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EthicsCaseStudyForm edit

Title Secondary use of a research database
Long Title Secondary use of a research database
Contributor/Contact M. E. Blair Holbein, PhD, BCAP (Blair.Holbein@UTSouthwestern.edu)
Contributor Details M. E. Blair Holbein, PhD, BCAP
Director, Clinical Investigator Resource Center
UT Southwestern Medical Center
CTSA UT Southwestern
Case Study Provided You are an IRB member reviewing a protocol. The project is from the Bioinformatics department. They have received an exceptionally large grant from Verybig Corp to develop a health information data repository which includes a very innovative genetic information component.
Accompanying the grant is a contract to use the database to track healthcare information on Verybig employees. Since Verybig has a self-insured healthcare plan, they want to be able to track health information for their employees derived from healthcare results and claims and plan to access the information to make “wellness” interventions.
Data Acquisition, Management, Sharing and Ownership Topics
Ethical values behind the scientific standards for data acquisition_management_sharing and ownership,
Data acquisition issues,
Data storage protection and archiving,
Data sharing,
Legal aspects of data ownership and rights,
Data privacy
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 M. E. Blair Holbein, PhD, BCAP
URL http://www.utsouthwestern.edu/education/medical-school/departments/clinical-sciences/divisions/ethics-health-policy/index.html
RCR Keyword Conflict of Interest
Other RCR Keywords Bioinformatics Department; Claims; Contract; Database to Track Healthcare Information; Employee’s Privacy; Employees; Grant; Health Information Component; Human Subjects; IRB Member; Protocol; Self-insured; Wellness Interventions
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: r2 - 28 Oct 2011 - 13:21:33 - MaryBanach
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