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Reflections on chairing a human research ethics committee0

 

Prof Colin Thomson AM

Chairing an HREC can be complicated, demanding, stressful and tiring but also stimulating, rewarding, satisfying and hugely enjoyable. In this article, I reflect on my experience of being a chair of four HRECs in universities, public health organisations and public sector agencies. Of course I accept, from watching a number of other committees, the ways chairs guide committees to their decisions vary widely, express different personal experiences and can be affected by an institutional environment. As a result, these reflections are not intended to appear as a set of instructions for other chairs.

 

The invitation

So, where to begin? One point is at the invitation: am I equipped to take on this role and what do I need to know about the committee and the institution it advises? An HREC chair requires some exposure and familiarity with the ideas that are central to the ethics of human research and a sense of what reaching a decision in an ethics review requires. Ethics committees are unlike typical administrative committees in some significant aspects. The central difference is the nature of the subject matter and the decisions that need to be made: of their nature, they are less definitive than administrative decisions but share, with those, the need for adequate reasons and justification. In this tension between ethical judgement and adequate justification lies their challenge.

AHRECS offers a coaching service for Chairs (and for HRECs/RECs).  This involves observations of 3 committee meetings, meetings with specialist  consultants and a written report. Email coaching@ahrecs.com to find out more.

Other personal considerations include not only do I have the time but what is important to me in the role? For me, this has not been one consideration but a blend. The intellectual challenge of sound ethical analysis, appreciation of the creativity and skill of good research design and the refinement of inter-personal skills: all harnessed toward enabling ethically sound human research.

 

Decision-making

HREC decisions are rarely clear approvals or rejections but tend to be conditional: of the ‘not yet approved’ kind. Notification of those decisions should provide clear reasons and  practical advice: committees show respect for researchers by providing reasons for the outcome and advice about responding. At the same time, outcomes should fairly reflect the position that the committee has come to – and this can be difficult.

I have always found it challenging recapping and summarising fairly and accurately what different members of the committee have said and blending those into a reasonably clear outcome that the HREC can agree to at the meeting. Doing so is much easier after the meeting when settling the minutes and providing advice to applicants. But are such clarifications what the committee has agreed to or are they expressing a chair’s preference for the outcomes?

One discussion strategy that I watched with admiration in in one committee and tried, with some success, to emulate was to follow the same order of issue category for each proposal:

  1. does the proposal have value and validity and, if not, what do we need to know to be satisfied that it does?
  2. what risks to participants or others does the project involve; how is it planned they will be mitigated and are we satisfied with the level of mitigated risk?
  3. how are participants being recruited and how is their consent being sought, gained and recorded?
  4. are there issues of fairness in the imposition of burdens of participation on a particular population?

This worked well because members who, for example, would always have questions about consent, knew that they did not need to raise them at the start of the discussion of that proposal because that subject matter would be addressed in due course.

It also made it easier to recap the committee’s discussion. Sometimes it can be useful to do this at the conclusion of the discussion of each category – doing so meant that I did not have to remember all that was said 15 minutes ago or rely on notes taken while I was listening. Further, I found that it could be as inclusive as starting with an open invitation for ‘any comments’ and also avoided disordered and repetitive discussion.

I did find that acceptance of such a structure by a committee used to lack of structure took longer and required constant reinforcement. I came to realise that it was practice, rather than prescription, that generated acceptance of the strategy but maintained a relaxed and comfortable informality.

 

Working with an HREC

Here, a skill that comes with getting to know a committee well is knowing who to refer to, of whom to ask questions, who is likely a waste time with irrelevant matters and how to courteously persuade them to desist. These are generic chairperson skills but the nature of discussion at an ethics committee can make them more sensitive because ethics opens a wide arena for personal yet legitimate and relevant opinions. Dismissing one of these requires tactical use of reasoned ethical analysis lest it be treated as merely personal.

A central feature of an effective chair is to have the ongoing confidence and support of all members of the HREC, even if there are differences of opinion as to proposed outcomes of a review. I have chosen not to introduce each application with my own analysis and my recommended conclusions. My preference has been for discussion and development of a consensus view rather than to aim for an outcome that, in anticipation, I would have preferred. Doing so reduces the risk of closing down discussion and, depending on the relative status or perceived status of the chair vis-vis other members, chilling some members’ input.

