Ms. Brenna M. Smith
EOHSI
170 Frelinghuysen Road
Piscataway, NJ 08854
Phone: 732-445-0120
Fax: 732-445-0959
Email: brensm@eohsi.rutgers.edu
Projects are approved by an IRB located at: Univ. of Wash., Univ. of Med. & Dent of NJ, & Rutgers Univ.
The approving IRB operates under a Multiple Project Assurance (MPA) recognized by DOE or by the Department of Health and Human Services (HHS).
MPA number of the IRB: M1183, M1467, M1370
Number of Human Subjects Projects reported: 8
Project Identifier: CRESP-95-E96-108
Project Title:
Use of Ecological Resources at DOE Sites
Principal Investigator:
Dr. Joanna Burger
Principal Investigator's Institution: Rutgers University
Project started in: 1995
Project Funding Information:
Project received funding in Fiscal Year 1998.
Project used human subjects in Fiscal Year 1998.
Funding Sources:
Total Funding: $200,000
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Expedited
Most Recent Approval: October 09, 1997
IRB Approval Number: E96-108
Number of Human Subjects who participated in this project/protocol during
FY 1998 (10/1/97 - 9/30/98): 800
Type of Human Subjects Involvement:
DOE has a number of sites in 34 states, and many of these are important ecologically. Some of the larger sites contain some of the only remaining pristine habitats in their regions, and house endangered species as well as other critical resources. The overall objective of this research is to evaluate how people view and use ecological resources on DOE sites, and to evaluate how these views affect future land use preferences.
Our overall methodology is to interview subjects who use the sites, or reside in the general region. We interviewed sportsmen who actually used the sites (hunters, fishermen), local people who might use the sites, and regional people who might use the site or have interest in the activities on the site. Major activities of interest were recreational.
Interviews are conducted in person, but there are no individual identifiers associated with the interviews. The questionnaire instrument has been field tested, and contains a number of sections dealing with demographics (age, sex, ethnicity, income), views on environmental problems, days devoted to different recreational activities (hunting, fishing, camping, hiking), future land use preferences, and consumption information.
During the interviewing we did not ask for names of the individuals to protect the subjects, they were informed of our overall objectives, and we did not take any biological material from any subjects. In all cases, we asked people if we could interview them. There were no risks associated with our interviews.
Project Identifier: CRESP-96-058M
Project Title:
The Examination of Peripheral Blood Lymphocyte Proteins as Predictors of Risk
Principal Investigator:
Dr. Edward Yurkow
Principal Investigator's Institution: Rutgers University
Project started in: 1996
Project Funding Information:
Project received funding in Fiscal Year 1998.
Project used human subjects in Fiscal Year 1998.
Funding Sources:
Total Funding: $10,000
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: October 07, 1997
IRB Approval Number: 97-058M
Number of Human Subjects who participated in this project/protocol during
10/07/96 - 10/07/97: 11
Type of Human Subjects Involvement:
Objectives:
1) To develop an in vitro laboratory-based test that will be used to determine the exposure of individuals to environmental agents;
2) To develop an in vitro laboratory-based test that will be used to determine the sensitivity of individuals to environmental agents.
Methodology:
The peripheral blood of human subjects will be cultured in the laboratory with and without treatment with selected chemical agents. Following a 48h incubation period, the cells will be analyzed for specific cellular proteins that reflect the response of the cell to the chemical. The basal and treatment-induced levels of these proteins will reflect the exposure and/or responsiveness of the individuals to various types of environmental stress. The findings will contribute to our understanding of the response of individuals to environmental stress and their sensitivity to environmentally-induced diseases. These studies will also contribute to the design of risk assessment projects.
Ionizing Radiation, Radioactive Substances and Chemical Agents:
Human subjects are healthy men and women between the ages of 20 and 30 who have no known history of exposure to any chemical, radioactive substance or ionizing radiation.
Involvement of Human Subjects:
Ten milliliters of blood is drawn from each human subject by a trained phlebotomist. The subject may experience a slight pin-prick sensation during sample acquisition. Each subject reads and signs a consent form and the information is totally confidential.
Project Identifier: CRESP-96-27-0009-E
Project Title:
Laboratory Evaluation of Field Collected Cells
Principal Investigator:
Dr. Timothy K. Takaro
Principal Investigator's Institution: University of Washington
Project started in: 1996
This project ended in Fiscal Year 1998.
Project Funding Information:
Project received funding in Fiscal Year 1998.
Project did not use human subjects in Fiscal Year 1998.
