University of California Ethical Values & Conduct and Conflict of Interest for Researchers Compliance Briefing This material is a copy of the online training version of this module. This material is provided for information purposes only and cannot be used for completion of the course requirement.
Introduction Dear Colleagues: Supporting the University's mission of teaching, research, and public service requires a dedication to the highest ethical standards. All UC employees are expected to conduct University work in accordance with the University of California Statement of Ethical VaIues and Standards of EthicaI Conduct. In support of this expectation, we require that all University of California employees complete training in this area on an annual basis. This training exists to remind each of us that the University of California acts from the values of honesty and integrity in all we do. Laws, rules, and regulations change frequently and, particularly in the current environment, there are increasing pressures to do more with less and to make decisions quickly. The training is intended as a reminder of the parameters within which we all must operate as stewards of a public institution. We encourage you to discuss this training with colleagues, to provide feedback, and to incorporate the Statement of Ethical Values and Standards of Ethical Conduct into your daily work culture. Our pledge is to support you in these efforts. Thank you for your steadfast commitment and service to the University of California, and for your important role in making the University of California an organization of which we can all be proud. Sincerely, Mark G. Yudof President Sheryl Vacca Senior Vice President Chief Compliance & Audit Officer
Briefing Objectives By the end of this briefing, you will have learned : About expectations and obligations with respect to your University employment How the University’s ethical values and standards of ethical conduct apply to your work life How one of the standards, Conflicts of Interest, relates specifically to your role as a researcher About federal and state conflict of interest laws and disclosure requirements How to report instances of non-compliance This briefing includes fictional scenarios which demonstrate the value of ethical awareness and compliance while helping you evaluate appropriate responses to situations similar to those you may experience while working as a researcher at the University. This content of this briefing is intended for University researchers and should take approximately 45- 60 minutes to complete.
Statement of Ethical Values Adopted by The Regents of the University of California, May, 2005 Members of the University of California community are committed to the highest ethical standards in furtherance of our mission of teaching, research and public service. We recognize that we hold the University in trust for the people of the State of California. Our policies, procedures, and standards provide guidance for application of the ethical values stated below in our daily life and work as members of this community. We are committed to: Integrity We will conduct ourselves with integrity in our dealings with and on behalf of the University. Excellence We will conscientiously strive for excellence in our work. Accountability We will be accountable as individuals and as members of this community for our ethical conduct and for compliance with applicable laws and University policies and directives. Respect We will respect the rights and dignity of others. Additional Reading: Statement of Ethical Values (213k PDF)
Standards of Ethical Conduct Adopted by The Regents of the University of California, May, 2005 All members of the University community, including The Regents, Officers of The Regents, faculty and other academic personnel, staff, students, volunteers, contractors, agents and others associated with the University are expected to abide by these Standards of Ethical Conduct: 1.Fair DealingFair Dealing 2.Individual Responsibility and AccountabilityIndividual Responsibility and Accountability 3.Respect for OthersRespect for Others 4.Compliance with Applicable Laws and RegulationsCompliance with Applicable Laws and Regulations 5.Compliance with Applicable University Policies, Procedures and Other Forms of GuidanceCompliance with Applicable University Policies, Procedures and Other Forms of Guidance 6.Conflicts of Interest or CommitmentConflicts of Interest or Commitment 7.Ethical Conduct of ResearchEthical Conduct of Research 8.Records: Confidentiality/Privacy and AccessRecords: Confidentiality/Privacy and Access 9.Internal ControlsInternal Controls 10.Use of University ResourcesUse of University Resources 11.Financial ReportingFinancial Reporting 12.Reporting Violations and Protection from RetaliationReporting Violations and Protection from Retaliation Pursuit of the University of California mission of teaching, research and public service requires a commitment to ethical conduct by all. The Standards of Ethical Conduct reflect our belief in ethical, legal and professional behavior in all of our dealings inside and outside the University. Additional Reading: Standards of Ethical Conduct
Your Employment Obligations As an employee of the University of California, it is important that you: Know the applicable laws, regulations and policies that affect your employment responsibilities. Understand the Statement of Ethical Values and Standards of Ethical Conduct and University policies and procedures related to your employment responsibilities. Ensure your actions are consistent with the Statement of Ethical Values and Standards of Ethical Conduct. Report instances of non-compliance.
