If you cannot stand before the public and defend an academic researcher receiving money from whatever the source may be, whether it is a pharmaceutical or any other company, and you have to pretend it is being laundered. The question of where. The question is whether the science was valid, good, strong, academic, unbiased, straightforward, peer-reviewed science.
As a dean, Dr. Korn, do you agree with Mr. Hutt's statement? I don't understand laundering because it is not a concept that I use. When I was talking before about the Mega Foundation's money, I was thinking of it as grants that were coming into very specific people for very specific research projects, but coming in as grants through the university. That is not a laundering phenomenon. It is simply a matter of tracking the research portfolio that is going on within a place at any one time and assuring that whatever institutional assurances have to be met by federal and other regulations are in conformity.
That is all. There is no laundering involved. There is no deception involved. KORN: Sure. We get gifts. Everybody gets gifts. That is the difference between a gift and a grant. A gift is a general award of funds for some very general use, and a grant is much more specific and targeted, usually with a named investigator and expected outcomes.
They are different and equally acceptable. Such "financial distancing" by foundations may be quite variable. The Lilly Foundation, for instance, will support no research in the health area; other corporations, however, use their foundations to promote their own views.
Another form of financial distancing is the blind trust, in which control of equity is transferred to a fiduciary for the course of a researcher's involvement in a study.
Such an arrangement might lessen, at the margin, the likelihood of insider trading. It would only affect personal financial gain, however, not prevent biased research, and it is the latter that reflects the intent of financial distancing.
For instance, a blind trust would not provide a solution for the investigator who has a substantial holding in a closely held company whose product is involved in PORT studies or is competitive with such a product because the investigator is not really "blind" to this holding in the hands of the fiduciary.
One way to deal with problematic arrangements is to establish rules internal to the research group. For instance, Healy and her colleagues described decisions by the key investigators in a new multicenter clinical trial of treatment after coronary-artery bypass graft surgery. Among their decisions were not to buy, sell, or hold stock or stock options in the companies manufacturing or distributing the medications they were testing and not to serve as paid consultants to these companies throughout the study Healy et al.
This arrangement has been hailed as sound protection against this form of financial conflict of interest Relman, Another example is the decision by members of the Dartmouth assessment team not to accept honoraria or consulting fees and not to own stock whose value is affected by urologic treatment, the area under study by their team Wennberg, b.
Several ways to define acceptable activities and the oversight procedures to permit those and only those activities might be outlined in theory.
In practice, the approach of the Harvard University Faculty of Medicine offers some useful guidance. The Harvard University Faculty of Medicine's new rules distinguish three relationships: 1 those requiring special attention and specific approval, 2 those permitted with oversight, and 3 those that are routinely allowable. An example would be individuals with particularly strong financial interests in the outcome of a research study e.
Specific financial thresholds for compensation or equity are often used, with the assumption that greater financial interests pose more risk, but this approach fails to account for the findings that even small gifts and relationships may influence individuals.
Moreover, the relative value of comparable financial interests to different individuals may not be possible to discern or meaningfully assess. The use of blind trusts and requirements for complete divestiture are not frequently employed in regulating scientific investigators. It is unclear how these would be managed and regulated in the academic medical research setting or the consequences of such approaches. The second type of strategy tends to focus on the process, i.
As examples, these include education of investigators regarding elements of research design that can help limit or prevent the influence of bias, informed and non-conflicted IRB review of research proposals, rigorous overview by research supervisors, and public registration of trials.
These all can help build a system or context in which the research takes place that increases the capacity to obtain scientifically valid research outcomes that are not unduly influenced by secondary interests of individual investigators.
In this regard, elements of research design, such as adequate blinding and allocation techniques, appropriate comparisons, and proper data analytic techniques, can diminish some of the effects of secondary interest and bias. However, excessive levels of scrutiny of researchers and their methods beyond the level of the laboratory or clinical research group could become intrusive to a degree that investigators and their immediate supervisors find onerous, so a balance must be struck.
Institutions and the institutional leadership often have relationships with industry, and these represent conflicts that may impact how the work of individual investigators is viewed.
It is thus important that attention be given to the conflicts of decision-makers in their management roles, including the institutional, department, and research group leadership.
Avoiding conflicts among the leadership and of the members of committees that regulate research should also be understood as an area where particular conflicts may pose special risk, but also where prevention, attention, and management of conflicts may provide institutional solutions. The IRB is often poorly equipped to manage their own conflicts, especially those which are indirect and non-financial, and greater attention to effective review and guidelines for the management of conflicts of interest of members of the IRB should receive greater attention as part of a comprehensive conflict of interest management program [ 33 ].
The third strategy, in addition to the individual and the research process, is a focus on close, skilled, and non-conflicted review of the outcome or product produced by the investigator and the research itself. This final piece is exemplified by the journal editorial process, particularly peer review. This approach has been advocated as a solution for addressing the myriad of non-financial conflicts that may pose an enormous challenge to identify, catalogue, assess, and address. Transparency and disclosure are the weapons they have aggressively deployed.
These three aspects of conflict management are not mutually exclusive domains. As an example, the level and scope of peer review and analysis of evidence for the development of clinical practice guidelines require the creation of teams that can compensate for individual weaknesses, whether scientific or due to risk of conflict from secondary interests.
