april 2019 health professions council of south …2019 3 chairperson’s note the professional board...

Dietetics & Nutrition

NEWSApril 2019

Health Professions Council of South Africa

Newsletter - Professional Board for Dietetics and Nutrition

Dietetics & Nutrition NEWS April 2019 2

ContentsContentsChairperson’s Note ..................................... 3.

What does work done in the Committee of Preliminary Inquiry of the Professional Board for Dietetics and Nutrition (DNB) entails ........................ 4.

HPCSA CPD Committee Proposed Model for MOL ............................................ 5.

HPCSA Model for Maintenance of Licence to Practise .................................................... 5.

Information on the Proposed roles and responsibilities of the Dietitian-Nutritionist were gathered from the following stakeholders................................................ 7.

References and Abbreviations used in the document .................................................... 8.

Trends in complaints on unprofessional conduct received by the Committee of Preliminary Inquiry of the Professional Board for Dietetics and Nutrition? ........................ .9.

How to Earn your CEUs ............................... 11.


Chairperson’s Note

The Professional Board for Dietetics and Nutrition has been striving towards achieving its obligation of guiding the profession and protecting the public. The Board members, task team and secretariat are in the process of finalising guidelines, rules, documents and SOPs that were identified as due for review or were not available. The task teams working on the Enteral and Parenteral Prescription guideline were in contact with SAPRA regarding prescription rights for certain products and gave feedback in October 2018, and we hope to make this guideline available soon. The Board is also working on the Scope of Practice of both Dietetics and Nutritionists to submit updates of the Standards Generating Body (SGB) documents to South African Qualifications Authority (SAQA) after input from institutions of higher learning has been received.

The past 24 months has been a time of transition and change for the Health Professions Council of South Africa (HPCSA) as well as for the Board (DNB). The turn-around-plan has been developed and is almost 50% done, and with it comes change. Practitioners will soon experience further changes which will make interaction with the HPCSA much smoother and pleasant experience. These changes have also been introduced at Board level where the demand for paper based meetings which require printing of huge agendas at high costs, is now something of the past. All documentation is now prepared in an electronic format, which not only improves our carbon footprint, but also the efficiency of distributing agendas in preparation for meetings and other forms of facilitating communication. All hard copy documents at the HPCSA have been captured in electronic format, and from now on, all platforms are developed to make electronic access for members more accessible.

Members will start experiencing changes in the speed of delivery of services as well as feedback time. The internet platform has been upgraded to a viable system to accommodate 20 times more members than it was originally planned for. Staff members are being re-skilled or up-skilled to fill specific jobs. As a Board, we can already see the benefits of this turn-around plan and we are excited to experience the new systems in full force.

The Board has recently completed the re-development of the assessment tool for universities training professionals and also the accreditation of service learning facilities used in the training. Provinces are now very strict in allowing students to train if a facility has not been approved and accredited by the HPCSA. The list of accredited service learning facilities will be kept up to date at all times and made available to National Department of Health for information purposes. All facilities must be re-assessed and re-accredited every 5 years. It is currently not clear what the influence of the National Health Insurance will be on training of professionals, but we foresee that it will always be part of the public health sector.

The level of compliance to Continuing Programme Development (CPD) requirements by our members are a cause for concern. Practitioners are reminded to undertake CPD activities that relate to the profession and the relevant scopes of practice. To track CPD compliance it is the responsibility of all members to supply the HPCSA with correct details regarding change of address, qualifications, phone numbers, e-mail, etc. The online system is easy to use and changes can be made quickly. In future, only members without any e-mail access (which is very few) will receive any hard copies of correspondence, and this will eventually phase out as well, for the HPCSA to function in a more “Green” environment. Please participate and convey the information to colleagues that may not have ready access to internet and electronic devices.

The Scopes of practice for both the professions have been send to the Minister of Health for signature and promulgation, and we were recently informed that it has been submitted to the office of the minister for finalisations and then hopefully, promulgation soon. We will keep you up to date on this issue. The Board is doing its best to address the large number of fly-by-night “specialists” infringing on the Scopes of practice of both our professions by reporting them to the Inspectorate Office for investigation. We have also updated the “Regulations regarding the Names not to be used by persons not registered in the professions” (see previous newsletter), and we are waiting for promulgation thereof. The fact that all of the Ethical guidelines/booklets are being reviewed and written for modern times, and new ones being drafted (e.g. Social media), is a positive outcome of the work done by the HPCSA. These Ethical guidelines will be made


What does work done in the Committee of Preliminary Inquiry of the Professional Board for Dietetics and Nutrition (DNB) entail?

Mrs HE Koornhof, M Nutrition

available soon on the HPCSA website.

The Board would like to caution the public and institutions against the use of unregistered practitioners. The Health Professions Act No. 54 of 1974 entitles only registered persons to practise their profession within the Republic of South Africa. This applies to all professions registerable under the HPCSA in terms of the Act. Institutions should ensure that foreign qualified practitioners, volunteers and visiting students are appropriately registered with the HPCSA before engaging in any clinical practice and clinical learning within the borders of South Africa.

There are a number of Dietitians and Nutritionists in all the provinces, compiling a list of members without current employment. Please participate in this endeavour and submit your details to the provincial representative. The Board hopes to be of service to all members and we invite communications, questions, plans, initiatives and participation in solutions at all times. Hope you all have a fruitful year ahead.

Prof SM Hanekom, PhD Nutrition Chairperson for Dietetics and Nutrition Board

The Health Professions Council of South Africa (HPCSA) is committed to protecting the public and guiding the different professions falling within its ambit. Council, in conjunction with its 12 Professional Boards, is committed to promoting the health of the population, determining standards of professional education and training, and setting and maintaining excellent standards of ethical and professional conduct and practice.

The role of DNB Committee of Preliminary Inquiry is to assist and ensure that the registered dietitians and nutritionists have a critical role to play in the investigation and finalisation of complains that the HPCSA receive from the public and other professionals that are referred to the committee.

The DNB Committee of Preliminary Inquiry has the power to institute disciplinary proceedings regarding any complaint, charge or allegation of unprofessional conduct against any dietitian or nutritionist registered with Council. If the dietitian or nutritionist, as a registered practitioner, transgresses the Rules & Regulations, related to the Health Professions Act, 56 of 1974, the practitioner will be subjected to a disciplinary process.

The HPCSA webpage on Professionals regarding Professional Conduct & Ethics sites the following examples of unprofessional conduct against which we may take disciplinary steps are unauthorised advertising, over-servicing of patients, criminal convictions, improper relationships with patients, improper conduct of practitioners, operational procedure without patient’s permission or consent. Furthermore, disclosure of information concerning patient without his / her permission, incompetence about treatment of patients, excessive fees charged or overcharging, insufficient care towards patients, racial discrimination and rude behaviour towards patients are also examples of unprofessional conduct. This list is not exhaustive, and a practitioner accused of unprofessional conduct may be charged in terms of the Ethical rules of Conduct as well as the regulations and policy guidelines that have been developed to provide guidance to healthcare professionals.

The DNB Committee of Preliminary Inquiry is comprised of five DNB members. Representation is in important on this committee, and therefore the membership includes the following: one DNB member who is a registered Dietitian, one who is a registered Nutritionist, one DNB member with Higher education experience, one DNB member who is a Community representative and DNB member who is the National Department of Health’s representative.

On a positive note, it is possible to say that the DNB Committee of Preliminary Inquiry is not a very busy committee, but nonetheless the committee is concerned about a trend that we are often seeing in the type of complaints against dietitians, that tabled at our meetings.

This concern related to the fact it seems as if some dietitians do not at all times keep detailed clinical notes of every consultation, including time spent per patient consultation and time spent on developing patients’ nutrition care plans. Doing the aforementioned are basic elements of good and sound professional conduct, and furthermore this information should form the basis of your billing process. In the past three years, the DNB Committee of Preliminary Inquiry have seen many comprehensive audits done by specialized medical fraud companies on behalf of medical aids. Practitioners will require the aforementioned evidence to proof their innocence in the type of cases tabled with the Prelim Committee in the complaints submitted by these firms. Due to lack of the necessary documentation to support their professional service, delivered professionals appear guilty.

