The goal of this research is to understand how study coordinators in clinical research deal with recruitment, informed consent, and retention of subjects. The focus is on potential conflicts between obligations to the PI and the studyto increase recruitment and obligations to subjects who may be ambivalent. Seven focus groups of study coordinators, including two at the NIH, three at UNC, and two from study coordinators working in the private sector, were conducted. We found that study coordinators are often engaged with the ethically sensitive issues that arise during subject recruitment, retention, and informed consent. They constantly balance three types of advocacies: advocacy for the patient, the subject, and the study. Throughout the conduct of a clinical trial, study coordinators must address and resolve conflicts that arise from the potential incompatibility of these three advocacies. Despite expected differences by workplace, focus group participants across all settings identified each of the advocacies and the need to keep them in balance. Our results provide clear evidence that study coordinators are key moral agents in research activities.

Agency
National Institute of Health (NIH)
Institute
National Human Genome Research Institute (NHGRI)
Type
Intramural Research (Z01)
Project #
1Z01HG000142-03
Application #
6681531
Study Section
Molecular Genetics B Study Section (MGB)
Project Start
Project End
Budget Start
Budget End
Support Year
3
Fiscal Year
2002
Total Cost
Indirect Cost
Name
Human Genome Research
Department
Type
DUNS #
City
State
Country
United States
Zip Code