Ms. Pamela S. Bonee
ORISE/CPD
P.O. Box 117
Oak Ridge, TN 37831-0117
Phone: 423-576-3147
Fax: 423-241-2923
Email: boneep@orau.gov
Projects are approved by an IRB located at: Oak Ridge Institute for Science and Education.
The approving IRB operates under a Multiple Project Assurance (MPA) recognized by DOE or by the Department of Health and Human Services (HHS).
MPA number of the IRB: M-1394
Number of Human Subjects Projects reported: 16
Project Identifier: ORAU-78-96
Project Title:
Use of Ca-DTPA and Zn-DTPA for Chelation Therapy of Heavy Metals
Principal Investigator:
Dr. Ronald E. Goans
Principal Investigator's Institution: Oak Ridge Associated Universities
Project started in: 1978
Project Funding Information:
Project received funding in Fiscal Year 1997.
Project used human subjects in Fiscal Year 1997.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: August 14, 1997
IRB Approval Number: 96
Number of Human Subjects who participated in this project/protocol during
FY 1997 (10/1/96 - 9/30/97): 2
Type of Human Subjects Involvement:
Chelation therapy for internal contamination of heavy elements in radiation accidents. Radioactive materials are not administered internally.
IND 4041, Trisodium calcium diethylenetriaminepentaacetate (Ca-DTPA) and IND 14603, Trisodium zinc diethylenetriaminepentaacetate (Zn-DTPA) are investigational new drug applications which are administered by Oak Ridge Associated Universities under contract with the U.S. Department of Energy, Contract No. DE-AC05-76OR00033. Both forms of DTPA have been widely used in the U.S. and in Europe for many years as chelating agents for plutonium and for other heavy elements such as americium, californium, and curium.
Ca-DTPA is approximately 10 times more effective than Zn-DTPA for the initial chelation of transuranic elements. Therefore, Ca-DTPA should be used whenever larger body burdens of transuranics are involved. Ca-DTPA is the drug of choice for initial patient management of internal contamination with transuranic elements unless contraindicated. After approximately 24 hours, however, Zn-DTPA is, for all practical purposes, as effective as Ca-DTPA. This comparable efficacy, coupled with its lesser toxicity, makes Zn-DTPA the preferred agent for protracted therapy. The effectiveness of chelation therapy is highly dependent not only on the metal itself, but also on the chemical and physical characteristics of the compound at the time of DTPA administration. Because of the efficiency of chelation decreases with time, DTPA should be given within 6 hours of exposure.
No serious toxicity in human subjects has been reported as a result of over 600 Ca-DTPA administrations in recommended doses. In addition, no serious adverse effects have been noted as a result of over 1000 doses of Zn-DTPA in the recommended dosage. Patient consent is obtained and documented prior to entry into the program.
The consent form has been modified to comply with recommendations of the ORAU/ORNL Committee on Human Studies. Included in the consent form is a statement addressing confidentiality of the identity of the patient, and the manner in which the research data will be used/published.
Project Identifier: ORAU-80-58
Project Title:
Whole Blood Procurement, Consent for Research Waiver Form and Payment Authorization
Principal Investigator:
Dr. L. G. Littlefield
Principal Investigator's Institution: Oak Ridge Associated Universities
Project started in: 1980
Project Funding Information:
Project received funding in Fiscal Year 1997.
Project used human subjects in Fiscal Year 1997.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: August 14, 1997
Number of Human Subjects who participated in this project/protocol during
FY 1997 (10/1/96 - 9/30/97): 5
Type of Human Subjects Involvement:
Objectives of studies using human blood are to conduct in vitro exposures of cells to radiation or chemicals to learn how genotoxic agents cause damage to human chromosomes. In other studies, cells are used to test experimental variables that affect culture or freezing of material. Standard laboratory techniques are applied to expose cells in vitro. The only "procedure" involving the blood donor is the venipuncture to collect the blood samples. As explained on the Consent Form, the only anticipated risks are the minor discomfort associated with the needle stick or in very rare instances, minor bleeding at site of venipuncture.
The consent form has been approved by NIH and the IRB. The consent form addresses the issue of patient privacy, and that the patient will not be identified in any publication of results of this program.
Project Identifier: ORAU-80-60
Project Title:
Comprehensive Epidemiology Study of Department of Energy Atomic Workers
Principal Investigator:
Dr. Donna L. Cragle
Principal Investigator's Institution: Oak Ridge Associated Universities
Project started in: 1980
Project Funding Information:
Project received funding in Fiscal Year 1997.
Project used human subjects in Fiscal Year 1997.
