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Conducting research with (not on) consumers in health – exploring ethical considerations0

 

Authors: Joan Carlini,1 Kristen Ranse,2 Noela Baglot,3 and Laurie Grealish2

1. Griffith Business School, Griffith University, Southport campus, Queensland. Email: J.Carlini@Griffith.edu.au.
2. Menzies Health Institute Queensland and School of Nursing & Midwifery, Griffith University and Nursing & Midwifery Education and Research Unit, Gold Coast Health.
3. Health service consumer.

Growing healthcare demands and limited resources raises concerns about the sustainability of practical benefits resulting from research. The Consumers’ Health Forum of Australia and the National Health and Medical Research Council have developed a Statement on Consumer and Community Involvement in Health and Medical Health Research to better align the health and medical research with community need and improve research impact.  However, the traditional research-to-practice pathway can result in findings that are not “implementable”, which has led to the active recruitment of consumers’ views in co-design of interventions.  Consumers are now recognised as valuable knowledge resource to improve the relevance and translation of research into practice.

Co-design with consumers and community organisations

Co-design is the practice of consumers and suppliers, such as researchers and clinicians, coming together to look at a problem and design a solution together.  Consumer engagement in healthcare is considered critical to safe and high quality services. While health service consumers, often labelled as patients or clients, are the subject of research in order to better understand health and illness, engaging consumers in the conduct of research is emerging as an important area for consideration in health service research.

In healthcare, co-design can strengthen the relations between the community and academia, and ensure the relevancy of the research question and intervention. Despite the benefits of using co-design, there are also unique challenges that can become apparent. The co-creation process involves collaboration between researchers and consumers from the outset, making pre-specification of interventions unlikely.

End of life project background

In our project, researchers partnered with clinicians and consumers in the development of an intervention to support people near end of life to achieve a death at home. Consumers were involved in developing the intervention, which consisted of (1) a brochure outlining key considerations to achieve a death at home and (2) the process of discharge home near end of life. Consumers were members of two design groups, one for each part of the intervention and others attended a workshop to review the brochure and process. Please see our earlier article for more information.

Unlike participatory action research, in co-design consumers are focused on the intervention rather than the research process itself. Consumers contributed to the quality of the information that people might need when considering a death at home, including the processes that facilitated the transition home.

Method of engagement

In the co-design process, researchers modified established research techniques, such as nominal group technique, to distil those features of the discharge process and brochure that were considered most important. The group negotiated importance and inclusion of various elements in the drafting process. In these discussions, the importance of some elements were not equally valued by consumers, clinicians and researchers leading to rich and robust debate. The groups met over five meetings and through these meetings developed rapport that enabled frank discussion and the ability to work towards consensus that was consumer-led.

Ethical principles applied

The importance of engaging with consumers as partners in research must be carefully considered in the design and conduct of research to ensure that ethical principles are upheld. In considering how consumer engagement can support the research project’s fulfilment of ethical principles, including those in the National Statement, we consider the following:

Voluntary

The consumers involved in the project were invited to attend based on their history as a health consumer and interest in end of life care.  Their engagement in the project was voluntary, and they had the freedom to participate at a level of their choosing (i.e., attend meetings, community forum, out of session meetings).

Nonmaleficence

The researchers took care to ensure that the wellbeing of the consumers was maintained. One consumer’s recent lived experience with the topic meant that the researcher would informally check-in on the welfare of the consumer and gather feedback on the process, participation, and interactions of the previous meeting.

Beneficence

The group Chairs carried responsibility to support the group to establish a shared vision about the value of keeping the person who is dying at the centre of care. The complexities of how beneficence can be achieved, and possible barriers, emerged during meeting discussions and this information was used to support the implementation plan. For example, as the discussions progressed, the value of a formal family meeting and the need for general practitioner and transition nursing support was considered essential to enact patient and family well-being.

