Ms. Pamela S. Bonee
ORISE/CPD
P.O. Box 117
Oak Ridge, TN 37831-0117
Phone: 865-576-3147
Fax: 865-241-2923
E-mail: boneep@orau.gov
Number of Human Subjects projects reported: 19
| ORAU-78-96 | "Use of Ca-DTPA and Zn-DTPA for Chelation Therapy of Heavy Metals" |
| ORAU-79-63 | "The U.S. Radiation Accident Registry Follow-Up Program" |
| ORAU-80-58 | "Whole Blood Procurement, Consent for Research Waiver Form and Payment Authorization" |
| ORAU-80-60 | "Comprehensive Epidemiology Study of Department of Energy Atomic Workers" |
| ORAU-80-61 | "The DTPA Registry Follow-Up Program" |
| ORAU-89-60a | "Amendment - Comprehensive Epidemiology Study of Department of Energy Atomic Workers: National Death Index" |
| ORAU-91-81 | "Use of Prussian Blue for Internal Decontamination of Radiocesium" |
| ORAU-91-83 | "Identification and Abstraction of Death Certificates for National Registry of Persons Exposed to Hazardous Substances" |
| ORAU-92-102 | "Former Radiation Worker Medical Surveillance Program at Rocky Flats" |
| ORAU-94-106 | "Department of Energy Epidemiologic Surveillance Data Center" |
| ORAU-99-87a | "Beryllium Workers Follow-up Study, Phase II: Screening for Beryllium Sensitivity and Definitive Diagnosis of Chronic Beryllium Disease. Amendment - to add Former Beryllium Workers at all DOE sites where Beryllium was used." |
| ORAU-00-108 | "Update of a Mortality Study of Titanium Dioxide Workers" |
| ORAU-02-117 | "National Immunization Program (NIP) Parent-Decision Model" |
| ORAU-03-121 | "Evaluation of Fingertip Thermal Sensors in Thermography Research Project" |
| ORAU-03-PANTEX 1 | "Former Pantex Worker Medical Surveillance Program" |
| ORAU-04-123 | "Audience Need and Preference Study" |
| ORAU-04-126 | "Remote Deception Detection Using Volatile Chemical Emissions Research Project" |
| ORAU-04-127 | "Survey of Respiratory Symptoms Among Workers in the Forrestal Building" |
| ORAU-04-128 | "Evaluation of the Safe Handling and Movement of Nursing Home Residents Document" |
"Use of Ca-DTPA and Zn-DTPA for Chelation Therapy of Heavy Metals"
Principal Investigator: Dr. Patrick C. Lowry, Oak Ridge Associated Universities
Project started in: 1978
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Oak Ridge Institute for Science and Education
Most recent approval: 11/20/03
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 3
Reporting period for number of human subjects:
Other: 06/01/03 to 05/31/04
Explanation:
US FDA Reporting Year
Type(s) of Human Subjects Involvement:
Investigational new drug (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. New supplies of DTPA have been imported from Heyl, GmBH in Berlin during this reporting period only for the Strategic National Stockpile, Centers for Disease Control. REAC/TS and co-invesitgators in the study did not receive new DTPA during this reporting period. Both Ca- and Zn-DTPA are approved by both the U.S. Food and Drug Administration and DOE/Environment, Safety and Health, and meet the chemical specifications of the U.S. Pharmacopeia (USP 23) and that of the European Union (Pharm. Eur.) Ca- and Zn-DTPA have recently (late in the reporting period) been classified by the U.S. FDA as New Drug Application and are no longer considered investigational (INDs).
DTPA belongs to the group of synthetic polyamino polycarboxylic acids which form stable complexes (metal chelates) with a large number of metal ions, especially the transuranic elements. The drug effectively exchanges calcium or zinc for another metal of greater binding power and carries it to the kidneys where it is then excreted. Historically, in the DOE laboratory complex, DTPA has been quite successful in promoting urinary excretion of the actinide elements in accident situations where inhalation or systemic uptake through wounds was involved.
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 the efficiency of chelation decreases with time, DTPA ideally should be given within six hours of exposure.
Accidents involving internal contamination with the actinide elements (Pu, Am, Cm) occur in the DOE complex and both Ca-DTPA and Zn-DTPA have proven effectiveness in the medical management of these cases. Anyone in the DOE system or elsewhere with internal exposure to actinides (Pu, Am, Cm, etc.) is eligible for treatment with Ca-DTPA and Zn-DTPA. Most cases of internal contamination involve inhalation of the material, but uptake through wounds has occured in some reporting periods.
Three cases involving use of DTPA are recorded on the Radiation Emergency Assistance Center/Training Site (REAC/TS) registry for this reporting time period, one case with external skin contamination with Pu-239, two cases with puncture wounds with Pu-239.
