Data Safety and Monitoring Board
The Baromedical Research Foundation places high priority on ensuring the safety of patients enrolled into its clinical trials. Responsibility for overseeing data safety and monitoring exists at several levels. However, the Foundation’s Director holds overall responsibility. Others charged with patient safety include the Foundation’s Data Safety and Monitoring Board, each trial’s principal investigator and, most importantly, the investigators conducting the trials.
Data Safety and Monitoring
A provision of acceptance of some U.S. federally funded human research is that a Data Safety and Monitoring Board be in place. Such a Board must be multidisciplinary, and is charged with overseeing the monitoring of participants, conduct, progress, and validity and integrity of the data of each clinical trial. Commonly, the Board is composed of representatives from pharmacology, biostatistics, ethics and unaffiliated researchers with experience in the topic being investigated. The Board meets on a regular basis with the research team and independent of the team. Board meetings may result in decisions that range from full or conditional approval to continue, to suspension or closure of a trial.
The Role of the Foundation DSMB
All of the research currently being conducted by the Baromedical Research Foundation is supported by donations and grants from private individuals, organizations and philanthropic foundations. Consequently, the federal requirement to incorporate a Data Safety and Monitoring Board does not apply. However, the Foundation’s commitment to patient safety and ethical practice is such that a decision was made in 2005 to constitute such an oversight body.
Because of the limited funding available to the Foundation to conduct the clinical trials currently underway, there is no direct financial support for the Board. Consequently, the Board’s mission and expectations do not match exactly those required of federally funded research.
The Foundation’s DSMB role is as follows:
- Familiarize themselves with all of the clinical research protocols.
- Evaluate the progress of the trials, and undertake periodic assessments of data quality, participant recruitment, accrual and retention, performance of trial sites and other factors that can affect study outcome.
- Review major proposed modifications to each study prior to their implementation.
- Make recommendations to the Foundation’s director and principal investigator(s) concerning continuation or closure of each study.
The DSMB will be provided with study progress reports on a periodic basis. Frequency will, in large part, be dependent upon patient recruitment and reported complications. The DSMB will otherwise have unfettered access to the accrual data at all other times.
Each DSMB member has agreed to participate without financial compensation, for which the Foundation is most grateful.
Board Members:
DSMB Position - Radiation Oncology Expert
|
|
Dr. John Feldmeier, DO |
Dr.Feldmeier is Professor and Chairman, Department of Radiation Oncology, at the Medical College of Ohio, in Toledo, Ohio. Dr. Feldmeier underwent fellowship training in hyperbaric medicine and residency training in radiation oncology while a member of the United States Air Force, in the early 1980’s. Since that time, John has become a leading international authority on both the late effects of radiation tissue injury and the therapeutic basis of hyperbaric oxygenation. John has published extensively on this subject, and currently heads the Undersea and Hyperbaric Medical Society’s Hyperbaric Oxygen Committee.
DSMB Position - Hyperbaric Physician Expert
|
|
John Benjamin Slade, M.D. |
Dr. Slade received his B.S. degree from the United States Air Force Academy. He attended Case Western Reserve Medical School, in Ohio, and undertook a family practice residency at David Grant Medical Center, Travis Air Force Base. He later became a flight surgeon and completed a fellowship in hyperbaric medicine at the USAF School of Aerospace Medicine. Dr. Slade serves as a hyperbaric physician at Northbay Center for Wound Care. He is boarded in Family Practice and Undersea and Hyperbaric Medicine. He serves on several Undersea and Hyperbaric Medical Society committees, is an author of several publications and a frequent and accomplished lecturer.
DSMB Position - Safety and Technical Expert
|
|
Wilbur "Tom" Workman, MS, CAsP, CHT |
Mr. Workman is the director of Quality Assurance & Regulatory Affairs for the UHMS and is responsible for the development and management of the Clinical Hyperbaric Facility Accreditation Program. He retired from the USAF as a Colonel after 23 years of service devoted to aerospace and hyperbaric physiology. Mr. Workman is currently the Chairman of both, the National Fire Protection Association's Technical Committee for Hyperbaric and Hypobaric Facilities and the Medical Systems Subcommittee of the American Society of Mechanical Engineers Pressure Vessel for Human Occupancy Technical Committee. He serves as a board member of the National Board of Diving and Hyperbaric Medical Technology. Mr. Workman received the Craig Hoffman Memorial Award for his contributions to diving safety, has more than 130 publications and presentations to his credit, including editorship of “Hyperbaric Facility Safety: A Practical Guide”. Mr. Workman is board certified by the Aerospace Medical Association in Aerospace Physiology.
DSMB Position - Biostatistics Expert
|
|
John Wanzer Drane, P.E, Ph.D |
Dr. Drane is a Professor within the Department of Public Health at East Tennessee State University. He holds degrees in Mechanical and Nuclear Engineering from Louisiana Technical University and Oak Ridge School of Reactor Technology respectively, and was awarded his Ph.D. in Biometry from Emory University. Dr. Drane’s research interests include space-time statistical methods, biometric modeling, health behavior statistics, imputations of multi-prompt sample surveys and community trials.
DSMB Position - Bioethics Expert
|
|
George Khushf, Ph.D. |
Dr. Khushf was awarded a B.S. in civil engineering from Texas A & M University. As a Fulbright Graduate Fellow, he studied philosophy and theology at the University of Tubigen, in Germany. Both his Master's and PhD were obtained from Rice University. Since 1995, Dr. Khushf has served as Humanities Director, Center for Bioethics, at the University of South Carolina, where his duties extend to Chair of both the Bioethics Search Committee and the Medical Humanities Committee.
Dr. Khushf's editory and advisory roles are extensive. He has acted as issue editor for several journals and is a reviewer for the Oxford University Press and numerous other publishers. Lecture presentations have taken Dr. Khushf across the U.S. and into Europe and the Far East. He is extensively published in a wide cross-section of bio-ethics, medical and healthcare journals and textbooks.