Institutional Conflicts Of Interest Research Articles

Managing institutional conflicts: Stakeholder accounts of communication between conflict of interest and technology transfer offices.

There have been repeated calls for academic institutions to develop policies and procedures to manage institutional conflicts of interest (ICOI) arising from technology transfer activities. While prior research has examined adoption of ICOI policies by medical schools and universities, little is known about how these institutions handle ICOI in practice, hindering the development of evidence-based recommendations to improve ICOI management. To address this gap, we conducted semi-structured interviews with 25 senior administrators responsible for research integrity and conflict of interest issues at academic institutions. Data were analyzed using a descriptive qualitative content analysis approach, combining flexible coding to index the interview data with close examination, interpretation, and synthesis of coded content. Participants identified communication and information sharing between conflict of interest (COI) and technology transfer (TT) offices as a critical factor in the effective management of ICOI and suggested several strategies to strengthen coordination between these offices. These findings suggest that academic research institutions could strengthen COI programs by taking measures to improve communication and information sharing between COI and TT offices.

Rebalancing commercial and public interests in prioritizing biomedical, social and environmental aspects of health through defining and managing conflicts of interest.

Biomedical research is intended to benefit human beings and their health. Toward that end, scientific norms involve examining and criticizing the work of others and prioritizing questions that should be studied. Yet, in areas of health research where industry is active, it has often utilized well-honed strategies aimed at evading scientific standards and at dominating the research agenda, largely through its financial support and lack of transparency of its research practices. These tactics have now been documented to uniformly support industry products. Commercial entities are aided in this pursuit by public policy that has significantly embedded commercial interests and agendas into federal research funding and infrastructure. Therefore, to understand the resulting landscape and its effect on priority in health research agendas, traditional definitions of individual conflicts of interest (COI) and the less well developed institutional COI must be supplemented by a new construct of structural COI, largely operating as intellectual monopolies, in support of industry. These arrangements often result in financial and reputational resources that assure dominance of commercial priorities in research agendas, crowding out any other interests and ignoring justified returns to the public from investment of its tax dollars. There is no sustained attention to mechanisms by which public interests can be heard, normative issues raised, and then balanced with commercial interests which are transparently reported. Focus on research supporting approval of commercial products ignores social and environmental determinants of health. Commercial bias can invalidate regulatory research protections through obscuring valid risk-benefit ratios considered by IRBs.

How Do Institutional Conflicts of Interest Between Pharmaceutical Companies and the Healthcare Sector Become Corrupt? A Case Study of Scholarship Donations Between Department of Clinical Anesthesiology, Mie University, and Ono Pharmaceutical in Japan.

Institutional conflicts of interest (ICOIs) with pharmaceutical companies can bias internal operation of healthcare organizations. Naturally, a scholarship donation—which is a donation scheme unique to Japan, provided to healthcare organizations and their subunits to encourage educational and academic activities related to the development of new drugs—fall into the ICOI category. While anecdotal evidence exists that scholarship donations have been used as bribes by pharmaceutical companies, there has been little case study research that would illuminate the workings of this “gray area” mechanism. From this perspective, we offer an in-depth analysis of a recent scandal involving the Department of Clinical Anesthesiology, Mie University and Ono Pharmaceutical, where a scholarship donation was used by a pharmaceutical company to increase the prescription of one of its key drugs at a hospital department. Available evidence also suggests that a professor based within the department originally requested a scholarship donation from the company, which became an initial trigger of the scandal. We argue that by scrutinizing scholarship donations we can gain insight into problems specific to ICOIs between the pharmaceutical companies and the healthcare sector in Japan. In addition, scholarship donations can be understood as a form of “gifts” which have been found to underpin certain forms of pharmaceutical companies' promotional activities in Japan but also in other countries. We conclude by highlighting potential institutional remedies, which may alleviate ICOIs and corrupt behavior affecting the healthcare sector.