After completing the standard consent form, the worker with skin contamination was treated with one dose of Ca-DTPA mixed with 5 ml of diluent applied topically for three days for skin contamination with Pu-239. No changes in blood pressure or vital signs were noted. No adverse effects were noted. Urine Biodosimetry was not performed.
After completing the standard consent form, the workers with puncture wounds both received one dose of intravenous Ca-DTPA, and both had the area of contamination at the injection sited incised. One of the workers had received a treatment with DTPA in 1986. No changes in blood pressure or vital signs were noted in either patient. No adverse effects or complications were noted. Urine dosimetry on one of the workers with a puncture wound revealed a rapid decrease in measured DPM the first day after treatment, with a virtual return to near baseline on subsequent days. The dosimetry was done on spot urines, however, not on 24-hour urine samples. No changes in blood pressure or vital signs were noted. No adverse effects were noted. Urine dosimetry was not done on the second patient. The treating physicians in all three cases were either a co-investigator or under the supervision of a co-investigator.
No serious toxicity in human subjects has been reported as a result of 640 separate patients administered DTPA (either intravenously by slow IV push, by IM, or by nebulizer) in recommended doses for a total of 4,681 separate doses current through the reporting period (the one case where DTPA was use for external decontamination is not included in the totals). In addition, no serious adverse effects have been noted as a result of over 1,000 doses of Zn-DTPA in the recommended dosage given to individual subjects. The project is approved by the Oak Ridge Site-wide IRB, which also has addressed privacy issues related to this project.
"The U.S. Radiation Accident Registry Follow-Up Program"
Principal Investigator: Dr. Patrick C. Lowry, Oak Ridge Associated Universities
Project started in: 1979
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Identifier or number: 63
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Oak Ridge Institute for Science and Education
Most recent approval: 11/20/03
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Fiscal Year 2004
Type(s) of Human Subjects Involvement:
The Radiation Emergency Assistance Center/Training Site (REAC/TS) Accident Registry is an invaluable historical 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 many cases, we have complete accident reconstruction, human factors data, medical and laboratory data, patient history transcribed from a live interview at REAC/TS, and multiple kinds of health physics data. This database is an invaluable resource for DOE and other governmental agencies interested in the human factors aspects of radiation-induced injury.
One of the most important aspects of medical management of a radiation accident is early dosimetry information. However, in many cases, both the magnitude of the accident and the dosimetry profile(s) of the victim(s) are not known for days to weeks. Data from the REAC/TS Accident Registry were recently used to develop an early dose assessment algorithm for high-level gamma accidents. This algorithm (Goans et al, Health Physics 72(4): 513-518, 1997) provides a simple dose-estimation algorithm based on lymphocyte kinetics from prior radiation accidents. In FY 2001, this work was extended to encompass criticality accidents (Goans et al, Health Physics 81(4): 446-449, 2001). These papers represent excellent examples where retrospective analysis of accidents has been used to further the medical treatment of future cases.
In FY2002 to 2004, the USFDA almost exclusively used data from the REAC/TS radiation registry and the DTPA registries as a basis for moving Ca- and Zn-DTPA from an IND classification (investigational) to a New Drug Application, allowing more general accessability to DTPA to the general medical community.
In FY 2004, no radiation accidents were reported to REAC/TS. Up to September 30, 2003 the REAC/TS Accident Registry contained data on 2,176 events involving approximately 133,802 individuals. The U.S. Radiation Accident Registry currently contains medical and health physics data on 134 radiation-related fatalities (26 U.S. accidents, 100 non-U.S. accidents, eight location of accident not noted, likely due to record error precomputerization), and 427 radiation accidents involving 3,053 significant exposures.
As usual, the response from REAC/TS continues to occur through interaction directly with the private sector, through all aspects of the DOE system, various state and foreign agencies, and with the Nuclear Regulatory Commission (NRC).
An individual's consent to participate in the DTPA Registry/follow-up medical program is obtained by the co-investigator physician at the time of the initial DTPA treatment. All data collected for the Registry will be encoded and entered into the password-protected computerized data bank maintained at ORAU as part of the DOE Record System as described in the Federal Register. The information contained in the Registry is extracted from individual records which are retrievable only by REAC/TS staff by name or other personal identifier. The information, therefore, is included in a DOE Privacy Act system of records and will not be disclosed to third parties without written consent of the participant. Written consent for approved epidemiological research studies using redacted (no identifiers) records is obtained from DTPA registry participants at the same time informed consent is obtained, prior to first DTPA treatment.
"Whole Blood Procurement, Consent for Research Waiver Form and Payment Authorization"
Principal Investigator: Dr. Donna L. Cragle, Oak Ridge Institute for Science and Education
Project started in: 1980
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Oak Ridge Institute for Science and Education
Most recent approval: 11/19/03
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Fiscal Year 2004
Type(s) 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 workplace. The results from this testing are used to establish the range of values for a normal test and to identify the cut-off values to be used in identifying abnormal tests in beryllium-exposed workers. 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.