The purpose of this briefing is to raise continued awareness of the University’s Statement of Ethical Values and Standards of Ethical Conduct and to convey University employment obligations with respect to ethical and compliant behavior. The purpose is not to teach University policy but to familiarize University employees with important ethics and compliance information, issues and resources. Ethics and compliance are not new to the University of California. Many University locations, divisions and the faculty already have longstanding ethical codes of their own, as well as "Principles of Community" addressing our shared commitment to respect each others’ roles, diverse backgrounds and personal responsibilities. Ethical and compliant practices are core to the University and its mission of teaching, research and public service. Ethics and Compliance at the University: Principles & Practices
Scenario: Grant Fund Hopscotch Brad, an analyst, approaches Fred, one of the principal investigators (PI) in his department and comments that he noticed an irregularity as he was preparing some reports. Brad stated that a colleague of Fred’s, Joshua, is getting paid from Fred’s grant fund but has been working on a project funded by a different grant for the past nine months. Fred takes this information seriously, as he has had heard similar concerns about the appropriateness of other charges to his grant. Which of the following statements related to this scenario are true? (You may select more than one option) A) If Joshua charges time to and receives salary from a grant on which he is not working, he has caused two grants to be falsely reported. B) Adequate controls do not appear to be in place to prevent or detect inaccurate charges. C) As long as both funds are in the same department, either may be used to pay Joshua. D) As PI, Fred has the responsibility to regularly check the financial reports for his grant. E) The situation involves Brad's allegation of wrongdoing, so Fred should inform the Locally Designated Official (LDO).
Feedback Text The best answers are A,B,D and E. Proceed to next page to read a discussion of this scenario. Scenario: Grant Fund Hopscotch
Discussion: Grant Fund Hopscotch Grants are an important University resource and should not be misused or abused. Each employee in this scenario must exercise responsibility and accountability to assure that grants are charged only for time actually worked and within the approved program for that grant. As the principal investigator (PI), Fred has responsibility over not only the research but the corresponding financial transactions, and accordingly he should make reasonable inquiries as to the financial information on his grant. While initially looking into the matter, Fred may want to consult with his location’s Locally Designated Official (LDO), the person who administers the Whistleblower Policy.Locally Designated Official (LDO) If Fred concludes that no problem exists but Brad still thinks something improper is going on, Brad can contact the LDO directly to report his concerns. Such reports are treated confidentially by the University, and those who make them are protected from retaliation. The following Standards of Ethical Conduct apply:Standards of Ethical Conduct 2.Individual Responsibility and AccountabilityIndividual Responsibility and Accountability 4.Compliance with Applicable Laws and RegulationsCompliance with Applicable Laws and Regulations 9. Internal ControlsInternal Controls 11. Financial ReportingFinancial Reporting 12. Reporting Violations and Protection from RetaliationReporting Violations and Protection from Retaliation
Scenario: Favor for Faye? Coach Betty is a new coach in the Athletic Department and is responsible for overseeing the summer swim camp. Assistant Coach Faye has been a great help to Betty since she joined the department, and Betty wants to be able to return the favor. Betty knows Faye’s son would like to be a swim camp instructor, but she also knows the hiring process is very competitive. She indicates to Juan, the business officer in charge of hiring swim instructors, that she would like to make sure Faye's son gets one of the jobs. Juan informs Betty that all applicants have to go through the normal recruitment process. Betty responds that she owes it to Faye, and besides, there shouldn't be any questions about favoritism since she knows Faye’s son is an avid sports lover. Which of the following are true statements? (You may select more than one option.) A. It is unfair for Coach Betty to bypass the appropriate channels to fill an open position. B. Hiring for University jobs must follow relevant laws and University policies regarding open recruitment. C. Giving a job as a favor is not an appropriate use of University resources. D. As administrative support staff, Juan should not question Coach Betty's request.
Scenario: Favor for Faye? Feedback Text The best answers are A, B, and C. Proceed to next page to read a discussion of this Scenario.
