Ms. Sherry E. Davis-Cross
902 Battelle Blvd.
K1-67
Richland, WA 99352
Phone: 509-375-3610
Fax: 509-375-2592
Email: Sherry.Davis-Cross@pnl.gov
Projects are approved by an IRB located at: Pacific Northwest National Laboratory.
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: DOE.MPA.PNNL96-2000
Number of Human Subjects Projects reported: 13
Project Identifier: PNNL-94-4
Project Title:
PBPK Breath Analysis Instrumentation Demonstration
Principal Investigator:
Dr. Karla D. Thrall
Project started in: 1994
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.
IRB Review:
Type of Review: Full Board
Most Recent Approval: June 05, 1998
Number of Human Subjects who participated in this project/protocol during
FY 1998 (10/1/97 - 9/30/98): 6
Type of Human Subjects Involvement:
The goal of this research is to develop procedures and demonstrate the use of a portable or semi-portable real-time monitoring instrument for characterizing human tissue levels of volatile chemicals in waste-site cleanup workers--such as carbon tetrachloride, toluene, or benzene.
Human subjects will be sought from staff at various DOE sites. The subjects will be asked to breathe into a breath-inlet system connected to a mass spectrometer for a period of 2-3 minutes upon entering and exiting chemical hazards control zones in which they work. Various organic chemicals found in the exhaled breath will be identified and quantified. Workers will not be exposed to any chemical other than that which occurs in their routine cleanup activities.
Risk: Readings are expected to be well within allowable occupational exposures. Standard medical practices will be used to minimize any risk of respiratory infection which could result from use of the breath-inlet device and appropriate confidentiality practices and Informed Consent will be employed according to federal regulation.
Volunteers will be consented before they enter into the project.
Project Identifier: PNNL-96-17
Project Title:
Breast Cancer Prevention, Education, and Detection
Principal Investigator:
Dr. Heinz J. Roye
Project started in: 1996
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.
IRB Review:
Type of Review: Expedited
Most Recent Approval: March 06, 1998
Number of Human Subjects who participated in this project/protocol during
FY 1998 (10/1/97 - 9/30/98): 45
Type of Human Subjects Involvement:
The overall purpose of this program is to develop a breast cancer genetic screening and counseling module for high-risk women to determine genetic susceptibility for breast cancer in military women beneficiaries, and to develop education programs for youth and mature/multi-ethnic beneficiaries.
Subjects will be asked to fill out a questionnaire, and they will be interviewed by a doctor or nurse and a genetic counselor to determine their family history and potential genetic risk for breast cancer. A chart will be developed indicating family members and any cancer that they can remember them having had. They will be asked to give the genetic counselor documents to verify the information (medical report documenting diagnosis). The information will help the subject's health care provider and genetic counselor determine if they are eligible for the project and for testing for BRCA1 and BRCA2 genetic mutations.
Risks: Possible emotional distress at the outcome of the tests and the decision to inform family members. Special attention must be paid to the possible mixing of medical and genetic records.
Privacy/confidentiality/consent: Subjects will be consented twice during this project, first before they complete a questionnaire, perform pre-test counseling and education, and second before providing a blood sample for genetic testing. Records for this project are accessible only to specific researchers, IRB, physicians and genetic counselors conducting the study. Information gained from this study may be used as part of a scientific publication, but subjects will in no way be personally identified.
Project Identifier: PNNL-96-20
Project Title:
Study of Heat Stress and Performance in Carpenters at DOE Sites
Principal Investigator:
Mr. Wilfred Cameron
Principal Investigator's Institution: United Brotherhood of Carpenters Health and Safety Fund
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: January 20, 1998
Number of Human Subjects who participated in this project/protocol during
FY 1998 (10/1/97 - 9/30/98): 3
Type of Human Subjects Involvement:
The objective of this work is to identify factors that place people at risk of heat stress by studying volunteers working under hot and cool conditions. Factors under study include: workplace temperature, work effort level, work duration, physical condition, and medical history. Subjects doing routine work, using protective clothing and in containment will be tested during the summer months for the effects of heat stress. Their temperature and activity levels will be closely monitored during their work day to obtain objective evidence of the physiological condition and the development of heat stress. Urine samples and weight will be taken three times a day to determine fluid balance and fluid consumption. Cognitive, motor (strength) and balance tests will be given in the morning (baseline) and when they complete work to identify early indicators of heat stress onset, such as changes in behavioral performance and physiological measures of blood pressure, pulse, temperature and hydration.
