EHR 244 Lecture 2 Conflict of Interest HEK LdP.pdf

Ethics and Human Rights 244 Etiek en Menseregte 244 Prof LM du Plessis Lecture 2: Conflict of Interest Acknowledgement: Mrs HE Koornhof (DNB - HPCSA)  Lecture outcome / Lesing uitkoms Discuss how basic ethics principles apply to various aspects of Human Nutrition and Public H...

Ethics and Human Rights 244 Etiek en Menseregte 244 Prof LM du Plessis Lecture 2: Conflict of Interest Acknowledgement: Mrs HE Koornhof (DNB - HPCSA)  Lecture outcome / Lesing uitkoms Discuss how basic ethics principles apply to various aspects of Human Nutrition and Public Health practice to manage ethical issues and dilemmas and to guide professional conduct (conflict of interest). Bespreek hoe basiese etiese beginsels van toepassing is op verskeie aspekte van Menslike Voeding en Publieke Gesondheidspraktyk om etiese kwessies en dilemmas te bestuur en professionele gedrag te rig (konflik van belange). Professional Board for Dietetics and Nutrition Roadshow 28 July 2023 Conflict of Interest and the Dietetics and Nutrition profession “Conflicts of interest (COI) exist in every step of life and in every corner of society, including medicine and science”. Reference: Committee on Conflict of Interest in Medical Research, Education, and Practice. Board on Health Sciences Policy (consensus report). Washington: The National Academies Press; 2009 Outline of presentation Defining Conflict of Interest (CoI) Unpacking Conflict of Interest Professionalism duties and Conflict of Interest - HPCSA guidelines Identifying a Conflict of Interest - prevent, identify, manage & monitor and disclose Public Health Nutrition, Research and Conflict of Interest  Defining Conflict of Interest (CoI) definition is important "A conflict of interest is a set of circumstances that creates a risk that professional judgement or actions regarding a primary interest will be unduly influenced by a secondary interest.“ (ref: Conflict of Interest in Medical Research, Education, and Practice. Institute of Medicine (US) Committee on Conflict of Interest in Medical Research, Education, and Practice; Lo B, Field MJ, editors. Washington (DC): National Academies Press (US); 2009.) “CoI is typically the potential that exists for not acting objectively” J Vogelzang, Chair of Academy of Nutrition and Dietetics, Ethics Committee 2019-2020 This is for understanding  Unpacking Conflict of Interest Individual conflict of interest arises when the pursuit of the private or secondary interests of an individual has the effect of compromising or interfering with the objectives of a joint endeavour. Organizational or institutional conflict of interest arises when pursuit of an organization’s interests, whether “private” or secondary, has the effect of compromising or interfering with the objectives of the joint endeavour. Judgement and integrity are hallmarks of professionalism. CoI, bias and dishonesty signify a spectrum of threats to judgement and integrity.  Unpacking Conflict of Interest As professionals we all have CoIs Conflicts may be: Internal e.g., personal interest in reputation and advancing your career External e.g., a financial interest in a for-profit business Few professionals are intentionally dishonest. Important to recognize we have CoIs. Be conscious of the risk of CoI, and work together to protect professional judgement and integrity. There is a need for a thoughtful conversation on how to protect professional judgement and integrity. Unpacking Conflict of Interest - Terminology 1. Actual conflict of interest 2. Potential conflict of interest 3. Perceived conflict of interest 1. Actual conflict of interest A real conflict of interest that exists for an individual or organization at the beginning of its participation in the organisation. 2. Potential conflict of interest Some interests have the potential to create a conflict of interest in the future, even though not be doing so yet A real conflict of interest might not exist for an individual or organization at onset of its participation in a project, but could arise over time as circumstances evolve.  3. Perceived Conflict of Interest Individuals (or organizations) participating in an initiative may have differing perceptions about the extent to which private or secondary interests conflict with the interests of the organisation/ project. Perceived conflict of interest may be based on how a particular individual views a situation, and often depends on the context in which it is observed. 