The Nathaniel Centre

Ethics Committees – guardians of research participants’ rights or expediters of clinical research?

Sharron Cole

If the September response of the Government to the Health Select Committee's 'Inquiry into improving New Zealand's environment to support innovation through clinical trials' is implemented, there is the real likelihood that the role of regional health and disability ethics committees (HDEC) will become one of rubberstamping and expediting research rather than one of giving considered and principled analysis to ensure that the research is ethical and that there are adequate safeguards to protects the rights and interests of research participants.

The main aim of the Select Committee's inquiry was to ascertain how clinical trials and research proposals can be streamlined and how an effective clinical trials environment can be created. It identified the current system of ethical review as one of the main obstacles to delivering efficient clinical trial outcomes and made a large number of recommendations to radically alter the system of ethical review.

A number of submitters to the Select Committee inquiry, principally pharmaceutical companies and researchers, argued that the present ethical review system is 'overly bureaucratic' and that it is a hindrance to research, with one submitter arguing that it 'has become so unwieldy it is unethical'. Interestingly, submitters with an ethical expertise and a number of consumer groups argued that while the present process can always be improved (usually simply addressed by better resourcing), there was no evidence to suggest that the present system needed a major overhaul or to substantiate the allegations that the present system of ethical review was either flawed or a major hindrance to the carrying out of effective research.

Not all the Select Committee's fifty four suggestions have been taken up by the Government but it has accepted most of the recommendations which in summary are:

• developing standardised operating procedures for ethics committees (to have effect from 1 July 2012). These standardised operating procedures will:
• • introduce timelines for full review (35 days) and expedited review (15 days)
  • expand the expedited review pathway to include some clinical trials, and clarify and reduce the scope of HDEC review as a whole (focus more narrowly on ethical issues)
  • reduce duplication by clarifying the roles of HDECs, researchers, localities, and the Standing Committee on Therapeutic Trials
  • define when amendments to approved studies themselves require HDEC review
• developing shorter, simpler application forms (by mid-Jan 2012)
• implementing an online application system, with a 'central clearing house' (by 1 July 2012)
• reducing the number of committees from seven to four
• reducing committee size from twelve to eight members, including at least three lay members

The main concern that emerges from the Government's acceptance of many of the committee's recommendations is that the present primary objective of ethical review to 'safeguard the rights and interests of participants in research and innovative practice, and consumers of health and disability services' will be diminished.

The present carefully constructed system, which has been shaped by New Zealand's unique society, protects research participants by having:

1. Regionally-based ethics committees, in touch with and responsive to the needs of their local communities. The proposal to have fewer ethics committees will mean a move to a more centralised system with a loss of the unique advantages offered by the regional system.
2. Regionally-based committees which allow local iwi to have input, in line with Treaty obligations. The place of the Treaty in the system of ethical review is unique to New Zealand and means the principles of the Treaty are honoured.
3. Committees with twelve members, including six lay members, which give extensive scientific, medical, ethical, legal, disability, Maori and many other perspectives. It is the composition of ethics committees with people of different backgrounds each adding to the deliberation of ethical views that is one of the strengths of the present system. As C Wright Mills says, thinking in terms of a variety of viewpoints, "catching light from as many angles as possible."
4. Independent scientific, research and medical expertise which means an assurance that the research has scientific integrity and strengthens the committee's understanding of the scientific and clinical issues and of risk/benefit, thus contributing to more ethical, stronger decision making. The government's proposal is to take away this expertise and for the investigator or sponsor to obtain peer review. This is of real concern as the pharmaceutical companies are significant funding sources for researchers, making it extremely difficult for investigators to obtain un-conflicted or independent review.

Since 2007, many observational studies have received expedited review as they are reviewed by only the chair or deputy chair. The Government now proposes that expedited review should be available not only for observational studies but also for some 'low risk clinical trials'. It is not clear who will determine which trials constitute 'low risk' and thus qualify for chair-only review but the spectre of exposure to unanticipated risk is certainly raised. The proposal to include clinical trials in expedited review is both puzzling and concerning as the National Ethics Advisory Committee, whose primary function is to provide advice to the Minister of Health on ethical issues of national significance, had in 2009 identified interventional clinical trials as having a greater potential to cause harm and thus requiring close ethical scrutiny.

Since 2002, I have given a number of presentations on the system of ethical review in New Zealand, noting the strengths as outlined above but also outlining my concerns:

• Lessons of past quickly forgotten e.g.
• • Greenlane Hospital and collection of babies' hearts
  • Physiotherapy on babies at National Women's Hospital
• Attempts to revise history – e.g. the 'Unfortunate Experiment'
• Perception of lack of real commitment to, and understanding of, the importance of ethical review
• Low priority given to ethical matters e.g. length of time to review Operational Standard, lack of resourcing, lack of advertising
• 'Generalists' and vested interests appear to ignore the input of experienced working ethicists

As the New Zealand system of ethical review arose from the recommendations of the Cartwright Report, it behoves any reviewer to keep in mind Judge Cartwright's strong criticism of the poor quality of review surrounding clinical research at the time. She was fiercely critical, among many other things, of the lack of independence and impartiality of the Hospital Ethics Committee that approved Professor Green's research. She was pessimistic about the then existing medical establishment to develop a system of ethical review that would give adequate protection to research participants.

The ever shrinking and increasingly restricted nature of ethics committees since 2004, culminating in these proposed radical changes, makes it very difficult to be at all optimistic about the robustness of ethical review in the future.

Ethically compromised vaccines and Catholic teaching

Kevin McGovern and Kerri Anne Brussen

Ethically compromised vaccines are vaccines where the virus used in the manufacture of the vaccine has been cultured in a cell line developed from tissue grown from an aborted foetus. Vaccines are ethically compromised by this connection to abortion. Within the Catholic Church, the Pontifical Academy for Life has called for research and development of alternative vaccines which are ethically acceptable. Until alternative vaccines are developed, it has also accepted the use even of these ethically compromised vaccines in order to protect children, pregnant women and the population as a whole from the risk of contracting serious disease.

Vaccination and the Catholic Church

It has been alleged that Pope Leo XII (1823-29), stated, "Whoever allows himself to be vaccinated ceases to be a child of God. Smallpox is a judgement of God, the vaccination is a challenge toward heaven." While this text is often attributed to Leo XII, there is no official record of the comment. An article by Keefe attempts to track the origin of the statement. It concludes that Pope Leo XII did not say this, but that it could at the most represent his views when he was a cardinal.

