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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

Consumer Co-design for End of Life Care Discharge Project0

 

In this issue, we are publishing an account of an end-of-life project in whose design there are some features that add to its ethical interest. Many of us are familiar with institutional policies about consumer engagement in human research and have served on project reference groups, but perhaps have less experience with the successful – and ethical – implementation of these. This project may add some valuable understanding of these matters, including:
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  • What insights do the design and information groups offer into the practice of research co-design?
  • Do those insights help to clarify the distinction between co-design and participatory action research?
  • Do those groups have advantages in demonstrating the project’s fulfilment of ethical principles of beneficence, respect or justice
  • Could those groups have a role in overseeing the ethical conduct of a project?
  • Given the subject of this research project, what sort of projects might make best use of groups such as those in this project?

We have invited the author and the research team to provide some follow-up reflection on issues such as these as the project progresses and is completed

.
The End of Life Care Discharge Planning Project is led by Associate Professor Laurie Grealish from Griffith University. This research project partners with consumers at all stages, allowing consumers significant contribution. As part of the Queensland Health End of Life Care Strategy, Gold Coast Health is developing a process to support discharge for people near end of life who would like to die at home. A Productivity Commission Report in 2017 noted that although over 70% of Australians prefer to die at home, less than 10% do. This is attributed to the need for improvement in the transition between hospital and community care.

The outcomes of this study are expected to include: (1) an evidence-based discharge process and infrastructure to enhance the transition from hospital [medical wards] to home for end of life care; (2) end of life care information brochure for patients and their family carers; (3) stakeholder feedback to indicate that the process is feasible and satisfactory; and (4) a health service and non-government organisational partnership network to monitor the discharge process and enhance future integrated models of end of life care. Ethical approval has been granted by the Gold Coast Health Human Research Ethics Committee and Griffith University Human Research Ethics Committee.

For the research design stage, three groups were established: 1) Project reference group, 2) Project design group, and, 3) Project information group.

1. Project reference group – The aim of the project reference group is to consider the analysed data and reports from the sub-committees, provide advice on, as well as monitor, implementation strategies. This group is led by Associate Professor Laurie Grealish and has membership from a wide range of stakeholders including hospital clinicians and managers, researchers, community groups, non-government organisations and consumers.

2. Project design group – The purpose of this group is to design an evidence-based discharge process to enable people near the end of life to return home to die if this is their wish. Dr Kristen Ranse from Griffith University is the Chair of this group and the membership of the group includes representatives from Gold Coast Health, consumers, and non-government organisations.

3. Project information group – Led by Dr Joan Carlini from Griffith University, this group is to provide expert advice about what information people need as they consider dying at home. It was identified early by the group that there is an overwhelming amount of information available online and in brochures, leading to confusion. Since this group has stakeholders from a wide range of representatives from health care providers, nongovernment organisations, community groups as well as consumers, there has been a healthy generation of discussions. The consumers on the team led the way in selecting pertinent information and producing a draft document. This was then further modified by the committee, ensuring that the booklet is concise, but also a thorough source of information for end of life care.

The next stage of the project runs from Janulary to July 209, with implementation, data collection and anlaysis, and dissemination of finding.

Contributor
Dr. Joan Carlini, Lecturer, Department of Marketing, Griffith University | Griffith University profile, LinkedIn profile (log in required), Twitter – @joancarlini |

This post may be cited as:
Carlini, J. (18 January 2018) Consumer Co-design for End of Life Care Discharge Project. Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/consumer-co-design-for-end-of-life-care-discharge-project

Undue Influence in Research Between High-Income and Lower-Income Countries0

 

Red Thaddeus D. Miguel

According to the Belmont Report (1979), respect for persons incorporates two ethical convictions: individuals are to be treated as autonomous agents, and those with diminished autonomy are entitled to protection.

It is because of these guiding principles that we, researchers and health practitioners, are extremely careful in planning and designing our research on populations who are more likely to have diminished autonomy. We endeavour to protect vulnerable groups in our studies because their circumstances make them more susceptible to being taken advantage of. To do otherwise, according to Gillet (2008), would simply be selfish and would be acting in bad faith. In fulfilment of their mandate, ethics review boards likewise have clear guidelines in the protection of vulnerable populations. Unlike protocols for the protection of minors, pregnant women, prisoners, terminally ill, intellectually challenged, and militarized to name some of the most common guidelines for vulnerable populations, guidelines for impoverished population may be more difficult to construct. As laid out by the Guidelines for Good Clinical Practice (1996, p.8), impoverished persons may have the propensity to be unduly influenced by the expectations of benefits associated with participation. But how does one judge whether a token for participation is enough to influence the decision of a person? For children, for example, being below a certain age is understandably a reason to protect the child’s interest and warrants the use of assent forms. However, for the economically disadvantaged drawing the line is more difficult to assess.

