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Ethics, Security and Privacy – the Bermuda Triangle of data management?0

 

Malcolm Wolski and Andrew Bowness
Griffith University

 

To manage sensitive research data appropriately, ethics, security and privacy requirements need to be considered. Researchers are traditionally familiar with ethics, but often have not considered the privacy and security pieces of the puzzle. Our reasons for making this statement are:

  • IT products used in research change rapidly
  • Legislation changes rapidly and there are jurisdictional issues
  • Most researchers are not legal or IT experts
  • No one teaches them enough basics to know what is risky behaviour

The recent revision to the Australian Code for the Responsible Conduct of Research (2018) on Management of Data and Information in Research highlights that it is not just the responsibility of a university to use best practice, but it is also the responsibility of the researcher. The responsible conduct of research includes within its scope the appropriate generation, collection, access, use, analysis, disclosure, storage, retention, disposal, sharing and re-use of data and information. Researchers have a responsibility to make themselves aware of the requirements of any relevant codes, legislation, regulatory, contractual or consent agreements, and to ensure they comply with them.

It’s a complex world

However, this is becoming an increasingly more complex environment for researchers. First, privacy legislation is dependent on jurisdiction of participants. For one example, a research project involving participants in Queensland is impacted by not only the Australian Privacy Act but also the Queensland version (Information Privacy Act 2009 Qld), and, if a participant or collaborator is an EU citizen, the General Data Protection Regulation (EU GDPR).

Secondly, cybersecurity and information security activities in universities have increased dramatically in recent times because of publicised data breaches and the impact of data breach legislation. If your research involves foreign citizens, you may also find foreign legislation impacting the type of response required.

Thirdly, funding agencies, such as government departments are increasingly specifying security and privacy requirements in tender responses and contracts.

These are having an impact on research project governance and practices, particularly for projects where the researcher has identified they are working with sensitive data. While the conversation typically focuses on data identified under the privacy acts as sensitive (e.g. Personally Identifiable Information (Labelled) under the Australian Privacy Act), researchers handle a range of data they may wish to treat as sensitive, whether for contractual reasons (e.g. participant consent, data sharing agreements) or for other reasons (e.g. ethical or cultural).

We have noticed an increasing trend within institutions where researchers are being required to provide more information on how they manage data as specified in a proposal or in a data sharing agreement. This typically revolves around data privacy and security, which is different from the ethics requirements.

What does “security” and “privacy” mean to the practitioner

IT security is more about minimising attack points though process or by using IT solutions to prevent or minimise the impacts of hostile acts or alternatively minimise impacts though misadventure (e.g. leaving a laptop on a bus). Data security is more in the sphere of IT and not researchers. This is reflected in which software products, systems and storage are “certified” to be safely used for handling and managing data classified as sensitive. IT usually also provides the identity management systems used to share data.

We have also noticed that researchers are relying on software vendors’ website claims about security and privacy which is problematic because most cloud software is running from offshore facilities which do not comply with Australian privacy legislation. Unless you are an expert in both Australian legislation and cybersecurity you need to rely on the expertise of your institutional IT and cybersecurity teams to verify vendors’ claims.

In the current environment, data privacy is more about mandated steps and activities designed to force a minimal set of user behaviours to prevent harm caused through successful attacks or accidental data breaches. It usually involves punishment to force good behaviour (e.g. see Data Breach Legislation for late reporting). Typically, data privacy is more the responsibility of the researcher. It usually involves governance processes (e.g. who has been given access to what data) or practices (e.g. what software products the team actually uses to share and store data).

What we should be worrying about

The Notifiable Data Breaches Statistics Report: 1 April to 30 June 2019 highlighted that only 4% of breaches, out of 254 notifications, were due to system faults, but 34% were due to human error and 62% due to malicious or criminal acts. Based on these statistics, the biggest risk associated with data breaches is where the data is in the hands of the end-user (i.e. the researcher) not with the IT systems themselves.

We argue the risks are also greater in research than the general population because of a number of factors such as the diversity of data held (e.g. data files, images, audio etc), the fluidity of the team membership, teams often being made up of staff across department and institutional boundaries, mobility of staff, data collection activities offsite, and the range of IT products needed in the research process.

For this discussion, the focus is on the governance and practice factor within the research project team and how this relates back to the ethics requirements when it has been highlighted that the project will involve working with sensitive data.