Risk to the volunteers, who will perform no more than their routine work activities during this study, is minimal. Note: This study will continue, but it will not be performed at the Hanford Site in FY99.
Informed Consent will be obtained by researchers following an information/training session. Confidentiality and privacy issues are addressed as part of Informed Consent.
Project Identifier: PNNL-96-4
Project Title:
Field Evaluation of Polarized and Full Spectrum Polarized Lighting
Principal Investigator:
Mr. Eric E. Richman
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 05, 1998
Number of Human Subjects who participated in this project/protocol during
FY 1998 (10/1/97 - 9/30/98): 18
Type of Human Subjects Involvement:
The purpose of this research is to determine any potential energy savings associated with the use of full spectrum and polarized lighting in federal office spaces in place of current standard lighting. Over an 18-20 week period, the lighting in the subject's offices will be changed several times and they will be asked to give their candid evaluation, once a week in a one-page survey, of how effective, comfortable, and useful the lighting is in each case. An initial survey will be conducted to gather basic information about the subjects and their current lighting situation.
Risk is nonexistent.
There is no risk to privacy as the identity of the human subjects will be coded and their responses to the survey will never be associated with their names. The subjects will be notified of the study and their rights in a project announcement letter.
Project Identifier: PNNL-97-1
Project Title:
Comprehensive Occupational Health Surveillance
Principal Investigator:
Dr. Scott Barnhart
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: Expedited
Most Recent Approval: March 02, 1998
Number of Human Subjects who participated in this project/protocol during
FY 1998 (10/1/97 - 9/30/98): 352
Type of Human Subjects Involvement:
The purpose of this study is to identify and describe the physical and chemical hazards that may exist in the subject's natural work environment. The findings of this study will be used to develop health and safety programs that are more focused and better able to decrease the potential health risks related to exposures.
Researchers will conduct interviews with employees at their normal worksite. The interviews will consist of a series of open-ended questions and will take 20-30 minutes to complete. Subjects will be asked to provide their job title and work location. Interviewers will ask about worker's activities at their site and if they are involved in any occupational health and safety mandated medical surveillance programs. Of particular interest is possible hazardous exposures that workers believe they may be exposed to and the protective equipment they use when working.
Risks are expected to be minimal. There may be some anxiety on the subjects part regarding their managements opinion where certain questions are concerned. They will be assured that site management has approved the study.
Subjects will be consented and informed of their rights to privacy, including the disposition of records. Code numbers will be assigned to each subject.
Project Identifier: PNNL-97-10
Project Title:
Screening For Chronic Beryllium Disease at Hanford
Principal Investigator:
Dr. Tim 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: Expedited
Most Recent Approval: July 08, 1998
Number of Human Subjects who participated in this project/protocol during
FY 1998 (10/1/97 - 9/30/98): 445
Type of Human Subjects Involvement:
The purpose of this initial study of beryllium exposure at Hanford is to determine the prevalence of beryllium sensitization in an exposed population of Hanford workers, and to begin to determine the high risk jobs of former workers and high risk areas for exposure in future remediation workers. Initial determinations of sensitization will be cross-sectional and will be linked to retrospective chest radiograph and spirometry data where available. This sensitization/disease prevalence and exposure information will be used to determine the feasibility of medical monitoring for beryllium disease in exposed workers in a second study.
Subjects will be asked to: (1) fill out and return a Consent Form and a Hanford Worker Beryllium Survey (phone contacts will be available for questions); (2) grant permission to review employment and medical records to see if they may have been exposed to beryllium while on the job; and (3) let a licensed person collect a blood sample to determine if there is an immune reaction to beryllium.
Risk to privacy is minimized by the careful control, storage, and destruction of personal identifiers and blood samples.
Subjects will be consented at required stages of this program.
