Ms. Pamela S. Bonee
ORISE/CPD
P.O. Box 117
Oak Ridge, TN 37831-0117
Phone: 423-576-3147
Fax: 423-241-2923
E-mail: boneep@orau.gov
Number of Human Subjects projects reported: 23
| 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-00-105 | "Infrared Thermography to Detect Intentional Deception" |
| ORAU-00-ORAU-00-108 | "Update of a Mortality Study of Titanium Dioxide Workers" |
| ORAU-01-109 | "Measurements of DU in Gulf War Veterans" |
| ORAU-01-110 | "Testing of Environmental Health Calendar" |
| ORAU-01-BWXT-2 | "National Digital Mammography Archive (NDMA), Phase II" |
| ORAU-02-112 | "Utility of the SASSI Instrument for Identifying Possible Alcohol Abuse Among DOE Workers" |
| ORAU-02-113 | "Validation of the NNSA Computer-Based Clearance Process" |
| ORAU-02-114 | "Message Based Intervention for Technology Transfer" |
| ORAU-02-115 | "Qualitative Research - Health and Safety Information Needs in Small Business" |
| ORAU-02-116 | "Formative Research: Bioterriorism Preparedness" |
| ORAU-02-117 | "National Immunization Program (NIP) Parent-Decision Model" |
| ORAU-02-118 | "Racial and Ethnic Adult Immunization Issues" |
Other projects of interest associated with this site:
| BNL-01-354 | "Medical Surveillance of former BNL Employees Identified as Beryllium Exposed" |
"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: 12/01/01
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 1
Reporting period for number of human subjects:
Other: 06/19/01 to 05/31/02
Explanation:
FDA Reporting Year
Type(s) of Human Subjects Involvement:
Accidents involving internal contamination with the actinide elements (Pu, Am, Cm, etc) occur in the DOE complex and both Ca-DTPA and Zn-DTPA have proven efficacy 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 usually occurs at least once each reporting period.
One case recorded on registry for time period. Subject had Am-241 exposure likely more than 10 years ago at university at which he is employed. Upon discovery of internal contamination (predominantly bone)and explanation of chelation options and effectiveness, chose chelation therapy with Ca DTPA. After completing standard consent form, subject received first dose of Ca DTPA at REAC/TS, no abnormal effects noted, and elected to received follow-up doses with physician in home town/state who was made co-investigator. Second dose received approximately three months later with no abnormal effect. Third and final dose planned for October/November 2002.
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.
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. A new supply of DTPA has been recently imported from Heyl, GmBH in Berlin and distributed to all 40 current DTPA co-investigators. This distribution has been approved by both the US FDA and DOE/EH. In addition, the drug meets the chemical specifications of the US Pharmacopeia (USP 23) and that of the European Union (Pharm. Eur).
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 should be given within 6 hours of exposure.
No serious toxicity in human subjects has been reported as a result of 635 separate patients administered DTPA (either intravenously by slow IV push or by nebulizer) in recommended doses (for a total of 4675 separate doses; current through 10/2001). In addition, no serious adverse effects have been noted as a result of over 1000 doses of Zn-DTPA in the recommended dosage given to a single individual.
The project is approved by the current 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.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Oak Ridge Institute for Science and Education
Most recent approval: 12/01/01
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 12
Reporting period for number of human subjects:
Fiscal Year 2002
Type(s) of Human Subjects Involvement:
The 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 was 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 FY 2002, 12 radiation accidents were report to REAC/TS, 11 from same exposure to Cs-137 and one from Ir-192. In the case of the Cs-137 exposure, symptoms and physical findings were marginal and atypical for radiation, and it was unclear whether actually findings were due to toxic or radiation exposure. No medical treatment related to radiation exposure was reported. The findings from the Ir-192 partial body exposure reported to the Registry were mild/localized peripheral burns which resolved in typical manner of radiation burns.