Expanding Conflicts of Interest in Public Health Research

Expanding Conflicts of Interest in Public Health Research

Ethics Centers’ Conflicts of Interest and the Failure of Disclosure to Remedy this Endemic Problem

Individual and institutional conflicts of interest arise with increasing frequency and negative sequelae as universities and their principals, as well as individual faculty members, engage in research (and other activities) with support from profit/not-for-profit entities. This essay examines how institutional and individual conflicts of interest (COI) arise for ethics centers and their faculty/staff, respectively. It defines COI, endorses a reasonable person standard for determining when COI exist, and considers problems that arise when disclosure of COI is embraced as a remedy for them. It argues that transparency and disclosure are generally inadequate measures to address COI, especially those of ethics centers. It concludes by sketching other measures that may be ingredients in attempts to avoid, manage, or mitigate the COI of ethics centers and their faculty/staff.

Reporting of conflicts of interest by authors of primary studies on health policy and systems research: a cross-sectional survey

ObjectivesThe objective of this study was to assess the frequency and types of conflict of interest (COI) disclosed by authors of primary studies of health policy and systems research (HPSR).DesignWe...

Conflict of Interest in Scientific Research in China: A Socio-ethical Analysis of He Jiankui's Human Genome-editing Experiment.

Extensive conflicts of interest (COI) at both individual and institutional levels are identifiable in scientific research and healthcare in China, as in many other parts of the world. A prominent new case from China is He Jiankui's experiment that produced the world's first gene-edited babies and that raises numerous ethical, political, socio-cultural, and transnational questions. Serious financial and other COI were involved in He's genetic adventure. Using He's infamous experiment as a case study, this paper explores the wider issue of financial and other COI in scientific research and healthcare in China, especially institutional conflict of interest (ICOI) and policy-related COI. Taking a socio-ethical perspective, it examines China's state policies and its massive efforts to transform and commercialize scientific research, the lack of policies and oversight mechanisms for regulating COI, as well as major ethical issues arising from COI including the undermining of public trust. Some practical suggestions are offered for institutional reform and institutional development so that COI, particularly ICOI, can be avoided or more effectively managed in scientific research in China.

4507 Developing and implementing a Principal Investigator (PI) primer to improve the conduct of human research at the University of Minnesota

OBJECTIVES/GOALS: 1.Assess the institutional and individual training needs and gaps in the conduct of human research for PIs at the University of Minnesota.2.Define the training program’s learning objectives.3.Develop and implement an in-person training session that addresses the gaps.METHODS/STUDY POPULATION: Establish a planning committeeIdentify required and optional training that is already available for PIs, then determine gapsUnderstand research training needs based on conversations with departmental and human research protection program leaders.Develop learning objectives and curriculum based on Federal and Local regulations, guidelines, and policies.Establish a feedback loop regarding research compliance with the HRPP, to assess trends and ensure continuous improvement.Evaluate the training program’s participants using confidence and satisfaction measures.RESULTS/ANTICIPATED RESULTS: Developed and piloted a 90-minute in-person training program entitled “PI Primer” with the goals of: Increasing awareness and knowledge of the role and responsibilities of the Principal Investigator (PIs) according to the International Harmonization for Good Clinical Practice (ICH-GCP), Federal Regulations (FDA, DHHS, ect.), and University of Minnesota Policies.Identifying root causes for receiving an FDA 483 (inspection findings).Addressing and preventing common inspection findings (CAPA).Describe individual and institutional conflict of interest (COI), and identify the key steps necessary to manage COIs.DISCUSSION/SIGNIFICANCE OF IMPACT: OHRP’s guidance on the “Responsibilities of Investigators” states that it is the Institution’s responsibility to provide human research training on a wide variety of topics to ensure the ethical conduct of research and protection of participants. PI Primer provides an in-person forum for investigators to build upon required responsible conduct of research and good clinical practice training to be able to apply the role and responsibilities of a PI to their own research. PI Primer also establishes a network of PIs in order to enhance connectivity and shared learning.

Further insights on institutional conflicts of interest in research settings

Further insights on institutional conflicts of interest in research settings

Institutional conflict of interest: attempting to crack the deferiprone mystery

A recent study by Olivieri et al, published in PLOS ONE, reports that between 2009 and 2015 a third of patients with thalassaemia in Canada’s largest hospital were switched from...

