‘Ethics in Practice’ Conference

  • Peter Dunne
Health

Tena koutou katoa, good morning, and thank you for the invitation to speak today at the opening of the Research Ethics conference in New Zealand, Ethics in Practice, held here at Otago University.

I would like to begin by welcoming all of you, including those of you who have travelled from overseas to share your knowledge with us in New Zealand. I would like to acknowledge the organisers, Associate Professor Martin Tolich and Dr Barry Smith. Thank you for organising this event – I am confident that important discussion will take place. It is motivating to see so many people passionate about ethics.

Thank you to the speakers who have come from around New Zealand to bring their unique perspectives and insight to us as well. It is encouraging to see so many students, members of ethics committees, researchers, academics and members of the public who have come to engage, contribute and provide an audience for the speakers.

As Associate Minister of Health with the relatively new delegation of ethics committees, it is my pleasure to be here – I have found my responsibility in this area to be engaging, thought provoking, and of critical importance to the wider health sector.

Because the fact is, development of new medical treatments would not happen without health research, and the active role of research participants.

There are no short cuts – new medicines are not registered because one group feels passionately about them, or because a manufacturer claims to have discovered a wonder-drug. Behind every discovery of a new medicine and treatment are thousands of people who were involved in health research.

That approach is a fundamental cornerstone of our system, and will remain so. No responsible New Zealand government should ever bow to approving a medicinal product on the basis of public clamour, interest group pressure, or dubious science. New Zealanders demonstrate this country’s strong sense of altruism in their participation in research, taking part for the future improvement of people’s lives.

It is therefore of utmost importance to protect the participants rights, a key role of our ethics committees and one they, and I take very seriously.

Research in New Zealand is diverse and innovative. In New Zealand we conduct research to develop new medicines, compare existing treatments to find out which works better, and create new and novel ways of treating health problems.

New Zealand is world-leading in its intensive care research – let me give you some examples. Among patients who are hospitalised with severe traumatic brain injury, 60% either die or survive with severe disability.

One particular treatment - a decompressive craniectomy - showed promise in reducing deaths caused by traumatic brain injuries. To see whether this treatment that had started to become commonplace was the best approach, a study was conducted.

The Decompressive Craniectomy in Diffuse Traumatic Brain Injury study was published in 2011. This study showed that what appeared to be a treatment with good outcomes, in fact ended up being worse for patients. The study’s results, by changing standard practice, also saved an estimated 20 million dollars a year for New Zealand.

Another study conducted in New Zealand is the CHEST trial. This trial was a National Health and Medical Research funded study conducted in New Zealand and Australia. It was the largest double-blind randomised controlled trial ever performed in critically ill patients. It showed that resuscitation with starch containing colloid fluid, which is the most common artificial colloidal solution in the world with sales of millions of litres worldwide, led to an increased risk of severe acute kidney injury requiring renal replacement therapy.

This study had an immediate worldwide impact with black box alerts issued by the Food and Drug Administration, suspension of marketing by the Emergency Nurses Association and National Health Service and more than a 70% decrease in use in Australia and New Zealand. This led to millions of dollars saved and many instances of acute dialysis treatment prevented.

By conducting research we are changing the way we treat patients by making evidence based decisions.

Another example of practice changing research comes from Wellington where the Gillies Mcindoe Research Institute is based. Dr Swee Tan founded the institute. Dr Tan and his team discovered the genes that control the growth and regression of strawberry birthmarks. They found that stem cells arising from the placenta are the origin of strawberry birthmarks, and they have learned how to manipulate these tumour stem cells so as to cause them to self-destruct.

In a world first achievement, the team led by Dr Tan and collaborators succeeded in transforming strawberry birthmark stem cells into fat cells, bone cells and red blood cells. The institute’s ground-breaking research on treating strawberry birthmarks has potentially enormous implications for the treatment of other tumours, including cancer.

A number of highly regarded experts and organisations in the international community recognise the immense potential of the discoveries of the team at the institute.

These ground-breaking discoveries underpin the new treatment of strawberry birthmarks that enable these disfiguring and sometimes dangerous tumours to be treated inexpensively in a matter of months, rather than years, with children gaining a better quality of life. The new treatment is much cheaper, faster, more effective and produces fewer side effects than traditional treatments. This line of research is novel and has the potential to revolutionise the understanding and treatment of cancer and other diseases.