The purpose of the lymphocytes drawn on healthy individuals is to provide control cells for beryllium sensitization studies only and are not used as part of any protocol that involves human subjects. The consent form is provided and payment authorization is obtained by laboratory personnel. The results of the tests are stored only under a laboratory identifier code. Aggregate results are used to set the normal values for each new lot of serum used in the laboratory.
During FY2004, no new serum lots were tested, therefore no control samples were required.
"Comprehensive Epidemiology Study of Department of Energy Atomic Workers"
Principal Investigator: Dr. Donna L. Cragle, Oak Ridge Associated Universities
Project started in: 1980
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Oak Ridge Institute for Science and Education
Most recent approval: 11/19/03
IRB approval number: 60
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 986
Reporting period for number of human subjects:
Fiscal Year 2004
Type(s) of Human Subjects Involvement:
ORISE supports the DOE Office of Health Programs and the National Institute for Occupational Safety and Health (NIOSH) in a number of activities utilizing retrospective occupational records located at various DOE facilities. These 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. Scanning original facility documents for NIOSH use in worker studies.
4. Analyzing cause of death data with respect to exposure level using standard dose-response methodology.
5. Analyzing cause of death data in a descriptive manner.
During FY2004, a descriptive mortality report was prepared for the Pittsburgh Energy Technology Center, involving analyses of 123 deaths among 986 current and former workers.
"The DTPA Registry Follow-Up Program"
Principal Investigator: Dr. Patrick C. Lowry, Oak Ridge Associated Universities
Project started in: 1980
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Oak Ridge Institute for Science and Education
Most recent approval: 11/20/03
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 3
Reporting period for number of human subjects:
Other: 06/01/03 to 05/31/04
Explanation:
FDA reporting year
Type(s) of Human Subjects Involvement:
The purpose of the DTPA Registry Follow-up Program is to document cases where diethylenetriaminepentaacetate (DTPA) is used, both in the DOE complex and elsewhere in the U.S., to document drug safety and efficacy and to maintain a comprehensive registry of medical information in these cases for both the DOE and the FDA. Ca-DTPA and Zn-DTPA are distributed by Oak Ridge Associated Universities (ORAU) under contract with the U.S. Department of Energy.
Other than a shipment of Ca- and Zn-DTPA consigned to the Strategic National Stockpile (SNS), no new supplies of either Ca- or Zn-DTPA for REAC/TS or its co-investigators have been imported from Heyl, GmBH in Berlin during this reporting period. A shipment of DTPA is expected during the next reporting period. Both Ca- and Zn-DTPA are approved by both the U.S. FDA and DOE/EH, and meet the chemical specifications of the U.S. Pharmacopeia (USP 23) and that of the European Union (Pharm. Eur.)
DTPA belongs to the group of synthetic polyamino polycarboxylic acids which form stable complexes (metal chelates) with a large number of metal ions, especially the transuranic elements. The drug effectively exchanges calcium or zinc for another metal of greater binding power and carries it to the kidneys where it is then excreted. Historically, in the DOE laboratory complex, DTPA has been quite successful in promoting urinary excretion of the actinide elements in accident situations where inhalation or systemic uptake through wounds was involved.
Three cases involving use of DTPA are recorded on the Radiation Emergency Assistance Center/Training Site (REAC/TS) Registry in this reporting period, one case wtih external skin contamination, two with puncture wounds.
The worker with skin contamination was given treated with one dose Ca-DTPA mixed with 5 ml of diluent applied topically for three days for skin contamination with Pu-239. No changes in blood pressure or vital signs were noted. No adverse effects were noted. Urine Biodosimetry was not performed.
After completing the standard consent form, the workers with puncture wounds both received one dose of intravenous Ca-DTPA, and both had the area of contamination at the injection sited incised. One of the workers had received a treatment with DTPA in 1986. No changes in blood pressure or vital signs were noted in either patient. No adverse effects or complications were noted. Urine dosimetry on one of the workers with a puncture wound revealed a rapid decrease in measured DPM the first day after treatment, with a virtual return to near baseline on subsequent days. The dosimetry was done on spot urines, however, not on 24-hour urine samples. No changes in blood pressure or vital signs were noted. No adverse effects were noted. Urine dosimetry was not done on the second patient. the treating physicians in all three cases were either a co-investigator or under the supervision of a co-investigator.
The status of the REAC/TS DTPA Registry through June 2004 shows 37 active co-investigators throughout the country. Since the beginning of the Registry, 641 patients have received 4,682 doses of DTPA with an adverse reaction rate under 1.5 percent, mostly very minor. Our extensive documentation of DTPA usage therefore demonstrates the inherent safety of the drug. 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 are modified periodically according to recommendations of the IRB, DOE/HQ, the FDA, and an independent review committee commissioned by the DOE. The consent form has been modified in FY 2003.
