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: 27
| 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-ORAU-00-108 | "Update of a Mortality Study of Titanium Dioxide Workers" |
| 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 Project of the Computer-Based Clearance Process" |
| ORAU-02-114 | "Message Based Intervention for Technology Transfer" |
| ORAU-02-116 | "Formative Research: Bioterriorism Preparedness" |
| ORAU-02-117 | "National Immunization Program (NIP) Parent-Decision Model" |
| ORAU-03-118 | "Racial and Ethnic Adult Immunization Issues" |
| ORAU-03-119 | "CDC National Immunization Program (NIP) Web Site Utilization Study" |
| ORAU-03-120 | "NIOSH Dose Reconstruction" |
| ORAU-03-121 | "Evaluation of Fingertip Thermal Sensors in Thermography Research Project" |
| ORAU-03-122 | "Formative Research: Smallpox Immunization for Medical Personnel" |
| ORAU-03-123 | "Audience Need and Preference Study" |
| ORAU-03-124 | "Consumer Health Resource Information Service (CHRIS) Project: Health Questionnaire" |
| ORAU-03-125 | "Minority Perceptions of Public Health Issues in Indiana" |
| ORAU-03-PANTEX 1 | "Former Pantex Worker Medical Surveillance Program" |
"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: 11/14/02
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: 06/01/02 to 05/31/03
Explanation:
US FDA Reporting Year
Type(s) of Human Subjects Involvement:
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.
One case involving use of DTPA is recorded on the Radiation Emergency Assistance Center/Training Site (REAC/TS) registry for this reporting time period. One subject had Am-241 inhalation exposure at work. Upon discovery of internal contamination and explanation of chelation options and effectiveness, the subject chose chelation therapy with Ca-DTPA and Zn-DTPA. After completing the standard consent form, the subject received one dose of Ca-DTPA and 10 doses of Zn-DTPA over a three-month period at his private physician's office in his home town/state. The physician was made co-investigator. No abnormal effects or complications were noted during or after the total dose regimen. More doses are planned in the next reporting period, based on the results of biodosimetry.
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.
Investigational new drug (IND) 4041, trisodium calcium diethylenetriaminepentaacetate (Ca-DTPA), and IND 14603, trisodium zinc diethylenetriaminepentaacetate (Zn-DTPA), are new drug applications which are administered by Oak Ridge Associated Universities under contract with the U.S. Department of Energy. No new supplies of DTPA 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. 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-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.
No serious toxicity in human subjects has been reported as a result of 638 separate patients administered DTPA (either intravenously by slow IV push, by IM, or by nebulizer) in recommended doses (for a total of 4,679 separate doses; current through reporting period). 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.
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Oak Ridge Institute for Science and Education
Most recent approval: 11/14/02
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 2003
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 FY 2003, three radiation accidents were report to REAC/TS, one from exposure to Fl-18, one from exposure to Am-241 and one from I-131. In the case of the Fl-18 exposure, symptoms and physical findings were mild/localized peripheral burns which resolved in typical manner of radiation burns. The findings from the I-131 exposure were marginal; however, the exposure may cause delayed organ damage and be associated with the stochastic risk of cancer; such results are likely to occur over a multi-year period and are unlikely to be obtained by the registry. The findings from the Am-141 exposure were marginal for deterministic symptoms and signs, but biomonitoring revealed a definite subclinical exposure with possible stochastic risks. Patient was treated with 11 doses of diethylenetriaminepentaacetate (DTPA) for the Am-141 exposure in this reporting period and further treatment in the next reporting period is likely, based on the results of ongoing biomonitoring.
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-US 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: 11/14/02
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 38
Reporting period for number of human subjects:
Fiscal Year 2003
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. Consent form 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.
"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: 11/14/02
IRB approval number: 60
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 14645
Reporting period for number of human subjects:
Fiscal Year 2003
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: 11/14/02
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: 06/01/02 to 05/31/03
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 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.
No new supplies of DTPA 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.
