Conflicts of Interest

Researchers’ interests can and often do conflict with one another. The advancement of knowledge is usually best served by sharing ideas with colleagues, putting many minds to work on the same problem. But personal gain is sometimes best served by keeping ideas to oneself until they are fully developed and then protected through patents, copyrights, or publications. Legitimate research interests can create competing responsibilities and lead to what is commonly called conflicts of interest.

 

Financial Conflicts of Interest

Financial conflicts of interest are situations that create perceived or actual tensions between personal financial gain and adherence to the fundamental values of honesty, accuracy, efficiency, and objectivity.

Financial interests are not inherently wrong. Researchers are permitted to benefit financially from their work. A 1980 Congressional law known as the Bayh-Dole Act encourages researchers and research institutions to use copyrights, patents, and licenses to put research ideas to use for the good of the public. Prior to this time, there were no uniform policies regulating the ownership of ideas developed with public funding. Bayh-Dole essentially gives that ownership to research institutions as an incentive to put ideas to work for the overall good of society. It not only approves of but, in fact, strongly encourages researchers and research institutions to have financial interests as a way of ensuring that the public’s investment in research is used to stimulate economic growth.

While financial interests should not and in most instances do not compromise intellectual honesty, they certainly can, especially if the financial interests are significant. Universities are currently starting hundreds of new businesses based on researchers’ ideas. Some of these businesses will generate significant profits (hundreds of thousands to millions of dollars each year). If the difference between commercial success and failure rests on one key publication, the pressure to put the best face on that publication can be considerable.

Financial conflicts also arise from the ever-present pressure researchers have to secure funds to support their research. A private sponsor might withdraw support from a project if it does not produce the “right” results. Success in the stiff competition for research grants can rest on having the “right” preliminary results. Research is expensive, funding often in short supply. The pressure simply to survive, much less profit personally, can and does create financial conflicts of interest.

Federal policies. Concerns about the actual or potential adverse effect of financial interests on research prompted the Public Health Service (PHS) and the National Science Foundation (NSF) to adopt conflict of interest policies in the mid-1990’s. These policies require research institutions to establish administrative procedures for:

  • reporting significant conflicts before any research is undertaken;
  • managing, reducing, or eliminating significant financial conflicts of interest; and
  • providing subsequent information on how the conflicts were handled.

Significant financial conflict is defined as:

  • additional earnings in excess of $10,000 a year, or
  • equity interests in excess of 5 percent in an entity that stands to benefit from the research.

The financial interests of all immediate family members are included in these figures.

State and local policies. Although the Federal requirements apply only to PHS- and NSF-funded research, many research institutions have adopted global policies that apply to all researchers. Many also use different values for defining significant, to as low as any financial interest. Researchers therefore should check their local conflict-of-interest policy to find out when and what they are required to report. They also need to keep in mind that many states have their own conflict-of-interest policies, which apply to all state-paid employees.

Professional societies and journal policies. A number of professional societies have issued reports or made -recommendations on appropriate ways to handle conflicts of interest. Similarly, more and more journals now require researchers to disclose real or potential financial conflicts. Sometimes disclosure must be made to the journal editor, who decides what, if any, action is needed. Sometimes disclosures must be included in the publication itself. Before submitting an article to a journal for publication, researchers should carefully check and make sure they have followed that publication’s conflict of interest policies.

 

Conflicts of Commitment

Conflicts of commitment arise from situations that place competing demands on researchers’ time and loyalties. At any time, a researcher might be:

  • working on one or more funded projects;
  • preparing to submit a request for a new project;
  • teaching and advising students;
  • attending professional meetings and giving lectures;
  • serving as a peer reviewer;
  • sitting on advisory boards; or
  • working as a paid consultant, officer, or employee in a private company.

Each of these activities requires time and makes demands on a researcher’s institutional commitments. Care needs to be taken to assure that these commitments do not inappropriately interfere with one another.

Allocation of time. Researchers must be careful to follow rules for the allocation of time. Federally funded researchers must follow the rules for cost accounting published by the Office of Management and Budget in a document known as Circular A-21. Most research -institutions also have rules for how researchers spend their time, particularly time serving as paid consultants, giving paid lectures, or working as an employee in a private company. At a minimum, these rules require that researchers:

  • honor time commitments they have made, such as devoting a specified percentage of time to a grant or contract;
  • refrain from charging two sources of funding for the same time; and
  • seek advice if they are unsure whether a particular commitment of time is allowed under an institution’s or the Federal Government’s policies.

Although researchers will frequently work on several projects at the same time, in the final analysis primary work obligations must be met. In addition, the time devoted to one project ordinarily cannot be billed to another.

Relationships with students. Academic researchers involved in start-up ventures often have opportunities to hire students. This puts them in a situation where they can hire their own students. As mentors, they have a primary obligation to help students develop into independent researchers. As heads of start-up companies, their primary obligation is to see promising ideas commercialized. While the two responsibilities can complement one another, they can also be in conflict. Should an individual who is both the researcher’s student and employee be advised to develop a promising idea that could lead to an independent career or to work on a more routine problem that will benefit the start-up company? Situations such as these create conflicts and should be avoided or appropriately managed.

Use of resources. Equipment and supplies purchased with public funds can easily be used to advance private research interests. While this might seem like a harmless practice, particularly if the equipment is not in constant use, unless a researcher has permission to use the equipment to support private research, this practice is not appropriate. The equipment can be used for other university work since this is allowed by the government. But it cannot be used for a personal project without permission. It also cannot be used for research that is explicitly prohibited by the Federal government, such as stem cell research using lines not authorized by the President’s policy.

