This howtoregulate article focuses on using regulations to protect the impartiality of decisions and research in the public interest. All too often we see stories breaking about the alleged impropriety of important decisions or research that served a narrow interest at odds with the public interest. Sobering indeed, is the phenomenon of scientific deniers or the rejection of scientific evidence as a basis for government decisions and policy. Impartiality is an important factor in public trust of democratic and scientific institutions, such as universities and government departments. In using regulations to protect the principle of impartiality we look at some examples of how this is done at the international and national level, ending with some recommendations to improve regulatory measures.
In the howtoregulate article “Countering unfair lobbying” it was investigated what could be done to counter unfair or disproportionate lobbying by reflecting on the official’s approach to dealing with lobbyists. Some of the reflections, include:
- Analyse the interests of the lobby organisations you are confronted with. Put yourself in their shoes.
- Based on the analysis of their interests: what measures are they most likely to request?
- What would be the negative side-effects of the measures they request for others, the common interest, but also for the lobby organisation or its constituency? List all these negative side-effects.
- Identify scientific arguments defending your position and involve scientists if needed.
- Identify legal arguments / legal constraints imposing or defending your position.
- Are there alternative measures that would accommodate the lobby organisations’ interests and requests without disproportionately harming the common interest?
- Are there measures that would be recognised as accommodating their interests (whilst not doing so in reality) without disproportionately harming the common interest?
This article on using regulations to protect the impartiality of decisions and research in the public interest expands on the part of the offical and looks at the system where such decisions and research take place.
A. International and supra-national law about impartiality or undue influence
1. Regulating impartiality is multifaceted, and to be effective needs to focus on the ethics and integrity of the people involved in such decisions, continuous training, declarations of interests, monitoring and external supervision. At the international and multi-lateral level conventions concerning corruption usually include provisions for impartiality, undue influence or conflict of interest of public officials. Most international organisations have rules about impartiality, such as the United National Secretary General, OECD Code of Conduct for Officials, the European Commission, and International Committee of the Red Cross.
2. In terms of scientific research conducted by public universities or scientific institutions global rules concerning human research is fairly advanced. This International Compilation of Human Research Standards managed by the US Department of Health and Human Services is comprehensive. However, there are no globally binding rules requiring states to ensure that public decisions or public research be made impartially.
I. United Nations (UN) and its agencies
3. The UN’s Joint Inspection Unit (JIU) is the only independent external oversight body of the UN system mandated to conduct evaluations, inspections and investigations system-wide. In 2017 conducted a review of mechanisms and policies addressing conflict of interest in the UN system, which presents a very useful summary of the obligations of the international civil service. On joining the UN all international civil servants must make a declaration:
I solemnly declare and promise to exercise in all loyalty, discretion and conscience the functions entrusted to me as an international civil servant of the United Nations, to discharge these functions and regulate my conduct with the interests of the United Nations only in view, and not to seek or accept instructions in regard to the performance of my duties from any Government or other source external to the Organization.1
4. The Guidelines for cooperation between the UN and the business community were developed in 2000 and facilitate the formulation and implementation of cooperation between the UN and the business community in a manner that ensures the integrity and independence of the UN. Business partners are chosen based on their commitment to the ten principles outlined in the UN Global Compact. General partnership principles must be guided by:
- advancing UN goals,
- clearly delineated roles and responsibilities,
- integrity and independence,
- no unfair advantage, and
Any use of the name or logo of the UN by a business partner must be approved by the UN Office of Legal Affairs. The JIU reviewed corporate sponsorship in the UN in 2009 and their report is a well summarised reference for large organisations, with complex processes that wish to improve their regulation of corporate sponsorship. The UN also has principles and guidelines for Corporate Sponsoring in the UN System.
(a) The Convention Against Corruption
5. The UN Convention Against Corruption is the international community’s response to the corrosive effects of corruption on the state, democracy and the rule of law. It contains several articles about the role of public officials and the importance of measures and systems to manage and avoid conflicts of interest.
Article 7. Public sector: … strengthen systems that promote transparency and prevent conflicts of interest.
Article 8. Code of conduct for public officials: … promote, inter alia, integrity, honesty and responsibility among its public officials (1.) and … requiring public officials to make declarations to appropriate authorities regarding, inter alia, their outside activities, employment, investments, assets and substantial gifts or benefits from which a conflict of interest may result with respect to their functions as public officials (5.).
Article 12. Private sector: concerns criminalising corruption in the private sectors, and measures and systems to prevent corruption.
Article 18. Trading in influence: concerns criminalising bribery of public officials.
Article 36. Bodies to investigate: concerns bodies specialised in combatting corruption through law enforcement and granting such bodies independence to carry out this function.
The definition of “public official” is quite expansive and its widest meaning may include “any person who performs a public function or provides a public service as defined in the domestic law of the State Party…”2. Such a definition most likely would include any researchers working in a publicly-funded university.
(b) World Health Organisation (WHO)
6. The WHO has a guide known as the Framework of engagement with non-Sate actors (FENSA), which was revised in 2016 and an evaluation report of its implementation and efficacy is expected to the be considered by the Executive Board in January 2020. The FENSA explicitly prohibits engagement with the tobacco industry or non-state actors that work to further the interests of the tobacco industry3 (5.5) and the arms industry (5.6). For entities receiving funding from other entities linked to the arms industry, a case-by-case assessment is made on the acceptability of funding from such entities. At 5.7 WHO is cautious when engaging with non-state actors whose policies or activities are negatively affecting human health and are not in line with WHO’s policies, norms and standards, particularly noncommunicable diseases and their determinants. The alcohol industry, the food and beverage industry (including producers of breast mil substitutes) and the chemical industry are cited as industries requiring case-by-case assessment. The WHO recognises that companies and their foundations are to be treated the same, so if a partnership with a business is not approved, it will similarly apply to the business foundation regardless of its articles of foundation (5.8.1).
7. The WHO Framework Convention on Tobacco Control (FCTC) is a unique treaty in that it recognises the conflict of interest between the tobacco industry and State Parties obligations to public health.
Recognising the need to be alert to any efforts by the tobacco industry to undermine or subvert tobacco control efforts and the need to be informed of activities of the tobacco industry that have a negative impact on tobacco control efforts.
