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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

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

Smarter proportional research ethics review0

 

Rushing toward a faster review decision should not mean relaxing standards or playing chicken with stricter central control

Gary Allen, Mark Israel and Colin Thomson

Too often, there is a danger that ‘expedited ethical review’ (a term not used in the National Statement since 1999) might equate to an approach that abridges the review process to the point where it’s little more than a friendly exchange between peers or a nod to seniority. We won’t call out the well-reported cases where it is hard to fathom how they were granted ethics approval. Such cases should make us uncomfortable, because they are invitations to replace institutional self-regulation with something hasher and unsympathetic.

Don’t get us wrong, we’ve spoken often and enthusiastically about the value of well-designed proportional review arrangements. We have assisted many clients, large and small, to design and implement such arrangements and believe that they form part of a well-conceived review system.

A proportional review arrangement can deliver a review outcome much faster than consideration by a human research ethics committee, but instead of a ‘Claytons’ or mock-review, it should have the following features:

  1. While there can, and should, be a mechanism to do an automated quick self-assessment of whether a proposed project qualifies for ethics review other than by a research ethics committee, the process should:
    1. not rely on questions along the lines of “Is this a low risk research project?”
    2. draw on, reference and link to guidance material.
    3. when using trigger questions, ensure they are nuanced, with probing sub-questions.
    4. include confirmation of a quick assessment by an experienced ethics officer or chairperson.
    5. retain an applicant’s responses, both as a record of what they said about the project, and for future evaluation of whether the arrangement is correctly assessing new projects and guiding applications along the correct review pathway.
  2. The process should preferably be online, easily (re)configurable, easily auditable, with information entered by applicants and ‘triaged’ by an ethics officer.
  3. A quality online system will populate committee papers and reports, will issue reminders and will populate with known information.
  4. While many projects may be reviewed outside of the human research ethics committee, the reviews should be conducted by experienced persons, who participate in annual professional development and who can draw upon internal and external policy and resource material.

In Australia, an institution’s proportional review arrangements might include the following pathways:

  1. Prior review– Research that has already been reviewed by another HREC, appropriately delegated review body, or an international body equivalent to an Australian research ethics review body.
  2. Scope checker– A test to confirm whether a proposed project is in fact human research.
  3. Exemption test– A test to determine whether the proposed research is a type an institution could exempt from ethics review as per the National Statement.
  4. HREC review required test– A test to confirm whether the research project is of a type the National Statement specifies must be reviewed by a HREC.
  5. Institutional exemption test– Many institutionsexempt some categories of human research from research ethics review (e.g. universities often exempt course evaluations and practical activities for a teaching-learning purpose).
  6. Negligible risk research– Subject to qualifying criteria an institution might establish a negligible risk review pathway in which applications are considered administratively.
  7. Low-risk, and minimal ethical issue research– Subject to qualifying criteria, proposed projects that are low risk and have minimal ethical sensitivity could be reviewed by the chair of the research ethics committee.
  8. Low-risk, some ethical issue research– Again subject to qualifying criteria, proposed projects that are low risk but have some ethical sensitivity could be reviewed by a small panel of the research ethics committee (including external member of the committee).
  9. HREC review – Only human research (see 2), that has not previously been reviewed (see 1) that is not exempt (see 3 and 4) and has not been classified as negligible risk (see 6) or low risk (see 7 and 8) needs to be reviewed by HREC.

An arrangement with the features listed above would allow for review that is proportional, timely, efficient and justifiable. Reviews that are merely expedited or fast places us all at risk. The increasing examples of “how could that have been approved?” makes it feel as though some institutions are gambling that a desire to meet researchers’ calls for quick, if superficial, review won’t be exposed by unethical practice. Perhaps they are correct, but every new reported review misstep makes us more nervous. Realistically, establishing a nationally administered reliable, robust and agile proportional review process requires substantial investment of time and other resources so is unlikely to happen.  But, what poor review processes could do is invite far more detailed direction on how institutions can design, conduct and monitor processes outside of a HREC. In our experience, there are greater and longer-lasting benefits that can accrue from an institution having a high quality approach to proportional review.

The above is a summary of the discussion we typically include in blueprint documents about establishing a robust proportional review arrangement. We have included some further notes on this topic on our https://www.ahrecs.vip and Patreon pages.

Please contact us at proportional@ahrecs.com if you would like to discuss how we might assist your institution.

This post may be cited as:
Allen, G., Israel, M. & Thomson, C. (26 August 2019) Smarter proportional research ethics review.  Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/smarter-proportional-research-ethics-review

Research Ethics Review as a Box-Ticking Exercise0

 

Associate Professor Angela Romano | Faculty Research Ethics Adviser, Creative Industries Faculty, Queensland University of Technology

 

My role as a university Research Ethics Advisor involves an interesting range of activities, although sadly there is less actual advising than I would like. As Faculty Research Ethics Advisor (FREA) for the Queensland University of Technology’s Creative Industries Faculty, I review ethics applications for a wide variety of projects, ranging from negligible risk to high risk; manage a team of six Research Ethics Advisors, who review applications for projects with negligible to low risk; conduct training workshops and drop-in sessions for researchers to seeking advice research ethics; and answer queries about multitudinous ethics-related issues.

In practice, however, most of my work relates to checking ethics applications that are submitted in order to ensure that they are ready for review, then overseeing the review process and completing the associated paperwork. Since I commenced the FREA’s role almost a year ago, I have tried to increase the number and depth of conversations with colleagues and research students about broader issues of ethics, rather than simply how to complete an application. I see the culture changing, but most discussion continues to be initiated by an onus to complete ethics applications and focuses on application requirements.