Help!!

We have worked closely with researcher groups for many years and have noticed a common problem. Researchers are confronted with numerous legislative, regulatory, policy and contractual requirements all written in terminology and language that bears little resemblance with what happens in practice. For example, to comply with legislation:

  • what does sending a data file “securely” over the internet actually look like in practice and which IT products are “safe”?
  • Is your university-provided laptop with the standard institutional image certified as “safe” for data classified as private? How do you know?
  • Is your mobile phone a “safe” technology to record interviews or images classified as private data? What is a “safe” technology for field work?

Within the university sector a range of institutional business units provide support services. For example, IT may provide advice assessing the security and privacy compliance of software, networked equipment or hardware infrastructure and the library may provide data management advice covering sensitive data. At our institution, Griffith University, the eResearch Services and the Library Research Services teams have been working closely with research groups to navigate their way through this minefield to develop standard practices fit for their purpose.

What we think is the best way forward

Our approach is to follow the Five Safes framework which has also been adopted by the Office of the National Data Commissioner. For example:

  • Safe People Is the research team member appropriately authorised to access and use specified data i.e. do you have a documented data access plan against team roles and a governance/induction process to gain access to restricted data?
  • Safe Projects Is the data to be used for an appropriate purpose i.e. do you have copies of the underlying data sharing/consent agreements, contracts, documents outlining ownership and licensing rights?
  • Safe Settings Does the access environment prevent unauthorised use i.e. do IT systems and processes support this and are access levels checked regularly?
  • Safe Data Has appropriate and sufficient protection been applied to the data i.e. what is it and does it commensurate with the level of risk involved?
  • Safe Outputs Are the statistical results non-disclosive or have you checked rights/licensing issues?

Expect to see a lot more of the Five Safes approach in the coming years.

References

Hardy, M. C., Carter, A., & Bowden, N. (2016). What do postdocs need to succeed? A survey of current standing and future directions for Australian researchers.2, 16093. https://doi.org/10.1057/palcomms.2016.93

Meacham, S. (2016). The 2016 ASMR Health and Medical Research Workforce Survey. Australian Society of Medical Research.

Contributors

Malcolm Wolski, Director eResearch Services, Griffith University

Andrew Bowness, Manager, Support Services, eResearch Services, Griffith University

This post may be cited as:
Wolski, M. and Bowness, A. (29 September 2019) Ethics, Security and Privacy – the Bermuda Triangle of data management?. Research Ethics Monthly. Retrieved from: https://ahrecs.com/research-integrity/ethics-security-and-privacy-the-bermuda-triangle-of-data-management

The need to seek institutional approval to survey staff – was this a misunderstanding of the purpose of Guideline 2.2.13 in the National Statement on Ethical Conduct in Human Research?0

 

Katherine (Kate) Christian, Carolyn Johnstone, Jo-ann Larkins and Wendy Wright
Federation University

 

We have conducted a research project investigating the factors contributing to the satisfaction – or dissatisfaction – of early-career researchers (ECRs) from across Australia working in the sciences. A requirement of our ethics approval was a need to provide evidence from every university and research institute of permission to approach their staff to invite their participation in our research.

This requirement was a consequence of answering ‘yes’ to the following question:

If your research involves participants from other organisations (e.g. educational institutions, companies, agencies, collectives), you may need to obtain authorised approval before approaching participants, eg: Department of Education and Training, School Principals, School Councils (for research involving Government schools); Catholic Education Office (Catholic schools); School Boards (Independent schools); Senior Officers (Commercial or Government entities); Elders (Aboriginal communities); or Representative bodies (Collectives). Copies of approval letters must be attached to this application or, if pending at the time of submission, forwarded to HREC when available. Some authorities may decline to provide permission letters until ethics approval has been granted. In such cases, you should submit your application to the HREC for provisional approval pending receipt of the documentation.

Does research involve or impact on participants from external agencies or organisations?  Yes  No

 

 

Our project entailed collection of data from researchers, typically from other institutions, no more than ten years past the award of their PhD who could be participants in a focus group, one-on-one in-depth interviews or in a national on-line survey. The precise method for extending invitations to participants for each of these activities (which included email invitations, social media posts, and advertising by relevant bodies) was specified in the ethics application and approved by our Human Research Ethics Committee (HREC). In most cases email approaches were to be made by third parties, for example distribution of a forwarded email; otherwise email contact was limited to those people whose contact details were known or publicly available.

