Issues affecting research


All stages of biomedical research are influenced by their sources of funding. An extensive literature addresses the ways in which the design, conduct, outcomes and publication of research may be affected by industry support and, importantly, by researchers’ relations with industry, especially the pharmaceutical industry. This might take the form of researchers receiving financial or in-kind support to conduct a study or recruit participants, or being employed directly by a company.

Matters are complicated further by the increasing involvement of individual researchers in the commercialisation of their own work, and increasing acceptance that they may retain intellectual property, hold patents and maintain shareholdings in pharmaceutical or biotechnology companies related to their research. These circumstances raise particular questions about the independence of research and the reliability of data that are made available to the public.

Non-pecuniary interests also have the potential to impact negatively upon the independence and reliability of research and its dissemination. Researchers may, for example, be tempted to distort the design, conduct or publication of research because they are intellectually committed to a particular hypothesis, wish to protect their academic or clinical reputations, or need more publications for academic advancement. In many cases, these may be more significant than financial considerations.

While competing interests may not themselves result in harm to others involved in research, they may raise concern because of their potential to do so. In addition, they may complicate the process of interpreting the presentation of research results and impair public confidence in medical research.

These issues apply both to clinical and basic research. The vast majority of clinical trials are funded by the pharmaceutical industry. Clinical researchers may benefit directly from their research financially through payment for work performed in enrolling and managing patients in industry-sponsored studies or indirectly through investment in, or ownership of, companies sponsoring clinical trials, as a result of which they may have beneficial interests in the outcomes of these trials. They may also benefit from their research through non-financial means.

Opportunities to profit from clinical research financially or academically may affect or appear to affect researchers’ commitments to their primary obligations to pursue new knowledge or understanding through research, and to protect patients’ and research participants’ interests. Competing or conflicting interests may influence study design (including selection of study drug doses and comparison with placebo or active comparator), patient selection, data collection and analysis, adverse event reporting, or the presentation and publication of research findings. Financial conflicts may also arise when an investigator becomes involved in a commercial venture that may impinge on other aspects of his or her research.

The arguments about whether investigators with direct financial interests in the outcomes of research should be permitted to participate in such research are complex, as indeed are the organisation and structure of individual research projects. It is important that this complexity is appreciated and that a flexible approach is maintained. In individual instances, it is often possible to identify specific moments in the research process at which dualities may become conflicts and to devise specific strategies to protect the integrity of the research process.

These Guidelines do not purport to provide a comprehensive guide for the conduct of research or of the business of Human Research Ethics Committees, for this, refer to the relevant extant publications. However, it is recognised that in such publications, the relationships between individual researchers and other practitioners involved in the conduct of research and industry are often either not well covered or do not contain sufficient detail to provide guidance to researchers working in particular settings. Accordingly, the following notes and recommendations are intended to enhance existing practices and provide a practical guide to practitioners.

Responsibilities of investigators

Open all

Overview of responsibilities of researchers

The responsibilities of investigators paid to conduct or recruit patients for clinical trials are treated in detail elsewhere, but are summarised here. Many of these principles would apply even to investigator driven research, where non-pecuniary interests can cause similar distortions.

To guard against dualities becoming conflicts, investigators and Human Research Ethics Committees should consider whether:

  • the questions to be addressed by the proposed study are sufficiently important to justify the involvement of participants. For example, is it merely a promotion to familiarise health practitioners with a drug or device to encourage a particular brand usage, or a commercial undertaking to permit drug registration in the absence of any substantive scientific content? If so, researchers should reconsider their involvement.

  • the discomfort and inconvenience or risks, to which participants are to be exposed, are justified by the benefits of the study, taking into account the nature of the project, the participant population to be studied and the likely benefits

  • the design of the study is appropriate and will meet the study’s objectives, including whether the use of placebos as comparators is justified when there is available treatment that has been clearly shown to be effective – this is of particular importance when the test drug is related to a currently available medication

  • patients will be able to consent freely to participation and whether other consent issues are satisfactorily addressed

  • relevant social or cultural issues are adequately taken into account

  • the information to be provided to patients includes an adequate description of the nature of the project and any risks or potential discomfort associated with it

  • potential participants are likely to be subject to any form of coercion

  • payments to research participants are large enough to constitute an inducement to participate in the project

  • the institution has the resources (investigations, bed usage and staff time) to conduct the research to a high standard

  • there is adequate separation between funders and researchers, and researchers have control over the conduct and publication of the research

  • the results are going to be published, regardless of the outcomes of the trial and all data will be made available to other researchers

All research projects involving human participants should be in accordance with relevant guidelines published by the National Health and Medical Research Council (NHMRC), the Therapeutic Goods Administration, the Health Research Council of New Zealand, the World Medical Association and other relevant bodies, and should be assessed by a Human Research Ethics Committee, which is constituted and functions in accordance with the National Statement on Ethical Conduct in Human Research.