To ensure your optimal professional practice it is essential that private practising dietitians engage extensively and often with the HPCSA’s General Ethical Guidelines for the Healthcare Professions, Booklets number 1, 2, 3, 4, 5, 9 as well as the booklet on Undesirable Business Practice. These booklets are available at the following link: http://www.hpcsa.co.za/Conduct/Ethics


HPCSA Moving Towards Maintenance of LicensureBackground

In 2007 Continuing Professional Development (CPD) became compulsory for all professions registered with the HPCSA. From the outset, the goal was to encourage practitioners to update their knowledge and skills to enable ethical and competent practice. The focus of the HPCSA’s current system of CPD has been largely on continuing education, to update knowledge. Literature however suggests a need for a comprehensive system of CPD – beyond knowledge gain – as a method of addressing performance inadequacies of the professional as well as at the overall health care systems level. This comprehensive system of CPD is referred to as Maintenance of Licensure in this article to avoid confusion with CPD as it has always been referred to at HPCSA. While on one hand continuing education is acknowledged to be a core component of continuous professional development, Maintenance of Licensure as envisaged is more comprehensive and addresses a wider range of skills, including education, training, audit, management, team building and communication.

HPCSA CPD COMMITTEE PROPOSED MODEL FOR MOL

In 2013 the HPCSA decided that all practitioners will be required to have a license to practice their professions. The primary purpose of such a decision was to ensure that all practitioners, under the jurisdiction of the HPCSA, maintain and improve their professional knowledge, skills and performance for improved patient outcomes and health systems.

In keeping with the HPCSA’s mandate of protecting the public and guiding the professions, the CPD Committee of the HPCSA has critically reflected on the current programme in light of research and international trends in CPD. The rationale is to provide a model that guides genuine learning and enables improvement of professional competence and performance, rather than a system of CPD which has equated the number of hours/CEUs accumulated with competence. Currently, many practitioners meet mandatory CPD CEUs opportunistically, erratically or casually. In contrast, the Maintenance of Licensure model places greater responsibility on practitioners to set out their CPD requirements and demonstrate how their CPD activities improve their professional performance and patient health. Such a model more explicitly recognizes that different professionals will have different development needs and require individual practitioners to take greater ownership of their professional development.

The model is depicted in the figure below:

HPCSA MODEL FOR MAINTENANCE OF LICENCE TO PRACTISE

Reflection on own practice entails critically looking at oneself across four domains; viz

DOMAIN 1: PROFESSIONALISM – encompassing Good practice, Integrity, Intercultural competence

DOMAIN 2: SAFETY AND QUALITY – relates to Systems one has in place to protect patients/clients, how one responds to risks to safety, and how they protect patients/clients from risks posed by colleagues

DOMAIN 3: COMMUNICATION is about communicating effectively, working constructively with colleagues and where necessary delegating effectively

DOMAIN 4: KNOWLEDGE, SKILLS AND PERFORMANCE entails developing and maintaining professional performance, applying knowledge and experience to own practice and maintaining clear, accurate and legible records

Determining Learning Needs can be achieved by using the following methods:

Self-assessment of competence & performance

Audit of practice or work ethic

Peer feedback, in same profession

3600 feedback from patients or clients, from families one interacts with, from other colleagues one works with who are not necessarily in the profession


Developing Individualised Learning Plan is achievable through:

1. Setting own CPD programme as follows: Embarking on Continuing Education - 20 hours per year - Learning related to performance improvement Involvement in Accredited activities e.g. attending Conferences, workshops, courses, producing Publications, engaging in research programmes Involvement in Non-accredited activities e.g. Self-directed learning programmes, Journal reading

2. Ensuring own practice is audited at least once a year – systematic critical analysis of own practice, or having a senior managing own performance.

3. Participation in Peer review for at least 10 hours per year – Examples include Joint review of cases, review of charts, Inter-professional review of cases, Mortality and morbidity meetings

4. Ethics- related learning or practice - 5 hours per year

Implementation of Learning Programme : CPD, which is already an HPCSA requirement, is a key component of the maintenance of licensure program and is a major component in the implementation process. There are additional requirements to demonstrate competence and performance, including peer review and engagement, audit, multisource feedback, and evaluation of competence and performance.

Application of Learning to practice - Practitioners are required to determine their own learning needs, then devise an individualised CPD programme that meets these learning needs, with the ultimate aim being to improve their own practice.

Evaluating Competence and performance is comprehensively done every 5 years; It is proposed this will constitute a Competence Assessment(summative) which may be done online or through a training institution and Performance assessments which include 3600 /multisource feedback and Assessment of practice.

In ConclusionThe CPD Committee has and will continue to consult iteratively with a wide range of stakeholders in refining and implementing the guidelines and standards for the comprehensive CPD programme which will be linked to maintenance of licensure. The CPD Committee welcomes and values all perspectives and commits itself to thoroughly reviewing and considering all submissions arising out of the consultation process. The feedback received will influence the final proposal.

(This article is adapted from the concept document put together by the CPD Committee starting in 2014, as well as the presentation from Prof. Sanjila Singh to the Interboard Forum that was held on 31st July 2017. Prof Singh is a member of the task team of the CPD Committee that is spearheading the Maintenance of Licensure programme)

WHAT WILL THE FuTuRE HOLD FOR OuR PROFESSIONS?

The registration of the dietetics profession with the HPCSA was promulgated in 1980 and the first Professional Board for Dietetics was established in 1981. The first task of the Board was the development of the minimum standards for the training of dietitians. Since then the competencies of the dietitian have been revised in 1994 and in 2001 of which the most significant development during this period has been the extension of the area of community nutrition from none in 1980, to about 5% in 1987 to at least 25% in 2001. The register for nutritionists was eventually promulgated in the Government Gazette in 2008 with the Grandfather clause registration process closing in March 2010.

As a statutory body the HPCSA is guided by a formal regulatory framework and this includes the founding Act, the Health Professions Act 56 of 1974. The vision of the HPCSA is “Quality and Equitable Healthcare for All”.

The vision and mission of the Professional Board for Dietetics and Nutrition (DNB) stipulates:

Vision: A trustworthy, credible, transparent and accountable Board that serves the interest of the profession and the public.

Mission: To protect and serve the public and guide the profession.

The above is given practical effect through ensuring excellence of dietetics and nutrition service delivery and thereby protecting the South African public by:

• Maintaining and enhancing quality of practice.

• Safeguarding the integrity of dietetics and nutrition professionals registered with the Board.

• Promoting the nutritional health of all South Africans.

• Being a Board that is willing and able to be efficient in their support and service delivery.

• Communicating effectively to all stakeholders.

A Task Team (TT) was appointed on 26 Feb 2014 to address the current overlapping scopes and competencies for dietitians and nutritionists. Given the current burden of disease profile, the overlapping scopes of practice of the dietetic and nutritionist professionals, the training of nutrition professionals, the lack/absence of community service positions for nutritionists, the local and global economic climate and a range of other situations that are influencing the nutrition agenda in South Africa, it was necessary to review the position of the two nutrition professions in South Africa.

The TT first met on 17 March 2014 and was mandated to present to the Board a comprehensive overview (situation analysis) and a suggested plan on the way forward for training of nutrition professionals and


to define the roles and competencies of the “new” Dietitian-Nutritionist in the well-being of the South African population.

The TT aimed to:

• provide appropriate background information of the current situation regarding training in South Africa;

• describe the roles of the nutrition profession (current and future opportunities) in the different sectors (public and private);

• describe the skills and competencies required to execute these roles;

• establish the number of known practitioners in the sectors;

• establish the required number of Dietitian-Nutritionists (DN) for the sectors;

• compare the skills and competencies of the DN as identified with the current skills and competencies for dietitians and nutritionist as contained in the Standards Generating Body (SGB) documents;and

• submit a recommendation to the Professional Board for Dietetics and Nutrition on the way forward by 11 July 2014.

Information on the proposed roles and responsibilities of the Dietitian-Nutritionist were gathered from the following stakeholders:

• Association for Dietetics in South Africa (ADSA)

• Nutrition Society of South Africa (NSSA)

• Department of Health – National and Provincial

• Department of Education, including Early Childhood Development

• Department of Agriculture

• Department of Social Development

• United Nation agencies, e.g. Unicef

• NGO’s

This information was used to put together the proposed purpose, scope and competencies of the 2Dietitian-Nutritionist. The final report (2‘THE ROLES AND COMPETENCIES OF THE NUTRITION PROFESSION IN THE WELL-BEING OF THE SOUTH AFRICAN POPULATION) dated 11 July 2014 has been shared, orally and in writing, with all the stakeholders (universities included) on several occasions and at the Nutrition Conference of 2016.

