Ms. Sharon
K.
Friend
Human Research Protection Program
3333 California Street, Suite 315
San Francisco, CA 94118
Phone: 415-476-1814
Fax: 415-502-1347
E-mail: sharon.friend@ucsf.edu
Number of Human Subjects projects reported: 3
| UCSF-95-A100424 | "Dynamic Cardiac SPECT Imaging" |
| UCSF-96-P01 DE09859 | "Characterization and Modification of Dentin" |
| UCSF-05-A100431 | "Comparative Genomic Analysis of CV Gene Regulation" |
"Dynamic Cardiac SPECT Imaging"
Principal Investigator: Dr. Elias H. Botvinick, University of California, San Francisco
Project started in: 1995
Status of the Research this Fiscal Year:
Recruitment and/or enrollment of new participants or review of records/specimens continue.
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Identifier or number: H260-23928
Institutional Review Board (IRB) Review:
Type of Review:
Full Board
Approving Institution: University of California, San Francisco
Most recent approval: 04/12/07
IRB approval number: H260-23928-04
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 1
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
The kinetic behavior of the myocardial perfusion agents, 99mTc-teboroxime and 201Tl, which are extracted by and released, or washed out of, the left ventricular myocardial tissue, will be measured in dynamically acquired single photon emission computed tomography (SPECT) images, refined and expressed mathematically in their 3-D spatial distribution. In dynamic image acquisition, the intensity and location of incoming data are monitored and recorded serially over time. These mathematical algorithms will then be applied with the evaluation of the sensitivity of dynamic, SPECT myocardial perfusion imaging (MPI) of 99mTc-teboroxime and 201Tl for the diagnosis of myocardial ischemia and for determination of viable myocardial tissue and compare them with current static MPI methods. We will determine the kinetic characteristics of 99mTc-teboroxime and 201Tl which have advantages in assessing tissue perfusion and viability.
"Characterization and Modification of Dentin"
Principal Investigator: Dr. Sally J. Marshall, University of California, San Francisco
Project started in: 1996
Status of the Research this Fiscal Year:
Recruitment and/or enrollment of new participants or review of records/specimens continue.
Funding for Human Subjects Research:
This project does not involve the use of multiple protocols/subprojects.
Identifier or number: 77816
Institutional Review Board (IRB) Review:
Type of Review:
Expedited
Approving Institution: University of California, San Francisco
Most recent approval: 02/15/07
IRB approval number: H5687-04447-19
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 7
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
Purpose:
The research seeks to resolve the contradictions surrounding the structure and properties of dental hard tissues with the goal of developing more conservative treatment options for dental caries. As part of this research, we use the hard x-ray beamlines at the Stanford Synchrotron Radiation Laboratory and Advanced Light Source at Lawrence Berkeley National Laboratory for x-ray characterization of these hard tissues. Two primary techniques are x-ray microtomography, which is used to characterize the microstructure and mineral concentration, and x-ray small angle scattering, which is used to probe the mineral/collagen binding in these tissues. From these studies, we hope to develop a better understanding of biomineralization of dental tissues and to develop techniques for restoring affected carious tissues.
Methodology:
This project will involve subjects who are patients that have teeth scheduled for extraction for clinical reasons at the University of California, San Francisco (UCSF) clinics. Prior to extraction of teeth, the patient will be asked by the supervising dentist if they would like to participate in a research study at the UCSF School of Dentistry by donating the extracted tooth to a project to characterize dentin. Each patient who agrees to participate will be paid $15 for his or her cooperation. Each subject will sign a consent form that has been approved by the UCSF Committee on Human Research. By agreeing to participate in this project, each subject is agreeing to release his or her extracted tooth to the principal investigator, to complete questionnaires concerning fluoride history, and to release the principal investigator from any liability related to procedures for collecting teeth or any subsequent changes in their dental status. Participation in this study will take an additional ten minutes in order to complete a history form. There will be no patient contact with researchers from UCSF, nor will there be any patient contact with employees of the Stanford Synchrotron Radiation Laboratory.
Human teeth will be used in this study. The subjects will be drawn from the general patient population of the UCSF dental clinics who require extraction of one or more teeth.