The eligible population was adult, clearly defined and without special risks; individuals were able to offer informed consent as defined in the overarching principle for consent in the National Statement defined in Section 2.2.1:

The guiding principle for researchers is that a person’s decision to participate in research is to be voluntary, and based on sufficient information and adequate understanding of both the proposed research and the implications of participation in it.

An attempt to meet the requirement to seek approval for people to be invited to take part in the survey from the prospective 37 universities and many independent research institutes was extremely arduous and a significant barrier to recruitment. We question whether seeking this approval added ethical value, and indeed, whether it may have been required because of a misunderstanding of the purpose of the National Statement, in particular of Section 2.2.13:

Within some communities, decisions about participation in research may involve not only individuals but also properly interested parties such as formally constituted bodies, institutions, families or community elders. Researchers need to engage with all properly interested parties in planning the research.

Section 2.2.13 of the National Statement is placed in the section ‘Where others need to be involved in participation decisions’ and appears directly after a section relating to potential participants who lack the capacity to consent. This requirement appears on the documentation of some other Australian HRECs, (including Australian Catholic University, University of Melbourne,  Menzies Research Institute). However, we believe this section of the National Statement is intended to apply to research conducted within organisations and communities that have a duty of care towards people – or groups of people – who are at risk, such as Aboriginal and Torres Strait Islander peoples, school students or adults with special needs.

Alternatively, it could be construed the request to obtain approval is a misunderstanding of the first part of 3.1.16 and that HRECs take the view that the institutions, in their capacity as employers, have a duty of care as ‘gatekeepers’ for their employees.

Researchers and reviewers should consider the degree to which potential participant populations might be over‑researched or may require special consideration or protection and the degree to which the flow of benefits to that population (or to individual participants) justify the burdens.

The latter part of this section suggests that individuals within the ECR population that we were attempting to sample could have been permitted to make up their own minds about participation, as they do not fall into the type of special category suggested.

Equally, people should not be denied the opportunity to exercise self-determination or obtain the potential benefits of research solely because they are a member of a population that might be over-researched or may require special consideration or protection, such as Aboriginal and Torres Strait Islander peoples.

The literature about the work-life of ECRs in STEMM disciplines in Australia does not show evidence of an over-researched ECR population or a group which merits special consideration. We are aware of only two national surveys of Australian ECRs in STEMM in recent years (Hardy, Carter, & Bowden, 2016, Meacham, 2016).

If any university staff member received an invitation to participate from an external researcher, whether directly or forwarded from an internal address, it is unlikely they would have wondered if either the researcher, or they, needed permission from the organization. Instead, they would make an individual decision on participation or otherwise, and act accordingly.

We used several recruitment strategies. Since all the potential participants worked at universities and research institutes, a direct approach to these entities provided the logical and, indeed, preferred avenue. Organisations and associations whose members were likely to represent the target audience were also approached; these ‘umbrella’ groups were very supportive ofrequests for assistance with recruitment of participants and, more generally of the research. They extended an invitation to their members on behalf of the project team via broadcast email and social media. Another HREC-approved method of recruitment was via social media. Social media, which has no boundaries, proved itself to be a successful avenue for recruitment and due to its very nature and culture of sharing brought in responses from prospective participants based at many universities from which we had received no response to our initial request for approval to recruit their staff. Such responses did not violate ethics requirements, again bringing into question the merits of seeking institutional approval.

We did not interpret the requirement to obtain approval as being necessary for the ‘umbrella’ organisations as they do not have the same responsibility for, or duty of care to, the ECRs. This highlights another anomaly in the interpretation of the guidelines: what constitutes ‘an organisation’ from which approval might be required? So saying, we interpreted the ready agreement of these organisations to share the invitation, whether by distributing the link by email or by promoting it on social media, as implicit approval.

We recommend that HRECs amend their forms to permit researchers to offer further explanation about the nature of the people being recruited and their capacity to freely make a consent decision so that the Committee members can make appropriate decisions about the need for institutional approvals. We argue that these approvals should only be required when the research participants need a particular level of protection.