Explanation:
Samples were collected from subjects in previous years; this year involved sample analysis only
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
Protocol/Subproject Identifier: 27-0009-E
IRB Review:
Type of Review: Full Board
Most Recent Approval: September 04, 1998
IRB Approval Number: 280249E
Number of Human Subjects who participated in this project/protocol during
10/01/97 - 09/30/98: 0
Samples were collected during FY97 and analyzed in FY98
Type of Human Subjects Involvement:
Heat stress is a significant exposure for remediation workers at hazardous waste sites. This study will determine if mRNA heat shock proteins up-regulate in heat-stressed Hanford remediation workers, and if this biomarker can be used to assess risk from such an exposure.
Uroepitheleal cells are harvested from routine urine collections at the Hanford site, and the mRNA activity is analyzed in the laboratory at the University of Washington. The subjects are workers at the Hanford Nuclear Reservations tank farms that were recruited for this study on heat stress. The tank farms at Hanford are located along the Columbia River and often experience summer temperatures above 90 degrees Fahrenheit. Because of the extremely hazardous contents of the tanks, and the poor characterization of their contents, fully self-contained occlusive suits are often worn by workers in this area.
Methods
Voided urine samples are collected before and after the work shift. Following the measurement of specific gravity and the pH, the sample is centrifuged, and the cell pellet is collected and resuspended in a solution containing RNAse inhibitors. The resuspended cells are then frozen on dry ice, and are transported to the laboratory. Commercially available cDNA stress response gene probes are used to characterize the induction of the stress response in uroepithelial cells. The probes include genes coding for the heat stress proteins of the Hsc70 family, and more general stress response genes, such as, thiol glutathione, Gadd43, Gadd153 and p21(Waf1). Because there is a wide variation in the species and quantity of mRNA induction depending upon the cell type, this study aims to identify the stress genes that are most responsive in the transitional uroepithelieal cells harvested in a routinely voided urine sample.
The only samples obtained from the subjects are routine voided spot urine samples collected in privacy. University of Washington investigators will not know the identity of the subjects at any time. Data are identified by a number with the consent form, which is the only document having both a name and number. A member of a cooperating research group from Michigan State University will maintain the identification information.
Adverse effects are not anticipated as subjects will only provide investigators with a urine specimen.
Due to difficulties in recruiting subjects during summer 1998, no additional progress has been made since last year's renewal (9/97).
Project Identifier: CRESP-96-E97-026
Project Title:
CRESP-SLUDGE Surveys and Interviews
Principal Investigator:
Dr. Michael Greenberg
Principal Investigator's Institution: Rutgers University
Project started in: 1996
Project Funding Information:
Project received funding in Fiscal Year 1998.
Project used human subjects in Fiscal Year 1998.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Expedited
Most Recent Approval: March 01, 1997
IRB Approval Number: E97-026
Number of Human Subjects who participated in this project/protocol during
FY 1998 (10/1/97 - 9/30/98): 210
Type of Human Subjects Involvement:
Surveys of Local Officials in Towns with Small DOE Sites:
The objective of this part of the project is to assess the concerns and opinions of local planners, health officers, tax assessors and municipal executives about the presence of small, formerly used sites in their communities. These sites belong to the FUSRAP program (now under the direction of the Army Corps of Engineers), UMTRA program, or are weapons sites that are small in size with relatively low levels of contamination.
Where possible, these local officials were asked, either in person or by telephone, to answer a series of questions about the perceived impacts of the site on their community's health and economic well-being, and about the public participation process. Most of the question were close-ended scale questions, and a few were open-ended.
The purpose of the project was explained to all interviewees, and participation was purely voluntary. Responding officials were promised that they would not be mentioned by name in any publication of results. No information of a personal nature was asked, therefore there are no risk to the individuals who participated.
Interviews in Economically Stressed Regions:
The objective of this part of the project is to obtain the opinions of local economic development planners in regions that have been affected by the loss of a major employer or industry about the impacts of the closing on the region's economy and demography and about the process of economic recovery. The results will be used to draw lessons that could apply to regions facing the effects of the downsizing of the nuclear weapons complex.
The officials were asked a set of open-ended questions by telephone. The researcher took notes as the interview was conducted, and will aggregate the findings into several general observations.
The purpose of the project was explained to all interviewees, and participation was purely voluntary. Responding officials were promised that they would not be mentioned by name in any publication of results. No information of a personal nature was asked, therefore there are no risks to the individuals who participated.