Risk:
There are no physical risks involved beyond normal dental treatment. All records, fluoride histories, and teeth will be coded for anonymity. These will be accessible only to project personnel transferring data to computer files and to the principal investigator. Signed consent forms will be stored in a locked area and will be accessible only to the principal investigator and to Dr. G. Marshall, who is responsible for tooth collection. Anyone who does not wish to complete the fluoride history form may withdraw from the study at any time. Patients will not be individually identified in any publications resulting from this study.
Benefits:
There is no direct benefit to the subject. The benefit to society at large is that a better restorative material system may be developed as a result of this project.
"Comparative Genomic Analysis of CV Gene Regulation"
Principal Investigator: Dr. Anne M. Slavotinek, University of California, San Francisco
Project started in: 2005
Status of the Research this Fiscal Year:
Recruitment and/or enrollment of new participants or review of records/specimens continue.
This project does not involve the use of multiple protocols/subprojects.
Identifier or number: H41842-22157
Institutional Review Board (IRB) Review:
Type of Review:
Full Board
Approving Institution: University of California, San Francisco
Most recent approval: 09/06/07
IRB approval number: H41842-22157-06
Additional IRB approvals from other institutions:
Type of Review:
Expedited
Approving Institution: University of California, San Francisco
Most recent approval: 12/14/06
IRB approval number: H41842-26613-03
Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 16
Reporting period for number of human subjects:
Year prior to last IRB approval date
Type(s) of Human Subjects Involvement:
Objectives:
Our overall goal is to investigate the molecular genetic etiology of congenital diaphragmatic hernia (CDH) in humans. This common birth defect is associated with significant perinatal mortality and long-term morbidity. Mutations have been demonstrated in several different genes in syndromic CDH, but the pathogenesis of non-syndromic CDH in humans is unknown.
Methodology:
We are using array comparative genomic hybridization (array CGH), to identify submicroscopic chromosome aberrations and to map chromosome aberrations in patients who have CDH and additional malformations. We have identified four CDH-critical regions at 15q26.1-15q26.2, 8p23.1, 4p16.3, and 1q41-1q42 using array CGH. We hypothesized that mutations in one or more genes in these CDH-critical intervals can cause CDH. We have sequenced candidate genes from these regions and identified two genes that we would like to study further to establish their importance in human CDH. The first gene, HLX1, was located in the 1q41-1q42 deleted interval and was sequenced because loss of function of this gene has caused diaphragmatic hernia in mice. We sequenced 26 patients with CDH and found a single amino acid substitution, p.A235V, that was not present in 140 ethnically matched control chromosomes. The second gene, ARRDC4, was the only deleted gene in the 15q26 interval in one patient with CDH. We consider that mutations in these genes are likely to be predisposing factors for the development of CDH in humans and plan to continue investigating the role of both of these genes in diaphragm development.
Human Subjects:
We have two CHR-approved protocols for this project. The first, Molecular Genetic Analysis of Fraser Syndrome and Fryns syndrome (CHR 41842-22157-05), enables us to approach individuals and family members with congenital diaphragmatic hernia through their physicians for venipuncture to obtain a blood sample that is used to obtain DNA and to make a lymphoblastoid cell line for molecular genetic studies. These studies are all in vitro and there is no exposure of human subjects to treatments or other interventions. If possible, existing DNA samples or tissue samples can be used. The second protocol, Molecular Genetic Analysis of Congenital Diaphragmatic Hernia Using DNA Obtained from Blood Spots (CHR 41842-26613-02), enables us to use previously collected blood spots for in vitro genetic studies from patients with congenital diaphragmatic hernia. The samples do not come with identifiers.
There are no studies involving genetic engineering on these samples and no reproductive studies. The cell culture experiments involve use of lymphoblastoid cell lines for obtaining DNA and RNA and for obtaining metaphase spreads for fluorescence in-situ hybridization.
Risks to Human Subjects:
Risks for the first protocol include the risk of venipuncture, such as transient local pain and bruising/bleeding. There is also the risk that publication of a pedigree or clinical photographs may inadvertently enable family members to be identified, but this risk is small, and to date, we have not published pedigrees and have only published photographs with patient consent.
Privacy/Confidentiality:
Measures to protect privacy and confidentiality include coding blood samples before use, keeping the sample key in a locked computer in a locked office in a locked corridor, and not sharing identifying information with other researchers.