Does this study require an IRB review?

No. The Code of the Federal Register identifies six categories of research which are specifically exempt from IRB review as they pose no human risk. The specific reference is: 45 CFR 46.101(b) item #4: Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens. If the information is recorded by the researcher in such a manner that participants cannot be identified. If these criteria are met the research is deemed exempt from IRB review. 

If this study is considered exempt from IRB Review, why was it submitted to the St. Luke’s Medical Center, (Aurora Health Care, Milwaukee, WI) for review?

To provide formal confirmation of the exempt status of this registry, and to facilitate participation by hyperbaric facilities across the US, the study was submitted to the Aurora IRB to establish a formal, objective determination of its exempt status. The Aurora IRB declared the Radionecrosis Registry to qualify for exempt status. A copy of this letter and determination is provided via an attached pdf file. 

Are there any concerns regarding the Health Insurance Portability and Accountability Act (HIPAA)?

No. HIPAA seeks to insure the anonymity of patients. If records have been “de-identified”, then in accordance with 45 CFR 46.101(b) you are simply working with depersonalized data. There are no restrictions on the use or disclosure of de-identified health information {45 C.F.R. §§ 164.502(d)(2), 164.514(a) and (b)}. 

What happens to the data which is entered into the Radionecrosis Registry?

The data is merged into one single data center and the outcomes of patients treated with HBOT will be compared against the "natural" outcomes for patients with radiation injury who have not received HBOT ("historical controls") as described in the literature. In addition to the clinical comparison, a financial assessment of the two groups will also be performed utilizing several different cost models / scenarios. These findings will be summarized and reported in a white paper.

Do you have to be a doctor to contribute?

No. The actual person entering the data does not have to be a physician. However, a physician must provide the final review and approval of entered patient data to ensure the accuracy and interpretation of the patient record.

Can I give more than 24 months of data?

No. Only patients who have completed their HBOT treatment within the 24 month time frame (January 1st, 2004 – December 31st, 2005) can be submitted and entered into the Registry. For example a patient who started HBOT on November 20th, 2005 but did not complete their treatments until Jan 8th, 2006 would fall outside the study date restrictions. On the other hand, if the patient’s last treatment was December 31st, 2005, this patient record could be entered into the registry.

What if I am a new center and we began seeing patients after the start of the study?

You may enter patient data for any patient that completed HBOT during the period between January 1st, 2004 and December 31st, 2007.

If my patient did not respond well to HBOT, should this data be entered?

Yes. All contributors are required to enter ALL outcomes or records which can be retrieved - REGARDLESS of the RESULTS (good, bad, or no change).

What if a patient died unexpectedly half way thru their treatment such as a car accident or heart attack? Do I include those cases?

No. This record would not be submitted. The study criteria includes only those patients who COMPLETED their entire HBO treatment DURING the 24 month study period.

Who are the principle investigators?

Bob Bartlett MD, UHM, FACHM and Jeffery Niezgoda MD, UHM, FACHM are the principle investigators. However multiple individuals have contributed to the initial review and design of the study. They include Caroline Fife, MD, Bob Warriner, MD, Eric Kindwald, MD, John Feldmeier, MD, David Hurley, MD, Roberto Penna, MD, Craig Broussard, PhD, Steve Martin, PhDc and Matt Richardson.

How is this study being funded?

The American College of Hyperbaric Medicine and Hyperbaric and Wound Care Associates have provided the initial financial and technical resources. However, Sechrist Industries and Environmental Tectonics Corp have recently committed financial resources to the Registry. In addition, several other hyperbaric manufactures, professional organizations and clinical services companies have now pledged support for this important study.

Should I pull the records for patients with a prior history of radiation to the mandible who received HBO in preparation for tooth extraction?

No you will not need to review the records of those patients who received HBO in preparation for tooth extraction. The registry is only tracking patients with clinically manifest (active) disease. Although patients with a history of radiation are at risk for osteoradionecrosis, they do NOT HAVE ACTIVE disease. The registry is only designed to follow the outcomes of those patients who already have symptoms secondary to radiation injury.

What should I do if I cannot access the radiation registry using a hospital computer?

The Registry is accessible from any location that has Internet access. Some facilities block web pages that they are not familiar with. You may access the registry from an Internet-ready computer by typing http://rrr.achm.org. Also, please use our Case Submission Form to manually write down data and then submit it later from an Internet-ready computer. If you have large quantities of data to submit (i.e. over 80+ cases) and do not have the capabilities to enter the data yourself, then please contact This e-mail address is being protected from spam bots, you need JavaScript enabled to view it for additional options.