Funding Sources:
Total Funding: $0
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: August 14, 1997
IRB Approval Number: 60
Number of Human Subjects who participated in this project/protocol during
FY 1997 (10/1/96 - 9/30/97): 3,695
Type of Human Subjects Involvement:
This is a comprehensive, records-based retrospective epidemiologic study of employees of MED/AEC/DOE and its prime (M&O) contractors nationwide. The total number of individuals included in the study to date (including FY96) is 429,668. It was initiated in FY78 by DOE Energy Research, Office of Health and Environmental Research (RT 0101). It was transferred to Environment, Health and Safety, Office of Health in FY91 (HA 01 17), and is now a NIOSH management responsibility.
ORISE supports the DOE Office of Environmental, Safety and Health in a number of technical areas. The principal area is to serve as the Epidemiologic Surveillance Data Center. In this capacity the following tasks are performed:
1. Receive data transmissions from epidemiologic surveillance sites and provide data management and quality assurance on the data received,
2. Provide quality assured nosologic coding for epidemiologic surveillance data,
3. Analyze data and construct reports for epidemiologic surveillance,
4. Perform required Quick Response epidemiologic reviews and studies, and
5. Analyze data covering a 10-year period generated from return-to-work clearances and other illness and injury records from the Sandia National Laboratory.
Other tasks involve rapid response and investigation of worker health concerns. In this capacity, the following activities may be performed:
1. Interviews of present and former workers to gather data about specific workplace hazards.
2. Submission of lists of workers who have unique exposures to the statewide tumor registry in order to monitor cancer incidence in the group.
The National Institute for Occupational Safety and Health (NIOSH) and DOE activities include:
1. Compiling rosters of workers from hard copy records.
2. Collecting death certificates for DOE worker populations; coding causes of death and entering codes to computer files.
3. Analyzing cause of death data with respect to exposure level using standard dose-response methodology.
4. Analyzing cause of death data in a descriptive manner.
Consent forms are not utilized due to the fact that this is a records based study and identification of individuals is not revealed. There is no risk to individuals because of the study.
The procedures used to obtain additional information on deceased study subjects from next-of-kin, physicians, hospitals, and/or others in support of the Project ORAU-60 have been reviewed by the IRB. The Board feels these procedures will continue to provide appropriate protection to the respondents with respect to maintaining confidentiality, protecting their privacy, and avoiding or minimizing any emotional or other harm that may affect the respondent.
Project Identifier: ORAU-80-61
Project Title:
The DTPA Registry Follow-Up Program
Principal Investigator:
Dr. Ronald E. Goans
Principal Investigator's Institution: Oak Ridge Associated Universities
Project started in: 1980
Project Funding Information:
Project received funding in Fiscal Year 1997.
Project used human subjects in Fiscal Year 1997.
Funding Sources:
Included in EHW 1307 funding (Radiation, Medicine and Cytogenetics Program Funding)
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: August 14, 1997
IRB Approval Number: 61
Number of Human Subjects who participated in this project/protocol during
FY 1997 (10/1/96 - 9/30/97): 2
Type of Human Subjects Involvement:
In the last reporting period, June 1, 1996 to May 31, 1997, 2 patients received IV DTPA for a total of 9 doses. The status of the Radiation Emergency Assistance Center/Training Site (REAC/TS) DTPA Registry through June 1997 shows 45 active co-investigators throughout the country. Since the beginning of the Registry, 615 patients have received 4549 doses of DTPA. We feel that the REAC/TS DTPA Registry is a valuable resource for the medical follow-up of workers involved in accidents involving the transuranic elements.
The DTPA package inserts and the consent form have been modified according to recent recommendations of the IRB, DOE/HQ, the FDA, and an independent review committee commissioned by the DOE.
Project Identifier: ORAU-80-63
Project Title:
The U.S. Radiation Accident Registry Follow-Up Program
Principal Investigator:
Dr. Ronald E. Goans
Principal Investigator's Institution: Oak Ridge Associated Universities
Project started in: 1980
Project Funding Information:
Project received funding in Fiscal Year 1997.
Project used human subjects in Fiscal Year 1997.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: August 14, 1997
IRB Approval Number: 63
Number of Human Subjects who participated in this project/protocol during
FY 1997 (10/1/96 - 9/30/97): 437
Type of Human Subjects Involvement:
Radiation accident statistics - Human subjects are not administered external ionizing radiation.
Internal administration of radioactive substances to human subjects.
Radiation accident statistics - Human subjects are not administered internal radioactive substances.