Since this time there have been many affirmations from the Vatican supporting vaccination and the development of new vaccines to combat the consequences suffered from many infectious diseases.

Vaccines

Vaccines are produced from either a weakened or killed form of the infectious agent. When a person is vaccinated, an immune response occurs, similar to that which arises with natural infection. Thus, immunity to a disease is acquired without experiencing the disease. Viruses for viral vaccines can be grown in a selection of cell lines. These can be Vero cells (derived from adult African green monkeys), or MRC5 and WI-38 cells (human diploid cell lines). The yolk sac or the allantoic cavity of chicken eggs can also be utilised for viral growth for vaccine production.

Vaccines available in New Zealand

Medsafe (New Zealand Medicines and Medical Devices Safety Authority) is responsible for the regulation of vaccines (and other medical needs). Through the examination of the globally available data they ensure that approved vaccines are safe for use by the New Zealand population. Vaccines are assessed in view of a risk-benefit balance to the population.

In 2011, the New Zealand government provided funding for eleven different childhood vaccines. Additionally, the influenza vaccine is provided to those aged sixty-five and over. New Zealand's level of immunisation has been described as 'mediocre'. Grant et al suggest that in New Zealand structural and organisational issues in a general practice setting could affect immunisation delivery. New Zealand does not have compulsory vaccination.

McIntyre et al suggest that in a pluralistic society compulsory vaccination is not an option. Vaccines fulfil the ethical criteria of a preventative measure in children. Justice and charity call parents to provide the best possible care for their child.

People also dissent against vaccination for different reasons. One of the major concerns is vaccine safety. The risks need to be weighed up against the benefits, and the risk of an adverse event is often much smaller than the health risks associated with the disease.

The use of animal products in vaccine production may influence whether vegans and vegetarians may vaccinate. Those of Muslim or Jewish faith may avoid products that include a pork derivative. Some Catholics have raised concerns regarding vaccines produced from viruses cultured on cell lines that were derived from foetuses aborted during the 1960s. They are concerned that by using these vaccines they could be complicit in co-operation with the original abortion from which the cell lines were derived.

Ethically compromised vaccines

Of the eleven vaccines that are part of the New Zealand childhood immunisation schedule only two vaccines fall into the ethically compromised category. They are: the rubella vaccine (part of the measles, mumps, rubella vaccine), as well as vaccines that contain polioviruses grown in human diploid cells as opposed to Vero cells. Other vaccines not on the New Zealand immunisation schedule that are classified as ethically compromised are: chicken pox, zoster (shingles), Hepatitis A, and the rabies vaccine.

Ethically compromised vaccines are cultured in cell lines known as human diploid cells. The most commonly utilised cell lines are, WI-38 (Wistar Institute) and MRC-5 (Medical Research Council). WI-38 was derived from lung tissue from a three month gestation foetus in 1964. Swedish parents who felt they had too many children, chose to abort the child. The MRC-5 cell line was derived from the normal lung tissue of a fourteen-week-old foetus that was aborted in 1966. This abortion from a twenty-seven-year-old mother was for 'psychiatric reasons.' Stocks of cells are not replenished from repeated abortions.

The rubella virus strain RA27/3 routinely used in the rubella vaccine was cultured from foetal tissue from an aborted foetus during the 1964 epidemic. The mother was exposed to rubella during the early stages of pregnancy. Pruss notes that by using RA27/3, use is not made of foetal tissue but only of a virus which had invaded the foetus. He argues that the continued use of RA 27/3 is therefore more easily justified than the continued use of the cell lines derived from foetal tissue. As he observes, "It is not the body that is used, but the body's enemy."

The history of the rubella vaccine provides an insight into the use of RA27/3 and human diploid cells. In 1969 and 1970 when rubella vaccines were first licensed around the world, the USA decided to licence vaccines developed using animal cell lines and other strains of the rubella virus. A number of problems gradually emerged. Vaccines developed using duck embryo and dog kidney strains caused significant joint reactions. Some people vaccinated with virus strains other than RA 27/3 when exposed to wild rubella virus became infected, while others vaccinated with strain RA 27/3 when exposed to wild rubella virus, did not exhibit symptoms of rubella infection. Europe had licensed the vaccine developed with RA 27/3 and the vaccine showed a respectable safety record. Thus, the USA decided that it would be preferable to use the rubella vaccine developed from RA 27/3.

The Vatican statement on ethically compromised vaccines

In June 2003, an American organisation called the Children of God for Life wrote to the Vatican seeking advice about ethically compromised vaccines. In June 2005, they received a response from the Pontifical Academy for Life. The then-President of the Pontifical Academy for Life, then-Bishop (now Cardinal) Elio Sgreccia noted in a cover letter that this statement had been approved by the Congregation for the Doctrine of the Faith.

To examine this issue, the statement draws upon an important Catholic principle, the Principle of Cooperation in Wrongdoing. When it considers the "doctors or parents who resort to these vaccines for their children," the statement provides four conclusions:

Firstly, when a choice exists between an ethically compromised vaccine and another vaccine which is not ethically compromised, the Pontifical Academy states that we have a "grave responsibility" to use the vaccine which is not ethically compromised. At the same time, however, the statement also recognises that there might be obstacles to doing this because "grave forms of allergy" have occurred with some of the uncompromised vaccines. If the risk of allergic reactions raises serious concerns, the duty to use uncompromised vaccines may cease.

Secondly, when no ethically acceptable alternative vaccines exist, doctors and families have a duty of "putting pressure on the political authorities and health systems so that other vaccines without moral problems become available." We should do this "by all means (in writing, through the various associations, mass media, etc.)."

Thirdly, as regards those ethically compromised vaccines without an acceptable alternative, "it is right to abstain from using these vaccines if it can be done without causing children, and indirectly the population as a whole, to undergo significant risks to their health." This might be possible, for example, if a vaccine offered protection only against a not very serious condition. It is not really possible if a vaccine protects against a serious condition.

Finally, if a failure to vaccinate exposes children and the general population to "considerable dangers to their health, vaccines with moral problems pertaining to them may also be used on a temporary basis." In these situations, the Pontifical Academy finds that there is a "proportional reason, in order to accept the use of these vaccines in the presence of the danger of favouring the spread of the pathological agent, due to the lack of vaccination of children."

