Commentary:
CHARTERED STATUS FOR VACCINOLOGISTS
R.E.Spier
Vaccine Series Editor in Chief
President of the International Society for Vaccines
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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.
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1. What is Chartered Status?
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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.
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1.1 Licence to Practice
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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.
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1.2. Recognition by Society
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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.
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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.
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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.
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1.3. Self Regulation
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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.
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1.4. Declaration of Purpose
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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.
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2. Why Bother?
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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.
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2.1. Benefit to the Society
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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.
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[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)]
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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.
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2.2 Benefit to the Vaccinologist
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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.
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2.3 Assurance of Standards
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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.
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2.4 Uniformity of Standards
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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.
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2.5. Contract with other Vaccinologists
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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.
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2.6. Enhancement of Status
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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.
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3. What then is the social contract?
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There are three parts to the social contract as delineated below.
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3.1 From the Vaccinologist to the Society
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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.
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3.2 From the Society to the Vaccinologist
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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.
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3.3 From one Vaccinologist to another Vaccinologist
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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.
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4. Why not piggyback on an existing corporate body?
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4.1. Vaccinology is Unique
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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.
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4.2. Vaccinology emerges as a discipline based on the integrated synthesis of subsets
of other basic disciplines.
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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.
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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.
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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.
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4.3. Vaccinology has recently emerged to become an advanced retooled molecular based
operation.
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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.
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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.
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4.4. Scale up factors of 1025
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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.
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4.5. The public perception of Vaccinology
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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.
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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.
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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.
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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.
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5. What is Needed to Achieve Chartered Status?
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5.1. Social legislation that requires the use of the Chartered Vaccinologist in
specified situations
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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.
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This legislation will not proceed unless and untill the Vaccinologists as a group
become organised and sue or petition for it from the legislatures.
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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.
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5.2. A body that is licensed to issue Charters
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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.
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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.
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5.3. A set of standards of performance
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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.
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5.4. The judgement of individuals against the performance standards required
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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.
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Such a system will have the power to revoke the right to practice as a licensed
agent of the profession.
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5.5. The establishment of a code of behaviour
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The chartering body has to establish and publish a code of behaviour or ethics.
Stephen Unger would have such a code provide;
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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.
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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.
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6. What has to Happen?
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6.1. Establishment of an International standard of attainment
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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.
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6.2. The Establishment of a body of people who can generate and oversee the activities
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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.
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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).
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6.3 The adoption of the code of practice.
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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.)
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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
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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.
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6.5 Establishment and maintenance of a Register of International Vaccinologists
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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.
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(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.)
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Appendix I
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Draft Code of Conduct for Vaccinologists.
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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
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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
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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
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whereas there is deep public concern as to the production and promulgation of Vaccines
and
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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,
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it is yet useful to formulate a code whereby the conduct of Vaccinologists might
be regulated.
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The Code:
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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.
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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.
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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.
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1.1.1 The Vaccinologist will not take risks whose consequences are likely to be
deleterious to humanity.
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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.
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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.
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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.
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1.2.1 The Vaccinologist will familiarise him/herself with methods involved in assessing
risk, in managing risk and in communicating risk.
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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.
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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.
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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.
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2.1 Vaccinologists should not accept work which is outside their competence to perform.
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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.
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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”.
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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.
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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.
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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.
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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.
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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.
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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).
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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)
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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.
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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.
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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.
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