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Title Retrospective Chart Review
Long Title Retrospective Chart Review
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

Case Study Provided Medical residents and fellows are required to complete a research project during their training. Many design a retrospective chart review because they can do their research in off hours and answer a research question in a reasonable amount of time.
A genetic mutation causes a condition called hereditary non-polyposis colorectal cancer (HNPCC). People with this mutation have about an 80% chance of developing colorectal cancer at some point in their lives. They also have about a 50% chance of developing uterine cancer. It follows that women with endometrial cancer may have a greater risk for developing colon cancer.
One resident designed a protocol to review all cases of endometrial cancer over the past five years to determine whether these patients had been screened for colorectal cancer, as recommended. She submitted the protocol to the IRB requesting a Waiver of Informed Consent and Authorization, since she planned to assign study numbers and not record any identifiers. The IRB approved her protocol as submitted.
After reviewing the first 125 cases, she found that only half the women were screened for colorectal cancer, and two of them had developed it. Before completing the other 125 cases, she asks her advisor how she should handle the results. Her advisor tells her to contact the IRB.
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 STSIís Educational Program
URL http://www.stsiweb.org/index.php/about/bio/diamant
RCR Keyword

Other RCR Keywords Colon Cancer; Colorectal Cancer; Conflict of Interest; Endometrial Cancer; Fellows; Genetic Mutation; Genetic Testing; Hereditary Non-polyposis Colorectal Cancer (HNPCC); Human Subjects; IRB; Minimal Risk; Protocol; Research Project; Residents; Retrospective Chart Review; Screened; Study Numbers; Uterine Cancer; Waiver of Informed Consent and Authorization
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.
References

Other

Topic revision: r3 - 28 Oct 2011 - 13:30:41 - MaryBanach
 
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