Chapter 7 Conflict Of Interest PDF

Conflict of Interest Chapter 7  What is conflict of interest (COI)? Improperly managed conflicting competing interest “Conflict of interest” or “financial conflict of interest” is a legal term. The appearance or perception of personal, professional, financial, or other private in...

Conflict of Interest Chapter 7  What is conflict of interest (COI)? Improperly managed conflicting competing interest “Conflict of interest” or “financial conflict of interest” is a legal term. The appearance or perception of personal, professional, financial, or other private interests of a person or institution that compromise objective judgment and professional practice  Conflict of Interest Source: Collaborative Institutional Training Initiative, 2018.  Where can conflicts of interest arise in scientific enterprise? Research workers may possess information of substantial economic value Individuals working in clinical trials The public is harmed to a far greater extent when a conflict of interest is allowed to influence a clinical decision to market a drug for human use To purchase an item of laboratory equipment from a particular vendor or to hire a relative to work in the laboratory of a scientist. Universities and their faculties have entered into business relations with the private sector for a number of reasons and may lose objectivity in making decisions.  Discussion Questions What are some conflicts of conscience that might be faced by scientists? For any examples, consider that the scientist in question has come to you for advice. Describe the advice you would provide, along with your rationale. Describe a conflict of effort that might be faced by a predoctoral or a postdoctoral trainee. Propose a mechanism for managing the conflict. A journal that publishes basic and applied biomedical research findings plans to change its peer review policy, eliminating the inclusion of editorial board members and reviewers who work for corporate entities. Defend or critique this proposal. What are the differences in equity ownership of common stock and a mutual fund? Do mutual funds and common stocks create the same level of financial conflict of interest?  Conflict of Conscience Does not involve financial reward or personal gain, but is based on personal views Research and research results that could be used to provide new knowledge to diagnose, treat, or prevent infectious diseases could also be used to create novel biological weapons by individuals or groups with evil intent Personal beliefs continue to intrude into the content of curriculum and textbooks about the origin of species and into research on embryonic stem cells. May reject proposals that use fetal tissues. Impact on scientist objectivity and reviewing manuscripts and proposals.  Discussion Questions What are some conflicts of conscience that might be faced by scientists? For any examples, consider that the scientist in question has come to you for advice. Describe the advice you would provide, along with your rationale. Describe a conflict of effort that might be faced by a predoctoral or a postdoctoral trainee. Propose a mechanism for managing the conflict. A journal that publishes basic and applied biomedical research findings plans to change its peer review policy, eliminating the inclusion of editorial board members and reviewers who work for corporate entities. Defend or critique this proposal. What are the differences in equity ownership of common stock and a mutual fund? Do mutual funds and common stocks create the same level of financial conflict of interest?  Conflict of Efforts A number of students, postdoctoral fellows, or faculty members spending an unacceptable amount of time away from the campus. A conflict of effort is serious when the scientist is not available for scheduled classes, for student advising, for guidance of research trainees, for oversight of research projects and resource accountability, and for assigned administrative and service duties. Most universities allow 20% of a faculty member’s effort or 1 day per week for consultation and outside professional activity. Scientists who establish for-profit companies may experience increasing demands on their time that interfere with their ability to fulfill assigned duties.  Conflict of Interest Conflict of interest is distinctly different from conflict of effort and conflict of conscience. It is wrong to accept an expensive gift as an inducement to select a particular vendor. Travel Expenses. A scientist studying the mechanism of action of an antibiotic may be invited to participate in a conference sponsored by the pharmaceutical company distributing the antibiotic, targeted to physicians who will prescribe the drug. The scientist may be paid a generous speaker’s fee or honorarium and provided luxury travel and lodging accommodations. Scientist-consultants have the responsibility—or, in many cases, the requirement—to disclose to their employers any agreements to perform consulting services. Moreover, scientist-consultants should not participate as evaluators of grant or contract proposals submitted by companies for which they serve as consultants. Most state and federal agencies are subject to statutes or have rules that preclude a scientist from hiring or supervising an immediate member of his or her family or of the same household.  