One case involving use of DTPA is recorded on the Radiation Emergency Assistance Center/Training Site (REAC/TS) Registry for the time period. The subject had an Am-241 inhalation exposure at work. Upon discovery of internal contamination and explanation of chelation options and effectiveness, the subject chose chelation therapy with Ca-DTPA and Zn-DTPA. After completing the standard consent form, the subject received one dose of Ca-DTPA and 10 doses of Zn-DTPA over a three-month period at his private physician's office in his home town/state. Physician was made co-investigator No abnormal effects or complications noted during or after the total dose regimen. More doses are planned in the next reporting period, depending on the results of biodosimetry.
In the reporting period, June 1, 2002, to May 31, 2003, one patient received DTPA for a total of 11 doses, including one dose of Ca-DTPA and 10 doses of Zn-DTPA. Additional treatment is likely in the next reporting period, based on the dosimetry findings.
The status of the REAC/TS DTPA Registry through June 2001 shows 38 active co-investigators throughout the country. Since the beginning of the Registry, 638 patients have received 4,679 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: 11/14/02
IRB approval number: 60a
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 908
Reporting period for number of human subjects:
Fiscal Year 2003
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: 11/14/02
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: 06/01/02 to 05/31/03
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.
Interestingly, the most recent use of Prussian Blue has been in medical treatment of intentional poisoning with thallium. In the current reporting period (6/1/02-5/31/03) there have been three cases of 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. Additionally, in the last three years prior to the current reporting period, DOE has also made Prussian Blue available to three patients in the U.S. with severe thallium poisoning and one patient with chronic and severe thallium poisoning. 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 faeces. 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. A shipment of Prussian Blue is expected early in the next reporting period.
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, and 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 ORAU's 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: 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: 11/14/02
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 2003
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.
"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: 11/14/02
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 190
Reporting period for number of human subjects:
Fiscal Year 2003
Type(s) of Human Subjects Involvement:
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 their own 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: 11/14/02
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 78491
Reporting period for number of human subjects:
Fiscal Year 2003
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: 11/14/02
IRB approval number: ORAU(99)-87a
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 1725
Reporting period for number of human subjects:
Fiscal Year 2003
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). 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. 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: 11/14/02
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 2003
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 currently in the process of being expanded to include two 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 U.S. 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.
"National Digital Mammography Archive (NDMA), Phase II"
Principal Investigator: Ms. Barbara G. Beckerman, BWXT
Project started in: 2001
This project ended in fiscal year 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: Oak Ridge Institute for Science and Education
Most recent approval: 11/14/02
IRB approval number: BWXT(01)-2
Explanation of IRB approval:
A progress report and update was provided to the IRB and approved on November 14, 2002 and was approved, effective for one year beginning and ending November 11, 2003. 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: 270
Reporting period for number of human subjects:
Fiscal Year 2003
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 digital imaging performed 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, because the data are being shared across the healthcare enterprise in the course of testing and development.
"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
This project ended in fiscal year 2003.
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: 11/14/02
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 642
Reporting period for number of human subjects:
Fiscal Year 2003
Type(s) of Human Subjects Involvement:
The objective of this research was 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 was strictly voluntary. Participants completed an anonymous, 15-minute, self-administered, written SASSI questionnaire. No personal identifiers were affixed to the questionnaire; participants placed the completed questionnaire in a blank envelope and placed it in a box. Participants were asked to provide only gender and generic age grouping data by ten-year increments. The pseudo alphanumeric numbers were generated by a computer algorithm and affixed using stickers to avoid any duplication.
Participants were recruited at two DOE sites at a location commonly frequented by employees, such as the on-site cafeteria. A $5 compensation was provided to participants.
There were no risks or discomforts involved in this study. Participation was strictly voluntary. Privacy and confidentiality were assured as no identifying information was collected.
"Validation of the NNSA Project of the Computer-Based Clearance Process"
Principal Investigator: Dr. Gerhard R. Eisele, Oak Ridge Institute for Science and Education
Project started in: 2002
This project ended in fiscal year 2003.
