Certain COI Management Plans (CMPs) for bench, animal, and human subject research incorporate a data steward or data steward committee.
A data steward or data steward committee provides a safeguard against any possible bias in the design, conduct, or reporting of research where an investigator holds an outside financial interest giving rise to a conflict. Data stewards are responsible for meeting with the designated study team periodically, but not less than annually, to review data collection and interpretation.
Data stewards submit annual reports to the COI Office and COI Committee (COIC) documenting dates and times of meetings and providing their opinion on integrity and interpretation of data.
Cases Requiring Data Steward Oversight
The placement of a data steward or data steward committee is generally at the discretion of the COI Committee and/or the conflicted investigator's department chairperson or equivalent supervisor.
However, the following specific cases may require data steward oversight:
- Any study with a PI and/or co-investigator(s) holding a relevant Significant Financial Interest (SFI) when there are no other non-conflicted faculty-rank investigators on the study team
- FDA-covered clinical studies when the Principal Investigator (PI) holds a SFI
- Animal research projects with a conflicted investigator subject to COI management that have a USDA Pain and Distress Classification of Category "E"
Report Template and Guidance Information
Data Steward Report (Microsoft Word) »
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