What to do with data from participants who have withdrawn from a research study?
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A patient compliance intervention has been ongoing for one year in a county Public Health tuberculosis clinic. The recruitment efforts are focused on a vulnerable population that are primarily lower socioeconomic, unemployed, homeless, and suffer for a number of other medical and social problems. The research protocol requires research staff to conduct a medical chart review and administer a baseline interview following recruitment. Despite obtaining informed consent, some of the data collected will be highly sensitive. After twelve months (data collection period is 24 months), the principal investigator finds that 20% of the recruits have withdrawn for various reasons (some have died, moved away, were incarcerated). While the research protocol is fairly clear on recruitment procedures, there is minimal information regarding procedures following participant withdrawal. While the participants' informed consent provided permission to collect and analyze data, a research assistant questions the principal investigator's decision to use data from participants who have withdrawn from the study. The issue in question is whether withdrawing participants are viewed as also withdrawing their permission to analyze the collected data. A decision has to be made at the midpoint of data collection. What should the researchers do with this data?Taking the role of the researcher, decide to act on one of the following options:
|  | The researchers decides to continue collecting data and intend to use baseline data for analysis. How should the data be handled?
|  | The researchers decide to remove data collected from subjects who have withdrawn and only analyze those who completed intervention.
|  | The researchers decide to keep the data from subjects who withdrew and ask a new research question: Are subjects who withdraw from intervention different from those who complete an intervention?