3. Perceived Conflict of Interest Perceived Conflict of Interest is sometimes based on the possibility or appearance of a potential conflict of interest despite the fact that the individual/ organization with a perceived conflict has not behaved in a way that has caused any damage to the endeavour or particular initiative. Reality of Divergent or Competing Interests It is common for individuals (or organizations) participating in any joint endeavour to have private or secondary interests that are unrelated to their activities in the joint endeavour. Divergent or Competing Interests exist when individuals (or organizations) have differences of opinion on an issue, when their values or even their interests extend in different directions, or when their intentions differ. Divergent or competing interests can/must be brought into synergy through dialogue, debate and negotiation. Value of HPCSA’s Ethical booklets Provide ample guidance on Potential Conflict of Interest. Being registered as a healthcare professional with the Health Professions Council of South Africa (HPCSA) confers one the right and privilege to practise a profession. Correspondingly, practitioners have moral and ethical duties to others and society in general. https://www.hpcsa.co.za/ Choose: Core Operations→ Professional Practice → Ethics HPCSA’s Ethical booklets with CoI guidance Booklet no Topics covered 1 Guidelines for Good Practice - Reference to CoI: Core ethical values and standards: Beneficence and Non-maleficence Extensive guidance regarding duties of professionals and how to avoid CoI 2 Ethical and professional rules of the HPCSA- Health Professions Act, 1974 (Act No. 56 of 1974) Reg no. 717, 4 August 2006, as amended by Government Notice No. R 68 of 2 February 2009 Multiple registration and avoidance of CoI with Informed Consent 11 Guidelines on Overservicing, Perverse Incentives and Related Matters Very NB Rule 3- Advertising booklet for Rule 7- Commission, Charging or Receiving Fees & Overservicing PPDs Rule 23- Manufacturing & Preferential Usage or Prescriptions Rule 24- Referrals CPD and how to avoid CoI in sponsorship and funding; provide in professional needs of target group; 13 General Ethical Guidelines for Health Researchers 16 Ethical Guidelines on Social media (2019 POLICY ON BUSINESS PRACTICES (2016)- section 2.3 Corporate involvement HPCSA and Potential Conflict of Interest HPCSA Guidance regarding professional duties state: No duty is absolute or can be held without exception irrespective of time, place, or circumstance. This is not surprising, since different duties may prescribe opposite decisions and actions in specific or real-life situations. For example, practitioners’ duties to patients may compete with employers’ expectations. Or the duty to respect a patient’s confidentiality may clash with the duty to protect innocent third parties from harm. These are instances of conflicts of interest or dual loyalties. HPCSA and Potential Conflict of Interest REGARDING PATIENT’S BEST INTERESTS OR WELL-BEING HCPs should inform patients if they are in the employ of, in association with, linked to, or have an interest in any organisation or facility that could be interpreted as potentially creating a conflict of interest or dual loyalty in respect of their care of that patient. HPCSA and Potential Conflict of Interest To avoid Potential Conflict of Interest HCPs should: Act in their patients’ best interests when making referrals and providing or arranging treatment or care. Always seek to give priority to the investigation and treatment of patients solely based on clinical need Avoid over-servicing and only recommend or refer patients for necessary investigations and treatment, and should only prescribe treatment, drugs or appliances that serve the needs of their patients Declare to their patients – verbally and by a displayed notice – any pecuniary interest they have in institutions, diagnostic equipment, or the like to which they make referrals. Act in their patients’ best interests when making referrals and providing or arranging treatment or care. HPCSA and Potential Conflict of Interest To avoid Potential Conflict of Interest HCPs should: Refrain from coercing patients or their family members They should not ask for, or accept any incentive, from colleagues to whom they refer patients as it may affect or be seen to affect the healthcare practitioners’ judgement. Treat patients referred to them in the same manner in which they would treat their own patients. Not service a patient in more than one capacity or charge fees based on more than one consultation where health practitioners are registered with more than one statutory council or professional board or in one or more categories within the same professional board. HPCSA and Potential Conflict of Interest becomming a dietitian, pharmacist and HPCSA Booklet 2: “Multiple registration pyschologist at once, and work with a patient using one of your profession, and dont make them work at once 