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Conflict of Interest

Curricular Objectives

  1. To understand fiduciary duties
  2. To know the distinction between primary and secondary interests
  3. To be able to discuss methods of resolving or managing conflicts of interest

Summary of Case

Dr. Answers has obtained a grant from Advanced Microbiotics to assess the effectiveness of a new antimicrobial prophylaxis regimen for preventing wound infection. Accrual is slow, because the regimen requires preoperative treatment. The patients are difficult to identify, contact, inform, and enter into the study under the same-day surgery program. The scientific consultant from the company advises that it is their standard practice to offer a financial incentive to solve accrual problems. Dr. Answers offers a finder's fee of $100 to surgical residents who will recruit patients into the study. The research ethics board questions the propriety of the finder's fee, arguing that the research program will take time away from the care of other patients and may foster an unprofessional attitude toward research and patient care among the residents. The residents feel that they can maintain their objectivity, help advance a worthwhile study, and gain needed supplemental income. If you were the resident representative on the research ethics board, what advice would you give to its members?


Lesson Plan

Question 1:

How many would vote in favour of the finder's fee? How many opposed? How many don't know? Explore and discuss the views, justifications, and counterarguments.

Question 2:

What's wrong with paying the resident $100 to find patients and enter them in a scientifically and ethically approved clinical trial?

Answer:
The residents' primary duties include caring for patients, learning surgery, and teaching students. Using the time allocated for these duties to earn additional money from Advanced Microbiotics could deflect the resident away from these primary duties. The professional recommendation that a patient should enter a research study might be interpreted by some patients as a degrading use of them, especially if they were to be informed that the resident is being paid to make this recommendation. Even though the study is sound, the appearance of exploitation for financial gain undermines trust in the resident and in the institution to which the patient has come for care. The patient's trust in the resident, as a representative of that institution, should not be exploited for the financial benefit of the resident.

Question 3:

If it is acceptable for a business entity like Advanced Microbiotics to use financial rewards as incentives to attain its goals, why is it unacceptable in the medical setting?

Answer:
One of the differences between the ethic of business and the ethic of medicine relates to the acceptability of exchanging money for goods, services, or good will. Under the business ethic, monetary incentives and rewards are generally accepted means of influencing behaviours and decisions that advance the overall goal of the company, which is to provide a service or a product at a profit. The goals of medicine are to prevent or cure disease, to treat patients' symptoms, relieve their suffering, and to improve or maintain their functional abilities. The goals are pursued within a "social contract" that constrains the extent to which doctors may use their knowledge to influence the decisions of vulnerable patients. The fundamental covenant between doctors and patients requires that patients may trust, without fear of exploitation for gain, that the doctor will advise them and guide their decision making from a position of neutrality, or bias toward putting the patient's interest above others.

Question 4:

Would it be acceptable for residents to accept a fee for simply looking through charts to identify potential patients for recruitment into the study?

Answer:
This approach would reduce the impact of persuasion of patients to give consent, but raises the issue of confidentiality of the records of patients who are not directly under the resident's care. This is an example of how secondary personal gain can distract a professional from the primary goal of conscientious patient care, with all of its customary ethical safeguards, including confidentiality. This variant of the finder's fee proposal introduces a new ethical violation, breach of confidentiality. Public disclosure of the practice would undermine confidence and trust in residents and in the institution.


Bioethics Bottom Line

Professional judgement is trusted by patients and society because of the fiduciary duty doctors accept to rank their primary interests (appropriate patient care, valid research, truthful and unbiased teaching) above such secondary interests as personal gain, promotion, fame, or other benefits. This fiduciary duty derives from the covenant of trust and the principle of justice. Justice requires that reasonable expectations should be met, particularly by those who have created the expectation. Doctors profess their intention to serve patients and society in this way. The expectation is that primary interests or purposes will be placed above secondary gains when conflicts arise.

A problem arises when doctors and others do not recognize the seductive interference of secondary gain (it's only a trip, meal, etc.). A second problem is the perception of interference with primary duties even when no such interference occurs. The custom of accepting favours and financial inducements is more prevalent and accepted in business; it is more prevalent within medicine in some parts of the world than in others. The goal is not to eliminate all conflicts of interest, as they are inextricable from our lives, but to prevent secondary gain from dominating or appearing to dominate professional decisions or choices. When physicians endorse products or tests, or present data favouring a particular manufacturer, their credibility is reduced when they receive secondary benefits from the manufacturer.

Maxims:

  1. Assume that it is difficult to detect improper influence of secondary gains in oneself or in colleagues.
  2. Maintain public confidence in individual and collective professional judgement by minimizing the opportunity or appearance of improper influence on professional judgement.

Dimensions by which the risk and impact of interference may be measured are:

  1. Severity (likelihood of influence, threshold value of the gift, durability of the relationship with the giver).
  2. The scope of the harm (NSABP protocol violations caused widespread anguish among breast cancer patients).
  3. The extent of discretion in professional choice (data technician vs. principal investigator).
  4. Extent of accountability (to what degree are decisions of the professional unreviewed).

Remedies:

  1. In small communities, virtue and local reputation may protect professional judgement from conflicts of interest.
  2. Regulation by the profession provides more assurance than individual discretion.
  3. Disclosure is the most commonly prescribed remedy. It gives those who would be affected the opportunity to assess the risk that secondary gain might improperly influence the judgement of the professional. It may be difficult to interpret and may increase anxiety by revealing a problem without solving it.
  4. More stringent methods include mediation (through blind trusts), abstention (analogous to judicial refusal), and prohibition, including divestiture from secondary interests.

References

Thompson DF. Understanding financial conflicts of interest. New Engl J Med 1993; 329: 573-6

Further Reading:

Shimm DS, Spece RG. An introduction to conflicts of interest in clinical research. In: Spece RG, Jr., Shimm DS, Buchanan AE, editors. Conflicts of interest in clinical practice and research. New York: Oxford University Press; 1996. p 361-76.

Erde EL. Conflicts of interest in medicine: A philosophical and ethical morphology. In: Spece RG, Jr., Shimm DS, Buchanan AE, editors. Conflicts of interest in clinical practice and research. New York: Oxford University Press. 1996. p. 12-41.

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