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Drug trials must not abuse peoples’ rights, European Bishops tell EU

26 May

Drugs trials necessary but must respect the vulnerable

Drugs trials are necessary before drugs come to market, but those conducting them have ethical duties to obtain consent and respect the rights of those from developing countries, says a statement on behalf of all Catholic Churches in the European Union.

COMECE, the Commission of the Bishops’ Conferences of the European Union, issued the statement through its Bioethics committee in response to the EU Proposal for “A Regulation on clinical trials on medicinal products for human use’ which aims at re-launching clinical research within the EU while at the same time ensuring protection to participants as well as the reliability of the acquired data. The European Commission proposed regulation which will be submitted to a vote of the European Parliament next 29 May

The statement on Ethical assessment of clinical trials on medicinal products: Respect and protection of vulnerable persons and populations  was released by COMECE this week in English and French.

Importance of consent

“Many people who are unable to give consent as well as people from less-developed countries often participate in clinical trials.” The COMECE statement asks how we can better protect them and vulnerable populations against abuse in the process.

The COMECE bioethics team conclude that  EU proposal could go further in the protection of the people concerned. A spokesperson said:

“The COMECE Secretariat welcomes this proposal for a Regulation as it goes in the right direction. The COMECE Reflection Group on Bioethics has monitored the issue from the launch of the public consultation by the European Commission and publishes today its Opinion on this proposal for a Regulation. ”

Key ethical concerns and principles

The COMECE team underlined some principles which they feel should be implemented in the proposed EU Regulation :

Volunteering

“The appreciation of the value of voluntary participation in research projects for the good of the community:  granting financial incentives to any person agreeing to take part in some medical research therefore raises ethical issues.”

Protecting those particularly vulnerable

“A key ethical consideration for research carried out on human subjects is that of respecting and protecting particularly vulnerable people and populations who could be unduly used as easily-exploitable objects for experiments.”

Benefits for the population concerned, especially in developing countries

“Clinical research with a disadvantaged or vulnerable population or community is justified only if it responds to its health needs and priorities and if it is likely that such a population or community will benefit from the results of the research.”

Security of the participants to tests

“The subject of research may agree to become involved in a research protocol that does not fully respond to the individual’s own interests but will do so for the good of others, in the “medical interest of the community” and consequently for the “common good”, insofar as the patient’s physical or psychological integrity is not endangered.” This underlines the importance of full and informed consent.

Benefits to the person incapable of consent

“Trial medicinal products should not be given to persons who are not capable of giving their consent except in cases where the same results cannot be obtained by resorting to persons capable of giving their consent and if the foreseeable benefits/predictable risks ratio is to their advantage.”

Ethics of testing in emergency situations

As for clinical trials in emergency situations, “the only acceptable research is specific research on individuals placed in such a situation that one may have good grounds for anticipating a direct benefit with regard to their condition and that would present a minimal risk and only impose a minimal burden. It is also important to give a sufficiently precise definition of the terms “minimal risk” and “minimal burden”. ”

The full statement on Ethical assessment of clinical trials on medicinal products: Respect and protection of vulnerable persons and populations is available in English and French

Vatican supports new direction on health for World Health Organization

25 May

This week has seen several interventions by the Vatican delegation to the World Health Organization’s key decision making body.

The Sixty-sixth World Health Assembly , which is the  decision-making body of the World Health Organization , and in turn the  public health body of the United Nations was taking place this week in Geneva.

Catholic support for improving population health

Archbishop Zygmunt Zimowski,  head of the Holy See’s delegation, in a brief but wide-ranging speech

  • called on WHO to affirm the centrality of spiritual needs to any approach to universal health care
  • supported the WHO’s aims to prevent non-communicable diseases such as Heart Disease and Cancer
  • affirmed the need to control and prevent disease in older people
  • supported WHO intentions to further reduce preventable deaths especially in women and children but differed on emergency contraception from WHO’s suggested stance
  • reminded the WHO of the significance of the Catholic Church’s health care agencies and infrastructure (up to 25% of HIV care worldwide, over 50% of health care in some countries)

Archishop Zimowski’s intervention is covered in more detail on Catholics in Healthcare blog.