By the creation of a group of individuals with the requisite complementary qualifications as well as different conflicts, the body as a whole can potentially function in an effective fashion in which undue secondary influences on particular individuals are much less likely to adversely affect the group process. These authors propose a limited number of questions to identify non-financial conflicts relating to four categories, including interest of: the individual, through personal beliefs; others, through personal relationships; the institution, through institutional relationships; and career advancement, which relates to all three of the other categories.
They then describe a five-step process for identifying, measuring, and managing non-financial conflicts of interest. This process requires transparency in documentation, accounts for context, and relies on judgment in evaluating risk of particular conflicts.
It is most applicable to teams, such as systematic review teams and practice guideline development committees, but their strategy for identifying and assessing non-financial conflicts may be applicable in other settings, even when all of the proposed management strategies may not. Conflicts of interest are pervasive in medical research but must be managed effectively to maintain the integrity of research and public trust. Although most of the focus on conflicts and their management has been on financial conflicts, it is likely that non-financial and intrinsic conflicts have similar potential for creating bias and exerting undue influence on the judgment and actions of the investigator.
Further efforts are needed to develop and test methods for effectively identifying conflicts of interest, and strategies for their management should be evaluated for their capacity to promote high quality research, protection for research subjects, and public trust in medical research. This article does not contain any studies with human or animal subjects performed by any of the authors.
This article is part of the Topical Collection on Ethics. National Center for Biotechnology Information , U. Curr Rev Musculoskelet Med. Published online Apr 8. Paul L. Author information Copyright and License information Disclaimer. Romain, Phone: , Email: ude. Corresponding author. This article has been cited by other articles in PMC. Abstract Conflicts of interest represent circumstances in which professional judgments or actions regarding a primary interest, such as the responsibilities of a medical researcher, may be at risk of being unduly influenced by a secondary interest, such as financial gain or career advancement.
Keywords: Conflict of interest, Research, Disclosure, Financial interests, Non-financial interests, Intrinsic interests. Introduction Medical research requires people, time, and money. What are conflicts of interest? Managing conflicts of interest It can readily be seen that the extent and variety of conflicts poses a substantial management challenge, and reliance upon good intent and good character is inadequate to address these issues [ 20 ].
These include the following: Regulation of the individual Design and regulation of the research process Critical assessment of the research product Regulation of the individual The strategies that have received the most attention typically focus on the individual researcher, such as disclosure of financial interests or prohibition from research on a product in which one has an equity interest.
Design and regulation of the research process The second type of strategy tends to focus on the process, i. Critical outcomes assessment The third strategy, in addition to the individual and the research process, is a focus on close, skilled, and non-conflicted review of the outcome or product produced by the investigator and the research itself. Strategies with mixed focus and non-financial conflict management These three aspects of conflict management are not mutually exclusive domains.
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Privacy Policy. Make a comment. Nonetheless, there is a need to define a level above which all financial interests will have to be viewed with suspicion.
It suggests that institutional ECs and investigator both have the responsibility of identifying such conflicts and to ensure that these do not compromise the protection of human subjects.
Cancer Research UK has listed eight types of relationships between investigators and sponsors that constitute a COI and these are as follows:. These guidelines mentions COI and state under the general principles 2. Whatever level of investment is decided upon to constitute a COI, it is sure to be challenged.
It is admitted that there is little logic for choosing a particular level, nonetheless a line needs to be drawn somewhere, so that we may say that an investment below this level does not constitute a COI, whereas that above it, does. Thus, there is a legal requirement that COI be identified and managed; it is therefore strange that some authors believe that there is no legal requirement for declaration of COI.
A detailed investigation covering four clinical trials all sponsored by multinational companies observed that investigators were paid significant amounts for recruiting patients from their own practice as trial subjects. Such a practice also constitutes a COI. Most clinical trials are now blinded, and the investigators would find it difficult to manipulate results even if they wanted.
Such a manipulation would, however, be possible at the level of the data analysis. Data management staff often decides on the statistical tests to be used, and unblinding, they could knowingly or otherwise alter data to suit the sponsors or other parties. It is extremely essential to check COI at this level, as most investigators would not even know if results were altered during analysis of data. A number of universities including that of Alaska and Columbia require examination of COI of data management personnel.
The way journals ask about and report COI of authors varies widely, leading to confusion among authors and readers. The form was thrown open to the public for comment and based on the feedback, a number of changes have been instituted. The major change is removal of competing interests of the author's spouse or minor children and nonfinancial competing interests.
Changes in scope and disclosure were made, but they relate to investigators receiving grants from the National Institutes of Health NIH only. This COI comes into play when a sponsor pays unreasonably high amounts per patient, for positive results.
It is clarified that the author has no personal knowledge of any such case, yet its possibility cannot be discounted.
In addition to investigators, EC members need to declare COI, as they have significant powers over the trial process. Yet, it should be realized that the EC is a multimember body and COI of one or two members may not be damaging. However, the possibility that the member with COI has a major role to play in the decision process exists.
The Indian GCP guidelines also require the members of the EC who have a COI to declare the same and withdraw from the decision making process and the same should be recorded in the minutes 2. However, the Indian guidelines do not define the level at which investment or financial interest in a company constitutes a COI.
There is an urgent need to do so. During an EC meeting, it is recommended that any member with a COI declares the same at the beginning of the meeting and walks out when the particular project is being discussed. A declaration at the beginning of the year is practiced by some ECs; however, it does not cover changes in investments or relationships that take place continually. Lastly, there is a negative sort of COI. A negative COI is one that occurs when loyalty toward one sponsor leads to wilful damage to a competitor's study or molecule.
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