During the reporting period June, 1996 to June, 1997, 3 U.S. radiation accidents were recorded involving 3 individuals and 3 foreign accidents were recorded involving 113 individuals. Sixty-two radiation incidents were documented involving 221 people and 7 foreign incidents were recorded involving 100 individuals. In addition, the Radiation Emergency Assistance Center/Training Site (REAC/TS) responded to 64 calls for assistance. The REAC/TS Accident Registry is an invaluable resource for research into the mechanisms of radiation accidents, as well as a useful compilation of biochemical data collected during medical management of these cases.
In consenting to participation in the Registry program, participants agree to the release to REAC/TS of relevant medical records and to direct or indirect follow-up. Participation is voluntary and flexible; it can be terminated on request. Inability to recruit eligible persons into the active follow-up program does not preclude their inclusion without identification in the Registry's summary statistics on radiation accidents.
Risks are limited to those associated with routine health evaluation (e.g., drawing blood for standard hematologic and clinical laboratory assays), and to providing personal data that while protected by the Privacy Act, also is subject to access under the Freedom of Information Act (FOIA).
Project Identifier: ORAU-89-60a
Project Title:
Amendment - Comprehensive Epidemiology Study of Department of Energy Atomic Workers
Principal Investigator:
Dr. Donna L. Cragle
Project started in: 1989
Project Funding Information:
Project received funding in Fiscal Year 1997.
Project used human subjects in Fiscal Year 1997.
Funding Sources:
Total Funding: $0
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: August 14, 1997
IRB Approval Number: 60a
Number of Human Subjects who participated in this project/protocol during
FY 1997 (10/1/96 - 9/30/97): 43,999
Type of Human Subjects Involvement:
This project is specific for the use of the National Death Index (NDI) to link death information to the DOE worker populations. The NDI is a specialized source of death data and certificates retrieved under this protocol that are maintained and shared under a restrictive set of rules set forth by the NDI. The estimated volume of data collection under this protocol was 53,300 records for FY97. The data collection activities for FY97 included the Hanford Facility in Richland, Washington, and the Savannah River site in South Carolina.
The procedures used to obtain additional information on deceased study subjects from next-of-kin, physicians, hospitals, and/or others in support of the Project ORAU-60 has been reviewed by the IRB. The Board feels these procedures will continue to provide appropriate protection to the respondents with respect to maintaining confidentiality, protecting their privacy, and avoiding or minimizing any emotional or other harm that may affect the respondent.
Consent forms are not utilized due to the fact that this is a records based study and identification of individuals is not revealed. There is no risk to individuals because of the study.
Project Identifier: ORAU-91-80
Project Title:
Study of Morbidity and Mortality From Selected Causes Among Oak Ridge Y-12 Sheet Metal Workers
Principal Investigator:
Dr. Elizabeth A. Dupree Ellis
Principal Investigator's Institution: Oak Ridge Associated Universities
Project started in: 1991
Project Funding Information:
Project did not receive funding in Fiscal Year 1997.
Project did not use human subjects in Fiscal Year 1997.
Explanation:
No additional information was collected from human subjects in FY97. There has been no activity on the study this year.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: August 14, 1997
Number of Human Subjects who participated in this project/protocol during
FY 1997 (10/1/96 - 9/30/97): 0
Type of Human Subjects Involvement:
The objective of this study is to evaluate the health status of a group of sheet metal workers who worked in metal fabrication operations at the Oak Ridge Y-12 Plant between 1947 and 1988. Both morbidity and mortality will be examined with special emphasis on those cause-specific cancer outcomes of expressed worker concern and any outcome expected to result from known or suspected operations.
A case series study design will be used. The study population will be all workers ever employed in the metal fabrication operations at Y-12 between May 1947 and December 1988. Work histories will be used to identify these workers. Non-radiation exposures will be identified through monitoring records and interviews with knowledgeable workers. From this information, a telephone questionnaire will be developed to collect information about cancer incidence, medical and occupational history, and specific demographic and life-style information. The study subjects will be contacted by mail to ask them to participate with a telephone contact attempted for non-respondents. Next of kin will be contacted if the study subject is deceased. Death certificates will be requested for those study subjects who have died. The study population will be matched against the Tennessee Cancer Reporting database to identify incident cancer cases. None of the study subjects will be exposed to ionizing radiation, radioactive substances or chemical substances in the course of this study. Approximately 250 subjects have been included in the study to date.
Confidentiality of identifiable information is maintained by separating all identifiable data collected on the questionnaire from the remainder of the questionnaire data. All records are kept in a locked storage area protected by combination locks on the doors and a sonar alarm system. Only personnel with a "need-to-know" have access to the data.
The only risk human subjects are exposed to is loss of privacy if the information collected on the questionnaire is released in identifiable form.