Consumers were included as committee members and accepted as part of the group, with all group members, who were representing a range of stakeholders with an interest in discharge home near end of life, invited to contribute their views at each meeting. All stakeholders were valued as being integral to the solution. In this project, consumers were considered as experts, understanding what happens outside of hospital and in the community, and directing the researchers to focus on family limitations as well as strengths. Because the group members were focused on the same, shared goal early in their work together, the process provided respect for families who decide to die at home, as well as those who may need to return to hospital.

Fidelity

Minutes were taken at each meeting, with action items discussed at the beginning of each meeting. Member were accountable for actions that they had agreed to undertake, with outcomes discussed at the meeting. The finalised draft of the two documents, the information brochure and discharge process, were circulated to the consumers, as members of the respective design groups, for comment. The consumers’ commented on how pleased they were to see the tangible outcome.  In another example, when one researcher (JC) was preparing this article, she spoke with one of the consumers about her experience with the co-design approach of the project.  Later, when the researcher provided a hard copy of the draft article to the consumer, she responded happily that her view “was well developed & expressed clearly”.

Respect

Respect for consumers who would be using the intervention was considered important during the groups’ deliberations. For example, consumer members of the information committee, tasked to design a brochure to support patients and families, were invited to review readily available resources about dying at home available in Queensland and other Australian jurisdictions. Through this activity, they were able to identify the information and conversations that would be most important in the local context. They also contributed to the language used in the brochure, supporting the use of example questions to focus health professionals on what was important to the consumer, making the planning process more personalised.

Justice

In relation to justice, this intervention and associated project provides guidance on the appropriate clinical and non-clinical people and resources that can enhance a person and family’s experience of dying at home. In the Gold Coast community, this project provides a vehicle for people living with chronic, life limiting diseases to imagine an end of life experience that is not in the hospital. Within the brochure, information about the financial, social and personal challenges of caring for a person at home is explored, ensuring that people have awareness of those challenges and can plan for them.

Safety

All members of the co-design teams should be well supported in a safe environment. A structured timeline indicating the milestones were developed in advance, thus setting a framework for meeting agendas.  This structure allowed participants to feel secure in knowing the process, approaches and activities that would be covered.  Both of the Design Group chairs were experienced researchers and knowledgeable about the process of co-design. As Chairs, they ensured that the conduct of all members were respectful, hence creating a safe and supportive atmosphere.

The future of consumer engagement in research

Based on our experiences, consumers as experts on health services added value to the outputs of the design process. In this study, there were specific value assumptions associated with consumer engagement in the intervention design process, including:

  • Clear expectations of consumer contribution, the anticipated project outcomes, and some knowledge or experience of the issue under investigation enhances contribution;
  • Consumers require formal training in consumer advocacy and require the time, understanding and passion to sustain their commitment; and
  • Engagement is enhanced by effective communication in regard to formal agendas, written minutes and ongoing personal communication.

Image source: Gold Coast Hospital Health Service, Achieving end of life care at home, A guide for patients and their family carers (2019)

In our case, consumers with experience of end of life care, as either a family member or a paid carer, were able to make a sound contribution that enhanced discussions and the final product. Other stakeholders including clinicians from the hospital, community health service providers and researchers expressed learning from the insights provided by the consumers.

In this project, consumer engagement through co-design was limited to developing the intervention. Consumer contribution has been found to enhance scientific and ethical standards, provide legitimacy and authority, and increases project credibility. Our experience resonates with these findings.

As consumer advocacy training becomes more sophisticated, there are clear opportunities to involve consumers more actively as members of research governance groups and in some cases, research teams. Consumers bring an experiential perspective, often grounded in local context that can be particularly helpful in translational or implementation research, an emerging research discipline in Australia. We invite other researchers, consumers and clinicians to contribute to this constructive conversation about the value of involving consumers in research co-design, with a view to satisfying the national quality standard in health care, focused on Partnering with Consumers. Not only can the quality of research improve, but consumer engagement can assist with focusing on matters of importance to the local community, increase public confidence in research through openness and transparency, and increasing local community understanding of research.