In footnote 16, the statement notes that rubella causes "grave congenital malformations in the foetus, when a pregnant woman enters into contact, even if it is brief, with children who have not been immunized and are carriers of the virus." It makes the chilling observation that "in this case, the parents who did not accept the vaccination of their own children become responsible for the malformations in question." Indeed, if some women in this situation decide to abort, the Pontifical Academy even states that the parents whose unvaccinated children carried this infection bear some moral responsibility for these abortions. All things considered, then, even allowing for the current need to use ethically compromised vaccines, vaccination against rubella and other serious diseases truly is the more pro-life decision.

Herd immunity

Herd immunity is when a significant proportion of a population (or 'herd') are vaccinated. Their presence provides a measure of protection for individuals who are not vaccinated or who have not developed immunity, even after vaccination or exposure to natural infection. Based on such variables as the virulence of the disease, scientists have calculated herd immunity thresholds for various diseases. This is the proportion of the population who must be disease-resistant in order to effectively prevent the persistence of that disease within that population. For example, rubella cannot persist within a community in which 80-85% of the population are disease-resistant. By contrast, pertussis (whooping cough) is more infectious, and its herd immunity threshold is 92-94%. Herd immunity can provide some protection for infants who are too young to be vaccinated, pregnant women, immunocompromised individuals and people with various medical conditions who cannot always be vaccinated.

By contributing to herd immunity, the decision to vaccinate is also a contribution to the common good of society. Vaccination benefits society as a whole and particularly benefits those vulnerable individuals who must rely on herd immunity for some measure of protection against disease. In contrast to those who contribute to the common good through vaccination, those who do not vaccinate benefit from herd immunity without contributing to it. Grabenstein reports that for this reason sociologists refer to those who do not vaccinate as "free-riders" or "free-loaders." He adds that "such behaviour" is "inequitable and uncharitable." Further, "if enough people 'free-load,' then the community's collective immunity dissipates and disease outbreaks resume."

However, herd immunity has its limitations. Herd immunity can be weakened if the numbers of those who do not vaccinate grow. A further problem is the 'clustering of exemptions.' This means that those who do not vaccinate often congregate together in the same reasonably small geographic area, compromising herd immunity. Bliss provides a poignant historical example with his examination of the smallpox outbreak in Montreal in 1885, when some French Catholics refused vaccination.

Conclusion

The Catholic Church does not dismiss the problem of ethically compromised vaccines. To the contrary, it calls for research and development of alternative, ethically acceptable vaccines. It also exhorts all people including parents to join in this call. However, until alternative vaccines are developed, it also accepts the use even of these ethically compromised vaccines in order to protect children, pregnant women, and the population as a whole from the risk of contracting serious disease. The teaching of the Catholic Church provides no support for the refusal of vaccination against serious disease, even if the only available vaccines are ethically compromised.

Rev Kevin McGovern is a priest of the Rockhampton Diocese, Australia. Since 2007 he has been Director of the Chisholm Centre for Health Ethics in Melbourne.

Mrs Kerri Anne Brussen has a background in science with over 20 years in various laboratories. Her recent studies in theology provide a background to the intersection of science with Church teaching.

Richard A. McCormick, Health and Medicine in the Catholic Tradition (New York: Crossroad, 1987), 17.

Donald J. Keefe, "Tracking a Footnote," Fellowship of Catholic Scholars 9, no. 4 (1986): 6-7 at 7. Keefe's article details how an unsourced footnote and unsubstantiated comments can lead to inaccuracies in the historical record. Atkin and Tallett suggest that Pope Leo XII left vaccination as an optional practice, and that some priests at the time did see it as interfering with the natural processes of the body. For this, see Nicholas Atkin and Frank Tallett, Priests, Prelates & People: A History of European Catholicism since 1750 (New York: I.B. Tauris & Co., 2003), 103.

Sanofi Pasteur; GlaxoSmithKline; American Type Culture Collection

Ministry of Health, "Medsafe (New Zealand Medicines and Medical Devices Safety Authority)," New Zealand Government, http://medsafe.govt.nz/

Cameron C Grant et al., "Factors associated with immunisation coverage and timeliness in New Zealand," British Journal of General Practice 60, no. 572 (Mar 2010): 113-20 at 113.

Peter B. McIntyre, Alison H. Williams, and Julie E. Leask, "Refusal of parents to vaccinate: dereliction of duty or legitimate personal choice?" Medical Journal of Australia 178, no. 4 (2003): 150-151 at 150.

The frequently asked questions page of the New Zealand Immunisation Advisory Centre website has comprehensive and succint responses to most fears that parents have regarding immunisation. http://www.immune.org.nz/frequently-asked-questions

Barbara E. Eldred et al, "Vaccine components and constituents: responding to consumer concerns," Medical Journal of Australia 184, no. 4 (2006): 170-5 at 173.

Pontifical Academy for Life, "Moral Reflections on Vaccines Prepared from Cells Derived from Aborted Human Fetuses," The National Catholic Bioethics Quarterly 6, no. 3 (2006): 541-550 at 543.(NCBQ) The statement is also available at Children of God for Life (CGL), http://www.cogforlife.org/vaticanresponse.pdf. The two records of the statement differ in that the third footnote in the NCBQ version is missing from the CGL version. As a result, all subsequent footnotes are numbered differently. In this article, we cite the NCBQ version.

Rene Leiva, "A Brief History of Human Diploid Cell Strains," The National Catholic Bioethic Quarterly 6, no. 3 (2006): 443-451 at 445; Pontifical Academy for Life, 542-3

Stanley A. Plotkin, "The History of Rubella and Rubella Vaccination Leading to Elimination," Clinical Infectious Diseases 43, Suppl 3 (2006): S165-6;

Alexander R. Pruss, "Complicity, Fetal Tissue, and Vaccines," The National Catholic Bioethics Quarterly 6, no. 3 (2006): 461-470 at 465.

Plotkin, S165-6.

Pontifical Academy for Life.

Ibid., 547-548. This teaching is repeated in the Congregation for the Doctrine of the Faith's most recent statement on bioethics, which states that "danger to the health of children could permit parents to use a vaccine which was developed using cells of illicit origin, while keeping in mind that everyone has a duty to make known their disagreement and to ask that their healthcare system make other types of vaccine available." For this, see Congregation for the Doctrine of the Faith, Instruction on Certain Bioethical Questions (Dignitas Personae), #35, Holy See, http://www.vatican.va/roman_curia/congregations/cfaith/documents/rc_con_cfaith_doc_20081208_dignitas-personae_en.html

For a useful diagrammatic explanation of herd immunity, see (US) National Institute of Allergy and Infectious Diseases (NIAID), "Community Immunity ('Herd' Immunity), NIAID, http://www.niaid.nih.gov/topics/pages/communityimmunity.aspx

John D. Grabenstein, "The Value of Immunization for God's People," National Catholic Bioethics Quarterly 6, no. 3 (2006): 433-442 at 436-437.

