: Protection of human subjects from investigators' conflicts of interest is critical to the integrity of clinical investigation. Personal financial conflicts of interest are addressed by university policies, professional society guidelines, publication standards, and government regulation, but "intrinsic conflicts of interest"—conflicts of interest inherent in all clinical research—have received relatively less attention. Such conflicts arise in all clinical research endeavors as a result of the tension among professionals' responsibilities to their research and to their patients and both academic and financial (...) incentives. These conflicts should be disclosed to research subjects and managed as assiduously as are financial conflicts of interest. (shrink)

In seeking to clarify the concept of conflict of interest (COI) in debates about physician–industry relationships, Howard Brody (2011) highlights the extent to which the prob- lem turns on a common pejorative understanding of COI. Whether it is the academic or public policy “pharmapologists” or “pharmascolds” talking about COI, there is often a straightforward and overly simplistic correlation made: that is, a conflict of interest—by definition—leads to fraudulent or corrupt behavior. The same type of reasoning is com- monly found in (...) discussions about COI outside the health sciences, most notably in news stories about the awarding of government contracts or the behaviour of corporate executives. The problem is that in focusing on dramatic failures to manage COI (e.g., around Vioxx), there is a tendency to strongly associate COI with extreme forms of financial and even criminal misconduct, leaving the public, policymakers, academics, and professionals with a skewed and limited understanding of the concept. (shrink)

Physicians, scholars, and policymakers continue to be concerned about conflicts of interests among health care providers. At least two main types of objections to conflicts of interest exist. Conflicts of interests may be intrinsically troublesome if they violate providers’ fiduciary duties to their patients or they contribute to loss of trust in health care professionals and the health care system. Conflicts of interest may also be problematic in practice if they bias the decisions made by providers, adversely impacting patient outcomes (...) or wastefully increasing health care costs. This latter objection may be observed in differences in the prescriptions written, procedures performed, or costs billed by health care professionals who have conflicting interests, when compared to those that do not have such financial relationships. (shrink)

As the debate over how to manage or discourage physicians? financial conflicts of interest with the drug and medical device industries has become more heated, critics have questioned or dismissed the concept of ?conflict of interest? itself. A satisfactory definition relates conflict of interest to concerns about maintaining social trust and distinguishes between breaches of ethical duty and temptations to breach duty. Numerous objections to such a definition have been offered, none of which prevails on further analysis. Those concerned about (...) conflicts of interest have contributed to misunderstandings, however, by failing to demonstrate when social arrangements leading to temptations to breach duties are in themselves morally blameworthy. Clarifying ?conflict of interest? is important if we are eventually going to develop productive modes of engagement between medicine and for-profit industry that avoid the serious ethical pitfalls now in evidence. (shrink)

The physician-researcher conflict of interest, a long-standing and widely recognized ethical challenge of clinical research, has thus far eluded satisfactory solution. The conflict is fairly straightforward. Medical research and medical therapy are distinct pursuits; the former is aimed at producing generalizable knowledge for the benefit of future patients, whereas the latter is aimed at addressing the individualized medical needs of a particular patient. When the physician-researcher combines these pursuits, he or she serves two masters and cannot — no matter how (...) well-intentioned — avoid the risk of compromising the duties owed in one of the professional roles assumed. Because of the necessary rigidity of a research protocol, the more demanding of the two masters is frequently the research.The problem of the physician-researcher conflict has been evident since the first attempts to regulate human research in the United States. Otto E. Guttentag, a physician at the University of California School of Medicine in San Francisco, addressed the conflict in a 1953Sciencemagazine article. (shrink)

If clinical trials become a commercial venture in which self-interest overrules public interest and desire overrules science, then the social contract which allows research on human subjects in return for medical advances is broken.BackgroundIn the past two decades, the involvement of non-academic sponsors of biomedical research, particularly clinical trial research, has increased exponentially. The value of such sponsored research is difficult to ascertain. However, it is estimated that, between 1980 and 2003, overall research and development expenditures by US pharmaceutical companies (...) increased from $2 billion to $33 billion and that, in 2001, clinical trial research expenditures in Canada totaled $800 million to $1 billion.The source of funding for biomedical research has shifted significantly from predominantly government and private foundations to industry. By 2002,70% of funding for clinical trials came from industry. These factors have affected the conduct of research, particularly clinical trial research, in a variety of ways. (shrink)

There is no doubt that industry-sponsored biomedical research is under the microscope. Unfortunately, this new era of skepticism prematurely rushes in doubts of the ethos of science. Skepticism can lead to positive changes, but only when timely and supported by sound reasoning. Snapshot views and theories, especially those that result in costly new regulations and inefficient policies often do more harm than good. Many critics would have the reader doubt scientific integrity because they believe that the relationship between the pharmaceutical (...) industry and biomedical research poses an unavoidable and dangerous conflict of interest. However, these conflicts are neither unavoidable nor dangerous per se. (shrink)

