information or biospecimens through intervention or interaction with the individual, and, uses studies, or analyzes the information or biospecimens; or
  • obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

HRP-503 Protocol with Instructions. Use this form if you will be:

  • interacting, intervening, or communicating with human subjects.
  • collecting new data, images, biological specimens or associated data from humans.

HRP-583-TEMPLATE-Data Application. Use this form if you will be using existing data only:

  • The term “data” used in this document should be considered broad in nature. It applies to data of all types that originate from humans. This includes images and photographs; biometric data; telecommunications data; video or voice recording; social media data;  physical sensor data such as EEG/EKG/Fitbit; radiology data; human physiological measurements such as spirometry, weight, blood glucose, blood pressure; demographics and toxicokinetic data from pharmaceutical studies; and survey or questionnaire data collected in other studies.

HRP-584-TEMPLATE-Specimen Application. Use this form if you will be using existing specimens only:

  • The term “biospecimen” in this document should be regarded as including biospecimen-associated data.