The International Society for Vaccines is an organization that engages, supports, and sustains the professional goals of a diverse membership in all areas relevant to vaccines - 2017 ISV Annual Congress
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Chartered Status for Vaccinologists

Commentary: CHARTERED STATUS FOR VACCINOLOGISTS
R.E.Spier
Vaccine Series Editor in Chief
President of the International Society for Vaccines
This paper sets out the case for the establishment of the Chartered (i.e. Professional) Vaccinologist. As in other professional disciplines there is a core requirement to make clear to society the nature of the contract between the individual practitioner and the wider community. This is particularly the case when a new discipline emerges. What follows amplifies these statements and is intended to provide the groundwork for the eventual emergence of the new discipline with the acquisition of professional status by its practitioners.
1. What is Chartered Status?
Chartered status implies that there is a legal document that sets out the empowerment of an individual to act within a defined category of areas. In some countries this is referred to as certification.
1.1 Licence to Practice
In the UK, USA and many other countries, the professions generally governed by charter are; Medicine, Architecture, Law, Pharmacy, Accountancy, Civil Engineering, Electrical Engineering, Mechanical Engineering, Aeronautical Engineering, Nautical Engineering and others. The principle characteristic of such professions is that the individuals who offer services in these areas cannot sell their services directly to a client unless they have a licence to practice issued by their professional institution. Within companies it is customary to have a designated responsible individual who signs the documents or products that are ready for use by purchasers. In some professions this has to be a licence holder. People who are not licensed can practise under the auspices of a professional licence holder as in a large organisation or company or they can practise under a title other than the ones designated in the licences of the accredited professional bodies.
1.2. Recognition by Society
The institution issuing the licence is normally recognised by the society as having the authority to issue such licences to practice. In England there is the device of the Privy Council composed of people whose service to the society has been of an exemplary and beneficial nature. This body provides the authority for universities to issue degrees in their own right. It also provides professional institutions the right to issue licences to practice for suitably qualified members of such institutions. The situation described below provides social recognition for the activity of the delegation of the authority to issue licences.
In the case of Vaccinologists, an authority such as the World Health Organisation or the United Nations (UNESCO) may be deemed appropriate bodies to authorise such chartering activities.
A second facet of this recognition by the society is that some activities are confined to those people who hold and can display the official licence. Examples of such individuals are; the person to signs the certificate of release of a vaccine lot for sale and use, the person who sets up a vaccination campaign; a person who designs effects, interprets and publishes safety and efficiency tests; a person who manages the transfer of technology from the bench to the manufacturing system; members of regulatory agencies for vaccines; people who design and assay putative vaccines from pathogenic organisms etc.
1.3. Self Regulation
In recognising the authority of an institution to issue a licence to practice, it has to be made clear how the quality of licence holders is to be both determined and maintained. Therefore there are clear intra-institutional structures that are designed for the self regulation of the quality of the activities of individuals to whom licences are given and also there have to be established appropriate bodies to revoke licences and to discipline errant licence holders who have brought the profession into disrepute.
1.4. Declaration of Purpose
In promoting a charter it is clear that there has to be a mission or aims statement under which the chartering institution operates. This provides a point of contact between outside agencies and the institution. It also affords guidance to institution members and affirms the limits and boundaries of their professional responsibilities. Nevertheless, it is also clear, that whatever are defined as such limits to the profession, the licensee is bound not to proceed outside the area of his/her own competence.

2. Why Bother?

 

There are those who argue that it is not necessary for Vaccinologists to seek chartered status as it may interfere with the command relationships within companies. The counter arguments are summarised below.
2.1. Benefit to the Society
As in other professions it has been demonstrated that society is the gainer by the establishment of a contract between the professional and the society. That such an arrangement brings comfort and understanding in areas where the average member of the society is all too willing to admit to complete ignorance is a key point in this interaction. It is implicit in the contract that the professional will not take undue advantage of the special abilities that he/she possesses and that at all times the benefit of the society and/or the individual members (clients, patients) is the objective of the activity.