An individual's consent to participate in the DTPA Registry/follow-up medical program is obtained by the co-investigator physician at the time of the initial DTPA treatment. All data collected for the Registry will be encoded and entered into the password-protected computerized data bank maintained at ORAU as part of the DOE Record System as described in the Federal Register. The information contained in the Registry is extracted from individual records which are retrievable only by REAC/TS staff by name or other personal identifier. The information, therefore, is included in a DOE Privacy Act system of records and will not be disclosed to third parties without written consent of the participant. Written consent for approved epidemiological research studies using redacted (no identifiers) records is obtained from DTPA registry participants at the same time informed consent is obtained, prior to first DTPA treatment.
"Amendment - Comprehensive Epidemiology Study of Department of Energy Atomic Workers: National Death Index"
Principal Investigator: Dr. Donna L. Cragle, Oak Ridge Institute for Science and Education
Project started in: 1989
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Oak Ridge Institute for Science and Education
Most recent approval: 11/19/03
IRB approval number: 60a
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Fiscal Year 2004
Type(s) of Human Subjects Involvement:
This project uses the National Death Index (NDI) to link death information to worker or special exposure populations. The NDI is a specialized source of death data. Death certificates retrieved under this protocol are maintained and shared under a restrictive set of rules set forth by the NDI.
During FY2004, this data source was not used. It is anticipated that there will be futures uses of the NDI.
"Use of Prussian Blue for Internal Decontamination of Radiocesium"
Principal Investigator: Dr. Patrick C. Lowry, Oak Ridge Institute for Science and Education
Project started in: 1991
Funding for Human Subjects Research: No Funding Sources Reported
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Oak Ridge Institute for Science and Education
Most recent approval: 11/20/03
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Other: 06/01/03 to 05/31/04
Explanation:
U.S. FDA reporting period
Type(s) of Human Subjects Involvement:
Prussian Blue (ferric ferrocynate) is well-studied as an ion-exchange resin which is quite efficacious in the decorporation therapy required for patients' high body burdens of radiocesium or radiothallium. Anyone in the DOE system or elsewhere in the U.S. with internal contamination with radiocesium or radiothallium is eligible for treatment with Prussian Blue.
There has been no use of Prussian Blue in the most recent reporting period (6/1/03 to 5/31/04) for internal contamination with either radiocesium or radiothallium. Interestingly, the most recent and common use of Prussian Blue in the U.S. has been in medical treatment of intentional poisoning with thallium. There have been six cases of elemental (non-radioactive) thallium poisoning treated with Prussian Blue provided by the Radiation Emergency Assistance Center/Training Site (REAC/TS) under the compassionate gesture protocol, including one child, in the last four reporting periods (6/1/00 to 5/31/03). Without this compassionate gesture, it is likely that at least one or more patient would have died or had neurological sequelae. None of these cases report any side effects other than mild obstipation and blue feces. No cases of internal contamination with radiocesium or radiothallium have been reported in the U.S. during this reporting period.
ORAU-81, Use of Prussian Blue for Internal Decontamination of Radiocesium and Thallium, has been granted FDA IND 51,700. A supply of Prussian Blue, obtained from the German company Heyl GmBH, is currently distributed to seven co-investigators in the DOE complex. Despite the approval of an New Drug Application (NDA) for Prussian Blue to Heyl GmBH, the IND for Prussian Blue is planned at this time to continue. It will be decided later in the year, after discussions with FDA and DOE whether to continue the study under the NDA.
Prussian Blue is to be used in the U.S. DOE complex as a decorporation agent for patients internally contaminated with medically significant amounts of radiocesium and radiothallium. In this document, the name Insoluble Prussian Blue (PB) without further specification indicates the following compound: Ferric(III) hexacyanoferrate(II) "insoluble PB," Fe4 [Fe (CN)6]3, molecular weight: 859.3, Color Index No. 77.510, and CAS Registry No. 14038-43-8. Insoluble Prussian Blue has been recommended for years as the drug of choice by national and international radiation protection societies for use in treating internal contamination with radiocesium. It was effectively used in the treatment of patients contaminated with Cs-137 in the 1987 Goiania, Brazil accident under temporary clearance by FDA for "compassionate use" by the ORAU's REAC/TS program.
Prussian Blue is distributed by Oak Ridge Institute for Science and Education (ORISE). ORISE is managed by Oak Ridge Associated Universities (ORAU), under contract with the U.S. Department of Energy (DOE). Insoluble Prussian Blue (PB), ferric hexacyanoferrate, Fe4[Fe(CN)6]3 is a drug that enhances excretion of isotopes of cesium and thallium from the body by means of ion exchange. It has had a long and successful history in the treatment of internal contamination with radiocesium. In the normal course of DOE operations, internal contamination with radioactive cesium is thought to be more likely than with radiothallium.