References

Hardy, M. C., Carter, A., & Bowden, N. (2016). What do postdocs need to succeed? A survey of current standing and future directions for Australian researchers.2, 16093. https://doi.org/10.1057/palcomms.2016.93

Meacham, S. (2016). The 2016 ASMR Health and Medical Research Workforce Survey. Australian Society of Medical Research.

Contributors

Katherine Christian, Federation University Australia School of Arts, Mt Helen Campus, Ballarat, Victoria

Carolyn Johnstone, Federation University Australia School of Arts, Mt Helen Campus, Ballarat, Victoria

Jo-ann Larkins, Federation University Australia School of Science, Engineering and Information Technology, Gippsland Campus, Churchill, Victoria

Wendy Wright, Federation University Australia School of Health and Life Sciences, Gippsland Campus, Churchill, Victoria[MI3]

Sources

Menzies Research Institute
https://www.menzies.edu.au › Research › Forms › HREC_Application_Form

Australian Catholic University
https://www.acu.edu.au/research/research-ethics-integrity-and-compliance/research-ethics
https://www.acu.edu.au › assets › Ethics_Guidelines_revised_March_2012

University of Melbourne
https://staff.unimelb.edu.au/__data/assets/pdf_file/0009/1977543/HRE-Application-Guidance-V-1.1.pdf

This post may be cited as:
Christian, K., Johnstone, C. Jo-ann Larkins, J. and Wright, W. (17 September 2019) The need to seek institutional approval to survey staff –was this a misunderstanding of the purpose of Guideline 2.2.13 in the National Statement on Ethical Conduct in Human Research?. Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/the-need-to-seek-institutional-approval-to-survey-staff-was-this-a-misunderstanding-of-the-purpose-of-guideline-2-2-13-in-the-national-statement-on-ethical-conduct-in-human-research

We respect you… we just don’t need to hear from you any more: Should the consumer and their community participate in research as partners instead of just being subjects?1

 

By
Dr Gary Allen| Senior Policy Officer, Office for Research Griffith University | Ambassador Council the Hopkins Centre|
Ambassador MS Qld | Member Labor Enabled| Senior Consultant AHRECS

Associate Professor Carolyn Ehrlich| the Hopkins Centre| Research fellow at Griffith University

On behalf of the consumer inclusion in ethics research project, The Hopkins Centre, Griffith University

Much has already been said about the significance of the 2018 update to the Australian Code for the Responsible Conduct of Research. The Australian Code describes the national framework for the responsible conception, design, conduct, governance and reporting of research. Collectively this is referred to as research integrity. The Australian Code has changed from a 37-page book of detailed and prescriptive rules to a six-page book of high-level principles and responsibilities.

This is not another piece arguing the pros and cons of the flexibility of principles or the certainty of a single national standard.

Instead, this is a discussion about an important idea, which was present in the 2007 version of the Australian Code, but that was discarded without explanation or acknowledgement in the 2018 update. This important idea relates to consumer and community participation and its extension to consumer and community involvement in research.

At provision 1.13 of the 2007 version of the Australian Code there was a simple statement that Australian research institutions and researchers should encourage and facilitate consumer and community participation in research. The provision was included in the 2007 version as one part of the implementation of the Statement on Consumer and Community Participation in Health and Medical Research (NHMRC and Consumers’ Health Forum of Australia Inc, 2002) and went on to underpin the updated version of that statement, which was released in September 2016.  The absence from the 2018 version of the Australian Code of even a brief reference to consumer/community participation in research is (or SHOULD be) a significant cause for concern.

That brief encouragement provided support for consumer-guided designs, research participants as co-researchers and action research across most disciplines. With a few sentences, it mainstreamed the Statement on Consumer and Community Participation in Health and Medical Research and reinforced the importance of consumers and communities beyond ‘just’ research subjects in medical research.

Examples of that participation include the role of consumers and community members:

  1. On a reference/advisory group (including providing lived-experience with regard to the focus, objectives and deliverables of a project)
  2. As co-researchers
  3. In providing lived-experience into the significance of risks, harms and burdens, and the degree to which the risks are justified by the anticipated benefits (see Pär Segerdah 2019).
  4. In providing valuable insights for service/clinical decisions (see Carlini 2019 for an example).

