NCRP

SC 4-7: Evaluating and Communicating Radiation Risks for Studies Involving Human Subjects: Guidance for Researchers and Reviewing Bodies

Members only

In the first quarter of 2014, a proposal to write an NCRP report on Evaluating and Communicating Radiation Risks for Studies Involving Human Subjects: Guidance for Researchers and Reviewing Bodies was approved by the BOD, and SC 4-7 was formed.

Tens of thousands of individuals participate annually in clinical trials and research studies involving human subjects. Many of these studies expose the subjects to ionizing radiation, often through imaging examinations. Currently, there is limited and varied guidance available to assist researchers and institutional review boards in preparing protocols that involve radiation exposure to humans. Further, institutional review board members may have only limited knowledge of which imaging studies utilize ionizing radiation [e.g., computed tomography (ionizing) versus magnetic resonance imaging (nonionizing)]. For those imaging procedures that do utilize ionizing radiation, researchers may not have determined absorbed doses, nor have the educational background to properly communicate to subjects the risk of potential health effects from radiation exposure. Consequently, researchers and institutional review board members would greatly benefit from clear guidance on assessing proper utilization of radiation, estimating radiation risks and benefits, and ensuring that informed consent statements have consistent, comprehensible and accurate language.

Topics to be included in this report are:

  • identification of experimental studies utilizing ionizing radiation;
  • assessment of proper utilization of radiation in a research protocol;
  • estimation of radiation absorbed dose;
  • estimation of radiation risks including adjustments for specific populations (e.g., young children versus terminally ill adults);
  • distinguishing between radiation required for standard patient care and that incurred specifically by research study design;
  • optimization of radiation dose;
  • important elements of informed consent statements for protocols involving ionizing radiation, including communication with appropriate risk language; and
  • templates for informed consent documents.

The first teleconference of the Committee (April 7, 2014) involved discussion of membership and the path forward for a report outline. At the second teleconference (May 8, 2014) there was additional discussion on Committee composition, as well as approval of the first teleconference minutes, receipt of comments towards finalizing the draft outline, and initial timeline planning. At the third meeting (webinar/teleconference, June 19, 2014) new Committee members were introduced, minutes of the second meeting were approved, a formatted draft report table of contents was reviewed, and comments towards finalizing the draft outline and writing assignments took place. Committee membership was again discussed with a decision to add a medical ethicist as a consultant and to table addition of patient/consumer advocate and other disciplines for the time being.

At the fourth meeting (webinar/teleconference, August 14, 2014) minutes of the third meeting were approved, submitted text was reviewed, the Committee writing assignments were updated, and the draft report was subsequently revised through revision 1g (August 24, 2014). Additional meetings were held during the fourth quarter: a fifth meeting on October 8, 2014; and, a sixth meeting on November 20, 2014. At both meetings, additional discussion took place on finalizing the approach to be taken with the draft report and changes were made in the planned organization. By the end of the quarter, the draft report had been revised through revision 2a (November 20, 2014) and all members had received writing assignments. A subject matter expert in radiation oncology physics was invited and agreed to join the Committee.

The Committee held meetings via webinar/teleconference on January 12, 2015 (seventh Meeting) and March 25, 2015 (ninth Meeting). The Committee had its first face-to-face meeting (eighth Meeting) at the University of California-Davis Medical Center campus in Sacramento, California February 9–10, 2015. At and following these meetings substantial progress was made on a draft report (revision 4L by the end of the quarter) and Committee membership was completed by adding Patricia Fleming (previously a consultant) and Steven Sutlief (Radiation Oncology Medical Physicist) as full members. By the end of the quarter, all sections of the draft report had text in place save the Executive Summary, Conclusions and Recommendations, and Appendices.

Committee meetings via webinar/teleconference were held on May 4, 2015 (10th meeting) and June 11, 2015 (11th meeting). Additional progress was made on the draft report which was in revision 4V by the end of the quarter. Additional work during the next quarter will focus on completing the Executive Summary, Conclusions and Recommendations, and Appendices.