Of the various radioisotopes of cesium, Cs-137 is the most important. Cs-137 is a common fission by-product material, a frequent active component of sealed sources, and an important radionuclide in radiation oncology. The use of Cs-137 falls under the jurisdiction of the Nuclear Regulatory Commission (NRC). It is a ubiquitous radionuclide found throughout the DOE system and in hospitals performing either gynecological brachytherapy or interstitial therapy for solid tumors. Until the Goiania incident in Brazil, there were very few cases of radiocesium contamination requiring decorporation therapy. However, there is an increasing potential for such contamination to occur and a need for specific therapy. Additionally, given its widespread availability and its chemical characteristics, it is considered as a prime candidate for use in a terrorist event, such as a dirty bomb. The recent increase in workers performing remediation work at hazardous waste sites also requires that clinicians have Insoluble Prussian Blue available and understand the nature of its pharmacodynamics.
"Identification and Abstraction of Death Certificates for National Registry of Persons Exposed to Hazardous Substances"
Principal Investigator: Dr. Elizabeth D. Ellis, Oak Ridge Institute for Science and Education
Project started in: 1991
Funding for Human Subjects Research: No Funding Sources Reported
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: Oak Ridge Institute for Science and Education
Most recent approval: 11/20/03
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Fiscal Year 2004
Type(s) of Human Subjects Involvement:
The objective is to determine vital status and retrieve hard-copy death certificates from states' vital records offices and electronic death information from the National Death Index (NDI) for individuals included in Agency for Toxic Substances and Disease Regisrty (ATSDR) disease registries. ATSDR provides identifying information and date and state of death information for individuals included in its registries. The Oak Ridge Institute for Science and Education (ORISE) matches this information against the Pension Benefits Information database to identify decedents and the NDI to retrieve death certificate and cause of death information. Based on data received from the NDI, requests are made to the states in which the deaths occurred for hard-copies of the death certificates. All electronic and hard-copy records are returned to ATSDR at the completion of project. Access to ATSDR data at ORISE is on a need-to-know basis. All research staff have signed confidentiality agreements as a condition of employment. All hard-copy records are kept in locked cabinets when not being used. Electronic files are accessed using a password. There was no activity on this project in FY2004.
"Former Radiation Worker Medical Surveillance Program at Rocky Flats"
Principal Investigator: Mr. Joe M. Aldrich, Oak Ridge Institute for Science and Education
Project started in: 1992
This project ended in fiscal year 2004.
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Identifier or number: 102
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Oak Ridge Institute for Science and Education
Most recent approval: 11/20/03
IRB approval number: 00005031
Explanation of IRB approval:
The approval period spans one year from approval date. Therefore, the current approval dates are from 11/20/2003 through 11/19/2004.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 53
Reporting period for number of human subjects:
Fiscal Year 2004
Type(s) of Human Subjects Involvement:
OBJECTIVES:
The objective of this program was to provide selected former radiation workers of the Rocky Flats Environmental Technology Site (formerly, Rocky Flats Plant) an opportunity to receive follow-up medical monitoring and to have their lifetime internal radiation dose updated. Additionally, this program will provide information on long-term health effects following exposure to radiation as a result of work at Rocky Flats.
Former radiation workers were invited to participate in the program if they meet specific criteria for radiation exposure received while they worked at Rocky Flats, if a review of their exposure record indicates a significant likelihood that an internal deposition or external dose may have occurred that was not well evaluated in the past, or if they request to participate.
Those participants for whom there was a potential for unrecorded dose or whose updated total effective dose equivalent (TEDE) is 20 rem or more were invited to return for subsequent medical examinations and, for selected repeat participants, dose evaluation on a periodic basis, currently about every three years. These eligibility criteria were subject to change based on a change in DOE directives.
Participation in the program was completely voluntary. Consent was documented by participant and witness signatures on a consent form. Individuals could withdraw from the program at any time.
METHODOLOGY AND INVOLVEMENT OF HUMAN SUBJECTS:
Participants were asked to complete a Health and Exposure History questionnaire that summarized their work, health, and family medical history. A medical examination and radiation exposure history review were scheduled, and a letter was sent to them with information about their trip, examination times, locations, and pre-authorized travel and lodging reimbursements.
The medical examination, typically included the following:
* blood and urine samples to be analyzed by a clinical laboratory for a panel of health indicators, such as liver, kidney, and thyroid function, cholesterol and glucose levels, and prostate-specific antigen (PSA), if requested by male participants,
* a chest x-ray, with associated external exposure to ionizing radiation,
* a respiratory function test,
* vision and hearing tests,
* height, weight, and vital signs measurements,
* a test for occult blood in a stool sample,
* an electrocardiogram, and
* a physical examination.
The blood samples were taken from a vein in the participant's arm. There is little physical risk in a routine blood draw. As expected, there were a few people who experienced a slight pain and minor bruising did occur. There were no reported infections from the needle puncture required by this procedure.