A real example of this working well is of Cancer Australia which mandates the inclusion of consumers in their funding scheme, both in terms of applicants articulating how consumers are engaged (in the ways outlined above and also as reviewers and members of the review panels that evaluate grants). The inclusion of consumers improves projects immeasurably.  Cooperative cancer trials groups have a consumer advisory panel or committee. It would be unimaginable to do cancer trials without consumer involvement in their design. Such community participation is also evident in the recently approved research strategy at Epworth Health.

The above matters (such as whether a project is addressing a genuine community need and whether the risks of the project are justified by its benefits) can be especially significant for vulnerable individuals, especially persons living with ‘invisible conditions’, whereby people may have symptoms or disabilities that might not be immediately obvious to others, and/or when the ‘subjects’ of research are vulnerable, over-researched, or historically disenfranchised. Rather than protecting them from harm, and without a clear mandate for involving them more fully in the co-design and co-production of research that directly impacts their lives, there is a real risk of unintended consequences whereby these people may become even more disenfranchised, over-researched and vulnerable research ‘subjects’.

It is important to acknowledge that the 2016 Statement remains in place, the National Statement on Ethical Conduct in Human Research (2007 updated 2018) continues to articulate the core values of justice and respect, and the new Chapter 3.1 of the 2018 update of the National Statement on Ethical Conductmentions co-researcher designs. More specifically, paragraphs 1.1(a) and 2.1.5 identify community engagement as an important element in research design and planning. The omission from the Australian Code (2018) is out of step with the National Safety and Quality Health Service Standard which calls (2012 p15) for consumer and community involvement in deliberations about risk.

What is a concern now is that the overarching Australian Code for the Responsible Conduct of Research no longer urges publicly-funded research institutions to encourage consumer and community participation in research beyond them being the subjects of research.  On balance, this appears to be inconsistent with other relevant national research standards issued by the same agencies as the Code.

Those voices and perspectives were around before the 2007 version of the Australian Code and hopefully, they will continue to be into the future. That is true because it is becoming more widely accepted that consumers, such as people living with a chronic disease or disability and their carers, have a valuable perspective and a voice that should be listened to. One way a research project can have impact is by heeding those voices and meeting the needs of those Australians. However, in the 2018 update of the Australian Code, there is no longer an obligation on Australian institutions and researchers to encourage and facilitate consumer and community participation in research.

But will the same amount and scope of consumer and community-engaged research be conducted without that encouragement in the Australian Code?

It seems we are about to find out. We just wished there had been a national discussion about that change first – including targeted engagement with the populations who are now no longer encouraged to collaboratively participate in research, and who will potentially be relegated back to a position of being a subject within researcher designed projects and studies.

One way the current situation could be addressed would be in a good practice guide. The Australian Code (2018) is complemented with good practice guides, which suggest how institutions and researchers should interpret and apply the Australian Code’s principles and responsibilities to their practice. A good practice guide for collaborative research could reinforce the importance of consumer and community participation in research.

REFERENCES

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

NHMRC(2007) Australian Code for the Responsible Conduct of Research

NHMRC(2007 updated 2018) National Statement on Ethical Conduct in Human Research

NHMRC (2016) Statement on Consumer and Community Involvement in Health and Medical Research

NHMRC (2018) Australian Code for the Responsible Conduct of Research

NSQHS (2012) National Safety and Quality Health Service Standards

Pär Segerdah (2019) Ask the patients about the benefits and the risks. The Ethics Blog. Retrieved from: https://ethicsblog.crb.uu.se/2019/01/16/ask-the-patients-about-the-benefits-and-the-risks/

ACKNOWLEDGEMENTS

With grateful thanks to the following people for their contributions:

Delena Amsters, QHealth
Mark Israel, AHRECS
Mandy Nielsen, QHealth
Michael Norwood, Griffith University
Maddy Slattery, Griffith University
Colin Thomson AM, AHRECS
Nik Zeps, AHRECS, Epworth Healthcare

This post may be cited as:
Allen, G. & Ehrlich, C. (21 June 2019) We respect you… we just don’t need to hear from you any more: Should the consumer and their community participate in research as partners instead of just being subjects? Research Ethics Monthly. Retrieved from: https://ahrecs.com/research-integrity/we-respect-you-we-just-dont-need-to-hear-from-you-any-more-should-the-consumer-and-their-community-participate-in-research-as-partners-instead-of-just-being-subjects

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

 

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