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Empowering and enabling participation in human research: Reflections from two Queenslanders living with Multiple Sclerosis0

 

Dr Gary Allen
MS Qld Ambassador | AHRECS Senior Consultant | Member NS s4 review committee


Natalie Walsh
MS Qld Community Engagement Manager

Participation in ethical human research often provides four positive opportunities for persons living with MS:

(i) A welcome distraction from the sometimes-cruel realities of living with this progressive neurological condition.

(ii) An opportunity to provide insight into the practical challenges of symptoms that may be invisible to observers other than family, close friends and carers, and to give voice to the experiences of persons who are disenfranchised.

(iii) Access to whatever benefits are anticipated as a result of a project.

(iv) An opportunity to make a positive contribution to the body of knowledge and/or other public good.

The exclusion of people living with MS from research is a concern with regard to the ethical values of Justice (e.g. NS 4.5.3) and Beneficence because it denies access to the benefits described above, on the grounds of a disability. It is also a merit and integrity concern because, if a section of the community is excluded from a research project, there is at least the possibility the results might be different for people living with MS.

Prevalence in society
In Australia 1 in 5 people live with a disability. The average age of people diagnosed with MS is just 30 and 3 out of 4 are female.

On average, more than 10 Australians are diagnosed with MS every week. There are over 25,600 people in Australia living with MS, including 4,970 Queenslanders and the condition affects each person differently. The progress, severity and specific symptoms of MS cannot be predicted. MS is a lifelong condition for which a cure is yet to be found. However, doctors and scientists are making discoveries about the treatment and management of MS every day.

MS is one of the most common chronic neurological conditions of the Central Nervous System and may affect the brain, spinal cord and optic nerve and impacts more young people in Australia than any other chronic progressive neurological disease.

Symptoms and research
It is important to note that the symptoms associated with MS can be different differ in both presentation and severity for each individual.

Symptoms of MS will vary and are unpredictable.  No two people will experience the same symptoms to the same degree. Symptoms can come and go, and can also be affected temporarily by other factors such as hot weather or an infection.

Although MS can cause a wide variety of symptoms, most people only experience a small number of these.  For most of the common MS symptoms, there are now many effective forms of symptom management. It is also important to note that the symptoms listed here are not exclusive to MS and can appear in many different neurological conditions.

The symptoms of MS can be both visible and invisible to others and include:

  • Changes in memory, concentration or reasoning
  • Slurring or slowing of speech
  • Extreme tiredness (unusual fatigue): a debilitating kind of general exhaustion and weariness which is unpredictable disproportionate to the activity
  • Visual disturbance, including blurring of vision, double vision (diplopia), inflammation of the optic nerve (optic neuritis), pain and (rarely) loss of vision
  • Dizziness and vertigo
  • Emotional and mood changes
  • Pain
  • Altered sensation, such as tingling, numbness or pins and needles
  • Altered muscle tone, such as muscle weakness, tremor, stiffness or spasms
  • Difficulties with walking, balance or coordination: – these include loss of balance, tremors, unstable walking (ataxia), dizziness (vertigo), clumsiness of a limb, lack of coordination, and weakness (affecting in particular the legs)
  • Sexual changes
  • Bladder and bowel changes
  • Sensitivity to heat and/or cold

Exclusion
The exclusion of persons living with MS can typically occur in one of two ways:

(i) Intentionally because of the perceived vulnerability of the population, especially if an individual’s symptoms include impact on executive function, such as cognition and memory.

(ii) Unintentionally
……..a. because the research activities don’t accommodate the limitations imposed by an individual’s symptoms.
……..b. because communication is not extended to the networks outside of the research community.

Empowering and enabling participation
The exclusion of persons living with MS from research should be limited to circumstances where an individual’s symptoms would confound the collected data (e.g. a person with a severe intention tremor in their lead hand is unlikely to be able to quickly draw a shape they saw) or where they are especially vulnerable to harm (e.g. high-intensity exercise when their symptoms include autonomic impact on their cardiovascular system).

Rather than excluding potential participants who live with MS, researchers and review bodies are encouraged to consider:

(i) Whether the complexity of the research and nature of the risks are such that the competence of potential participants should be established. This might be explored in a simple conversation, as is recommended by paragraph 4.5.10 of the National Statement, e.g.

…….a. in the case of low risk anonymous data collection, accepting consent without establishing competence.

…….b. considering strategies to scaffold consent and respecting the wishes of individuals, even if substitute consent is required.

…….c. including a support person to provide individual assistance to participants

(ii) Conducting testing in a cool and bright location and at preferred times, such as mornings.

(iii) Allowing participants to request rest breaks with refreshments available

(iv) Supporting screen readers and closed captioning.

(v) Supporting suitable interface controls other than a mouse.

(vi) Reimbursing transport, parking or companion costs if travel is required.

Reference groups
The establishment of a reference group can be a valuable way to explore whether the anticipated benefits of a project are perceived as justifying the risks (as recommended by paragraph 2.1.5 of the National Statement), whether the support strategies are sufficient, and whether the language of the recruitment and consent materials are appropriate.

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

This post may be cited as:
Allen, G. & Walsh N. (1 October 2019) Empowering and enabling participation in human research: Reflections from two Queenslanders living with Multiple Sclerosis. Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/empowering-and-enabling-participation-in-human-research-reflections-from-two-queenslanders-living-with-multiple-sclerosis

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

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:
.

  • 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

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