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Identifier or number: 113
Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Oak Ridge Institute for Science and Education
Most recent approval: 11/14/02
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 195
Reporting period for number of human subjects:
Fiscal Year 2003
Type(s) of Human Subjects Involvement:
The objectives of the study were 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 the DOE Albuquerque Operations Office (ALO), and determine the average number of days saved by using the computerized process versus the standard process.
This was a pilot study that would allow participants to receive an interim DOE "Q" access authorization to begin work activities while being processed for a final Q access authorization. ALO personnel abstracted the data. Pseudo-identification numbers were used.
Although the hardcopy case records contained personal identifiers, these records were handled on site in an ALO secure facility with utmost care to ensure confidentiality for all study subjects. All records were 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 was shredded and copies of the information were 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
This project ended in fiscal year 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: Expedited
Approving Institution: Oak Ridge Institute for Science and Education
Most recent approval: 11/14/02
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 2003
Type(s) of Human Subjects Involvement:
The goal of this project was to increase the self-reported use of National Institute for Occupational Safety and Health (NIOSH) developed analytical methods for field portable exposure assessment by American industrial hygienists.
The NIOSH Health Communication Research Branch (HCRB) developed a survey and provided it to ORISE and provided a list of 360 names and telephone numbers for recipients indicating 180 recipients who had received information from NIOSH prior to survey participation. The survey application was web-based and installed on the ORISE intraweb.
Data were transferred to HCRB with neither the respondent's name or identification number. After HCRB has completed analysis of the data transferred, ORISE will destroy all recipients' identifying numbers in the telephone logs.
This project was completed in FY2003.
"Formative Research: Bioterriorism Preparedness"
Principal Investigator: Dr. Richard R. Tardif, Oak Ridge Institute for Science and Education
Project started in: 2002
This project ended in fiscal year 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: Expedited
Approving Institution: Oak Ridge Institute for Science and Education
Most recent approval: 11/14/02
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 180
Reporting period for number of human subjects:
Fiscal Year 2003
Type(s) of Human Subjects Involvement:
This effort addressed preparedness for response to the use of smallpox as a weapon of terror. The target audiences were the "general public" and physicians. Data were collected by means of focus groups of eight to nine people who are selected according to criteria described in the protocol. A moderator lead a discussion based on a series of questions.
The data from the physician group was be collected through individual interviews, and interviews were audio taped. ORISE maintained no identifiers connecting any data collected to any particular participant, nor provided personal identifiers to National Immunization Program (NIP) or others. Firms that conduct recruiting and host the sessions were 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: 11/14/02
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 2003
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.
"Racial and Ethnic Adult Immunization Issues"
Principal Investigator: Dr. Richard R. Tardif, Oak Ridge Institute for Science and Education
Project started in: 2003
This project ended in fiscal year 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: Expedited
Approving Institution: Oak Ridge Institute for Science and Education
Most recent approval: 11/14/02
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 2003
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 ORAU 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. Project was completed 10/21/03.
"CDC National Immunization Program (NIP) Web Site Utilization Study"
Principal Investigator: Mr. Freddy Gray, Oak Ridge Institute for Science and Education
Project started in: 2003
This project ended in fiscal year 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: Expedited
Approving Institution: Oak Ridge Institute for Science and Education
Most recent approval: 11/14/02
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 20
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
Over the past year, the National Immunization Program (NIP) website has been redesigned. While incidental and anecdotal evidence suggests that the changes have improved the overall usability of the site, there is not a baseline for comparison. As a result, NIP requested that ORAU assist them in conducting a formal usability study of their website.
Two key goals for the proposed NIP Website Usability Study are: evaluate the functionality and usability of the existing site, and identify gaps in the site content and organizational structure.
The proposed study will examine these categories: usability, readability, legibility, experience of "user-friendliness", and engagement. The study will set a usability benchmark for the site, establishing the current performance level for the site with audeince members as they complete tasks typical for the audience segment they represent.