Article 5 General Obligations
- In setting and implementing their public health policies with respect to tobacco control, Parties shall act to protect these policies from commercial and other vested interests of the tobacco industry in accordance with national law.
Article 13 Tobacco advertising, promotion and sponsorship
1. Parties recognize that a comprehensive ban on advertising, promotion and sponsorship would reduce the consumption of tobacco products.
Article 20 Research, surveillance and exchange of information
- (c) cooperate with competent international organizations to progressively establish and maintain a global system to regularly collect and disseminate information on tobacco production, manufacture and the activities of the tobacco industry which have an impact on the Convention or national tobacco control activities.
8. Arguably the obligations of the FCTC operate against impartiality in that there is bias against the tobacco industry, however, by encouraging vigilance of tobacco industry activities it serves to “level the playing field”. Our howtoregulate article “Tobacco control regulations: Combating the world’s leading preventable cause of death” contains a detailed explanation of the FCTC.
(c) Council for International Organizations of Medical Sciences (CIOMS)
9. CIOMS was jointly established by WHO and the UN Educational, Scientific and Cultural Organisation (UNESCO) to advance public health through guidance on health research including ethics, medical product development and safety. In 2016 it updated the International Ethical Guidelines for Health-related Research Involving Humans (Guidelines) to respond to pressing issues in research ethics, including:
- the need for research having scientific and social value;
- providing special guidelines for health-related research in low-resource settings;
- detailing the provisions for involving vulnerable groups in research; and
- describing under what conditions biological samples and health-related data can be used for research.
The scope of “health-related research” in these Guidelines refers to activities designed to develop or contribute to general health knowledge in the realm of research with humans, such as observational research, clinical trials, biobanking and epidemiological studies. These Guidelines represent best international practice for health-related research involving humans and of the 25 principles, the following touch upon the importance of impartiality in research:
1-Scientific and social value and respect for rights: researchers, sponsors, research ethics committees, and health authorities4, must ensure that proposed studies are scientifically sound5, build on an adequate prior knowledge base, and are likely to generate valuable information. […] Scientific and social value6 cannot legitimate subjecting study participants or host communities to mistreatment, or injustice.
8-Collaborative partnership and capacity-building for research and research review: Governmental authorities in charge of health-related research involving human participants have to ensure that such research is reviewed ethically and scientifically by competent and independent research ethics committees and is conducted by competent research teams (see Guideline 23 – Requirements for establishing research ethics committees and for their review of protocols). Where research capacity is lacking or underdeveloped, sponsors and researchers have an ethical obligation to contribute to a host country’s sustainable capacity for health-related research and ethical review. Before undertaking research in a community with little or no such capacities, sponsors and researchers should have a plan that describes how the research can contribute to local capacity. The kind and amount of capacity-building reasonably required should be proportional to the magnitude of the research project. A brief epidemiological study involving only review of medical records, for example, would require relatively little, if any, such development, whereas a considerable contribution is to be expected of a sponsor of a large-scale vaccine trial intended to last several years. The conduct of research must not destabilize health care systems, and ideally should contribute to them.
23-Requirements for establishing research ethics committees and for their review protocol:
All proposals to conduct health-related research involving humans must be submitted to a research ethics committee7to determine whether they qualify for ethical review and to assess their ethical acceptability, unless they qualify for an exemption from ethical review (which may depend upon the nature of the research and upon applicable law or regulations). The researcher must obtain approval or clearance by such a committee before beginning the research. The research ethics committee should conduct further reviews as necessary, for example, when there are significant changes in the protocol.
Research ethics committees must review research protocols according to the principles set out in these Guidelines.
Research ethics committees must be formally established and given adequate mandate and support to ensure timely and competent review according to clear and transparent procedures. Committees must include multidisciplinary membership in order to competently review the proposed research. Committee members must be duly qualified and regularly update their knowledge of ethical aspects of health-related research. Research ethics committees must have mechanisms to ensure independence of their operations.
Research ethics committees from different institutions or countries should establish efficient communication in cases of externally sponsored and multi-centre research. In externally sponsored research, ethical review must take place in both the host and the sponsoring institution.
Research ethics committees should have a clear procedure for researchers or sponsors to make legitimate appeals against the decisions of research ethics committees.
24-Public accountability for health-related research: Public accountability8 is necessary for realizing the social and scientific value of health related research. Therefore, researchers, sponsors, research ethics committees, funders, editors and publishers have an obligation to comply with recognized publication ethics for research and its results. Researchers should prospectively register their studies, publish the results and share the data on which these results are based in a timely manner. Negative and inconclusive as well as positive results of all studies should be published or otherwise be made publicly available. Any publication or report resulting from a research study should indicate which research ethics committee has authorized the study. Researchers and sponsors should also share information about and data from past research.
25-Conflicts of interest: The primary goal of health-related research is to generate, in ethically appropriate ways, the knowledge necessary to promote people’s health. However, researchers, research institutions, sponsors, research ethics committees, and policy-makers have other interests (for example, scientific recognition or financial gain) that can conflict with the ethical conduct of research. Such conflicts between the primary goal of health-related research and secondary interests are defined as conflicts of interest. Conflicts of interest can influence the choice of research questions and methods, recruitment and retention of participants, interpretation and publication of data, and the ethical review of research. It is therefore necessary to develop and implement policies and procedures to identify, mitigate, eliminate, or otherwise manage such conflicts of interest.
CIOM has developed a free online training (need to create an account) of Ethical Guidelines for Health-related research, which includes case studies and certificate of completion.
II. World Conference on Research Integrity
10. The World Conferences on Research Integrity (WCRI) is a global effort to foster the exchange of information and discussion about responsible conduct of research, with the aim to harmonise policies and joint action. The first five WCRI were convened by co-chairs and planning committees and since 2017 a Foundation was established to support the ongoing organisation and development of future WCRI’s and related activities. The WCRIs have produced two global statements on research integrity: the Singapore Statement in 2010 and the Montreal Statement in 2013.
11. The 2010 Singapore Statement set out four principles of responsible research: 1) honesty in all aspects of research, 2) accountability in the conduct of research, 3) professional courtesy and fairness in working with others, and 4) good stewardship of research on behalf of others.