Up to September 30, 2002 the REAC/TS Central Registry contained data on 2067 cases involving approximately 133,801 individuals. The US Radiation Accident Registry currently contains medical and health physics data on 134 radiation-related fatalities (30 US accidents; 104 non-US accidents), and 420 radiation accidents involving 3053 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 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: 12/01/01
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 3
Reporting period for number of human subjects:
Fiscal Year 2002
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 sensitivity studies only and are not used as part of any protocol that involves human subjects. Consent form and payment authorization is obtained by laboratory personnel. The results of the tests are stored only under a lab ID. Aggregate results are used to set the normal values for each new lot of serum used in the laboratory.
"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: 12/01/01
IRB approval number: 60
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 21100
Reporting period for number of human subjects:
Fiscal Year 2002
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.
"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: 12/01/01
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 1
Reporting period for number of human subjects:
Fiscal Year 2002
Type(s) of Human Subjects Involvement:
The purpose of the DTPA Registry Follow-up Program is to document cases where DTPA is used, both in the DOE complex and elsewhere in the US, to document drug 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 US Department of Energy.
Recently, a new supply of Ca-DTPA and Zn-DTPA was imported from Heyl, GmBH in Berlin and distributed to all 40 current co-investigators. This drug is approved by both the US FDA and DOE/EH, and meets the chemical specifications of the US 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.
In the last reporting period, June 1, 2000, to May 31, 2001, 1 patient received DTPA for a total of 2 doses. A third dose will be given in the next reporting period, FY 2003. No adverse reactions were observed in the two doses. Increased excretion of the radioactive compound (Americium) in the urine were noted after each dose.
The status of the Radiation Emergency Assistance Center/Training Site (REAC/TS) DTPA Registry through June, 2001 shows 40 active co-investigators throughout the country. Since the beginning of the Registry, 636 patients have received 4677 doses of DTPA with an adverse reaction rate under 1.5%, 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 not been modified in FY 2002.
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: 12/01/01
IRB approval number: 60a
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 849
Reporting period for number of human subjects:
Fiscal Year 2002
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.
"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: 12/01/01
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 1
Reporting period for number of human subjects:
Fiscal Year 2002
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 US with internal contamination with radiocesium or radiothallium is eligible for treatment with Prussian Blue.
Interestingly, the most recent use of Prussian Blue has been in medical treatment of intentional poisoning with thallium. In the last three years prior to FY2002, DOE has made Prussian Blue available to three patients in the US with severe thallium poisoning. In FY 2002, DOE also made Prussian Blue available for one patient with chronic and severe thallium poisoning. Without this compassionate gesture, it is likely that at least one patient would have died.
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 four co-investigators in the DOE complex.
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 cesium and thallium. 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
CAS Registry No. 14038-43-8
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 GoiGnia 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. 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.
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 Oak Ridge Associated Universities' Radiation Emergency Assistance Center/Training Site (REAC/TS) program.
"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:
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: 12/01/01
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 13614
Reporting period for number of human subjects:
Fiscal Year 2002
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 ATSDR disease registries. ATSDR provides identifying information and date and state of death information for individuals included in its registries. 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 no being used. Electronic files are accessed using a password.
"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
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: 12/01/01
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 181
Reporting period for number of human subjects:
Fiscal Year 2002
Type(s) of Human Subjects Involvement:
ABSTRACT
OBJECTIVES
The objective of this program is 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 radiation dose updated. Additionally, this program will provide information on long-term health following exposure to radiation as a result of work at Rocky Flats.
Former radiation workers are 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 is the potential for unrecorded dose or whose updated total effective dose equivalent (TEDE) is 20 rem or more may be 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 are subject to change as a result of program funding and DOE directive.
Participation in the program is completely voluntary. Consent is documented by participant and witness signatures on a consent form. Individuals can withdraw from the program at any time.
METHODOLOGY AND INVOLVEMENT OF HUMAN SUBJECTS
Participants are asked to complete a Health and Exposure History questionnaire that summarizes their work, health, and family medical history. A medical examination and radiation exposure history review are scheduled, and a letter is sent to them with information about their trip, examination times, locations, and pre-authorized travel and lodging reimbursements.
The medical exam, will typically include 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 are taken from a vein in the participant’s arm. There is little physical risk in drawing the blood. In a few people, slight pain and bruising occur. Rarely, an infection from the needle puncture results from the procedure.
