Institutional Review Board

Researchers

To complete an IRB application for your...

  • new study
  • interim request
  • amendment request
  • continuing review request
  • unanticipated problem / adverse event report

...use our online IRB Protocol Management system!



Extras:

  • Determine whether you need IRB approval by reviewing our flowchart (pdf)
  • Learn more about interim requests, amendments, continuing review requests, reporting unanticipated problems / adverse events, and reporting a project closed.
  • What is IRB Protocol Management?




maroon horizontal bar with text: Prepare Supporting Documents

The following items must be included with your online IRB application (as applicable):


In addition, all investigators must have completed human subject protections training before a new study application may be submitted to the IRB office.




maroon horizontal bar with text: Additional Information and Resources

For Research Involving:


Additional Information about:

 

Who Must be Included as an Investigator?

Internal and external individuals who meet the Office for Human Research Protection's definition of investigator.


Student Researchers

Policy No. 3.02

A faculty member must be listed as the principal investigator on student's IRB applications. Principal investigators / faculty members are ultimately responsible for the conduct of the research and compliance with IRB determinations, federal and state regulatory requirements, and human participant protection standards.

Faculty members should take an active role in ensuring that projects are conducted in accordance with the IRB's requirements. Meeting periodically with students to review their progress is one way to meet this responsibility.

The Virginia Tech IRB no longer requires that class research projects be approved by the IRB unless there is intention of publishing or disseminating study results. This includes independent class projects, class assignments, and undergraduate research. This does NOT include senior theses and doctoral dissertation research. Research for senior thesis and doctoral dissertation still require IRB approval.


Conflict of Interest

Policy No. 3.03

As it relates to human subjects research, a conflict of interest is defined as a set of conditions in which an investigator's judgment concerning a primary interest (e.g., subject's welfare, integrity of research) may be biased by a secondary interest (e.g., personal gain).

Researchers are required to report potential conflicts of interest within the appropriate IRB application(s).

A research investigator or IRB member is said to have a conflict interest whenever that investigator or IRB member, his or her spouse, or dependent child falls under any of the following conditions and/or meets the above definition:

  1. Is an investigator on the protocol (only applicable to IRB members)
  2. Has entered into a financial arrangement with the sponsor or agent of the sponsor, whereby the outcome of the study could influence the value of the economic interest
  3. Acts as an officer, director, or agent of the sponsor
  4. Has any equity interest in the sponsor exceeding $5,000 or 3% of the equity of the sponsor
  5. Has received any payments or other incentives from any sponsor that total in excess of $5,000
  6. Has identified him or herself for any other reason as having a conflicting interest

The IRB utilizes the DHHS's latest guidance document for direction on handling reported conflicts of interest.

Note: The VT University Legal Counsel provides information on filing a conflict of interest claim at http://www.ulc.vt.edu/ulc_faq.html#ConflictofInterest.


HIPAA: Health Insurance Portability and Accountability Act of 1996

HIPAA resources for research involving the use of individually identifiable health information collected in a setting related to the patient care process:

http://www.hhs.gov/ocr/hipaa/
http://privacyruleandresearch.nih.gov/