Ms. Sharon Friend
Committee on Human Research
University of California, San Francisco
San Francisco, CA 94143-0962
Phone: 415-476-1814
Fax: 415-476-8158
Email: ora%sfriend@ccmail.ucsf.edu
Projects are approved by an IRB located at: University of California, San Francisco.
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: M-1169
Number of Human Subjects Projects reported: 2
Project Identifier: UCSF-75-H1315-01884
Project Title:
Experimental Cytogenetics
Principle Investigator:
Dr. Sheldon Wolff
Project started in: 1975
Project Funding Information:
Project received funding in Fiscal Year 1995.
Project used human subjects in Fiscal Year 1995.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Expedited
Most Recent Approval: August 03, 1995
IRB Approval Number: H1315-01884-20
Number of Human Subjects in the Last Reporting Period for this Project: 6
(Reporting periods vary.)
Type of Human Subjects Involvement:
a. Objectives
The experiments are designed to gain information about the way in which the genetic material is arranged in chromosomes and the way in which radiation and other damaging agents such as mutagens or carcinogens bring about these effects.
b. Methodology
Biochemical and biophysical experiments are carried out in laboratory cultures of human blood lymphocytes that are obtained by simple venipuncture from people whose cells are known to respond to phytohemagglutinin (PHA) so that their chromosomes can be visualized in cytogenetic studies.
c. Exposure
Subjects are not exposed to any agents as a consequence of this research. The subjects only serve as a source of a few milliliters(mL) of blood which can be taken to the laboratory for treatment and subsequent study.
d. Involvement of Human Subjects
The experiments are carried out in vitro on cultured human blood that only serves as a source of G0 lymphocytes that can be stimulated to grow by the addition of PHA to the cultures. Each culture requires 0.3 ml of freshly drawn whole blood. Any given experiment will require between 3-20 ml of blood, which is drawn into heparinized vacutainers. The blood is drawn by simple venipuncture from the forearm of donors who are paid $10.00 for each donation. The blood is usually obtained from scientists and technicians in the laboratory who are known to have blood that responds well to PHA. Occasionally blood from people with a known genetic defect in DNA repair is used. In no case are experiments carried out on donors. All work is performed on the extracorporeal blood in tissue culture.
The informed consent form points out that the only risk is that the needle stick might possibly cause bruising or infection, but that this is highly unlikely. In the 20 years this project has been going on there have been no adverse reactions or complications.
Project Identifier: UCSF-89-H1351-00693
Project Title:
DNA Replication and Repair
Principle Investigator:
Dr. James E. Cleaver
Project started in: 1989
Project Funding Information:
Project received funding in Fiscal Year 1995.
Project did not use human subjects in Fiscal Year 1995.
Explanation:
No new cells were required during FY1995. Work continued on cells obtained during previous years.
Funding Sources:
Project does not involve use of multiple protocols/subprojects.
IRB Review:
Type of Review: Full Board
Most Recent Approval: May 11, 1995
IRB Approval Number: H1351-00693-16
Number of Human Subjects in the Last Reporting Period for this Project: 0
(Reporting periods vary.)
Type of Human Subjects Involvement:
a. Objectives
Patients with the clinically diagnosed diseases xeroderma pigmentosum (XP), Cockayne syndrome (CS), or other sun-sensitive disorders, or normal volunteer subjects will be asked to donate a 2-5 mm punch biopsy from the skin of the inner arm. These are to be used for in vitro analysis of radiation sensitivity DNA repair and DNA replication in order to identify the metabolic defects involved in the various forms of the disease.
b. Methodology
Patients will be of all ages including minors; approval for minors will be sought from parents. Volunteers will be obtained primarily from adult students or scientific visitors immediately prior to departure from the laboratory, or biopsies are sent from other institutions. Skin cultures are not established in a laboratory in which the donor is currently working. Patients and volunteers will be told that the procedure is for diagnosis of the disease or to obtain normal control cultures. Records of normal donors will only specify age, sex, date of biopsy, and initials of donor. Private records will be kept identifying XP and CS patients, including name, age, address, clinical conditions, etc., but in all publicly distributed information (lectures, papers, etc.), XP cell cultures are identified only by the code specified in Genetics, 79:215-225 (1975). All patients and donors at our institution will be given a copy of the "Patient's Bill of Rights" and a consent form.
c. Exposure
The materials, if any, to which subjects are exposed or with which subjects are treated in the study and the route of exposure to these materials:
Material 1: xylocaine Exposure 1: subcutaneous
d. Involvement of Human Subjects
Human subjects are only used as donors of skin biopsies. All work involving radiation exposure and radioisotopes is done on cells cultured from these biopsies. The biopsy procedure involves: 1) skin sterilization with alcohol rub, 2) local anesthetic (for skin biopsy) by subcutaneous Xylocaine injection, 3) the excision of 2-5 mm skin punch with standard dermatological procedure, 4) the small wound will be covered with a standard bandaid dressing and normal healing allowed to proceed. Dermatological procedures are done by a qualified dermatologist (Dr. J.H. Epstein, Dermatology Department, UCSF, or his designated substitute).