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Why do we need Category D appointments on HRECs and how should we find suitable people?0

 

Judith C S Redman

The compulsory presence of the Category D members on Australian Human Research Ethics Committees (HRECs) can be controversial. Category D used to be termed ‘minister of religion’ and most HRECs recruited ordained Christian ministers to fill these roles, although at least one of the Monash University HREC Category D members has been a rabbi (recruited by me). People question the need for a ‘religious perspective’ on HRECs, especially on those that regularly look at research concerning issues like abortion, contraception or euthanasia, or stem-cell research where ‘the Church’ is seen to have negative stances. I am a Uniting Church minister and a long-term university chaplain, which makes me a prime target for recruitment to the Category D position on university HRECs. I am currently in my 18th year as a Category D appointment, serving my fourth university. Clearly, it is something I find interesting and rewarding and I would like to offer some comments on the nature of the position.

First, referring to the category as ‘minister of religion’ is misleading, because the role is not to provide a religious perspective per se. ‘Minister of religion’ was included as a category (along with lay woman, lay man and member external to the institution) in the First Report by the NH&MRC Working Party On Ethics in Medical Research published in 1982 (p 20) and incorporated into the first National Statement published in 1983. In the 1999 version of the National Statement, the position was listed as: ‘at least one member who is a minister of religion, or a person who performs a similar role in a community such as an Aboriginal elder’ (NHMRC, 1999, p 16 – emphasis mine), thus hinting that it was not the minister’s religious perspective that was being sought. In fact, even when Australian society was far less multi-faith than it is today, no one clergy-person could provide a representative religious perspective. The 2007 National Statement made the purpose more overt in describing the category as ‘at least one person who performs a pastoral care role in a community, for example, an Aboriginal elder, a minister of religion’ (NHMRC, 2007 p 81). This wording has carried across to the current revision. (NHMRC, 2018 p 87).

What, then, is it that Category D members of HRECs bring to meetings? What is pastoral care? Finding a simple definition is somewhat challenging but Grove (2004, p. 34) defines it as ‘all measures to assist an individual person or a community reach their full potential, success and happiness in coming to a deeper understanding of their own humanness’. Pastoral carers are not therapists, but they do come into contact with human beings at high and low points of their lives. Often, however, they see more every-day lows than those that typically cause people to make appointments with therapists – and very few people will pay a therapist to share joys. They do, however, come to congregational clergy and Aboriginal elders to share the joy of the birth of a child and to mark other rites of passage within the life of their communities. Pastoral carers thus have insights into how people make meaning in their lives that many other people are not privileged to share. They can therefore offer broader perspectives on how participants might respond to some kinds of research than can many other HREC members.

Second, ‘the Church’ does not have a uniform perspective on biomedical ethical issues. While some denominations have specific stances on abortion, contraception, euthanasia, stem-cell research and so on, others do not. In my own denomination, most forms of contraception are widely accepted although some, such as the ‘morning after pill’ would divide members and clergy alike. Abortion, euthanasia and stem-cell research are all controversial, with Uniting Church members and clergy holding a range of opinions very close to the spread found in the wider community. It is therefore not possible to assume that any given Christian minister of religion will be against this kind of research as a matter of principle. This would also be true for pastoral carers from other world religions. Further, it is my experience as someone who has worked in a multicultural and multifaith university environment for several decades that while the things that divide religions are the things we notice most, we have far more in common than things that divide us. A fundamental part of most religions is an attempt to help people to understand what it means to be human, so someone with pastoral care experience from within a religious context can offer valuable insights into the human condition that are not bound by the teachings of her or his religion. They may well, for instance, have supported people making difficult decisions about biomedical ethical issues and have a better insight into whether the researchers have put appropriate measures in place for support of participants.

In addition, ministers of religion are not the only people on HRECs whose perspectives are shaped by religion. I have certainly known people serving in other roles on HRECs whose faith positions affect how they view some of the applications we are considering. The religious perspectives of Category D members are more likely to be overt, but any member of a HREC should declare a conflict of interest if s/he holds a faith/moral position that would not allow her/him to approve particular research no matter how well it complied with the National Statement. It is also quite likely that ministers of religion have studied ethics at a tertiary level as part of their ministry training.

Thus, I would argue that people with experience in providing pastoral care bring a unique and valuable perspective to the deliberations of HRECs, as long as they are selected with a little care. If you are responsible for recruiting members and biomedical research involving abortion, euthanasia, contraception or stem cell research and/or research around human sexuality and sexual orientation come up regularly in your business, you need to address the issues in your recruitment of Category D members. Although members of some religious groups are more likely to have problems with these issues, you cannot predict how a particular pastoral carer might react based on his or her religious group’s official policy. If you are replacing a Category D appointee or recruiting an extra one, the current one may be able to suggest colleagues that s/he thinks might be suitable. If you are setting up a new committee, the Category D appointees on nearby committees might have some ideas about suitable people. Some pastoral carers might even be willing to belong to more than one committee as long as the agendas are not too long and the meeting dates do not clash. In the end, however, you need to inform potential appointees about the kinds of issues you regularly deal with and ask them if they see any problem about their being able to assess these kinds of applications objectively. You also need to ensure that they understand that they are being recruited for their pastoral care experience not to provide a religious perspective. Taking these two steps should see your committee well served by your Category D appointments as they offer their particular perspectives on the applications before you.