Disclosure of affiliations. It is widely agreed that outside affiliations that create conflicts of interest should be listed on academic publications, but should researchers list their academic affiliations on other publications? As president or CEO of a new company, is it appropriate for a researcher to also note in the end-of-the-year financial report that she or he is also a full professor at a prestigious university? Should researchers who serve on private boards list their academic affiliation? Researchers must be careful to separate their academic or institutional work from their private work. In particular, they should not inappropriately use their institutional research affiliation to advance their private interests by implying, for example, that private work has the support of their research institution if it does not.

Representing outside entities. The results researchers commercialize in private ventures, such as drugs used in a university hospital, a software program used in an accounting office, or a consultation service for employees, might be used by their primary employer. In these cases, the researcher could be the resident expert on the goods and services in question. Each employer in this case presumably wants the best deal on the goods and services, whereas the researcher is also interested in personal profits, creating a conflict of commitment.

Since the situations described above are often not subject to specific policies or guidance, judgments about responsible conduct often rest with the researcher. In making judgments about the best way to deal with institutional conflicts, it is helpful to take into consideration:

  • how others will view your commitments and
  • the judgment of someone who has no stake in the outcome.

In addition, it is always a good idea, even if it is not required, to seek advice from an institutional official.

 

Personal and Intellectual Conflicts

Personal conflicts are usually the easiest to identify and resolve. Researchers generally should not serve as reviewers for grants and publications submitted by close colleagues and students. Their presumed interest in seeing their colleagues and students succeed could conflict with their obligation to makes judgments based solely on the evidence at hand. Most granting agencies require reviewers to disclose conflicts of interest, including personal conflicts, as a condition of service.

Intellectual conflicts are more difficult to identify, but are nonetheless important. If a researcher holds strong personal views on the importance of a particular area of research or set of research findings, those views should be disclosed so that others can take them into consideration when judging the researcher’s statements. The same is true of strong moral convictions that could influence a researcher’s scientific opinions. This is particularly true when researchers serve as expert witnesses or advisors. It is for precisely this reason that the National Academy of Sciences, which has provided essential science advice to the Federal Government since the Civil War, carefully considers all conflicts of interest when it sets up advisory panels.

 

Reporting Conflicts

If a researcher has a significant conflict of interest, as defined by Federal, state, institutional, journal, or other policies, it must be reported and managed or eliminated. “Managing” a conflict means finding a way to assure that the interests do not adversely influence the research. Some options for managing conflicts of interest include:

  • requiring full disclosure of all interests so that others are aware of potential conflicts and can act accordingly;
  • monitoring the research or checking research results for accuracy and objectivity; or
  • removing the person with the conflict from crucial steps in the research process, such as the interpretation of data or participating in a particular review decision.

These and other options are either worked out by a conflict of interest review committee or an administrator charged with overseeing conflicts of interest.
If the conflicts cannot be managed and could have an adverse impact on the research, then they must be eliminated, by divesting equity, reducing the income received from the research, assigning supervisory responsibilities to someone else, stepping out of the room when a particular proposal is discussed, or some other action.

Finally, it is important to note that research administrators, funding agencies, journal editors, and conflict of interest committees, not the researcher, should make final decisions about the management of conflicts of interest. This protects the researcher from charges of acting in her or his own interest and helps assure that the most responsible decisions are made.

 

Resources

Association of American Medical Colleges. Guidelines for Dealing with Faculty Conflicts of Commitment and Conflicts of Interest in Research, Washington, DC: AAMC, 1990.

National Institutes of Health. “Objectivity in Research,” Federal Register 60, 132 (1995): 35809-35819. (Link )

National Science Foundation. “Investigator Financial Disclosure Policy,” Federal Register 60, 132 (1995): 35820. (Link )

US Congress. 105th Congress. First Session. Federal Advisory Committee Act Amendments of 1997, PL 105-153 (1997). (Link )

Office of Management and Budget. Circular A-21, Washington, DC: OMB, 2000. (Link )

Association of American Universities. Report on Individual and Institutional Financial Conflict of Interest, Washington, DC: AAU, 2001. (Link )

Food and Drug Administration. Guidance: Financial Disclosure by Clinical Investigators, Washington, DC: FDA, 2001. (Link )

Office for Human Research Protections. Public Health Service. 2004 Final Guidance: Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subject Protections, Washington, DC: OHRP, 2001. (Link )

Association of American Medical Colleges. Task Force on Financial Conflicts of Interest in Clinical Research Protecting Subjects, Preserving Trust, Promoting Progress II: Principles and Recommendations for Oversight of an Institution’s Financial Interests in Human Subjects Research, Washington, DC: AAMC, 2002. (Link )

Council on Government Relations. Recognizing and Managing Personal Conflicts of Interest, Washington, DC: COGR, 2002. (PDF )

Drazen, JM, Curfman, GD. “Financial Associations of Authors,” The New England Journal of Medicine 346, 24 (2002): 1901-1902. (Link )

Institute of Medicine. National Academies of Science. Study Conduct: Bias and Conflict of Interest, Washington, DC: IOM, nd.

 

General Information Web Sites

Association of American Universities. Conflict of Interest and Misconduct, nd. (Link )

Association of University Technology Managers. Home Page, nd. (Link )

National Institutes of Health. Office of Extramural Research. Conflict of Interest, nd. (Link )

 

The Graduate School wishes to thank the Office of Research Integrity for the use of the mentoring material above. The source is the text book, ORI Introduction to the Responsible Conduct of Research, by Nicholas H. Steneck, Ph.D., HTML Version, September, 2006, updated from Revised Printed Edition, June, 2004.