The Professional Board for Dietetics and Nutrition decided, based on a collective decision-making process of previous Task Teams and the input and comments received from all stakeholders, on 25 September 2014 that in future only one nutrition professional (Dietitian-Nutritionist) will be trained and registered. The Professional Board acknowledges

that a small number of individuals are not in favour of the training of only one nutrition professional. The Board also acknowledges that this process will take some time to complete and will have organisational, social, regulatory, economic, or other factors that may be directly relevant to the curriculum implementation. These issues will be addressed when the time comes.

Bachelor’s degree (4-year integrated programme)

Dietitian-Nutritionist

(NQF exit level 8)

Coursework

Masters

Specialist

Therapeutic Nutrition

(NQF 9)

PhD

(NQF 10)

(does not lead to any new registerable category – not accredited by Board)

Coursework

Masters

Public Health Nutrition

(NQF 9)

Coursework

Masters

Other Programmes

(NQF 9)

Research

Masters

Nutrition/Dietetics

(NQF 9)

(does NOT lead to a new registerable

specialization category – not accredited by Board)

Post-graduate professional / registrable category as per area of specialization. Qualification can be offered as a Masters or a PG diploma or an Honours depending on the institutional choice re research component. The coursework must equip the graduate with the relevant competencies for that area of specialization. Vertical articulation between registers possible by completion of required qualification. Other possibilities will be developed in collaboration with the training institutions and based on the need in the country

degrees (NQF exit level 9) and a Doctoral degree (NQF exit level 10).

Figure 1 below provides a proposed conceptual framework for the training of registerable Dietitian-Nutritionists (3NQF exit level 8), as well as possible post-graduate qualifications, including Master’s degrees (NQF exit level 9) and a Doctoral degree (NQF exit level 10).

Figure 1: Proposed conceptual framework for Dietitian-Nutritionist

The above conceptual framework is underpinned by the following:

• The professional qualification for the Dietitian-Nutritionists will be at NQF level 8 (4-year Bachelor’s degree as default position although alternative combinations of qualifications should be possible – within the limitations of the 4HEQSF). Work integration should be planned from the first year (NQF 5) level.

• The Dietitian-Nutritionists will register with the Professional Board of the 5HPCSA.

• Community service of one year will follow the 4-year degree.

• Registration in the Independent Practice category as a Dietitian-Nutritionists is possible after finalising community service.

• This registration will be maintained by complying with the 6CPD rules, payment of yearly fees and other regulations of the HPCSA.


• A professional Master’s degree could lead to specialisation in a specific field and could therefore be regulated and accredited by the Professional Board. Registration in a specialisation sub-category with the Professional Board is then possible.

• It is suggested that a Master’s in Nutrition/Dietetics by full thesis would not include a wide enough range of competency development in any specialisation area and will therefore not lead to a registerable qualification (initial or specialisation sub-category registration still in place).

Need for change

Although the HPCSA does not have any jurisdiction over the Department of Health, or vice versa, both organisations report to the Minister of Health. The mandate of the HPCSA, however, prescribes that the strategic plans, aims and objectives of the HPCSA Council, and thus its Boards, should be in line with the strategic plans of the Department of Health. Therefore, the Human Resources (HR) Department of the National Department of Health has been involved with the process from the beginning and attended the meetings of the Task Team. However, the Professional Board will meet with the HR again to discuss the career path of the Dietitian-Nutritionist within the Department of Health, assistance with training (work integrated learning using different platforms) of the Dietitian-Nutritionist and the compulsory community service year. It must be clear, however, that the Dietitian-Nutritionist is not trained for public service only, and they will still fulfil an important role within the private sector addressing a large range of nutrition-related illnesses and challenges.

When will the change take place?

The main objective of this initiative is for the simultaneous submission by the 10 relevant tertiary institutions, of complete proposals to 7CHE/8SAQA/9DoHET, based on approved new qualification outcomes for the Dietitian-Nutritionist, within 54-60 weeks of awarding the tender (expected early in 2019). This project will be conducted for the Professional Board for Dietetics and Nutrition and the maximum allocated time until completion is 18 months. As soon as the newly developed programs have been submitted, it will be assessed by 7CHE/8DoHET and this could take up to 12-30 months. Implementation of the new qualifications will therefore not happen overnight.

What is required from the project and who is the target audience?

• The target audience is the 10 tertiary institutions countrywide (South Africa) currently training Dietitians and Nutritionists.

• It is required that tertiary institutions submit their letter of intention to change, and a preliminary draft of the intended changes and new curriculum, substantiated according to the new outcomes document, to the HPCSA and specifically the

Professional Board for Dietetics and Nutrition, for approval, before further actions is taken. This needs to be done at least 6 months before final submission to 7CHE.

• It was requested by CHE that all 10 tertiary institutions submit their applications for new curriculum for training of Dietitian-Nutritionists simultaneously to CHE/DoHET and SAQA on a date that will be coordinated to fit all institutions.

Key issues to be managed throughout the project lifecycle

• The main issue with this project is that it can take 12 to 30 months to have curriculums approved by CHE/SAQA and DoHET, if the new curriculums are submitted simultaneously.

• New curriculums can’t be implemented if not published in university yearbooks, and the approval may arrive too late for presenting in a specific year and will have to stand over for the next year.

• Each step of the process needs to be analyzed and evaluated against efficiency, relevance, effectiveness, impact and sustainability. This may lead to needed changes in the implementation of timelines, but are allowed within reason, and with the due date for delivery in mind.

References and abbreviations used in the document:

1. The scope of the profession of the dietitian and nutritionist: 5 October 2015

2. THE ROLES AND COMPETENCIES OF THE NUTRITION PROFESSION IN THE WELL-BEING OF THE SOUTH AFRICAN POPULATION (11 July 2014)

3. NQF: National Qualifications Framework

4. HEQSF: Higher Education Qualification Sub-framework

5. HPCSA: Health Professions Council of South Africa

6. CPD: Continuing Professional Development

7. CHE: Council on Higher Education

8. SAQA: South African Qualifications Authority

9. DoHET: Department of Higher Education and Training


Mrs HE Koornhof, M Nutrition (US); Prof EC Swart, PhD (UWC)

The Health Professions Council of South Africa (HPCSA) is committed to protecting the public and guiding the different professions within its ambit. Council, in conjunction with its 12 Professional Boards, is committed to promoting the health of the population, determining standards of professional education and training, and setting and maintaining excellent standards of ethical and professional conduct and practice.

The DNB Committee of Preliminary Inquiry (CoPI) has the power to institute disciplinary proceedings regarding any complaint, charge or allegation of unprofessional conduct against any dietitian or nutritionist registered with the HPCSA. If the dietitian or nutritionist, as registered practitioner, transgresses the Rules & Regulations, related to the Health Professions Act, 56 of 1974, the practitioner will be subjected to a disciplinary process. The role of DNB members on this CoPI is to advise the legal department of the HPCSA on discipline specific professional conduct related to such complaints, charges or allegations.

The HPCSA webpage sites the following examples of unprofessional conduct: unauthorised advertising, over-servicing of patients, criminal convictions, improper relationships with patients, improper conduct of practitioners, operational procedure without patient’s permission or consent, disclosure of information concerning a patient without his / her permission, incompetence about treatment of patients, excessive fees charged or overcharging, insufficient care towards patients, racial discrimination and rude behaviour towards patients. This list is not exhaustive. A practitioner accused of unprofessional conduct may be charged in terms of the Ethical rules of Conduct as well as the regulations and policy guidelines that have been developed to provide guidance to health professionals.

Nortje & Hoffman (2015) reviewed ethical misconduct cases among dietetic practitioners is South Africa from 2007 -2013. This study was based on all guilty verdicts by the HPCSA against dietetic practitioners that breached professional standards and ethical misconduct in this period. They found that only five out of seven cases that served were found guilty of misconduct. Since 2017/2018, 18 cases were received by the DNB CoPI of which 03 were concluded with a guilty verdict. 15 are pending. The guilty verdicts of unethical behaviour against dietetic practitioners in comparison to other health professions in South Africa are very low. Nortje & Hoffman (2015) described improper professional conduct and incompetent treatment of patients/clients as the most common transgressions. Subsequently, fraudulent billing has emerged as the most common cause of guilty verdicts within the DNB CoPI with 01 verdicts. Comprehensive audits done by specialized medical fraud companies on behalf of Medical Aids with the absence of detailed clinical notes of every consultation, including time spent in direct patient consultation and time spent on developing patients’ nutrition care plans, usually results in guilty verdicts. Failure of practitioners to respond timeously to complaints and charges further contribute to this outcome.