Protecting Breastfeeding From Conflicts of Interest

In order to maximize profits from sales of breastmilk substitutes, manufacturers use a whole gamut of strategies to interfere with the effective implementation of policies that protect, promote, and support breastfeeding (e.g., the International Code of Marketing of Breastmilk Substitutes with its subsequent World Health Assembly resolutions and the Global Strategy on Infant and Young Child Feeding). Their strategies create, among other problems, personal and institutional conflicts of interest. Effective Conflict of Interest policies are therefore needed for ensuring that governments, international organizations, non-governmental organizations, and health professionals can protect their independence, integrity, and credibility in order to work in the best interests of children. Conflicts of interest are discussed by Dr Lida Lhotska and Dr Judith Richter, who have been actively involved in these issues internationally. Lida Lhotska holds a BSc in Biology and a PhD in Anthropology. Her international work spans over 25 years. She headed the Infant Feeding and Care team for UNICEF and subsequently joined the IBFAN-Geneva Infant Feeding Association team, always focusing on advancing the protection of breastfeeding through legal and other policy measures. Judith Richter has a multidisciplinary background combining knowledge in the humanities with health sciences (PhD Social Sciences; MA Development Studies; MSc Pharmaceutical Sciences). Her work as a freelance researcher for United Nations agencies, governments, and civil society organizations and networks has centered on safeguarding their capacity to hold transnational corporations accountable. In her interview, Judith Richter explains why conflict of interest regulation matters to health professionals working in the field of lactation. (MA = Maryse Arendt; LL = Lida Lhotska; JR = Judith Richter).

A Content Analysis of Patient Advocacy Organization Policies Addressing Institutional Conflicts of Interest

Introduction: Patient advocacy organizations (PAOs) provide patient education, raise public awareness, and influence health policy for a wide range of diseases. These organizations frequently receive financial support form from drug, device, and biotechnology companies. Though PAOs often develop policies to address institutional conflicts of interest arising from industry relations, little is known about the substance of these policies. Methods: We sampled all PAOs that are members of the National Health Council. Using a standardized search strategy, all policies were obtained from each organization if publicly available. We reviewed policies for content related to restrictions on corporate partnerships, disclosure of corporate funding, and governance and monitoring of corporate partnerships. Results: We found that 24 of 47 (51%) organizations had policies that addressed institutional conflict of interest. A total of 9 of those 24 (38%) policies placed any restriction on the types of corporations that the PAO would or would not partner with. While 16 of the 24 (67%) outlined some process for disclosure of the organization’s corporate donors, only 5 of 24 (21%) specified a manner for disclosing the financial value of those donations. Further, 15 of the 24 (63%) policies identified the person or persons responsible for approving corporate partnerships. However, 17 (71%) failed to address or specify the person(s) responsible for ongoing review of those partnerships. Conclusion: Nearly half of the organizations studied did not have publicly available conflict of interest policies. Among those that did, few policies had a substantial level of detail or limitations to guard against conflicts of interest.

Conflicts of interest disclosure policies among Chinese medical journals: A cross-sectional study.

ImportanceConflicts of interest (COI) disclosure policies are critical to enhancing the integrity of research. However, it is unclear how Chinese medical journals interpret and enforce such policies.ObjectivesThe goal of this investigation is to determine the current status of COI disclosure policy enforcement in Chinese medical journals and to promote comprehensive COI policies.MethodsIn this cross-sectional study conducted from September 1st to October 29th 2017, journal instructions, websites and print issues of journals indexed by the Core Journals of China (version 2014), in the medical and health sector, were reviewed to identify whether COI disclosure policies existed and how complete these policies were.ResultsOf 248 eligible journals, 78 (31%) mentioned COI policies; 9 (4%) applied standardized disclosure forms; 18 (7%) required disclosure statements in articles; 4 (2%) mentioned policy bases; none validated disclosed COIs; 2 (1%) mentioned how they dealt with breaches; 18 (7%) involved the management of disclosed COIs; and 62 (25%) and 55 (22%) noted financial and nonfinancial COIs, respectively. Seventy-eight journals (31%) mentioned COIs in research and authors’ obligation towards disclosure; 2 (1%) and 6 (2%) mentioned family members’ and institutional COIs, respectively. Twenty-two and 11 journals mentioned at least one form of financial and nonfinancial COI type in research, respectively. Seven journals (3%) required disclosure of the source of financial support in research, but no journals mentioned the amount of support. Seven (3%) and 12 (5%) journals mentioned COIs in the editorial process and peer-review, respectively. Clinical journals (45%) paid more attention to COI policies than non-clinical journals.ConclusionsApproximately one-third of Chinese medical journals had COI policies, and of the journals that mentioned financial COIs most required nonfinancial COIs. However, the extent to which journals implemented COI policies was insufficient. There is a generic lack of standardized disclosure forms and management of COIs in most journals. The subject and details of COIs involved in the editorial and peer-review process received less attention than those in research.