Michael Bliss, The Making of Modern Medicine - The Turning Points in the Treatment of Disease (Chicago: University of Chicago Press, 2011), 22-30.

Eugenics, past and future

Ross Douthat

THE current issue of the Yale Alumni Magazine includes a portrait of Irving Fisher, a Yale economics professor in the 1920s and ’30s and a giant of his field. The author, Richard Conniff, takes note of Fisher’s prodigious professional accomplishments and his private decency in order to foreground the real subject of his article: the economist’s role as one of his era’s highest-wattage proponents of eugenics.

The American elite’s pre-World War II commitment to breeding out the “unfit” — defined variously as racial minorities, low-I.Q. whites, the mentally and physically handicapped, and the criminally inclined — is a story that defies easy stereotypes about progress and enlightenment. On the one hand, these American eugenicists tended to be WASP grandees like Fisher — ivory-tower dwellers and privileged have-mores with an obvious incentive to invent spurious theories to justify their own position.

But these same eugenicists were often political and social liberals — advocates of social reform, partisans of science, critics of stasis and reaction. “They weren’t sinister characters out of some darkly lighted noir film about Nazi sympathizers,” Conniff writes of Fisher and his peers, “but environmentalists, peace activists, fitness buffs, healthy-living enthusiasts, inventors and family men.” From Teddy Roosevelt to the Planned Parenthood founder Margaret Sanger, fears about “race suicide” and “human weeds” were common among self-conscious progressives, who saw the quest for a better gene pool as of a piece with their broader dream of human advancement.

This progressive fascination with eugenics largely ended with World War II and the horrors wrought by National Socialism. But while the West has discarded the theory of the eugenics era, the practice urged by Fisher and others — the elimination or pre-emption, through careful reproductive planning, of the weaker members of the human species — has become a more realistic possibility than it ever was in the 1920s and ’30s.

The eugenicists had very general ideas about genetics and heredity, very crude ideas about intelligence, and deeply poisonous ideas about racial hierarchies. They did not have, as we do, access to the genetic blueprints of individuals — including, most important, human beings still developing in utero, whose development can be legally interrupted by the intervention of an abortionist.

That access, until recently, has required invasive procedures like amniocentesis. But last week brought a remarkable breakthrough: a team of scientists mapped nearly an entire fetal genome using blood from the mother and saliva from the father. The procedure costs tens of thousands of dollars today, but the price will surely fall. And it promises access to a wealth of information about the fetus’s biology and future prospects - information that carries obvious blessings, but also obvious temptations.

Thanks to examples like Irving Fisher, we know what the elites of a bygone era would have done with that kind of information: they would have empowered the state (and the medical establishment) to determine which fetal lives should be carried to term, and which should be culled for the good of the population as a whole. That scenario is all but unimaginable in today’s political climate. But given our society’s track record with prenatal testing for Down syndrome, we also have a pretty good idea of what individuals and couples will do with comprehensive information about their unborn child’s potential prospects. In 90 per cent of cases, a positive test for Down syndrome leads to an abortion. It is hard to imagine that more expansive knowledge won’t lead to similar forms of prenatal selection on an ever-more-significant scale.

Is this sort of “liberal eugenics,” in which the agents of reproductive selection are parents rather than the state, entirely different from the eugenics of Fisher’s era, which forced sterilization on unwilling men and women? Like so many of our debates about reproductive ethics, that question hinges on what one thinks about the moral status of the fetus. From a rigorously pro-choice perspective, the in utero phase is a space in human development where disease and disability can be eradicated, and our impulse toward perfection given ever-freer rein, without necessarily doing any violence to human dignity and human rights.

But this is a convenient perspective for our civilization to take. Having left behind pseudoscientific racial theories, it’s easy for us to look back and pass judgment on yesterday’s eugenicists. It’s harder to acknowledge what we have in common with them. First, a relentless desire for mastery and control, not only over our own lives but over the very marrow and sinew of generations yet unborn. And second, a belief in our own fundamental goodness, no matter to what ends our mastery is turned.

This article first appeared in the New York Times on 9 June 2012.

Reprinted with permission.

©2012 The New York Times

(Distributed by The New York Times Syndicate)

Ethically Compromised Vaccines in New Zealand

Kerri Anne Brussen and Kevin McGovern

Ethically compromised vaccines are vaccines where the virus used in the manufacture of the vaccine has been cultured in a cell line developed from tissue grown from an aborted foetus. In New Zealand, an ethically compromised vaccine is the only vaccine available for Chicken pox (varicella), shingles (zoster), Hepatitis A, and rubella (which is part of the MMR - measles, mumps, rubella - vaccine). The poliovirus vaccine component of Quadracel, and Poliacel, is ethically compromised. However, there are a number of ethically uncompromised vaccines approved for use where the  poliovirus component is grown in African green monkey kidney cells (Vero). The rabies vaccine, Verorab, is not as ethically compromised and is the preferred option to Mérieux Inactivated Rabies Vaccine (MIRV) which is an ethically compromised vaccine. This article lists the ethically compromised vaccines available in New Zealand, and explains why they are ethically compromised. It also explains when and why vaccination should still be accepted even when the only available vaccine is ethically compromised.

Medsafe (New Zealand Medicines and Medical Devices Safety Authority) is responsible for the regulation of vaccines (and other medical needs). Through the examination of the globally available data they ensure that approved vaccines are safe for use by the New Zealand population. Vaccines are assessed in view of a risk balance benefit to the population.[i]

Immunisation against rubella and the polioviruses are part of the New Zealand immunisation schedule. Chicken pox, Hepatitis A and rabies although not part of the immunisation scheme have vaccines approved for use in New Zealand as these vaccines may need to be administered for protection against an occupational health risk or to prevent a health risk whilst travelling outside New Zealand.

