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.

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.

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.

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?

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.

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.

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.