The penalty for most of these transgressions is financial, however Nortje and Hoffmann (2015) suggested that part of the penalties should be ethical awareness training for transgressors. These authors also stressed that there should be in-depth training in ethics which include bioethics and professional integrity for dietetic and nutrition professionals on undergraduate and postgraduate level. In a study done on undergraduate dietetics students regarding what these students think professionalism entails, it was found that professionalism attributes are not attained continuously for dietetic students (Marais D, Marais M, Visser, Boome & Taylor, 2012).

A client/patient is in a vulnerable position when he/she is consulted. The dietitian is obligated to take care of such a client/patient thus focusing on causing no harm, including exploitation (i.e. non-maleficence) and strive for beneficence in order for the client/patient to benefit from consulting a dietitian. Nortje & Hoffmann (2015) suggested, based on their findings, that in order to adhere to ethical principles, clients/patients must not be treated as a means to an end. Within a public health context, the same principles apply to a nutritionist advising clients/groups, with the additional consideration of utilitarian approaches (the greatest good for the greatest number) which are often applied to justify nutrition interventions within community nutrition whilst deontology (the rightness of given features of an activity versus the outcome of the activity) may guide general acceptability of dietary guidelines, food products, and/or supplements (Kunneke, Swart & Nortje, 2018).

To ensure optimal professional practice by registered dietitians and nutritionists, it is essential that practitioners engage extensively and often with the HPCSA’s General Ethical Guidelines for the Healthcare Professions, Booklets no 1, 2, 3, 4, 5, 9 as well as the booklet on Undesirable Business Practice. These booklets are available at the following link:

http://www.hpcsa.co.za/Conduct/Ethics

References:

Marais, D., Marais, M., Visser, J., Boome, C., & Taylor, D. (2012). What do dietetics students think professionalism entails? African Journal of Health Professions Education, 4(1), 28-33.

Nortje, N., & Hoffmann, W. (2015). Ethics misconduct among dietetic practitioners in South Africa (2007-2013). South African Journal of Clinical Nutrition, 28(2), 77-80.

Kunneke, E., Swart, R,. & Nortje, N. Ethics for the Dietetic Profession – A South African Perspective. Chapter 5 IN Nortje N, Hoffman WA & de Jongh J. Healthcare ethics for Africa. Book accepted for publication – chapter being revised April 2018.

Trends in complaints on unprofessional conduct received by the Committee of Preliminary Inquiry of the Professional Board for Dietetics

and Nutrition ?


Ava il ab le on l ine at www.sc ienced i rect .com

ScienceDirectwww.nr jour na l . com

Research Article

Nutrition: ethical issues and challenges

Robert B. Rucker, Michael R. Rucker

a Department of Nutrition, Meyer Hall, University of California-Davis, Davis, CA 95616, USA b Active Wellness, Inc, 4000 Bridgeway, Suite 101, Sausalito, CA 94965, USA

A R T I C L E I N F O

Article history:

Received 19 July 2016

Revised 17 October 2016

Accepted 18 October 2016

Keywords:

Research ethics

Misconduct

Fraud

Research ethics

Nutrition and politics

Nutrition and religion

A B S T R A C T

For nutrition and its associated disciplines, ethical considerations related to research are often complicated by factors that range from the use of experimental research designs that are overly holistic to inextricable links between nutrition research and marketing. As a consequence, there is the need for constant vigilance to assess and deal with apparent conflicts of interest. Also, there are few scientific disciplines that are defined by cultural, religious, or political codifications as is nutrition. Accordingly, examples of historical, cultural, and political events are described that have influenced ethical approaches related to nutrition research. Furthermore, nutrition research questions are often multifaceted and require dealing with complex variables. In this regard, ethical principles and perspectives that have relevance to data acquisition, the publication and translation of nutrition research, and the marketing of nutritional products and concepts are highlighted.

© 2016 The Authors. Published by Elsevier Inc. This is an open access article under the CC

BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

1. Introduction

For nutrition and associated disciplines, the development of clear ethical guidelines for research and practice is wrought with complexity. For example, few scientific disciplines are defined by cultural, religious, or political codifications or laws as is nutrition. Moreover, few disciplines have such direct links to product marketing. Accordingly, nutrition is often viewed as controversial because of a need for policies and ethical approaches to aid in resolving areas of conflict (eg, marketing self-interests or conflicts of interests related to funding).

The translation of nutrition research has also stimulated a thriving industry of allied health professions that provide various levels of intervention, such as the self-monitoring of physical activity or the manipulation of diet presumed related to improving nutrition. To this

point, the need for articulation of policy and ethical considerations is viewed as serious enough that the American Society for Nutrition has recently created an Advisory Committee to focus on “improving and ensuring the public trust in academic and professional scientific societies through best practices in scientific rigor and transparency,” which is a task made difficult, given that many of the conflicts evolve from groups that the American Society for Nutrition relies for support (eg, agricultural commodity organizations and similar marketing groups with various self-interests).

Concerning this review, discussions of ethics are now a common feature of academic curricula and the underpinnings for research societies’ and journals’ “codes of conduct.” Abbreviations: COPE, Committee on Publication Ethics; DSHEA, Dietary Supplement Health and Education Act; FDA, Food and Drug


Administration; FTC, Federal Trade Commission; GMOs, genetically modified organisms; RDA, recommended dietary allowances.

Corresponding author. Department of Nutrition, Meyer Hall, University of California-Davis, Davis, CA 95616, USA. Tel.: +1 530 7537485;

fax: +1 530 752 8966.

E-mail address: [email protected] (R.B. Rucker).

http://dx.doi.org/10.1016/j.nutres.2016.10.006

0271-5317/© 2016 The Authors. Published by Elsevier Inc. This is an open access article under the CC BY-NC-ND license

(http://creativecommons.org/licenses/by-nc-nd/4.0/).

Consequently, a primary objective is to provide ethical perspectives and background with a focus on data acquisition and translation, publication and communication, monitoring, and the marketing of research findings. Examples of historical, cultural, and political events that have influenced nutrition and health policies and practices are also described.

2. Historical, cultural, and religious influences

As Levinovitz [1] has noted, many individuals have value systems that address perceptions of their nutrition and health with an intensity that is similar to their religious beliefs. In this regard, nutrition has an extensive history of cultural and religious codices and influences [2,3]. For example, most of the major religions have dietary guidelines that are followed to varying degrees, such as fasting, dietary exclusions (eg, alcohol, certain or all types of animal flesh), or the premises for which foods are sold, prepared, or eaten (eg, Jewish kosher laws). The recognition of such codices and influences is important not only for their historical significance but for their potential to influence research objectives or nutritional interventions. Research questions that have a religious principle as a component may ignore appropriate controls, develop exclusions or inclusions for subject selection that may insert bias, or ask questions that are less hypothesis-driven than purpose-driven [4-8]. For example, science-based vs faith-based approaches to questions often seek to understand the world in a manner that is intrinsically opposite. A faith-based approach may have as an obligation the interpretation of research observations so that they are consistent with a particular belief system. An important feature of a faith- or belief-based approach is the ease to which

it is influenced by confirmation bias (or confirmatory bias), the tendency to interpret information in ways that confirm preconceptions. Science-based approaches do not have such obligations. As a first principle, scientific objectivity is not guided by a perpetual belief system and, when optimal, excludes tendencies that can prejudice consideration of a question.

For early nutrition research efforts, a goal was often to seek or justify dietary protocols to aid in the modification of certain behaviors. In the United States, colorful examples include the work of Sylvester Graham, an 18th century Presbyterian minister and social reformer, whose design of the graham cracker was prompted by a belief that a vegetarian diet would suppress carnal urges [9,10]. His 19th and 20th century Adventist counterparts, John and William Kellogg, founders of the Battle Creek Sanitarium, also promoted nutrition, mostly vegetarianism, as a belief system and a means of achieving moralistic goals [9].

However, their successful attempts at developing a corn flake cereal were not without ethical dilemmas. The initial joint venture between John Kellogg and William Kellogg terminated when William Kellogg split off to form the W.K. Kellogg’s Company. One of their disagreements had to do with adding sugar to John Kellogg’s original product. Also, there were ethical conflicts between patients at the sanitarium and the Kellogg brothers. William Kellogg provided valuable information related to cereal processing to C.W. Post, a sanitarium patient, who later started C.W. Postum, which eventually evolved into the General Foods Corp. C.W. Post, however, was accused of appropriating information related to cereal formulations from William Kellogg, that is, allegedly stole an intellectual property. Later, C.W. Post was also accused of marketing misconduct. The magazine, Collier’s Weekly, objected to C.W. Postum advertisements for its principal product, Grape Nuts, because of their assertion that Grape Nuts could cure appendicitis [11].

