11.0 Conflicts of interest

11.0 Conflicts of interest

This section will help you identify and manage any perceived or actual conflict of interest in your research.

Conflict of interest (COI) is an ethical issue that can arise in many situations, and is common in research.

Conflicts of interest can:

  • raise questions about the integrity of your research
  • increase the perceived or actual risks to human research participants
  • compromise the flow of genuine results from the research
  • tarnish both your reputation and Deakin University and
  • undermine public confidence in, and willingness to support human research.
Without public trust, there is no human research, so it is vital that you do – and be seen to do – the right thing.

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11.1 What is a conflict of interest?

Conflict of interest is discussed in Section 7 of the Australian Code for the Responsible Conduct of Research and in the National Statement in chapter 5.4.

The National Statement (p 89) defines conflict of interest in human research as follows:

A conflict of interest in the context of research exists where:

  • a person's individual interests or responsibilities have the potential to influence the carrying out of his or her institutional role or professional obligations in research; or
  • an institution's interests or responsibilities have the potential to influence the carrying out of its research obligations.

Research related conflicts of interest can include:

  • Your research is sponsored by an organisation with a significant interest in generating particular results, eg .
    A company testing a new product might try to set up the research in the way most likely to get a positive result. If your research returns an unfavourable result, the company might use a confidentiality agreement to prevent or limit you publishing your results.
  • You have some form of direct finanical interest in the results of the research, eg.
    You will be paid a 'per participant' fee by a sponsor, or a bonus for a positive outcome.
  • Your research involves issues of interest to another organisation with which you have an affiliation, eg.
    Your research surveys employee compliance with company procedures and you are a regular consultant for, or shareholder in, the company.
  • Your research involves the assessment of a service or program that you are responsible for, eg.
    You design and implement a service for a government department, and as part of that implementation you conduct a client satisfaction review.

You may behave impeccably and be confident that there is no real conflict of interest present in your research, but any perceived or actual COI requires attention. This does not (necessarily) mean that your research is unethical, or should be abandoned or modified. It does require that the COI be disclosed and managed. 

You must disclose any real or potential conflict of interest in your ethics application for the project.

If you fail to disclose such conflict of interest risks, the ethics review will conclude that you:

  • Failed to identify the conflict of interest, or
  • Are ignorant of the importance of disclosure, or
  • Intentionally withheld the conflict of interest.

Expect ethical approval for your project to be delayed or even withheld.

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11.1.2 How do I recognise a perceived conflict of interest?

To recognise a perceived conflict of interest, picture your project from a layperson's point of view, eg.

  • If you receive a substantial 'per participant' payment from your sponsor, this might create a perception that your team 'makes a profit' on the research.
  • In fact, the complexity of your testing procedures means the per participant payments don't cover your project expenses
  • Far from making a profit, your project funds must be topped up by Deakin University.
  • To avoid the perception of profit, you would clarify the scale of payments necessary to do this type of research.

Transparency is an important element of participant goodwill. It enhances the degree to which others will view your research as being of the highest integrity.

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11.2 Common areas of researcher conflict of interest

11.2.1 Funding and sponsorship of research

All research is funded in some form or another. Some research is directly funded or sponsored through some form of commercial research arrangement. The presence of such funding or sponsorship does not automatically create a real or perceived conflict of interest.

If you receive such funding, consider how this support might be seen to impact upon your research: could it alter the design, conduct and publication of results, other than for externally valid and scientifically justifiable reasons?

Even if you are confident that the funding source for the research will have no ethical impact, would a person outside of the team or Deakin be equally confident? If not, you should consider your research funding as a real or perceived conflict of interest, and disclose it accordingly.

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11.2.2 Direct financial benefit

Conflict of interest due to direct financial benefit occurs if you (the researcher), the sponsor of the research, or whoever recruits for the project, receives money from the research.

  • This excludes your base salary or wages as a researcher, or research funds from a competitive grant scheme.
  • It includes situations where you receive a bonus for a particular research outcome, or where you receive some form of per-participant payment.