Project Identifier: PNNL-97-2
Project Title:
Medical Surveillance Program/Former DOE Workers
Principal Investigator:
Dr. Scott M. Barnhart
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: Expedited
Most Recent Approval: March 03, 1998
Number of Human Subjects who participated in this project/protocol during
FY 1998 (10/1/97 - 9/30/98): 1,162
Type of Human Subjects Involvement:
The focus of the Needs Assessment phase of this project is to identify former Hanford workers who may be at significant risk for disease based on workplace exposure to radioactive or other hazardous substances and to establish contact with the workers. Based on the information collected, the project teams will make recommendations to DOE concerning the need for future follow-up programs, including plans for the development of medical monitoring for former workers that would be funded by Congress. Phase II is the implementation of medical monitoring programs for targeted groups of former workers. These programs seek to benefit workers by helping to prevent or minimize illnesses related to exposures in years past, and to improve the health of the former worker.
Risk to subjects is minimal. Codes will be used to protect personal data and all records will be destroyed at the close of the project.
Subjects will be consented as necessary at each stage of the project.
Project Identifier: PNNL-97-5
Project Title:
Former Workers' Notification and Medical Screening - Hanford
Principal Investigator:
Dr. Knut Ringen
Principal Investigator's Institution: Center to Protect Workers Rights
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 involves use of multiple protocols/subprojects.
Number of protocols/subprojects associated with this project: 1
Protocol/Subproject # 1
Protocol/Subproject Identifier: 97-5
IRB Review:
Type of Review: Full Board
Most Recent Approval: May 20, 1998
Number of Human Subjects who participated in this project/protocol during
FY 1998 (10/1/97 - 9/30/98): 500
Type of Human Subjects Involvement:
The objective of this project is to implement the notification, health evaluation (including medical screening) and intervention program for former building and construction trades workers at the DOE Hanford site who may have been exposed to health hazards as result of prior work at Hanford.
Specific aims for Phase II are:
1. Identify and locate former workers who are consider "at risk".
2. Ascertain the health concerns of workers identified in Phase I.
3. Communicate risk information to the workers and discuss actions to be taken.
4. Provide medical screening.
5. Assist in coordination of referrals, diagnostic work up, and follow-up treatment.
6. Ensure dialogue with local parties concerned with the project.
7. Evaluation project impact, including former workers satisfaction with the project.
Risks to the subjects, such as possible loss of privacy is minimized by coding and multiple layers of protection to the data. All personal data is coded and encrypted and maintained in separate data bases.
Subjects will be well informed of the purpose of the program and will be consented as required during various phases of the research.
Project Identifier: PNNL-97-6
Project Title:
Inherited Breast Cancer, Identification, Education, Counseling and Testing of High Risk Patients in a Military Setting
Principal Investigator:
Dr. Heinz J. Roye
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: Expedited
Most Recent Approval: March 05, 1998
Number of Human Subjects who participated in this project/protocol during
FY 1998 (10/1/97 - 9/30/98): 75
Type of Human Subjects Involvement:
The objective of this project is to develop a breast cancer genetic screening and counseling module for high-risk women to determine genetic susceptibility for breast cancer in military women beneficiaries, and to develop education programs for youth and mature multi-ethnic beneficiaries.
Researchers will ask patients and clinicians their opinions about the dissemination and satisfaction with breast cancer education and information on early detection of breast cancer. Human subjects will be part of the Familial Breast Cancer Project that will include genetic counseling, testing, and receipt of test results.
Risk of loss of privacy is minimized by separation of research and medical or genetic records.
Subjects will be consented as required during the research.
Project Identifier: PNNL-97-8
Project Title:
Fundamental Research on Solvent-Laden Soils
Principal Investigator:
Dr. Karla D. Thrall
Project started in: 1997
Project Funding Information:
Project did not receive funding in Fiscal Year 1998.
Project did not use human subjects in Fiscal Year 1998.
Explanation:
Work was funded late in FY97. Human Subjects work will begin in FY99.
Funding Sources:
No Human Subjects work conducted in FY98
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: September 24, 1998
Number of Human Subjects who participated in this project/protocol during
FY 1998 (10/1/97 - 9/30/98): 0
Type of Human Subjects Involvement:
Subjects skin will be exposed to small amounts of hazardous chemicals in soil or water to determine possible absorption, detectable through breath analysis.
