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EthicsCaseStudyForm edit

Title A "too friendly" DSMB
Long Title A "too friendly" DSMB: Data Safety and Monitoring Board Case Study
Contributor/Contact Daniel T. Lackland, DRPH (lackland@musc.edu)
Contributor Details Daniel T. Lackland, DRPH
Department of Neurosciences Institute for Human Values in Health Care
Medical University of South Carolina
19 Hagood Ave.
Charleston, SC 29403
Case Study Provided A clinical investigator is doing a study involving the use of cardiovascular agents in combination. Recognizing the requirement for the DSMB by NIH, the investigator carefully prepares his recommendation.

In the past, the investigator has felt the DSMB has slowed his research significantly. Thus, he has recommended members of the DSMB “friendly” to his research. Over drinks at a conference, he indicated he has the DSMB in the “palm of my hand.” An investigator who focuses on ethics was furious and contacted the NIH and institution research division. NIH demands the university resolve this situation as they have already approved the DSMB.
Data Acquisition, Management, Sharing and Ownership Topics
Ethical values behind the scientific standards for data acquisition_management_sharing and ownership,
Scientific methodology issues including research design_objectivity and bias,
Special issues related to scientific roles
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
Significance of misconduct,
Factors that contribute to scientific misconduct,
Other serious deviations from scientific best practices,
Regulations and policies addressing misconduct,
Responding to observed misconduct
Conflicts of Interest, Law and Policy Topics
The significance of conflicts of interest,
Types_definitions and examples of conflicts of interest,
Institutional conflicts of interest,
Managing conflicts of interest
Human Subjects Human subjects research

URL https://sctr.musc.edu/
RCR Keyword Research Misconduct, Grant, Conflict of Interest, Delaying the Review Process
Other RCR Keywords Cardiovascular Agents; Clinical Investigator; Conference; Contacted the NIH and Institution Research Division; DSMB “friendly” to his Research; DSMB Slowed his Research; Ethics; Requirement for DSMB by NIH; Resolve; University
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 - 12 Nov 2011 - 16:10:39 - MarkYarborough
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