Conflict of Interest in Clinical Research

Disclosure, Independence and Managing Conflicts at the Research Site

For every member of a research site team: coordinators, investigators and sub-investigators, research nurses, pharmacists and regulatory staff. What a conflict of interest is and why it matters to participants, data and the site; the US rules (FDA financial disclosure under 21 CFR Part 54, Forms FDA 3454 and 3455, and the Public Health Service rule for federally funded research, 42 CFR Part 50 Subpart F) and the IRB's role; what ICH E6(R3) and the Declaration of Helsinki expect, with regional pointers for the EU and UK marked as orientation, not legal advice; conflicts by role at the site; and managing and documenting conflicts through disclosure, recusal, management plans, consent and escalation. Five modules, each with an assessment graded at 80 percent, plus a final assessment. Draft: not yet reviewed by a subject-matter expert. Your institution's policy and your sponsor's instructions may add requirements.

15 lessons, about 78 minutes. Free, in your language.

What a Conflict of Interest Is and Why It Matters

The US Rules

GCP and International Expectations

Conflicts by Role at the Site

Managing and Documenting Conflicts