The objective of this research is to determine real-time response for human percutaneous bioavailability of organic solvents in soil and water. This data will be used in biologically based dose-response models to estimate human health risk assessments.
Subjects will be exposed to various organic solvents (trichloroethylene) over varied amounts of time, either by a patch that holds the solvent against the skin, or by moving their hand through soil or water. At predetermined intervals, their breath will be analyzed to detect any biological uptake of the solvents.
Exposure to the solvents could make subjects dizzy. However, at the doses planned for the study, side effects and long term effects are not expected. Risk is considered minimal.
Pregnant volunteers, those with skin disease, or known allergic reaction to the solvents will be excluded from this project. All other subjects will be consented.
Project Identifier: PNNL-98-7
Project Title:
Surveillance Methods for Solvent-related Hepatotoxicity
Principal Investigator:
Dr. Carl A. Brodkin
Principal Investigator's Institution: University of Washington
Project started in: 1998
Project Funding Information:
Project received funding in Fiscal Year 1998.
Project did not use human subjects in Fiscal Year 1998.
Explanation:
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Expedited
Most Recent Approval: January 19, 1998
Number of Human Subjects who participated in this project/protocol during
FY 1998 (10/1/97 - 9/30/98): 0
Type of Human Subjects Involvement:
The objective of this research study is to assess hepatic ultrasonography and other biochemical tests of liver function in solvent exposed workers for comparison to workers not exposed to solvents, to determine the efficacy of these potential surveillance methods for detecting solvent-related hepatotoxicity.
A structured interview using a questionnaire eliciting data on demographics, occupational and environmental exposure history, alcohol consumption, medication use, and cigarette smoking will be administered by phone at the subject's homes. Blood samples will be performed by a phlebotomist and a certified sonographic technician will perform sonography at a local medical facility. This is a cross-sectional study, as described above.
Risk to subjects is minimal and related only to temporary discomfort associated with venipuncture.
All data will be coded with access limited to the study PI, coordinator and co-investigators. Data will be protected by computer with restricted access and locked files.
Project Identifier: PNNL-98-5
Project Title:
Advanced Techniques in Latent Fingerprint and Visualization
Principal Investigator:
Dr. Gary M. Mong
Project started in: 1998
Project Funding Information:
Project received funding in Fiscal Year 1998.
Project did not use human subjects in Fiscal Year 1998.
Explanation:
Human Subjects involvement not yet initiated.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: February 23, 1998
Number of Human Subjects who participated in this project/protocol during
FY 1998 (10/1/97 - 9/30/98): 0
Type of Human Subjects Involvement:
Objectives: To obtain samples of human sebaceous secretions as they appear on human fingerprints, phalanges, or palms. Subjects will be grouped according to approximate age and sex. There is no desire or possibility of using the data collected to identify individuals; project is interested in chemical constituency of the materials collected only.
Methodology: Subjects are asked to voluntarily touch small filter paper media. A number is assigned to the sample to cross-correlate age and gender. No personal identifiers are used. Samples are then subjected to chemical identification testing.
Substances: Subjects contact soft filter medium only, no hazardous materials will contact the subjects.
Human Subjects: Are not exposed to any hazardous materials or undue risks. No physical identifiers, names, or other personal information are taken. Subjects are asked to have not used certain cosmetics within 6 hours and are given a consent form to sign.
Project Identifier: PNNL-98-1
Project Title:
Military Relocation Questionnaire
Principal Investigator:
Ms. Judith Bradbury
Project started in: 1998
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.
IRB Review:
Type of Review: Expedited
Most Recent Approval: December 04, 1997
Number of Human Subjects who participated in this project/protocol during
FY 1998 (10/1/97 - 9/30/98): 377
Type of Human Subjects Involvement:
The objective of this project was to determine whether current business practices could be successfully applied to the military relocation process.
PNNL conducted an independent survey of relocating military personnel to determine whether those receiving the services provided by the Army were more or less satisfied than who receive current existing services. Telephone surveys of relocating military personnel who had received new services were compared with military personnel who had received currently existing services to compare satisfaction with each.
Personnel information was coded to protect the privacy of the survey participants.