12. The 2013 Montreal Statement concerns research integrity in cross-boundary research collaborations: 1) general collaborative responsibilities, 2) responsibilities in managing the collaboration, 3) responsibilities in collaborative relationships, and 4) responsibilities for outcomes of research.
13. In 2017 the Amsterdam Agenda was agreed which places greater emphasis on the assessment of efforts to improve integrity in research and the use of empirical information in developing research integrity policies by:
- Establishing a “Registry for Research on the Responsible conduct of Research” (RRRCR), which will seek to encourage researchers to plan, conduct, report and share their research around six key elements:
- (1) Problem. The particular shortcomings they are addressing, such as selective reporting, poor mentoring or inadequate quality assurance.
- (2) Impact. An estimation of the relative impact of the shortcomings on the reliability of research, on trust in the research enterprise, on the responsible use of research funds and on other relevant measures of responsible research.
- (3) Intervention. The specific way(s) they plan to address the identified shortcoming(s), such as through training, outcomes assessment, quality checks, or reinforcements that encourage responsible behaviour.
- (4) Hypothesis or Anticipated Outcomes. The changes expected as a result of the intervention.
- (5) Assessment. How they plan to test their hypotheses and to assess whether the outcomes have been achieved.
- (6) Data sharing. How data (quantitative and qualitative) will be shared.
- Encouraging funding institutions to support research on research integrity;
- Raising awareness of the importance of research integrity and its use in evidence-based policy-makers; and
- Reporting on the response to the RRRCR at the next WCRI with the goal or organising and prioritising future research on research integrity.
A useful summary of the most recent WCRI in 2019 can be found in the Chinese Journal of Medical Ethics (in Chinese but easily read using the translation service of any web browser).
III. Committee on Publication Ethics (COPE)
14. Is a UK-registered charitable company and a registered charity with the objective “to educate and advance knowledge in methods of safeguarding the integrity of the scholarly record for the benefit of the public”. COPE was established to provide a range of services and products aimed primarily, but not exclusively, at editors and publishers of scholarly journals and designed to provide advice and guidance on best practice for dealing with ethical issues in journal publishing. Its Core Practices guidelines outline policies and practices required for journals and publishers to reach the highest standards in publication ethics. The Core Practices cover the following areas:
- allegations of misconduct;
- authorship and contributorship;
- complaints and appeals;
- conflicts of interest/competing interests;
- data and reproducibility;
- ethical oversight;
- intellectual property;
- journal management;
- peer review process; and
- post-publication discussions and corrections.
With a strong focus on education, COPE aims to move the culture of publishing towards one where ethical practices become a normal part of publishing culture. COPE’s other activities include a monthly newsletter, annual seminars, and an audit tool for members to measure compliance with its Core Practices.
IV. Organisation for Economic Development (OECD)
15. OECD Staff Regulations, Rules and Instructions Applicable to Officials of the Organisation provide that the basic principles, rights and duties of officials are:
- independence and international character9,
- integrity and loyalty ii) conduct themselves with objectivity and impartiality and avoid any conflict of interest, or appearance of conflict of interest, in the performance of their duties10,
- tact and discretion11,
- basic individual rights and rights of association12, and
- Protection of officials in the performances of their duties13.
16. The OECD Global Science Forum (GSF) supports countries to improve their science policies and share in the benefits of international collaboration to address complex and inter-related societal, environmental and economic challenges. Specifically, the GSF serves its members in the formulation and implementation of their science policies by:
- exploring opportunities and mechanisms for new or enhanced international co-operation in selected priority areas
- defining international frameworks for national or regional science policy developments
- addressing the science policy dimensions of issues of global concern.
The GSF’s principal customers are the government science policy officials who bring issues to the GSF for deliberation and analysis in an intergovernmental setting. The GSF has developed a “Best Practices for Ensuring Scientific Integrity and Preventing Misconduct” based on a conference of member states held in Tokyo in 2007. The aim of the best practice is to ensure integrity in science by recognising that it is a complex, multifaceted task, touching upon education, publication, the functions of scientific and academic institutions, and the responsibilities of funding agencies. It focuses on the practical and administrative dimensions of dealing with allegations of misconduct.
17. The OECD Directorate of Science, Technology and Innovation (STI) develops evidence-based policy advice on the contribution of science, technology and industry to well-being and economic growth. The STI has developed a report Research Ethics and New Forms of Data for Social and Economic Research, which sets some basic rules that underpin an ethical approach to research using new forms of data and economic research.Two general concerns relating to social research cover how researchers relate to each other and their own methodological standards, and how researchers relate to the surrounding world, primarily the data subjects.
18. According to the Code of Good Administrative Behaviour for Staff of the European Commission in their Relations with the Public, European Commissioners and the staff of the European Commission have a duty to the Community interest, as well as the public interest. This duty means that the public legitimately expects quality service and an administration that is open, accessible and properly run. The standard of service is to be courteous, objective and impartial. European Commissioners have additional rules laid out in the European Union Treaties that provide that the independence of Commissioners must be beyond doubt.14 Although Member States put forward candidates for consideration as Commissioners, Member States are to respect their independence and shall not seek to influence Commissioners in the performance of their tasks. Other measures to ensure the independence and impartiality of the Commissioners, includes:
- declaration of interests, which are provided in a machine readable format,
- publishing information on the meetings between Commissioners and interest representatives,
- publishing the costs of Commissioner’s individual business travels,
- a list of gifts received by the Commissioners,
- notification rules of up to 2 years for post term activities, where the activity relates to the Commissioner’s former portfolio it must be consulted with the Independent Ethical Committee, and
- sanctions for any breaches of these ethical obligations include, the Court of Justice may deprive former Commissioners of their rights to a pension or other benefits, a reprimand for current Commissioners or requesting a resignation.15
19. In terms of research impartiality and integrity the European Code of Conduct for Research Integrity is an attempt to “formulate the principles of research, to define the criteria for proper research behaviour, to maximise the quality and robustness of research, and to respond adequately to threats to, or violations of, research integrity”.16 The purpose of the Code is to serve the research community as a framework for self-regulation, and is aligned with the World Conference on Research Integrity. The Code covers principles of reliability, honesty, respect and accountability, as well as describes good research practices and violations of research integrity.