We would like to build upon Judith’s excellent post about the pastoral position in future editions with similar commentaries about other positions.  Please contact us on HREC_members@ahrecs.com to discuss.

References

Grove, M. (2004). The Three R’s of Pastoral Care: Relationships, Respect and Responsibility. Pastoral Care in Education, 22(2), 34-38. doi:10.1111/j.0264-3944.2004.00261.x.

National Health and Medical Research Council (Australia) (1982). First Report By NHMRC Working Party on Ethics In Medical Research: Research in Humans. National Health and Medical Research Council, Canberra, ACT.

National Health and Medical Research Council (Australia) (1999). National Statement on Ethical Conduct in Research involving Humans. National Health and Medical Research Council, Canberra, ACT.

National Health and Medical Research Council (Australia) (2007). National Statement on Ethical Conduct in Human Research. National Health and Medical Research Council, Canberra, ACT.

National Health and Medical Research Council (Australia) (2018). National Statement on Ethical Conduct in Human Research, updated 2018. National Health and Medical Research Council, Canberra, ACT.

Contributor
Rev Dr Judith C S Redman, Chaplaincy Coordinator, Charles Sturt and La Trobe Universities, Albury-Wodonga Campuses | jredman@csu.edu.au

This post may be cited as:
Redman, JCS (27 March 2019) Why do we need Category D appointments on HRECs and how should we find suitable people? Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/why-do-we-need-category-d-appointments-on-hrecs-and-how-should-we-find-suitable-people

Institutional approaches to evaluative practice0

 

Gary Allen, Mark Israel and Colin Thomson

In 2001, the NHMRC published its policy document When does Quality Assurance in Health Care Require Independent Ethical Review? The document was rescinded in 2007 and is no longer available since the update to the NHMRC website in 2018. Several changes led to the rescinding of the 2001 policy document:

    1. The release of the 2007 edition of the National Statement provided a mechanism for exempting work with de-identified data where the work involved no more than negligible risk.
    2. The 2007 edition of the National Statement established clear criteria for determining whether research could be reviewed outside of an HREC (e.g. a project cannot involve any greater than a low risk of harm and cannot involve matters the National Statement specifies as requiring HREC review). [1]
  1. The ‘pressure to publish’ has meant a significant amount of work that used to be conducted as an evaluation or for quality assurance is now being submitted for publication to refereed journals.
  2. Figure 1 – A version of this image, which is not watermarked, is available from https://www.patreon.com/ahrecs with a USD3/month subscription.

    Stakeholders and funders require services and expenditure to be based on robust evidence and analysis.

As a result,the distinctions between research, evaluative practice and quality assurance have become blurred to the point of no longer being helpful and the research ethics review mechanisms for exemption, proportional review and mandated HREC review in specified circumstances, might be sufficient for the appropriate handling of evaluative practice.

Nevertheless, submissions to the NHMRC’s Australian Health Ethics Committee prompted the release in 2014 of Ethical Considerations in Quality Assurance and Evaluation Activities.

Ethical Considerations in Quality Assurance and Evaluation Activities describes whether quality assurance and evaluation work requires research ethics review and the most appropriate way to approach that review. It:

  1. discusses how such activities can be conducted over a spectrum of work, which may change over time and the divide between evaluative practice and human research can be porous,
  2. concedes HREC review is often not helpful when the primary purpose of the activity is to inform and improve an organisation’s practice (rather than contribute to the wider body of knowledge),
  3. describes four matters [2] to which the design and conduct of evaluative practice must adhere,
  4. describes four criteria to identify where oversight but not review is required, [3]
  5. directs institutions to establish policies with regard to these matters, [4]  and
  6. at provision (e) describes circumstances where consideration of the need for review is required [5] and, where it is, offers guidance at provision (f) to appropriate levels of review.

The 2014 policy document therefore provides criteria to determine whether an institution’s evaluative practice/quality assurance activity requires:

  1. only administrative consideration [6] to confirm that the institution’s policies relating to the use of those data to assess its services are being/have been adhered to in the design of the work,
  2. a special research review process [7] within the organisation to test whether HREC review is required and to confirm the institution’s policies relating to evaluative practice have been adhered to in the design of the work, or
  3. ethics review by an HREC or another review body.

