Conflicts of Interest in Research School of Pharmacy October 13, 2009 Joe Giffels Research Integrity Office firstname.lastname@example.org www.umaryland.edu/research_integrity Some Things to Think About
The Federal Trade Commission will try to regulate blogging for the first time, requiring writers on the Web to clearly disclose any freebies or payments they get from companies for reviewing their products.
The FTC said Monday its commissioners voted 4-0 to approve the final Web guidelines, which had been expected. Violating the rules, which take effect Dec. 1, could bring fines up to $11,000 per violation. Bloggers or advertisers also could face injunctions and be ordered to reimburse consumers for financial losses stemming from inappropriate product reviews.
The commission stopped short of specifying how bloggers must disclose conflicts of interest. Rich Cleland, assistant director of the FTC's advertising practices division, said the disclosure must be "clear and conspicuous," no matter what form it will take.
Situation in which the integrity of academic activity, especially research, may be, or may be perceived to be, compromised by financial or other interests.
Reputation is a key asset
It’s all about gaining acceptance of a new idea
Passion for the enterprise is essential
Produces data which may be built upon
Uses the scientific method
Rules out alternatives to an idea
Avoids risky approaches to a problem
Produces something marketable
Uses business development models
Develops support for an idea
Is comfortable accepting and managing risk
Institutional vs Invididual CoI
Financial interests steer the academic activity to the point where it is compromised
Financial interest gives the appearance that the academic activity may be compromised
Deciding not to publish research results which would be harmful to the entity
Agreeing to develop a research protocol to the entity’s specifications
Falsifying or fabricating research results which would be beneficial to the entity
Conducting research which poses significant risk in order to develop a technology licensed by the University
Relationship betweenFunding Source and Conclusion amongNutrition-Related Scientific Articles
Data from Lesser, et al. PLoS Medicine, Jan 2007, pp 0001-0006
Conflict of Commitment
Code of Maryland Regulations
15-501 and 15-523
USM Policy On Conflicts of Interest In Research or Development
UMB Procedures Implementing Board of Regents Policy on COI…
UMB IRB Policies and Procedures
6c: Investigator and Study Personnel Conflicts of Interest http://medschool.umaryland.edu/orags/hrpo/HRPP_Policies.pdf
Alice Pharmer is a SOP faculty member whose research involves predictors of the extent to which a generic drug will be substituted for an established product. Over the years, she has published regularly in the scientific literature. She is known for having developed “Pharmer’s Almanac,” a list of predictors and their relative contributions to a utilization algorithm.