Massive Faculty Donations and Institutional Conflicts of Interest

Most research universities have concrete policies for navigating the conflicts of interest of faculty members. Policies that might constrain university administrators acting on behalf of their schools, so-called institutional conflicts of interest, are absent or poorly developed at most places that could benefit from them. Researchers have argued for the illustration of institutional conflicts as a foundation for policy development. Here, we show the failure of research accountability when a faculty member made massive gifts to a leading American public research university, the University of Washington in Seattle, thereby creating allegiances that undermined commitments to academic values. Correspondence, some from thousands of pages acquired through the Washington State Public Records Act, show faculty colleagues, department chairs, deans, a provost, presidents, and the Board of Regents soliciting and accepting the donor's money but not sufficiently guarding the integrity of science when that was required. These records offer a rare look inside a university scientific misconduct investigation, a process typically shrouded in secrecy under the guise of confidentiality. They amount to a forensic analysis of what can go wrong with science at the nexus of a secret history of misconduct, spectacularly ambitious science, and large donations. The inabilities of federal and state authorities to reckon with institutional conflicts of interest are highlighted. The collective inaction can be understood within Lessig’s framework of institutional corruption. The failings described herein are metaphorical holes in the safety net intended to protect the integrity of American science, a shared practice that is under increasing strain. All public records are available from the authors upon request. Those cited here are included in an appendix posted by the journal.

Institutional Conflicts of Interest and Public Trust

Institutional Conflicts of Interest and Public Trust

Conflicts of interest disclosure forms and management in critical care clinical practice guidelines.

Trustworthy clinical practice guidelines (CPGs) require identification and careful management of conflicts of interest (COIs) among all participants in the guideline development. Furthermore, COIs are more common than anticipated. However, there are no universally accepted methods to identify and manage COIs. To describe and summarize the current COI disclosure forms and management policies in selected critical care professional societies that develop high-impact CPGs. In addition, we aim to provide suggestions to guideline developers on how to identify and manage different types of COIs. We searched PubMed and MEDLINE for CPGs published between 2013 and 2018 in English language and addressed general critical care topics. We then ranked the CPGs according to the numbers of citations and selected the first five critical care professional societies that sponsored the guidelines. We obtained the most recent COI declaration forms and management policies. Two reviewers abstracted data on different types of COI in each of the disclosure forms and management policies. All selected professional critical care societies require that members declare direct financial COIs; four societies inquire specifically about intellectual COIs (involvement in primary research). Three out of five societies require members to disclose indirect institutional financial COIs; however, none inquire about other forms of institutional COI. We developed, by consensus, a streamlined framework to classify and manage different types of COIs. The current COI disclosure forms of selected professional societies provide more attention to financial disclosures and COIs and less attention to detecting and managing intellectual COIs, while rarely addressing institutional COIs. We provide some suggestions for guideline developers on the classification and management of different COIs in the context of CPGs.

