USDOE Human Subjects Research Database, Fiscal Year 2007

Queens College of the City University of New York

Public Information Contact:

Dr. Steven B. Markowitz
Center for the Biology of Natural Systems, Queens College
163-03 Horace Harding Blvd.
Fourth Floor
Flushing, NY 11365

Phone: 718-670-4184
Fax: 718-670-4189
E-mail: smarkowitz@qc.cuny.edu

Institutional Review Board (IRB):

Projects are approved by an IRB located at: Queens College of the City University of New York
The approving IRB operates under an OHRP assurance.
OHRP assurance number: FWA00005031

Human Subject Projects:

Number of Human Subjects projects reported: 6

QC-99-C-7-1-98-02 "Medical Surveillance of Former and Current Workers at the DOE Gaseous Diffusion Plants, Phase II: Medical Screening"
QC-00-C-99-08-25-01 "Medical Surveillance of Former Workers at INL, Phase II; Medical Screening"
QC-04-04-06-07-01 "Medical Surveillance of Former Y-12 and Oak Ridge National Laboratory Workers at the Department of Energy and Early Lung Cancer Detection. Phase II Medical Screening"
QC-05-05-10-04-05 "Medical Surveillance of Former Workers at Fernald Phase II: Medical Screening"
QC-05-05-10-04-06 "Medical Surveillance of Former Workers at Mound, Phase II: Medical Screening"
QC-07-QC C-06-10-19-01 "Medical Surveillance for the Former Brookhaven Plant Workers, Phase II: Medical Screening"

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Project Identifier: QC-99-C-7-1-98-02

Project Title:
"Medical Surveillance of Former and Current Workers at the DOE Gaseous Diffusion Plants, Phase II: Medical Screening"

Principal Investigator: Dr. Steven Markowitz, Queens College, City University of New York

Project started in: 1999

Status of the Research this Fiscal Year:
  Recruitment and/or enrollment of new participants or review of records/specimens continue.

Project Funding Information:

This project received funding during fiscal year 2007.

Funding for Human Subjects Research:

DOE: Department of Health Studies
$1,129,870.00 for: Fiscal Year 2007
We have a combined budget for the Gaseous Diffusion Plant Workers Program, Idaho Nuclear Engineering Program, and Mound Program.
Percent of funding associated with the use of human subjects: 100

Information on Use of Human Subjects:

This project does not involve the use of multiple protocols/subprojects.

Identifier or number: C-7-1-98-02

Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Queens College of the City University of New York
Most recent approval: 05/17/07

Additional IRB approvals from other institutions:
Type of Review: Full Board
Approving Institution: Oak Ridge Site-wide Institutional Review Board
Most recent approval: 04/22/07

Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 684
Reporting period for number of human subjects: Fiscal Year 2007

Type(s) of Human Subjects Involvement:

Collection of personally identifiable bodily materials (blood or blood products, urine, cells, tissue, teeth, organs, excreta, etc):
  • Using bodily materials collected specifically for this project.
Use of personally identifiable data from questionnaires, surveys, or epidemiological studies:
  • Using data collected from subjects specifically for this project.
Abstract:
(a. Objectives, b. Methodology, c. Ionizing Radiation, Radioactive Substances, or Chemical Substances to which human subjects are exposed, d. Involvement of Human Subjects [d.1. procedures used, d.2. risks if any])

This is a medical screening and education program that is designed to detect potentially work-related chronic lung disease, hearing loss, and beryllium sensitivity. In addition, there is an early lung cancer detection component that uses low dose computed tomography (CT) scanning to identify potentially malignant nodules for referral for proper diagnosis and treatment. (The lung cancer component ended July 2006.)

Go to list of projects at Queens College of the City University of New York

Project Identifier: QC-00-C-99-08-25-01

Project Title:
"Medical Surveillance of Former Workers at INL, Phase II; Medical Screening"

Principal Investigator: Dr. Steven Markowitz, Queens College, City University of New York

Project started in: 2000

Status of the Research this Fiscal Year:
  Recruitment and/or enrollment of new participants or review of records/specimens continue.

Project Funding Information:

This project received funding during fiscal year 2007.