Discussion Questions What are some conflicts of conscience that might be faced by scientists? For any examples, consider that the scientist in question has come to you for advice. Describe the advice you would provide, along with your rationale. Describe a conflict of effort that might be faced by a predoctoral or a postdoctoral trainee. Propose a mechanism for managing the conflict. A journal that publishes basic and applied biomedical research findings plans to change its peer review policy, eliminating the inclusion of editorial board members and reviewers who work for corporate entities. Defend or critique this proposal. What are the differences in equity ownership of common stock and a mutual fund? Do mutual funds and common stocks create the same level of financial conflict of interest?  Scientific Conflict of Interest Members of editorial boards have occasionally been accused of delaying publication of the results of a competitor in order to gain priority and recognition that strengthens applications for funding from granting agencies. Members of editorial boards have also been accused of being uncritical of manuscripts that present results favoring a method or product in which the reviewer has a personal interest. Many journals that publish articles related to commercial methods or products are asking both authors and reviewers to disclose their financial interests. Most national grant review panels and advisory boards have established conflict- of-interest guidelines. The NIH asks individuals evaluating grant or contract proposals and applications to avoid participation in the review of submissions from organizations in which they (i) have a financial interest; (ii) are directors, officers, consultants, or employees; or (iii) are prospective employees or shareholders.  Discussion Questions What are some conflicts of conscience that might be faced by scientists? For any examples, consider that the scientist in question has come to you for advice. Describe the advice you would provide, along with your rationale. Describe a conflict of effort that might be faced by a predoctoral or a postdoctoral trainee. Propose a mechanism for managing the conflict. A journal that publishes basic and applied biomedical research findings plans to change its peer review policy, eliminating the inclusion of editorial board members and reviewers who work for corporate entities. Defend or critique this proposal. What are the differences in equity ownership of common stock and a mutual fund? Do mutual funds and common stocks create the same level of financial conflict of interest?  Equity Interests Public institutions restrict the circumstances under which scientist- entrepreneurs may receive grants or contracts through their universities from a corporation in which they are in management positions or equity owners or both. A research institution that accepts an equity position in a start-up company is likely to offer encouragement to the scientist- entrepreneur at critical times.  PHS-Funded Research Not Required Disclosure Salary, royalties, or other remuneration paid to the investigator from the institution that currently employs the investigator Income from investments in mutual funds or retirement accounts, as long as the investigator does not make the investment decisions. Income for services (honoraria, advisory committees, etc.) and travel paid by a government agency, a US institution of higher education or a research institute affiliated with a US institution of higher education, a medical center, or an academic teaching hospital Source: Collaborative Institutional Training Initiative, 2018.  Case 14 Andre Cesar is completing his degree at Research University. He has conducted some successful and exciting research in the laboratory of Dr. Ellen Zinderoff. Dr. Zinderoff’s project was supported in part by a research contract with Innovations, Inc. Dr. Zinderoff and the members of her laboratory developed new, rapid, accurate assays that can be adapted to kits for direct sale to the public. Innovations, Inc., is considering developing and marketing these kits but has not made a definite decision. Leaper Enterprises offers Andre a position in a new unit of the company to apply his training to develop kits based on the technology that he learned and helped develop in Dr. Zinderoff’s laboratory. Discuss any conflict that Andre may have in accepting a position in a company that competes with Dr. Zinderoff’s sponsor.  Case 15 Dr. Cecilia Jonas is on the editorial board of the leading chemical engineering journal. Dr. Jonas receives a manuscript for review reporting results similar to those in her draft manuscript. Dr. Jonas is awaiting the replication of one experiment involving a novel method of polymer separation in order to prepare a new figure with better-defined graphical data. Although Dr. Jonas’s manuscript has content distinctly different from the one received for review, she believes it is likely that the impact of her publication will be greatly reduced by the publication of the competing manuscript. Dr. Jonas redirects her effort toward the completion and submission of her manuscript, setting aside the manuscript to be reviewed. Within 2 weeks, her well-prepared manuscript is submitted to another quality journal in the field of chemical engineering. Dr. Jonas then, over the next several days, critically reviews the manuscript that she received; makes a number of insightful suggestions, as she usually does; and returns the manuscript to the editor with the recommendation that the paper be accepted after major revision. She also requests that the revised article be sent to her for final consideration on publication. What are the real or perceived conflicts of interest confronting Dr. Jonas as a member of an editorial board? Has she acted ethically and responsibly? If not, what do you think she should have done in this situation?  