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Title Uwelcome Secondary findings by the DSMB
Long Title Uwelcome Secondary findings by the DSMB
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
CTSA MUSC
Case Study Provided A new drug to reduce obesity is in a late phase of study. The results are very significant regarding weight reduction. However, there appears a higher prevalence of depression in some of the trial participants. The study design did not include an assessment to determine if depression was associated with the treatment. In response to the finding the investigators indicated that "obese people tend to be more depressed.
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
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

URL https://sctr.musc.edu/
RCR Keyword Ideas
Other RCR Keywords Assessment for Depression; Investigators; Late Phase; New Drug; Prevalence of Depression; Reduce Obesity; Study Design; Treatment; Trial Participants
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: r2 - 12 Nov 2011 - 16:13:55 - MarkYarborough
 
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