20. The European Network of Research Integrity Offices (ENRIO) brings together experts who are dealing with questions about research integrity. ENRIO is an informal network aiming to enhance research integrity in a world with growing international cooperation. Its fairly young having been founded in 2008 and will hold its first conference on Research Integrity Practice in 2020. The recommendations of its first publication in 2019 on Recommendations for the Investigation of Research Misconduct is essential reading for any country seeking to regulate better its oversight systems of research and it clearly presents the conundrums inherent in research ethics.
21. Embassy for Good Science manages the online community platform for research integrity and ethics. The Embassy offers help to anyone seeking support in handling day-to-day research practices and dilemmas. Its declaration for doing good science provides that . The platform contains information and resources about research ethics, can connect you with discussions in the research community and offers knowledge through training.
B. National laws about impartiality or undue influence
In a democracy, decisions should be made in the public interest. When decisions are not based on the public interest and are influenced in such a way that the decision serves a narrow interest such as a business or an individual, then public trust in institutions goes down. Public trust is actually an important factor in the rule of law and the principle of impartiality is protected in most democracies.
I. Rules about impartiality of public officials
1. The federal and state public services of Australia are a good example of a jurisdiction with clear rules about impartiality in the public service. In the Australia state jurisdiction of Western Australia (WA), the rules governing impartiality are contained in the following key WA legislation:
- Public Sector Management Act 1994: Section 7 contains eight public administration and management principles to be observed and Schedule 4 provides that the Public Sector Commissioner must declare that she/he will impartially execute the office and perform the functions of commissioner accord to law; and
- Corruption, Crime and Misconduct Act 2003: contains provisions where the Commissioner or Parliamentary Inspector may declare that she/he is unable to act due to an actual or potential conflict of interest (s. 13 & s. 195 ss. 3).
Further explanatory material about good governance for WA public sector agencies can be found on the Public Sector Commission website, with very clear legislative lines of operation for each principle. In the example of Principle 5: Ethics and integrity, integrity is defined as acting with “care and diligence and make decisions that are honest, fair, impartial, and timely, and consider all relevant information”. Integrity is further defined into specific categories and these categories have additional explanation, making it clear as to what is meant by ‘conflicts of interest’, ‘acting with integrity when making decisions’ and ‘political impartiality’.17 The definition of political impartiality is particularly good:
The public sector serves the public as determined by the democratically elected Government of the day, without bias towards one political party or another. This ‘political impartiality’ endures so there is continuity in the business of government regardless of which party is in power.
Impartiality means neutrality, independence and objectivity, fairness and balance, open-mindedness and even-handedness. This detachment does not mean apathy, indifference or unresponsiveness to public policy priorities determined by the Government and parliament.
Political impartiality requires public officers to demonstrate loyalty to the state of Western Australia, led by the elected Government, and to successive governments, and enables successive governments to have confidence in the public sector. In addition, the way public servants interact with the community affects the perceptions and attitudes the community have of public sector agencies and officers.
Serving the public interest also involves identifying and promoting opportunities to serve the Western Australian public, and advocating innovative solutions to community concerns. In serving the duly elected Government, a balance needs to be maintained between the dual roles of public servants being responsible to the minister and responsive to the public.
2. The WA legislation also clearly defines what misconduct is:
minor misconduct occurs is a public officer engages in conduct that adversely affects […] the honest or impartial performance of the functions of a public authority […] constitutes or involves the performance of his or her functions in a manner that not honest or impartial […]or constitutes or involves a breach of trust[.]
3. The WA Guidelines on Sponsorship in Government requires sponsorship of research projects that could relate to or influence public policy to be scrutinised more carefully. In the Australian state of Victoria, the guidelines on sponsorship are to be developed by each department according to their specific area and must ensure impartial, fair and ethical behaviour:
How to act in the public interest by restricting sponsorship to appropriate activity of government, facilitating open and effective competition around sponsorship opportunities and ensuring no conflicts of interest.18
II. Rules about impartiality in research
4. Generally, the rules about impartiality involving research of human subjects is clear, noting the implications for human health if not regulated. Research not involving human subjects is for the most part not regulated, except where the research may touch on regulated subjects eg. nuclear material, chemicals, biological material, critical weapons components etc.
5. The US Federal Drug Administration regulates well research involving human subjects, particularly where the end purpose is to put a product to market.19 All applications to market a product must include all clinical research and this research must include financial disclosures of each person involved in the research.20
Sec. 54.5 Agency evaluation of financial interests.
(a) Evaluation of disclosure statement.FDA will evaluate the information disclosed under 54.4(a)(2) about each covered clinical study in an application to determine the impact of any disclosed financial interests on the reliability of the study.[…]
(b) Effect of study design. In assessing the potential of an investigator’s financial interests to bias a study, FDA will take into account the design and purpose of the study. Study designs that utilize such approaches as multiple investigators (most of whom do not have a disclosable interest), blinding, objective endpoints, or measurement of endpoints by someone other than the investigator may adequately protect against any bias created by a disclosable financial interest.
(c) Agency actions to ensure reliability of data. If FDA determines that the financial interests of any clinical investigator raise a serious question about the integrity of the data, FDA will take any action it deems necessary to ensure the reliability of the data including:
III. Effective internal and/or external supervision function
6. New Zealand employs a number of regulatory measures for internal and external supervision of public decisions. Firstly, some public decisions, and the manner in which they may be made and the considerations to be taken into account are proscribed in legislation. For example applications for marine consent, marine dumping consent and marine discharge with the economic exclusive zone must follow the decision-making criteria outlined in the Exclusive Economic Zone and Continental Shelf (Environment Effects) Act 2012. This Act proscribes over 20 considerations the decision-maker must take into account:
(a) any effects on the environment or existing interests of allowing the activity, including—
(i) cumulative effects; and
(ii) effects that may occur in New Zealand or in the waters above or beyond the continental shelf beyond the outer limits of the exclusive economic zone; and
(b) the effects on the environment or existing interests of other activities undertaken in the area covered by the application or in its vicinity, including—
(i) the effects of activities that are not regulated under this Act; and
(ii) effects that may occur in New Zealand or in the waters above or beyond the continental shelf beyond the outer limits of the exclusive economic zone; and
(c) the effects on human health that may arise from effects on the environment; and
(f) the economic benefit to New Zealand of allowing the application; and
(k) relevant regulations (other than EEZ policy statements); and
(l) any other applicable law (other than EEZ policy statements);
7. Measures aimed at internal and external supervision include the register of interests (online) of the decision-makers interests, the procedures the decision-makers must follow, recording of meeting minutes of the decision-makers (example here) and well-explained procedures on how to appeal the decision through the High Court.21
8. Australia provides effective regulation for the external supervision of all research it publicly funds through its national competitive research grants, which are all peer-reviewed22 and externally supervised by the Australian Research Council (ARC) and the National Health and Medical Research Council (NHMRC). Both the ARC (Australian Research Council Act 2001) and the NHMRC (National Health and Medical Research Council Act 2002) are independent statutory bodies established to foster research integrity in their respective fields of science. Nationally the federal government funds about one third of research and development, state and territory governments also fund research but their share could not be assessed to determine the over all breakdown between public and private funding of research.23 As the ARC and NHMRC are concerned with research publicly funded, their responsibility does not extend to research privately funded.
