Dr. Barbara
J. Trask
Fred Hutchinson Cancer Research Center
1100 Fairview Avenue N. C3-168
P.O. Box 19024
Seattle, WA 98109-1024
Phone: 206-667-1470
Fax: 206-667-4023
E-mail: btrask@fhcrc.org
Number of Human Subjects projects reported: 1
"Analytical Cytogenetics and Gene Mapping"
Principal Investigator: Dr. Barbara J. Trask, University of Washington
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: University of Washington
Most recent approval: 07/10/00
IRB approval number: 95-1085-E08
Explanation of IRB approval:
previous IRB approval for 7/12/99 - 6/11/00
current IRB approval for 7/10/00 - 7/9/01
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 9
Reporting period for number of human subjects:
Other: 11/10/92 to 06/05/00
Explanation:
Duration of project.
Type(s) of Human Subjects Involvement:
The goal of the projects covered by this human subjects project is to develop and validate improved procedures for mapping of the genome, characterization of normal variation at the DNA level, detection of chromosomal abnormalities associated with human disease, and identification of genes whose mutation causes human disease. Procedures involve flow cytometric quantification of chromosomes isolated from dividing cells, analysis of DNA sequences by polymerase chain reaction (PCR) and sequencing, and fluorescence in situ hybridization (FISH) of specific DNA sequences in dividing and non-dividing cells.
DNA sequences are mapped to their chromosomal location using peripheral blood cells from normal donors. Polymorphism in the distribution of telomeric repeats is being studied using tissue culture lines and normal control samples for FISH and DNA analyses. Chromosomal abnormalities are being detected and progress is being made toward identifying the genes involved by using FISH to map specific DNA sequences to chromosomes maintained in tissue culture lines; cells from normal donors serve as an important control for the normal pattern of hybridization.
Human subjects are involved to obtain blood for biomedical and biochemical tests outside the human body. Peripheral blood is obtained by venipuncture. Volunteers will donate 5 ml of blood, which will be collected under conventional sterile conditions. Blood samples are used to prepare microscope slide preparations or suspensions of chromosomes, either directly or after short-term culture to produce dividing cells. In some cases, DNA analyses such as PCR or hybridization are conducted. Donors fall into 2 classes: (1) normal donors (local volunteers within the department) who are more than 18 years of age, a maximum of 50 subjects per year; and (2) individuals with known chromosome abnormalities and genetic disease who are more than 18 years of age, a maximum of 50 subjects per year (although most samples in class 2 are obtained as established cell lines). Donors in the two classes will donate a maximum of 10 and 2 times per year, respectively. Normal donor samples will be identified only by a code number in subsequent experiments, thus assuring donor confidentiality. The link between code number and subject name will be kept in a locked computer file by the principal investigator (PI). Blood samples of patients will be obtained at other institutions in the course of our collaborator's experiments or during routine clinical evaluation. The samples will be encoded at the collaborating institutions, and donor identities will not be known to the investigators at the University of Washington, thus assuring donor anonymity. The principal investigator requires that human subjects approval be obtained at the collaborating institutions for this project. Normal donors are randomly selected, balanced in numbers between males and females and different ethnic backgrounds.
The possible risks and discomforts from the procedures are considered unlikely, but include temporary pain, bruising and soreness of affected tissue or surrounding region, formation of scar tissue, and infection. No in vivo studies are performed. Samples are collected specifically for this project, but donors are selected purely on the basis of their willingness to donate blood. Some donors are asked to donate additional samples to reduce variability (normal polymorphism) in our analyses.
All donors are fully informed of the procedures and use of samples and sign an explanatory consent form approved by the Human Subjects Review Board at the University of Washington. The identity of donors is not linked to samples and is kept in a confidential file.
The study may not result in direct benefits to individual subjects, but it may contribute to the understanding and detection of human disease and may, therefore, be of some benefit to human society in the future.