A Committee meeting via webinar/teleconference was held on September 11, 2015 (12th meeting). Substantial progress was made on the draft report which was in revision 5c by the end of the third quarter.

The 13th Committee meeting via webinar/teleconference took place on November 3, 2015. An Appendix A Working Group meeting via webinar/teleconference took place on December 9, 2015. Additional progress was made on all sections of the draft report by the end of the fourth quarter of 2015.

The 14th, 15th and 16th meetings via teleconference/webinar of the were held on January 12, 2016; February 19, 2016; and March 22, 2016. A second and final meeting of the Appendix A Working Group meeting via webinar/teleconference was held on February 9, 2016. Substantial progress was made on developing a final consolidated draft report by the end of the first quarter of 2016.

The 17th meeting of the Committee is scheduled to be held at NCRP on April 9, 2016.

NCRP is grateful to the Centers for Disease Control and Prevention for financial support of this work.

The membership of SC 4-7 is:

Timins J

JULIE E.K. TIMINS

Timins J

is a Diagnostic Radiologist, board-certified in General Radiology and in Nuclear Medicine. Her medical practice has been varied, including Chair of Nuclear Medicine at the Veterans Administration Hospital in Lyons, New Jersey; 10 y as Staff Radiologist at Robert Wood Johnson University Hospital, New Brunswick, New Jersey; 11 y in an inner-city hospital in Jersey City; and over 4 y in a suburban out-patient imaging facility specializing in Mammography and Women's Imaging in Morristown, New Jersey. Dr. Timins is Chair of the New Jersey Commission on Radiation Protection, and sits on the New Jersey Radiologic Technology Board of Examiners. She served on the NCRP Board of Directors, and received a Commendation for Outstanding Service on the 2010 Annual Meeting Program Committee – "Communication of Radiation Benefits and Risks in Decision Making." She is past president of the Radiological Society of New Jersey and recipient of that organization's Gold Medal Award. Dr. Timins was honored as a Fellow of the American College of Radiology, and has served that organization on the Council Steering Committee and as Chair of Practice Guidelines and Technical Standards, on the Commission on Quality and Safety.

She is a recipient of the Advisory Committee Service Award of the U.S. Food and Drug Administration, in recognition of distinguished service on the National Mammography Quality Assurance Advisory Committee. The American Association for Women Radiologists has honored Dr. Timins with the Professional Leadership Award for Mid Career/Senior Faculty and the President's Award. In appreciation of service as an Affiliate Member of the Conference of Radiation Control Program Directors, she was presented with the Board of Directors Award for Outstanding Achievement in the Field of Radiation Protection, for participation on the H-30 Task Force and development of the White Paper on Bone Densitometry.

Julie E.K. Timins, Chair
Bushberg-J

JERROLD T. BUSHBERG

Bushberg-J

is the Senior Vice President of NCRP, and Clinical Professor of Radiology and Radiation Oncology, University of California (UC) Davis School of Medicine. He is an expert on the biological effects, safety, and interactions of ionizing and nonionizing radiation and holds multiple radiation detection technology patents. Dr. Bushberg is an elected fellow of the American Association of Physicists in Medicine and the Health Physics Society. He is certified by several national professional boards with specific subspecialty certification in radiation protection and medical physics and currently serves as a Director of the American Board of Medical Physics. Dr. Bushberg was awarded the Warren K. Sinclair Medal for Excellence in Radiation Science by NCRP in 2014. Prior to coming to the UC Davis Health System as technical director of Nuclear Medicine, Dr. Bushberg was on the faculty of Yale University School of Medicine where his research was focused on radiopharmaceutical development.