9. Peer review is defined in the Australian Code for the Responsible Conduct of Research (the Code) as “the impartial and independent assessment of research by others working in the same or a related field”. The ARC and the NHMRC have established an independent body, the Australian Research Integrity Committee (ARIC), to review institutional processes used to manage and investigate potential breaches of the Code.24 ARIC aims to ensure that in investigating potential breaches of the Code, institutions observe proper processes. However, the results of their investigations are not made public.
IV. Effective deterrence sanctions
10. Where jurisdictions have legislation governing the conduct of officials in public functions, there will always be a part of the legislation that concerns breaches and sanctions. For jurisdictions cited in this article, the following list outlines the sanction:
- Western Australian Public Sector Management Act 1994: Division 2 – Substandard performance, whereby:
Section 79 (1) performance of an employee is substandard if and only if the employee does not, in the performance of the functions that he or she is required to perform, attain or sustain a standard that a person may reasonably be expected to attain or sustain in the performance of those functions.
Section 79 (3) [sanctions for substandard performance]
(a)withhold for such period as the employing authority thinks fit an increment of remuneration otherwise payable to that employee; or
(b)reduce the level of classification of that employee; or
(c)terminate the employment in the Public Sector of that employee.
- Western Australian Public Sector Management Act 1994: Division 3 – Disciplinary matters, whereby an employee commits a breach of discipline because he/she disobeys or disregards a lawful order, contravenes any provision of the Act applicable to that employee or any public sector standard or code of ethics, commits an act of misconduct, is negligent or careless in the performance of his/her functions or commits an act of victimisation (section 15 of the Public Interest Disclosure Act 2003). Sanctions could include suspension of employment pending breach of discipline or criminal charge, and once decision made termination of employment and where a criminal charge is sustained the corresponding criminal penalty. These regulations were recently used to prosecute Western Australia’s biggest corruption scandal of AU$22 million stolen by a senior official, which was discovered during routine governance check.25
- US FDA officials have post-employment restrictions about working for the “other side”26, the sanctions include one year imprisonment, civil action of US$50,000 for each violation or the amount of compensation which the person received or offered for the prohibited conduct, whichever amount is greater27.
11. As most jurisdictions regulate officials’ conduct regarding public decisions and usually include codes of ethics, they also have good training regimes. The Western Australian Public Sector Commission has developed an accountable and ethical decision-making training programme. The Australian and New Zealand School of Governmentreleased a paper in March 2019 entitled “Being a trusted and respected partner: the APS’ relationship with Ministers and their offices”, which was a research paper for the Australian Public Service Review Panel, outlining the complexity of ‘being impartial’ in practice, particularly in the current global climate of hyper politics and populism. The US Office of Government Ethics has useful topics such as financial conflicts of interest and impartiality, use of government position and resources etc. which are written in a way that officials are clear on how to approach problems. The OECD produced this report “Ethics Training for Public Officials”, which provides useful insights and case studies about best practices for implementing ethics training, some good insights include:
- “special attention should be paid to the preparation and design of ethics training; such training should be specially developed for individual public institutions, or target group of officials. They should address legal requirements/rules and values; they should be practical and based on real cases relevant to the activities of the institution or group of officials; … and should be delivered using interactive approaches”;
- As the needs for integrity training vary significantly between countries, it is important to understand these needs before embarking on a long-term investment in training programmes. A needs assessment can help prioritise and focus training efforts and improve their cost effectiveness. Surveys or studies that analyse the level of corruption or the level of integrity in the public administration could help diagnose the problems and evaluate the training needs.
- To be effective, ethics training requires many new skills, knowledge of ethics issues specific to a given institution, and the use of modern training techniques. The experience of several countries (e.g. Estonia, Spain) shows that when trainers from institutions delivering ethics training work very closely with the managers of the institutions to which the training is provided, better results are achieved.
- Follow-up measures are useful to support the application of the newly acquired knowledge by the participants in the training courses in their work. The measurement of such follow-up may include individual action plans for participants and coaching at the workplace. It may also be possible to include ethics as an element of civil servants’ performance appraisal. This option may be particularly important for civil servants working in high corruption risk sectors.28
12. In the field of research, the Irish Universities Association (IUA), a company limited by guarantee with charitable status, represents the Irish public research system and seeks to Irish research meets the highest standards of integrity. Through its “Policy Statement on Ensuring Research Integrity in Ireland” it commits the main organisations in Irish research to the highest standards of integrity in carrying out their research so that partners, the public and other stakeholders, and the international research community have full confidence in the Irish research system. The Policy Statement recognises the importance of training, supervision and mentorship in fostering a culture of integrity and their goal is provide research integrity training for all researchers across their career path and training in rigorous research design, methodology and analysis for new researchers. As the IUA is represented by Ireland’s seven universities, they a lot of influence in the education of researchers and so research integrity is inculcated during doctoral training, recognised in the national policies and guidelines: the “National Framework for Doctoral Education”29and “Irelands Framework of Good Practice for Research Degree Programmes”30.