Project Identifier: ORAU-91-81
Project Title:
Use of Prussian Blue for Internal Decontamination of Radiocesium
Principal Investigator:
Dr. Ronald E. Goans
Project started in: 1991
Project Funding Information:
Project did not receive funding in Fiscal Year 1997.
Project used human subjects in Fiscal Year 1997.
Explanation:
This is a new investigational drug application for IRB review. The final version will be submitted to the FDA for funding.
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: August 14, 1997
IRB Approval Number: 81
Number of Human Subjects who participated in this project/protocol during
FY 1997 (10/1/96 - 9/30/97): 1
Type of Human Subjects Involvement:
Medical decorporation therapy of accidentally ingested radiocesium and thallium
Medical decorporation therapy of accidentally ingested radiocesium. Human subjects will not be administered radioactive substances.
ORAU-81, Use of Prussian Blue for Internal decontamination of radiocesium is being prepared for submission to the FDA as an investigational new drug application. A draft of this application with the history of Prussian Blue, a comprehensive bibliography, investigator's CVs, and product information from the German company Heal GUM have been included in the protocol for review by the IRB.
A. Objectives
Insoluble Prussian Blue (PB), ferric hexacyanoferrate, is a drug that enhances excretion of isotopes of cesium and thallium from the body by means of ion exchange. The ORISE undertaking for this Investigational New Drug (IND) will: (1) make PB more widely available at DOE facilities for physicians to treat individuals with significant radiocesium contamination, and (2) quantitate efficacy and establish a drug profile based on wider experience.
B. Methodology
Subjects known or strongly suspected of being internally contaminated with radiocesium will be offered the drug. These patients will be required to sign an informed consent form approved by the ORNL/ORAU institutional review board in order to participate in the study. They will be monitored as clinically required for adverse reactions during radionuclide decorporation therapy. The IND collaborators will be required to submit all available treatment and bioassay data, along with listed side-effects and other observations to ORAU, who will compile the data and submit necessary IND information in an annual report to the FDA. The research stimulated will lead to optimization of the dosage schedule for PB.
C. Ionizing radiation, radioactive substances, chemical substances.
Pharmaceutical-grade PB (Radiogardase) will be obtained from the Heyl GMBH, a German manufacturer. Co-investigators for the IND will comprise medical directors at DOE contractor facilities and other physicians with a need to have PB readily available to treat patients with possible internal contamination from radiocesium.
D. Involvement of human subjects.
The principal investigators will enforce the procedures of the Committee on Human Studies in obtaining informed consent from the subjects under study. The investigators recognize that they retain the primary responsibility for safeguarding the interests of the participants under study. Any significant changes in methods of procedure or the development of unexpected risks will be immediately reported to ORAU/ORNL Committee on Human Studies. PB is a non-resorbable compound acting only in the gastrointestinal tract. In previous studies, an upper therapeutic range of PB was tentatively established at approximately 10 g orally per day in divided doses. Doses higher than 10 g per day resulted in an increased incidence of gastritis, constipation and diarrhea.
A supply of PB has been obtained from the German company Heyl GMBH, and we are in the process of setting up a PB Registry at Radiation Emergency Assistance Center/Training Site (REAC/TS). The FDA has granted IND 51,700 to ORISE's PB investigational drug application.
Project Identifier: ORAU-91-82a
Project Title:
Studies to Establish and Define ORAU Laboratory Standards for Lymphocyte Proliferation Tests (LPT)
Principal Investigator:
Dr. L. G. Littlefield
Principal Investigator's Institution: Oak Ridge Associated Universities
Project started in: 1991
Project Funding Information:
Project received funding in Fiscal Year 1997.
Project used human subjects in Fiscal Year 1997.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: August 14, 1997
IRB Approval Number: 82a
Number of Human Subjects who participated in this project/protocol during
FY 1997 (10/1/96 - 9/30/97): 35
Type of Human Subjects Involvement:
The objectives are to define the range and variability in the proliferative response of human lymphocytes to in vitro exposure to beryllium salts. This specific study involves blood samples from control persons who have never been at risk for exposure to beryllium in the work place. Standard laboratory methods for separating and culturing cells are used. The only procedure that directly involves the blood donor is the venipuncture that is used to collect the blood sample. The only risks anticipated are the minor bleeding at the site of the venipuncture.
Project Identifier: ORAU-92-87
Project Title:
Oak Ridge Y-12 Beryllium Workers Follow-Up Study, Phase II: Screening for Beryllium Sensitivity and Definitive Diagnosis of Chronic Beryllium Disease
Principal Investigator:
Dr. Donna L. Cragle
Principal Investigator's Institution: Oak Ridge Associated Universities
Project started in: 1992
Project Funding Information:
Project received funding in Fiscal Year 1997.