[The first such contract or Oath may be seen in the writings of Hippocrates (460-377 BCE) (W. H.S. Jones translation for the Loeb Classical Library, vol 1 pp299,1923)]
A conflict of interest may occur between the client and the society when benefits are assessed. Each such issue may be examined on a case by case basis but in each event it is the duty of the professional not to bring the profession into disrepute. The professional has to be on the look out for conflicts of interest and where these involve the employing client or organisation it is the professionals’ responsibility to bring the issues to the table quickly with a view to arriving at an ethically appropriate solution.
2.2 Benefit to the Vaccinologist
As the Vaccinologist is contracted to effect social benefit he/she can claim a special dispensation when it comes to remuneration. For to contractually relinquish the opportunity for unbridled self-gain, there has to be some compensation in the form of additional compensation.
2.3 Assurance of Standards
When a person with chartered status offers to provide services to the society or individuals within the community then the recipient of those services can be assured that the individual who is to practice their profession is competent to fulfil the conditions of the contract entered into. This stems from the realisable expectation of the customer/contractor that the purveyor of the services is educated and capable in both the theoretical and practical aspects of the subject area. And, what is more, is schooled ethically and bound morally by a code of practice that ensures that malpractice will not occur.
2.4 Uniformity of Standards
As the world shrinks with every advent of a more rapid and cheaper rate of transportation and communication, individuals do not feel constrained by their country of origin when it comes to practising their profession. To ensure that when they do step foot abroad they practice at a standard that is expected in that foreign country, it is necessary to establish the equivalence of their professional qualifications. Again one sure route to this end is to have equivalent understandings, capabilities and codes of conduct of the professional in all countries or member states.
2.5. Contract with other Vaccinologists
It is as important for all Vaccinologists to understand the rules of the game as it is for the development of the understanding between the Vaccinologist and the society. From such appreciations comes the self help and guidance that underscores the apprentice route to the fully fledged practitioner. Furthermore the bond between similarly qualified and committed professionals is a constraint on untoward behaviour as much as it can become a support when members of the profession are unjustly arraigned as being in default of their duties.
2.6. Enhancement of Status
There is something that sets the professional apart. He/she has to have spent much time in training, in accepting a code of practice and conduct, in foregoing present pleasures to achieve future satisfactions. Such commitment to service justifies an enhanced status and respect from those who have not made such sacrificial decisions or who have not made a large investment in personal skills and understandings. Nevertheless, a high status has to be earned; it is not there as of right. A proper, deliberate and considered demeanour is a prerequisite of high status as flippancy, profligacy and promiscuity detract from social esteem.
3. What then is the social contract?
There are three parts to the social contract as delineated below.
3.1 From the Vaccinologist to the Society
It is expected that the Vaccinologist will provide to the society improvements in health care based on the use of prophylactic materials. He/ she will also communicate to society the risks and benefits of such materials and will carefully and thoroughly monitor the application of prophylactics as they are used society-wide. In pursuing these activities the Vaccinologist will effect the tasks safely with the health and welfare of vaccinees in mind at all times. The research, development and test work will be done with competence and will be reported on with openness, comprehensiveness and honesty. (It should be recognised that factuality, objectivity or truthfulness are not capabilities that can be achieved in an absolute sense). In all contracts there will be a commitment to fair and equitable dealing.
3.2 From the Society to the Vaccinologist
In exchange for #3.1 above the Vaccinologist might have a reasonable expectation from society for a reasonable fees or salary that properly reflects the status and recognition that should be accorded such individuals. There may also be won a reputation for being trustworthy, responsible and worthy members of the community.
3.3 From one Vaccinologist to another Vaccinologist
It may be expected that there will develop inter-relationships between Vaccinologists that will protect them against injury and provide support groups to prevent transgression. It is often the case when whistle-blowing episodes are reported that the instigator of the action is black-balled by those affected by the action. However, as it is a duty of professionals to stand together, support may be on hand for those who have to cast the first stone in a situation where a wrong has been, or is about to be, committed. There are other obligations of professional Vaccinologists such as the need to deal fairly with one another and to impart both knowledge and skills to trainees.