Participants were asked to provide one or two separate 24-hour urine excretion samples for analysis for plutonium and/or americium. A lung count for americium-241 and, by inference, plutonium, were performed at Rocky Flats. Occasionally, counts were made also on former contaminated wound sites and the skull and/or liver. None of these counts were invasive or painful; the detector was simply placed on the outer surface of the location being counted.
Radiation exposure history and lung count and urine analysis results were used to further refine participants' calculated radiation doses, using the internal dosimetry computer code, CINDY, and individual retention and excretion patterns for plutonium and americium.
There was minimal financial cost to the participant for program activities. The program paid for pre-authorized travel and lodging costs for the medical examination and lung count, as well as shipping expenses for return of the urine samples.
Participants received the results of medical and dosimetry tests and measurements, with a recommendation that participants provide the medical information to their personal physicians for inclusion in their medical files and for any appropriate follow-up. The program did not contact their physicians directly except in cases of emergency or at the participants' request.
Personally-identifiable medical examination and dose assessment results were maintained as confidential information and were not released to anyone outside the program without the participants' written permission, as required by law or DOE directive, or as indicated on the consent form. Individuals involved with the program have access to their own records only after having signed a document acknowledging their understanding of record confidentiality.
Records were also used in the program database; such as, a list of participants in the program and information summarized from their employment history and medical and dose assessment records. Personal identifiers were not published in any reports generated from the DOE former radiation worker database. However, privacy and confidentiality of medical records cannot be guaranteed. Access to or release of these records could be required under court order or DOE directive.
"Department of Energy Epidemiologic Surveillance Data Center"
Principal Investigator: Dr. Elizabeth D. Ellis, Oak Ridge Institute for Science and Education
Project started in: 1994
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Oak Ridge Institute for Science and Education
Most recent approval: 11/20/03
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 80969
Reporting period for number of human subjects:
Fiscal Year 2004
Type(s) of Human Subjects Involvement:
The purpose is to undertake regular and systematic collection, analysis, and interpretation of data on illness and injury in the DOE work force. The objectives are: determine rates of illness and injury among workers; identify increases in the risk of disease among workers; provide data in response to questions from workers, physicians, and others about possible occupational health effects; and identify areas in which further investigation or analytic studies should be initiated. This ongoing surveillance requires regular collection, maintenance, and interpretation of illness and injury, demographic, and job-related data. Electronic data submissions are received at regular intervals from the participating DOE sites. The data are placed in the epidemiological surveillance database where the data are evaluated for quality and completeness. The illness and injury are nosologically coded. The data are processed into annual reports for each site that include characterization of the work force included in the epidemiological surveillance program at the site and an evaluation of the observed illness and injury trends at each site. All data used for epidemiological surveillance are routinely collected for other purposes. Data for individual workers are identifiable only by an encrypted number. Each participating site uses its own encryption algorithm. ORISE does not have access to any of the encryption algorithms. In FY2004 the program was renamed Illness and Injury Surveillance Program with 15 DOE sites participating.
"Beryllium Workers Follow-up Study, Phase II: Screening for Beryllium Sensitivity and Definitive Diagnosis of Chronic Beryllium Disease. Amendment - to add Former Beryllium Workers at all DOE sites where Beryllium was used."
Principal Investigator: Dr. Donna L. Cragle, Oak Ridge Institute for Science and Education
Project started in: 1999
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Oak Ridge Institute for Science and Education
Most recent approval: 11/20/03
IRB approval number: ORAU(99)-87a
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 1209
Reporting period for number of human subjects:
Fiscal Year 2004
Type(s) of Human Subjects Involvement:
This project began as a research effort for screening current and former workers at the Y-12 Plant in Oak Ridge, Tennessee. At the beginning of FY1999, the scope was expanded to include former workers at all DOE facilities where beryllium was used.
The Former Beryllium Workers Medical Surveillance Program (BMSP) is composed of five interrelated tasks and includes the identification, notification, scheduling, initial testing, and retesting of former employees of DOE sites who believe they were exposed to beryllium during their employment. Rosters of former employees from DOE sites under the BMSP are obtained and appropriate BMSP notification letters and participation forms are sent to persons on these rosters. Individuals indicating a desire to participate in the BMSP are tested for sensitivity to beryllium and may also be given a chest x-ray if they report respiratory symptoms compatible with chronic beryllium disease (CBD). Persons who show sensitization to beryllium on the first test may be scheduled for a second test to confirm the abnormal finding. Further medical evaluation to determine the presence of CBD may be offered to those who have a normal test, but have suspicious lung pathology on chest x-ray examination or symptoms of CBD that cannot be explained by other disease processes. Retesting is offered once every three to five years to former employees who are found to have normal test results. In addition, retesting is offered every year to former employees who had an abnormal chest x-ray possibly associated with CBD.
Blood is drawn from all study participants for a beryllium lymphocyte proliferation test (Be-LPT). 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.