In this century, for those who have certain religious beliefs, the use of genetically modified organisms (GMOs) may be unacceptable. Consider that for many individuals, particularly those with biology training, the value of genetically modified organisms or foods (GMOs) for increased crop production, disease and pest resistance, or improved nutritional quality is apparent and viewed as important. The arguments for such modifications often invoke ethical principles that favor utilitarian approaches (eg, “the greatest good for the greatest number”). For others, however, the cloning and manipulations of genes are considered wrong on moral grounds [12-14]. The religious objections range from the view that human-


made genetic modifications are tantamount arrogantly assuming God-like roles to the violation of given religious food laws or codifications (eg, aversion to the use of animal or human genes in plants to enhance growth or a given nutritional quality). Concerning ethics, what often is invoked on the religious side of the GMO argument is deontology, a form of ethical argument that determines rightness by given features of an act or activity in contrast to the outcomes of an act or activity [15]. The point here is that belief systems have been and are an important part of nutrition’s research history. Ethical issues that have a bearing on animal rights and use, GMOs, and human rights including informed consent are often addressed using differing ethical approaches that set the stage for controversies for which there can be few clear resolutions.

3. The role of politics

The nature and scope of nutrition and its health-related industries dictate the need for various regulations and accordingly the interaction with governing bodies. Some of the control regarding how evidence-based information is used and interpreted lies also with the ultimate consumer. A good example of consumers having a direct voice in the use of science-based information is the controversies over fluoridation and nutritional supplements. The translation of science regarding fluoridation and dental health into public policy often has been the result of public referenda or elections in contrast to a formulation of policies arising out of focused scientific discussions, that is, whether or not to add given amounts of fluoride to a public water supply [16].

Some direct political intercessions have also either ignored or impeded judgments based on scientific findings. Two prominent examples are past legislative bills offered by Senator William Proxmire from Wisconsin and Senator Orrin Hatch of Utah [17]. In the mid-1970s, the Food and Drug Administration (FDA) proposed new marketing rules to combat public confusion about dietary supplements in part to address deceptive claims, as well as use the best science- based information at the time (eg, information that evolved from the development of the Recommended Dietary Allowances). It was proposed that vitamin preparations containing vitamins in amounts greater than their respective Recommended Dietary Allowances could be regulated as “over-the-counter” drugs.

This action was opposed by the National Health Federation, which organized a campaign producing more than a million letters to Congress urging the

passage of laws to stop the FDA’s regulations. The so-called Vitamin Bill, introduced by Senator Proxmire, passed by a vote of 81 to 10, in spite of opposition by the American Medical Association, the National Nutrition Consortium, the American Dietetic Association, the Society of Food Technologists, the Consumers Union, and the Pharmaceutical Manufacturers’ Association.

Senator William Proxmire again became a standard bearer for the supplement industry, when he sponsored the 1976

Proxmire Amendment that became section 411 of the Federal Food, Drug, and Cosmetic Act. The amendment prohibited the FDA from establishing standards that might limit the potency of given dietary supplements. As intended, such non–science- based congressional intercession compromised an important aspect of the FDA mission. As the late Thomas Jukes noted, “the bill served to entrench megavitamin folklore, based on the principle that if a little is good, more is better” [18]. Next, came the Dietary Supplement Health and Education

Act of 1994 (DSHEA; Public Law 103-417), which in part defined a dietary supplement as a food in contrast to a potential drug [19]. Under the DSHEA, dietary supplement manufacturers are allowed to market claims about the effect of given supplements. The only notification the consumer receives is a disclaimer. The DSHEA also expands the types of products marketed as “supplements.” For example, almost any substance consumed orally derived from a natural product may be defined as food, which brings forward issues from ignoring not only science and evidence-based principles but also apparent conflicts of interests [17,19]. In addition to the relative absence of regulations, those who sell nutritional products may also be poorly equipped to make judgments regarding the use of dietary supplements and natural consumable products. For example, although pharmacy outlets are a major vehicle for supplement sales, a recent Canadian study reported that only 2% of pharmacists indicated a level of knowledge to advise about supplements and complementary and alternative health care products [20,21].

For many, the rationale and need for the National Center for Complementary and Integrative Medicine (formerly the National Center for Complementary and Alternative Medicine, and before that the Office of Alternative Medicine) is also an ethics-related concern [22-25]. From its inception, there have been conflicts between its political allies and research directors. Senator Thomas Harkin from Iowa was a primary advocate and influential in increasing research funding


for the then Office of Alternative Medicine. However, he was also a critic of its management, expressing concern about the “unbendable rules of randomized clinical trials.” A notable Senator Harkin assertion is “one of the purposes of this center was to investigate and validate alternative approaches…I must say publicly that it has fallen short. I think quite frankly that in this center and in the office previously before it, most of its focus has been on disproving things rather than seeking out and approving.” An obvious counter to Senator Harkin’s assertion is that science- and evidence-based policies are about truth and require reasoned oversight, and not laissez-faire approaches that carry with them variable or conditional ethical constraints.

With ample resources, establishing purposeful research centers are among what most might view as an appropriate political and public service activity. Indeed, there are strong arguments for a center directed at what some call alternative medicine, given the public support for the concept [25,26]. There remains, however, an unequivocal obligation to raise ethical questions when there are political influences directed at modulating the outcome or nature of the research product. It is also reasonable to ask whether resources for naturopathic medicine (based on vitalism and self-healing) or homeopathy (based in part on principles, such as the potency of substances increase in proportion to their dilution) are well spent or in the broad public best interest [25].

4. Sources of funding and related conflicts of interests

The relationship of nutrition to the food and health-related industries also comes with a set of ethical obligations. A study by Lesser et al [27] in part addresses this point. The study was designed to assess potential influences by sponsors regarding the health effects related to consuming 1 of 3 beverages (soft drinks, milk, and juice). Examination of approximately 200 published research papers indicated that the funding source was associated directly with the conclusions. For interventional studies, unfavorable outcomes were observed in none of the industry-funded studies, although about 40% of the studies with no industry funding indicated an adverse outcome on the studied health effect or indicator.

In a thoughtful editorial in response to the study by Lesser

et al [27], Katan [28] emphasizes the well-taken point that a mere association between funding and outcome does not by itself indicate bias. When producers

fund nutritional studies, particularly in support of eventual marketing, it might be expected that there may be an anticipation of a favorable outcome, although such expectations should signal the need to be ethically vigilant. In an editorial [29] related to Katan’s comments [28], some suggestions for ethical vigilance include:

• structuring the researchsoasnot to favoragivenoutcome;

•developingclearunderstandingsbetweentheclientand the researcher; and

• publishing the results whether they are favorableor not to the client, providing full disclosures for all participants.

Is such vigilance important? Given the recent revelations regarding the Sugar Research Foundation (SRF), the answer is regrettably more yes than no. Kearns et al [30] have reviewed internal documents of the SRF, which indicate that SRF- sponsored research programs throughout the 1960s and 1970s were designed to downplay the negative aspects that sucrose had on health. It is now apparent that the SRF had a significant influence on publications that promoted fat and cholesterol as the major dietary causes of coronary heart disease, particularly those that lessened the potential importance of sugar. The SRF also apparently influenced the National Institute of Dental Research to shift emphasis to dental caries interventions other than restricting sucrose. Accordingly, it is reasonable to consider how the research landscape and perhaps policy regarding sugar (or any given commodity) might be viewed currently if the above suggestions for ethical vigilance had been followed as early as the 1960s and 1970s.

Nonetheless, it also is important to acknowledge that being overly restrictive regarding funding conflicts does have consequences. The funding of research in many areas important to nutrition would likely be diminished. The process could also result in the arbitrary exclusion of individuals with salient expertise from commissions or advisory groups for which the expertise could be of great value.

In this regard, the European Food Safety Agency’s Conflict of Interest Practices Committee, based on an independent audit, chose not to strengthen their conflict of interest policies [31]. Instead, the committee elected to address issues of financial conflict and bias with reasoned approaches and management, rather than follow an arbitrary set of guidelines. The guidance offered by the North America Working


Group on Guiding Principles of the International Life Sciences Institute is another example of reasoned approaches that provide transparency and a platform for discussions directed at potential funding conflicts of interests (cf. Table 1) [32].