Funding for Human Subjects Research:

DOE: Office of Health Studies
$376,623.00 for: Fiscal Year 2007
We have a combined budget for the Gaseous Diffusion Project, the Idaho National Laboratory Project, and the Mound Project.
Percent of funding associated with the use of human subjects: 100

Information on Use of Human Subjects:

This project does not involve the use of multiple protocols/subprojects.

Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Queens College of the City University of New York
Most recent approval: 05/17/07

Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 425
Reporting period for number of human subjects: Fiscal Year 2007

Type(s) of Human Subjects Involvement:

Collection of personally identifiable bodily materials (blood or blood products, urine, cells, tissue, teeth, organs, excreta, etc):
  • Using bodily materials collected specifically for this project.
Use of personally identifiable data from questionnaires, surveys, or epidemiological studies:
  • Using data collected from subjects specifically for this project.
Abstract:
(a. Objectives, b. Methodology, c. Ionizing Radiation, Radioactive Substances, or Chemical Substances to which human subjects are exposed, d. Involvement of Human Subjects [d.1. procedures used, d.2. risks if any])

This is a medical screening and education program that is designed to detect potentially work-related chronic lung disease, hearing loss, and beryllium sensitivity.

Go to list of projects at Queens College of the City University of New York

Project Identifier: QC-04-04-06-07-01

Project Title:
"Medical Surveillance of Former Y-12 and Oak Ridge National Laboratory Workers at the Department of Energy and Early Lung Cancer Detection. Phase II Medical Screening"

Principal Investigator: Dr. Steven Markowitz, Queens College, City University of New York

Project started in: 2004

Status of the Research this Fiscal Year:
  Recruitment and/or enrollment of new participants or review of records/specimens continue.

Project Funding Information:

This project received funding during fiscal year 2007.

Funding for Human Subjects Research:

DOE: Office of Health Studies
$2,444,692.00 for: Fiscal Year 2007
We have a combined budget for the Y-12 and Oak Ridge National Laboratory Project, Fernald Project, and the Brookhaven Project.
Percent of funding associated with the use of human subjects: 100

Information on Use of Human Subjects:

This project does not involve the use of multiple protocols/subprojects.

Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Queens College of the City University of New York
Most recent approval: 05/17/07

Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 2088
Reporting period for number of human subjects: Fiscal Year 2007

Type(s) of Human Subjects Involvement:

Collection of personally identifiable bodily materials (blood or blood products, urine, cells, tissue, teeth, organs, excreta, etc):
  • Using bodily materials collected specifically for this project.
Use of personally identifiable data from questionnaires, surveys, or epidemiological studies:
  • Using data collected from subjects specifically for this project.
Abstract:
(a. Objectives, b. Methodology, c. Ionizing Radiation, Radioactive Substances, or Chemical Substances to which human subjects are exposed, d. Involvement of Human Subjects [d.1. procedures used, d.2. risks if any])

This is a medical screening and education program that is designed to detect potentially work-related chronic lung disease, hearing loss, and beryllium sensitivity. In addition, there is an early lung cancer detection component that uses low dose computed tomography (CT) scanning to identify potentially malignant nodules for referral for proper diagnosis and treatment.

Go to list of projects at Queens College of the City University of New York

Project Identifier: QC-05-05-10-04-05

Project Title:
"Medical Surveillance of Former Workers at Fernald Phase II: Medical Screening"

Principal Investigator: Dr. Steven Markowitz, Queens College of the City University of New York

Project started in: 2005

Status of the Research this Fiscal Year:
  Recruitment and/or enrollment of new participants or review of records/specimens continue.

Project Funding Information:

This project received funding during fiscal year 2007.

Funding for Human Subjects Research:

DOE: Office of Health Studies
$873,104.00 for: Fiscal Year 2007
We have a combined budget for the Y-12 and Oak Ridge National Labortory Project, Fernald Project and Brookhaven Project.
Percent of funding associated with the use of human subjects: 100

Information on Use of Human Subjects:

This project does not involve the use of multiple protocols/subprojects.

Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Queens College of the City University of New York
Most recent approval: 10/03/06

Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 242
Reporting period for number of human subjects: Fiscal Year 2007

Type(s) of Human Subjects Involvement:

Collection of personally identifiable bodily materials (blood or blood products, urine, cells, tissue, teeth, organs, excreta, etc):
  • Using bodily materials collected specifically for this project.
Use of personally identifiable data from questionnaires, surveys, or epidemiological studies:
  • Using data collected from subjects specifically for this project.
Abstract:
(a. Objectives, b. Methodology, c. Ionizing Radiation, Radioactive Substances, or Chemical Substances to which human subjects are exposed, d. Involvement of Human Subjects [d.1. procedures used, d.2. risks if any])

This is a medical screening program that is designed to detect potentially work-related chronic lung disease, hearing loss, and beryllium sensitivity.

Go to list of projects at Queens College of the City University of New York

Project Identifier: QC-05-05-10-04-06

Project Title:
"Medical Surveillance of Former Workers at Mound, Phase II: Medical Screening"

Principal Investigator: Dr. Steven Markowitz, Queens College of the City University of New York

Project started in: 2005

Status of the Research this Fiscal Year:
  Recruitment and/or enrollment of new participants or review of records/specimens continue.

Project Funding Information:

This project received funding during fiscal year 2007.

Funding for Human Subjects Research:

DOE: Office of Health Studies
$1,004,329.00 for: Fiscal Year 2007
We have a combined budget for the Gaseous Diffusion Project, Idaho National Laboratory Project, and Mound Project.
Percent of funding associated with the use of human subjects: 100

Information on Use of Human Subjects:

This project does not involve the use of multiple protocols/subprojects.

Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Queens College of the City University of New York
Most recent approval: 10/03/06

Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 242
Reporting period for number of human subjects: Fiscal Year 2007

Type(s) of Human Subjects Involvement:

Collection of personally identifiable bodily materials (blood or blood products, urine, cells, tissue, teeth, organs, excreta, etc):
  • Using bodily materials collected specifically for this project.
Use of personally identifiable data from questionnaires, surveys, or epidemiological studies:
  • Using data collected from subjects specifically for this project.
Abstract:
(a. Objectives, b. Methodology, c. Ionizing Radiation, Radioactive Substances, or Chemical Substances to which human subjects are exposed, d. Involvement of Human Subjects [d.1. procedures used, d.2. risks if any])

This is a medical screening and education program that is designed to detect potentially work-related chronic lung disease, hearing loss, and beryllium sensitivity.

Go to list of projects at Queens College of the City University of New York

Project Identifier: QC-07-QC C-06-10-19-01

Project Title:
"Medical Surveillance for the Former Brookhaven Plant Workers, Phase II: Medical Screening"

Principal Investigator: Dr. Steven B. Markowitz, Queens College of the City University of New York

Project started in: 2007

Status of the Research this Fiscal Year:
  Project funded, but no participants have been enrolled to date.

Project Funding Information:

This project received funding during fiscal year 2007.

Funding for Human Subjects Research:

DOE: Environmental Management (EM)
$174,621.00 (Est.) for: Fiscal Year 2007
We have a combined budget for the Atomic Trades and Labor Council Program, Fernald Program, and Brookhaven Program.
Percent of funding associated with the use of human subjects: 100

Information on Use of Human Subjects:

This project does not involve the use of multiple protocols/subprojects.

Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Queens College of the City University of New York
Most recent approval: 11/07/06

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 2007

Type(s) of Human Subjects Involvement:

Collection of personally identifiable bodily materials (blood or blood products, urine, cells, tissue, teeth, organs, excreta, etc):
  • Using bodily materials collected specifically for this project.
Use of personally identifiable data from questionnaires, surveys, or epidemiological studies:
  • Using data collected from subjects specifically for this project.
Abstract:
(a. Objectives, b. Methodology, c. Ionizing Radiation, Radioactive Substances, or Chemical Substances to which human subjects are exposed, d. Involvement of Human Subjects [d.1. procedures used, d.2. risks if any])

This is a medical screening and education program that is designed to detect potentially work-related chronic lung disease, hearing loss, and beryllium sensitivity.

Go to list of projects at Queens College of the City University of New York