Ballad Health Institutional Review Board

Ensuring ethical standards and patient privacy in Ballad Health research

Ballad Health (BH) is committed to ensuring that the rights, welfare and privacy of human research participants are adequately protected in all research activities conducted at Ballad Health. The Institutional Review Board (IRB) is the administrative body charged with the responsibility of reviewing all research involving human participants prior to the initiation of the research.

What is the Ballad Health IRB’s role?

Human subjects research at Ballad Health is guided by the ethical principles set forth in the Belmont Report (Ethical Principles and Guidelines for the Protection of Human Subjects of Research). The minimum standards are set by the Department of Health and Human Services regulations at 45 CFR part 46 and the Food and Drug Administration’s regulations at 21 CFR part 50 and 21 CFR part 56.

The BH IRB serves as the IRB-of-record for all BH employees and associated trainees.

At any given time, the BH 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.

The BH IRB Committee members are drawn from Ballad Health and communities throughout the Appalachian Highlands. Committee members are both affiliated and not affiliated with Ballad Health and play an essential role in bringing diversity and experience to the reivew of human participant research applications.

How does it work?

Ballad Health-affiliated investigators and trainees

Anyone affiliated with Ballad Health who is pursuing a research project must receive approval from the BH IRB before commencing their study, including the solicitation of any human participants and the collection of any data.

Trainees completing educational requirements must have the BH IRB review the proposal – regardless of the methodology to be employed – before the study can be initiated.

ETSU employees and students

The East Tennessee State University (ETSU) IRB serves as the IRB-of-record for ETSU employees and trainees conducting research using Ballad Health data, patients or facilities. Additionally, the BH must be notified of any relevant ETSU research using Ballad Health data, patients or facilities.

When to submit your proposal

The BH IRB Committee meets on the second Tuesday of each month. New research proposals that require the approval of the convened IRB must be submitted no later than 21 days in advance of the meeting. Continuing reviews, amendments and other submissions of already approved research that require the approval of the convened IRB must be submitted no later than 14 days in advance of the meeting.

Each submission has an expiration date of one year. Before expiration, investigators can renew or terminate the study.

Getting started

The BH IRB uses IRBNet for all submissions. IRBNet also houses all required forms for submissions.

All study staff must complete the CITI Human Subjects Protections, Conflict of Interest, and Good Clinical Practice modules before the BH IRB can approve a study.

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 investigator is asked to make changes required by the IRB.

Important resources

Collaborative Institutional Training Initiative (CITI) Training

  • The BH 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. View/download the Human Research Operations Manual [PDF 2.63 MB]
  • CITI is a web-based program in the ethics of human subject research that the BH 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. 

IRBNet

  • IRBNet 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 study staff and IRB staff may interact with one another.

Other resources

Contact us

For additional information, contact the BH IRB at IRB@balladhealth.org.

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