Much attention has been focused in recent years on the ethical acceptability of physicians receiving gifts from drug companies. Professional guidelines recognize industry gifts as a conflict of interest and establish thresholds prohibiting the exchange of large gifts while expressly allowing for the exchange of small gifts such as pens, note pads, and coffee. Considerable evidence from the social sciences suggests that gifts of negligible value can influence the behavior of the recipient in ways the recipient does not always realize. (...) Policies and guidelines that rely on arbitrary value limits for gift-giving or receipt should be reevaluated. (shrink)

Despite a decade of federal regulation and debate over the appropriateness of financial ties in research and their management, little is known about the actual decision-making processes of university conflict of interest (COI) committees. This paper analyzes in detail the discussions and decisions of three COI committees at three public universities in California. University committee members struggle to understand complex financial relationships and reconcile institutional, state, and federal policies and at the same time work to protect the integrity of the (...) scientific process, the autonomy and intellectual freedom of their faculty colleagues and students, and the financial interests of the university. (shrink)

Concerns about the influence of financial interests on research have increased, along with research dollars from pharmaceutical and other for-profit companies. Researchers’ financial ties to industry sponsors of research have also increased. Financial interests in biomedical research could influence research design, conduct, or reporting, and could compromise data integrity, participant safety, or both. Investigators’ financial ties with for-profit companies may influence reported scientific results, and may have compromised research participant safety.Disclosure is one commonly accepted method of managing financial relationships in (...) order to minimize possible threats to scientific objectivity, the safety of research participants, or public trust in the integrity of clinical research. Disclosure is presumed useful to the extent that “it gives those who would be affected, or who are otherwise in a good position to assess the risks, information they need to make their own decision.”. (shrink)

We conducted this study to determine whether medical schools address conflicts of interest among their IRB members and staff, and, if so, in what ways. We analyzed the conflict of interest policies for 121 U.S. medical schools whose research is funded by the National Institutes of Health. About three-quarters of the schools we studied have written policies that address IRB conflicts of interest, and almost 80% of them defined the term, although their definitions varied substantially. The majority of IRBs explicitly (...) prohibit a conflicted member from participating in discussion and voting, but few explicitly prohibit serving as a reviewer or extend their policies to cover IRB staff. This illustrates important gaps in these policies. A few policies even conflict with federal requirements. More specific policies might improve consistency and increase confidence in the integrity of IRB oversight. (shrink)

Most people know precious little about the risks and benefits of participating in a clinical trial--a medical research study involving some innovative treatment for a medical problem. Yet millions of people each year participate anyway. Patients at Risk explains the reality: that our current system intentionally hides much of the information people need to make the right choice about whether to participate. Witness the following scenarios: -Hundreds of patients with colon cancer undergo a new form of keyhole surgery at leading (...) cancer centersnever -Tens of thousands of women at high risk of developing breast cancer are asked to participate in a major research study. They are told about the option of having both breasts surgically removed but not told about the option of taking a standard osteoporosis pill that might cut the risk of getting breast cancer by one-half or more. Patients at Risk written by two nationally prominent experts, is the first book to reveal the secrets that many in the research establishment have fought long and hard to keep from patients. It shows why options not commonly knownincluding getting a new treatment outside of a research studycan often be the best choice. It explains how patients can make good decisions even if there is only limited information about a treatments effect. And it does this through the eye-opening stories of what is happening daily to thousands of people. Day after day, we are learning how little we know about what really works. Headlines regularly announce that a previously unquestioned treatmenthormone replacement therapy, drugs such as Vioxx or Celebrexmay now be much riskier than we thought. The latest book in a surge of recent books criticizing the medical establishment (but the first to look at clinical trials specifically), Patients at Risk helps to empower patients to survive in a world of medical uncertainty, and makes positive recommendations for systemic reform. (shrink)

The policy changes governing the relations between the pharmaceutical, medical device and service industries and academic clinical research physicians, recommended by the Institute of Medicine,1 the American Academy of Medical Colleges,2 and much discussed in the media and on our campuses, aim to create some protective ethical firewalls. However, some potentially critical consequences of these steps are missed if we do not acknowledge what else is on the table, and who is sitting at it. By only reacting defensively to the (...) juggernaut of righteous indignation over the loss of purity in a faculty physician's approach to medical problem solving, we are allowing the process to blind us to the difficulties in establishing fair and equitable management of all of the potential conflicts of commitment and conflicts of interest we incur, not only as faculty members, but also as departments and academic medical centres . Critically, this involves all sources of revenue—private, commercial and public—that support our professional and institutional commitments as well as our personal finances.i To counter the present crackdown on inappropriate financial relationships effectively, we will need to reframe the questions, and convince all stakeholders to the process that there is more to this crisis than can be resolved through our public confessions of commercial largesse obliged. The Phrma Code guidelines3 have resulted in what is believed to be a defensible, if as yet legally untested, compartmentalisation of the commercial sector's marketing, medical education and research sponsorship activities. We at the AMC are a long way from understanding how those same missions, as they emanate from our multifarious commitments, can be isolated and individually managed. Defining the parameters for establishing institutional conflicts of interest and commitment are beyond our essay's scope, but with the very public emphasis on capitalist subversion of …. (shrink)