The presence of a direct financial benefit does not automatically create a real conflict of interest, but does create aperceived conflict of interest which should be disclosed.

Under that National Statement participants in research have the right to be informed of financial arrangements in relation to the research, so if either the researcher or the recruiter has a directly financial interest (eg a doctor who is paid a fee to enrol patients with a particular condition in the study) this should normally be disclosed to research participants.

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11.2.3 Other direct benefits from results

Other direct benefits can be hard to identify. Extra money is straight-forward, but these are extra benefits you get from the research, either as a researcher, or sponsor of the research. It includes anything that is not money, but is - or could be seen as - a 'personal, professional and institutional advantage'.

Deakin expects both staff and student researchers to have a strong interest in the pursuit of their research. The general contribution of successful research to your career, or your completion of a graduate research project is not considered a conflict. An offer of guaranteed promotion - overt or implied - in exchange for a particular outcome from your researchwould be a direct benefit, a very obvious conflict of interest, and highly unethical!

The key issue is whether the direct benefit is likely to influence how you conduct or publish the results of your research. For example, if you use a particular government-funded pharmaceutical, and you plan to conduct research about the long-term efficacy of that drug (which might result in an increase or decrease to the funding of that drug), you might be considered to have a direct benefit from the research.

If you are unsure whether or not you have such a benefit, consult with a Human Research Ethics Advisor or an appropriate person within your School or Faculty.

The presence of a direct non-financial benefit does not automatically equate to a real conflict of interest, but in most cases it should be treated as a perceived conflict of interest, and disclosed.

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11.2.4 Conflict of roles

Conflicts of role occur when the researcher's role in conducting the research is - or may be - at odds with another role they have. This can often be an issue when the researcher is a research student who also has a role in the organisation hosting the research (eg a teacher doing research at their own school).

Role-related conflicts, real or perceived, are one of the most common sources of complaint about the conduct of research and raise the following ethical issues:

  • Impact upon the recruitment and informed consent process
    Potential participants may feel obliged to participate because of their existing relationship with the researcher, or because the researcher is senior to them in the organisation.
  • Impact upon the risks to participants
    A researcher's other roles can add risks to participants, because although they see themself as a researcher, they may also receive identified information in their other role. Sometimes just knowing who has participated, or not, in the research can represent a risk.
  • Impact upon the validity of the results
    Under certain circumstances, where a researcher has a pre-existing relationship with participants, some individuals may feel it expedient to provide a particular response to the research question which may not be an accurate representation of the facts.
  • Violate privacy
    In their other role, the researcher may have access to personal information and attempt to use this access for research purposes: this is highly unethical and potentially illegal.

Most conflicts of role can be eliminated at the design stage of your research project. Sometimes, the most appropriate course is full disclosure of the conflict to participants, ensuring completely voluntary and informed consent is obtained.

However, we do encounter situations where the conflict between the roles is so significant that it is not possible to conduct the research as planned. In such a case you might consider going to a different organisation, or changing the types of data gathering proposed.

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11.3 Disclosing Researcher Conflicts of Interest

Having identified a real or perceived conflict of interest or role, you must disclose this conflict to the following stakeholders.

11.3.1 Disclosure to Deakin

You must disclose a conflict of interest when seeking approval from Deakin to conduct the research.

Usually this will involve disclosure of the conflict to the appropriate executive member of your school (Head of School) or Faculty (PVC or Associate Dean Research), or to the Deputy Vice-Chancellor (Research). This disclosure must be explicit: do not assume it will happen as part of the ethical review process.

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11.3.2 Disclosure to Human Research Ethics Committee or Advisory Group

You must disclose a conflict of interest in your application for ethics approval for the project. Under the National Statement paragraph 5.2.7 you should also disclose to the ethics reviewer the amount and sources of funding for your research.

This is vital to ensure that the researcher receives further advice on the conflict, that any ethical clearance granted to this work is informed by the presence of the conflict, and that the work with the conflict has official sanction.