Project used human subjects in Fiscal Year 1997.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: August 14, 1997
IRB Approval Number: 87
Number of Human Subjects who participated in this project/protocol during
FY 1997 (10/1/96 - 9/30/97): 350
Type of Human Subjects Involvement:
The overall purposes of the Y-12 Beryllium Workers Study, sponsored by the U.S. DOE and conducted by the Center for Epidemiologic Research (CER) at the Oak Ridge Institute for Science and Education (ORISE) are to: (1) investigate variables that may contribute to interlaboratory differences in results from the peripheral blood lymphocyte proliferation test (LPT) for chronic beryllium disease (CBD); (2) assess the sensitivity, specificity, and predictive value of the peripheral blood LPT and other noninvasive procedures and their potential use as routine screening tests for CBD; and (3) determine the prevalence of CBD among current and former beryllium exposed employees at the Oak Ridge Y-12 Plant. The first two objectives are addressed under a research protocol. The third objective is addressed through an initial screening program and a subsequent follow-up surveillance program, both designed to incorporate findings from the research phase. Several cases of CBD have already been diagnosed at the Y-12 Plant. The screening program will be developed to identify other cases if they exist, and those who are sensitized to beryllium, so that they may be placed under medical surveillance and/or early treatment. The rationale for the surveillance program is based on the implied assumption that early detection of beryllium sensitization or CBD among present and former beryllium workers will result in a more favorable prognosis.
All study participants receive a physical examination, chest x-ray, complete blood count, and breathing test. Blood for a LPT is drawn at the same time as that for the blood count. There is little physical risk in drawing the blood. In a few people slight pain and bruising may occur. Rarely is an infection from the needle puncture possible.
A small number of participants (2-5%) are referred for a definitive diagnosis, including bronchoscopy, bronchial alveolar lavage and lung biopsy.
Discomfort from the bronchoscopy is modest and consists mainly of pressure in the nose and some coughing until the bronchial tubes are numbed. An intravenous tube is in place during the procedure. A minor risk from the IV may occur if it slips out of the vein and fluid enters the tissues possibly causing pain or allowing medication that is being injected through the tubing to leak and cause inflammation. Before the procedure, the study participant is sedated. If a person is extremely sensitive to the medication, they may enter a deep sleep, in which case medication to counteract narcotics are required.
Bronchoscopy with biopsy may occasionally result in bleeding in some people, possibly requiring hospitalization for observation. An additional risk of the bronchoscopy with the biopsy procedure is rupture of the outer lining of the lung resulting in an air leak, requiring the insertion of a small tube to remove the air that escapes into the chest cavity. Other possible risks are the development of fever, or rarely, development of pneumonia.
Extremely rarely, a very sensitive individual could die from a complication from the procedure (much less than 1%). These risks are discussed with the individuals prior to their undergoing the definitive diagnosis procedures.
Project Identifier: ORAU-94-91
Project Title:
Establishing Background Level of Chromosomal Translocations
Principal Investigator:
Dr. Alfred F. McFee
Principal Investigator's Institution: Oak Ridge Associated Universities
Project started in: 1994
Project Funding Information:
Project received funding in Fiscal Year 1997.
Project used human subjects in Fiscal Year 1997.
Funding Sources:
National Cancer Institute
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: August 14, 1997
IRB Approval Number: 91
Number of Human Subjects who participated in this project/protocol during
FY 1997 (10/1/96 - 9/30/97): 4
Type of Human Subjects Involvement:
Chromosomal translocations induced in lymphocytic stem-cells can be used to evaluate possible radiation exposure to individuals occurring years earlier. Recently-developed techniques for fluorescence in situ hybridization (FISH) make the routine quantitation of translocations feasible, whereas the procedure has previously been prohibitively tedious. We are currently conducting major studies on potentially exposed populations. However, sufficient data on background levels of translocations in normal unexposed persons are not currently available for comparison. This study will provide data on translocation rates in normal unexposed individuals for comparison to levels detected in potentially-exposed populations. It will also allow us to estimate the variability among individuals, and, thus, to determine the sample sizes needed for population evaluation studies. Peripheral blood lymphocytes from donors will be cultured in vitro and prepared for metaphase chromosome analysis. Chromosomal translocations will be quantitated following treatment by FISH methodology. A total of 1600 metaphases are examined from each culture.
Risks involved are those associated with drawing a peripheral blood sample of approximately 30 cc. We anticipate an ultimate sample group of 20 or more donors.
The study is not designed or intended to provide any relevant information on individual blood donors. An explanation of the possible risks and benefits is contained in the consent form. The consent form was approved by the ORAU/ORNL IRB.
