Ethical Aspects of Research

General

All research supported by the Heart Foundation on human participants or animals must conform to the following ethical principles which are based on those of the Health Research Council.

The Heart Foundation expects investigators to conduct and report their work with objectivity and scientific honesty, bearing in mind and reporting on the limitations of the research design. As part of the obligation to the research participants and (where relevant) the community concerned and the public at large, investigators must ensure that the results of the research and an account of the methods employed are adequately disseminated. They must refrain from making claims or advancing conclusions that are not supported by evidence. Investigators must also recognise the boundaries of their professional competence and must not undertake research of any kind that they are not qualified to carry out.

It is a basic tenet of research with human participants that their interests, whether individual or collective, must always take precedence over the interests of others. Where conflict may arise, particularly concerning the larger public good, open discussion must be invited. Investigators must periodically review the ethics of their research. If significant variations to the protocol have occurred or if the interim results of the research indicate that it may not be ethical to continue, they must approach their local ethics committee at an early stage for comment and further discussion.

Ethics Approval

In any research project involving experimentation, the Applicant must submit an approval by an appropriate independent ethics review committee or indicate that this process is in progress. A copy of the ethics committee's approval must be forwarded with the application. Grants will not be activated without this approval.

Research protocols must not be modified subsequently without an amendment approved or a new approval being obtained.

All Applicants must agree (by selecting 'I Agree' in the Applicant Agreement section of an online Application form) that the research conforms to the ethical standards of the Heart Foundation, as outlined in this section.

Research Involving Human Participants

The Heart Foundation endorses the following guiding principles for clinical investigators as adopted by the Health Research Council, based on the Declaration of Helsinki and revised by the 35th World Medical Assembly.

The investigator must be satisfied by forethought, by study of the literature and by consultation that the proposed research is likely to contribute to the understanding of the matter being investigated. The investigator must be satisfied that, where appropriate, research on human participants is based, as far as possible, on the results of experiments conducted in vitro or on animals.

The investigator must be satisfied that adequate facilities will be used for the solution of the problem being investigated.

The investigator must be satisfied that the research will not impose unreasonable discomfort or hazard upon the participant. In order to ensure the safety of the participant in any untoward event, the investigator must ensure that appropriately qualified persons are present during experiments and that proper facilities are at hand to ensure the safety of the participant in any emergency.

The investigator must appropriately modify or discontinue the research, if it becomes apparent that the procedure is likely to cause unreasonable risk to the participant or participants.

The investigator must be satisfied that the participant or the guardian has been informed, in terms capable of being understood, of the nature and purpose of the proposed research, methods to be employed, and possible risks and discomfort that may be involved.

Before the research is undertaken, the investigator must obtain the free consent of the participant, or guardian, in writing and in the presence of a witness. The consent must be obtained without the exertion of pressure on the participant and without dependence on any obligation of the participant toward the investigator.

Special care must be taken in the case of participants at particular risk, for example, children, the mentally infirm and the unconscious patient. Children must never be the participants of research which could appropriately be undertaken in adults. In the case of unconscious patients, the written consent of the next-of-kin must always be obtained.

The participant or the guardian shall be free at any time to withdraw consent for further participation in the research and must be made aware of his right in this respect.

New therapeutic or experimental procedures which are at the stage of early evaluation and which might have long-term effects should not be undertaken unless adequate provision has been made for long-term care and observation of the participant, as appropriate.

Research funded by the Heart Foundation must conform to the above principles. Grants may be terminated at any time, should the Scientific Advisory Group judge that the principles have not been observed.

Social, Community-Based and Health Services Research

The responsible authority must make every effort to safeguard the rights of individuals. Ethical considerations which are applicable to individual participants must, insofar as possible, be applied in the community context. All reasonable means must be used to inform the community involved of the aims and intent of the proposed research and the possible advantages or disadvantages which may arise from it.

Obtaining and use of Privileged Information

All information that can be related to an identified individual must be treated as confidential. It may be communicated only to investigators who are engaged in research in the interests of the health of the community and only if, in the opinion of the professional practitioner holding that information, such communication will not harm the participant's interests.

The transfer of confidential medical information between members of the medical profession is an accepted practice in certain contexts. The Heart Foundation accepts that non-medically qualified investigators do, at times, have access to such information and must ensure that their studies are reviewed by a properly constituted ethics committee. Particular care should be taken to ensure confidentiality of material passed between investigators during the course of their research.

The results of investigations must never be presented in such a way that identification of individual participants might be possible.

Research Involving Animals

A 1983 amendment to the Animals Protection Act (Sections 19A and 19B) prohibits any research, experimental, diagnostic, toxicity or potency testing work involving the manipulation of any live animal “…. unless that work (is) …. carried out in accordance with a code of ethical conduct relating to the welfare and humane treatment of the live animal involved".

The Heart Foundation will require all Applicants for research grants involving experimentation with animals to conform to the following:

The application must include a written certificate of approval from an ethics committee properly constituted under the Animals Protection Amendment Act 1983. Applicants will be expected to abide by the Code of Recommendations and Minimum Standards for the Care and Use of Animals for Scientific Purposes. (Code of Animal Welfare Number 17, 1995. Prepared by the Animal Welfare Advisory Committee of the Ministry of Agriculture, PO Box 2526, Wellington.)

Researchers applying to The Heart Foundation for project support should use alternatives to live animals wherever possible.

Research studies involving animals must be designed to provide specific and significant information and avoid the unnecessary sacrifice of animals.

When animals are used, the experimental design should prevent their unnecessary death.

Animals used for experimental purposes must be lawfully acquired. They must be kept and used in strict compliance with the relevant laws and by-laws.

Animals used for experimental purposes must be treated with care and must be properly fed.

Animal accommodation must be adequate in size and must be maintained in a sanitary condition.

During operative procedures, appropriate anaesthetics must be used to eliminate sensitivity to pain. This point must be especially noted when neuro-muscular blocking agents are used. Where a recovery from anaesthesia is necessary during a study, any pain must be relieved by appropriate measures. Where recovery from anaesthesia is not intended, the animal must be killed in a humane way at the conclusion of the experiment. The post-operative care of animals must be such as to minimise discomfort and pain and should be consistent with the accepted practice of veterinary surgeons.

The principal investigator has the ultimate responsibility for the conduct of the research project, including the appropriate care and management of the animals throughout the course of the experiment.

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