Discussion: Favor for Faye? The following Standards of Ethical Conduct apply:Standards of Ethical Conduct 1. Fair DealingFair Dealing 2. Individual Responsibility and AccountabilityIndividual Responsibility and Accountability 4. Compliance with Applicable Laws and RegulationsCompliance with Applicable Laws and Regulations 5. Compliance with Applicable University Policies, Procedures and Other Forms of GuidanceCompliance with Applicable University Policies, Procedures and Other Forms of Guidance 10. Use of University ResourcesUse of University Resources Coach Betty does not know whether Faye’s son is qualified to be a swim instructor. Regardless, she and Juan should approach the situation with some awareness of the Standards of Ethical Conduct that apply to such issues. Bypassing the normal recruitment procedures is unfair to both internal staff seeking promotional opportunities and to external candidates interested in working for the University. Failing to go through the formal application process violates University policies that require open recruitment in most cases, and may also violate federal regulations. Furthermore, a University position is a resource and should be allocated to the best qualified candidate in a pool of qualified candidates. If you have questions about whether or not human resources policies are being violated, you should ask your supervisor or the Human Resources department at your location.
Scenario: Cliff’s Consulting Cliff is a junior faculty member in the History department who was recently hired to teach multiple sections of his specialty, Greek history. Cliff is also a talented web designer, and to make extra money, he recently entered into an outside consulting agreement with a company to design its website. The extra work is keeping him up very late at night, and to meet the company deadlines, he also uses many of his office hours to work on the website. Cliff is so tired that he is barely able to stay focused when lecturing. His students have been complaining that he is falling behind with grading, and his colleagues have also expressed concern about his lack of participation in department meetings. Should Cliff continue with his consulting arrangement while still a full-time employee of the University? (You may select more than one option.) A. No. Cliff should make sure his outside interests do not interfere with his University responsibilities. B. No. Cliff is not being respectful to his students and colleagues. C. Yes. Cliff is probably just tired from having to teach so many sections of Greek history. D. No. Cliff is misusing University resources to work on outside activities for personal gain.
Scenario: Cliff’s Consulting Feedback Text The best answers are A, B, and D. Proceed to next page to read a discussion of this scenario.
Discussion: Cliff’s Consulting The following Standards of Ethical Conduct apply:Standards of Ethical Conduct 3. Respect for OthersRespect for Others 6. Conflicts of Interest or CommitmentConflicts of Interest or Commitment 10. Use of University ResourcesUse of University Resources While University employees may be able to hold outside jobs and enter into outside consulting agreements, Cliff’s primary problem in this scenario is that his outside interests are affecting his duties as a University employee. Because he is not fully participating in teaching/learning opportunities, either as a lecturer and as a colleague, he is not demonstrating respect for his colleagues and students. He is also misusing University time and resources for personal gain. If you have questions about whether or not an outside professional activity is appropriate, you should ask your supervisor or the Academic Personnel office.
The “Wall Street Journal Test” While the previous case studies demonstrate specific violations of ethical standards, not all situations are as clear-cut. There are some activities that, while legal and not explicitly prohibited by University policy, may not pass what is known as the “Wall Street Journal Test”. That is, if what you are doing were to appear on the front page of the newspaper, would you feel proud of your actions? The easiest way to stay out of a trouble spot is to ask yourself in these situations, "Would I want to read about this in the newspaper or online?" Other questions you might ask include: How would I explain what I'm doing to my family? What would my supervisor or colleagues think about what I’m doing? Would talking about this at a non-University social event make me feel embarrassed or uncomfortable? Am I uneasy when I hear about colleagues doing this?
Conflicts of Interest The University’s Academic Personnel Manual states the important principle that University researchers must be free to pursue knowledge and that this freedom, which is essential to the research process, must not lightly be abridged. When a researcher has a financial interest similar in nature to those required to be reported under the University Conflict of Interest Code requiring disclosure, his or her judgment may appear to be affected by potential financial gain rather than by the pursuit of knowledge. The University community must address these issues collectively to assure the public that appropriate fundamental principles central to the research process will be followed.
Conflicts of Interest in Academic Research The majority of the University’s research funding comes from public sources, such as the federal government. With this support comes public scrutiny about research methods and results. In addition, private industry also funds research at the University of California. While this support can provide resources that would not otherwise be available, industry funding and the often complex relationships between industry and researchers have raised public concerns about the trustworthiness of the data that result from such relationships. Evidence from published research and individual cases also indicate that conflicts of interest have a real and negative impact on research integrity. The University community must address the potential bias in proposing, conducting and supporting research.