Reporting of Financial and Non-financial Conflicts of Interest in Systematic Reviews on Health Policy and Systems Research: A Cross Sectional Survey

Background: Systematic reviews are increasingly used to inform health policy-making. The conflicts of interest (COI) of the authors of systematic reviews may bias their results and influence their conclusions. This may in turn lead to misguided public policies and systems level decisions. In order to mitigate the adverse impact of COI, scientific journals require authors to disclose their COIs. The objective of this study was to assess the frequency and different types of COI that authors of systematic reviews on health policy and systems research (HSPR) report. Methods: We conducted a cross sectional survey. We searched the Health Systems Evidence (HSE) database of McMaster Health Forum for systematic reviews published in 2015. We extracted information regarding the characteristics of the systematic reviews and the associated COI disclosures. We conducted descriptive analyses. Results: Eighty percent of systematic reviews included authors’ COI disclosures. Of the 160 systematic reviews that included COI disclosures, 15% had at least one author reporting at least one type of COI. The two most frequently reported types of COI were individual financial COI and individual scholarly COI (11% and 4% respectively). Institutional COIs were less commonly reported than individual COIs (3% and 15% respectively) and non-financial COIs were less commonly reported than financial COIs (6% and 14% respectively). Only one systematic review reported the COI disclosure by editors, and none reported disclosure by peer reviewers. All COI disclosures were in the form of a narrative statement in the main document and none in an online document. Conclusion: A fifth of systematic reviews in HPSR do not include a COI disclosure statement, highlighting the need for journals to strengthen and/or better implement their COI disclosure policies. While only 15% of identified disclosure statements report any COI, it is not clear whether this indicates a low frequency of COI versus an underreporting of COI, or both.

Disclosure is Inadequate as a Solution to Managing Conflicts of Interest in Human Research.

Disclosure is a common response to conflicts of interest; it is intended to expose the conflict to scrutiny and enable it to be appropriately managed. For disclosure to be effective the receiver of the disclosure needs to be able to use the information to assess how the conflict may impact on their interests and then implement a suitable response. The act of disclosure also creates an expectation of self-regulation, as the person with the conflicting interests will be mindful of their own potential biases and aware that their decisions may be monitored. This article discusses some of the problems of relying on disclosure as a solution to address conflicts of interest in research, including the added complexities around institutional conflicts of interest. The case of Dan Markingson illustrates these issues and highlights the vulnerable position relying on disclosure as a solution leaves research participants in.

The vicious circle of patient-physician mistrust in China: health professionals' perspectives, institutional conflict of interest, and building trust through medical professionalism.

To investigate the phenomenon of patient-physician mistrust in China, a qualitative study involving 107 physicians, nurses and health officials in Guangdong Province, southern China, was conducted through semi-structured interviews and focus groups. In this paper we report the key findings of the empirical study and argue for the essential role of medical professionalism in rebuilding patient-physician trust. Health professionals are trapped in a vicious circle of mistrust. Mistrust (particularly physicians' distrust of patients and their relatives) leads to increased levels of fear and self-protection by doctors which exacerbate difficulties in communication; in turn, this increases physician workloads, adding to a strong sense of injustice and victimization. These factors produce poorer healthcare outcomes and increasingly discontented and angry patients, escalate conflicts and disputes, and result in negative media coverage, all these ultimately contributing to even greater levels of mistrust. The vicious circle indicates not only the crisis of patient-physician relationship but the crisis of medicine as a profession and institution. Underlying the circle is the inherent conflict of interest in the healthcare system by which health professionals and hospitals have become profit-driven. This institutional conflict of interest seriously compromises the fundamental principle of medical professionalism-the primacy of patient welfare-as well as the traditional Chinese ideal of "medicine as the art of humanity". Patient trust can be restored through rectifying this institutional conflict of interest and promoting medical professionalism via a series of recommended practical measures.

Funding, Institutional Conflicts of Interest, and Schools of Public Health

Individual researchers are accustomed to declaring conflict of interest (COI), if it exists, when submitting manuscripts for publication or in public presentations. In this Viewpoint we focus on an equally important issue—whole-institution COIs, specifically financial COIs in schools of public health, and address 2 interlinked questions: When does this funding represent an important conflict and what can schools of public health do about it? This topic is particularly important because academic schools of public health today have little choice but to accept extramural funding. Schools of public health derive income from 2, or sometimes 3, sources. State schools derive some income from the state, although this source of funding is rapidly diminishing. Other schools rely on income from tuition and extramural sources in the form of grants, contracts, or philanthropy. The majority of the budget of leading schools of public health is often derived from extramural sources. Divesting from such sources would mean a much narrower scope of work, and consequently less potential effect on the health of the public.