Attachment 4 Consent Information Sheet

Attachment 4

U.S. Nuclear Medicine Technologists Feasibility Study

Consent Information Sheet

Introduction: You are invited to be in a research study about the work history and radiation safety practices of certified nuclear medicine technologists. You were selected as a possible participant because you were first certified as a nuclear medicine technologist (NMT) after 1980. Active, retired, and former NMTs are invited to participate in this study.

This study is being conducted by Bruce H. Alexander, PhD in the School of Public Health at the University of Minnesota, in collaboration with the National Cancer Institute, the American Registry of Radiologic Technologists (ARRT), and the Nuclear Medicine Technologists Certification Board (NMTCB).

Participating in this study includes completing a questionnaire about your experience working with nuclear medicine procedures and your employment history. If you agree, we will also request your historical film badge dose readings from dosimetry providers, such as Landauer. We estimate that it will take you about 10 minutes to review the consent information and ask any questions that you may have, and about 20 minutes to complete the questionnaire.

Background Information: The purpose of this study is to test the feasibility of conducting a large scale study of certified nuclear medicine technologists to understand radiation-related cancer and other disease risks in people who have worked as an NMT. About 1,500 nuclear medicine technologists are being asked to participate in this feasibility study.

Procedures: If you agree to be in this study, you will be asked to do the following:

• Complete an on-line survey about your experience working with nuclear medicine procedures. The survey asks questions about the types and frequency of nuclear medicine procedures you performed and related work practices.

• Provide a brief employer history, including the names of current and past employers specific to your work in the field of nuclear medicine.

• Allow researchers to obtain historical records of your film badge dose readings from dosimetry providers, such as Landauer. The information you provide about your employers will be used to identify your badge dose records in the dosimetry provider databases. Dosimetry information will not be provided to participants because we cannot ensure the accuracy of the matches or the completeness of the data.

The information you provide will be used to evaluate participation and completeness of the data. It will also be used to estimate cumulative organ-specific radiation doses to technologists who perform nuclear medicine procedures.

Risks: There is a very small risk that someone could trace the information in a scientific database back to you, but we will make every effort to protect your privacy under the Privacy Act of 1974.  There are no other known risks associated with your participation in the study.

Benefits: There is no direct benefit to you for participating in this study. The information obtained in other studies of medical workers has been helpful for establishing practices that minimize radiation exposure and for understanding health risks to medical workers exposed to radiation. We hope the information gathered in the current survey will continue to be helpful in these ways.

Confidentiality: Collection of this information is authorized by The Public Health Service Act of 1974. Please be assured that information you provide will be kept private under the Privacy Act and personally identifiable information will not be disclosed to anyone but the researchers conducting the study, except as otherwise required by law. The data collected may be made available to other researchers with interests in radiation exposure and health outcomes, but no personally identifiable information that links your data to you will be provided. Any published results from this survey will be reported in statistical summaries only and will never include a participant’s name.

Voluntary Nature of the Study: Your participation in this study is completely voluntary and failure to answer any particular question or the information collection as a whole will not affect your current or future relations with the University of Minnesota, the National Cancer Institute, the American Registry of Radiologic Technologists (ARRT), and the Nuclear Medicine Technologists Certification Board (NMTCB). By contacting the research staff at the University of Minnesota at (800) 447-6466 or usnmt@umn.edu, you can also withdraw from the study at any time without affecting those relationships. Your data can be withdrawn from the database, if requested, but cannot be withdrawn from analyses that have been completed or are underway.

Contacts and Questions: This study is being conducted by Bruce H. Alexander, PhD in the School of Public Health at the University of Minnesota, in collaboration with the National Cancer Institute, the American Registry of Radiologic Technologists (ARRT), and the Nuclear Medicine Technologists Certification Board (NMTCB). If you have any questions about this study or about your rights as a study participant, please contact the research staff at the University of Minnesota: call (800) 447-6466 or email usnmt@umn.edu.

If you have any questions or concerns regarding this study and would like to talk to someone other than the researcher(s), you are encouraged to contact the Research Subjects’ Advocate Line, D528 Mayo, 420 Delaware St. Southeast, Minneapolis, Minnesota 55455; (612) 625-1650.