University of Washington

Funding for Human Subjects Research:

DOE: Office of Biological and Environmental Research (OBER)

$15,000.00 for: Fiscal Year 2007
Funding ended in FY2006, continued with carryover.
Percent of funding associated with the use of human subjects: 0

Information on Use of Human Subjects:

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

Identifier or number: 5067

Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: Fred Hutchinson Cancer Research Institute
Most recent approval: 12/14/05
IRB approval number: 5067
Explanation of IRB approval:
We finished accruing samples for this project in 2006. There was no funding for accuring samples in FY 2007.

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:

External use of ionizing radiation on human subjects:

• Other. Explain:

Treated with radiation for cancer/bone marrow transplant.

Internal use of chemical substances (solid, liquid, or gas) on human subjects:

• Other. Explain:

Treated with chemotherapy/immunotherapy for cancer.

Collection of personally identifiable bodily materials (blood or blood products, urine, cells, tissue, teeth, organs, excreta, etc):

• Using cells cultured in a laboratory.
• Using bodily materials collected specifically for this project.
• Using existing specimens or samples of bodily materials collected for another purpose.

Use of personally identifiable data from questionnaires, surveys, or epidemiological studies:

• Using existing data that were collected for other purposes or projects.

(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])

Over the past three decades, the successful treatment of malignant and non-malignant diseases with hematopoietic stem cell transplantation (HSCT) has resulted in an increasingly large cohort of long-term surviving patients. Many of these patients were treated with TBI (total body irradiation, whole body exposures to fractionated or low dose rate ionizing radiation) as conditioning in preparation for transplantation. While this population is by definition cancer susceptible, it is useful for studies on radiation sensitivity and cancer susceptibility because they often show second cancers at sites that are much different from that of the original presenting disease, and there are appropriate controls available that have similar patient characteristics but are not treated with radiation. Also, while this population contains individuals exposed to relatively large doses of radiation, it provides us with a system to test hypotheses concerning radiation sensitivity and cancer susceptibility; i.e., what proportion of radiation-induced tumors develop in genetically-defined radiation-sensitive individuals? In addition to the clinical histories of the HSCT patients, we have normal lymphocytes and fibroblasts collected prior to any radiation exposure for many of these individuals, and some fibroblast samples collected one-year after HSCT.

Along with signing consents for treatment according to Fred Hutchinson Cancer Research Center (FHCRC) protocols, patients can also give consent to have blood and skin biopsies collected for investigational purposes. The risk of diverting small aliquots of peripheral blood for research purposes is negligible. Skin biopsy sites, generally on arm or back, heal within days, and leave minimal scars. The need for medical intervention as part of the acquisition of research samples is considered extremely unlikely. Documentation of informed consent is obtained at the time. Samples will only be taken from donors who give informed consent using forms approved by the FHCRC Institutional Review Board. Family history will be obtained in such a way as to protect the confidentiality of relatives of patients. Family history data are obtained using questionnaires and consent forms approved by the FHCRC Institutional Review Board. Only relative's initials will be requested on the family history form. Confidentiality of individuals is protected by referring to specimens by code number. Subjects will not be identified individually in any publication or other public presentation of the study.