27. A HCP who holds registration with more than one statutory council or professional board or in one or more categories within the same professional board shall at all times ensure that - (a) no conflict of interest arises from such multiple registration in the rendering of health services to patients; if (b) patients are clearly informed at the start of the consultation of the profession in which the practitioner is acting; (c) informed consent regarding the profession referred to in paragraph (b) is obtained from the said patient; (d) patients are not consulted in more than one capacity or charged fees based on more than one such consultation” HPCSA and Potential Conflict of Interest HPCSA Booklet 11- Guidelines on Overservicing, Perverse Incentives and Related Matters HPCSA requires that HCPs should at all times act in the best interests of their patients and regard the clinical needs of their patients as paramount Always try to avoid potential conflicts of interest and maintain professional autonomy, independence and a commitment to the relevant/ applicable professional and ethical rules and policies Any conflicts of interest, incentives or forms of inducement that threaten such autonomy and that do support first priority to the clinical needs of patients, are unacceptable. HPCSA and Potential Conflict of Interest HPCSA Booklet 11- Guidelines on Overservicing, Perverse Incentives and Related Matters The ownership and use of high technology equipment creates a special problem, not only because of its inappropriate use by health care practitioners who are not properly qualified, but also due to overservicing by appropriately qualified health care professionals. Booklet 11 also covers the problems related to the use of high technology equipment. In particular, it needs to be emphasised, that over servicing of any kind is unacceptable. HPCSA and Potential Conflict of Interest HPCSA Booklet 11- Guidelines on Overservicing, Perverse Incentives and Related Matters CONTINUING PROFESSIONAL DEVELOPMENT (CPD) need to know the examples, for test and exam purposes. Collaborative efforts – Make sure that such efforts is in keeping with their ethical duties towards patients and society. Educational needs of targeted group - CPD activities should address the educational needs of the targeted health care group. Health care provider organisations: Decision re content and choice of CPD activities, including funding arrangements lies with the health care provider organisations such as professional associations, their branches and groups, and should not be in a position of conflict of interest by virtue of any relationship with the funding body. Organisers may acknowledge financial or other aid received, but should not identify any specific products. Generic names of products should be used rather than trade names in the course of continuing professional development activities. HPCSA and Potential Conflict of Interest HPCSA Booklet 11- Guidelines on Overservicing, Perverse Incentives and Related Matters CPD – continued Funding: Funds for continuing professional development activities should preferably be in the form of an educational grant payable to the health care provider organisation arranging the activity. Booklet 11 also covers aspects related to Travel, lodging and other expenses with regard to the attendance of CPD events and also of international events, which carry a huge potential for conflict of interest. HPCSA and Potential Conflict of Interest HPCSA Booklet 13- General Ethical Guidelines for Health Researchers Regarding Potential Conflicts of Interest All health researchers should: 1) Declare to all research participants any conflicts of interest they may have in institutions, equipment, research sponsors etc. This includes the need to declare whether the research is being conducted for academic purposes. 2) Disclose any potential conflicts of interest to their research ethics committee before the research commences. 3) Design their research to exclude any potential conflicts of interest with sponsors or collaborators HPCSA and Potential Conflict of Interest HPCSA Booklet 16- Ethical Guidelines on Social media (2019) Section 9 deals with Conflicts of Interest Social media is also a popular tool advertising /promotion of goods and services; with the growing online market being prominent in business practice. When using social media, even if via personal or anonymous blogs, HCPs must comply with the HPCSA rules on advertising practice, including not engaging in active or passive touting and canvassing or allowing others to do so on their behalf. Touting involves drawing attention to one’s professional goods or services by offering guarantees or benefits that fall outside one’s scope