4. Why not piggyback on an existing corporate body?
4.1. Vaccinology is Unique
Vaccinology deals with living organisms or parts thereof which can be incorporated into prophylactic preparations. Its continued development and penetration into most areas of health care will expand in the future so that it may replace the therapeutic approach as the mainstay for healthcare in this or the next century.
4.2. Vaccinology emerges as a discipline based on the integrated synthesis of subsets of other basic disciplines.
Whereas it is well recognised that there are established institutes and societies that cater for the biochemist, the biologist, the biochemical engineer, the cell culturist, the process engineer, the geneticist, the microbiologist, the immunologist and the ecologist, there is not a recognised organisation that serves the needs of Vaccinologists. Vaccinologists routinely work in some, or many of the above single discipline areas. Such work requires a fusion of the principles of these disciplines to achieve effective productivity in any one given area. This author, when operating as a Vaccinologist, needed to use knowledge and skills from such areas as microbiology, biochemistry, genetics, immunology, vaccinology, process engineering and cell culture in a manner that fully integrates these, once independent, disciplines to a unified new discipline to achieve high productivity systems for vaccines. It may be thought that this is an impossible task. Yet it has to be recognised that in such a synthesis, specifically useful subsets of the basic disciplines are used in concert with an overarching vaccinology discipline that puts into a new perspective the way we generate and use information relevant to the advancing of processes leading to safe and effective vaccines.
There are those who think that skimming the verbally descriptive aspects of the different subdisciplines makes for the education of a Vaccinologist. Yet in spite of the complexity of the materials and processes it is possible to apply mathematics (numerical descriptors), models and stringent experiments to arrive at new and improved ways of understanding or doing things. It can be as hard-edged as any chemical engineering treatment can achieve.
The integration of basic disciplines into integrated new disciplines is not new; consider Biochemistry, Chemical Engineering, Microbiology, Control Engineering or the newly emergent Psycopharmacology or Psychoneuroimmunology.
4.3. Vaccinology has recently emerged to become an advanced retooled molecular based operation.
In 1975 we have the Cohen-Boyer patent for genetic engineering of prokaryotes; in the same year we have the Kohler-Milstein discovery (unpatented at the time!!) of the use of animal cell hybridomas for the production of monoclonal antibodies. 1978 saw the Berg paper on the genetic engineering of animal cells in culture and since then we have learned how to engineer virtually all the life forms on the planet. Additionally the automation of DNA synthesis and sequencing operations coupled with the use of computers has achieved the establishment of data bases out of the messages embodied in the genes of living organisms. These key technical discoveries and abilities have retooled the activities that have sought to derive benefit from biological entities. This developmental process continues apace with more versatile and less expensive tools competing for a share of the limelight with yet more sophisticated and multipurpose contrivances.
This new tooling operation owes much to biochemical, genetic engineering, computer and robotic developments. Again it is well to consolidate this activity area under one societal roof and recognise that something radically different is afoot in the modern manifestation of Vaccinology.
4.4. Scale up factors of 1025
There are few industries that have to scale up processes from a single molecule (molecular weight 100,000) to the level of tens of kilograms.
4.5. The public perception of Vaccinology
As Vaccinology deals with powerful materials that are made to interact intimately with the bodies of the humans and animals to which they are applied, it is necessary for Vaccinologists to enter into a special relationship with the public so as to establish their bona fides and commitment to responsible actions.
There is a well developed coterie of organisations whose purpose is to denounce and decry the efficacy, safety and benefits of vaccination. The arguments used range from the admonitions that humans should not interfere with the work of the God in bringing disease to people for their bad behaviour to the setting of the value of an individual life as equal to that of many tens of hundreds of individuals who would otherwise have died from a vaccine preventable disease.
We therefore have to have an understanding with society as to what we are about as Vaccinologists. That we seek to use the new technologies only for benefit and that we are open, willing and desirous of working with the society to come to mutually agreed understandings of what is meant by safety and benefit.
The members of other institutes and societies do not have as necessary a requirement to make themselves open to the society as does the Vaccinologist. For this we need to establish a new modus vivendi, a new social contract; for the powers that are vested in the vaccinology activity are of a different order of magnitude when compared with the traditional disciplines.