Any participant who has one abnormal Be-LPT will be mailed an information package explaining the new Department of Labor (DOL) Energy Employees Occupational Illness Compensation Program Act of 2000 (EEOICPA) and how to apply for benefits through this program. These participants may receive a second Be-LPT through the ORISE program while waiting to be accepted for benefits from DOL. When accepted into the DOL program, all further medical examinations and benefits for the participant should be coordinated and guaranteed by DOL. The DOL program will cover medical monitoring even if the participant chooses not to have a repeat test or if the repeat test is normal. Through this program, participants will have further diagnostic procedures to determine if they have CBD.
The majority of participants who have an abnormal Be-LPT apply and are accepted to the DOL program for further follow-up. A small number of participants with abnormal Be-LPTs (10 to 15 per year) do not wish to apply for the DOL benefits and are referred for a definitive diagnosis through the ORISE program. The diagnostic testing may include 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 (IV) 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 one percent). These risks are discussed with the individuals prior to their undergoing the definitive diagnosis procedures.
Informed consent is obtained for all participants in the Former Beryllium Worker Medical Surveillance Program. Test results are confidential, but not anonymous, but testing staff will only discuss these results with the participant or persons approved by the participants. Participants are free to withdraw at any time without penalty or loss of benefits.
"Update of a Mortality Study of Titanium Dioxide Workers"
Principal Investigator: Dr. Elizabeth D. Ellis, Oak Ridge Institute for Science and Education
Project started in: 2000
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Oak Ridge Institute for Science and Education
Most recent approval: 11/20/03
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 4203
Reporting period for number of human subjects:
Fiscal Year 2004
Type(s) of Human Subjects Involvement:
The original purpose of the study is to update the cohort mortality study of workers exposed to titanium dioxide. The study is being expanded to include two additional worker cohorts and to include a hazards assessment as part of the analysis. The major components of the new study are computerization the worker roster and work history; vital status ascertainment using national databases, death certificate retrieval, and cause of death information retrieval; a hazards assessment analysis; comparison of the mortality among the workers to the U.S. general population; and analysis of the risk of mortality related to hazards in the workplace. Since this study will be carried out using existing records, the risks to the study participants originate from loss of privacy of the workers or their survivors. To minimize this risk, access to records is on a need-to-know basis only. All research staff who have access to the records have signed a confidentiality agreement. When not in use, records are kept in locked cabinets. Access to electronic data is password protected.
"National Immunization Program (NIP) Parent-Decision Model"
Principal Investigator: Dr. Richard R. Tardif, Oak Ridge Institute for Science and Education
Project started in: 2002
This project ended in fiscal year 2004.
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: Oak Ridge Institute for Science and Education
Most recent approval: 11/14/03
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Fiscal Year 2004
Type(s) of Human Subjects Involvement:
The data collected in this study will be used by the National Immunization Program (NIP) to formulate a health communication effort. The effort will focus on determining why parents choose or do not choose to vaccinate their children. NIP has requested that ORAU assist in the development and testing of a parent-decision model of child immunization.
Data are to be collected by means of telephone interviews. Participants for these interviews will be first-time parents of children under the age of two years. Once personal identifiers have been verified, individual telephone interviews are to be audio recorded. Cash incentives or gift certificates will be provided and mailed to the participants once their signed informed consent forms have been received. Data collection and anlysis were completed 10/21/03; the draft report is in review.
ORAU will not provide any personal identifiers to NIP or Carnegie Mellon University. ORAU will retain indefinitely, as part of the program's project files, the confidentiality agreements, one set of audio tapes, and at least one copy of any report produced. ORAU will deliver the report and one set of audio tapes to NIP. The information that ORAU obtains and sends to Carnegie Mellon University and CDC/NIP will contain no personal identifiers, and no personal identifiers will be used in reports. All records will be kept in locked files, and only persons employed by ORAU and working on the study will have access to the records.
Project has been completed and final report has been delivered.
"Evaluation of Fingertip Thermal Sensors in Thermography Research Project"
Principal Investigator: Dr. Gerhard R. Eisele, Oak Ridge Institute for Science and Education
Project started in: 2003
This project ended in fiscal year 2004.
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Identifier or number: 121
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Oak Ridge Institute for Science and Education
Most recent approval: 11/20/03
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Fiscal Year 2004
Type(s) of Human Subjects Involvement:
The objective of this research was to develop and test feasibility of a prototype system to detect deception by utilizing small thermal sensor devices to provide data on temperature responses of fingertip regions of the human hand. A set of four innocuous detectors were to be affixed passively to the fingertips arranged in a hand-outline template. The sensor equipment was designed to detect variations in fingertip temperatures by monitoring the minute electrical signals produced by changes in blood flow volume and capillary constriction controlled by the human body's autonomic nervous system.
