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Ballad Health Institutional Review Board
Ensuring ethical standards and patient privacy in Ballad Health research
The Ballad Health Institutional Review Board (IRB) is an independent committee that conducts scientific and ethical review of all Ballad Health research involving patients.
The purpose of the IRB is to maintain ethical research practices among staff and any affiliated students.
What is the Ballad Health IRB’s role?
The Ballad Health IRB operates as a separate committee from Ballad Health research, with the authority to approve or disapprove any associated research proposal or protocol. It's the IRB-of-record for all Ballad Health employees and associated students who are conducting research within Ballad Health facilities.
At any given time, the IRB oversees more than 200 active protocols, including those studies the IRB has determined to be exempt from IRB review. The IRB receives over 1,000 separate submissions – including annual reviews, amendments and safety events – each year.
IRB members are drawn from Ballad Health and communities throughout our region, including the Tri-Cities of Bristol, Kingsport and Johnson City. There are approximately 15 members of the Ballad Health IRB, who play an essential role in bringing diverse backgrounds and experience to the review of research applications.
How does it work?
Ballad Health-affiliated investigators and students
Anyone affiliated with Ballad Health who is pursuing a research project must receive approval from the IRB before commencing their study, including the solicitation of any human participants and the collection of any data.
For the purposes of students completing educational requirements, the IRB must review every research proposal – regardless of the research methodology to be employed – before the study can be conducted.
ETSU employees and students
If any East Tennessee State University employee or student is interested in doing research using Ballad Health data, patients or facilities, the ETSU IRB is the IRB-of-record. The Ballad Health IRB must be notified of any relevant ETSU research.
When to submit your proposal
The IRB meets on the second Tuesday of each month. Research proposals for upcoming full board meetings are required to be submitted no later than 14 days in advance of the meeting.
Each submission has an expiration date of one year. After expiration, you have the opportunity to renew your study for another year at the annual review, or you may terminate your study at any time.
To complete the application process for your planned research study, you will need access to use IRBNet.
Before being granted access, you'll need to complete CITI training. You may register for the IRBNet ahead of completion of your CITI training, but you will not be able to submit any forms to the IRB in support of your application until you upload your training certificates to IRBNet.
Generally, the turnaround time after receiving a submission in IRBNet is 4-6 weeks. There are times where this can take longer, especially if the researcher is asked to make required changes by the IRB.
Collaborative Institutional Training Initiative (CITI) Training
- The Ballad Health IRB has written policies requiring all personnel involved in research – in any manner – to have documented training in human subject protections regardless of the funding source.
- CITI is a web-based program in the ethics of human subject research that the Ballad Health IRB uses to conduct the initial education as well as continuing education requirements. CITI is recognized by the Department of Health and Human Services' Office of Human Research Protections as meeting the educational requirements of FDA 45 CFR 46.
- The IRBNet program for human subject research was built with support by the National Institutes of Health and other industry leaders, including the FDA. IRBNet provides a secure data system that supports the strict requirements of the federal government for uploading and storing research-related documents.
- IRBNet is where you will upload all your study's signed and dated documents, where your IRB-approved documents will be placed, and where the research staff and IRB staff may interact with one another.
- Ballad Health Research Frequently Asked Questions – Common questions about Ballad Health Research, our facilities, timelines and the IRB
- U.S. Department of Health & Human Services Searchable Database – U.S. HHS rules and regulations for the protection of human subjects
- FDA Code of Federal Regulations Searchable Database – FDA enforcement regulations
- Good Clinical Practice Searchable Database – FDA resources for assisting investigators, sponsors and organizations in complying with U.S. law
Are you interested in pursuing research with Ballad Health? Do you have questions about research team, facilities or the Ballad Health IRB?
Reach out to us at BHResearchstartup@balladhealth.org and we'll get back to you as soon as we can.