Conflicts of Interest

Summary

Author: Michael Kalichman, 2001
Contributors: P.D. Magnus, Dena Plemmons
Updates: Michael Kalichman, 2016


What is a conflict of interest?

We often find ourselves faced with two or more competing interests, creating the perception, if not the reality, of an increased risk of bias or poor judgment.

We are most familiar with financial conflicts. For example, a researcher could be studying a new product for which they will receive significant financial rewards if their studies result in positive findings. However, conflicts can come from many other competing interests, such as career advancement or responsibilities to family or friends.

What should you do?

Background



Overview


Financial vs. Non-Financial Conflicts

A common worry is that financial interest in the outcomes of research can result in unethical behavior or even criminal misconduct.

However, it is also plausible that interests other than financial interests could compromise the responsible conduct of research.

Examples of non-financial interests that might conflict with the integrity of science include:


Conflicts of Conscience

Another potential conflict can come in the form of conscience. An individual might suffer a conflict of conscience if, for example, the mission or expectations of the institution are incompatible with his or her personal values.

Risks of Conflicts of Interest

Risks of conflicts of interest are not merely hypothetical. Financial conflicts are associated with altered outcomes of research. For example:


Intentional Bias: Is it Research Misconduct?

Conflicts of interest do not necessarily amount to research misconduct. However, if the potential for personal gain is great, then principles that guide responsible conduct in research may be compromised. In an extreme case, it is conceivable that someone could knowingly compromise principles of good scientific practice in pursuit of a particular research finding our outcome.

Unintentional bias

Conflicting interests are more likely to result in unintentional rather than intentional bias. For example:

Unintentional bias can be a more serious threat than deliberate misconduct, because even those who are biased would be unaware of the ways in which their behavior had been altered.

Disclosure of Conflicts

Declaring that you have a conflict of interest is typically called disclosure.

In practice disclosure of research conflicts usually occurs only for financial interests. Historically, such disclosure was not routine, even in the biomedical literature (Krimsky and Rothenberg, 2001):

Today, most journals require disclosures of financial conflicts. Disclosure not only alerts readers to the increased possibility of unintentional bias, but it could strengthen the resolve of an individual researcher to choose research designs that minimize the risk of their bias.

Perceptions may outweigh even the best of practices

When large sums of money are involved, it may be difficult for the public, legislators, the judicial system, and even colleagues to be convinced that results were not biased for personal gain.

Perceived impropriety can result in consequences as damaging as if intentional misconduct had been committed.

With increased media, governmental, and public scrutiny, a researcher's reputation, research funding, and employment can depend as much on perceptions of integrity as on integrity itself.

Regulations and Guidelines



A variety of regulations and guidelines govern the disclosure and management of conflict of interest. Although many concerns could be generalized to any form of conflict of interest, the focus of regulations tends to be financial. The most relevant of these are federal regulations, notably those of the Public Health Service (PHS) and National Science Foundation (NSF).


Professional societies and journals are another important source for guidance on the management of conflicts of interest. These are quite variable in their scope and not always enforced, but three examples are noteworthy:
  1. Requirements for publication in the New England Journal of Medicine.
    As early as 1984, the journal requested that "all authors disclose to [the Editor] any associations they had with businesses that could be affected by their work -- including direct employment and consultancy, stock ownership, and patent-licensing arrangements." (Angell and Kassirer, 1996).
  2. Policy statement from the American Society of Gene Therapy (ASGT).
    The ASGT concluded that "investigators and team members directly responsible for patient selection, the informed consent process and/or clinical management in a trial must not have equity, stock options, or comparable arrangements in companies supporting the trial." (Woo, 2000).
  3. Guidelines from the Association of American Medical Colleges and the Association of American Universities (AAMC-AAU, 2008)
    This report resulted in 15 recommendations to address conflicts of interest through the roles and responsibilities of individuals, institutions, and at the federal government.
These guidelines and regulations represent a recognition by regulatory and scientific communities that the integrity of science is placed at risk by the presence of unmanaged or substantial conflicts of interest.

Discussion

Discussion Questions

  1. Define conflict of interest.
  2. List and describe three distinct conflicts of interest that are not financial.
  3. What interests, other than financial, do you have in obtaining positive results in your research?
  4. Why is a financial conflict of interest not necessarily considered to be misconduct? Discuss circumstances under which a financial conflict of interest might result in misconduct.
  5. If you were reading the work of another scientist, then what, if anything, do you need to know about interests of that scientist that might be in conflict with a published work? If it were relevant to the subject of the paper, which of the following would you want to know about an author's interests:
      a. Financial stake (e.g., ownership, stock, stock options) in a company that markets the product discussed in the paper
      b. Financial stake (e.g., ownership, stock, stock options) in a company that markets a product similar to the one discussed in the paper
      c. Previous support (e.g., research materials, grants, or contracts) from a company that markets the product discussed in the paper
      d. Current or previous role as a consultant with a company that markets the product discussed in the paper
      e. Physical or psychological conditions (e.g., depression or diabetes) of the author that are also the subject of the paper
      f. Sexual orientation of the author for research that excludes, or includes, a genetic basis for homosexuality
Case Studies



Resources

  1. AAMC-AAU Advisory Committee on Financial Conflicts of Interest in Human Subjects Research (2008): Protecting Patients, Preserving Integrity, Advancing Health: Accelerating the Implementation of COI Policies in Human Subjects Research. AAMC.
  2. Angell M, Kassirer JP (1996): Editorials and conflicts of interest. New England Journal of Medicine 335(14): 1055-6.
  3. Brainard J (2000): The Ties That Blind? (financing that might influence medical research) Chronicle of Higher Education. Sept. 8, 2000 47(2): A31.
  4. Krimsky S, Rothenberg LS (2001): Conflict of interest policies in science and medical journals: Editorial practics and author disclosures. Science and Engineering Ethics 7:205-218.
  5. NSF (2016): NSF Conflict of Interest Policy.
  6. PHS (2011): Subpart F—Promoting Objectivity in Research. Code of Federal Regulations.42 C.F.R. Part 50, Subpart F.
  7. Stelfox HT, Chua G, O'Rourke K, Detsky AS (1998): Conflict of interest in the debate over calcium-channel antagonists. New Engl J Med 338(2): 101-106.
  8. Woo SL (2000): Policy of the American Society of Gene Therapy on financial conflict of interest in clinical research. Mol Ther 1(5 Pt 1): 383-4.
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