Ethically compromised vaccine production

The virus used in the production of some vaccines is cultured in cell lines known as human diploid cells. These cells lines were originally developed from tissue from an aborted foetus. Vaccines are ethically compromised by this connection to abortion. The most commonly utilised cell lines are WI-38 (Wistar Institute) and MRC-5 (Medical Research Council).[ii]

WI-38 was derived from lung tissue from a three month gestation foetus in 1964.^[iii] The parents, living in Stockholm, chose to abort the child as they felt that they had too many children.^[iv] The MRC-5 cell line was derived from the normal lung tissue of a fourteen-week-old foetus that was aborted in 1966. This abortion from a twenty-seven-year-old mother was for ‘psychiatric reasons.’^[v] Stocks of cells are not replenished from repeated abortions.[vi]

Pontifical Academy for Life – Moral Reflections on Vaccines

In 2005, the Pontifical Academy for Life issued Moral Reflections on Vaccines Prepared from Cells Derived from Aborted Human Foetuses. Drawing upon the Catholic principle of cooperation in wrongdoing, this statement reaches three important conclusions. First, when a choice exists between one vaccine which is ethically compromised and another vaccine which is not ethically compromised, the Pontifical Academy states that we have a “grave responsibility” to use the vaccine which is not ethically compromised. Second, when only ethically compromised vaccines are available, the Academy calls on health professionals and health consumers alike to put “pressure on the political authorities and health systems so that other vaccines without moral problems become available.” Finally, until ethically uncompromised vaccines are developed, the Pontifical Academy for Life supports the use of even these ethically compromised vaccines so as to prevent serious health risks particularly for children and pregnant women.[vii]

Ethically Compromised Vaccines Available in New Zealand[viii]

Rubella

The rubella vaccine which is given as part of the combined MMR (mumps measles and rubella) vaccine and which is administered at fifteen months and four years is an ethically compromised vaccine. The virus for the vaccine is cultured in a human diploid cell line.[ix] Rubella is a highly contagious disease with transmission between people occurring through respiratory secretions. In developed countries the average number of transmissions from a single case of rubella is between three and eight. The ready transmission of rubella means it is very difficult to avoid the infection in pregnant women. Further if a pregnant woman is infected, the risk of infection of her unborn baby is very high (about 95%). Congenital rubella syndrome involves serious consequences for the unborn child, including congenital heart disease, cataracts and deafness, along with other problems.[x]

Vaccines manufactured with viruses cultured in non-human cell lines have not proved to be as effective or safe as the ethically compromised vaccines against rubella.[xi] Due to the serious health risks which would otherwise be faced by children, pregnant women and particularly the unborn children of pregnant women, the Pontifical Academy for Life encourages vaccination with rubella vaccine even though this vaccine is ethically compromised.^[xii]

Polio

Vaccination against polio is often carried out in combination with other childhood vaccines at six weeks, three and five months. A booster is given at four years of age.

There are a number of poliovirus vaccines approved for use in New Zealand that are considered ethically uncompromised. The polioviruses component of the Infanrix hexa/penta or Infanrix-IPV, and Boostrix-IPV all distributed by GlaxoSmithKline are grown in Vero cells, as are the polioviruses component in the Sanofi Pasteur vaccines, IPOL, Adacel Polio and Pediacel. However, the Sanofi Pasteur vaccines, Quadracel, and Poliacel contain polioviruses that have been cultured in the human diploid cell line, MRC-5. Thus, Quadracel and Poliacel are considered ethically compromised.Like Infanrix-IPV Quadracel vaccinates against diphtheria, tetanus, pertussis and the polioviruses. Infanrix –IPV can replace Quadracel and is not an ethically compromised vaccine.[xiii]

Although polio has been eradicated from all but three countries globally, vaccination must continue until global eradication and cessation of vaccination is declared.^[xiv] Poliovirus is spread by the faecal oral route and travellers must be re-vaccinated if travelling to an endemic country if they have not been vaccinated in the previous ten years. Previous generations remember the devastation of polio epidemics which are now essentially unheard of today. One in 200 infections leads to irreversible paralysis, usually in the legs.More extensive paralysiscan result in quadriplegia and in the most severe cases, bulbar polio, where the poliovirus attacks the nerve cells of the brain stem, reducing breathing capacity. Among those paralysed, 5% to 10% die when their breathing muscles become immobilized. Around 40% of people who survive paralytic polio may develop post-polio syndrome 15–40 years after the original illness.[xv]

Although there are a number of ethically compromised poliovirus vaccines available in New Zealand they are not routinely offered as part of the immunisation schedule. Infanrix-hexa and Boostrix-IPV which are not ethically compromised, are the two vaccines listed on the New Zealand immunisation schedule, thus the issue of being offered vaccination with an ethically compromised poliovirus vaccine is unlikely. However, if you are seeking to vaccinate with a poliovirus vaccine that is not on the schedule check the information available from the manufacturer to ascertain the cell line that the polioviruses were cultured in for the production of the vaccine. If the cell line is a human diploid cell line, an alternative ethically uncompromised vaccine should be accessed where possible.

Chicken Pox (Varicella) and Shingles (Zoster)

Varicella (chicken pox) vaccine is not part of the routine immunisation schedule in New Zealand, however it is recommended for children aged 12 months to 12 years.[xvi] McCartney and Burgess suggest that cost and the concern of adding another injection to the immunisation schedule have influenced the decision not to include chicken pox on the immunisation schedule in New Zealand.[xvii]

Varicella and zoster vaccines (combined or individual) approved for use in New Zealand are considered ethically compromised as part of the production process for the vaccines includes culturing in a human diploid cell line.[xviii] The potential for a latent infection^[xix] with varicella virus meant that much caution was taken during the development and trialling of the varicella vaccines as it had to be not only efficacious but also safe.^[xx]

Chicken pox is often thought of as a mild childhood infection, often more of an inconvenience. However, a varicella infection in a pregnant woman can be as devastating as a rubella infection. Intrauterine infection may cause a spontaneous abortion, premature delivery or stillbirth.^[xxi] Features of congenital varicella syndrome (CSV) may include: limb hypoplasia, neurological abnormalities, ocular anomalies, and low birth weight. Intrauterine or early postnatal infection can cause neonatal varicella infection. Infection manifested within five days before or two days after delivery is serious as it may become disseminated and a 20% mortality rate has been reported.^[xxii] Infection with varicella can also be more severe in adults than in children.[xxiii] The Pontifical Academy’s statement supported vaccination against rubella because of the serious health risks which would otherwise be faced by children, pregnant women and particularly unborn children. The same conclusion applies to chicken pox: it is recommended that immunisation with the varicella vaccine is undertaken even though this vaccine is ethically compromised.