Some studies have questioned whether incentives impair the ability of participants to make decisions about risk. These claims have cited the studies of Halpern et al. (2004) and Bentley and Thacker (2004), which find participants are not likely to forego the risks of participation when offered greater compensation.However, these findings were based on hypothetical enrolment and were done with small sample sizes. More important for this discourse, however, is that these studies were done in developed countries. In a study by Kass et al.(2005), participants of studies implemented in developing countries (LMICs) were noted not only to be facing challenges in understanding the study protocol thus affecting their autonomous decision making, but were also noted to participate primarily because of the incentives presented.As Benatar (2002) notes great disparities exist in health and wealth between developed and developing countries and therefore ethical standards must take into consideration the differences and adapt to the rising level of research in developing countries.

Recognizing the imbalances of power, resources, and knowledge that exist in the setting of research between high-income and lower-income, the Global Code of Conduct for Research in Resource-Poor Settings (2018) outlines guidelines to avert ethics dumping in lower-income setting. Article 6 of the guidelines tackle specifically the topic of compensation and benefits, ‘Researchers from high-income settings need to be aware of the power and resource differentials in benefit-sharing discussions, with sustained efforts to bring lower-capacity parties into the dialogue’.

Coming from an LMIC, I could not agree more with the guidelines set. In gauging the amount for benefits, one has to be careful with the amount being paid to participants for their involvement so as not to cause undue influence to those who wish to participate in the study; including the local parties into the dialogue is therefore vital to upholding ethical standards. What is acceptable in one country may cause undue influence in another, especially to economically disadvantaged persons in LMICs. Moreover, even within the LMIC itself, interactions between researchers from a high-income region and participants from a low-income area likewise pose some problems and therefore knowing the local factors that could cause undue influence is important.

In the Philippines for example, a number of factors are involved when it comes to deciding the amount of compensation. For example, the daily minimum wage in one area of the Philippines is 265.00 Philippine Pesos (~AUD7), while in other areas this could be as high as 512.00 Philippine Pesos (~AUD13). For this reason, I have been involved in a study that handed out supplies worth 40 Philippine Pesos (~AUD1), yet in another study we thought it was appropriate to hand out 1,000 Philippine Pesos (~AUD25). In making our decision as to how much to pay participants, we conduct our research based on the principles set forth by the Philippine Health Research Ethics Board’s National Ethical Guidelines for Health and Health-Related Research (2017, p.20):

35.4 Research participants shall be reimbursed for lost earnings, travel costs, and other expenses incurred when taking part in a study. Where there is no prospect of direct benefit, participants may be given a reasonable and appropriate incentive for inconvenience. The payments shall not be so large as to induce prospective participants to consent to participate in the research against their better judgment (undue inducement).

With this we make sure that our computation includes all the components set forth by this guideline, thus we try to include lost earnings, reimbursement for travel, incentives, and other expenses incurred by the respondent. In valuing exactly how much each of these costs, we don’t have a memorandum on the exact cost to follow instead we rely heavily on the nature, population, and area of the study.

Upon discussing this topic with two of my colleagues I find that we share similar techniques in estimating the value of each of the cost. Other researchers in the country may have different techniques, but the following are a few of the methods I have compiled from discourse with my colleagues on how to approximate the amount to compensate the participants.