5. What is Needed to Achieve Chartered Status?
5.1. Social legislation that requires the use of the Chartered Vaccinologist in specified situations
As with the other professions, it is necessary to have some, one, Vaccinologist assume the responsibility for the production and promulgation of a product of the Vaccinology activity. This requirement should be ensconced in the law. It therefore requires legislators to enact the necessary statutes adumbrating the terms and conditions under which the chartered Vaccinologist will serve the society.
This legislation will not proceed unless and untill the Vaccinologists as a group become organised and sue or petition for it from the legislatures.
To some extent, this is a chicken and egg situation. Legislation is required to establish the position of the chartered Vaccinologist; and the chartered Vaccinologist is required to press for the appropriate legislation. As in evolution the twin activities of pressing for legislation and chartered status may proceed in concert.
5.2. A body that is licensed to issue Charters
Here we have another problem. While the United Kingdom has its Privy Council we have a model situation for the ratification of the chartering activity of a professional institution. Other member states of the European Union do not possess this route to the chartered status. Rather they rely on local universities or institutes assuming the mantle of the chartering body. Tradition and reputation become the foundations on which such an activity can be based.
Nevertheless, to achieve a harmonization of standards on an international dimension it may well be necessary to acquire the necessary political institutions to achieve the chartering activity. This issue could be brought before the World Health Organisation or the United Nations (UNESCO). Vaccinologists working through their member state representatives on these bodies could achieve the necessary charters within a manageable time scale.
5.3. A set of standards of performance
Not only must the Vaccinologist have a contract with the society but such individuals must also be able to deliver on that contract. For this reason, they have to be educated and demonstrate that they have achieved the necessary standards of being able to understand and apply theory; to put into practice the skills and crafts that have been learned and that they are versed in the ethical appreciations that will enable them to prejudge their actions so that they perform their professional acts with a continuing desire and intent to generate added social benefit.
5.4. The judgement of individuals against the performance standards required
Whatever body is set up to provide for the emergence of the professional, chartered Vaccinologist that body will also have to establish the appropriate committees or councils that will monitor the activities of the member Vaccinologists and to subject members who bring the profession into disrepute to disciplinary action. It may well be that there should be lay representation on such judgemental panels; for the message has to be promulgated that the self-regulation of the professional Vaccinologists is above reproach and is of such a high standard that society may be reassured of the probity of the whole vaccinology activity.
Such a system will have the power to revoke the right to practice as a licensed agent of the profession.
5.5. The establishment of a code of behaviour
The chartering body has to establish and publish a code of behaviour or ethics. Stephen Unger would have such a code provide;
1. recognition by members of a profession of their responsibilities,
2. create an environment where ethical behaviour is the norm,
3. a guidebook in particular situations,
4. the process of developing and modifying the code can be valuable to the profession,
5. an educational tool focussing attention in classes and meetings,
6. the code can indicate to others that the profession is seriously concerned with responsible professional conduct.
To acquire chartered status the Vaccinologist would have to publicly and ceremonially affirm his/her commitment to follow the code. Transgressions of the code would be serious matters and would jeopardise the continuance of the perpetrator within the profession.
6. What has to Happen?
6.1. Establishment of an International standard of attainment
The presentation of certificates of tertiary education in relevant subjects over a 6 year period plus a certified record of over 5 years of practice in a relevant area (or the equivalent in additional years of practice or performance in the form of papers, reviews and patents) is a possible and practicable way of establishing a level field academic attainment in part fulfilment of the requirements of becoming a chartered Vaccinologist.
6.2. The Establishment of a body of people who can generate and oversee the activities
It is clearly necessary to establish a society/institution/academy/corporate entity to promulgate the professional and chartering activities for Vaccinologists. To get such an organisation off the ground it will be necessary to gather together the senior Vaccinologists who are already recognised as such or would wish to be recognised as such to form the Fellowship of such a body. A suggestion as to who such individuals might be is set out below.
All individuals who wish to be associated with such a body and have more than 100 publications in Vaccinology (refereed papers + reviews + chapters in books + books, or the equivalent of such 100 publications in experience on the shop floor or in teaching, shall be deemed worthy of becoming the Fellows of the Body (Student Members and Ordinary Members will then be defined by the Fellows).
