Page 8 - Research Compliance Welcome Package

BSWH Conflict of Interests Management
Research Compliance Tip Sheet
Considerations for key study personnel (KSP) with outside professional activities/industry relationships
MONETARY THRESHOLDS TO CONSIDER
$5,000 (further analysis required for PHS-funded research) $25,000 (can’t obtain consent or collect research data) $50,000 (not allowed to serve in PI role)
KEEP IN MIND
 Further detail regarding COI in BSWH research may be found in the Financial Conflicts in Research Policy (BSWH.CMPL.RES.006.P)
 PHS-funded research (and other non-PHS agencies that require compliance with the PHS regulation) is subject to 42 CFR 50, Subpart F
 The BSWH COI Program currently operates on the fiscal year (July 1st - June 30th) while Open Payments Data reflects data from the previous calendar year
All Key Study Personnel
PHS-Funded Key Study Personnel
Additional Requirements
COI disclosure prior to engagement in research
COI disclosure prior to application for funding
BSWH determination relative to a financial COI for threshold of $5,000
Restrictions for thresholds of $25,000 and $50,000
Required COI training
PHS REGULATION
• 42 CFR 50, Subpart F: Responsibility of Applicants for Promoting Objectivity in Research for Which PHS Funding is Sought
• Requires disclosure:
• No later than the time of application for funding
• At least annually thereafter
• Within 30 days of discovering/acquiring a new significant financial interest
• Requires education on COI (BSWH uses the CITI program for this education):
• Prior to engaging in research
• Every four years
• Immediately in certain circumstances (e.g., investigator new to institution)
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10/30/18