Zoster (shingles) vaccination is recommended for persons in the 60-79 year old age group. Zoster vaccination is estimated to prevent up to 50% of the cases of shingles (re-activation of the chicken pox virus in later life), and two-thirds of post-herpetic neuralgia (damage to the nerves after an outbreak of shingles) in this age group. If shingles does occur, then the duration of the episode and the severity of the pain are diminished by up to 60% if a person has received the zoster vaccination. The risk for transmission of zoster to household contacts is approximately 15.5%.[xxiv] The need to be vaccinated with zoster should be discussed with a medical practitioner. Some people may decide to abstain from this ethically compromised vaccine if they can do so without posing a serious threat either to their own health or to the health of others.

Hepatitis A

Hepatitis A vaccine is not part of the New Zealand immunisation schedule. In New Zealand, Hepatitis A vaccination is recommended for chronic carriers of Hepatitis B and C, people with chronic liver disease and certain occupational groups particularly those that could be exposed to faecal material.[xxv]

Due to the difficulty in culturing and obtaining high yields of the Hepatitis A virus, vaccine production for Hepatitis A was modelled on the practice of producing vaccines in human diploid cell lines.[xxvi] Hepatitis A vaccines, are therefore ethically compromised as the virus is cultured in MRC-5 for vaccine production.[xxvii] The current vaccine has an almost 100% efficacy, which means that research into this virus is now a low priority and therefore does not attract the levels of funding of other Hepatitis viruses.[xxviii]

Hepatitis A is usually spread via the faecal-oral route, and transmission by an infected person to others in the home occurs easily. An infection with Hepatitis A can often result in hospitalisation. The death rate is approximately 3-6 deaths per 1,000 cases.[xxix]

Thus, immunisation with Hepatitis A vaccine is to be encouraged in circumstances where it is needed, and if travel is undertaken to an area of high prevalence or poor sanitation.

Rabies

The Rabies vaccine (Mérieux Inactivated Rabies Vaccine (MIRV)) manufactured by Sanofi Pasteur Pty Ltd is an ethically compromised vaccine grown in human diploid cells.[xxx] The rabies vaccine, Verorab manufactured by Sanofi-Pasteur is cultured on the Vero cell line. However, the initial culturing of the virus was in WI-38.[xxxi]

As death is always the outcome from a bite or scratch from an infectious animal, then vaccination with rabies vaccine should be encouraged for travellers who will be spending prolonged periods (i.e. more than one month) in rural areas of rabies endemic regions. Although the rabies virus used in the production of the Verorab vaccine was initially cultured on a human diploid cell the vaccine is manufactured using Vero cell line, thus it is considered the less ethically compromised of the two approved rabies vaccines in New Zealand and should be sourced and used if rabies vaccine is required. In the event of exposure to rabies, vaccination should never be refused even if only an ethically compromised vaccine is the only vaccine available.

Rabipur Inactivated Rabies Virus Vaccine, manufactured by CSL Biotherapies/Novartis Vaccines is available in Australia and is manufactured from virus grown in purified chick embryo cell. Thus, it is not ethically compromised.[xxxii] This vaccine is not available in New Zealand; however, re-evaluation of the available vaccines for rabies could consider the approval of Rabipur to provide an ethically uncompromised choice when providing rabies vaccination.[xxxiii]

Conclusion

In the statement of the Pontifical Academy for Life, the Catholic Church calls for the development of ethically uncompromised vaccines. Until such vaccines are available, however, the Church encourages vaccination to protect the general population and especially children, pregnant women and unborn children from serious health risks. Vaccination is a contribution to the best possible health care and wellbeing for all in our community.

The information in this article is subject to change as immunisation schedules may vary and alternative vaccines may be introduced. To check whether a vaccine is ethically compromised, consult the vaccine manufacturers’ product description. This should include the cell line or method of culturing of the virus in the vaccine. Any vaccine that is cultured in human diploid cells, most often MRC-5 or WI-38, or in a cell line described as human embryonic is ethically compromised.

Summary of Recommendations

Rev Kevin McGovern is a priest of the Rockhampton Diocese, Australia. Since 2007 he has been Director of the Chisholm Centre for Health Ethics in Melbourne.

Mrs Kerri Anne Brussen has a background in science with over 20 years in various laboratories. Her recent studies in theology provide a background to the intersection of science with Church teaching.

Compassionate nevertheless – in praise of reluctant caregivers

Michael McCabe

Jesus said, “What do you think? A man had two sons. He went to the first and said, ‘Son, go and work today in the vineyard.’ His son answered, ‘certainly sir’, but did not go. He then went to the second son and said the same. But he answered, ‘I will not go.’ But later he thought better of it and went. Now which of these two did his father’s will? They answered, ‘the second son.’ (Matthew 21:28-32)

The parable of the two sons in Matthew’s gospel has similarities to the more familiar story in Luke’s gospel of the forgiving father. Although that parable is more commonly known as the story of the prodigal son, it is also a story about a reluctant caregiver – an older brother who stays at home, duty-bound to do the right thing, but completely consumed by anger and regret. In the Matthean parable the second son is up-front about his reluctance, “I will not go,” but does not let this fact preclude his helping out his father. Though reluctant, his presence makes a difference in the vineyard.

The reluctant caregiver referred to by Paula Span focuses her attention on the needs of her frail mother-in-law. There is a heroic quality about her care precisely because it is focused on the other rather than on the self. She may well be reluctant but she is actively involved in caring for her mother-in-law.

Contrast that with the jarring image of the retirement village resident who was dead for two weeks in his apartment before being found, or another man dead for a month in his housing complex all the while surrounded by neighbours. What might their story have been with the presence of a caregiver in their lives, even a reluctant one?

Illness and infirmity provides a backdrop where old wounds and unresolved conflicts return. These may or may not find a place of equipoise so that differences on many levels remain. Chronic illness, such as dementia or Alzheimer’s disease, not only destroys existing relationships but also possibilities for relationships that never existed or relationships that were defective and impoverished. Consequently, possibilities for mutual reconciliation become increasingly one-dimensional as the health of a family member slowly or radically diminishes. Even so, a focus on what is best for the patient can help find a way through this real sense of loss and disappointment, notwithstanding the pitfalls of paternalism or abandonment.