"NIOSH Dose Reconstruction"
Principal Investigator: Dr. Richard Toohey, Oak Ridge Institute for Science and Education
Project started in: 2003
This project ended in fiscal year 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: Oak Ridge Institute for Science and Education
Most recent approval: 02/26/03
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 2003
Type(s) of Human Subjects Involvement:
This project develops radiation dose reconstructions for claimants under the Energy Employees Occupational Illness Compensation Program Act. Personally identifiable data include exposure, employment, and medical data, as well as a telphone interview. Originally it was thought that the use of one claimant's data to assist in developing dose reconstructions for other claimants who were co-workers constituted research, and so the project was submitted for IRB review. Subsequent discussion with the sponsor, National Institute for Occupational Safety and Health (NIOSH), led to the conclusion that this use of data does not constitute research, and subsequent review by the Oak Ridge Site-wide IRB has determined that this project is exempt. Consequently, no further reporting will be made and the project will be considered closed in terms of human subjects participation.
"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
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: 12/13/02
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 2003
Type(s) of Human Subjects Involvement:
The objective of this research is 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 will be affixed passively to the fingertips arranged in a hand-outline template. The sensor equipment is 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) will be recruited to participate in this study and go through an informed consenting process. Data will be collected from each subject who will be asked two series of ten questions regarding a clandestine item in his/her possession. Moderate compensation will be offered for participation. Test data will be organized using fictitious code numbers and will not be personnally identifiable in any way at any stage of the study.
"Formative Research: Smallpox Immunization for Medical Personnel"
Principal Investigator: Dr. Richard Tardif , Oak Ridge Institute for Science and Education
Project started in: 2003
This project ended in fiscal year 2003.
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Identifier or number: 122
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: Oak Ridge Institute for Science and Education
Most recent approval: 12/04/02
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 89
Reporting period for number of human subjects:
Fiscal Year 2003
Type(s) of Human Subjects Involvement:
This research focused on testing information materials, as well as identifying knowledge, attitudes, and beliefs that would facilitate or hinder recruitment for smallpox immunization among those for whom it is recommended. The information was provded to the states and territories to assist them in implementing a national program.
The Oak Ridge Institute for Science and Education (ORISE) provided technical assistance to the National Immunization Program (NIP) in this effort. The design, conduct, analysis, and reporting of research form a portion of that assistance.
Project completed January 2004; final report provided to IRB.
"Audience Need and Preference Study"
Principal Investigator: Ms. Deborah McFalls, Oak Ridge Institute for Science and Education
Project started in: 2003
This project ended in fiscal year 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: Expedited
Approving Institution: Oak Ridge Institute for Science and Education
Most recent approval: 04/08/03
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 230
Reporting period for number of human subjects:
Fiscal Year 2003
Type(s) of Human Subjects Involvement:
Processed a survey for the Centers for Disease Control and Prevention and the National Institute for Occupational Safety and Health (CDC/NIOSH) with 320 students in six schools in the Anderson County School System in East Tennessee. The focus of the survey was on collecting information that will assist NIOSH researchers in the development of an Internet site containing workplace safety information for young people. This project was completed in FY 2003.
"Consumer Health Resource Information Service (CHRIS) Project: Health Questionnaire"
Principal Investigator: Ms. Rose Durham, 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.
Identifier or number: ORAU-03-124
Institutional Review Board (IRB) Review:
Type of Review: Expedited
Approving Institution: Oak Ridge Institute for Science and Education
Most recent approval: 05/30/03
IRB approval number: ORAU(03)-124
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 346
Reporting period for number of human subjects:
Fiscal Year 2003
Type(s) of Human Subjects Involvement:
The Consumer Health Resource Information Service (CHRIS) Project is a faith-based pilot program designed by the Medical Education and Outreach group (MEO) of Oak Ridge Associated Universities (ORAU), Oak Ridge, Tennessee. The mission of the project is to assist national efforts with addressing minority health disparities. Its purpose is to address minority health disparities through community level health intervention and prevention measures in six predominately African-American churches in the inner city of Knoxville, Tennessee. The project is consistent with the overall objective of Healthy People 2010, which strives to reduce or eliminate health disparities among minorities. The project’s design includes intervention and prevention health strategies such as information dissemination, health education, health assessments, and health screenings conducted by parish nurses at each of the participating churches.