Dr. Bushberg has served as an advisor to government agencies and institutions throughout the nation and around the world on the biological effects and safety of ionizing and nonionizing radiation exposure. He has worked for the U.S. Department of Homeland Security, the World Health Organization, and the International Atomic Energy Agency as a subject matter expert in radiation protection and radiological emergency medical management. Dr. Bushberg has responsibility for medical postgraduate education in medical physics, radiation (ionizing and nonionizing) protection, and radiation biology. The third edition of the textbook "The Essential Physics of Medical Imaging," authored by Bushberg, Seibert, Leidholdt, and Boone, is used extensively by radiology residency programs throughout the United States.

jerrold t. bushberg
Fleming P

PATRICIA A. FLEMING

Fleming P

is Provost, Senior Vice President of Academic Affairs, and Professor in Philosophy at Saint Mary's. She received her master's and doctorate from Washington University in St. Louis, Missouri. While there, she served as the assistant editor of the Philosophy of Science Journal. She has also served as a consultant to the Organization for Economic Co-operation and Development/Nuclear Energy Agency in Paris, France. Dr. Fleming has published and lectured internationally on the ethical and epistemological issues associated with the disposal of high-level nuclear waste, including the use of expert elicitation methodology in site characterization, waste management and indigenous populations, informed consent in stakeholder populations, and circularity in regulatory policy.

Dr. Fleming's familiarity with ethical concerns regarding the health effects from radiation exposure led to her appointment on the National Academy of Science Committee to Assess the Scientific Information for the Radiation Exposure Screening and Education Program. She served on the Veterans Board on Dose Reconstruction from 2005 to 2013.

patricia a. fleming
Kroger-L

Linda A. Kroger

Kroger-L

is Assistant Clinical Professor of Radiology at the University of California (UC) Davis School of Medicine and has served as the Radiation Safety Officer for the UC Davis Health System for the past 10 y. Ms. Kroger received her undergraduate degree and her Masters Degree from Rutgers University. She has been with UC Davis for 25 y. Prior to her arrival at UC Davis, Ms. Kroger worked for private industry in biopharmacology research and drug development. She transitioned to cancer research when she joined UC Davis in 1988. From 1988 through 2000, her research focused on the development of new radiopharmaceuticals for both diagnostic imaging and treatment of non-Hodgkin’s lymphoma and breast cancer. Since assuming her role as Radiation Safety Officer in 2003, she has focused on regulatory compliance, quality assurance issues as well as education of medical students, residents and fellows with the overall goal of improving workplace radiation safety. Ms. Kroger oversees the nonclinical aspects of nuclear medicine training for the radiology residency program at UC Davis. In addition, she has taken an interest in radiologic emergency preparedness. Ms. Kroger has authored or co-author more than 50 peer-reviewed journal articles and has presented at numerous scientific conferences. She has served in a number of roles in both the local chapter as well as the national Health Physics Society and been an active participant on NCRP committees since 2005.

linda a. kroger
Leidholdt

EDWIN M. LEIDHOLDT, JR.

Leidholdt

is a program manager in the National Health Physics Program, Veterans Health Administration, U.S. Department of Veterans Affairs (VA). His areas of interest include technical quality assurance and dose reduction in medical imaging and medical response to radiological incidents. He is certified by the American Board of Radiology in Medical Nuclear Physics and Diagnostic Radiological Physics. He received a PhD in Nuclear Engineering, a Master of Applied Mathematics, a Master of Engineering in Nuclear Engineering, and a BS in Nuclear Engineering, all from the University of Virginia. He has served as a Radiation Safety Officer at two VA medical centers, as technical director of nuclear medicine at one, and as the Radiation Safety Program Manager for the former Veterans Health Administration Western Region.

He is a Clinical Associate Professor of Radiology at the University of California, Davis, and a Clinical Adjunct Professor of Radiology at the University of Texas Health Science Center at San Antonio. He is a co-author of six scientific papers and abstracts, one textbook chapter, and one textbook, in its third edition. He served on the scientific committee that wrote NCRP Report No. 165. Dr. Leidholdt served as a surface line officer in the U.S. Navy from 1971 until 1975.

edwin m. leidholdt, jr.
Miller D

DONALD L. MILLER

Miller D

is the Chief Medical Officer for Radiological Health in the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health. He was previously Professor of Radiology and Radiological Sciences at the Uniformed Services University of the Health Sciences in Bethesda, Maryland and an adjunct investigator in the Radiation Epidemiology Branch of the National Cancer Institute.