Participants may be 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, may be performed at Rocky Flats. Occasionally, counts are made also on former contaminated wound sites and the skull and/or liver. None of these counts is invasive or painful; the detector is simply placed on the outer surface of the location being counted.
Radiation exposure history and lung count and urine analysis results are 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 is minimal financial cost to the participant for program activities. The program pays 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 receive 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 does not contact their physicians directly except in cases of emergency or participant request.
Personally-identifiable medical examination and dose assessment results are maintained as confidential information and are 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 participants’ records only after having signed a document acknowledging their understanding of record confidentiality.
Records also will be used in the program database - a list of participants in the program and information summarized from their employment history and medical and dose assessment records. Personal identifiers are 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 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: 12/01/01
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 53044
Reporting period for number of human subjects:
Fiscal Year 2002
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.
"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: 12/01/01
IRB approval number: ORAU(99)-87a
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 4317
Reporting period for number of human subjects:
Fiscal Year 2002
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 FY99, 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). All persons who show sensitization to beryllium on the first test are scheduled for a second test to confirm the abnormal finding. Further medical evaluation to determine the presence of CBD is offered to those identified as beryllium sensitized (two abnormal tests) or who have suspicious lung pathology on chest x-ray examination. Retesting is offered once every three years to former employees who are found to have normal test results. In addition, retesting is offered every year to former employees who have a single abnormal blood test for sensitization to beryllium that was not confirmed by the second test or whom 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.
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.
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.
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.
"Infrared Thermography to Detect Intentional Deception"
Principal Investigator: Dr. G. R. Eisele, Oak Ridge Institute for Science and Education
Project started in: 2000
This project ended in fiscal year 2002.
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Identifier or number: 105
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Oak Ridge Institute for Science and Education
Most recent approval: 04/23/02
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 2002
Type(s) of Human Subjects Involvement:
The purpose of this study done by the Center for Human Reliability Studies at ORISE is to assess the utility of infrared (IR) thermography to provide a non-intrusive adjunct to the polygraph for determining trustworthiness and reliability of personnel with security access authorizations.
The complete study consists of three phases. Phase I and Phase II are part of the current study. Objectives include the following:
-Phase I establishes the baseline for human IR thermal responses
-Phase II determines characteristics of IR responses in simulated interviews involving deception
-Phase III (to be detailed, proposed, and performed at a later time) will demonstrate the effectiveness of IR thermography as an adjunct to the polygraph under actual field operating conditions.
Cost effectiveness is an important consideration in this project. For this reason, a teaming arrangement was formed with the Oak Ridge National Laboratory to provide the IR imaging system, thus incurring no up-front equipment procurement costs. An advantage of the system is that test subjects can be observed and IR images displayed and recorded in real-time as data collection proceeds. Study participants are volunteers (with informed consent) recruited from the local community, including students from local colleges, the regional medical center, and general population. There are no known risks of any harmful exposure, since this is strictly a passive thermal system. Participant privacy and confidentiality were preserved with use of approved informed consent forms, one for Phase I and one for Phase II testing.
Details of the test protocols for Phase I and Phase II were different and are reflected in the individual consent forms. In both phases, however, individual participants were asked to provide data under similar circumstances that involved sitting in front of IR camera equipment and having their IR images recorded for analysis. The difference in Phase II involved the introduction of deception in questions. Data in Phase I were obtained under neutral conditions.
The study yielded a body of data that was analyzed using appropriate statistical techniques. Phase II test work was completed in FY 2001, data were analyzed, and the project report is in final stages of preparation.
For continuation of this project, there are two amendments: 00-105a and 00-105b. The first is to develop a device to monitor heart rates and the other is to perform extended research in thermography, both for enhanced deception detection.
Original protocol completed. Amendment (00)-105a never funded. Amendment (00)105b will not be started until FY2003.