Published Research Related to Conflict of Interest A growing body of research has examined the effects of favors, gifts, and other incentives on the behavior of recipients. This research shows that people act in their own interest without being aware of the effect of outside influences on their actions. Study Examples: (Steinman, Shilpak & McPhee 2001): In a survey of 105 residents at the University of California, San Francisco; 60% of the respondents said gifts do not influence the types of medicines they choose for patients, but only 16% felt that other doctors were similarly unaffected. (Dana & Lowenstein, 2003): Surveys reviewed show that investigators failed to recognize the possibility of unconscious bias in their own work, however, they anticipated the impact of bias on the research of others. (King-Casas, Tomlin, Anen, Camerer, Quartz, & Montague, 2005): These findings raise the question of whether relatively subtle acts of benevolence may generate reciprocal behavioral responses on the part of the recipient – responses that may not reach the level of conscious intention. Full references for these and other studies can be found at the end of this course.
What is an Interest? Researchers may have many different interests that motivate them to perform their work, including: The advancement of knowledge for the benefit of society Professional advancement Personal gain These interests are all legitimate incentives to perform research; however they can and often do create a perceived or actual conflict of interest. For example, a researcher who discovers a new vaccine may produce direct societal benefits but may receive significant reputational and economic benefits as well. A conflict of interest occurs when an individual or organization has an interest that might compromise the objectivity of the research. A conflict of interest exists even if no improper act results from it, and can create an appearance of impropriety that can undermine confidence in the conflicted individual or organization. Conflicts cannot always be avoided but, at a minimum, they must be managed, reduced, or eliminated.
Scenario: Friends in High Places The chair of the chemistry department has been asked to sit on a scientific advisory board for a local environmental foundation. The board reviews grant applications and makes recommendations to the foundation. A junior colleague in the chemistry department has applied to the foundation for a grant to develop environmentally-friendly substitutes for chlorofluorocarbons commonly used in refrigeration units. The chair is familiar with the work of the young scientist and believes that it has the potential to significantly advance the field. The project would also support the chair’s goal of finding more interdisciplinary projects on which his department could collaborate with the engineering department. Does the chair have a conflict of interest that may prevent him from reviewing his colleague’s grant application? A. Yes, and it will automatically prevent him from participating in the review. B. No, his professional connection to the researcher does not amount to a conflict of interest. C. Yes, but the sponsor’s conflict of interest rules will determine if he may participate in the review.
Scenario: Friends in High Places Feedback Text The best answer is C. Proceed to next page to read a discussion of this scenario.
Discussion: Friends in High Places Not all conflicts of interest result from financial interests. The chair’s interest in the success of his University colleague and department is in conflict with his duty to the foundation to be an impartial reviewer using objective scientific standards. The affiliation raises the possibility that his decision could be based on his ambitions for the young scientist or his own plans for his department. At a minimum, this conflict should be disclosed to the foundation and the chair should strongly consider recusing himself. Public and private sponsors of research often will not allow one University faculty member to review the work of another. Therefore, it is important to ask about a sponsor’s conflict of interest rules before beginning to perform such reviews.
Financial Conflicts of Interest Financial conflicts of interest are situations that create perceived or actual tensions between personal financial gain or loss and adherence to the fundamental values of honesty, accuracy, and objectivity. As in the case of other conflicts, holding financial interests related to research is not inherently wrong. Researchers are permitted to benefit financially from their work. However, financial conflicts of interest can lead to the perception that these interests could affect research outcomes. Because of the concerns about financial conflicts of interest affecting research outcomes, many federal granting agencies, including the Public Health Service, have established conflict of interest rules that require the University to: Report significant financial interests before any research is undertaken Manage, reduce, or eliminate significant financial conflicts of interest Provide subsequent information to the funding agencies on how the conflicts were handled
Significant Financial Interest under Federal Law Significant financial interests are defined under federal law to be anything of monetary value above a certain threshold in a company or entity engaged in work that appears reasonably related to the research. These include: A salary or other payments for services (e.g. consulting fees or honoraria) of more than $10,000 in a single year. An equity interest (e.g. stocks, stock options, or other ownership interests) that: oexceeds $10,000 in fair market value, or orepresents an ownership interest greater than 5 percent in a single entity. Intellectual property rights (e.g. patents, copyrights, or royalties from such rights). A management position in a company or other entity (e.g. board member, director, officer, partner, or trustee) It is also important to note that these disclosure obligations apply to the research team, not just the principal investigator. Note: Lawrence Berkeley National Laboratory employees (including faculty researchers) are also subject to specific disclosure requirements in accordance with the DOE/UC contract as articulated in Laboratory policy.
