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Draft Statement on Consumer Involvement in Health and Medical Research submission

This submission reflects the views of
Organisation Name: 
General Ethical Issues Sub-comm, Alfred Hospital Ethics Comm
Please identify the best term to describe the Organisation: 
Personal Details
Q1. The aim of revising the Statement is to improve language and accessibility. Are there further improvements that should be considered?: 


1. At whom is the Statement directed?  I.e. to whom does it need to be accessible, at what kind/s of reader/s does the language need to be pitched?

2. Some of the language used is jargonistic – e.g. “add value” [p.6 “consumer and community involvement must add value to the research”] – does this mean ‘should not be tokenistic’? 

Further improvements:

3. Under ‘Why is consumer and community involvement important?’, the following point could be captured:

  • There is a tendency for research to follow the interests of the pharmaceutical industry, or be institution-driven, and for researchers to ‘follow the herd’.  Consumer and community involvement helps to (a) guard against the biases and agendas of outside parties and (b) align research with the issues and interests of the public.

4. The Statement could be improved by addressing the following questions: Who are the decision-makers about what health and medical research gets done?  Who ‘sets the agenda’?  Is this largely dictated by funding bodies?  How does society say what the priority is?  In the NHMRC funding process, no power is given to the consumer.  Who is representing this perspective?

5. The Statement needs more context – what is its purpose, for whom is it intended?

6. The Statement sits by itself’ and ignores the broader context of consumer engagement as a key priority in the Australian health system, which is a requirement of the National Safety and Quality Health Service Standards – specifically, Standard 2 “Partnering with Consumers”.  Institutions must meet these National Standards for accreditation, and improving partnerships with consumers is integral to service improvement.  Much work has been done by health institutions in the area of consumer engagement since the Statement first came out in 2002 and this ‘resource’ is not acknowledged.

Note: General Comments are included at Question 5 as there is no box for these.

Q2. The draft revised Statement contains five definitions: Community, Consumer, Consumer Representative, Involvement and Stakeholders (refer page 4). Are the definitions satisfactory? Are additional definitions required? : 
  1. This approach is rather legalistic.  If the document was clearly written, would it be necessary to include definitions? Words such as ‘involvement’ are readily understood and illustrated by the document as a whole.
  2. The concept of ‘consumer’ is not captured.  Although this will vary according to context, the current definition is so broad that it encompasses everyone.  The definition needs to incorporate what the key attributes are, not just who consumers are.
    [As an example: Alfred Health uses the term ‘consumers and carers’ and its meaning is more specifically someone with experience of a health situation (patient, former patient, carer/family member).  ‘Consumers and carers’ bring a patient/carer/family member/community perspective; they are not pseudo staff and give a view (not the view) of those accessing the service.]
  3. The difference between ‘consumer’ and ‘community member’ is unclear.  The latter is used throughout, but not defined. 
  4. Is the role of a consumer representative to bring the view of ‘a reasonable person in the community/general public’ and the role of the community representative to represent a particular ‘stakeholder’ or interest group’?
  5. The term ‘consumer representative’ may be (mis)understood as meaning the formal nominee of a particular interest group.  The last sentence of the definition is problematic and should be removed [“They may be nominated by a consumer or community organisation and be accountable to them.”].
  6. The term ‘consumer organisations’ is used in other definitions but is not defined itself.  Some examples could also be included.
  7. There is no single generic ‘consumer’; what is needed is someone who will be open and listen, and who will make an effort to balance different agendas.
  8. The definition of ‘consumer representative’ implies that some kind of ‘official’ status is necessary – e.g. someone from the Consumer Health Forum.  A consumer representative should not be limited to delegates from formal consumer organisations/forums and these should not be seen as some kind of ‘official voice’.
  9. ‘Consumer group’ can be a deceptive description.  These groups may present as ‘lay’ or as the ‘voice of the disease’ but are often not an independent voice.  Many consumer groups are funded by the pharmaceutical industry, and act as lobby groups to get drugs on the market.  An ethics committee is much more likely to be independent.
  10. The meaning of ‘community’ in the document is more specific than it is in common usage (i.e. ‘community’ is usually used interchangeably with ‘the public’).

  11. The very specific concept of “community” (in the context of this document) is not clearly conveyed.  The role of a community representative is very different to that of a consumer representative.  The purpose of consulting a community representative is to respect the particular group, and to set up processes and methodology in accordance with the needs of that group/community.  Community representation will differ according to local needs.  In each case the community will have very specific interests.  When researching a particular community, the researchers need to think about how they will interface with and engage that community and convince them that the research is to their benefit. Some communities are very vulnerable; researchers often lack awareness of the issues and need a community representative to guide them.

Q3. The draft revised Statement outlines the Key Elements that underpin effective involvement and Levels of Involvement (refer page 5). You are invited to comment on the identified Key Elements and Levels of Involvement.: 

Under ‘Elements for consumer and community involvement’:

  1. The requirements of ‘active involvement at all stages’ and the inclusion of consumer and community members on ‘all decision-making committees’ are too absolute because involvement at all stages and levels is not always inappropriate. Involvement on ALL decision-making committees should not be mandated.  Multiple strategies and levels of involvement are needed.

