Institutional Review Board
- Institutional Review Board
- Getting Started
- New Research Submission
- Existing Research Submissions
- Conflict of Interest
- Meeting Dates
- Open Trials & Research
The Institutional Review Board (IRB) for Indiana University Health Ball Memorial Hospital and its entities are responsible for the review and approval of all research involving human subjects conducted under the auspices of these institutions. The IRB is charged with protecting the rights and welfare of human research subjects recruited to participate in research activities and to ensure compliance with applicable hospital policies and federal regulations.
Effective January 1, 2017:
- New Good Clinical Practice (GCP) training requirement for Principal Investigators of interventional clinical studies
- New IRB fee structure for industry sponsored research
IRB Registration & Compliance
The Indiana University Health Ball Memorial Hospital Institutional Review Board (IRB) complies with all federal requirements for IRB as defined in DHHS regulations 45 CFR Parts 46 and 164 and Food and Drug Administration regulations 21 CFR Parts 50 and 56.
What is the IRB Office?
The IRB Office provides support to the IU Health Ball Memorial Hospital Institutional Review Board (IRB) which is responsible for reviewing all research involving human subjects, ensuring the protection of human subjects in research conducted by researchers at the hospital (including non-IU Health Ball Memorial Hospital researchers using subjects at IU Health Ball Memorial Hospital hospital), and overseeing the hospital’s compliance with the federal regulations and guidelines.
Why Do You Need Approval?
Under Federal regulations and hospital policy, all researchers who conduct research that involves human subjects or materials of human origin must submit an application to the IRB. Approval of the research protocol must be in place BEFORE the research begins. This includes data collection, which refers to any gathering of information from or about living human beings.
Research includes not only physicians, but also, fellows, nurses, pharmacists, research conducted for master theses and doctoral dissertations, and may include undergraduate, staff and postdoctoral research as well.
What Records Are Kept?
The IRB Office maintains the following files:
- Federal regulations and communications, as well as letters of assurance.
- Minutes of the IRB meetings.
- Protocols and correspondence sent to, and received from, investigators.
- Protocols from which approval has been withheld and for which suitable remedial action has not yet been taken.
All protocols are kept for a minimum of three years after completion of the research and then may be destroyed.