Project Identifier: ORAU-95-83
Project Title:
Identification and Abstraction of Death Certificates for the Agency for Toxic Substances and Disease Registry
Principal Investigator:
Dr. Elizabeth A. Dupree Ellis
Principal Investigator's Institution: Oak Ridge Associated Universities
Project started in: 1995
Project Funding Information:
Project received funding in Fiscal Year 1997.
Project used human subjects in Fiscal Year 1997.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: August 14, 1997
IRB Approval Number: 83
Number of Human Subjects who participated in this project/protocol during
FY 1997 (10/1/96 - 9/30/97): 423
Type of Human Subjects Involvement:
The objective of this work is to retrieve and verify the death certificate (DC) and code all causes of death on the DC for individuals identified by the Agency for Toxic Substances and Disease Registry (ATSDR). The deceased individuals are identified through community survey questionnaires administered by ATSDR personnel to household residents who live around superfund sites. In addition, disease conditions and work history information collected on questionnaires administered by ATSDR personnel will be coded to ICD9-CM and to the Bureau of Census occupation and industry codes, respectively. These data will be maintained by ATSDR as part of The National Exposure Registry.
All records are sent to ORISE by ATSDR in hard-copy and machine-readable form. If retrieval of DCs is requested, records will be submitted to the National Death Index (NDI) for identification of deceased individuals. Attempts will be made to retrieve a DC for each person identified as dead. A DC request will be made to the state in which the person died. The DC returned by the state will be verified as belonging to the person for whom it was requested. Once the DC has been verified, it will be deidentified and sent to Medical Coding and Consultation, Inc. (MCCS) located in Rolesville, NC for nosologic coding of all causes of death to the ICD9. The codes returned from MCCS along with selected information from the DC will be computerized. All records will be returned to ATSDR as work is completed.
Because ORISE has no direct contact with human subjects, there are no consent forms for this project. While in ORISE's custody, all records are kept in a secure area protected by a sonar alarm system. Only personnel with a "need-to-know" have access to the records. Risks resulting from participation in this part of the study are loss of the privacy of the deceased survivors if confidentiality of the records is breached.
Project Identifier: ORAU-96-98
Project Title:
Improved Systems for Worker Exposure Surveillance
Principal Investigator:
Mr. William G. Tankersley
Project started in: 1996
This project ended in Fiscal Year 1997.
Project Funding Information:
Project received funding in Fiscal Year 1997.
Project used human subjects in Fiscal Year 1997.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: October 11, 1996
IRB Approval Number: 98
Number of Human Subjects who participated in this project/protocol during
FY 1997 (10/1/96 - 9/30/97): 234
Type of Human Subjects Involvement:
a. Objectives
A major challenge to occupational health care professionals is responding to the need for routine health and hazards surveillance of large numbers of employees for possible exposure to potentially hazardous materials. For practical and economic reasons, monitoring data are collected on only a fraction of the population potentially exposed and/or for only a fraction of time during which exposure may occur. Since it is impractical or impossible to monitor all workers for every substance and physical hazard to which they may be exposed, a practical and affordable system based on indirect or qualitative data, such as work area, task, and materials available for exposure, is needed and is achievable. Such a system would provide information to plant health physicists, industrial hygienists, and medical staff making exposure control decisions, and would provide similar data to occupational researchers and epidemiologists for the analysis of possible associations between occupational exposures and excess disease.
The present research is aimed at developing a tool to complement existing worker exposure assessment programs, and provide surveillance for a greater percentage of the worker population. Specifically, the objective is to develop and test in a working environment, a system based on readily available bar code technology for continual tracking of workers and recording the primary substances to which they are potentially exposed.
b. Methodology
The tracking system will include the following components:
1. bar code badges identifying each employee to be monitored;
2. bar code data scanners (five, fixed type hard wired to dedicated personal computers);
3. personal computers to collect scanned data and link these data with other system and personal data; and
4. software for the collection of bar code data and for the maintenance of a database containing the collected data.
Workers will be responsible for interacting with the data collection system by passing their employee badge through a bar code reader. It is estimated that approximately 700 workers will interact with this system over the life of this project. The PC monitor will display information identifying ORAU as the project contractor, DHHS-CDC as the sponsor, William Tankersley as the person to contact with questions, and participation in the research as voluntary. A statement of the research will also be available for the worker to take with her/him.
The actual tracking procedure will be as follows. A worker will present his bar code badge bearing an employee identification number (i.e., the Lockheed Martin Energy Systems employee badge) to the scanner as he/she enters and exits a monitored work area. System information including scanner location, date, and time of entry are linked to the employee identification data. For the system to perform optimally, cooperation will be required of workers (presenting badge at each entry and egress), supervisors (providing instructions and encouragement for compliance with the tracking system procedures), and the plant health care personnel (designating appropriate substances as potential exposures for each location). Finally, it is planned to conduct brief interviews at the end of the pilot period to record the worker's opinions of the tracking system.