Since payments to investigators, departments and institutions have ethical implications, the Human Research Ethics Committees should be made aware of financial arrangements for research projects and specially sponsored clinical trials, including proposed payments to researchers and research participants. If physicians are to receive payments for assisting with the recruitment of a research study, the details of such payments should be disclosed to potential participants. In addition, the provision of other resources required to carry out the study should be explicitly declared according to institutional ethical and governance guidelines.

Where there is a competing interest, because researchers or their departments are being compensated, paid to conduct research or recruit participants, or have interests in the outcome, the following steps should be followed:

  • Competing interests should be fully disclosed by the researchers and considered by the relevant community or communities, in this case usually a research ethics committee or the researchers’ organisations.

  • An assessment should be made concerning whether competing interests constitute a conflict of interest and, if so, how likely the conflict is to distort the research process.

  • The decisions and practical outcomes of these deliberations and actions should be communicated to the constituency affected, including fellow researchers and research participants.

  • Competing interests, whether financial or non-financial, should be disclosed to research participants, to regulators as required by statute or regulation, to research funders or sponsors, to the editors of any publications to which manuscripts concerning the research are submitted, and in any substantive public communications of the research results, whether oral or written.

  • Where conflicts arise, special arrangements may need to be created to separate the different roles and interests of the researchers, these will often include: the appointment of independent researchers to approach and interact with participants, ‘arm’s-length’ processes to collect, store and analyse data and to monitor safety, and the development of clear policies regarding publication and dissemination of results. The specifics of these arrangements will depend on the nature of the conflict and the structure of the research project itself.
Key points
  • Competing interests should be disclosed to all relevant parties, including participants and the public.

  • The different roles and interests of the researches should be kept distinct in order to protect the integrity of the research process and research participants.

Responsibilities where a researcher is offered financial compensation for being an investigator in a clinical trial

Researchers involved in industry-funded studies may receive financial compensation for their roles as investigators. This can take the form of direct payment for services, compensation for personal and departmental expenses, gifts or untied funds, and financial incentives for recruitment of participants. At all times, the benefits a clinician or department gains from the conduct of an industry-sponsored clinical trial should be subject to review and approval by an appropriately constituted ethics committee.

It is appropriate that adequate compensation is provided for personal expenses arising from the trial, including reimbursement of practice expenses where applicable. The amount of compensation should reasonably relate to income or time lost, bearing in mind that the meaning of what is ‘fair payment for services rendered’ may be ambiguous. Any assistance received for a project should be paid into a specially designated fund established for the conduct of research, which is subject to auspice and audit according to established institutional guidelines. Other uses of these funds should adhere to the institution’s arrangements.

Financial incentives for the recruitment of patients, whether in the form of payments on a per-capita basis or of other arrangements, directly raise the possibility of a conflict between the research and clinical responsibilities of a physician and his or her financial gain. For this reason, such arrangements should be specifically approved by a responsible ethics committee and care should be taken that participants are included in the trial only according to the approved protocol and inclusion is not influenced by the payment system. All payments to clinician-researchers or the departments in which research is conducted should be fully declared to trial participants.

Research consent forms should also disclose the existence of any other significant financial interests or any other relevant relationships between the researcher and the company. In no event should referral (‘spotter’) fees be paid to investigators or other clinicians.

Key points
  • Financial compensation for participating as an investigator in a clinical trial should be commensurate with the work performed.

  • Remuneration for research participation should be paid into a specially designated fund, which is subject to auspice and audit according to institutional guidelines.

  • All payments to clinician-researchers or the departments in which research is conducted.

Responsibilities where a researcher does not have an institutional affiliation

Research projects conducted by private investigators without institutional affiliations may pose additional challenges. This is because on the one hand, surveillance and monitoring of the conduct of such projects is more difficult and, on the other, the investigators do not have access to the protection of such institutions. Where possible, research projects conducted by private practitioners should include investigators with institutional affiliations and be assessed by an ethics committee associated with that institution, which is also responsible for monitoring and oversight of the research.

