Conflicts of interest
This presentation is the property of its rightful owner.
Sponsored Links
1 / 18

Conflicts of Interest PowerPoint PPT Presentation


  • 70 Views
  • Uploaded on
  • Presentation posted in: General

Conflicts of Interest. CIPP 909 Research Ethics March 10, 2010. Joe Giffels Research Integrity Office [email protected] Some Things to Think About. Which aspects of a given situation constitute CoI? Which are directly financial and which are not?

Download Presentation

Conflicts of Interest

An Image/Link below is provided (as is) to download presentation

Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.


- - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - -

Presentation Transcript


Conflicts of interest

Conflicts of Interest

CIPP 909 Research Ethics

March 10, 2010

Joe Giffels

Research Integrity Office

[email protected]


Some things to think about

Some Things to Think About

  • Which aspects of a given situation constitute CoI? Which are directly financial and which are not?

  • How can CoI affect the conduct of research? Of the scientific record?

  • What are the ramifications of CoI for scientists as researchers? As consumers of scientific information?


Some more things to think about

Some More Things to Think About

  • What can scientists do to avoid the ramifications of CoI?

  • What regulations apply to CoI in research?

  • How is CoI in research routinely managed?

  • How shouldCoI in research be managed?


Conflicts of interest

Conflict of Interest

Situation in which the integrity of academic activity, especially research, may be, or may be perceived to be, compromised by financial or other interests.


Conflicts of interest

Conflicts of Interest

  • Most are financially based

  • Some are just accepted

    • Owning an hypothesis

    • Research results as proprietary information pending publication

    • Continuing research support

    • Developing intellectual property


Conflicts of interest

Similarities

Scientist

Entrepreneur

Reputation is a key asset

It’s all about gaining acceptance of a new idea

Passion for the enterprise is essential


Conflicts of interest

Differences

Entrepreneur

Scientist

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


Conflicts of interest

Sources of Potential Conflict

  • Consultant

  • Speaker

  • Stock or Other Equity

  • Management Position

  • Income from Royalties or Licensing Fees

  • Board or Scientific Advisory Board Member

  • Gift

  • Relationship with Competitor

  • Loans (To or From)

  • Family Member has Relationship

Institutional vs Invididual CoI


Conflicts of interest

Does conflict of interestpresent a legitimate concern?

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

Maintaining full academic integrity would compromise the business plan and/or require excess resources


Conflicts of interest

Examples of What We are Guarding Against

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


Conflicts of interest

Relationship betweenFunding Source and Conclusion amongNutrition-Related Scientific Articles

  • 111 of 206 articles declared financial sponsorship

    • 22% had all industry funding

    • 47% had no industry funding

    • 32% had mixed funding

  • Funding source was significantly related to conclusions for all article types (p=0.037)

    • Odds ratio of favorable to unfavorable conclusions for all industry funding vs no industry funding was 7.61

  • Interventional studies

    • 0% unfavorable conclusions for all industry funding

    • 37% unfavorable conclusions for no industry funding

Data from Lesser, et al. PLoS Medicine, Jan 2007, pp 0001-0006


Conflicts of interest

October 25, 2009

University Doctors Got Paid in Drug's Sales Campaign

Money for speeches highlights murky area for conflicts of interest

Getty Images

By Paul Basken

Fourteen university-affiliated physicians collected more than $400,000 from the makers of the anti-cholesterol drug Vytorin as part of a campaign to encourage the use of the medication. The 2008 campaign went on after an internal company study showed that the drug, with several billion dollars in sales, had little or no overall value for most patients.


Maryland public ethics law

Maryland Public Ethics Law

Code of Maryland Regulations

15-501 and 15-523


Conflicts of interest

Applicable Policies and Procedures

USM Policy On Conflicts of Interest In Research or Development

www.umaryland.edu/hrpolicies/section3/t30111sa.html

UMB Procedures Implementing Board of Regents Policy on COI…

www.ord.umaryland.edu/researchers/policies/umproceed.php


Conflicts of interest

Applicable Policies and Procedures(cont’d)

UMB IRB Policies and Procedures

6c: Investigator and Study Personnel Conflicts of Interest http://medschool.umaryland.edu/orags/hrpo/HRPP_Policies.pdf


Conflicts of interest

NIH Objectivity In Science

http://grants1.nih.gov/grants/compliance/42_CFR_50_subpart_F.htm


Conflicts of interest

Reporting Requirements

  • Internal to UMB

    • As required in provisions

    • Annually

    • Whenever a significant change occurs

  • External to UMB

    • Chancellor

    • State Ethics Commission

    • Public Record

    • Research Sponsors, where applicable


Conflicts of interest

Exemption Provisions/Conditions(examples)

Conflict of Commitment

Insider Trading


  • Login