This guidance addresses whether an investigator may retain and analyze data already collected where a subject withdraws from a study.
COUHES recommends that when seeking the informed consent of subjects, investigators explain to the subjects what will happen with their data when they decide to withdraw from the research.
When subjects withdraw from a study before their participation is complete or before data analysis for the study has concluded, investigators should inform subjects during the informed consent process whether they intend to either:
- retain and analyze already collected data relating to the subject up to the time of subject’s withdrawal; or
- honor a research subject’s request that the investigator destroy the subject’s data or that the investigator exclude the subject’s data from any analysis.
When a subject’s participation is complete and data analysis has concluded, our ability to honor a subject’s request to withdraw from a study is limited. All such requests will be reviewed on a case-by-case basis.
This guidance applies to human subjects research that is NOT subject to FDA regulations or the HIPPA Privacy Rule.