Acknowledgement

This project was supported by a Queensland Health Clinical Excellence Division, Care at End of Life SEED funding grant (2018). Project team members include Grealish, L., Cross, A., Sharma, S., Carlini, J., Ranse, K., Hiremagalur, B., & Broadbent, A..

This post may be cited as:
Carlini, J., Ranse, K., Baglot, N. and Grealish, L. (26 February 2019) Conducting research with (not on) consumers in health – exploring ethical considerations. Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/conducting-research-with-not-on-consumers-in-health-exploring-ethical-considerations

 

Sage Methods Minute. January Spotlight: Research Ethics0

 

January’s Methods Minutes, a monthly newsletter produced by Sage Publishing, is a special issue focused on social research ethics. It reviews two articles and one book from Sage’s extensive collection on research ethics and also links to an article by Janet Salmons on the importance of research ethics in an ethics-challenged world. Finally, it introduces a video of Mark Israel (AHRECS) discussing the importance of integrating ethical principles in the design of the project from the outset.

The full page can be seen at http://info.sagepub.com/q/1fcUbqkq9C2tGu15bd0Q65f/wv

Contributor
Dr Mark Israel. Senior Consultant AHRECS
AHRECS profilemark.israel@ahrecs.com

This post may be cited as:
Israel, M. (26 February 2019) Sage Methods Minute. January Spotlight: Research Ethics. Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/sage-methods-minute-january-spotlight-research-ethics

The Ethics of Evaluation Research0

 

Evaluation research is used to assess the value of such things as services, interventions, and policies. The term ‘evaluation research’ makes it seem homogeneous but in fact evaluation research draws on a range of theoretical perspectives and a wide variety of quantitative and qualitative methods. However, there are three things evaluation research usually does that set it apart from other kinds of research. It:

  1. asks what is working well and where and how improvements could be made;
  2. involves stakeholders; and
  3. offers practical recommendations for action.

The American Evaluation Association (AEA), with members from over 60 countries, has five ‘guiding principles’ which ‘reflect the core values of the AEA’ (2018):

Systematic inquiry: evaluators conduct data-based inquiries that are thorough, methodical, and contextually relevant.

Competence: evaluators provide skilled professional services to stakeholders.

Integrity: evaluators behave with honesty and transparency in order to ensure the integrity of the evaluation.

Respect for people: evaluators honour the dignity, well-being, and self-worth of individuals and acknowledge the influence of culture within and across groups.

Common good and equity: evaluators strive to contribute to the common good and advancement of an equitable and just society.

The question of how research ethics review processes should engage with evaluation research has not yet been definitively decided in many research institutions in Australia and New Zealand. Helen Kara’s article alerts us to the degree to which evaluation researchers encounters novel ethical issues. We shall explore some of the possible institutional approaches in a forthcoming Patreon resource.