13. The Irish “National Framework for Doctoral Education” recommends that there be an integrated programme of personal and professional development for all research students. “Ireland’s Framework of Good Practice for Research Degree Programmes” recommends that procedures are in place to make students aware of appropriate professional standards, including with respect to research integrity, and that they should be supported to exercise those professional standards via, for example, appropriate induction, training, and mentoring. The Deans of Graduate Studies across the seven universities agreed a “skills statement”31 for PhD graduates. This emphasises the skills that PhD graduates should have acquired during the course of their PhD (either through formal training and/ or research experience). Specifically, PhD graduates should understand and apply ethical principles and good research practices in their research, including the use of appropriate methodologies, correct allocation of credit and authorship, and avoidance of research misconduct.
VI. Transparency measures
14. For the public to be assured that decisions and research are conducted impartially and in the public interest transparency is key. The scope of the principle of impartiality is that one is impartial and appears impartial. For this reason some measures to ensure the appearance of impartiality are used such as precluding persons from involvement in decisions that affect their family or their financial interest. Evidently, transparency is a measure that strengthens the appearance of impartiality because it shows the public official is open to sharing the internal mechanisms that make up decisions in the public interest. New Zealand has many transparent measures that start at the top such as the Prime Minister releasing online the records of Cabinet decisions about ministerial travel32, requests for official information made by the public are released online and government-collected data sets are also available online.
15. Some universities list their corporate sponsors but details on the amount of funding and to which particular research the funding goes is not so easy to find:
- Australian National University, John Curtin School of Medical Research; and
- University of Michigan, list of sources of funding (government , private and all).
C. Operational recommendations to improve regulatory measures to protect impartiality
Based on the research of various jurisdiction’s regulations concerning decisions and research in the public interest the following recommendations are made to improve measures to protect impartiality.
- Define impartiality and appearance of impartiality.
Various definitions exist for impartiality which at one end of the spectrum concerns equal treatment of all rivals or disputants through to affecting all equally.33 Another definition is an ability to judge or consider something fairly without allowing your own interest to influence you. Someone who is impartial is not directly involved in a particular situation and is therefore able to give a fair opinion or decision about it.34 Some jurisdictions require public decisions and research to be conducted impartially, other jurisdictions require that decisions/research not be unduly influenced. The latter begs the question of the situations where it would be permissible or justified for a decision to be duly influenced. Therefore terms such as impartial or avoid undue influence should be clear in regulation and list concretely the situations that should be avoided, either a list of illicit behaviours or as explicit bans (eg. prohibiting industry-affiliate programmes in public health research).
By listing situations that should be avoided, regulation can also preserve the appearance of impartiality as a value to be protected. Examples of regulation aimed at protecting the appearance of impartiality include exclusion of individuals who have a direct or indirect financial interest in the decision or research and exclusion of individuals who have a relationship with those involved in the decision or research. Scientific journals, such as PLOS, in a self-regulatory move as part of the global system of scientific integrity, also state that they avoid conflicts of interest by not publishing authors with ties to the tobacco industry35. PLOS contains a clear policy on the interests to be declared.
- Establish basic procedural and substance rules on impartiality with regard to nomination to public functions.
The Australian National Health Act 1953 and the National Health (Pharmaceutical Benefits) Regulations 2017 is an example of basic procedural and and substance rules on impartiality with regard to nomination to Pharmaceutical Benefits Advisory Committee (decide which medicines will be publicly subsidised). The Health Act 1953 outline the categories that would make for an impartial committee: industry, consumers, health economists, practising community pharmacists, general practitioners, clinical pharmacologists, specialists and any other person the Minister is satisfied has the qualifications or experience (Section 100A). The Health Regulations proscribe specific bodies, listed by category; industry organisations, consumer organisations and professional associations, to each nominate three people from their organisation for consideration to join the Committee (Sections 86-88). These proscribed bodies have their own governance processes that outline how members within the organisation are nominated for leadership roles.
- Establish basic procedural and substance rules on impartiality with regard to the execution of public functions.
The Western Australian Public Sector Management Act 1994 has very clear rules on impartiality about the execution of the Public Sector Commissioner’s public functions, including promoting overall efficiency and effectiveness of the Public Sector, providing advice to Ministers, planning for the future management of the sector and setting the standards for codes of ethics and conduct (Division 2 – Functions of Commissioner).
- Establish basic procedural and substance rules for third parties dealing with persons in public functions.
Using Western Australia again as an example of basic rules for third parties dealing with persons in public functions, the Integrity (Lobbyists) Act 2016 regulates all third parties engaged in lobbying activities with a government representatives. A lobbying activity means communicating with a government representative for the purpose of influencing, whether directly or indirectly, State government decision-making (Section 4). The purpose of the Act is to provide for the registration of people who undertake lobbying activities, provide for the issuing of a code of conduct for such registered persons and prohibit registered persons from agreeing to receive payment or rewards that are dependent on the outcome of lobbying activities (Section 5). Any lobbyist who wishes to have contact on behalf of a client with a government official is required to be registered, and a government official is not permitted to have dealings with a lobbyist who is not registered. Section 9 provides a list of persons not required to register such as persons from non-profit organisations or an organisation constitute to represent the interests of its members (eg. trade union, law society etc.). The Western Australian Public Service Commission implements these rules online, which makes for a more streamlined process.
- Establish transparency rules for all financial links between persons in public functions and private companies or institutions.
Using the same regulations as above all members of the Pharmaceutical Benefits Advisory Committee are required to disclose pecuniary interests. If a matter before the Committee concerns a pecuniary interest of a member, that member is required to disclose the interest and must not take part in the meeting during the consideration of that matter unless the other members present at the meeting agree otherwise, and both the disclosure and the decision about the disclosure must be recorded (Section 94).
Other examples of transparency rules for financial links between persons in public functions and private companies or institutions, include:
- Requiring the online publishing of all financial links of persons in public functions (PLOS and New Zealand Parliament)
- Requiring public listed companies to publish research it funds, scientists it funds, the foundations it funds and other related collaborations (eg. Dow Chemical36, Bayer collaborations with bee-related research37)
- Providing an online system encouraging disclosure of funds in particular areas of interest to the public, such as climate change, medicines, universities, food policy. [eg. US Open Payments is a national disclosure program that promotes a more transparent and accountable health care system by making the financial relationships between applicable manufacturers and group purchasing organisations and health care providers (physicians and teaching hospitals) available to the public].
- Requiring research to disclose who funded the research, including significant funders of the school or faculty.
These measures would help reduce secrecy about industry funding generally and improve people’s awareness of the issues involved with certain types of funding and sponsorship.