Project Identifier: CRESP-97-041-96
Project Title:
Cohort Study of Former Employees of a Chloralkalai Plant in Brunswick, Georgia
Principal Investigator:
Dr. Howard Frumkin
Principal Investigator's Institution: Emory University, School of Public Health
Project started in: 1997
This project ended in Fiscal Year 1998.
Project Funding Information:
Project received funding in Fiscal Year 1998.
Project did not use human subjects in Fiscal Year 1998.
Explanation:
Samples were collected from subjects in previous years; this year involved sample analysis only.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
Protocol/Subproject Identifier: 041-96
IRB Review:
Type of Review: Full Board
Most Recent Approval: February 04, 1998
IRB Approval Number: 041-96
Number of Human Subjects who participated in this project/protocol during
10/01/96 - 09/30/98: 0
Samples were collected during FY '97. Samples were analyzed in FY '98.
Type of Human Subjects Involvement:
This study is a subproject of a study that was initiated at Emory University. The original project, as well as an amendment to allow this subproject, was approved by the Emory University Human Investigations Committee.
The original project investigates adverse health effects among approximately 200 former employees of a choralkalai plant in Brunswick Georgia, and 200 unexposed controls. In the plant, chlorine products were manufactured using mercury from 1956 through 1994. The toxic exposure from mercury is of primary interest. In recent years, considerable concern has arisen locally about the plant, and it was named a Superfund site in 1995. The larger study is conducted in collaboration with the Glynn County Health Department. Two new scientific questions being addressed are the role of the dimercapto succinic acid (DMSA) chelation challenge in assessing the level of exposure to mercury, and the effect of mercury on urinary porphyrin profiles. Three additional hypotheses are also being addressed, relating to the neurobehavioral, renal, and reproductive toxicity of mercury; this part of the study serves to replicate previous findings.
This subproject for which we are reporting, examines some biochemical aspects of urothelial cells collected from the urine of chloralkalai plant workers occupationally exposed to mercury. The subproject requires no additional urine than that which was supplied for the original study.
Methods
This subproject involves centrifuging the samples, decanting the supernatant, resuspending the pelleted cellular material and freezing it. The collected cells are then examined by members of the University of Washington (UW) laboratory for indications of mercury-induced changes in mRNA expression.
Human Subject Involvement
The risks to humans, as stated in the original application, are minimal and include the possibility of invasion of privacy through disclosure of medical information, the discomfort of phlebotomy and nerve conduction testing, and possible adverse effects of DMSA. The protocol describes how each of these risks will be controlled. The most serious potential risk, that of adverse reaction to DMSA, is very low in the context of only two doses of the medication. Individuals who are G-6-PD deficient, who may react adversely (based on one reported case) will not receive the medication.
This subproject does not have any personal identification information from the human subjects.
In this period, samples have been collected, minimally processed, and stored. Analysis for mercury induced gene expression changes will occur in 1998. Porphyrin analysis has been completed.
This project was discontinued as of 8/98 because laboratory analyses demonstrated background mercury levels in workers.
Project Identifier: CRESP-97-26-0807-B/C
Project Title:
Human Reproductive Endocrine Effects of Controlled Toluene Exposure
Principal Investigator:
Dr. Elaine M. Faustman
Principal Investigator's Institution: University of Washington
Project started in: 1997
This project ended in Fiscal Year 1998.
Project Funding Information:
Project received funding in Fiscal Year 1998.
Project used human subjects in Fiscal Year 1998.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
Protocol/Subproject Identifier: 26-0807-B/C
IRB Review:
Type of Review: Full Board
Most Recent Approval: August 06, 1997
IRB Approval Number: 270983-A/C
Number of Human Subjects who participated in this project/protocol during
08/06/96 - 08/06/97: 11
Type of Human Subjects Involvement:
inhalation exposure for occupational exposure research
The goal of this project is to determine whether the inhalation of volatile solvents, at levels permitted under current regulatory guidelines for occupational exposure, affects blood levels of reproductive hormones which are involved in regulating sperm production in men and egg maturation and release in women. Such hormone measurements could then potentially be used to monitor the reproductive health of exposed workers, providing an early warning of those at risk for more serious reproductive effects.
This study evaluates the effects of exposure to solvents on reproductive hormones, luteinizing hormone and follicle stimulating hormone in men and women. It requires frequent blood sampling before, during and after a 3 hour exposure to solvents by inhalation. Prior to the study, potential participants are asked to fill out a medical history questionnaire and are given a brief physical examination. On the day prior to the scheduled exposure, women of child bearing potential will provide a blood sample of 5 ml from an arm vein for a pregnancy test.
