VT Human Subjects Protection Tutorial
1. Welcome --- 2. Reason for Training --- 3. Importance of Compliance --- 4. History --- 5. Selection of Subjects --- 6. Recruitment --- 7. Consent --- 8. Paying Subjects --- 9. Confidentiality & Anonymity --- 10. Who Regulates Your Research? --- 11. VT IRB Submissions --- 12. Continued Compliance ---QUIZ
11 Virginia Tech IRB Submissions, What You Need to Know
Please visit the Virginia Tech IRB website at http://www.irb.vt.edu for information regarding:
- How to complete an application
- To find IRB application forms
- To learn more about the Virginia Tech IRB
- For help developing your study procedures and forms, for example, your consent form
- Overview of & links to federal regulations
- And more
VT IRB Approval, When is it Required?
The flow chart "Activities Requiring Approval.pdf" is an aid for researchers to determine when VT IRB approval is required.
Researchers must seek and obtain IRB approval BEFORE conducting any research type activities involving human subjects, including informal recruitment.
There is occasional confusion about research that is "exempt." Some individuals have mistakenly assumed that "exempt research" does not need IRB review. However, "exempt" means that it falls within a narrowly defined category of research needing administrative review rather than full board review. For further information about different review types (e.g., Exempt, Full Board Review), visit our website at http://www.irb.vt.edu/pages/categories.htm.
A human subject is a living individual about whom a researcher obtains either: 1) data through intervention with the individual; or (2) identifiable private information.
Research is defined as 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.
In addition, VT IRB approval must be obtained for all senior theses and dissertation research even if there is no intention to publish or disseminate the results. IRB approval is no longer required for class projects.
Types of Submissions
All application forms are located on our website for downloading at: http://www.irb.vt.edu/pages/researchers.htm.
New Study
Before beginning your research involving human subjects, you need to obtain IRB approval. The IRB must review and approve all study documents pertaining to human subjects, including but not limited to: 1) advertisements & invitation letters, 2) survey instruments, including questionnaires & interview scripts, 3) consent document(s), and 4) the Research Protocol (which is an application form found on our website at the above link).
Amendment Request
Researchers must report all changes of study procedures, study personnel, or changes to study forms (e.g., questionnaires, interview questions, invitation letters, etc.) to the IRB BEFORE implementing the change. Basically, if there is a change to any of the documents originally submitted to the IRB, or if there is an addition of a study document, the IRB needs to be informed. To report changes, researchers must complete an Amendment Request form (found on our website at the above link).
Continuing Review Request
(Also called re-approval)
Studies are approved for a specified period of time, no longer than 12 months. Your IRB approval letter will contain your study’s expiration date (Exempt approvals do not expire). It is essential that you request and obtain IRB re-approval to your study before it expires if you plan to continue the study past the 12-month approval period. If you close your study (i.e., data analysis is complete at Virginia Tech and all activities involving human subjects are complete), report this to the IRB via e-mail at irb@vt.edu.
The IRB office will prompt you to re-approve your study or report it as closed within two months of your study’s expiration date; however, it is ultimately the responsibility of the Principal Investigator to re-approve the study or report the study as closed in a timely fashion.
Failure to report your study as closed, or to request and receive IRB re-approval before the study’s expiration date will result in the following:
- Letter to department head and all researchers reporting that the study has expired
- All study procedures involving human subjects and data analysis must halt immediately
- Any data collection occurring during the period of expiration must be destroyed
- The expiration will be recorded by the IRB office as an incident of noncompliance
- Additional consequences may occur
Adverse Event Reports
Adverse Events are new findings or unexpected problems whose nature, severity, and frequency are not described in the information provided to the IRB or to study participants. Examples include unexpected complications experienced by a subject, missteps in the documentation of consent, or breaches of confidentiality. It can represent a new symptom experienced by a study subject or an exacerbation or worsening of an existing condition.
Any problems involving the conduct of the study or subject participation (including recruitment, consent, screening and termination) should be reported immediately. For example, if a subject complains about any aspect of his or her treatment as a study subject, this should be reported and the subject should be referred to the IRB Chair for assistance. An Adverse Event Report form can be found on our website at the above link.
Approved Applications
All correspondence from the IRB office is through email. Once an application is approved by the IRB, all investigators listed on the application will receive an official approval letter via email. Retain this official approval letter. The Graduate Department will request a copy of this letter prior to graduation.
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