I learned very early that I lacked depth in a number of perspectives that are intended to be reflected in the composition of the committee. This is of central importance: the decision is a decision of the whole committee and one that the whole committee can agree to. Frequently, the outcome I foresaw in reviewing an application in preparation for a meeting was not the one that the HREC reached. In preparing for meetings, as a result of these experiences, I would identify issues that, in my view, needed more attention from the researcher but I learned to remain open to other issues that had not occurred to me.

Following a meeting in which such an outcome is reached, the ongoing challenge is to explain to an often disgruntled researcher why the committee reached that view and why further refinement or modification of the application is needed for approval. Here, the burden often falls on the chair and the HREC executive officer. However, where the difference between a researcher and the committee lies in, for example, the traditions of the research discipline involved, I have tried to include the appropriate researcher member of the HREC in order to demonstrate respect to the researcher and to the committee.

There is a tension between the authority that a chair is often seen to have and the humility that a chair needs to bring to the role. The authority of the chair is not the same as the authority of the committee, even if some researchers think that it is or should be. Because it is essential that a committee be seen to be the decision-maker, explaining those decisions often requires more input than just from the chair.

 

The background of a chair

Would these challenges be reduced if, unlike me, chairs were also active researchers? From a committee point of view a researcher-chair is likely to generate considerable respect from the members of the HREC but, because of her very expertise, may also chill contributions from those with far less research awareness. From an institutional point of view, appointment of a researcher does add status to the committee which is, in many people’s eyes, essentially a research activity. However, any researcher chair will have disciplinary boundaries and it can be difficult to represent the committee’s ‘not yet approved’ decisions to researchers from completely different fields. In my experience, this has generated unintended tensions for some chairs.

This raises another more general issue as to whether a chair should be an institutional employee or external to the institution. There are benefits and shortcomings in each. An internal chair will know the institutional landscape and culture and can bring stature to the committee: the appointment itself can testify to the importance that the institution attaches to the HREC. The shortcomings will often be related to research fields, as noted above. For external chairs, the degree of independence can also add to the status of the HREC, particularly where the reputation, professional status or achievements of the chair can signal to committee members and researchers the importance the institution places on the committee’s role. On the other hand, an external chair will usually have limited knowledge of an institution, of its ethos and its culture and this can limit effective communication: particularly in outreach activities.

Beyond the HREC processes, chairs can make significant and valuable contributions to an institution’s research culture by representing the HREC at governing body meetings; participating in outreach activities to promote awareness of (and debunk myths about) a committee and participate in professional development in human research ethics.

 

Enjoying meetings

My final comment echoes the final quality that I suggested at the beginning of this short reflection. HREC meetings should be enjoyable: it is a place where thoughtful, committed and articulate people come together and, so long as they respect and are willing to listen to one another’s points of view, can be an environment in which intelligent and enjoyable, even light-hearted (but not cynical), conversation adds to the fulfilment of an important and worthwhile role.

Contributor
Prof. Colin Thomson AM | Senior Consultant AHRECS | AHRECS profile | colin.thomson@ahrecs.com

This post may be cited as:
Thomson, C. (23 April 2019) Reflections on chairing a human research ethics committee. Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/reflections-on-chairing-a-human-research-ethics-committee

Conducting research with (not on) consumers in health – exploring ethical considerations0

 

Authors: Joan Carlini,1 Kristen Ranse,2 Noela Baglot,3 and Laurie Grealish2

1. Griffith Business School, Griffith University, Southport campus, Queensland. Email: J.Carlini@Griffith.edu.au.
2. Menzies Health Institute Queensland and School of Nursing & Midwifery, Griffith University and Nursing & Midwifery Education and Research Unit, Gold Coast Health.
3. Health service consumer.

Growing healthcare demands and limited resources raises concerns about the sustainability of practical benefits resulting from research. The Consumers’ Health Forum of Australia and the National Health and Medical Research Council have developed a Statement on Consumer and Community Involvement in Health and Medical Health Research to better align the health and medical research with community need and improve research impact.  However, the traditional research-to-practice pathway can result in findings that are not “implementable”, which has led to the active recruitment of consumers’ views in co-design of interventions.  Consumers are now recognised as valuable knowledge resource to improve the relevance and translation of research into practice.

