Institutional Review Board

Researchers

Steps for IRB Approval:

  1. Determine whether you need IRB approval (pdf)
  2. Apply to the IRB by completing the form "Research Protocol.doc" (see below), and review the instructions.
  3. Wait until you receive an approval letter (via email) before initiating activities involving human subjects (including recruitment).

maroon horizontal bar with text: Download Application Forms

For those of you who have submitted an application before, please note that we no longer require an Exempt, Expedited, or Full Review form, and the "Research Protocol" replaces the "Initial Review Application." Also, investigators' signatures are no longer required on the application. In lieu of signatures, all investigators must be copied on the submission email. If you are in the middle of completing an application using our old forms, please note that we will still be accepting the old forms during this transition period.


piece of paperResearch Protocol.doc

(instructions)


piece of paperAmendment Request Form.doc

(learn more...)


piece of paperContinuing Review Request Form.doc

(learn more...)


piece of paperAdverse Event Report.doc

(learn more...)


piece of paperInterim Request Form.doc

(what is Interim approval?)



maroon horizontal bar with text: Prepare Supporting Documents

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


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maroon horizontal bar with text: Additional Information and Resources

For Research Involving:

Additional Information about:


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Definition of Human Subjects Research

Human subjects research (as defined and regulated by federal law and Virginia Tech policies) involves a systematic investigation, including research and evaluation, designed to develop or contribute to generalizable knowledge (45 CFR 46.102d).

This is generally interpreted to mean that if the results of the work are meant to be published or disseminated to an unrestricted audience, it is considered as regulated human subjects research. However, the benchmark/goal of 'publishing' is not a part of the federal code. If an activity follows a deliberate plan whose purpose is to develop or contribute to generalizable knowledge, such as an exploratory study or the collection of data to test a hypothesis, it is research.

Examples of regulated human subjects research include: surveys, interviews, observations of activities or behaviors, exercise tests, blood collections, psychological or medical measurements or intervention, sensory responses to taste, smell, etc., and any research involving responses from people or access to records about people.


Definition of Human Subject

Human Subject is defined as a living individual about whom a research investigator (whether a faculty professional, research staff or student), conducting research, obtains either data through intervention or interaction with the individual, or specific identifiable private information about that individual (45 CFR 46.102f).

Generally, any University research that uses humans, human tissue, surveys of human subjects, or human subjects' records requires IRB review, irrespective of its funding source. The IRB's charge extends to research in the social and behavioral sciences as well as research in the health and biological sciences.

Intervention includes both physical procedures by which data are gathered (for example, venipuncture, electrocardiogram, electroencephalogram, muscle biopsy) and manipulations of the subject or the subject's environment that are performed for research purposes.

Interaction includes communication or interpersonal contact between investigator and subject.

Private Information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.

 

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Who Must be Included as an Investigator?

Internal and external key personnel responsible for the design and conduct of the study, or individuals planning to use the data for publication purposes. The Principal Investigator must be a VT faculty member.


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/

Student Researchers

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

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


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