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To complete an IRB application for your...

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

...use our new 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?

  IRB Protocol Management is a web-based system that allows researchers (both VT and non-VT) to submit IRB applications online, track the progress of submitted applications, and save IRB protocol-related documents online.

  Benefits of IRB Protocol Management:

  • Receive immediate feedback while completing an online application regarding missing information.
  • View your co-investigators' IRB training and CV requirement statuses, and auto-prompt him/her to meet the requirements.
  • Investigators' CVs are stored online, and therefore do not need to be provided with each individual IRB application.
  • Save and collaborate application drafts with your study team.
  • Track the progress and status of submitted applications.
  • View and download approved study documents from anywhere with Internet connection.
  • Download approval letters.

  PREVIEW THE SYSTEM. . .

  
  

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

• Recruitment Materials
• Consent Document
• Parental Permission & Assent Form (for research involving children)
• Data Collection Instruments - e.g., interview questions, surveys (protecting confidentiality & anonymity)
• CV, resume, or biosketch (i.e., brief summary of your professional / educational accomplishments) for all investigators

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

For Research Involving:

• Academic Assessment
• Alcohol Administration in Human Experimentation (recommendations from the National Advisory Council on Alcohol Abuse and Alcoholism)
• Audio / Video Recordings
• Children / Minors
• Cognitively Impaired
• College Students as Subjects
• Compensating / Paying Subjects
• Deception
• Elderly or Terminally Ill
• Homeless Subjects
• Minorities or Non-English Speaking
• Online Data Collection & Storage of Electronic Data
• Pregnant Women, Fetuses, or Human In Vitro Fertilization
• Prisoners
• Radiation
• Sensitive or Illegal Information

Additional Information about:

• Carilion Medical Center, Conducting Research with
• Certificate of Confidentiality
• Deadlines for Full Review Protocols
• DHHS Agencies, List of
• Failure to Submit an Acceptabl Protocol or Implement Required Revisions Policy (pdf)
• Educational Records: FERPA overview: NACUA Notes (pdf) 34 CFR Part 99: Part II (pdf)
• Genetic Information Nondiscrimination Act (Guidance from OHRP)
• Human Subject Research, Definition
• International Research
• Montgomery County Public Schools, Conducting Research at
• Post Approval Monitoring
• Responsibilities of Conducting Research
• Review Categories
• Sponsored Research
• Storage and Transfer of Human Subjects Research Records Policy (pdf)
• Training, Human Subjects Protection
• VCOM, Conducting Research with
• Virginia Tech Policy for Releasing VT Faculty, Staff, or Student Records and Contact Information (see policy 2010)

 

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.

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:

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 $10,000 or 3% of the equity of the sponsor
5. Has received any payments or other incentives from any sponsor that total in excess of $10,000
6. Has identified him or herself for any other reason as having a conflicting interest

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/