Dr. Miller earned a BA in Molecular Biophysics and Biochemistry from Yale University in 1972 and an MD from the New York University School of Medicine in 1976. He holds Board certification in both Diagnostic Radiology and Interventional Radiology. Prior to joining FDA, he engaged in the clinical practice of interventional radiology for nearly three decades.

He is a Fellow of the Society of Interventional Radiology and of the American College of Radiology, and is an Honorary Member of the American Association of Physicists in Medicine. He has served as a consultant to the International Atomic Energy Agency and the World Health Organization on issues related to radiation protection in medicine.

Dr. Miller was elected to NCRP in 2006. He serves currently as Co-Chair of Program Area Committee 4 (radiation protection in medicine), Chair of the Nominating Committee, and as a member or consultant to several scientific committees. He was Vice-Chair for NCRP Report No. 168 (Radiation Dose Management for X-Ray Guided Interventional Medical Procedures) and a consultant for NCRP Report No. 172 (Reference Levels and Achievable Doses in Medical and Dental Imaging: Recommendations for the United States).

He became a member of ICRP Committee 3 (Protection in Medicine) in 2010, and since 2013 has served as Vice-Chair of the Committee. He was an author of ICRP Publication 117 (Radiological Protection in Fluoroscopically Guided Procedures Performed Outside the Imaging Department) and Co-Chair for ICRP Publication 120 (Radiological Protection in Cardiology). He currently serves on three working parties of Committee 3.

Dr. Miller has authored more than 180 publications in peer-reviewed journals and more than 30 book chapters and reports. His research interests center on radiation protection in medicine, and include occupational radiation protection for interventional fluoroscopy, patient radiation doses and radiation protection in interventional procedures, and the development of U.S. national diagnostic reference levels for medical exposures.

donald l. miller
 162012_reiman001

Robert E. Reiman

162012_reiman001is Associate Professor of Radiology at Duke University Medical Center, and Associate Director of the Duke University Radiation Safety Division. Dr. Reiman received a BS in Physics and an MS in Public Health (Radiological Hygiene) from the University of North Carolina at Chapel Hill (UNC). After leaving UNC, he worked in the Biophysics Laboratory of the Memorial Sloan-Kettering Cancer Center in New York, where he developed quantitative scanning techniques for metabolic studies using 13N-labeled amino acids, labeled red blood cells, and radioactive iron. He subsequently obtained his MD degree from Case Western Reserve University School of Medicine, and completed a Nuclear Medicine Fellowship at Duke. He is certified by the American Board of Nuclear Medicine, and is a member of the Society of Nuclear Medicine and the Health Physics Society. As Associate Director, he coordinates the Radiation Safety Division’s patient care responsibilities in nuclear medicine, diagnostic radiology and radiation oncology, and assists the Nuclear Medicine Division with internal dosimetry issues. He develops and maintains web-based applications for radiation safety program administration and regulatory compliance, including a website used by clinical trial study coordinators at Duke and other institutions to create radiation risk statements for use in consent forms. He participates in the education of nuclear medicine and radiology house staff, medical physics residents, medical students and hospital staff. He has consulted with the American College of Radiology Information Network’s Radiation Safety Working Group on risk communication to patients and research subjects, and has served on the Board of Directors of the Medical Section of the Health Physics Society.

Robert E. Reiman
SeibertJA

J. ANTHONY SEIBERT

SeibertJA

is Professor of Radiology at the University of California (UC) Davis School of Medicine in Sacramento, California. He received a PhD in Radiological Sciences from UC Irvine in 1982, specializing in quantitative digital fluoroscopic imaging. Directly thereafter, he took a faculty position at UC Davis Medical Center, pursuing digital imaging research, physics education efforts for graduate students and radiology residents, as well as quality control for medical imaging equipment in Diagnostic Radiology.

