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Conflicts of Interest in Research School of Pharmacy October 13, 2009 Joe Giffels Research Integrity Office jgiff001@umaryland.edu www.umaryland.edu/research_integrity Some Things to Think About

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conflicts of interest in research

Conflicts of Interest in Research

School of Pharmacy

October 13, 2009

Joe Giffels

Research Integrity Office

jgiff001@umaryland.edu

www.umaryland.edu/research_integrity

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?
slide4
FTC: Bloggers must disclose payments for reviews By DEBORAH YAO, AP Business Writer - Mon Oct 5, 2009 2:47PM EDT

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.

slide5

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.

slide6

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
slide8

Similarities

Scientist

Entrepreneur

Reputation is a key asset

It’s all about gaining acceptance of a new idea

Passion for the enterprise is essential

slide9

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

slide10

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

slide11

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

slide12

Jesse

Gelsinger

slide13

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

slide14

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

slide15

Exemption Provisions/Conditions(examples)

Conflict of Commitment

Insider Trading

maryland public ethics law

Maryland Public Ethics Law

Code of Maryland Regulations

15-501 and 15-523

slide17

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

slide18

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

slide19

NIH Objectivity In Science

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

case study
Case Study

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.

questions
Questions
  • Does this line of research have intrinsic academic value?
  • Does this line of research have value outside of academe? To whom?
case study cont d
Case Study (cont’d)
  • Kamal Singh joins Dr Pharmer’s lab as a graduate student. Kamal wants to land a top management position in a pharmaceutical firm when he grows up. He is bright and something of an entrepreneur. He finds peer-reviewed research grant writing to be a tedious task and, in his case, a waste of time.
case study cont d23
Case Study (cont’d)
  • Kamal and Dr Pharmer agree that, for Kamal’s dissertation, he will develop a utilization algorithm for a specific drug. The chosen drug has been a blockbuster for Nofartis Pharmaceuticals, but will be coming off patent in 3 years. Kamal suggests to Dr Pharmer that they approach Nofartis for funding for Kamal’s dissertation research.
questions24
Questions
  • Would Nofartis be interested enough in this research project to provide funding?
  • If so, what conditions might Nofartis try to impose on Dr Pharma and Kamal?
  • What conditions should Kamal and Dr Pharma insist upon if they are going to accept funding from Nofartis?
case study cont d25
Case Study (cont’d)
  • A Research Agreement between the University and Nofartis is executed. Excellent progress is being made as evidenced by periodic reports prepared for Nofartis. At the end of 18 months, Dr Pharmer encourages Kamal to submit his utilization algorithm for this drug for publication and for presentation at an international conference.
questions26
Questions
  • What CoI issues might arise if:
    • Nofartis asks Dr Pharmer to be a paid consultant?
    • Dr Pharmer gets married and her new spouse owns 10,000 shares of Nofartis stock?
    • Nofartis suggests there will be a management trainee position waiting for Kamal when he graduates?
  • How might each of these financial conflicts of interest be managed?
conflicts of interest in research27

Conflicts of Interest in Research

School of Pharmacy

October 13, 2009

Joe Giffels

Research Integrity Office

jgiff001@umaryland.edu

www.umaryland.edu/research_integrity