Co-design with consumers and community organisations

Co-design is the practice of consumers and suppliers, such as researchers and clinicians, coming together to look at a problem and design a solution together.  Consumer engagement in healthcare is considered critical to safe and high quality services. While health service consumers, often labelled as patients or clients, are the subject of research in order to better understand health and illness, engaging consumers in the conduct of research is emerging as an important area for consideration in health service research.

In healthcare, co-design can strengthen the relations between the community and academia, and ensure the relevancy of the research question and intervention. Despite the benefits of using co-design, there are also unique challenges that can become apparent. The co-creation process involves collaboration between researchers and consumers from the outset, making pre-specification of interventions unlikely.

End of life project background

In our project, researchers partnered with clinicians and consumers in the development of an intervention to support people near end of life to achieve a death at home. Consumers were involved in developing the intervention, which consisted of (1) a brochure outlining key considerations to achieve a death at home and (2) the process of discharge home near end of life. Consumers were members of two design groups, one for each part of the intervention and others attended a workshop to review the brochure and process. Please see our earlier article for more information.

Unlike participatory action research, in co-design consumers are focused on the intervention rather than the research process itself. Consumers contributed to the quality of the information that people might need when considering a death at home, including the processes that facilitated the transition home.

Method of engagement

In the co-design process, researchers modified established research techniques, such as nominal group technique, to distil those features of the discharge process and brochure that were considered most important. The group negotiated importance and inclusion of various elements in the drafting process. In these discussions, the importance of some elements were not equally valued by consumers, clinicians and researchers leading to rich and robust debate. The groups met over five meetings and through these meetings developed rapport that enabled frank discussion and the ability to work towards consensus that was consumer-led.

Ethical principles applied

The importance of engaging with consumers as partners in research must be carefully considered in the design and conduct of research to ensure that ethical principles are upheld. In considering how consumer engagement can support the research project’s fulfilment of ethical principles, including those in the National Statement, we consider the following:

Voluntary

The consumers involved in the project were invited to attend based on their history as a health consumer and interest in end of life care.  Their engagement in the project was voluntary, and they had the freedom to participate at a level of their choosing (i.e., attend meetings, community forum, out of session meetings).

Nonmaleficence

The researchers took care to ensure that the wellbeing of the consumers was maintained. One consumer’s recent lived experience with the topic meant that the researcher would informally check-in on the welfare of the consumer and gather feedback on the process, participation, and interactions of the previous meeting.

Beneficence

The group Chairs carried responsibility to support the group to establish a shared vision about the value of keeping the person who is dying at the centre of care. The complexities of how beneficence can be achieved, and possible barriers, emerged during meeting discussions and this information was used to support the implementation plan. For example, as the discussions progressed, the value of a formal family meeting and the need for general practitioner and transition nursing support was considered essential to enact patient and family well-being.

Consumers were included as committee members and accepted as part of the group, with all group members, who were representing a range of stakeholders with an interest in discharge home near end of life, invited to contribute their views at each meeting. All stakeholders were valued as being integral to the solution. In this project, consumers were considered as experts, understanding what happens outside of hospital and in the community, and directing the researchers to focus on family limitations as well as strengths. Because the group members were focused on the same, shared goal early in their work together, the process provided respect for families who decide to die at home, as well as those who may need to return to hospital.

Fidelity

Minutes were taken at each meeting, with action items discussed at the beginning of each meeting. Member were accountable for actions that they had agreed to undertake, with outcomes discussed at the meeting. The finalised draft of the two documents, the information brochure and discharge process, were circulated to the consumers, as members of the respective design groups, for comment. The consumers’ commented on how pleased they were to see the tangible outcome.  In another example, when one researcher (JC) was preparing this article, she spoke with one of the consumers about her experience with the co-design approach of the project.  Later, when the researcher provided a hard copy of the draft article to the consumer, she responded happily that her view “was well developed & expressed clearly”.

Respect

Respect for consumers who would be using the intervention was considered important during the groups’ deliberations. For example, consumer members of the information committee, tasked to design a brochure to support patients and families, were invited to review readily available resources about dying at home available in Queensland and other Australian jurisdictions. Through this activity, they were able to identify the information and conversations that would be most important in the local context. They also contributed to the language used in the brochure, supporting the use of example questions to focus health professionals on what was important to the consumer, making the planning process more personalised.