He currently is Associate Chair of Imaging Informatics for the Department of Radiology, with continuing academic interests in digital mammography, computed tomography, interventional radiology, imaging informatics, and radiation dose tracking, assessment, and reporting. Former president of the American Association of Physicists in Medicine (AAPM) in 2011 and current Trustee of the American Board of Radiology, Dr. Seibert has served and continues to interact with many professional committees in regards to medical imaging issues and presenting technical / educational events for the AAPM, International Atomic Energy Agency, and other professional societies. For NCRP, he is a member of Program Area Committee 4. As a co-author of The Essential Physics of Medical Imaging textbook for diagnostic physics education, Dr. Seibert continues with the development of cutting edge imaging technologies and medical physics education to improve the state of imaging science for the betterment of patient care.

j. anthony seibert
Sutlief_S

STEVEN G. SUTLIEF

Sutlief_S

received his PhD in experimental particle physics from the University of Washington and subsequently completed a post-doctoral fellowship in radiation therapy medical physics at the University of Washington with research in intensity modulated radiation therapy. Since then he has been chief medical physicist at the Veterans Affairs (VA) Puget Sound Health Care System in Seattle and an affiliate faculty member in the University of Washington School of Medicine. He actively participates in the American Association of Physicists in Medicine, where he has served on many committees and on several task group reports. Dr. Sutlief has worked to advance radiation therapy within the VA, including agency-wide radiotherapy equipment modernization, radiotherapy device interconnectivity, consultation for the VA National Health Physics Program, participation in several investigations, and development of qualification standards for therapeutic medical physicists.

He has coauthored 45 articles and book chapters related to therapeutic medical physics. Dr. Sutlief developed and taught the physics curriculum for the Bellevue College Medical Dosimetry program. He has served as a consultant to the International Atomic Energy Agency and as a member of the Radiation Oncology planning group for the Integrating the Healthcare Enterprise. Recently Dr. Sutlief was a Co-organizer for the AAPM Summer School on Quality and Safety in Radiation Therapy and was a faculty member for the Veterans Health Administration Biennial Conference on Radiation Oncology. He is currently an NCRP Council member.

steven g. sutlief
Grissom-M

Michael P. Grissom

Grissom-M

MICHAEL P. GRISSOM is a Technical Staff Consultant for NCRP and is the President of MPG-HP, Inc., Riverside, California a private consulting firm. He is a recognized authority on operational health physics issues, particularly related to radiation protection in management, military, reactor, medical, and accelerator operations. During 20 y of service in the U.S. Navy, Mr. Grissom served as a Radiation Safety/Laser Safety Officer (hospital) and provided Radiation Health Officer support to the Naval Radiological Controls Program (propulsion, industrial and weapons).

Mr. Grissom conducted research in biophysics and radiobiological effects at the Armed Forces Radiobiology Research Institute, Bethesda, Maryland as a junior then senior scientist and served as the Director of Medical Records Search for the Navy Nuclear Test Personnel Review, Office of the Chief of Naval Operations, Washington, DC. Mr. Grissom provided support to the Effluent and Dose Assessment Group, Three Mile Island Unit 2 Recovery Team in 1979 to 1980. He has delivered numerous presentations at scientific and professional society meetings. In 2012, Mr. Grissom became a Fellow of the Health Physics Society (HPS).

He previously received the HPS Volunteer Award for services associated with the Medical Health Physics Section and is a Past President of the HPS Accelerator Section. He also served in a number of positions for Stanford University over a period of 16 y at the Stanford Linear Accelerator Center National Accelerator Laboratory, Menlo Park, California including Department Head, Operational Health Physics, and Assistant Associate Director for Environment, Safety and Health.

Michael P. Grissom, Staff Consultant
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Last modified: March 22, 2017