5. Behaviors that contribute to misconduct, malfeasance, and fraud

It is first important to note that there are distinctions between the terms that we use to describe questionable conduct, that is, misconduct, malfeasance, and fraud. Fraud is an explicit misrepresentation of fact, whether by word or conduct that is intended to deceive so that there is the need for a legal inquiry, because of potential injury. Malfeasance is often used to mean a fraud carried out by a public official, particularly when the malfeasance results in the violation of a public trust. Misconduct is most often used to describe a violation of the standard codes of scholarship and ethical behavior. Misconduct is used in a nonlegal sense to include unintentional actions resulting in inadvertent or poor judgment with the potential for correction. In a legal sense, the term (particularly when used in federal statutes) has much stronger implications. For example, at the State and Federal

levels, misconduct that arises from fabrication, falsification, or plagiarism in any phase of a research endeavor can result at the least in loss of funding. At most major research institutions, the punishment for misconduct ranges from notifications (eg, asking for journal retractions of flawed articles, recommending the termination of funding from sponsoring agencies, releasing information to the public) to denial of advancement or termination. Similar to many civil actions, the proof for misconduct relies on judgments based on the “preponderance of evidence.”

The factors that underlie fraud are both intrinsic and

extrinsic; that is, the factors may be a part of one’s lack of moral conscience to external motivating factors. For the latter, the pressure to engage in misconduct, as well as to overlook misconduct by colleagues, has been linked to (1) the “publish or perish” pressure at many research institutions, (2) a requisite for a high frequency of publication to obtain consistent funding, or (3) some exaggerated sense of self- importance by the investigator. Two additional factors, offered by David Goodstein, Vice Provost—California Institute of Technology [33]) are (1) the intuitive belief of what the answer should be, thus negating the need for experiments or adequate controls to address the research question, and (2) engaging in research activities for which individual

experiments are unlikely to be precisely reproduced. Both seem particularly relevant to nutrition and related health sciences. There are no easy solutions to these situations. Some require a change in institutional attitude or practice, for example, devising ways to equitably address decreasing resources, while dealing with the demands from a large number of researchers or the costs of doing 21th Century science [33].

Intrinsic or psychological factors, although not well understood, are possibly the most important underpinnings of scientific fraud. Two commentaries, one written for Science [34] by Efraim Racker and the other for Nature [35] by William James, are very useful. In the narrative by Efraim Racker, 4 individuals are described of whom one worked in Racker’s laboratory, whereas the others worked with Drs Carl Cori, Davis Green, Melvin Simpson, and Fritz Lipmann, a truly distinguished group (eg, 2 Nobel Prize laureates, 4 members of the National Academy of Sciences, all leaders at the time of major research departments). As might be expected, the offenders were all very smart, well trained, and initially

Table 1 – Provisions that lead to research transparency and integrity a

1. All forms of sponsored research must be factual, transparent, and designed objectively.

2. Research designs should follow accepted principles of scientific inquiry that evolve from or lead to independent hypotheses. Such designs should not favour a particular or specific outcome.

3. Control of both the final study design and research should be the product of and remain with the scientific investigator.

4. All data and control of statistical analysis should be the product of the principal investigator(s) or consultants, auditors, or reviewers, who can confirm no direct conflicts of interests.

5. Remuneration based on or geared to the outcome of a research activity should be transparent and always open to question.

6. Written agreements should underscore the obligation to attempt to publish the findings within some specified and reasonable time frame.

7. Full disclosures in publications and conference presentations of all financial interests should always be an expectation.

8. Participation in an undisclosed paid authorship


arrangement should be approached as a type of misconduct.

9. Researchers associated with contract research organizations or act as contract researchers have an obligation to make clear statements regarding the nature of the affiliation.

a Guidelines are taken directly or adapted from the International Life Sciences Institute North America, Working Group on Guiding Principles’ report: Funding food science and nutrition research: financial conflicts and scientific integrity [32].

well-screened before their appointments. Furthermore, an important characteristic of each of the laboratories is that considerable effort was directed at replication and validation, because of the high stakes for the research. Careful screening and worksite vigilance did not prevent misconduct. Racker describes individuals capable of misconduct as “professionals” with an “unbalanced mind,” that is, an otherwise potentially brilliant person with the intrinsic attributes to commit fraud. He further notes that such intrinsic values may not be easily modified. Likewise, William James comes to somewhat the same conclusion but uses as a label a “hoaxer, who is willing to take risks” to categorize misconduct.

Of the systematic research on the topic (cf. Ref. [36] and those cited), most studies indicate that the perpetrators usually cannot be definitively distinguished, except for some elevated level of ego, vanity, and self-aggrandizement, what is often referred to as narcissism. A vagary is that these same attributes in a different setting may contribute to professional success. Accordingly, mitigating fraud or misconduct is difficult. When misconduct is discovered, it obviously must be addressed aggressively with the knowledge that it may come with a considerable cost, ranging from the dismissal of a colleague to the costs associated with maintaining a high level of vigilance (eg, the costs of experimental research replication and validation).

6. Research journals and publication

Maintaining the integrity of science journals and the honest translation of findings to the consumer should be among our most serious concerns. Although integrity in reporting science starts with the researcher, it is also relatively easy to find flaws in the peer-review process and the roles that editors may play in compromising integrity. As an example, in 2015, the publisher, Springer, retracted 64 articles from 10 different subscription journals after an internal

investigation that uncovered fabricated peer-review reports [37]. In a notable example, the misconduct involved a construction of a “peer review and citation ring” using more than 100 bogus e-mail addresses and identities to generate fabricated reviews. [38].

Before the 1990s, several polls indicated that journals rarely had procedures for responding to allegations of research misconduct and were reluctant to accept retractions or corrections. Many journals, however, now follow the guidelines for editors offered by the World Association of Medical Editors [39] or the Committee on Publication Ethics (COPE) [40]. As a resource, COPE also maintains a searchable database with more than 500 cases that have involved some misconduct or editorial mismanagement for those who wish to analyze or research the topic of journal-related fraud. Although within the total scope of research reporting, the number of actual retractions is small (<0.05% of the millions of published articles), it is also apparent that for every clear case of misconduct, it is likely a harbinger for more.

Nevertheless, hundreds of publications on misconduct and ethics have been published over the past decade. For example, a simple PubMed (US National Library of Medicine, National Institutes of Health) search using “scientific misconduct” as a key phrase results currently in ~5000 citations. As Fang et al [41]

have reported, about 70% of retractions are attributable to some level of misconduct or carelessness based on a review of more than 2000 retracted biomedical and life-science research articles indexed by PubMed. The types of misconduct include evidence of suspected fraud (>40%), duplicitous publication, and plagiarism. Others have reported that more than 40% of surveyed researchers could provide examples of misconduct, but did not report them. It also has been observed that journals with high impact are more affected by fraud and errors than journals of lower impact. For the latter, plagiarism and duplication are more prevalent [42,43]. Furthermore, it has been observed that higher-impact journals are more likely to retract publications in which misconduct is a factor [44,45].

Regarding the darker side of the problem, it is now possible to publish fraudulent or careless research findings for a price, particularly when the marketing of the research product is an ultimate goal. The ability to purchase scientific authorship is also possible. The marketing of authorships is a cottage industry that has evolved out of Asian commercial editorial services. Most of these services are designed to improve the quality of scientific manuscripts; however, an investigation by Science [46] uncovered


that some services also provided opportunities to pay for authorships on papers written by other scientists. When there is little or no oversight, there are those who will find ways to “game the system.”

Despite the documented cases, however, our views and

judgments about misconduct often remain uncomfortable as a topic of discussion. Compromised reporting of misconduct may result from collegial or coworker grievances or institutional embarrassment. Also, misconduct, related to the research reporting process, is not viewed as a crime for which there is recourse in most courts of law. Nevertheless, whether an error, a misconduct, or a fraud, the increase in such problems has prompted Nature, Elsevier, and other publishers to adopt new editorial policies in attempts to improve the consistency and quality of reporting of submitted manuscripts. In most cases, the policies are directed at better documentation and validation of research methods. As previously noted, organizations such as World Association of Medical Editors and COPE have been particularly aggressive in suggesting guidelines and protocols for reducing fraud and misconduct [39,40].

It is important to emphasize that success can also play a role in misconduct. Many scientists are ill equipped to handle success. As observed by Ludwig and Longenecker [47], success can lead to complacency or the view that one has privileged access to certain information, which can lead to nonproductive collegial interactions. Success may also lead to the temptation to misuse resources and the personal belief that one has a right to manipulate outcomes. Ludwig and Longenecker [47] have coined this type of behavior as the Bathsheba syndrome, paradigmatic of the Old Testament King David-Bathsheba story, in which King David’s leadership becomes complacent and eventually corrupt. The “syndrome” helps to describe the tendency for groups and organizations to look the other way when a highly successful colleague is guilty of misconduct.