- Establish transparency rules for all non-financial links between persons in public functions and private companies or institutions (e.g. publicising past job-assignments).
Many jurisdictions have regulations that prevent public officials from working in companies that operated in areas to which that public official would have had information about for a specified time period, usually between one to two years after leaving the public office. See paragraph 10 about the US Food and Drug Administration’s post-employment restrictions. The US Food and Drug Administration has a permanent ban on ‘switching sides‘, which means that after leaving federal service, the official is prohibited from making a communication or an appearance before the government on behalf of her/his new employer, in which s/he participated personally or substantially. This permanent ban continues for the entire life of that particular matter the former official participated. For matters where the former official was not involved substantially or personally but the matter was one that fell under the official’s responsibilities then a two year ban applies.
Although these regulations exist they can be difficult to enforce and so additional regulatory measures could include:
- excluding companies who have engaged former officials from public tenders for a specified time period;
- for senior officials to pay a sizeable financial bond to be released after a specified time period on the condition that the official does not engage on issues related to former responsibilities; and
- requiring all communications to government from former senior officials to be recorded and published.
- Establish intra-administrative scrutiny mechanisms.
An example of an intra-administrative scrutiny mechanism is the peer review system used by the Australian Research Council for auditing all funding grants made, their guidelines are published online.38 Other examples include:
- providing a period of consultation with the public or publishing information in the public interest because pushing information to the public is a scrutiny in itself as decision makers would want to ensure that their decision was above reproach knowing that it would be “published”;
- establishing a threshold amount for funds to be scrutinised by an independent branch fo the same department or institute; and
- requiring reports to be produced to the Parliament.
- Establish whistle-blowing mechanisms
For the best practices for regulating whistleblowers see the howtoregulate article “Whistleblowers: protection, incentives and reporting channels as a safeguard to the public interest”.
- Establish penal and financial sanction systems (both for natural and legal persons involved).
Penal and financial sanctions should cover all “undesirable” behaviour, attribute proportionate and effectively deterrence sanctions and give advantages to whistleblowing or persons that cooperate; also include status sanctions like exclusion from public tenders, from grants, black-listing etc. See paragraph 10 of this article which outlines regulatory examples of such sanctions.
- Establish information mechanisms and trainings on all points (1) to (11).
For information mechanisms and training to work there must be an open organisational culture where measures dealing with impartiality and conflict of interest can be freely raised and discussed. Measures that support such a culture include:
- The publication of financial and non-financial disclosures, which serve as an information mechanism for scrutiny by the media or the public at (5) and (6);
- Providing training to the oversight bodies that provide scrutiny so that they are prepared for recognising and making decisions about conflicts of interest;
- Ensure wide publication, awareness and understanding of the conflict-of-interest policy through training and counselling.
- Review “at-risk” areas for potential conflict-of-interest situations.
- Identify preventive measures that deal with emergent conflict-of-interest situations.
- Establish periodic auditing of the system so created to permit further improvement.
The Australian Public Governance, Performance and Accountability Act 2013 requires Commonwealth entities and companies to have a system of independent review, for which a report must be given to the Finance Minister, in consultation with the Joint Committee of Public Accounts and Audit [Section 112 (1)]. Once the Finance Minister receives the report s/he has 15 sitting days to provide copies of those reports to each House of the Parliament [Section 112 (4)]. The medical journal PLOS provides in its Audit Committee Charter that the responsibilities of the Audit Committee is to oversee the performance and independence of the independent auditor and implement recommendations.
The Atlantic “Public Universities Get an Education in Private Industry: Can academic researchers remain impartial if they are beholden to corporate money?”
UK House of Commons Scient and Technology Committee “Research Integrity”
Ethical research http://satoriproject.eu/media/4.b-Country-report-China.pdf
Sponsorship of sports events
US government rules about sponsorship of universities
List of Research integrity links
OECD Guidelines for Managing Conflict of Interest in the Public Service
Moral Jeopardy: Risks of Accepting Money from the Alcohol, Tobacco and Gambling Industries by Peter Adams
Pathways of undue influence in health policy-making: a main actor’s perspective
Academic Capture Warning System Database
This article was written by Valerie Thomas, on behalf of the Regulatory Institute, Brussels and Lisbon.
1 UN Joint Investigation Unit, Review of mechanisms and policies addressing conflict of interest in the UN system (JIU/REP/2017/9) https://www.unjiu.org/sites/www.unjiu.org/files/jiu_rep_2017_9_english.pdf .
2 Article 2. Use of terms (a) page 8 https://www.unodc.org/documents/brussels/UN_Convention_Against_Corruption.pdf .
3 However, “it has proven difficult to come up with a consistent definition of how broadly “furthering the interests” should be interpreted. Similarly, WHO wants to promote its objectives by cosponsoring major global health events. Often, however, such events are also cosponsored by private sector entities with a potential commercial interest in the event’s outcomes. As a result, the Secretariat is reviewing its cosponsorship practices in order to increase engagement in a manner that is in line with the Framework. The extent to which non-State actors can contribute to the WHO’s normative work has also been hard to define, bearing in mind the importance of obtaining certain data and information, while at the same time balancing the risk that such actors will have an undue and unacceptable influence on the work of WHO. The financial and human resources required to develop and maintain an Organization-wide systematic due diligence and risk assessment system, both for the standard and the simplified procedures, remain an issue that will have to be further assessed in the evaluation planned for 2019.” Report by the WHO Director-General on Engagement with non-State actors, presented to the Executive Board at the 144th session (EB144/36, 23 Nov 2018), p. 2,http://apps.who.int/gb/ebwha/pdf_files/EB144/B144_36-en.pdf .
4 The Guidelines provide that such research personnel should have their education and experience to perform competently and with integrity verified (page 2), which includes receiving appropriate ethics education and training. Such verifications and confirmation of ethics training completed are to be submitted to the research ethics committee as part of the study approval process.