"Update of a Mortality Study of Titanium Dioxide Workers"
Principal Investigator: Dr. Elizabeth D. Elllis, 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: 12/01/01
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 4206
Reporting period for number of human subjects:
Fiscal Year 2002
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. However, consideration is being given to expanding the scope to include 2 additional worker cohorts and to include a hazards assessment as part of the analysis. The major components of the update will be computerization of data from the original study; vital status ascertainment using national databases; death certificate retrieval and cause of death information retrieval using the states' vital records offices and the National Death Index; and comparison of the mortality among the workers to the US general population. 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.
"Measurements of DU in Gulf War Veterans"
Principal Investigator: Dr. Richard E. Toohey, Oak Ridge Institute for Science and Education
Project started in: 2001
This project ended in fiscal year 2002.
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: 11/08/01
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 2002
Type(s) of Human Subjects Involvement:
The objective of this study was to determine if field-portable gamma-ray spectrometers used by REAC/TS for measurements of radioactive materials in radiation accident victims can quantify the activity of depleted uranium (DU) fragments embedded in the extremity tissues of Gulf War veterans.
Field-portable gamma-ray spectrometers were placed over the locations of known DU shrapnel deposits in four selected veterans of the Gulf war who were wounded by DU munitions in "friendly fire" incidents. Each measurement lasted approximately 30 minutes. The sensitivity of the method was determined and compared with results obtained on the same subjects at the Boston VAMC; similar results were obtained. No additional subject recruitment occurred in FY 2002.
Participants are selected by the Follow-up and Monitoring Program at the University of Maryland, and participation is completely voluntary. Participation and consent forms for both the University of Maryland program and the Oak Ridge Institute for Science and Education are used. Subjects will be identified only by a participant number assigned by VAMC, and the PI will not have access to the key. Records generated will contain no personal identifiers and will be stored under lock and key with ORISE WBC records. The signed consent form will be retained with the patient records at Baltimore VAMC.
"Testing of Environmental Health Calendar"
Principal Investigator: Dr. Richard R. Tardif, Oak Ridge Institute for Science and Education
Project started in: 2001
This project ended in fiscal year 2002.
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: 09/13/01
Explanation of IRB approval:
project completed within approved period
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 20
Reporting period for number of human subjects:
Fiscal Year 2002
Type(s) of Human Subjects Involvement:
Oak Ridge Institution for Science and Education (ORISE) provides technical assistance in health communication to the Agency for Toxic Substances and Disease Registry (ATSDR). ORISE is working with ATSDR to test the draft version of a calendar that is to provide information to parents on various environmental health issues. Data is to be collected by means of focus groups. 8-10 people will be selected as being the target audience and will be gathered at a facility. A moderator will lead a discussion based on a series of questions designed to prompt discussion of the subject of interest.
ORISE will maintain no identifiers connecting any data collected to any particular participant, neither will it provide any personal identifiers to ATSDR. Firms that conduct recruiting and host the sessions will be required to assign a random digital code to each participant's information and keep the key to the code. Informed consent will be obtained from all focus group participants.
The educational material was tested according to the protocol. Data collection and analysis was completed, and a report was delivered to ATSDR. Project complete.
"National Digital Mammography Archive (NDMA), Phase II"
Principal Investigator: Ms. Barbara G. Beckerman, BWXT
Project started in: 2001
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: 01/16/02
IRB approval number: BWXT(01)-2
Explanation of IRB approval:
A progress report and update was provided to the IRB and approved on January 16, 2002, and was approved, effective for one year beginning December 1, 2001 and lasting until November 30, 2002. Additional information regarding consent forms at the participating institutions was also provided to the IRB. This did not effect the original approval.
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 60
Reporting period for number of human subjects:
Fiscal Year 2002
Type(s) of Human Subjects Involvement:
This is an R&D project to develop and implement an integrated scalable testbed of a system that can be used as a national breast imaging archive and network infrastructure to support telemammography using Next Generation Internet technologies. There are four participating clinical centers participating in this research. All patients will have their imaging performed and digitized at the institution at which they are seeking clinical care. Each site will be responsible for consenting their own patients to participate. Images and data will be encrypted when transmitted over high-speed virtual private networks (VPNs), to ensure security to and from an archive that is being developed and maintained at the University of Pennsylvania.