In this regard, the former editor of Nutrition Research serves sadly as an example of institutional complacency [48-50]. A number of his articles have now been retracted, but no institutional charges of misconduct were ever filed by his home institution, the Memorial University of Newfoundland, illustrating a “tendency for organizations to look the other way when a highly successful colleague may be guilty of misconduct” [47].

For most, however, it is the less evident practices that

result in what is sometimes viewed as “misconduct.” Rather than an ethical breach, the underlying factors are statistical mistakes, poor judgments, or inadequate oversight resulting in flawed experimental design. As examples:

•Inclusionorexclusionbiasintheselectionof studiesfor use meta-analyses to gain greater statistical power [51]

• Data dredging, a search for statistical significancewithin given data sets (cf. Ref. 51 for examples)

•Designingexperimentsforthepurposeof obtaininga particular answer

What can the researcher do? For many types of errors, some approaches are to include independent consultants with appropriate skill sets to examine the data, design strategies directed at convergent and discriminant validation of given data sets, or develop a system for honest and independent in-house review or replication.

Fortunately, many journals now have mechanisms for the storage of original data sets, so that they can be examined and used by others. In this regard, the advice and statements adopted from the American Statistical Society [53] and Nuzzo [54] on statistical significance and P values are seminal (Table 2), That is, values for probability are mostly useful in making an inference for a null hypothesis and not for working backward to make a causal statement. It is also noteworthy that the editors of Basic and Applied Social Psychology have recently announced that the journal will no longer publish papers containing P values because such statistical analyses are too often used as criteria for “lower-quality research” [55].

7. The translation of research findings—another problematic ethical concern

A significant extension of nutrition and health-related research is the need to translate research finding so that they are useful to the client, whether a commercial venture, health professional, or the public. Apart of the process often involves communication through journalists and broadcast communicators. Analogous to biomedical research journal reporting, journalism and broadcasting also have defined codes

of ethics that focus on truth, minimizing harm, independence, accountability, and transparency (eg, the central tenets of the Society of Professional Journalist’s Code of Ethics). Regrettably, there are 21st century aspects of journalism that the codes


do not address, such as the apparent need to be entertaining and responding to a “24/7” news cycle [56-61]. For digital publishing platforms, the editorial process sometimes subordinates to the allure of “breaking” a story given the real-time nature of these new publishing mediums [56]. There is also a strong tendency to report highly positive or negative findings with an enthusiasm that is often not supported by the data in the original article, in part due to the decreasing number of trained journalists, who are being replaced by opinion communicators [57]. As an example, Lai and Lane [58] have reported that 43% of front-page stories reporting on medical research are based on research with mostly preliminary findings.

As we move forward, there is the reality that the journalistic landscape is indeed changing. Digital publishers and blogs from various organizations and stakeholders must also be considered as outlets. Most digital publishers, however, lack currently a well-tested system to assess ethical concerns. Although it is suggested that those interpreting science for the public should use some peer review as a benchmark [59], the nature of the newer venues for science communication causes such arguments to be obscured by First Amendment concerns. Regardless, procedures appropriate for a given venue should be developed. As noted by Ransohoff and Ransohoff [57], if the research community does little or nothing to address the problems of misleading public communications or translation, the consequence of lack of action is complicity. The problem is amplified, when there are multiple vested interests involved in research-related communication (eg, the researcher, the journalist, the institutional public relations officer, or the blogger/ publication editor). It is not uncommon for researchers from top institutions to distribute press releases with salient, yet limited, information about their research with the goal of self- promotion. This lack of detail leaves the burden of interpreting the research to a journalist who often is not well equipped or takes the time to present an accurate description of the work [59-61]. There must be freedom of the press and recognition of First Amendment rights, but there should be little tolerance for sensationalism and distortion of truth when it is done as a putative public service.

Although often far downstream from initial research efforts, product labeling is another form of research translation relevant to nutrition. The Nutrition Labeling and Education Act of 1990 and recent modifications [62-64] mandate the

Table 2 – Statements regarding the reliability of P values a

1. No single index should substitute for scientific reasoning.

2. P values and related analyses should not be reported selectively.

3. For proper inference all relevant data from a study should be reported.

4. P values are not a direct measure that the probability of a hypothesis is true.

5. P values are not a direct indication that data are produced by random chance alone.

6. Scientific conclusions should not be based only on whether a P value passes a particular threshold.

7. A P value is a statement about data in relationship to the stated hypothesis, not a declaration of a given explanation.

a Adapted from the American Statistical Association’s statement regarding the purpose and limitations of basing data interpretations on P values [53].

Labelling of nutritional information; yet, labeling is often viewed as confusing and misleading, even when it complies with existing regulations. Winters [65] and Mayhew et al [66] argue further that scientific rigor frequently is not met, which is troubling particularly when misleading marketing strategies target children. The difficulties with reinforcement have even led nutrition policy advocates, such as Marion Nestle [67], to suggest a return to the system that existed before the 1980s when health and nutritional claims were not allowed on packages, an argument also addressed by Winters [65].

8. Marketing

As a final point, few disciplines have the short temporal distance between the initial research results to the proposed application or market as does nutrition. In many cases, the research has inextricable links to a marketing decision, which may bring the researcher into the marketing process. As examples, those doing commodity-oriented research often have to deal with marketing agents, a commodity board, or other types of corporate concerns owing to the importance of the investigation to bring about a material change or have an effect on stakeholders at some level. In this regard, there are questions that one may use as benchmarks that lead to an ethical action.


•Doesthecompanyhavethewell-beingof allof itsconstituents as a working principle—from program design to member services?

•If theactivityscalesacrossinternationalordistinctregional boundaries or microcultures, does it ethically and effectively address particular sensibilities (eg, use of child labor, utilization of so-called out-sourced subjects [68]), lead to environmental waste, or bypass regulations?

•Doestheactivitypromisetoomuchorresultinanexclusionary practice or stigmatization?

•Ismarketingtheprimarydriverinanticipationof a pro business arrangement?

As a marketing case study, the nutritional supplement industry and its lobby are often viewed as nutrition’s corporate “gorilla in the room,” particularly given the vigorous efforts that are made to modulate political, regulatory, and judicial intercessions to effect positive outcomes on behalf of the supplement industry. To reiterate, under the DSHEA, dietary supplements do not need strict FDA approval before marketing their products. It is the company’s responsibility to provide assurance that its products are safe and efficacious. Although there are independent organic or natural product organizations that provide levels of credentialing and oversight services, it is usually a secondary agenda compared to their lobbying or marketing efforts. As an example, in a recent hearing before the Senate Commerce Committee on “Protecting Consumers from False and Deceptive Advertising of Weight- Loss Products,” the Natural Products Association supported government efforts to stop illegal consumer fraud, while opposing proposed requirements by the Federal Trade Com- mission (FTC) for additional studies and research before consumer advertising [69]. The FTC recommended that before the promotion of a given product, 2 double-blind, randomized control trials be performed to support legal structure-function statements. The Natural Products Association countered that the additional research efforts would be an inefficient use of resources and compromise innovation. A company’s First Amendment rights were also invoked along with the difficulty of recouping research dollars. With that said, the nutritional supplement market is clearly extraordinarily successful. About one-third of North Americans consume at least 1 of the 65 000 dietary supplements on the market on a regular basis. Based on several estimates, the global nutrition and supplement market takes in more than 100 billion dollars annually (about one-third in the United States) with a 6% to 7% annual rate of growth with little

documented commitments to research [70,71].

Is there aggressive regulation by the dietary supplement trade associates to stop illegal consumer fraud? Although their visible efforts obfuscate FTC and FDA rulings, evidence that trade and supplement associations engage in robust self- regulation is scant at best. Is regulation needed? Based on reports from 2004 to 2012, nutritional supplements accounted for more than half of the FDA class I drug recalls, even with the restrictions in place on the FDA because of the DESHA. A “class I” designation indicates that there is a reasonable probability of a serious adverse health consequence or death [72,73]. Given the current frequency of potential health consequences [72], it is reasonable to consider the admonition by Katz [73] that “Dietary supplements should be treated with the same rigor as pharmaceutical drugs and with the same goal: to protect consumer health.”

9. Concluding remarks

What follows are some additional opinions regarding attitudes that we judge to contribute to less than optimal ethical outcomes. They are offered in the same context as those provided by Goodstein [33], as noted in Section 5—behaviors that contribute to misconduct, maleficence, and fraud.