If you fail to disclose a real or potential conflict of interest, the ethics reviewer will conclude that you:

  • Failed to identify the conflict of interest, or
  • Are ignorant of the importance of disclosure, or
  • Intentionally withheld the conflict of interest.

Expect ethical approval for your project to be delayed or even withheld.

More seriously, if an undisclosed conflict is not recognised by the ethics review body, and emerges later, you risk being found to be in breach of Deakin University's research or ethics procedures – with dire consequences for both you and your project.

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11.3.3 Disclosure to human research participants

In the case of human research, arguably the most important disclosure is to potential participants. Often it is the potential participants themselves who can best judge the significance of a conflict of interest, and decide whether or not they still wish to participate in the research.

Disclosure is usually made as part of the informed consent material.

In some cases, it may be appropriate to also include the disclosure in the recruitment material, eg. if first contact with potential participants will be a letter, and the conflict of interest has a bearing on a potential participant's decision. The conflict of interest should be disclosed in both the letter and the informed consent material.

The National Statement has specific and extensive requirements for information that must be provided to potential participants during the recruitment process.

The amount of detail necessary to describe the real or perceived conflict of interest, depends on the seriousness of the conflict and the vulnerability of the potential participants. In most cases a sentence or two of explanation of the conflict and measures to address that conflict is sufficient.

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11.3.4 Disclosure to external bodies

This is most likely when the approval or agreement of an external body is a requirement for the conduct of the research. If a research project at a secondary school will require Department of Education and Early Childhood Development approval and the secondary school's agreement, the conflict should be disclosed to both parties.

11.3.5 Disclosure required for publication

The National Statement requires that, when publishing the results of your research, you disclose any actual or potential conflict of interest or affiliation that bears on the research (NS 5.2.11). This may be included in an appropriate statement of interest or other form when presenting findings in any form, including personal presentations and publications. Such disclosure is required for most forms of academic publication.

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11.4 Other Conflicts of Interest

Researchers are not the only people/entities whose interests can conflict with the proposed research.

11.4.1 Ethical Reviewer Conflicts of Interest

A conflict of interest can apply to members of Deakin's HREC or HEAGs: eg. where the researcher (or the academic supervisor of the researcher) seeking approval is also a member of the committee.

Where a conflict of interest exists, or potentially exists, the HREC/HEAG member must disclose their interest in the research. Deakin's ethics procedures require the member to absent him- or herself while the project is considered. The member may not take part in the decision regarding that project.

On occasion, the Deakin HREC or HEAG may seek expert advice from a person outside the committee. The expert is also required to disclose any actual or perceived conflict of interest in relation to the project on which their advice is sought.

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11.4.2 Institutional Conflicts of Interest

Conflict of interest may also apply in the case of an institution, where the institution has an interest in a particular research outcome or method, eg: the university might own the patent to a device being tested; or the research might reveal staff non-compliance with institutional requirements.

Deakin's interest in conducting high quality ethical research is NOT a conflict of interest.

You have an obligation to inform Deakin's HREC or HEAG if you are aware of an actual or perceived conflict of interest relating to an institution involved in the research. Include the conflict of interest in your application, and any measures to be taken to resolve or manage the issue stated. You may need to include a statement from an officer of the institution in your application.

Where an institution becomes aware of an institutional conflict which was not raised by the researcher, an officer of the institution must notify the review body (NS 5.4.2). Should a member of Deakin's HREC or HEAG become aware of an institutional conflict, the member must notify an appropriate officer of the institution (NS 5.4.4). If the researcher has not already raised the issue, he or she will also be informed of the perceived conflict and invited to comment on how it may be managed.

Where a potential conflict of interest relating to Deakin University is identified by the ethics review process, the Deputy Vice-Chancellor (Research) will be notified of the potential conflict of interest and invited to take any appropriate action to resolve or manage the issue, or to respond to specific matters raised by the HREC or HEAG.

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