This is unusual in being thorough – there is much more explanation in the document – and up to date. The Australasian Evaluation Society (AES) has Guidelines for the Ethical Conduct of Evaluations which were last revised in 2013. This is a much more discursive document – 13 pages to the AEA’s four – which offers guidance to evaluation commissioners as well as evaluation researchers. The AES guidelines also refer to and include Indigenous ethical principles and priorities. In particular, reciprocity is highlighted as a specific principle to be followed. This is another difference from the AEA document in which Indigenous evaluation and evaluators are not mentioned.
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The United Nations Evaluation Group also specifies evaluation principles in its ethical guidelines (2008) but they are 10 years older than the AEA’s. Beyond these, there are few codes of ethics, or equivalent, readily available from national and international evaluation bodies. Also, evaluation research rarely comes within the purview of human research ethics committees unless it’s being conducted within a university or a health service. And books on evaluation research rarely mention ethics.
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Recent research has shown that a proportion of evaluation researchers will assert that ethics does not apply to evaluation and that they have never encountered ethical difficulties in their work (Morris, 2015, p.32; Williams, 2016, p.545). This seems very odd to me, as I have been doing evaluation research for the last 20 years and I have encountered ethical difficulties in every project. It also seems worrying as I wonder whether the next generation of evaluation researchers are learning to believe that they do not need to think about ethics.
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In my recent book, Research Ethics in the Real World (2018), I demonstrated that ethical issues exist at all stages of the research process, from the initial idea for a research question up to and including aftercare. This applies to evaluation research just as much as it does to any other kind of research. I also demonstrated that there are some ethical considerations at the macro level for evaluation research, such as funding, stakeholder involvement, and publishing.
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Well-funded organisations or projects can allocate money for evaluation; poorly-funded ones cannot. This means that evaluation research is routinely done where funding is available rather than where evaluation is most needed. In the United Kingdom, where I am based, we have been undergoing an ideological programme of austerity involving massive cuts to public services over the last nine years. This has come from successive governments that have also prioritised evaluation research, funding expensive national ‘What Works’ centres on themes such as ageing, health, and childhood, right through the austerity years. Yet to the best of my knowledge there has been no evaluation of the impact of any service closure. This seems short-sighted at best – though it does illustrate my point that evaluation happens where money is being spent. Also, an explicit purpose of evaluation research is often to provide evidence to use in future funding negotiations, which means that results are effectively expected to be positive. This means that pressures associated with funding can introduce bias into evaluation research right from the start. Combine this with an evaluator who needs to be paid for their work in order to pay their own bills, and you have a situation that is well on its way to being a money-fuelled toxic mess.
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Involving stakeholders is a key principle of evaluation research. The AEA define ‘stakeholders’ as ‘individuals, groups, or organizations served by, or with a legitimate interest in, an evaluation including those who might be affected by an evaluation’ and suggest that evaluators should communicate with stakeholders about all aspects of the evaluation (2018). Again, here, the use of a single word implies homogeneity when in fact evaluation stakeholders may range from Government ministers to some of the most marginalised people in society. This can make involving them difficult: some will be too busy to be involved, some will be impossible to find, and some will not want to be involved. Which leaves evaluators caught between an impractical principle and an unprincipled practice. There is some good practice in stakeholder involvement (Cartland, Ruch-Ross and Mason, 2012:171-177), but there is also a great deal of tokenism which is not ethical (Kara, 2018:63). Also, even when all groups of stakeholders are effectively engaged, this can bring new ethical problems. For example, their values and interests may be in conflict which can be challenging to manage, particularly alongside the inevitable power imbalances. Even if stakeholders work well together such that power imbalances are reduced within the evaluation, it is unlikely those reductions will carry over into the wider world.
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Commissioners of evaluation are reluctant to publish reports unless they are overwhelmingly positive. I had an example of this some years ago when I evaluated an innovative pilot project tackling substance misuse. From the start my client said they were keen to publish the evaluation report. I worked with stakeholders to collect and analyse my data and made around 10 recommendations, all but one of which said words to the effect of ‘good job, carry on’. Just one recommendation offered constructive criticism of one aspect of the project and made suggestions for improvement. My client asked me to remove that recommendation; I thought about it carefully but in the end refused because it was fully supported by the evaluation data. We had two more meetings about it and in the end, my client decided that they would not publish the report. This was unfortunate because others could have learned from the evaluation findings and methods, and because failure to publish increases the risk of work being duplicated which results in public funds being wasted. Sadly, as a commissioned researcher, I had signed away my intellectual property so it was out of my hands. Everyone involved in evaluation research can tell these kinds of tales. However, it is too simplistic to suggest that publication should always be a requirement. In some cases, the publication could be harmful, such as when a critical evaluation might lead to the economy of service closure, to the detriment of service users and staff, rather than to more resource-intensive improvements in policy and practice. But overall, unless there is a good reason to withhold a report, the publication is the ethical route.
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As the AEA principles suggest, evaluation researchers are in a good position to help increase social justice by influencing evaluation stakeholders to become more ethical. I would argue that there are several compelling reasons, outlined above, why all evaluation researchers should learn to think and act ethically.
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References

American Evaluation Association (2018) Guiding Principles. Washington, DC: American Evaluation Association.