Scenario: An Affair of the Heart Dr. De la Coeur is a principal investigator on an NIH grant that is supporting his work on an experimental gene therapy program for heart disease victims at a University medical center. Because the program looks quite promising, Dr. De la Coeur has formed a corporation with some other researchers and investors called Heart Genetics, Inc. (HGI) to commercialize the research. Dr. De la Coeur owns 20% of HGI, and should the therapy prove to be successful, HGI could become very profitable. A colleague of Dr. De la Coeur recommends a patient to him for purposes of receiving the experimental gene therapy. Dr. De la Coeur enrolls the patient as a subject in his NIH study. To whom does Dr. De la Coeur’s ownership interest in HGI have to be disclosed? A. the University B. the patient C. both the University and the patient D. neither the University nor the patient
Scenario: An Affair of the Heart Feedback Text The best answers is C. Proceed to next page to read a discussion of this scenario.
Discussion: An Affair of the Heart Because Dr. De la Coeur’s ownership in HGI is over the 5% threshold, it must be disclosed to the University under the federal rules applicable to NIH research. In addition, California court decisions have held that a physician’s duty of disclosure extends to non- medical information. Furthermore, recent decisions from courts in other states have held the patient should be informed of the related financial interest held by the researcher. In addition to protecting subjects, researchers conducting clinical trials are well advised to make full disclosures for their own protection. Thorough disclosures of financial interests, beyond what is required by state and federal rules, may help the researcher in the event that a legal claim arises from a clinical trial. Campus resources are available to assist researchers in making these decisions.
Scenario: Tsunami Test The NSF has funded a study to develop a low-cost seismographic instrument to predict tsunami events caused by earthquakes. Professor Richter is the principal investigator and has been working on a conceptual design for this instrument. Professor Richter believes that this project would be a perfect test for a similar instrument in development at his own company, which he spun off from his University research almost a decade before. The company is privately held by the professor and two other investors, each of whom hold one-third of the company’s stock. The company has also received a $1 million venture capital funding. Although it has yet to bring a product to market, the company holds a number of patents which build on patents Professor Richter obtained before coming to the University. The professor believes that if the NSF project is successful, the value of the patents might increase substantially and attract additional funding. Does the professor have a significant financial interest in the company? (You may select more than one option.) A.Yes. His ownership interest in HGI is greater than 5%. B.Yes. The value of his stock and patents appears to exceed $10,000. C.No. The stock is not publicly traded so it does not have a fair market value exceeding $10,000. D.No. The value of the patents cannot be established before the conclusion of the study.
Scenario: Tsunami Test Feedback Text The best answers are A and B. Proceed to next page to read a discussion of this scenario.
Discussion: Tsunami Test Although it may not be possible to determine the value of the patents with certainty, the perceived long-term value of the patents attracted $1 million only two years before the NSF project. Such funding would qualify as “a reasonable measure of fair market value”, the test applied under the NSF rules. In addition, the professor’s interest should be disclosed to the campus Conflict of Interest Committee so that it may be reviewed. Because the value of his patents may be directly affected by the outcome of the research, the committee should determine whether any conflict management strategy is required.
California Financial Interest Disclosure In addition to the federal conflict of interest requirements, the California Political Reform Act requires all University employees with “principal responsibilities for a research project” to disclose their financial interests in certain nongovernmental sponsors of their research, such as a private company or nonprofit entity. University researchers must file the Form 700-U (81k PDF) with their respective campuses to report such financial interests.Form 700-U Research funding by certain nonprofit entities will not trigger disclosure. List of Non-governmental Entities Exempt From Disclosure Requirement
Financial Interests under California Law “Financial interest” has a different meaning under California law than it does under federal law. In most cases, California law is more stringent than federal law. The following interests are covered under the California definitions and must be disclosed on behalf of self, spouse or registered domestic partner, and dependent children when they involve the entity sponsoring the research. Investment - any financial interest in a business entity held by the researcher or his or her immediate family which totals $2,000 or more. Income – any payment including salary, wages, honoraria, consulting fees, expert witness fees, advances, proceeds from sale, or loan which totals $500 or more. Gift – anything of value for which the researcher has not provided equal or greater consideration to the donor, including items of value such as loan forgiveness. The gift is reportable if its value is $50 or more. Travel payments – advances and reimbursements for travel and related expenses, including lodging and meals. Depending on the circumstances, a travel payment may be treated as income or a gift. Management position – such as board member, consultant, member of scientific advisory board, director, officer, partner, or trustee held by the investigator.