5 Scientific value is defined (page 2) as the ability of a study to produce reliable, valid information capable of realizing the stated objectives of the research. The requirement of scientific value applies to all health-related research with humans, regardless of funding source or degree of risk to participants. In part, this is because a diverse range of stakeholders (including patients, clinicians, researchers, policy-makers, industrial sponsors and others) rely on the information that research generates to make decisions that have important consequences for individual and public health. For example, evidence produced in early phase research provides the foundation for subsequent studies, and methodological shortcomings can derail promising avenues of research and squander valuable resources. Many other forms of research, such as clinical trials, health systems research, epidemiological studies or post-marketing studies, generate data that are relevant for clinical decision-making, health and social policy, or resource allocation. Ensuring that studies uphold high scientific standards is essential for maintaining the integrity of the research enterprise and its ability to fulfil its social function.
6 Social value (page 1) refers to the importance of the information that a study is likely to produce. Information can be important because of its direct relevance for understanding or intervening on a significant health problem or because of its expected contribution to research likely to promote individual or public health. The importance of such information can vary depending on the significance of the health need, the novelty and expected merits of the approach, the merits of alternative means of addressing the problem, and other considerations. […] Researchers, sponsors, research ethics committees and relevant health authorities, such as regulators and policy-makers, must ensure that a study has sufficient social value to justify its associated risks, costs and burdens. In particular, there must be sufficient social value to justify risks to participants in studies that lack the prospect of potential individual benefit to them (see Guideline 4 – Potential individual benefits and risks of research).
7 Research ethics committees may function at the institutional, local, regional, or national levels, and in some cases at the international level. They must be established in accordance with rules set by a national or other recognized authority. Regulatory or other governmental authorities must promote uniform standards for committees within a country. Research institutions and governments must allocate sufficient resources for the ethical review process. Contributions of study sponsors to institutions or governments to support ethics review must be transparent. Under no circumstances may payment be offered or accepted to procure a committee’s approval or clearance of a protocol.
8 Health-related research functions well only in the presence of professional and public trust. Trust can be enhanced by ensuring public accountability for research and its results. Therefore, researchers, sponsors, research ethics committees, editors and publishers all have ethical obligations to ensure the public accountability of research. Page 9.
14 See the Code of Conduct for the Members of the European Commission page at https://ec.europa.eu/info/about-european-commission/service-standards-and-principles/ethics-and-good-administration/commissioners-and-ethics/code-conduct-members-european-commission_en .
16 All European Academies, The European Code of Conduct for Research Integrity, 2017, p. 3,https://ec.europa.eu/research/participants/data/ref/h2020/other/hi/h2020-ethics_code-of-conduct_en.pdf .
17Integrity in the Western Australian Public Service, https://icg.wa.gov.au/integrity-public-sector.
18 Sponsorship policy and guidelines of the Victorian Public Service, https://www.vic.gov.au/sponsorship .
19 US Food and Drug Administration Regulations about research involving human subjects, https://oprs.usc.edu/policies-and-procedures/fda/.
20 US 21CFR54.1 – FDA may consider clinical studies inadequate and the data inadequate if, among other things, appropriate steps have not been taken in the design, conduct, reporting, and analysis of the studies to minimize bias. One potential source of bias in clinical studies is a financial interest of the clinical investigator in the outcome of the study because of the way payment is arranged (e.g., a royalty) or because the investigator has a proprietary interest in the product (e.g., a patent) or because the investigator has an equity interest in the sponsor of the covered study. This section and conforming regulations require an applicant whose submission relies in part on clinical data to disclose certain financial arrangements between sponsor(s) of the covered studies and the clinical investigators and certain interests of the clinical investigators in the product under study or in the sponsor of the covered studies. FDA will use this information, in conjunction with information about the design and purpose of the study, as well as information obtained through on-site inspections, in the agency’s assessment of the reliability of the data.https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=54.1 .
22 Peer review rules of the Australian National Health and Medical Research Council https://www.nhmrc.gov.au/about-us/publications/australian-code-responsible-conduct-research-2018#block-views-block-file-attachments-content-block-1 .
23 Universities Australia, “Research Funding”, https://ai.google/principles/ .
25 Menagh, J., “Paul Whyte to plead guilty to 530 corruption charges in $22 million Department of Communities scam”, ABC news online, 13 December 2019, https://www.abc.net.au/news/2019-12-13/paul-whyte-to-plead-guilty-to-$22m-public-sector-corruption/11795212 .
26 United States Code, 2006 Edition, Supplement 5, Title 18 – CRIMES AND CRIMINAL PROCEDURE, section 207,https://www.govinfo.gov/content/pkg/USCODE-2009-title18/html/USCODE-2009-title18-partI-chap11-sec207.htm .
27 United States Code, 2006 Edition, Supplement 5, Title 18 – CRIMES AND CRIMINAL PROCEDURE, section 216,https://www.govinfo.gov/content/pkg/USCODE-2011-title18/pdf/USCODE-2011-title18-partI-chap11-sec216.pdf .
28 Study prepared by the OECD Anti-Corruption Network for Eastern Europe and Central Asia (ACN) and SIGMA (a joint EU-OECD initiative, principally financed by the EU, in co-operation with the OECD Public Sector Integrity Network), “Ethics Training for Public Officials”, 2013, pp. 21-24, https://www.oecd.org/corruption/acn/resources/EthicsTrainingforPublicOfficialsBrochureEN.pdf .
29 National Framework for Doctoral Education, 2015, http://hea.ie/assets/uploads/2017/04/national_framework_for_doctoral_education_0.pdf .
30 Ireland’s Framework of Good Practice for Research Degree Programmes, 2019, https://www.qqi.ie//Publications/Pages/Ireland’s-Framework-ofGood-Practice-for-Research-Degree-Programmes.aspx .
31 IUA Graduate Skills Statement, 2015, https://www.iua.ie/publication/view/iua-graduate-skills-statement-brochure-2015/ .
33 Merriam-Webster online https://www.merriam-webster.com/dictionary/impartial and Lexico Oxford onlinehttps://www.lexico.com/en/definition/impartiality .
34 Collins dictionary online https://www.collinsdictionary.com/dictionary/english/impartial .
36 Dow Chemical Global Sustainability Report 2018, page 57 provides a partial list of associations in which Dow is engaged and provides leadership support, https://corporate.dow.com/en-us/science-and-sustainability/reporting.html .
37 Bayer BEENOW – The Bee Health Magazine, https://www.bayer.com/en/beenow.aspx .
38 Australian Research Council Peer Review, https://www.arc.gov.au/peer-review.