Given many staff will want to publish the outcome of evaluations and there will be academic interest in matters related to evaluations/quality assurance, the institution’s arrangements must not preclude academic publication.

The following approach is recommended:

  1. The institution needs to know what evaluative practice is being conducted and so must have a mandatory process for review that is similar to a scientific research review committee, but is also an institutional policy process (its review feedback should provide advice to facilitate the planned activity and relate to how to conduct the work ethically and successfully).
  2. There is a mechanism for the research review of evaluative practice/quality assurance, with some such reviews being delegated to a special panel or administrative review.
  3. The review pathway being initially determined by the responses to a sequence of yes/no questions.
  4. The responses to the questions being reviewed by an ethics officer(in the case of clinical audits this the person conducts the initial assessment will need relevant clinical expertise) who confirms the review pathway.
  5. Every 12 months a small proportion of evaluative projects are randomly selected for audit, not to revisit the decision but to confirm the process is working correctly.
  6. Policy and guidance material informs the ethical design, conduct, reporting and publication of evaluative practice/quality assurance, as well as its ethics review.
  7. There are briefing sheets (two double-sided A4 pages)
  8. For researchers: summarising the institution’s arrangements for evaluative practice/quality assurance (including a summary of their responsibilities).
  9. For heads of school/department: discussing their role in the review of services/procedures/teaching and learning in their area.
  10. For editors/publishers: explaining the institution’s arrangements, for provision by researchers if they are asked to provide a copy of the HREC approval.
  11. If the institution has a network of collegiate Research Ethics Advisers (see our earlier blog post about REAs) some advisers should be experienced in the conduct of evaluative practice.

Available for USD10/month to subscribers, AHRECS has created notes to inform the in-house development of A, B and C. A USD15/month subscription provides access to our growing library of materials.

AHRECS would be delighted to discuss an arrangement where we provide feedback on the materials you produce in-house or us producing the materials for you.

Email us at Patron@ahrecs.com with any question about our Patreon page or becoming a patron, or Evaluative@ahrecs.com to discuss how we could assist you with regard to the ethics of evaluative practice.

[1] Because of design factors such as the deception of participants, and participant factors such as research with Aboriginal and Torres Strait Islander people.

[2] What really matters is that:

  • participants in QA/evaluation are afforded appropriate protections and respect
  • QA and/or evaluation is undertaken to generate outcomes that are used to assess and/or improve service provision
  • those who undertake QA and/or evaluation adhere to relevant ethical principles and State, Territory and Commonwealth legislation
  • organisations provide guidance and oversight to ensure activities are conducted ethically including a pathway to address concerns.

[3] In many situations, oversight of the activity is required, but an ethics review is not necessary. These include situations where:

  • The data being collected and analysed is coincidental to standard operating procedures with standard equipment and/or protocols
  • The data is being collected and analysed expressly for the purpose of maintaining standards or identifying areas for improvement in the environment from which the data was obtained;
  • The data being collected and analysed is not linked to individuals; and
  • None of the triggers for consideration of ethics review (listed below) are present.

[4]  ‘Organisations should develop policies on QA/evaluation which provide guidance for oversight of QA or evaluation activities. It is recommended that such policies address the following issues’.

[5] Triggers for consideration of ethics review include:

  • Where the activity potentially infringes the privacy or professional reputation of participants, providers or organisations.
  • Secondary use of data – using data or analysis from QA or evaluation activities for another purpose.
  • Gathering information about the participant beyond that which is collected routinely. Information may include biospecimens or additional investigations.
  • Testing of non-standard (innovative) protocols or equipment.
  • Comparison of cohorts.

[6] Preferably prior to data collection commencing, but in the case of data collected prior to the adoption of this document, the check must occur prior to any use of the collected data.

[7] A Panel should be created for the purpose of conducting these reviews. Even though there are undeniable advantages from this panel being comprised in full (or at least primarily) of members of the institution’s HREC, it must be stressed to Panel members there are important and valid differences between academic research and evaluative practice. For this reason, a proportion of the Panel members should not be drawn from the HREC and should be experienced in the conduct of evaluative practice.

A template for the institutional policy and suggestions for the associated guidance material can be found in the AHRECS subscribers area https://www.patreon.com/posts/25446938.  Available for USD15/month patrons.

 

Contributors
Dr Gary Allen, Senior consultant AHRECS | Profile | gary.allen@ahrecs.com
Dr Mark Israel, Senior consultant AHRECS | Profile | mark.israel@ahrecs.com
Prof., Colin Thomson AM, Senior consultant AHRECS | Profile | colin.thomson@ahrecs.com

This post may be cited as:
Allen, G., Israel, M. and Thomson, C. (18 March 2019) Institutional approaches to evaluative practice. Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/institutional-approaches-to-evaluative-practice

 

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

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