To evaluate the applicability of the collected data for determining the appropriateness of the employees enrolled in monitoring programs, the job title and department code of each employee who interacts with the scanning system will have go be known. When the data collection effort at the scanning stations is complete, we will submit a file of badge numbers to LMES management requesting that the job title and department code be provided for each badge number in the file. This file will contain all the badge numbers provided to us each quarter by the supervisors plus any additional badge numbers that have appeared in the project data base.
c. Ionizing Radiation, Radioactive Substances, or Chemical Substances
None
d. Involvement of Human Subjects
There are no health risks to the workers who participate in this study. The primary risk to the workers is use of the data collected for this project for purposes other that those stated in this project. In order to protect the confidentiality of those workers who routinely work in the areas where the five scanners are located, their badge numbers will be included in the request to LMES management to link job title and department code to the badge numbers collected in the project data base regardless of whether they interacted with the scanning station. The results of the surveillance system development project will be released to Lockheed Martin Energy Systems, Inc., the operating contractor of the Y-12 Plant, with no personal identifying information included.
Project Identifier: ORAU-97-OCAW1
Project Title:
Medical Surveillance for Former Gaseous Diffusion Plants, Phase I: Needs Assessment
Principal Investigator:
Mr. Robert E. Wages
Project started in: 1997
This project ended in Fiscal Year 1997.
Project Funding Information:
Project received funding in Fiscal Year 1997.
Project used human subjects in Fiscal Year 1997.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Expedited
Most Recent Approval: April 18, 1997
Number of Human Subjects who participated in this project/protocol during
FY 1997 (10/1/96 - 9/30/97): 194
Type of Human Subjects Involvement:
The objectives of this needs assessment are:
To identify the need for medical screening for health conditions related to occupational exposures.
a. This study of DOE workers at gaseous diffusion facilities is a one-year needs assessment to determine medical surveillance for former hourly and salaried workers at three sites: Portsmouth, Paducah and Oak Ridge (K-25).
A consortium of the Oil, Chemical and Atomic Workers International Union, Mt. Sinai School of Medicine, the University of Massachusetts at Lowell and the Alice Hamilton College is conducting the program.
1. To identify the need for medical screening for health conditions related to occupational exposures experienced by former workers at the three DOE gaseous diffusion plants; 2. To develop and describe a plan for conducting a medical screening program based on the findings of tasks undertaken to meet objective #1.
b. The methodology includes:
1. Review of previously completed epidemiological studies at DOE gaseous diffusion plants;
2. Collection and evaluation of information regarding occupational exposures of such former workers while working at the DOE study site;
3. Conduction of focus (discussion) groups from each site to give in-depth information about health concerns, current medical care, and interest in screening programs;
4. Conducting risk mapping sessions to get history of past exposures and working conditions by process and building;
5. Sending a self-administered mail questionnaire to a sample of former workers at the study sites to gain additional information on exposures, access and utilization of health care, and interest in screening programs.
We are also assembling rosters of names, last known addresses, and identifying information on the study cohort, testing our ability to locate these workers, and exploring ways to improve contact with them.
The number of human subjects is 120 for the self-administered questionnaire and 74 for the focus groups randomly selected from all three sites.
c: There is no exposure to ionizing radiation, radioactive substances, or chemical substances.
During the last phase of the needs assessment, we will be preparing a plan for the implementation of medical screening and risk notification, components of Phase II of the program.
One of the key and unique components of this needs assessment is the active involvement of the current and former workers in the project. Three worker investigators at each site, two active workers and one retired, are trained as worker-investigators. Their role is to conduct the risk mapping and focus group sessions and compile the health resources inventories.
d. Human subjects are involved in the project as recipients of health questionnaires and participants in focus groups which involve the former workers in a discussion of their perceptions about their risk of occupational disease, their current medical surveillance, their means of getting information on health questions, and their willingness to participate in a screening program. The only risk involved in discussions with former workers of their perceptions about their risk of occupational disease, is that the privacy of information shared in the focus groups and on the questionnaire might be violated. Measures to protect confidentiality will be taken.
Project Identifier: ORAU-97-UC1
Project Title:
Medical Surveillance Program for Construction Workers at Oak Ridge, TN
Principal Investigator:
Dr. Eula Bingham
Project started in: 1997
Project Funding Information:
Project received funding in Fiscal Year 1997.
Project did not use human subjects in Fiscal Year 1997.