Responding to WHO General Secretary on health of women and children

Dr Margaret Chan, Director General, outlined her goals for her time as Director General as including  “the health of women and of the people of Africa.” Archbishop Silvo Tomasi, the Holy See’s Permanent Observer to the United Nations and part of the Holy See’s delegation at the Assembly expressed his support for these objectives, and went on to explain the Catholic Church’s global and local experience in those areas.

Health of the people of Africa

The Archbishop went on to offer the experience of the Church in support of Dr Chan’s goal for improving the health of the people of Africa. “[M]any nations are still in the grip of famine, war, racial and tribal tensions, political instability and the violation of human rights.” Pope Benedict XVI’s exhortation to the international community is also very appropriate, “we must not forget Africa ….”

Emphasising the care of the whole person

Tomasi finalised his intervention with a vision of health that reminded the WHO of it’s own aspirational definition of health. We should seek a deeper care for every aspect of the human person.

“My delegation urges a perspective on health security that is grounded on an anthropology respectful of the human person in his or her integrity and looks far beyond the absence of disease to the full harmony and sound balance of the physical, emotional, spiritual and social forces within the human person.”

In recent years the Vatican has moved to emphasise not only its stance on reproductive health at WHO events but has taken on a stronger public health focus. This latest WHO Assembly has seen Vatican interventions aimed at sharing the wider health and social justice concerns of the Church.

World Health Organization told spiritual needs “integral” to universal health care

25 May

The Sixty-sixth World Health Assembly was told this week that any integral approach to universal health care coverage must include addressing the spiritual needs of populations.

The Assembly is the decision-making body of the World Health Organization , the health and public health body of the United Nations and has universal health care coverage as one of its key strategic aims.

In a wide-ranging intervention which also signalled strong Vatican support for universal health-care measures, Archbishop Zygmunt Zimowski, President of the Vatican’s Pontifical Council for Health Care Workers and head of the Holy See’s delegation to the World Health Assembly said that any “integral” approach to healthcare need must focus on “the spiritual state of the person” and not just medical interventions or economic growth.

“Health and development ought to be integral if they are to respond fully to the needs of every human person. What we hold important is the human person – each person, each group of people, and humanity as a whole.”

The archbishop said that health care contributes to the development of nations “and benefits from it.” The Holy See “strongly believes” that universal health care coverage as a goal of government policy is a more certain way to achieve “the wide range of health concerns,” including preserving present advances.

The archbishop said that health care contributes to the development of nations “and benefits from it.” The Holy See “strongly believes” that universal health care coverage as a goal of government policy is a more certain way to achieve “the wide range of health concerns,” including preserving present advances.

Archbishop Zimowski then turned to efforts to save the lives of millions of people who die each year “from conditions that can easily be prevented.” He praised a resolution before the assembly to improve the quality, supply and use of 13 “life-saving commodities.”

“The Holy See strongly agrees with the need to achieve further reductions in the loss of life and prevention of illness through increased access to inexpensive interventions that are respectful of the life and dignity of all mothers and children at all stages of life, from conception to natural death,” he said.

However, he voiced “serious concerns” about the assembly’s secretariat report and its executive board-recommended resolution that includes “emergency contraception.” He said some of these drugs have an abortifacient effect.

“For my delegation, it is totally unacceptable to refer to a medical product that constitutes a direct attack on the life of the child in utero as a ‘life-saving commodity’ and, much worse, to encourage ‘increasing use of such substances in all parts of the world’,” he said.

The archbishop welcomed the assembly’s proposed global action plan to control non-communicable diseases. He said his delegation was “especially pleased” that the plan recognizes the “key role” of civil society institutions including faith-based organizations in encouraging the prevention and treatment of these diseases.

“Our delegation is aware that Catholic Church-inspired organizations and institutions throughout the world already have committed themselves to pursue such actions at global, regional, and local community levels,” he said.

Archbishop Zimowski also voiced interest in aspects of preventing and controlling diseases in older age, noting faith-based institutions’ long tradition of care for the aged and the rapid growth of the elderly population. He noted that the Vatican will host an international conference Nov. 21-23 about caring for the elderly with neurodegenerative diseases.

 

Anscombe Bioethics Conference on “a giant among women philosophers”

15 May

The Moral Philosophy of  Dr Elizabeth Anscombe

On 27th and 28th September 2013 the Anscombe Bioethics Centre will host a major international conference on the moral philosophy of Elizabeth Anscombe, after whom the Centre is named.