Australasian Evaluation Society (2013) Guidelines for the Ethical Conduct of Evaluations. www.aes.asn.au

Cartland, J., Ruch-Ross, H. and Mason, M. (2012) Engaging community researchers in evaluation: looking at the experiences of community partners in school-based projects in the US. In Goodson, L. and Phillimore, J. (eds) Community Research for Participation: From Theory to Method, pp 169-184. Bristol, UK: Policy Press.

Kara, H. (2018) Research Ethics in the Real World: Euro-Western and Indigenous Perspectives. Bristol, UK: Policy Press.

Morris, M. (2015) Research on evaluation ethics: reflections and an agenda. In Brandon, P. (ed) Research on evaluation: new directions for evaluation, 31–42. Hoboken, NJ: Wiley.

United Nations Evaluation Group (2008) UNEG Ethical Guidelines for Evaluation. http://www.unevaluation.org/document/detail/102

Williams, L. (2016) Ethics in international development evaluation and research: what is the problem, why does it matter and what can we do about it? Journal of Development Effectiveness 8(4) 535–52. DOI: 10.1080/19439342.2016.1244700.
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Recommended reading

Morris, M. (ed) (2008) Evaluation Ethics for Best Practice: Cases and Commentaries. New York, NY: The Guilford Press.

Donaldson, S. and Picciotto, R. (eds) (2016) Evaluation for an Equitable Society. Charlotte, NC: Information Age Publishing, Inc.

Contributor
Helen Kara, Director, We Research It Ltd | profilehelen@weresearchit.co.uk

This post may be cited as:
Kara, H. (26 January 2019) The Ethics of Evaluation Research. Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/the-ethics-of-evaluation-research

Australia Day honours recognise contributions to human research ethics0

Posted by Admin in Human Research Ethics on February 25, 2019 / Keywords: , , ,
 

We wish to add our congratulations to two recipients of honours on Australia Day who have made important contributions to human research ethics in Australia over the last 35 years.

Distinguished Prof. Don Chalmers was chair of the Australian Health Ethics Committee (AHEC) from 1994 to 2000. During this time he, together with Regis Mary Dunne AO, conducted a national review of the role and functioning of institutional ethics committees which led directly to the first National Statement on Ethical Conduct in Research Involving Humans in 1999.

The 1999 National Statement replaced the 1966 NHMRC one-page Statement on Human Experimentation to which numerous supplementary notes had been added across three decades.  The 1999 document was a significant landmark in human research ethics in Australia, not only because it brought that NHMRC history together but also because it was endorsed by the Australian Vice-Chancellor’s Committee, the Australian Research Council. The Australian Academies of the Humanities, Science and Social Sciences also endorsed the Statement and it was supported by the Academy of Technological Sciences and Engineering. As a member of AHEC in 1998-99, I remember how Don led these initiatives and negotiations with characteristic diplomacy, tact and good humour.

Don has made important contributions to genetic and genomic research through the Centre for Law and Genetics at the University of Tasmania and to genomic screening and research through his membership of national working groups.

The national recognition of becoming an Officer of the Order of Australia is a fitting addition to his receipt of the NHMRC Ethics Award in 2010.

Prof. John McNeil, who had received an AM in 2008, was also appointed an Officer of the Order of Australia. Although his contributions have been primarily in clinical epidemiology, cardiovascular research and public health, the award also recognises his chairing of the human research ethics committee of the Alfred Hospital in Melbourne for 30 years.  I had the privilege of attending the committee’s meetings on several occasions and recognised the skill and experience that he brought to that role.

John’s commitment to the value of clinical registers was influential in his strong support for the introduction of an opt-out approach to Chapter 2.3 of the National Statement on Ethical Conduct in Human Research in 2014.

Prof Colin Thomson AM
AHRECS senior consultantcolin.thomson@ahrecs.com

This post may be cited as:
Thomson, C. (25 January 2019) Australia Day honours recognise contributions to human research ethics. Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/australia-day-honours-recognise-contributions-to-human-research-ethics

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