Volunteers (16 to 20) were to be recruited to participate in this study and go through an informed consenting process. Data were to be collected from each subject who were asked two series of ten questions regarding a clandestine item in his/her possession. Moderate compensation was to be offered for participation. Test data were to be organized using fictitious code numbers and not personnally identifiable in any way at any stage of the study.
The study was abruptly cancelled in FY 2004 by the sponsor due to budgetary realignments within the organization.
"Former Pantex Worker Medical Surveillance Program"
Principal Investigator: Dr. Arthur L. Frank, Oak Ridge Institute for Science and Education
Project started in: 2003
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Drexel University
Most recent approval: 04/22/04
IRB approval number: 02510-02p
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
Former worker projects have been initiated at numerous DOE sites around the U.S. This represents the Phase 1 assessment of the Pantex site near Amarillo, Texas to determine if sufficient exposures took place in the past to justify installing a medical surveillance program. Only filed data on workplace exposures and hazards at Pantex have been analyzed in Phase 1. No human subjects and no personally identifiable data were used to date. Significant exposures to a wide variety of potential hazardous materials were found to have taken place at Pantex. A recommendation has been made to undertake Phase 2. Phase 2 is currently under review for funding and is expected to be approved shortly.
"Audience Need and Preference Study"
Principal Investigator: Ms. Deborah McFalls, Oak Ridge Institute for Science and Education
Project started in: 2004
This project ended in fiscal year 2004.
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: Oak Ridge Institute for Science and Education
Most recent approval: 05/11/04
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 30
Reporting period for number of human subjects:
Fiscal Year 2004
Type(s) of Human Subjects Involvement:
This project, which was put on inactive status in November 2003, was reactivated in May 2004. The objective of the study was to collect information that will assist NIOSH researchers in the development of an Internet site containing workplace safety information for young people. Only the student's age and gender were recorded. Parents were asked through an E-mail to permit their children to provide input on the design of the opening page of the Web site using their home computers. ORISE developed the opening page of the Web site which was reviewed by 30 children. Afterwards, consulted with client, completed development of Web site, and submitted Web files to NIOSH. Project task has been completed.
"Remote Deception Detection Using Volatile Chemical Emissions Research Project"
Principal Investigator: Dr. Gerhard R. Eisele, Oak Ridge Institute for Science and Education
Project started in: 2004
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: Oak Ridge Institute for Science and Education
Most recent approval: 11/24/03
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
Fiscal Year 2004
Type(s) of Human Subjects Involvement:
The objective of the research is to test the feasibility of developing a system to detect intentional deception by monitoring small changes in natural volatile organic chemical emissions from the skin surface of individuals. All materials used in the study are innocuous and nontoxic to skin surfaces.
After the strictly voluntary consenting process is completed, study participants will first view a video of a police file of an actual real-life workplace violence indicent. The participant will next be asked to sit at a table in the testing facility with the forearm placed comfortably in a tubular sampling sleeve. The subject will be asked to intentionally lie when answering a question relevant to seeing the video.
Air samples will be drawn off the forearm in the tubular sleeve and captured in special sampling tubes designed to adsorb volatile natural organic compounds. The samples will then be analyzed using gas chromatography/mass spectrometry technology to indicate evidence of stress that could be associated with deceptive behavior.
"Survey of Respiratory Symptoms Among Workers in the Forrestal Building"
Principal Investigator: Dr. Elizabeth A. Ellis, Oak Ridge Institute for Science and Education
Project started in: 2004
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: Oak Ridge Institute for Science and Education
Most recent approval: 05/25/04
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 42
Reporting period for number of human subjects:
Fiscal Year 2004
Type(s) of Human Subjects Involvement:
The objective of this study is to investigate a health concern among DOE employees in the Forrestal Building in Washington, DC that their recurrent respiratory symptoms are related to their work environment.
A survey will be used to collect information about respiratory symptoms from about 75 employees who work in or near the area in which the concerned employees work. A letter and survey will be sent to each employee. After reading the letter, the employee will decide whether to complete and return the survey to DOE EH-6 staff. Pseudo-identifiers will be assigned to each survey before it is sent to ORISE for computerization.
"Evaluation of the Safe Handling and Movement of Nursing Home Residents Document"
Principal Investigator: Dr. Virginia Sublet, Oak Ridge Institute for Science and Education
Project started in: 2004
This project ended in fiscal year 2004.
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: Oak Ridge Institute for Science and Education
Most recent approval: 07/08/04
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 32
Reporting period for number of human subjects:
Fiscal Year 2004
Type(s) of Human Subjects Involvement:
The objective of the study is to evaluate the information and format contained in the Safe Handling and Movement of Nursing Home Residents document to determine if the information is understandable by appropriate target groups. The document will be disseminated to decision-makers in the nursing home industry as a means to increase awareness about the positive benefits for nursing homes of using mechanical lifting devices.
Data will be collected through focus groups. ORISE will not receive personal information about the participants nor will participants be asked to complete any written responses.
This project was completed in July 2004.