Much of ministry involves reaching out to the needs of the other from a position of having similar needs oneself. For example: the single woman at the heart of a parish or school community who is known for her wonderfully welcoming hospitality to the stranger or migrant, but who returns home to a lonely and solitary life; or the grandmother who spends her Sundays taking communion to the housebound and who has become an accepted part of these parishioners’ families even though she is denied access to her own grandchildren and has not seen them for several years; or the grandparents helping raise their grandchildren as well as caring for their own frail and aged parents. As one such person said to me recently, ‘when we got married 40 years ago this was not the retirement lifestyle we imagined we would one day be living!’

All of these caregivers, though reluctant to a greater or lesser degree, have the reach of compassion. This quality is easily lost, or at least under threat, when care of the vulnerable is commodified and commercialised or when communities and families become increasingly fragmented and isolated.

All caregivers minister out of their need and relational poverty but, by responding to real needs, they are helping to build communities of grounded faith and lived compassion. While they may well be reluctant and wounded healers, they are ministering nevertheless. To a greater or lesser degree the reluctant wounded caregiver dwells in every one of us highlighting our need to show gratitude for the wounded healers in our midst.

Simply put, all carers need to be reminded of the good that they do. Even when reluctant their kindness is a form of blessing, at a personal and communal level, as the late John O’ Donohue observes in his book Benedictus [2007:219]:

‘Perhaps we bless each other all the time, without even realizing it. When we show compassion or kindness to another, we are setting blessing in train. There is a way in which an act of kindness done becomes an independent luminous thing, a kind of jewel-box of light that might conceal itself for days or years until one day, when you are in desperate straits, you notice something on the floor at your feet. You reach for it and discover exactly the courage and vision for which you desperately hunger.’

Father Michael McCabe is Parish Priest of Our Lady of Kāpiti Parish, Te Whaea o Kāpiti.

The reluctant caregiver - a challenge for society

Anna Holmes

There is a paradox about caring – caring is supposed to arise out of compassion or a universal love of others but often is done out of a sense of duty. Paula Span writes well in “The Reluctant Caregiver” about care done out of duty not affection. Reluctant caregivers may be family, friends or neighbours as well as professional carers. Thanking a reluctant caregiver can make them feel ashamed because care is done from a sense of duty rather than compassion. I wonder if reluctant caregivers are compassionate and do not recognise it. Caring as a moral obligation can still be compassionate.

In New Zealand the numbers of those aged over 65 years will double to more than a quarter of the population over the next 50 years and the demand for caring will also increase. Technology will help with practical issues. There are already mobile apps that send messages to remind people to take their medications, or remind them to eat, or attend appointments. There are even small robots that can follow patients around and call for help when required.  However, these cannot meet the human need for connection and community.

There are various cultural and social dynamics at work that are making the provision of compassionate care more difficult. When visiting a rest home recently I asked some of the residents what had changed in New Zealand society since their youth. They replied: “There’s been a loss of community.”  “People are less caring now.” “It’s all the divorces and people living together so relationships don’t last.” “Families don’t live in the same place anymore.” “Our children are so busy with work and their families they haven’t time to see us.”

To these I would add the necessary increase in numbers of women working, the increased cost of education and training, smaller families and increased economic constraints around the help available to the frail. Regional health authorities reduce available funding for care in the community because funding complex technological medical care is seen as more important as it can be measured against ‘health targets’.

Over the past century, respect for the elderly has diminished in European societies. Various factors fuel a growing sense of ageism in these societies, particularly a shift towards individualism and materialism. Along with this is a lack of ethical reflection in policy. This results in older people being seen as consumers of goods without being contributors. It is as if the work, taxes, love and caring that they have contributed to society in the past has no value. It is not surprising that more elderly people consider themselves a burden.

As the number of elderly people increases, more New Zealanders who can afford it choose to live in retirement villages, which offer care at a price. They cannot provide the hope and connection of a multi-aged community and life often feels meaningless. They all too easily become ghettoes distanced from the rest of society. There is an urgent need to rediscover the place of elders as useful, contributing members of society.  A number of recent studies have shown that volunteering and being connected are important factors in health and longevity. [1] The problem is how to connect a fragmented society into an organic whole.

It is ironical that ‘undeveloped’ societies are better at this. A Tanzanian woman, speaking to medical students said Tanzanian children have a duty to care for their parents, including sharing any money with them. The old are treated with great respect and honour for they are the living history of the people. They help where they can and are not seen as, and nor do they feel themselves to be, a burden. They carry the wisdom and tell the story of the community. This is also the traditional way kaumatua are regarded and treated in Maori communities.

In 48 years of medical practice I have seen far more compassionate caregivers than reluctant ones. There is a clear duty to ensure that any ‘reluctance’ caregivers experience is not exacerbated by a lack of physical, emotional, spiritual or economic support. As a start, how about a care giving allowance that is adequate to maintain family income? 

As a society we have a responsibility to ensure the weakest and most needy have good care and support. If we fail to do this it will not be surprising that the elderly and frail feel they are an unwanted burden and might be tempted or coerced to seek death rather than life.

Dr Anna Holmes has recently completed a PhD on Embracing the paradox : Spirituality in General Practice . She is a Clinical Senior Lecturer, Department of General Practice, University of Otago. Over the past 48 years she has practised medicine in student health, rural practice, as a medical manager in the regional health authority, and in palliative care. Her experience includes work in a number of different cultures.

The reluctant caregiver

New York Times columnist Paula Span uses the term 'reluctant caregiver' to describe people who continue to care for someone even when they do it grudgingly. She concludes that reluctant caregivers probably deserve more credit than most, because they are not getting back the warmth, laughter, tenderness or sometimes even gratitude that others do, while they keep on doing the tough work.

Available online at: http://newoldage.blogs.nytimes.com/2013/02/20/the-reluctant-caregiver/?_r=0

Ethical challenges in advance care planning

A Submission to the National Ethics Advisory Committee

In New Zealand the National Ethics Advisory Committee (NEAC) has developed a draft consultation document exploring the ethical challenges in advance care planning encountered by health professionals. The intention of the consultation document was to further explore these challenges. The Nathaniel Centre responded with a submission to NEAC, which is summarised here.
For further information on advance care planning readers are invited to read the article "The Last Word: The Catholic case for advanced directives", in Issue 35 of The Nathaniel Report.