1. Emphasis is often given to research approaches that are too holistic in their experimental designs.

The point here is not an argument that a reductionist or basic approach is superior to a holistic or systematic approach in the conduct of research (also cf. Fang and Casadevall [74]). Both are essential in the development of interdependent and complementary views of complex and intergraded phenomena. It is often holistic or systematic approaches that have the most impact on eventual policy. Rather, it is the attitude that many take in approaching research questions from a holistic perspective. The importance of the research question should indeed help drive the overall research effort; however, if the correct methodology is not sufficiently developed or absent, there is a high probability that the work will have little value. The ethical dilemmas evolve when resources are used for research that is too descriptive, that is, provide little mechanistic insight. The value of the research training associated with the effort is also diminished when the correct tools and sufficient background information are not in place.

2. Nutritional studies often rely too heavily on the inappropriate application of statistics.


It is worth repeating that too many nutrition-related research papers are the product of so-called data dredging or statistical applications that simply would not be allowed in many other disciplines. This point was made elegantly by Feinstein [52] some 30 years ago, but remains a problem and contributes to the impression of “Why Most Published Research Findings Are False” as asserted by Fang et al [41]. To reiterate, more emphasis should be given to the design of experimental controls and approaches that lead to convergent validation of results.

3. There needs to be improvement in the interactions that researchers have with the various stakeholders involved in nutrition research and its translation.

The direct interaction of the researcher with commodity groups and the various research foundations that focus on nutrition needs to be continuously evaluated. The recent report of the SRF influence directed at cardiovascular and dental health assessments is a timely example [30]. Ques- tionable material published more than 5 decades ago still influences nutritional policy. Indeed, many commodity boards fund research under the auspices of their marketing divisions with the principal goal of obtaining an advertising banner or providing a “deflection” from an inconvenient health-related relationship. More negotiation and understanding are needed. There also needs to be better barriers constructed that separate research endeavors from marketing interests and influences. [72,73]. It is clearly disingenuous to argue that research relevant to marketing be held to lower ethical standards (cf. Section 8—Marketing).

4. Given the importance of nutrition research to health, those involved in research need to become more involved in the translation of their research findings.

As emphasized by Nosek et al [75] and others [56-61], the self-correction of misleading information is uncommon. When one’s work is provocative, it is important that the researcher is involved in its translation; otherwise, as asserted by Ransohoff and Ransohoff [57], the researcher may become a complicit collaborator in the misinformation process. The recent proliferation of journals and the introduction of entertainment components into journalism have changed the landscape of how information is disseminated. We all need to work at better understanding such changes.

5. It is important to review regularly the structures that support and define our research efforts and its use.

As a final point, given that lack of self-correction is common, we agree with the conclusion of Müller et al [76] that it is important to regularly review the structures that define or influence nutrition research (eg, from our journals to the various benefactors of the research). Although we are quick to judge individuals who are clearly guilty of misconduct, we often remain tolerant of ourselves and our colleagues in situations where consideration of an ethical principle may be inconvenient. Even more regrettable, the latter attitudes open the door to a wide variety of marketers, movements, and doctrines that rely heavily on supposition and pseudoscience. As a demarcation problem, it is another issue that effects nutrition more than many other science disciplines.

Acknowledgment

There are no conflicts of interests. Robert B. Rucker, PhD, has been active for 5 decades as an academic research director and consultant, and as such has received funding from both public (eg, National Institutes of Health, US Department of Agriculture, National Science Foundation) and private sources (eg, Chartable Leadership Foundation, Mitsubishi Gas and Chem Co). Michael R. Rucker, PhD, has experience and recognition as a health and wellness communicator (Active Wellness, Inc, Digital Technology Expert at Verywell.com).

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The article: Nutrition: ethical issues and challenges, was reproduced in this newsletter with permission of Elsevier and the Copyright Clearance Center’s Rights Link


You can obtain 2 CEus ethics credits for reading the article Nutrition: ethical issues and challenges and answering the accompanying questions

Questions 1-10: Choose the correct answer

1. For nutrition and associated disciplines, the development of clear ethical guidelines for research and practice is wrought with complexity. Aspects that define a scientific discipline such as nutrition include:

a. Cultural and religious influences

b. Political codifications or laws

c. All of the above

2. Whether you use a science-based or faith- based approach to framing your research question could lead to bias in the outcome of the research.

a. True

b. False

3. The control regarding how evidence-based nutrition information is used and interpreted lies also with:

a. The nutrition fraternity and

b. Nutrition and its health-related industries plus various regulations and interaction with governing bodies

c. The consumer

4. The fact that almost any substance consumed orally which is derived from a natural product may be defined as food, brings forward issues. These issues relate to:

a. Ignorance of science and evidence-based principles

b. Conflicts of interest

c. Total absence of regulations

4. a & b

5. A Canadian study reported that 20 % pharmacists had indicated they have an adequate level of knowledge to advise the public and consumers about supplements and complementary and alternative health care products.

a. True

b. False

6. A study by Lesser et al assessed the potential influences by sponsors regarding the health effects related to consuming 1 of 3 beverages (soft drinks, milk, and juice).

a. The study results showed that the relationship of nutrition to the food and health-related industries comes with a set of ethical obligations

b. Scrutiny of approximately 400 published research papers indicated that the funding source was associated directly with the conclusions.

7. Suggestions for ethical vigilance do not include:

a. Structuring the research question in a way that it does not favour a given outcome

b. Developing a clear understandings between the client and the researcher; and

c. To not publish the results when they are not favourable

8. A Working Group of the International Life Sciences Institute in North America developed a set of Guiding Principles, which is an example of reasoned approaches that provide transparency, and a platform for discussions directed at potential funding conflicts of interests. The following

Aspects are not included:

a. Remuneration based on or geared to the outcome of a research activity should be transparent and but not open to questioning

b. Written agreements should underscore the obligation to attempt to publish the findings within some specified and reasonable period.

c. Full disclosures in publications and conference presentations of all financial interests should always be an expectation.

d. Researchers associated with contract research organizations or act as contract researchers have an obligation to make clear statements regarding the nature of the affiliation

9. The European Food Safety Agency’s Conflict of Interest Practices Committee chose not to strengthen their conflict of interest policies, Instead the opted to:

a. Address issues of financial conflict and bias with reasoned approaches and management

b. Follow an arbitrary set of guidelines

10. The World Association of Medical Editors or the Committee on Publication Ethics


(COPE) have been particularly aggressive in suggesting guidelines and protocols for reducing fraud and misconduct to maintain the integrity of science journals and support the honest translation of findings to the consumer. The purpose of these different sets of guidelines are:

a. To have policies directed at better documentation and validation of research methods

b. To improve the consistency and quality of reporting of submitted manuscripts

c. Both of the above

11. The following are reasons why researchers need to become more involved in the translation of their nutrition research findings.

a. If the work is provocative, and the researcher is not involved in its translation, the researcher may become a complicit collaborator in the misinformation process

b. Self-correction of misleading information is common.

c. The recent explosion of journals with the introduction of entertainment components into journalism, have changed the landscape of how information is distributed.

d. All of the above

e. a & c


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1. Complete your personal details below

2. Read the article: article Nutrition: ethical issues and challenges and answer the questions

3. Indicate the answers to the questions by marking an “x” in the appropriate block at the end.

4. You will earn 2 CEUs (Level 1 - Ethics) if you answer 70% or more of the questions correctly. A score of less than 70% will unfortunately not earn you any CEUs.

5. Make a photocopy for your own records in case your answers do not reach us.

6. Scan and email or post your answers to:

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Please note: The answers should not reach us later than 31 May 2019. Answer sheets received after this date will not be processed.

HOW TO EARN YOuR CEus


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The Dietetics and Nutrition Newsletter is a newsletter for practitioners registered with the Professional Board for Dietetics and Nutrition. It’s produced by the Public Relations and Service Delivery Department, Health Professions Council of South Africa (HPCSA) building, 2nd floor, Madiba Street, Arcadia, Pretoria. Dietetics and Nutrition practitioners are encouraged to forward their contributions to [email protected] .The copyright in the compilation of this newsletter, its name and logo is owned by the HPCSA. You may not reproduce this newsletter, or its name or the logo of the HPCSA that appears in this newsletter, in any form, or for commercial purposes or for purposes of advertising, publicity, promotion, or in any other manner implying their endorsement, sponsorship of, affiliation with any product or service, without the HPCSA’s prior express written permission. All information in this newsletter, is provided in good faith but is relied upon entirely at your own risk. By making use of this newsletter and its information you agree to indemnify the HPCSA, Employees and Service Providers from all liability arising from its use.

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