Scenario: Election Day Professor Nancy Simon, a faculty member in the public policy department, is planning to study the effect of electronic voting machines on the accuracy of election results in California. Her project will require her to review current voting trends and to evaluate the usability of voting machines produced by the two main machine manufacturers. Professor Simon does not own stock in either company, but for the past two years she has received modest fees ($600) from one of the companies for speaking at an annual conference for county registrars, and that same company will be partially fund her research. Is Professor Simon required to disclose the payment in speaking fees on a Form 700-U? A. Yes, because the payment exceeds the $50 threshold for gifts. B. Yes, because the payment exceeds the $500 threshold for income. C. No, because she has never favored one type of machine over another. D. No, but she should strongly consider it because the company paying her may be affected by the results of her research.
Scenario: Election Day Feedback Text The best answer is B. Proceed to next page to read a discussion of this scenario.
Discussion: Election Day Speaking fees for conference presentations are considered income. The $600 in fees must be disclosed on the Form 700-U because it exceeds the $500 annual reporting threshold for income from the sponsor of the research. In this case, the “perception of a conflict of interest” concerns are increased because she has been paid by a voting machine manufacturer and has publicly supported the use of electronic voting.
Scenario: Free Lunch? A drug company is sponsoring a lecture series at the University. The company provides funding to offer lunch to the attendees, and also gives $750 to the department for each guest lecturer. The department manages the funds in accordance with the appropriate medical education standards, and selects the lecturers without either consulting the drug company or using a list provided by the company. Additionally the department discloses to the participants the fact that the drug company is supporting the series. Dr. Mittagessen, a University faculty member, is selected to provide one of the upcoming lectures. Dr. Mittagessen’s research is sponsored by the company. Does Dr. Mittagessen have to disclose the lecture fee on a Form 700-U because the drug company sponsors her research? A. Yes. The lecture fee counts as indirect income to Dr. Mittagessen from the sponsor above the $500 limit. B. No. The funds were given by the company to the department and the department allocated the funds to Dr. Mittagessen.
Scenario: Free Lunch? Feedback Text The best answer is B. Proceed to next page to read a discussion of this scenario.
Because Dr. Mittagessen is receiving the lecture fee from the department, not the drug company, the fee is not considered income from the drug company. However, the less autonomy the department has in making its decision, the more likely the speaker’s fee will constitute a financial interest in the drug company under state law. Such payments need to be scrutinized carefully. Even a payment that does not qualify as a financial interest under state law may raise the appearance of a conflict of interest. If the funds had been provided by the company and earmarked specifically for Dr. Mittagessen, then she would have to disclose the payment as “income” on the 700-U. Discussion: Free Lunch?
Scenario: Travel to Biopolis A drug company has established a large biotech research and development unit in the Biopolis section of Singapore. In anticipation of receiving a research proposal from a faculty member, the company invites him to visit its facilities to review and comment on a product, to discuss their independent research projects, and to explore the potential for collaborative research. The company offers to pay all of the travel expenses for the Singapore trip. If the company decides to fund the faculty member’s proposal, will he need to disclose the travel expenses on the Form 700-U? A. Yes. The travel payment is a gift to the faculty member and is reportable. B. No. The company is merely reimbursing the University for the faculty member’s transportation, lodging and food expenses while he is on University business.
Scenario: Travel to Biopolis Feedback Text The best answer is A. Proceed to next page to read a discussion of this scenario.
Discussion: Travel to Biopolis The faculty member did not provide services that were equal to or greater than the value of the travel payment and therefore the payment is treated as a gift. By inviting the faculty member to its facilities, the company identified who in the University could use the payment and under California laws these payments are treated as gifts to the traveler, not the University, and are reportable.
Managing Conflicts of Interest If a researcher has a financial interest that is required to be disclosed under federal or state rules, the interest must be reported to the location’s Conflict of Interest committee; the committee will determine whether a conflict of interest exists that must be managed, reduced or eliminated. “Managing” a conflict means finding a way to assure that the interests do not adversely influence the research. Typical conflict of interest management strategies may include: Requiring full disclosure of all interests so that others are aware of the potential conflicts and can act accordingly Monitoring the research or checking research results for accuracy and objectivity Removing the person with the conflict from crucial steps in the research process, such as the interpretation of data or participation in a particular review decision
Managing Conflicts of Interest (Cont’d) If the conflicts cannot be managed and could have an adverse impact on the research, then they must be eliminated or reduced to acceptable levels through management strategies, which may include, among other options: Divesting equity Reducing or eliminating the income received from the sponsor of the research Assigning supervisory responsibilities to another investigator The location’s COI committee, not the researcher, makes the final decision about the management of COI. If the conflict involves human subjects research, additional practices may be involved.