Gertrude Elizabeth Margaret Anscombe has been described as ‘a giant among women philosophers’, as ‘the greatest English philosopher of her generation’ and as one of the ‘pioneers of a genuine renewal of Catholic thought’. She was ‘a titan in the world of philosophy’ who was ‘widely recognised as one of the greatest philosophers of the twentieth century’.

The venue will be St Hugh’s College, Oxford (where Dr Anscombe was an undergraduate student).  The price is £140 for ‘early bird’ conference registration, light refreshments and lunch only for the two conference days (without accommodation). Concessions £70. For details please see the booking pages.

Participants, who are all bioethicists and moral philosophers of international standing, will include:
Christopher Coope,
Rev Prof Kevin Flannery SJ
Dr Mary Geach,
Rev David Goodill OP
Prof Luke Gormally,
Dr Edward Harcourt,
Dr David Albert Jones,
Prof Anselm Müller (Anscombe Memorial Lecturer 2013),
Dr Matthew O’Brien,
Prof Thomas Pink,
Prof Duncan Richter,
Dr Roger Teichmann,
Prof Jose Maria Torralba and
Prof Candace Vogler.

For more information, programme and to register visit here

http://bioethics.org.uk/detail/news_and_events/g_e_m_anscombe_s_moral_philosophy_conference

To read more about Elizabeth Anscombe read here

http://www.bioethics.org.uk/page/about_us/about_elizabeth_anscombe

Food for the journey, theological resources for healthcare

13 May

Food for the Journey, Theological Foundations of the Catholic Healthcare Ministry

The 2013 edition is now available from Catholic Health Association US.

For more than two decades, this formative resource has inspired the women and men who are leading and serving in Catholic health care.

The 2013 edition offers an updated look, but the same original text. In addition to the hardcopy edition, this resource is now available as an audio book in CDs or MP3 files as well as an eBook, which will be available in May. Also, CHA has produced a set of five notecards that includes some of the images from each of the chapters of the book and are blank inside.”

A Manifesto for Catholic Health and Social Care Workers

11 May

Reflection: A Manifesto for Catholic Health and

Social care Workers

Jim McManus

 

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I often get asked for resources to help  Catholics, other Christians and people of faith working in Health and Social Care. What people working at the most important end  – caring for and working alongside real people – seem to want more and more is something short which can remind and inspire them. What they want less and less is the long is the theological and policy justification, though people clearly want this done.   “We expect the Church to support us by advocating for us to Government, while nurturing and supporting us in our faith” was what one Director of Nursing and her team recently told me.

The points below are adapted from the Catholic Health Association of Texas. You can find many resources from a range of states and US wide at the Catholic Health Association of US website. They have devised a  statement of faith for Catholic presence in Healthcare. This covers both their healthcare facilities and their staff, as well as how they will deliver healthcare in a setting with a strong, visible Catholic Ethos. I have used this with small and large groups and so far everyone finds it useful.

 

We believe

  • in the dignity of the human person and in the resulting holistic approach to patient care which recognizes and integrates the physical, spiritual, emotional and psychological care of both patient and family.
  • in those Catholic/Christian principles and standards, which create a total environment which assist administration and medical staffs in making difficult ethical decisions.
  • in justice and equity for associates in the workplace that fosters personal and professional development, accountability, innovation, teamwork and commitment to quality.
  • that advocating for social justice can enable the neglected in society to empower themselves and their communities.
  • that the Catholic health ministries must recognize their social accountability to the communities they serve, developing policies and procedures to ensure this accountability, and responding pro-actively to engage in community outreach,
  •  each Catholic in healthcare is directly participating in the healing ministry of Christ and the mission of the Holy Spirit
  •  the Church should foster and maintain collaborative linkages with the broader community – Catholic, ecumenical and community-based to re-humanise healthcare
  •  that to be effective stewards of our ministry, we must develop organizational structures that promote management effectiveness, continuous quality improvement, well-trained medical staffs, and comprehensive programs and services.

 

Questions for Reflection or Discussion

When I have been working with groups on this statement, we often focus around three questions for discussion

  1. What is specifically Catholic about this understanding? Is it about the value we put on people?
  2. What would be your guiding principles and beliefs in healthcare work?
  3. Does healthcare in the UK need a statement of faith and values? If so, what can we add to that?