Combating the funding effect in science: what's beyond transparency?

• Author: Krimsky, Sheldon

INTRODUCTION

Professional ethics in government and in fields such as law, engineering, and accounting have evolved to protect the public from employee abuses and misconduct. Among those protections are rules that define, manage, or proscribe conflicts of interest. The term "conflict of interest" has been defined by Thompson as "a set of conditions in which professional judgment concerning a primary interest (such as a patient's welfare or the validity of research) tends to be unduly influenced by a secondary interest (such as financial gain)." (1) Before 1980, little if any attention was given to conflicts of interest in science and medicine. Beginning around that time, a major shift was taking place in sector boundaries affecting the media, finance, banking, medicine, and academia. The missions of distinctive sectors of our society were blended or superimposed onto one another. This has led to a fusion of sector goals and the creation of hybridized institutions. As examples, the entertainment and news sectors have, at times, become indistinguishable; banks and investment houses have begun adopting each other's roles. And, more to the point of this Article, universities have been investing in for-profit enterprises started by their faculty. The new partnership between academia and business was reinforced by the passage of the Bayh-Dole Act of 1980. (2) Under the new law, universities were accorded intellectual property rights from any discoveries that were made under government grants. Business and academia became intertwined through a mutually reinforcing body of legislative acts fostering technology transfer. These changes were the cultural counterpart to what was happening in the biological sciences when species barriers were broken with the discovery of recombinant DNA molecule technology. (3) The well-established biological boundaries that distinguished different life forms and the special features that distinguished socioeconomic institutions were disappearing. The new blended institutions of academia raised questions about changes in the normative framework that guided research practice and the commercial ventures within academic-clinical medicine. Mark Cooper argues that the commercialization of the university affects the faculty's choice of research problems "by shifting the focus of academic life scientists to a greater interest in research that generates patents or commercializable findings and away from research based on scientific curiosity and potential contributions to scientific theory." (4) The Bayh-Dole Act, along with a series of new federal laws, state economic development initiatives, and Presidential executive orders supporting university-industry partnerships, provided incentives for the development of a new class of entrepreneurial faculty who held onto their academic positions while setting up independent companies.

This Article examines the evolution of the public's concerns over conflicts of interest (COIs) in science (including medical science and the practice of medicine). I discuss the ethical foundations of COIs and the remedies that have been proposed by government, academic institutions, journals, and professional societies to address these concerns. The "funding effect" in science, an outcome in which commercial sponsorship of research influences its findings, will be explored. The role of transparency as an antidote to conflicts of interest will be examined. Also, the Article will identify initiatives designed to prevent and proscribe conflicts of interest rather than accepting them as inevitable and adopting transparency as the primary response. The thesis of this Article is that disclosure of a conflict of interest is a necessary but not sufficient response to address the most serious problems arising from blending academic science with commerce. I shall argue that when the autonomy of the scientist, the independence of the university, or the public's trust in academic research is compromised, conflicts of interest should be prohibited.

1. PUBLIC LAWS ON CONFLICTS OF INTEREST

   Policies on conflicts of interest have slowly evolved in federal law and regulation from an initial emphasis on government employees, later extended to government contractors, and more recently covering academic scientists in institutions that receive government funding. The Founding Fathers had some clear ideas about conflicts of interest in public life. They wrote three provisions into the Constitution that restricted the conflicts of interest of those who held posts in the Executive and Legislative branches of government. First, federal officials were prohibited from accepting gifts, holding employment, or receiving titles from foreign governments. (5) Second, members of Congress were denied the opportunity of being appointed to a federal office that was created, or whose salary was increased, during the member's term in Congress. (6) Third, members of Congress were prohibited from receiving an increase in salary until they stood for re-election. (7) Not until the infamous Watergate affair on June 17, 1972, during the presidency of Richard M. Nixon, when five men were arrested for breaking and entering into the Democratic National Committee headquarters at the Watergate Office complex in Washington, D.C., had Congress thought seriously about a comprehensive ethics law for government employees. In 1978 Congress passed the Ethics in Government Act, which required certain federal employees to disclose their finances, and established the Office of Government Ethics. Then, in 1989 the Ethics Reform Act was passed, which established post-employment restrictions for members of Congress and high-level congressional staff. It also banned honoraria for almost all government employees, and restricted federal employees from accepting gifts.

   Scientists at academic institutions were largely outside the scope of federal conflict of interest regulations before 1972, when the Federal Advisory Committee Act was passed. (8) The main conflict of interest provisions applying to scientists serving on federal advisory committees (called Special Government Employees or SGEs) are found in 18 U.S.C. [section] 208(a). The statute prohibits SGEs from participating on federal advisory committees on a matter that could affect their financial interest or that of members of their family or an organization on which they serve. Waivers can be granted (and many have been) when an administrator finds that the need for the individual's service outweighs the potential for a conflict of interest. (9) In 1995 the National Institutes of Health (NIH) and the National Science Foundation issued guidelines to universities for managing and documenting faculty conflicts of interest. (10)

2. ETHICAL FOUNDATIONS OF CONFLICTS OF INTEREST

   There are four ethical grounds for managing or proscribing conflicts of interest among university faculty. They can be characterized by the terms stewardship, transparency, consequentialism, and integrity of science. Stewardship pertains to the responsibility for the proper management of public funds and resources used in carrying out research. Transparency requires that the methods, sources of materials, background literature, contributions of authors to the research project, and limitations to the study are made available to the reviewers, journal editors, and readers. Consequentialism refers to the link between a behavior (such as a COl) and the quality of the research outcome (such as bias). Finally, integrity of science speaks to the public confidence in the scientific enterprise, which could be compromised despite complete transparency and an outcome of objective science.

   The ethical grounds for government conflict of interest policies can most readily be traced to the concept of "stewardship." Because elected officials and government employees are the temporary stewards of the laws, lands, and properties that have been placed under the authority of government, and because they also bear the responsibility for promoting the health and welfare of the citizenry, it is in the public's interest that these officials are devoid of conflicts of interest. Without laws prohibiting conflicts of interest for public officials, the citizenry could never be confident that "private gain" rather than "public interest" was the motivating force behind a decision.

   The stewardship concept has only limited application to academic scientists, who, after all, are not public employees. But they do receive federal research funds, and therefore they have a responsibility for the proper use (stewardship) of the funds. In 1994, the NIH issued a proposed rule on "objectivity in research," a term which became a euphemism for a conflict of interest policy. Under the rule, NIH stated: "prudent stewardship of public funds includes protecting federally funded research from being compromised by the conflicting financial interests of any Investigator responsible for the design, conduct, or reporting of PHS-funded research." (11) The NIH rule, which became part of the Code of Federal Regulations, had as its explicit goal "to ensure there is no reasonable expectation that the design, conduct, or reporting of research funded under [Public Health Service] grants or cooperative agreements will be biased by any conflicting financial interest of an Investigator." (12) Thus, the government had connected the concept of "stewardship" with research, and in doing so linked conflicts of interest with biased science.

   Scientists are stewards of the funds they receive from the federal government, and it is their responsibility to use these funds to generate "objective" knowledge untainted by bias and personal interest. The consequences of the NIH rule, which applied to all institutions that received NIH funding, was that the institutions were responsible for managing or preventing research conflicts of interest that could compromise the...