A long-held critique voiced by Western scholars about the review of human research ethics is that the process is excessively focussed on box ticking and bureaucratic compliance rather than meaningful deliberation about ethical issues (Floyd & Arthur, 2012; Johnsson et al., 2014; Schrag, 2011). Sociology and law professor Gresham Sykes forecast this problem more than 50 years ago when he noted: ‘There is the danger that an institutional review committee might become a mere rubber stamp, giving the appearance of a solution, rather than the substance, for a serious problem of growing complexity which requires continuing discussion’ (Sykes, 1967, p. 11).

Many contemporary research articles about human research ethics boards and review processes decry this so-called box ticking or rubber stamp mentality, but usually these articles discuss review boards or processes without considering the mindset of researchers themselves. As a FREA at a major Australian university, I see substantive numbers of researchers who would actually welcome a more rudimentary ‘tick and flick’ process, with short, simple forms that would promptly grant them a rubber stamp of institutional endorsement.

I have witnessed this attitude in many research teams in which research assistants, project managers or research students are given primary or sole responsibility for research ethics and the writing of ethics applications, with little to no input or oversight from team supervisors or leaders. Such conduct would not be tolerated in any other area of research activity. Those same research team leaders would never request their research assistant to write an application for a major research grant, ask their project manager to draft an article for a respected journal, or instruct one of their master’s or doctoral students to submit a report for Confirmation of Candidature or other major study milestone without a senior team member providing major input and checking the text prior to submission. Ethics applications are not directly attached to any KPIs, so these researchers simply do not see the writing of an ethics application as warranting the same level of attention.

At an institutional level, there is substantial variation among research leaders and administrators in their grasp of the principles of research ethics and their fondness for a box ticking approach. In my discussions with staff from different universities, I have heard numerous research leaders argue research ethics advisors and reviewers should ‘stick to ethics and stop providing feedback about methods’. The head of one research centre leader told me in all seriousness that ethics committees should not request amendments in an ethics application if their review processes reveal that ‘the project sucks’ as long as there were no ‘ethical problems’ such as risk of harm to participants.

One academic who held one of the most senior research leadership positions in his university was surprised when I explained to him that researchers could not simply state what methodology they were using , such as focus groups, then be given a checklist of the ethical risks that applied to that particular methodology. He told me that he had not realised the ethics committees needed to know details about the exact methods being used, nor had he previously considered that the risks relating to each element of the project might change according to numerous contextual factors, such as the topic being studied, the location of research, the nature of recruitment, and the age, education levels, employment and cultures of participants.

Such comments indicate a perspective about research ethics that is fundamentally at odds with the approach that is outlined in the National Statement on Ethical Conduct in Human Research(2018), which sets standards for human research in Australia. The National Statement is based on the premise that research ethics and methods are inextricably linked. Itdefines ‘merit and integrity’ as essential components of ethical research (Section 1). For a research project to have merit and integrity, it must be designed ‘using methods appropriate for achieving the aims of the proposal’; be conducted by researchers with ‘experience, qualifications and competence that are appropriate for the research’; and be supported by ‘facilities and resources appropriate for the research’ (Section 1.1). Section 3.1 outlines ethical issues in seven overlapping phases that occur in most human research, these being ‘Recruitment’, ‘Consent’, ‘Collection, Use and Management of Data and Information’, ‘Communication of Research Findings or Results to Participants’, ‘Dissemination of Research Outputs and Outcomes’ and ‘After the Project’.

It is hard to see how any research leader who is familiar with the National Statementcould define human research that ‘sucks’ or has manifest methodological problems as ‘ethical’, yet I have encountered this mindset surprisingly often. From my observation, scholars who believe that there is only a limited connection between research methods and ethics will also often express simplified notions about ethics assurance and demonstrate a fondness for ticking boxes and using cut-and-paste responses.

A number of scholars have argued that rather than rely on box ticking and a culture of enforcement through form filling, research institutions should build reflective practice about research integrity by developing resources and supporting professional development (Allen & Israel, 2018; Israel & Drenth, 2016). I agree with that perspective, but believe those researchers who favour a box ticking approach will have no impetus to change until their employers and funding institutions demonstrate that they value and reward a reflective approach to ethics in the same way that they show they value and reward successful grant applications, research publications or research student completions.

REFERENCES

Allen, G., & Israel, M. (2018). Moving Beyond Regulatory Compliance: Building Institutional Support for Ethical Reflection in Research. In R. Iphofen & M. Tolich (eds). The SAGE Handbook of Qualitative Research Ethics (pp. 276-289). London: Sage.

Floyd, A., & Arthur, L. (2012). Researching from within: External and internal ethical engagement. International Journal of Research & Method in Education, 35(2), 171-180. doi: 10.1080/1743727X.2012.670481

Israel, M., & Drenth, P. (2016). Research Integrity: Perspectives from Australia and Netherlands. Handbook of Academic Integrity, 789-808.

Johnsson, L., Eriksson, S., Helgesson, G., & Hansson, M. G. (2014). Making researchers moral: Why trustworthiness requires more than ethics guidelines and review. Research Ethics, 10(1), 29-46. doi: 10.1177/1747016113504778

National Statement on Ethical Conduct in Human Research 2007 (Updated 2018). The National Health and Medical Research Council, the Australian Research Council and Universities Australia. Commonwealth of Australia, Canberra.

Schrag, Z. (2011). The case against ethics review in the social sciences. Research Ethics, 7, 120-131. doi: 10.1177/174701611100700402

Sykes, G.M. (1967). Feeling our way: A report on a conference on ethical issues in the social sciences. American Behavioral Scientist, 10(10), 8-11.

This post may be cited as:
Romano, A. (22 June 2019) Research Ethics Review as a Box-Ticking Exercise Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/research-ethics-review-as-a-box-ticking-exercise

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