Under ‘Levels of Involvement’:

  1. The Statement makes only broad comments (motherhood statements) about levels of involvement.  References are provided for various models in Appendix 2; however, key areas or levels could be identified and/or a brief summary of the referenced models could be included (as is done for Appendix 3).
  2. Levels of involvement might include:
    - research strategy level (e.g. distribution of research funds)
    - hospital ethics committees
    - boards of large research institutes
    - large research projects
  3. Involvement might also include chairing a committee, rather than being a member, in some cases.  There is an expectation that only professional members can do this.
  4. The kinds of involvement need to be more differentiated.  In some cases, a specific view or perspective is required; in others, a ‘general view’ is more useful.
  5. The 3rd paragraph is problematic [“To ensure the integrity of health and medical research and accountability to the community, a researcher or research organisation intending to proceed without involving consumers and community members must be able to fully justify that intention.”]  To whom should they justify this?  Why would this ‘ensure the integrity’ of research?  Involving consumer and community members at ‘research level’ is most meaningful where the research/affected groups involves very substantial numbers.
  6. Similarly, the requirement that “the development of plans for consumer and community involvement will be required for each research project” [p.6 under ‘The Statement and researchers’] is too absolute.  This needs to be context-specific, to avoid tokenism etc.
  7. Alfred Health offers various levels of consumer participation and representatives are not included in all activities or all the time – there is ‘a time and a place’.  These levels are not hierarchical; involvement depends on what the person can bring.  Inclusion should be sincere and relevant.  The Guideline “Consumer and Carer Engagement in Service Improvement” (provided as an attachment to this submission) may be of interest.
Q4. The draft revised Statement includes information about how the Statement should be put into practice (refer page 5). You are invited to comment on this section, including whether additional information should be added. : 
  1. The ‘pointers’ provided in the Statement are too general and offer no practical assistance in achieving consumer and community involvement. 
  2. The intended outcomes of consumer and community involvement should be stated.  (What is consumer and community involvement intended to achieve?)
  3. Examples of methods for recruiting consumers would be helpful: e.g. advertisement, selection criteria, role statement, etc.
  4. The guiding principle should be that if consumers and community members are involved, it has to be in a meaningful and supported way.
  5. Ethics committees need to decide what questions to put to researchers about consumer involvement.  Researchers need to give a good account of what the consumer-relevant aspects of research are and how these will be dealt with.
  6. Care needs to be taken that consumer and community representatives:
    • do not assume legal responsibility, in the way that other members of a group might (e.g. board members, steering committee members).  Seeking representation on advisory committees, rather than committees that have a steering role, avoids this risk as advisory committees make recommendations rather than making and implementing decisions.
    • are given a meaningful role and not overwhelmed with technical minutiae that is outside their expertise.
    • are clear about what is required of them and the boundaries of their role.  This could be spelt out in a committee’s terms of reference, for example.  Organisations need to be honest about the extent to which consumers and community members can be included (and about the fact that they can’t always, and don’t always have to, be included).
  7. The NHMRC only gives funding if there has been consumer involvement.  This requirement needs to be more flexible, based on the organisation and need.
Q5. NHMRC is considering placing Appendix 4: Useful Resources on our website so that stakeholders can access examples of consumer and community involvement in health and medical research. Please tell us about exemplars that should be included.: 

 See Q.3, Point (8) – Attachment 1.

Another document that may be of interest is the Alfred Health ‘Patients Come First Strategy’ Policy – Attachment 2.

Please note that the two exemplars (Attachments 1 & 2) have been emailed separately to NHMRC receptionist, who was going to forward them to the relevant staff member.

General Comments:

-          The dilemma for research institutions, researchers and ethics committees is how to utilise consumer and community representatives most effectively.

-          Consumer and community involvement is potentially most effective and useful at an upper policy level, in setting/endorsing the general direction of research and monitoring the outcomes.

-          For some research (e.g. involving large and specific disease groups, where there are large ethical issues) involvement at the research project level is also worthwhile.  The level of involvement is very dependent on the context of the research.

-          ‘Consumer and community involvement’ should be about empowering the individual without allowing them to dictate outcomes. It is important that consumer representatives:

  • Feel valued.
  • Understand what they are there for.
  • Are included when/where their input is needed and their time is not wasted when they’re not needed.
  • Are fully informed about any responsibilities they may assume (e.g. legal liability) and be prepared to shoulder and share the burden.
  • Are not expected to take on responsibilities that they can’t really share.
  • Are appropriately selected to ensure they have the skills and ability to understand the subject matter and have meaningful input.

-          Consumer representatives are often sourced from consumer associations.  There are a number of concerns about this:

  • ‘Self-appointed’ representatives and ‘self-declared’ organisations can claim to be the only legitimate voice.
  • The range of representatives can be narrow and they may not have suitable expertise or interests (e.g. in research); this can hamper their ability to understand the issues.  This means their involvement can be merely tokenistic, and/or they can be intimidated or their views dismissed.
  • Considerable sitting fees are often charged.
  • One needs to be mindful that consumer and community involvement doesn’t become an ‘industry’ or another level of bureaucracy.
  • There are other ways that representative can be legitimately sourced (e.g. advertisements in local papers).

Page reviewed: 5 January, 2015