In addition, funds associated with the project should be distributed in accordance with the contractual arrangements approved by the ethics committee and conform to the normal requirements of the institution. Where a formal institutional attachment is not possible, an alternative arrangement should be made that also involves ethics committee review and oversight and clearly defined and transparent processes for the management of funds. The nature of the compensation to be paid to the investigators should be declared in the explanatory statement provided to potential participants.

Key points
  • Any research project conducted by private practitioners should include an investigator with an institutional affiliation and be assessed by an ethics committee associated with that institution.

  • Financial compensation or payment to clinician-researchers should be approved by a responsible ethics committee and declared to research participants.

Responsibilities where companies provide grants for research

Grants of money or equipment by pharmaceutical companies to hospitals, healthcare centres and universities specifically for the purposes of research are generally acceptable but should always be made to the institution and not to individuals, and should be appropriately acknowledged in research and other publications. If the donation is linked to, or contingent upon, a clinical trial or specific research project, a formal contractual arrangement which is open to scrutiny should be in place.

Before any form of industry support for research is accepted, the following general questions should be considered:

  • Is industry support necessary for the conduct of the research?

  • Are there alternatives to industry support for research that raise fewer ethical issues, for example support from professional organisations that do not have an interest in the content or outcomes of the research?

  • Is the support genuinely and clearly linked to research that is likely to benefit the community?

  • Do the potential supporter’s organisational history and practices, either locally or internationally, raise concerns?

  • Will the industry support be appropriately disclosed to the relevant Human Research Ethics Committees, research participants and the general public?

  • Will acceptance of industry support be likely to result in any actual or perceived loss of institutional independence as to research either during or after the period of support?

  • Would the proposed sponsorship raise concerns among patients, their families or the wider community?

  • Will the propriety of the sponsorship stand up to scrutiny by colleagues and the public?
Key points
  • Research grants from industry should be made to the institution and not to individuals, and should be appropriately acknowledged in research and other publications.

  • Researchers should not be subject to confidentiality agreements that are not time-limited or specific.

  • Restrictions on publication of trial results are likely to be inappropriate.

  • Sponsors should not participate in the design of studies or analysis of results.

  • Researchers should not be subject to confidentiality agreements which may prevent public disclosure of trial results.

Disclosure forms and processes

Submissions for publication

Submissions for publication should contain the following information:

  • All sources of revenue obtained by the authors in relation both to the study and to other studies over the previous three years.

  • All financial relationships outside the work in question, including grants, consulting fees, honoraria, support for travel, payment for writing or reviewing manuscripts, medicines, equipment and administrative support, board memberships, consultancies, employment, expert testimony, patents, royalties and other benefits unrelated to the reported study.

  • Any other relationships or activities that may have influenced the work.

Presentations at public forums that refer to research projects in which the presenter has been personally involved, including in scientific and educational meetings, should specify the sources of funding of the research itself, other industry associations and other interests that may have affected the design, conduct or interpretation of the work.

Researchers contributing to committees or panels preparing clinical guidelines or joint expert statements should ensure that similar disclosures are made in relation to each item under consideration. In such cases, it is often appropriate for the resulting publication to provide detailed annotations regarding the roles of each participant and the processes adopted to manage dualities and conflicts of interest.

Dissemination of results

Open all


All industry-sponsored clinical trials should be included on a relevant clinical trials register, and a commitment made to report all results.

Before an industry-supported study commences, the company and principal investigators should agree upon the conditions of access to the raw data from the study and how these are to be used, including in publication.

Publication of results, whether positive or negative, is expected. Ideally, this should be in a refereed journal. This should be clearly stated in the protocol and other relevant documents and in submissions to Human Research Ethics Committees. If a study is likely to have clinical relevance, a commitment to publish results should be a condition of both agreement to participate by researchers and approval by Human Research Ethics Committees.

It is desirable that the responsibility for decisions concerning publication and other forms of dissemination or results, including preparation of manuscripts and presentations at scientific meetings should lie with investigators who do not have financial or non-financial conflicts of interest. Decisions should be made without influence from the sponsoring company. With multi-centre trials, it is desirable that analysis of the results and preparation of results for publication are undertaken by a committee of investigators who are independent of the sponsoring company.

Financial and other support for any aspect of the project should be declared. This includes disclosures at scientific meetings, in educational sessions and in publications. Associations with sponsoring companies (e.g. shareholdings) and other competing interests of relevance to the content of the article should also be declared. These declarations should include both pecuniary and non-pecuniary interests.

