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
- 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
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.
……..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.
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.
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