Introductory comments
We strongly support the broad concept of advance care planning understood as "a voluntary process of discussion and shared planning for future health care" (NEAC Draft for Consultation, p.2) . We acknowledge that healthcare professionals are an integral part of the process of creating an effective advance care plan, but we believe that the document takes an overly narrow approach to the issue by defining it as essentially a process "between a person and health professionals" (p.2).
We advocate a broader understanding of advanced care planning and wish that the long term New Zealand strategy encourage persons to reflect on decisions about care and treatment at the end of life before they become chronically ill. As Daniel Sulmasy notes: "There is almost a moral imperative for people, realising that they very well might die in a state of mental incapacity and aware that each is the judge of his or her own limits, to execute advance directives in order to assist those who will make decisions for them." At the same time we recognise that advance care plans are not a panacea for the complexity of end-of-life decisions.
The process of planning for future health care should not be limited to a discussion between a person and their key health professional. This assumption reflects a particular western cultural perspective which gives undue emphasis to the person as an autonomous rational individual rather than an interconnected and interdependent person who is part of a community. Secondly, even within this perspective, we believe it is not best practice to adopt a process that centres advance care planning primarily on the person and their health professional. This can foster a fragmented approach to the care of the person, resting on a narrow view of health to the exclusion of other dimensions of well-being. We advocate taking a more holistic approach that includes addressing cultural, family and religious or spiritual needs.
Feedback on draft consultation
 The focus on the health professional reflects a too narrow view of health and well-being, and raises the potential for various conflicts of interest to arise. The health professional may exert significant influence over their patient and the direction that the planning takes; they are in a position of advising a person about the desirability or otherwise of refusing future treatments which they would otherwise be legally obliged to provide. They are, practically speaking, the 'gate-keepers' for precious and increasingly scarce health care resources.
 The practicalities of facilitating a thorough and ongoing robust process of advance care planning: Doctors work under extreme time pressures and fatigue and stress could easily affect the quality of the planning process. A good process requires space and time and therefore adequate resourcing. Lack of resourcing becomes a serious ethical issue.
 Involvement of family members or others in the process: There are times when people might need protection from their families' involvement. For a variety of reasons including their own feelings of inadequacy or an inability to provide care and support, family members might coerce the patient into a decision that they would not otherwise make. Aged Concern notes that 80 percent of elder abuse is carried out by families.
 There is only minimal reference to New Zealand's multicultural population. The premise of the draft consultation reflects largely Western individualistic notions of decision making which may not be viewed as appropriate by some people. In cultures where individuals are viewed as enveloped in connections to their families, communities, land and ancestors, the advance care planning approach as laid out in the draft consultation offers very limited arrangements and may even be an alienating experience. This will require much broader consultation and reflection.
 There are ethical issues generated by the confluence between personal choice and social and cultural context. All decisions are made in, and are shaped by, our context. In a society where the elderly are experiencing greater social isolation and where there is a view of the infirm and disabled as a 'burden' on family and society, a person's choice may reflect a societal notion that they have a moral responsibility to accept certain options, including limiting their care. This area also needs more reflection.
 The draft consultation notes the assumption of competence in the Code of Health and Disability Services Consumer's Rights. However, because of the particular vulnerability of certain patients (such as children and adults who may have diminished competence) who wish to formulate an advance care plan, there needs to be additional provision to ensure the full participation in the decision-making process of those deemed to be of 'diminished competence' or 'not competent'.
 We approve of advance care planning as "voluntary" but are concerned there is some evidence that such plans are being seen as a pre-requisite for acceptance into some aged care facilities (p.5). We strongly affirm the position that any decision by a person to decline to take part in care planning should not adversely affect the care and treatment they receive and that they should not be pressured or coerced into making or documenting advance decisions (p.7).
 We agree with the document's concern about placing too much emphasis on the 'plan' itself rather than the 'process' of planning. This could unwittingly lead to a minimalist 'tick box approach' as recently evidenced in the United Kingdom with the Liverpool Care Pathway.
 Advance care planning should be seen as an ongoing conversation and needs to be regularly reviewed and updated (p.4). The language used in this document and in promotional and educational material should reflect a focus on 'planning' rather than 'plans'. The terminology used needs greater consistency, clarity and precision.
 Our preferred approach to advance care planning is that a proxy be nominated by the patient, someone who knows the patient's values and wishes and with whom they have discussed their wishes on a regular basis. This typically results in an oral plan, or a combination of oral and written. We also favour a less-specific form of plan as discussed in the draft consultation (p.4). A person's preferences change as they cannot foresee how they might react to a particular situation, and a particular health-related experience can re-shape desires and preferences about care and treatment.
 We recognise the importance of health professionals being alerted to the existence of an advance care plan (p.11), whether written, oral or a combination, and the advance care planning process must take account of the fact that a plan may exist in any one of these forms. The existence of a plan on a data base must not become a substitute for ongoing discussion between the patient and/or family and health care team. An undue emphasis on gathering written advance care plans and storing them on a centralised database could militate against the need for flexibility and continuing review and discussion.
 We think it is particularly important to reflect on how the process of advance care planning could be integrated with the legal provisions for appointing an Enduring Power of Attorney
 Organ Donation: A strategy to implement advanced care planning that encourages persons to reflect on decisions about care and treatment before they become chronically ill provides an opportunity to prompt persons to reflect on their willingness, or otherwise, to become an organ donor. This may well assist in increasing the number of organ donations available.

Concluding Comments
We support encouraging persons to reflect on how their personal values shape the sort of care and treatment they want at the end of their life. We think it is critical that there is greater awareness of the context in which we live and which helps shape people's decisions and wishes. Without such reflection, advance care plans could unwittingly become a vehicle for imposing societal biases and prejudices about quality of life and the 'burdens of care' above authentic personal choice and the respect and care due to all persons by virtue of our dignity as humans.
We are concerned that the process of planning be broader than the person and their health professional and believe it is preferable for persons, having consulted with their health carers, to opt to give their loved ones or a significant 'other' substantial authority to interpret their wishes in whatever form they have been expressed. We advocate for health professionals to talk to a person who knows and has been selected by the patient rather than refer solely to paper or electronic records. However, the role of a 'proxy' also has its limits because patients frequently fail to discuss their preferences.
To conclude, we believe in a process that emphasises the ongoing nature of planning and review and that outlines specific directions rather than one that focuses on the completion of written plans that try to anticipate specific situations. This emphasis is also likely to be more inclusive of different cultural perspectives and values.
December 2013

Staff of The Nathaniel Centre