  1. First, we get to know the population of interest very well. This includes taking into consideration the cultural, historical, and geographic background of the region, province, city, municipality, and town. Towns inhabited by people of a certain religion for example should not be brought a specific type of food. Another example could be that because of the terrain of a certain town, getting to the interview may mean riding a motorcycle for an hour. Knowing this we will be able to estimate the reimbursement of travel better.
  2. Different areas at different times of the year will have different needs as well. Therefore, we make sure to take this into consideration. For example, if we know that classes are about to start in one area, we might offer school supplies to participants. Similarly, if it is the rainy season, one could probably give out umbrellas to respondents.
  3. Knowing the region, a general rule of thumb one of my colleagues utilizes is to base his computation on the regional minimum wage published and updated by the Department of Labor and Employment. Using the published minimum wage, he then computes the hourly wage and makes this the maximum compensation for every hour of participation.
  4. Another practice done is to discuss the amount with local government units. Talking to the officials in the town, we are able to gauge the average income of their residents as well as the usual occupation in the area.
  5. We also take into consideration the type of study being done and the inconvenience it could cause. For example, a more difficult questionnaire asking very specific points in the timeline of the patient’s disease may warrant higher compensation than a simple demographic survey.
  6. We talk to researchers or local data collectors who have done studies with the same population, or who have undertaken the same method. Knowing how the respondents reacted to a specific amount of bother fee in the past gives us a benchmark for our studies.
  7. During the conduct of pre-testing our tools, we likewise ask our colleagues for an estimate that they believe would be a reasonable compensation for participants who would answer the questionnaire.

After we have the appropriate ‘bother fee’ in mind, we then submit this to the research ethics committees responsible for the study area. We are then given feedback whether the amount is appropriate and reasonable.

This system seems to be working largely because of the safeguards and competency of local research ethics committee and partly because of our familiarity with the system being locals ourselves. However, I cannot help but wonder how the increasing number of research projects in developing countries can affect this process. With more studies being done in LMICs maybe there is now a need to perform research into this area specifically on the exact amount or situations wherein undue influence can unintentionally occur. For example, with the theories of colonial mentality, does research done by non-Filipinos affect the responses or even influence the participation of respondents in studies done in the Philippines? Due to the volatile weather in the Philippines affecting the prices of commodities every month, does the bother fee deemed appropriate in one month still assure that there won’t be undue influence in the other months? Does the status of diplomatic relations between other countries and the Philippines affect the decision of participants when dealing with researchers from another country? Are there undue influences caused by the perception of Filipinos about certain companies funding the studies?  Will the reputations of certain institutions or organizations leading the study cause participants to participate even if normally they would not have agreed to do so? Could certain areas in the Philippines be more susceptible to undue influence than other areas due to the large gaps in income and health services between regions? Knowing these may be helpful to local researchers and those who wish to do studies locally by providing us with evidence-based standards that could guide our data collection process away from undue influence.

The author declares that he has no affiliations with or involvement in any organization or entity with either financial or non-financial interest in the subject matter or materials discussed in this manuscript. The author has no conflict of interest.

Bibliography

Benatar SR (2002) ‘Reflections and recommendations on research ethics in developing countries’, Social Science & Medicine,1131–1141.

Bentley JP and Thacker PG (2004) ‘The influence of risk and monetary payment on the research participation decision making process’, Journal of Medical Ethics,200430293–298.

Gillett G (2008) ‘Autonomy and selfishness’Lancet, 372(9645):1214-5. https://doi.org/10.1016/S0140-6736(08)61507-X

TRUST Project (2018) Global Code of Conduct for Research in Resource-Poor Settings.http://www.globalcodeofconduct.org/ (Accessed September 8, 2018).

Halpern SD, Karlawish JHT, Casarett D, Berlin JA and Asch DA (2004) ‘Empirical assessment of whether moderate payments are undue or unjust inducements for participation in clinical trials’, Journal of the American Medical Association Internal Medicine, 164801–803.

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human use (June 10, 1996)ICH Harmonised Tripartite Guideline, Guideline for Good Clinical Practice E6(R1) Current Step 4 version. Available at: https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R1_Guideline.pdf (Accessed September 8, 2018).

Kass NE, Maman S and Atkinson J (2005) ‘Motivations, Understanding, and Voluntariness in International Randomized Trials’, IRB: Ethics & Human Research, 27(6):1-8.

National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1978) The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. Bethesda, Md.: The Commission. Available at: https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/read-the-belmont-report/index.html (Accessed August 20, 2018).

Philippine Health Research Ethics Board (2017) National Ethical Guidelines for Health and Health-Related Research, Department of Science and Technology – Philippine Council for Health Research and Development, p.20. Available at: http://www.ethics.healthresearch.ph/index.php/phoca-downloads/category/4-neg?download=98:neghhr-2017 (Accessed September 8, 2018).

Contributor
Red Thaddeus D. Miguel, Health Policy Researcher, Ontario, Canada
LinkedIn profileredasmph@gmail.com

This post may be cited as:
Miguel, Red TD. (27  September 2018) Undue Influence in Research Between High-Income and Lower-Income Countries. Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/undue-influence-in-research-between-high-income-and-lower-income-countries

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