Scenario: Green for Forester? Dr. Forester, a professor in the College of the Environment and Natural Resources has just received a three-year grant from the NSF to study the impact of bark beetle infestation on old-growth forests in Oregon and Washington. For the past ten years, Dr. Forester has been paid $11,000 a year to serve as a consultant to one of the largest lumber companies in the Pacific Northwest. The consulting work involves advising the company on sustainable timber management practices in general but does not include research on natural threats to the forest ecosystem, such as the one addressed by the NSF grant. Which of the following is likely the most appropriate course of action? A. The professor should disclose his consulting work for the company to his University research group and in publications and presentations on his research. B. The professor should suspend his consulting activities. C. The dean of the college should monitor the professor’s work on the study. D. Another faculty member in the college should be named principal investigator on the study.
Scenario: Green for Forester? Feedback Text The best answer is A. Proceed to next page to read a discussion of this scenario.
Discussion: Green for Forester? Significant financial interests are defined under federal law to be anything of monetary value above a certain threshold in a company or entity engaged in work that appears reasonably related to the research. While Dr. Forester’s income from the lumber company ($11,000) exceeds the federal threshold, his research for the NSF is on a specialized topic unrelated to his consulting work. Although the facts presented in the scenario do not constitute an actual conflict of interest, given Dr. Forester’s consulting work for the company and the controversial nature of the timber industry in general, he should be careful to manage any perception of a conflict of interest. The best way to do this is to disclose his consulting work for the company to his peers in his University research group and in any publications or presentations he makes based on this research. Situations such as these require a close examination of the facts, and the conflict of interest committee may make a range of different recommendations depending on the facts of the specific case.
Scenario: Under a Microscope? A principal investigator (PI) has developed a promising gene therapy technique for a pulmonary disease that primarily afflicts children. Although the disease can be managed to some degree through conventional drug therapies, the gene therapy offers the hope of an actual cure. The PI heads the Institute of Gene Therapy (IGT) within the School of Medicine. She is also the primary stockholder in a company that she started to bring her discoveries to market. The company has been very successful in finding start-up funding and is now providing 25% of IGT’s budget. The PI is interested in running a clinical trial at the University of one of her company’s prototype therapies. Which of the following might be appropriate conflict of interest management strategies? (You may select more than one option.) A.The professor should disclose her stock ownership when publishing results from the trial. B.The professor should divest all ownership interests in the company. C. A committee should be established to monitor the PI’s work on the study. E. Another faculty member in the school should be named as principal investigator on the study.
Scenario: Under a Microscope? Feedback Text The best answers are A,B, C, and D. Proceed to next page to read a discussion of this scenario.
Discussion: Under a Microscope? The PI appears to have significant professional and financial interests that could pose conflicts with her clinical trial proposal. In addition to her primary stock ownership of the company, she heads up the school’s Institute of Gene Therapy. Because the clinical trial involves research with human subjects, an additional level of scrutiny is required. Because of the number and significance of the PI’s financial interests, as the trial proceeds, effective management strategies must be employed to protect the human subjects and the integrity of the research. A combination of strategies is often recommended for more difficult situations such as this and practices vary by location.
Conflict of Interest Summary Conflicts of interest are inherent in modern research. As this course has shown, conflicts lie in the situations presented and are not dependent on the behavior of the individual. Therefore, managing a specific conflict is not simply a matter of the individual researcher deciding whether a financial interest could compromise his or her research. The institution and the researcher must jointly take the conflict into account when judging its impact on the objectivity of the study. To perform the necessary review and management of conflicts of interest, all interests related to the research, financial or otherwise, must be disclosed. A fundamental tenet of research integrity is that the methods used and the reporting of results are objective and free from bias. Thus, researchers should always be willing to voluntarily disclose interests that could give rise to potential conflicts as a way of protecting the integrity of their work. By so doing, researchers will be able to maintain public trust in their own work and in the work of the University.