of practice. An example is advertising free WiFi services to patients while waiting for their consultations. HPCSA and Potential Conflict of Interest HPCSA Booklet 16- Ethical Guidelines on Social media (2019) Section 9 deals with Conflicts of Interest Canvassing involves the promotion of one’s professional goods and services by drawing attention to one’s personal qualities, superior knowledge, quality of service, professional guarantees, or best practice. An example of canvassing is a HCP declaring on social media or posting patient reviews that state he or she is ‘the best health care practitioner in the country’. HCPs may not advertise, endorse or encourage the use of any hospital, medicine or health-related product on social media in a manner that unfairly promotes the practice of a particular HCP or practice for the purposes of financial gain or other valuable consideration. A failure to follow these guidelines when using social media will undermine public trust in the health profession. Identifying a Conflict of Interest this is important for test and exam purposes 1. Requires clear understanding of what a conflict of interest entails, to identify them. 2. Requires a sense of the complexity of conflict of interest. 3. Identifying a potential conflict of interest is one of the most important steps towards managing the situation. 4. Conflicts of interest exist when an individual puts their own interest above the interests of their clients and employers. when the person tells you more about their interest more over your interest, like the 5 star hotel being given to you Guiding Principles for Avoiding Conflicts of Interest Components of a Policy to manage Conflict of Interest PIMM Prevent Identify Manage Monitor Risk Transparency Due Diligence Procedures Mechanism Disclosure Reasonable Remedial action Assessments person This approach provides Capacity Building Guiding Principles for Avoiding Conflicts of Interest Act with integrity and in an ethical manner that enhances the reputation and impact of the organisation. Act in a way that establishes the highest standards of honesty and incorruptibility. Be mutually respectful and seek to earn the trust of those with whom you are working: Building the trust needed for collaboration requires respect for differences. Respect must be earned. Act with accountability - the obligation to be answerable for your actions and decisions, and to accept responsibility for them. Independence and Impartiality - act with professionalism; ensure that your personal views and convictions do not impact/ bias your professional conduct. Professional commitment - to act as role models and demonstrate leadership. Guiding Principles for Avoiding Conflicts of Interest The World Health Organisation’s ethical principles for staff confirm the aforementioned: Integrity Accountability Independence and Impartiality Respect for the dignity, worth, equality, diversity and privacy of all persons Professional commitment Guiding Principles for Avoiding Conflicts of Interest When in doubt, disclose potential Conflict of Interest. Any approach to preventing, identifying, managing and monitoring conflicts of interest should be based on the principle of mutual respect. Do no harm: As professionals our primary commitment is to realise society’s right to proper nutrition. Let this guide our actions and decisions! The possible negative consequences of all actions should be considered before any action is taken. Apply the reasonable person approach.  Public Health Nutrition, Research & CoI Interactions between commercial food and drink companies and professionals and bodies responsible for improving public health and health promotion have generated concerns for decades. Such interactions with industry are common among individual researchers: Article in British Medical Journal, van Tulleken, reported that cow’s milk allergy may be acting as a Trojan horse for the €44bn global breastmilk substitute industry to forge relationships with healthcare professionals in the UK and around the world. Further highlighted that many of those involved in producing milk allergy guidelines declared interests with breastmilk substitute manufacturers either at the time of writing or subsequently. A series of recent studies have highlighted links between nutrition researchers and Coca Cola, contributing to a narrative that pushes policy towards measures to increase exercise by children which is of course a good thing, while deflecting attention from the role of sugar-sweetened beverages in obesity and poor nutrition. Public Health Nutrition, Research & CoI Interactions between public health, paediatric and nutrition experts and commercial food and drink companies can undermine trust in researchers