6.3 The adoption of the code of practice.
The code of practice constitutes a set of rules or regulations that govern what is and is not acceptable practice. It is regulatory in that should a professional vaccinologist fail to observe the regulations that individual is liable to be stricken from the register of chartered or licensed vaccinologists. (A possible code may be seen in Appendix I.)
6.4 The Acquisition of the Authority to issue Licences from the appropriate International Body and to restrict particular vaccine related activities to licence holders
Once the body has formed and has become a legal entity (as the International Society for Vaccines has been established in the United States of America) it will pursue the objective of acquiring the recognised right to issue licences to practice as well as the promulgation of the necessary legislation that will limit the rights to constrain defined vaccine related activities to licence holders.
6.5 Establishment and maintenance of a Register of International Vaccinologists
An open and accessible register of Vaccinologists who are licensed to practice should be established under the aegis of the body that has been set up in #6.2 above. A committee of the licensing body has to be established to determine who shall or shall not be entered into the Register of Chartered Vaccinologists. Were a person to be struck off this register and feel that due process was not observed or was thought to be wanting, the right of appeal to a higher body may be sought. This latter body could be constituted from the directing board of the institution plus additional individuals from the community (e.g. established jurists) and from other chartering organisations.
(It may also be necessary to seek immunity from prosecution and damages were individuals to reject the way they have been treated by this committee and the higher body.)
Appendix I
Draft Code of Conduct for Vaccinologists.
Whereas the practice of Vaccinology may include operations involving the production and use of genetically engineered organisms of a unicellular or multicellular nature or parts thereof, some of which can, under the appropriate circumstances, replicate themselves, and
whereas the majority of Vaccinologists are either employed by companies or are owners or major shareholders of such companies, or are operating as consultants or are employed by a government research establishment or university as researchers and/or teachers and
whereas there is not yet established a body corporate which can be responsible for the licensing of appropriately qualified individuals, for promulgating this code of conduct and for bringing to discipline those who transgress this code and
whereas there is deep public concern as to the production and promulgation of Vaccines and
whereas there is a need for practising Vaccinologists to present to the public at large, their employers and fellow Vaccinologists their collective assurances for their responsible actions as well as expressing their rights, such as the right not to be asked to violate this code,
it is yet useful to formulate a code whereby the conduct of Vaccinologists might be regulated.
The Code:
1. The principal duty of the Vaccinologist is to use his/her knowledge and skills to bring benefit to society by the practice of his/her profession and to do, or intend to do, no harm.
1.0.1 The Vaccinologist will make him/her-self familiar with the laws of the land, which have a bearing on the activities of that Vaccinologist, and will operate at all times in accordance with those laws.
1.1 The Vaccinologist shall not knowingly or by negligence or by the non application of due diligence cause harm to people either within the organisation with which he/she is connected or to those outside that organisation.
1.1.1 The Vaccinologist will not take risks whose consequences are likely to be deleterious to humanity.
1.1.2 When taking risks which could affect others or the environment, Vaccinologists must engage in an appropriate consultative procedure and gain the approval of those who may have or have the prospects of being affected in any way by the experimentation.
1.1.3 The Vaccinologist will be knowledgeable about the regulatory and licensing bodies which control the manifestation of the work of the Vaccinologist and will refer to such bodies as is appropriate.
1.2 The Vaccinologist will make it his/her duty to be acquainted with those ideas and concepts which are commonly used to determine the nature of benefit.
1.2.1 The Vaccinologist will familiarise him/herself with methods involved in assessing risk, in managing risk and in communicating risk.
1.3 The Vaccinologist, in creating human benefit will seek to do so with the least suffering to other living beings; indeed it may well be possible to achieve benefit to such other organisms and where this is possible it should be done.
1.3.1 The Vaccinologist will inform him/her-self about the issues involved in “informed consent” with regard to experiments with humans, the Helsinki code for animal experimentation and further developments of that code for experiments with primates and will keep to the best practices as set out by such codes.