Public accessibility of clinical trial data

In addition to registration of descriptions of the design and methods of clinical studies, it should be a condition of both agreement to participate by researchers and approval by Human Research Ethics Committees that there is a commitment to make all results (both positive and negative) publicly available for scrutiny by other scientists and regulators. These data should, of course, be appropriately de-identified to protect the privacy and confidentiality of trial participants.

The data should be sufficient to allow the published outcomes of the study to be adequately verified and any adverse or unexpected outcomes to be identified. Access should be provided in a timely manner, with sufficient information about design and methods to permit meaningful analysis by independent researchers.

Guest and ghost authorships

A guest author is a researcher, usually with perceived prominence, who is included as an author to enhance the stature of a publication in spite of a lack of contribution to the project in question. A ghost author is someone, usually an industry employee, who has contributed to an article but who is not acknowledged in the publication.

The practices of including either category of author should be avoided. The integrity of scientific literature depends to some extent on the ability of readers to have confidence in the identity of the authors and adequate knowledge about their contributions, affiliations and any interests that may influence their work.

Complexities of the management of interests in research


While these conditions are desirable, they are often difficult to achieve in practice. In addition to facing pressure from companies to report only favourable results, investigators may themselves have competing interests as a result of being employees of the sponsoring company or having direct or indirect pecuniary or non-pecuniary interests linked to the trial outcomes. In multi-centre trials, it is often only the sponsoring company that has access to all data.

Although undesirable, members of data management boards may also face competing interests as a result of their relationships with sponsoring companies. Even if companies agree to submit negative results for publication, it is often difficult for authors to have papers reporting negative results accepted by journals. Further disclosure of conflicts of interest in publication is not in itself enough to ensure a disinterested presentation of data. Where publication in peer-reviewed journals proves to be impossible, researchers should attempt to make data available for public scrutiny through web publication or related resources. In particular, this may be an effective way of publishing negative results.

Key points
  • It should be a condition of both agreement to participate by researchers and approval by Human Research Ethics Committees that there is a commitment to make all results (both positive and negative) publicly available.

  • All clinical trials should be registered on an appropriate clinical trials registry.

  • Responsibility for decisions concerning publication of results should be taken by investigators without commercial conflicts of interest, and decisions should be made without undue influence from the sponsoring company.

  • Researchers should not agree to be authors on ‘ghost-written’ manuscripts.

Health professionals as members of Human Research Ethics Committees


Individuals may be called upon to become members of research ethics or scientific review committees. Committees are often asked to consider applications that have been developed jointly by investigators and industrial sponsors as local projects or parts of multi-centre trials. Following the accepted processes of such committees, individuals who are personally involved in these projects should disclose their interests and, where appropriate, recuse themselves from discussions. Where a committee is to discuss a project involving an industry partner with which an individual has a present or previous relationship that could raise the possibility of a conflict of interest, this should be openly declared. In these cases, it is the responsibility of either the ethics committee itself or another body identified to decide whether any additional steps need to be taken.

Human Research Ethics Committees have a responsibility to ensure that clinical trials are conducted in accordance with national standards, as set out in various statements. The responsibilities of these committees for reviewing clinical trials are treated in full detail elsewhere (e.g. the National Statement on Ethical Conduct in Human Research). To protect against the effects of undue influences both pecuniary and non-pecuniary on researchers, the considerations of Human Research Ethics Committees include the following:

  • Are the likely benefits of the proposed research sufficient to justify experimentation reasonable in terms of any risks or potential discomfort to participants?

  • What is the regulatory status of the drugs to be used in the study?

  • Is the design of the study appropriate to its aims and objectives? Is the study likely to provide an answer to the questions being asked? Are doses and durations of medications consistent with those used previously?

  • Does the protocol include a clear statement of the number of participants to be enrolled in the study, the proposed method of recruitment and of the selection of participants?

  • Do pre-clinical and clinical data indicate that the risks associated with the proposed use of the drug or devices are justified and acceptable? What procedures are proposed for monitoring safety? What are the criteria according to which the trial is to be stopped in the event of new data regarding safety or efficacy becoming available?

  • How is consent to be obtained? Have special provisions been made for the protection of vulnerable groups or individuals? Will participants be adequately informed about the implications for existing treatments that they might be receiving? Will participants be adequately informed about all payments made to researchers or other interests that researchers have in the research or its outcomes?

  • Are there resource issues that might affect the conduct of the trial or its outcomes? Do researchers face conflicts of interest? Are relevant dualities of interest to be disclosed to potential participants and institutions?

Feedback invited

Suggestions and critical comments from all members of the community are welcome at any time. Email us at

Back to Ethical Guidelines

Close overlay