Adequate security is critical to maintain patient confidentiality and the integrity of records. The combination of security layers will secure data from the local site to the archive. Although patient consent will not be required for clinical operation of the archive, patient consent will be obtained prospectively from patients contributing data to the testbed project.
"Utility of the SASSI Instrument for Identifying Possible Alcohol Abuse Among DOE Workers"
Principal Investigator: Dr. Gerhard R. Eisele, Oak Ridge Institute for Science and Education
Project started in: 2002
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Identifier or number: 112
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Oak Ridge Institute for Science and Education
Most recent approval: 04/04/02
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 295
Reporting period for number of human subjects:
Fiscal Year 2002
Type(s) of Human Subjects Involvement:
The objective of this research is to evaluate the effectiveness and utility of a leading self-administered screening questionnaire (SASSI-3)in the Department of Energy (DOE)Office of Health Programs to detect possible alcohol abuse or dependence in employees.
Participant involvement will be strictly voluntary. Participants will complete an anonymous, 15-minute, self-administered, written SASSI questionnaire. No personal identifiers will be affixed to the questionnaire; participants will place the completed questionnaire in a blank envelope and placed in a box. Participants will be asked to provide only gender and generic age grouping data by ten-year increments. If an individual would like to receive his or her test results, he or she will place a pseudo alphanumeric identifier on the front of the completed questionnaire. The pseudo alphanumeric numbers will be generated by computer algorithm using stickers to avoid any duplication.
Participants will be recruited at a DOE site at a location commonly frequented by employees, such as the on-site cafeteria. A $5 compensation will be provided to participants.
There is no risks or discomforts involved in this study. Participation is strictly voluntary. Privacy and confidentiality are assured as no identifying information will be collected.
"Validation of the NNSA Computer-Based Clearance Process"
Principal Investigator: Dr. Gerhard R. Eisele, Oak Ridge Institute for Science and Education
Project started in: 2002
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: 04/04/02
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:
The objectives of the study are to assess the effectiveness of the interim access authorization process via the Computer Based Clearance Process (CBCP), validate the accuracy of the interactive CBCP cases examined by Albuquerque Operations Office, and determine the average number of days saved by using the computerized process versus the standard process.
This is a pilot study that would allow participants to receive an interim Q access authorization to begin work activities while being processed for a final Q access authorization. ALO personnel will abstract the data. Pseudo-identification numbers will be used.
Although the hardcopy case records will contain personal identifiers, these records will be handled on site in an ALO secure facility with utmost care to ensure confidentiality for all study subjects. All records will be stored in a secured, locked area and available only with limited access. Upon completion of the study, the document that matches the pseudo-identifiers with individual identifiers will be shredded and copies of the information will be destroyed by shredding.
"Message Based Intervention for Technology Transfer"
Principal Investigator: Dr. Richard R. Tardif, Oak Ridge Institute for Science and Education
Project started in: 2002
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: 12/01/01
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 550
Reporting period for number of human subjects:
Fiscal Year 2002
Type(s) of Human Subjects Involvement:
The goal of this project is to increase the self-reported use of NIOSH developed analytical methods for field portable exposure assessment by American industrial hygienists.
The NIOSH Health Communication Research Branch (HCRB) will develop a survey and provide it to ORISE and provide a list of 360 names and telephone numbers for recipients indicating 180 recipients who will receive information from NIOSH prior to survey participation, and analyze the data collected by ORISE. The survey application is web-based and installed on the ORISE intraweb survey. The interviewer will bring up a blank survey form on his or her computer, enter the corresponding identification number assigned by ORISE, and enter responses as they are conducting the telephone survey.
Data transferred to NCRB will contain neither the respondent's name or identification number. After HCRB has completed analysis of the data transferred to them, ORISE will destroy all recipients' identifying numbers in the telephone logs.
Most recent phase of data collection completed and data delivered. Additional data collection is planned for March 2003.
"Qualitative Research - Health and Safety Information Needs in Small Business"
Principal Investigator: Dr. Virginia Sublet, Oak Ridge Institute for Science and Education
Project started in: 2002
This project ended in fiscal year 2002.