2. The Vaccinologist should act with integrity at all times and should seek to allay public concerns while enhancing public welfare and enhance the status and reputation of Vaccinologists and the profession of Vaccinology.
2.1 Vaccinologists should not accept work which is outside their competence to perform.
2.2 Vaccinologists should write and speak to the media with care and balance about those areas of Vaccinology on which they are competent to comment and may only engage in generalisation outside their sphere of expert knowledge where they have clearly stated/written their degree of competence in that area.
2.3 Vaccinologists should be honest in their dealings with others and not seek to create impressions which are not justified by the data or observations of which they are aware; they should be mindful that absolute statements about the truth or proof of a proposition are spurious and are hostages to fortune. Vaccinologists should not deliberately mislead others into beliefs which are potentially “unsafe”.
2.3.1 Vaccinologists should be open with their information and seek to help others progress their work except in situations where there are requirements to protect intellectual property.
2.4 Vaccinologists should not defame their fellow Vaccinologists. This does not mean that they should not provide accurate, fair and valuable criticism of the work proposed or effected by other Vaccinologists.
2.4.1 In the event that a Vaccinologist discovers that a fellow Vaccinologist has behaved, or is behaving, in a manner which would bring the profession into disrepute, it is that duty of that Vaccinologist to bring this matter to the attention of those authorities which can deal with the matter in the most appropriate way.
2.5 Vaccinologists may not solicit work by any method which is contrary to the best practice; bribes, inducements, quid pro quos and the use of agents are not allowed.
2.6 Vaccinologists must be sensitive and alert to the possibilities of conflicts of interests; where such occur they must bring them to the attention of the relevant parties and work with such individuals on how to resolve them.
2.7 Vaccinologists should not steal or plagiarise the written or spoken work of others; this applies to published papers, grant applications and papers in process of being refereed. The work of others, which is in the public domain, may be quoted and used giving due recognition to the first, originating, author(s).
2.8. Vaccinologists may not fabricate data, falsify data or selectively use only those data points which suit their purposes. Misleading statistical techniques or presentational techniques must also be avoided. The data chosen for presentation should faithfully represent to the best of the ability of the Vaccinologist the phenomena that are under investigation.
2.9 The Vaccinologist will keep in confidence data, information and intellectual property in those situations which she/he is so obliged either by verbal or written contract as set up by an employer or client.
He/she cannot use for personal benefit information which is not already in the public domain such as papers in the process of refereeing, grant applications in the process of evaluation and project reports which have not been published. They will also not abuse the consultation process and obtain information and guidance for which they have not compensated and/ or acknowledged the originator.
2.10 Vaccinologists who are in breach of serious criminal or civil laws of their country of residence forfeit the right to be members of the profession of Vaccinologists.
3. When employed, the Vaccinologist has a duty of care to his/her employers to achieve what is required by that employer while staying within the laws of the land and the provisions of this code.
While the basic relationship between employer and employee at law is that of “master and servant”, respectively, in the case of the Professional Vaccinologist a new relationship has to be struck such that the employer agrees that the Vaccinologist will, as an exception to, or within, the “master and servant” relationship, be permitted to follow the code of conduct as hereby drawn up. The professional Vaccinologist might find the practice of his/her profession unwise under conditions of employment where this requirement is not met.
3.1 When the Vaccinologist has individual dealings with a client (as in a consultation or through self-employment) it is required that a confidentiality agreement and a financial arrangement are determined before beginning any work.
3.2 The Vaccinologist has a responsibility to make known to those in authority or those who can effect preventive action, the practices of those Vaccinologists whose unrestrained actions might bring the profession into disrepute or endanger the public health, safety or well-being. (cf 2.4.1)
4. The Vaccinologist has a responsibility to educate those who aspire to become Vaccinologists through both the provision of guidance and instruction and in providing time and opportunities for others to provide education to the novice.
4.1 The Vaccinologist has a responsibility to maintain his/her own educational status at the state-of-the-art level, so that he/she is conversant with the most modern thinking and practices.
4.2 The Vaccinologist has a responsibility to advance the profession in all possible ways and so make it an ever more valuable adjunct to the human endeavour.