Justice

In relation to justice, this intervention and associated project provides guidance on the appropriate clinical and non-clinical people and resources that can enhance a person and family’s experience of dying at home. In the Gold Coast community, this project provides a vehicle for people living with chronic, life limiting diseases to imagine an end of life experience that is not in the hospital. Within the brochure, information about the financial, social and personal challenges of caring for a person at home is explored, ensuring that people have awareness of those challenges and can plan for them.

Safety

All members of the co-design teams should be well supported in a safe environment. A structured timeline indicating the milestones were developed in advance, thus setting a framework for meeting agendas.  This structure allowed participants to feel secure in knowing the process, approaches and activities that would be covered.  Both of the Design Group chairs were experienced researchers and knowledgeable about the process of co-design. As Chairs, they ensured that the conduct of all members were respectful, hence creating a safe and supportive atmosphere.

The future of consumer engagement in research

Based on our experiences, consumers as experts on health services added value to the outputs of the design process. In this study, there were specific value assumptions associated with consumer engagement in the intervention design process, including:

  • Clear expectations of consumer contribution, the anticipated project outcomes, and some knowledge or experience of the issue under investigation enhances contribution;
  • Consumers require formal training in consumer advocacy and require the time, understanding and passion to sustain their commitment; and
  • Engagement is enhanced by effective communication in regard to formal agendas, written minutes and ongoing personal communication.

Image source: Gold Coast Hospital Health Service, Achieving end of life care at home, A guide for patients and their family carers (2019)

In our case, consumers with experience of end of life care, as either a family member or a paid carer, were able to make a sound contribution that enhanced discussions and the final product. Other stakeholders including clinicians from the hospital, community health service providers and researchers expressed learning from the insights provided by the consumers.

In this project, consumer engagement through co-design was limited to developing the intervention. Consumer contribution has been found to enhance scientific and ethical standards, provide legitimacy and authority, and increases project credibility. Our experience resonates with these findings.

As consumer advocacy training becomes more sophisticated, there are clear opportunities to involve consumers more actively as members of research governance groups and in some cases, research teams. Consumers bring an experiential perspective, often grounded in local context that can be particularly helpful in translational or implementation research, an emerging research discipline in Australia. We invite other researchers, consumers and clinicians to contribute to this constructive conversation about the value of involving consumers in research co-design, with a view to satisfying the national quality standard in health care, focused on Partnering with Consumers. Not only can the quality of research improve, but consumer engagement can assist with focusing on matters of importance to the local community, increase public confidence in research through openness and transparency, and increasing local community understanding of research.

Acknowledgement

This project was supported by a Queensland Health Clinical Excellence Division, Care at End of Life SEED funding grant (2018). Project team members include Grealish, L., Cross, A., Sharma, S., Carlini, J., Ranse, K., Hiremagalur, B., & Broadbent, A..

This post may be cited as:
Carlini, J., Ranse, K., Baglot, N. and Grealish, L. (26 February 2019) Conducting research with (not on) consumers in health – exploring ethical considerations. Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/conducting-research-with-not-on-consumers-in-health-exploring-ethical-considerations

 

Sage Methods Minute. January Spotlight: Research Ethics0

 

January’s Methods Minutes, a monthly newsletter produced by Sage Publishing, is a special issue focused on social research ethics. It reviews two articles and one book from Sage’s extensive collection on research ethics and also links to an article by Janet Salmons on the importance of research ethics in an ethics-challenged world. Finally, it introduces a video of Mark Israel (AHRECS) discussing the importance of integrating ethical principles in the design of the project from the outset.

The full page can be seen at http://info.sagepub.com/q/1fcUbqkq9C2tGu15bd0Q65f/wv

Contributor
Dr Mark Israel. Senior Consultant AHRECS
AHRECS profilemark.israel@ahrecs.com

This post may be cited as:
Israel, M. (26 February 2019) Sage Methods Minute. January Spotlight: Research Ethics. Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/sage-methods-minute-january-spotlight-research-ethics

Consumer Co-design for End of Life Care Discharge Project0

 

In this issue, we are publishing an account of an end-of-life project in whose design there are some features that add to its ethical interest. Many of us are familiar with institutional policies about consumer engagement in human research and have served on project reference groups, but perhaps have less experience with the successful – and ethical – implementation of these. This project may add some valuable understanding of these matters, including:
.

  • 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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