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EthicsCaseStudyForm edit

Title We’re Not Recruiting Enough Participants!
Long Title We’re Not Recruiting Enough Participants!
Contributor/Contact John Banja, PhD? (jbanja@emory.edu)
Contributor Details John Banja, PhD?
Director, Sections Ethics in Research
Atlanta Clinical and Translational Science Institute
Emory University
Atlanta, GA 30322

CTSA Emory
Case Study Provided I recall a cancer study I participated in where our patient recruitment numbers were dismal. One day, though, a research associate received a call from a potential participant who said she received a letter inviting her to participate in a clinical trial. She said she would like to be enrolled. However, this potential participant was sent an invitation letter by mistake because she lived outside the geographical recruitment area that we stipulated in our proposal. Also, she said she was only interested in being in the experimental group, not in the control group.

The research associate knew that the randomization table indicated that the next several people to be enrolled were going to the control group, but he manipulated the randomization schedule so that he could enroll the patient in the intervention group. His rationalization was that the study enrollment was down, and if the potential subject was enrolled and then told she was going to be in the control group, she would drop out.

Was the associate’s recruitment manipulation unethical? What are the ethical factors that need to be considered?
Data Acquisition, Management, Sharing and Ownership Topics

Mentor and Trainee Responsibilities Topics

Publication Practices and Responsible Authorship Topics

Peer Review Topics

Collaborative Science Topics

Research Misconduct Topics
Significance of misconduct,
Other serious deviations from scientific best practices
Conflicts of Interest, Law and Policy Topics

Human Subjects Human subjects research

URL http://www.actsi.org/areas/erks/ethics/index.html
RCR Keyword Research Misconduct
Other RCR Keywords Biased; Cancer Study; Control Group; Experimental; Geographical Recruitment; Group; Intervention Group; Letter; Manipulated; Nonbiased; Patient Recruitment; Potential Participant; Randomization Table; Recruitment Manipulation; Recruitment Protocol; Research Associate
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: r1 - 02 Nov 2011 - 18:34:33 - DebieSchilling
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