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EthicsCaseStudyForm edit

Title Identifying Cancer Cells in Peripheral Blood
Long Title A New Procedure for Identifying Cancer Cells in Peripheral Blood Case Study 1
Contributor/Contact Barbara G. Bigby, ALM, CIP (Bigby.Barbara@scrippshealth.org)
Contributor Details Barbara G. Bigby, ALM, CIP
Director, Regulatory Services
Scripps Clinical Research
La Jolla, CA 92037
CTSA UC San Diego
Case Study Provided An investigator in the research institute has developed a new technique for identifying the presence of a cancerous tumor by analyzing cells from peripheral blood. The hypothesis is that certain markers on circulating epithelial cells will correlate with distant metastasis of a primary breast tumor. The researchers plan to study a group of subjects who have been diagnosed with breast cancer and a group of control women who had negative screens for breast cancer.
When this study was submitted to the IRB for review, the investigator stated that clinical staff would be used to obtain informed consent and blood samples. The samples would be coded and sent to the basic science researchers without identifiers. The IRB approved the protocol and the researchers began to collect samples. Shortly after collection began, the Principal Investigator contacted the IRB with an urgent announcement – cancer cells had been found in the peripheral blood of one of the “control” subjects. The investigator asked who should take responsibility for relaying the results to the subject.
Data Acquisition, Management, Sharing and Ownership Topics No Data acquisition_management_sharing and ownership Topics
Mentor and Trainee Responsibilities Topics No mentor and trainee responsibilities topics
Publication Practices and Responsible Authorship Topics No publication practices and responsible authorship topics
Peer Review Topics No peer review topics
Collaborative Science Topics No collaborative science topics
Research Misconduct Topics No research misconduct topics
Conflicts of Interest, Law and Policy Topics No conflicts of interest_law_and policy topics
Human Subjects Human subjects research
Citation Joel C. Diamant, MD, FACP, Co-program Director of the STSI’s Educational Program
URL http://www.stsiweb.org/index.php/about/bio/diamant
RCR Keyword

Other RCR Keywords Blood Samples; Cancer Cells found in one of the Control Subjects; Cancerous Tumor; Control Subjects without Breast Cancer; Epithelial Cells; Human Subjects; Informed Consent; IRB; Markers; Metastasis; Primary Breast Tumor; Principal Investigator; Protocol; Responsibility for Relaying Results to Subject; Samples are Coded; Subjects with Breast Cancer
Type of Case

Source for Topic Areas Du Bois, J., & Dueker, J. (2009). Teaching and Assessing the Responsible Conduct of Research: A Delphi Consensus Panel Report. Journal of Research Administration, 40(1), 49-70.


Topic revision: r3 - 28 Oct 2011 - 13:35:26 - MaryBanach
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