These are just some examples of the research that New Zealand conducts with the goal of treating and preventing disease and increasing the health and wellbeing of current and future New Zealanders.

There is a great amount of value in conducting research; however research usually involves some level of risk. Protecting participants and conducting ethical research involves a number of groups which must communicate and work together.

Researchers, ethics committees, universities, DHBs and government all have responsibilities to protect participants. Ethical research begins with asking the right study question and appropriately designing the research.

Researchers have a responsibility to anticipate the risks and aim to reduce them as much as possible. It is vital to support and educate researchers on how to do this. Researchers are also primarily responsible for conducting their studies in accordance with established ethical standards. Such ethical standards include those determined by the National Ethics Advisory Committee, a ministerial advisory committee.

All researchers have a duty to comply with the Committee’s Ethical Guidelines for Observational Studies and Ethical Guidelines for Intervention Studies when conducting health and disability research in New Zealand.

Other relevant guidelines include the Health Research Council’s Guidelines for Researchers on Health Research Involving Māori that inform researchers about consultation and the processes involved in initiating consultation with Māori.

As I stated in my opening remarks, Ethics Committees play an important role in protecting participants. There are four Health and Disability Ethics Committees in New Zealand and they are responsible for ensuring that research applications meet established ethical standards. The Committees safeguard participants by approving or declining research that occurs in New Zealand. The Committees weigh the risks posed to the individual research participants with the potential benefits for future generations of New Zealanders and are tasked with evaluating studies, identifying risks and providing ethical guidance to protect participants.

New Zealand’s robust ethical review processes and regulatory systems, diverse patient populations and high-quality clinicians and researchers make it a good place to conduct research. However, the Government is always looking for opportunities to improve New Zealand’s ability to conduct ethical research and to ensure that the benefits of health research are experienced by all.

Ethics is a dynamic subject area and we must continue to re-evaluate our strategies and processes to make sure we are providing high quality ethical review that results in ethical research. It is also important to consider the wider community and the impact the research will have on them.

Ultimately, good communication between researchers, participants, ethics committees and local communities is what facilitates ethical research.

Today speakers will explore how researchers and committees can better incorporate Māori views and research methods into their day to day practice. The Ministry of Health is committed to work to achieve better health outcomes for Māori. The Health and Disability Ethics Committee’s Secretariat held a Māori Health Research Ethics Symposium in conjunction with the Capital and Coast District Health Board in March this year.

The day highlighted the diverse range of people that are needed to improve our review pathways and guidance for conducting research. The speakers outlined some of the challenges that the research sector face as the ability to analyse tissue samples evolves. The high level of interest in the symposium led to another conference held in Auckland two days ago at the Ernest and Marion Davies Library.

The Ministry was there to provide feedback on its efforts to make Māori consultation more robust, as well as listen to international speakers discuss their own efforts to work with their indigenous populations to make research ethical.

The National Ethics Advisory Committee is also looking at how it can better integrate Māori ethical ideas and frameworks into its research guidelines. Some of you may have provided feedback earlier in the year in response to their discussion document on cross-sectoral ethics arrangements.

Your feedback will be very helpful as the Committee develops new ethical guidelines for health and disability research. I would encourage you to provide further input late this year when they consult on the draft new guidelines.

I am also expecting advice from the National Ethics Advisory Committee on what can be done to improve consultation with Māori and ensure research makes a greater contribution to Māori health outcomes. The Committee will review the responses and provide advice that can feed back into reviewing our guidelines and processes which help set the framework for New Zealand ethics committees to function, and to continue to protect participants and facilitate good research.

I would like to thank you for taking the time to be here today and to reiterate my best wishes to you all for a productive and informative weekend ahead. The ethics landscape is one that requires careful attention and continual review. May today be an opportunity to make relationships and promote discussion on how we can improve research that is conducted in New Zealand.

I wish you well in your ongoing work and research and look forward to seeing how the discussions today can become part of New Zealand’s ongoing efforts to promote ethical research.