I. Objectives:
One objective of the CHRIS Project is to conduct a congregational health assessment to study the current and imminent health status of at least 300 adult members, ages 18 and above (50 members from each of the six project churches). The Tennessee Office of Minority Health in conjunction with the Medical Education and Outreach group has designed a 15-page health questionnaire that will be used in the study. The study will be completely voluntary and will address socioeconomic information, lifestyles, medical history, minority health disparities, and leading health indicators. Information obtained from the study will be used in a collective fashion and will not personally identify any participating member. Data collected will be used to determine, design, and/or implement services that will further address minority health disparities and or/foster healthier lifestyles among the constituency. The study will be conducted at or about the same time at the six project churches. The study date is tentatively scheduled for May-June 2003. In the event that additional churches are added to the project in the future, the study will be conducted at those churches as well.
II. Methods of Procedure:
The instrument designed for the study is a 17-page Health Questionnaire that contains 50 close-ended questions (see Attachment). The questionnaire will either be self-administered or participants will be assisted by the parish nurses and/or volunteers, depending on participants’ reading and comprehension skills. If someone does need assistance, the parish nurse or a volunteer will read the questions to the participant and record his or her responses. Participants will be given every opportunity to complete the questionnaire on their own and will not be approached by the parish nurse and/or volunteer unless specifically requested. Participation in this health assessment is completely voluntary and strictly confidential. All information will be used in a collective fashion and no participant will be personally identified. Anticipated response time for completing the survey is an average of 20 minutes or less.
The questionnaires will be distributed and collected by the parish nurses and volunteers to members after Sunday morning services and after Wednesday night bible study class during the months of May and June 2003. In each session:
• Parish nurses will provide brief orientation and instructions for completing the Health Questionnaire.
• Participants will be informed that participation is completely voluntarily, and no information will be used for individual identification.
• Participants will be instructed to not answer questions that may be deemed uncomfortable, and they may end the process at any time.
• Parish nurses and volunteers will distribute the questionnaires and retreat to an area in the room away from the participants.
• Parish nurses and volunteers will only assist participants when asked.
• Participants will be instructed to enclose the completed questionnaire in an envelope provided, seal the envelope, and place the sealed envelope on a table near the front of the room.
• Parish nurses will collect the sealed envelopes and deliver the envelopes to the principal investigator.
The anticipated timeframe for data analysis is three to six months. The assistant principal investigator will report findings to the Medical Education and Outreach group and the Tennessee Office of Minority Health, and will work closely with the principal investigator to ensure efficacy of the overall process. Quantitative data from the study will be shared with local health care providers, collaborative partners, church members, and other interested parties. Outcome results will also be used to substantiate the need for programs and services when soliciting funding and grant awards.
III. Possible Hazards and their Evaluation: No possible hazards exist.
IV: Radioisotopes and New Drugs/Devices: None.
V. Institutional Review and Approval: Attached.
"Minority Perceptions of Public Health Issues in Indiana"
Principal Investigator: Dr. Richard Tardif, Oak Ridge Institute for Science and Education
Project started in: 2003
This project ended in fiscal year 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: Expedited
Approving Institution: Oak Ridge Institute for Science and Education
Most recent approval: 06/12/03
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 240
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
The Indiana State Department of Health (ISDH) commissioned ORISE to obtain information regarding public health communication issues for African-, Asian-, and Latino-Americans in the state. The objectives were to determine the level of concern about bioterrorism and other public health threats, determine how minority residents of Indiana receive health information, determine how they prefer to receive information, and determine the level of trust in the ISDH as a reliable and credible source of information.
Project completed in August 2003.
"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: Oak Ridge Institute for Science and Education
Most recent approval: 05/09/03
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 0
Reporting period for number of human subjects:
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.