Illegal activities and significant policy violations should always be reported in accordance with applicable laws and policies. The University is committed to responsible evaluation of all reports of violations of the Standards of Ethical Conduct and/or alleged improper activities on the part of members of the University community. The University has established processes for reporting and investigating any suspected wrongdoing, including an anonymous hotline people are encouraged to use if they don't feel comfortable bringing the matter forward openly. An individual who is made aware of an improper act should consult with someone at a higher level of authority or with the Locally Designated Official (LDO) to determine how to handle the matter. Reporting Improper Activities UC Whistleblower Hotline (anonymous/confidential) (800) 403-4744 or http://universityofcalifornia.edu/hotlinehttp://universityofcalifornia.edu/hotline
Decision-Tree for Reporting Compliance Concerns
Reporting Contact Info Locally Designated Officials (LDO) http://ucwhistleblower.ucop.edu/campusldo.htmlhttp://ucwhistleblower.ucop.edu/campusldo.html Campus Ethics and Compliance Officers (CECO) http://www.universityofcalifornia.edu/compaudit/campuscontacts.htmlhttp://www.universityofcalifornia.edu/compaudit/campuscontacts.html Campus Counsel http://www.ucop.edu/ogc/campuscounsel.html http://www.ucop.edu/ogc/campuscounsel.html Chief Compliance and Audit Officer Sheryl Vacca 510-987-9090 or http://www.universityofcalifornia.edu/compaudit/sherylvacca.html http://www.universityofcalifornia.edu/compaudit/sherylvacca.html UC Whistleblower Hotline (anonymous/confidential) (800) 403-4744 or http://universityofcalifornia.edu/hotlinehttp://universityofcalifornia.edu/hotline
Reminder: Your Employment Obligations As this briefing has shown, it is critical that all members of the University community: Know the applicable laws, regulations and policies that affect your employment responsibilities Understand the Statement of Ethical Values and Standards of Ethical Conduct and University policies and procedures related to your employment responsibilities Ensure your actions are consistent with the University Statement of Ethical Values and Standards of Ethical Conduct Report instances of non-compliance
References California Fair Political Practices Commission. (2008). 2 CCR 2 § 18702.4 (c). Academic decisions. Council on Governmental Relations. (2002). Recognizing and managing personal financial conflicts of interest. http://www.cogr.edu/docs/COIFinal.pdf Dana J. & Lowenstein, G. (2003). A social science perspective on gifts to physicians from industry. Journal of the American Medical Association, 290(2), 252-255. Glaser, B. E. & Bero, L. A. (2005) Attitudes of academic and clinical researchers toward financial ties in research: a systematic review. Science and Engineering Ethics, 11(4), 553-573. King-Casas, B., Tomlin, D., Anen, C., Camerer, C. F., Quartz, S. R., & Montague, P. R. (2005). Getting to know you: reputation and trust in a two- person economic exchange. Science 308(5718), 78-83. Korenman, S. G. (2006). Teaching the responsible conduct of research involving humans. Retrieved from: http://www.medsch.ucla.edu/public/korenman/default.htm Korn D. & Ehringhaus, S. (2007). The scientific basis of influence and reciprocity: a symposium. Washington, DC: AAMC, Baylor College of Medicine. National Science Foundation. (2005). Grant Policy Manual. (NSF Publication 05-131). Washington, DC: U.S. Government Printing Office. Steneck, N. H. (2007). Introduction to the responsible conduct of research. U.S. Department of Health & Human Services Office of Research Integrity, Washington, D.C. Steinman, M. A., Shilpak M. G., & McPhee, S. J. (2001). Of principles and pens: attitudes and practices of medicine, housestaff toward pharmaceutical industry promotions. American Journal of Medicine, 110(7), 551-557. University of California. (2003). Academic Personnel Manual. http://www.ucop.edu/acadadv/acadpers/apm/ University of California, Davis Health System. (2003). Conflict of Interest Primer. http://www.ucdmc.ucdavis.edu/compliance/pdf/coiprime.pdf U.S. Department of Health & Human Services, Food and Drug Administration. (1998). 21 CFR § 54. Financial disclosure by clinical investigators. U.S. Department of Health & Human Services, Public Health Service (1995)., 42 CFR § 50(f). Responsibility of applicants for promoting objectivity in research for which PHS funding is sought.
University of California Ethical Values & Conduct and Conflict of Interest for Researchers Compliance Briefing Although no single course can adequately address all potential ethical and conflict of interest dilemmas you might face as an important member of the University community, we hope that the information provided in this briefing will better equip you to make the right decisions and to act in an ethical and compliant manner. Thank you for your participation.