Explanation:
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Expedited
Most Recent Approval: August 14, 1997
Number of Human Subjects who participated in this project/protocol during
FY 1997 (10/1/96 - 9/30/97): 0
Type of Human Subjects Involvement:
A. Objectives (General) To assist in the development of a health surveillance program for building trades workers who may have been exposed to health hazards as a result of prior work at Oak Ridge. (Specific) (1) Identify and propose a resolution to policy issues involving medical intervention programs for former construction workers at Oak Ridge according to possible past exposures to hazardous substances. (2) Assist in developing the site risk characterization protocol. (3) Develop notification protocols and related worker education materials. (4) Develop a medical protocol. (5) Develop programs and procedures for determining program eligibility and claims management, including coordination and benefits. (6) Develop a data management plan for epidemiological analysis based on the program. (7) Develop an implementation plan for Phase II of the project.
B. Methodology. (1) Identify and locate workers and make lists of workers and crafts. (2) Document the history of construction and operations and raw up time lines and dates. (3) Identify sources of exposure data and create a database of available sources. (4) Determine significant hazards and make a list of significant hazards. (5) Identify markers of early adverse health effects and make a list of markers. (6) Hold medical surveillance ethics workshop and develop a guidelines document. (7) Locate hazards and make a list of specific locations. (8) Develop and design a process to triage medical surveillance efforts.
Involvement of Human Subjects. (1) Describe the procedures involving human subjects; gathering information about human subjects from questionnaires and other survey instruments. (2) Possible hazards and their evaluation; there are minimal risks to participants and many potential benefits. List of workers and individual worker histories will be kept in a locked and secure drawer, and will only be available to the Principal Investigator and the data entry person. There will be no sharing of identifiable data with employers or other types of organizations. Only group statistics will be presented. The data for anyone who withdraws will be retained and be included in initial descriptive information regarding the population of employees; withdrawals and other dropouts (e.g., lost to follow up if the program continues) will be described, as appropriate. Personal identifiers will not be used in any data sets available for analysis.
Project Identifier: ORAU-97-99
Project Title:
Effective Programs for Worker Notification: A Case Study on Contamination of Worker Hands and Automobiles at a Commercial Beryllium Machining Plant
Principal Investigator:
Ms. Elizabeth W. Carroll
Project started in: 1997
This project ended in Fiscal Year 1997.
Project Funding Information:
Project received funding in Fiscal Year 1997.
Project used human subjects in Fiscal Year 1997.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Expedited
Most Recent Approval: May 15, 1997
IRB Approval Number: 99
Number of Human Subjects who participated in this project/protocol during
FY 1997 (10/1/96 - 9/30/97): 28
Type of Human Subjects Involvement:
A. Objectives
The ORISE component of this study was to administer a survey developed by NIOSH, and modified with input from Department of Energy and ORISE reviewers, to 30 randomly selected, currently employed beryllium workers at the DOE Y-12 Plant. These respondents constituted a control group for a NIOSH Health Communications Research Branch (HCRB) case study of the effectiveness of worker notification at a facility (the Speedring precision machining plant in Cullman, Alabama) where beryllium contamination of workers' hands and automobiles has been assessed in a joint NIOSH/National Jewish Center project. The overall objective of this HCRB study is to evaluate the effectiveness of notification messages in promoting safety behaviors.
B. Methodology
Using a list of Y-12 beryllium workers provided by Lockheed Martin Energy Systems, ORISE randomly selected 30 Y-12 beryllium workers (using replacement of workers unwilling or unable to participate from a second pool), and asked these individuals to complete on two separate occasions, one month apart, a short questionnaire on their knowledge and attitudes about beryllium, its health effects, and workplace safety procedures that reduce exposure. Twenty-eight of the 30 completed the first questionnaire, and ORISE sent the surveys to NIOSH. The majority of respondents completed the second questionnaire on July 29, and collection of the remaining ones continued during the first two weeks of August.
Workers assigned individual codes to their surveys so that individual surveys completed at the two different times could be paired for purposes of analysis, without violating the confidentiality and anonymity of individual responses. On receipt of the second survey, each participant receives a small cash award ($10). NIOSH will use the completed control group surveys (including comparisons between the first and second responses) to assess the effectiveness of notifications given the Speedring workers.
C. Involvement of Human Subjects:
This survey posed no physical risks to the respondents. Participation by Y-12 workers may benefit them and their colleagues by helping NIOSH and DOE improve hazard communication programs. However, because the study specifically queried individuals identified as beryllium workers in the Y-12 Plant, ORISE staff followed all requirements for informed consent and protection of health research subjects in presenting the study to participants, administering the surveys, and handling the completed survey forms.