Each subject who is not pregnant will then be given two controlled exposures on separate days at least one month apart to toluene vapor in filtered air. The exposures may last two hours and are not more than the level of toluene permitted for workers on an 8 hour day, working lifetime basis (50 parts per million). At the beginning of each exposure day, a small plastic tube is inserted into a vein in the arm and will remain in place for the day. A local anesthetic, lidocaine, will be used at a dose of 0.1-0.3 ml to avoid discomfort during this procedure. During an 8 hour period, beginning before exposure and ending after the exposure, each subject will be asked to give a total of 28 blood samples (one half teaspoonful or less) from the arm vein.
The risk from chemical exposure to males and non-pregnant females is low--the exposure will be less than allowable occupational levels and will occur only twice. If a female is pregnant at the time of exposure, there is a small risk of damage to the embryo which could lead to spontaneous abortion or a birth defect. The risks associated with the catheter are encountered in any peripheral venipuncture: possible infection, irritation and inflammation of the vein and leakage of blood into the tissue surrounding the blood vessel.
Data from subjects is anonymous but coded, with the key to the coding kept in a separate locked location.
This project was started in November, 1996, and also received funding from an NIEHS Center pilot grant. Further, the investigator subsequently applied and was awarded additional funding through NIOSH (#1-R03-0H03468-01).
Project Identifier: CRESP-97-27-0228-C
Project Title:
Screening for Chronic Beryllium Disease at Hanford
Principal Investigator:
Dr. Timothy K. Takaro
Principal Investigator's Institution: University of Washington
Project started in: 1997
Project Funding Information:
Project received funding in Fiscal Year 1998.
Project used human subjects in Fiscal Year 1998.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: September 14, 1998
IRB Approval Number: 280287-C/E
Number of Human Subjects who participated in this project/protocol during
FY 1998 (10/1/97 - 9/30/98): 70
Type of Human Subjects Involvement:
To participate in the study, investigators obtain names of potential subjects from DOE. Subjects that respond are requested to provide information about work experience, exposures, smoking, and health status; and provide permission to review employment and medical records to determine the extent of beryllium exposure that they may have encountered.
Workers with prior exposure to beryllium are consented to provide 40ml of peripheral blood. The standard venous blood draw is slightly painful at the moment of venipuncture. Rarely, local transient swelling occurs and there is an extremely rare risk of infection from the procedure. Blood cells are isolated, cultured, and tested for beryllium sensitization using the lymphocyte proliferation test.
Personal identification is kept in a separate location from other information. Subjects sign an informed consent form that has been approved by the human subjects review committee.
In this period, the primary emphasis has been on identifying subjects, characterizing their exposure, and testing for beryllium sensitization among exposed workers. Until now, blood samples from 55 Hanford workers have been collected and tested for beryllium sensitization. Another major point of emphasis has been the development of a quantitative decision analytic framework for the use of biomarkers in medical surveillance.
This project is also supported by a NIOSH grant which is looking at former Hanford worker exposure.
Project Identifier: CRESP-97-27-0295-X
Project Title:
Analysis of Gene Expression Changes in Isolated Uroepithelial Cells
Principal Investigator:
Dr. Elaine M. Faustman
Principal Investigator's Institution: University of Washington
Project started in: 1997
This project ended in Fiscal Year 1998.
Project Funding Information:
Project received funding in Fiscal Year 1998.
Project did not use human subjects in Fiscal Year 1998.
Explanation:
Samples were collected from subjects in previous years; this year involved sample analysis only.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
Protocol/Subproject Identifier: 27-0295-X
IRB Review:
Type of Review: Expedited
Most Recent Approval: May 12, 1997
IRB Approval Number: 27-0295-X
Number of Human Subjects who participated in this project/protocol during
10/01/97 - 09/30/98: 0
Samples were collected from subjects in previous years and analyzed in FY98
Type of Human Subjects Involvement:
The purpose of this study is to analyze gene expression changes in isolated uroepithelial cells from individuals exposed to fly ash (at a coal-fired power plant in Slovakia). Dr. Janice Yager, at the Electric Power Research Institute, provided the urine samples, which will be analyzed by Dr. Sandra Kirchner.
The role of this project is solely to receive aliquots of coded urine samples (we do not receive any human identification information), isolate the UE cells, amplify the RNA and look for gene expression changes.
This project is a very small pilot study which examines the feasibility of using field-collected urine samples for gene expression biomarker studies.