and their scientific integrity. Concerns about interactions between researchers and commercial food and drink companies are well-founded as corporate interests typically prioritise investing in research that supports their policy and legal positions, and this can divert research attention away from questions that are more pressing for public health. An important element of maintaining public trust in the scientific process and credibility of published articles is whether conflicts of interest are transparently disclosed during the planning, implementation, writing, peer review, editing, and publication of scientific work. Determining what constitutes a conflict of interest can be difficult for researchers and editors as there is limited guidance available Public Health Nutrition, Research & CoI In a recent scientific article (2018) published in Annals of Nutrition and Metabolism, the authors of the article stated that they had “no conflicts of interest or financial ties to disclose” despite declaring that the writing of the article was supported by Nestlé Nutrition Institute. This Institute has clear links with Nestlé, the world’s biggest breastmilk substitute and complementary baby food manufacturer, and therefore it has a clear financial interest in the study. This occurs despite the WHO highlighting the need to avoid conflicts of interest in all areas relating to infant and young child feeding in at least eight World Health Assembly resolutions. Public Health Nutrition, Research & CoI Researchers and journals have important responsibilities regarding conflicts of interest. Researchers, journals, funders and others involved in the research process need to engage more critically with the challenges of conflicts of interest in research. Develop a clear understanding of what CoI is, and is not, how to identify CoI and its impact/s on scientific integrity, how to prevent them. Provide transparency in the reporting of conflicts of interest in research! Journal editors in particular have an important responsibility in fully understanding how conflicts of interest can impact on research findings and the credibility of published articles for journals and authors. Public Health Nutrition, Research & CoI Clear guidelines on managing interactions with commercial food and drink companies, including avoidance of damaging conflicts of interest, are urgently needed. Journals and Research institutions, Professional bodies and Funders should formulate or update clear guidelines regarding conflict of interest policies and ensure that authors, peer reviewers, editors, and editorial board members abide by these to promote trust in the scientific process and the credibility of published articles. NB new guidance: United Nations Children’s Fund (UNICEF), Engaging with the Food and Beverage Industry: UNICEF Programme Guidance, 2023.  References 1. HPCSA Booklet 1- GENERAL ETHICAL GUIDELINES FOR THE HEALTHCARE PROFESSIONS 2. Reference Note. Engaging in the SUN Movement: Preventing and Managing Conflicts of Interest. Reference note and Toolkit. January 2015. Global Social Observatory 3. Financial Conflicts of Interest and Reporting Bias Regarding the Association between Sugar-Sweetened Beverages and Weight Gain: A Systematic Review of Systematic Reviews. Maira Bes-Rastrollo, Matthias B. Schulze, Miguel Ruiz-Canela, Miguel A. Martinez-Gonzalez. PLOS Medicine December 2013, Volume 10 , Issue 12 4. United Nations Children’s Fund (UNICEF), Engaging with the Food and Beverage Industry: UNICEF Programme Guidance, 2023. 5. Best practices in nutrition science to earn and keep the public’s trust. C Garza, PJ Stover, SD Ohlhorst, MS Field, R Steinbrook, S Rowe, C Woteki, and E Campbell. Am J Clin Nutr 2019;109:225–243. 6. Child health, infant formula funding and South African health professionals: Eliminating conflict of interest. L Lake, M Kroon, D Sanders, A Goga, C Witten, R Swart, H Saloojee, C Scott, M Manyuha, T Doherty. December 2019, Vol. 109, No. 12 7. Conflict of interest in nutrition conference financing: Moving towards solutions after IUNS 2022. J Harris, A Carriedo, W Friere, LM du Plessis, J Yates, S Kadiyala, J Badham, S Gillespie, T Greiner, the Nutrition COI Action Group. ” World Nutrition, December,2022: 54–61. 8. Commercial interests, agenda setting, and the epistemic trustworthiness of nutrition science. Saana Jukola. 23 April 2019, Springer Nature 9. Time for complete transparency in public health nutrition research. M Hennessy, K Cullerton, etal. HRB Open Research October 2019. 10. Conflict of interest and professional ethics. S Semplici. Italian Journal of Pediatrics 2015, 41(Suppl 2):A65 11. Conflicts of interest and an approach to managing them. NE Fink. eJIFCC2020 Vol31No4pp292-301