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: 03/07/02
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 16
Reporting period for number of human subjects:
Fiscal Year 2002
Type(s) of Human Subjects Involvement:
The purpose of the study is to determine information needs and preferred media formats of small business owners with regard to safety and health information, especially information on hearing loss prevention programs and noise control.
Data will be collected by means of focus groups. A professional marketing research group will be employed by ORISE to select 8-10 participants for each of two focus groups, host two focus group meetings, and award minimal incentives to participants. ORISE will not receive personal information about the participants, nor will participants be asked to complete any written responses.
An ORISE focus group moderator will lead discussions based on a series of questions designed to determine information needs and preferred media formats, and gather information on the types of resources the participants currently use. The focus groups will be audio taped; no names or identifiers are used in the report.
Although a consent form and confidentiality statement will be retained by ORISE, there will be no key provided to ORISE that links the participant and the data collected. Confidentiality statements and audiotapes will be kept in a secure area until they are destroyed after the release of the final report.
This study has been completed and a report delivered to the sponsor.
"Formative Research: Bioterriorism Preparedness"
Principal Investigator: Dr. Richard R. Tardif, Oak Ridge Institute for Science and Education
Project started in: 2002
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: 04/17/02
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 20
Reporting period for number of human subjects:
Fiscal Year 2002
Type(s) of Human Subjects Involvement:
The National Immunization Program of the Centers for Disease Control and Prevention (NIP) strives to prevent and control vaccine-preventable diseases through technical assistance to health departments, research, and other activities. This effort addresses preparedness for response to the use of smallpox as a weapon of terror.
The Oak Ridge Institute for Science and Education (ORISE) will provide technical assistance to NIP. The design, conduct, analysis, and reporting of research are a portion of that assistance.
The target audiences will be the "general public" and physicians. Data are to be collected by means of focus groups of 8-9 people who are selected according to criteria described in the protocol. A moderator will lead a discussion based on a series of questions.
The data from the physician group will be collected through individual interviews, and interviews will be audio taped.
ORISE will maintain no identifiers connecting any data collected to any particular participant, nor provide personal identifiers to NIP or others. Firms that conduct recruiting and host the sessions will be required to not provide personal identifiers to ORISE or NIP.
"National Immunization Program (NIP) Parent-Decision Model"
Principal Investigator: Dr. Richard R. Tardif, Oak Ridge Institute for Science and Education
Project started in: 2002
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: 06/24/02
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 2002
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 is to be collected by means of telephone interviews. Participants for these interviews will be first time parents of children under the age of 2 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.
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.
"Racial and Ethnic Adult Immunization Issues"
Principal Investigator: Dr. Richard R. Tardif, Oak Ridge Institute for Science and Education
Project started in: 2002
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: 08/08/02
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 160
Reporting period for number of human subjects:
Fiscal Year 2002
Type(s) of Human Subjects Involvement:
One of the public health issues of current interest in the United States is that of health disparities among various racial/ethnic groups. More specifically, Hispanic-Americans and African-Americans typically obtain flu shots at lower rates than European-Americans. Earlier research by the National Immunization Program (NIP) examined the reasons why people, including Hispanic-Americans and African-Americans chose not to be immunized against influenza and pneumonia. NIP now wishes to conduct research to evaluate the newly-developed materials with these selected consumers.
The target audience will be Hispanic-Americans and African-Americans 65 years of age and older, and physicians who serve these populations.
Data are to be collected by means of focus groups. A person of African-American descent will moderate the groups of African-Americans. Sessions with Hispanic-Americans will be conducted in Spanish, and a translator will be available to perform simultaneous translation from Spanish to English. Audiotapes will be produced of both the original Spanish discussion and the English translation.
Data obtained from the physicians will be collected through individual interviews.
ORAU will not provide any personal identifiers to NIP or others; firms that conduct recruiting and host the sessions will be required to not provide personal identifiers to ORISE or NIP. ORAU will retain the Informed Consent Forms, one set of audiotapes, and at least one copy of any report produced; individual identities will be safeguarded. ORAU will deliver the report and one set of audiotapes to NIP. ORAU will not deliver to NIP any personal identifiers of participants.