Principal Investigators
Taking on the role of Principal Investigator for research studies can be a challenging task. Not only are you responsible for the overall conduct of the study, but you are also responsible for all of those individuals working on the study. The Vanderbilt IRB has specific policies and procedures related to the Responsibilities of Investigators. Please review these before you begin your study.
Steps to Get Your Study Started
Step 1 - Complete CITI Training
CITI (Collaborative IRB Training Initiative) - is an internet-based set of educational modules focused on the protection of human participants in research. It is sponsored by a consortium of IRB professionals and researchers from universities and medical schools across the country and is administered by the University of Miami.
Completing a set of basic CITI modules is required per IRB Policy VIII.A. You can also review additional information about CITI by clicking HERE or by going directly to the CITI Homepage.
Step 2 - Choosing an Application
The application you need to complete depends on the type of research study you will be conducting. Many of the applications available have a set of accompanying instructions that provide background on the type of information you should include in each section. All IRB forms and applications are available on our website for you to download and complete at your convenience. Currently, we have two methods available to submit your study: paper/hardcopy and electronically through DISCOVR-E. Please note that the forms you need to use are different based on the type of submission you plan to pursue. Hardcopy forms can be downloaded from our Forms Page and electronic forms can be downloaded from the DISCOVR-E Library.
Please use the Application Decision Tree shown below to help you determine which application you need to complete. A PowerPoint slide show is also available to help you with your application selection. If after reviewing this information you still have questions, please to not hesitate to contact the IRB at 322-2918.
| How to Determine the Appropriate IRB Application for Your Research |  |
Key Definitions
Human Subject - A living individual about whom an investigator (whether professional or student) conducting research obtains data through intervention or interaction or identifiable private information.
Research - A systematic , including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
Exempt Categories/Criteria
Category (b1) - Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
Category (b2) - Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior, unless: (i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.
Category (b3) - Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under category (b2) if: (i) the human subjects are elected or appointed officials or candidates for public office; or (ii) Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
Category (b4) - Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publically available or if the information is recorded by the Investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
Category (b5) - Research and demonstration projects which are by or subject to the approval of Department or Agency heads, and which are designed to study, evaluate, or otherwise examine: (i) Public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs.
Category (b6) - Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.