# Presentation: 727277

## Conflict of Interest in Human Subjects Research

- Bette-Jane Crigger, PhD

**Notes:**
When Lynn Cates & I discussed how I might focus this talk, she said I should talk about what most passionately interests me. So I will. And I’ll start with my favorite slide . . . 

## Diverging Interests

- Competing Responsibilities

## Defining conflict of interest

- Over *and* under interpreted:
- Not every financial interest is a conflict of interest, ethically or legally
- Not every conflict of interest involves financial interests

## “Conflicts of interest are a ‘set of conditions in which professional judgment concerning a primary interest (such as a patient’s welfare or the validity of research) tends to be unduly influenced by a secondary interest (such as financial gain)’.”

- Bekelman JE, Li Y, Gross CP. Scope and impact of financial conflicts of interest in biomedical research. A systematic review. *JAMA *2003;289:454-65, 454 [emphasis added].

## Conflict of interest—why worry?

- Potential adverse effects on
- Safety, well-being and rights of human research participants
- Integrity of research and quality of data
- Dissemination of data and scientific collaboration
- Public safety and well-being
- Public trust in the research enterprise

## Types of conflict

- Conflicts involving benefits received (financial, professional, etc.)—which can be institutional as well as individual
- Conflicts involving dual roles—which again can be individual or institutional
- Conflicts involving institutional structures and processes

## Benefit-driven conflicts

- “Significant financial interest”
- Consulting fees, honoraria, gifts, “in kind” compensation from a financially interested company
- Equity interests
- Royalty income
- Nonroyalty income not directly related to the costs of the research
- Service as an officer, director, or in another fiduciary role for a financially interested company

## Role-driven conflicts

- Incommensurate responsibilities:
- Clinician-investigator
- Promote the health and welfare of the individual patient
- Promote the advancement of science in the public interest

## IRB
Protect human subjects of  research
Serve the interests of the research institution

- Protect human subjects of  research
- Serve the interests of the research institution

## “Structural” conflicts--IRBs

- Reporting relationships that can compromise independence
- Disproportionate representation among members
- Institutional vs. noninstitutional
- Professional vs. lay
- Departmental/disciplinary diversity

**Notes:**
IG:  “We found several examples of hospital IRBs that are housed in offices of grants and contracts or in clinical research programs, the very offices geared to bring in research dollars.” (1998: 7)

## Managing conflict

- Conflicts involving benefits received
- Disclose competing interests
- Monitor conduct of research
- Divest
- Forgo research in which there are significant conflicts that cannot be effectively managed

## Conflicts involving multiple roles
Disclose research responsibilities
Prohibit recruitment by treating health care professional
Prohibit research involving investigator’s current/former patients

- Disclose research responsibilities
- Prohibit recruitment by treating health care professional
- Prohibit research involving investigator’s current/former patients

## Structural conflicts
Maintain “structural distance” in reporting relationships
Separate responsibilities for financial decisions and research decisions
Assure diversity of perspectives and institutional relationships in IRB composition

- Maintain “structural distance” in reporting relationships
- Separate responsibilities for financial decisions and research decisions
- Assure diversity of perspectives and institutional relationships in IRB composition