Case 16 Dr. Rudee Prasad is an independent consultant in drug-related toxicology. Dr. Prasad also holds an adjunct faculty position at the local university, where he lectures to pharmacology graduate students and medical students. He also serves occasionally on state and federal advisory panels on product safety. Dr. Prasad invests a portion of his income in stocks of biomedical companies. A candidate drug being developed by a company for which he is consulting has impressed Dr. Prasad, and he has made sizable investments in the company. The company contracts with Dr. Prasad for a final toxicological assessment before submitting a request to initiate a clinical phase 2 study to determine the efficacy of the candidate drug. Dr. Prasad is astonished and alarmed to discover during his review of materials from the animal studies and the phase 1 study that use of the drug is associated with serious and extensive nuclear aberrations in bone marrow and gonadal tissue. Dr. Prasad realizes that these findings will result in a delay or cancellation of the proposed phase 2 study. As he prepares his detailed report for the company, he notifies his investment counselor to sell all of his stock in the company over the next several weeks. What are Dr. Prasad’s obligations to avoid using confidential information for personal gain? What are Dr. Prasad’s real or perceived conflicts of interest? What third parties may be harmed by Dr. Prasad’s actions?  Focus on Financial Conflicts of Interest Focus on the potential for the financial interests of individual researchers, and those of their immediate family members, to affect the design, conduct, or reporting of their research Source: Collaborative Institutional Training Initiative, 2018.  Insider Trading The scientist agrees to avoid discussing proprietary information in the presence of unauthorized parties, including family members and friends. Proprietary information includes but is not limited to, the company’s future plans and ideas, trade secrets, financial information, technical and research data, and operating strategies that are not generally known to the public. A scientist may become aware of information relating to the economic value of a product or potential product. A toxicologist, for example, may be involved in a project in which a serious adverse effect of a marketed drug is discovered, and this result will jeopardize the continued approval of the drug. By virtue of the paid relationship between the scientist and the company, the scientist is an “insider” and is restricted from using confidential information to personal advantage, that is, to sell stock of a company whose drug faces liability suits or loss of market share or to buy stock of a company on the verge of introducing a highly valued new drug.  PHS-Funded Research Required Disclosure Publicly traded entity Income in excess of $5,000 during the past 12 months Stock valued in excess of $5,000 at the time of disclosure A combination of the above two items (stock and income) that exceeds $5,000 Non-Publicly traded entity Any amount of equity (stock, stock options, or other ownership interest) Compensation that exceeds $5,000 in the past 12 months Source: Collaborative Institutional Training Initiative, 2018.  How to avoid conflict of interest? This policy requires researchers to disclose all significant financial interests. The threshold for a significant financial interest is $5,000 Advisory boards of executive agencies have increasingly insisted on disclosure of past and present financial interests and have excluded persons with financial interests in the product or the company. A research worker and the supervisor need to discuss the guidelines for speaker’s fees, consulting fees, and other financial incentives.  Investigator and Institution Responsibilities and COI Rules All U.S. institutions receiving federal funds for research are required to develop policies and procedures for disclosure of potential conflicts of interest and for developing safeguards and processes for managing conflicts of interest The regulations apply to both the awardee institution and subrecipient organization for any individual who meets the definition of "investigator.” Regulations can apply to collaborators, consultants, postdoctoral fellows, graduate students, and others PHS regulations may apply according to the terms and conditions of a non-PHS grant program and their institutional policies Source: Collaborative Institutional Training Initiative, 2018.  PHS-Funded Research Required Disclosure Income related to intellectual property rights paid by any source other than the investigator's current institution (NIH: receipt of income exceeding $5,000) Travel paid by an entity, including non-profit organizations, but excluding travel sponsored by or reimbursed by a government agency, a U.S. institution of higher education or a research institute affiliated with a US institution of higher education, a medical center, or an academic teaching hospital Need to disclose: the name of entity, purpose, destination, and duration of the travel Any other interests required under the institution's policy Source: Collaborative Institutional Training Initiative, 2018.  Investigator Responsibilities Source: Collaborative Institutional Training Initiative, 2018. Common COI Management Plan Source: Collaborative Institutional Training Initiative, 2018. Ethics in Research Keykavous Parang