Recommendations from the Code of Ethics for the New Zealand Medical Profession.
- Before initiating or participating in any clinical research, doctors should assure themselves that the particular investigation is justified in the light of previous research and knowledge. Any proposed study should reasonably be expected to provide the answers to the questions raised. There must be an assessment of predictable risks and burdens in comparison with foreseeable benefits to the participants or to others. All studies involving patients should be subject to the scrutiny of an appropriately constituted ethics committee, which must be independent of the investigator and the sponsor and of any kind of undue influence.
- Doctors should be assured that the planning and conduct of any particular study is such that it minimises the risk of harm to participants. When comparing active treatments, the control group should receive the best currently available and accepted treatment, in accordance with a reasonable body of medical opinion.
- A placebo-controlled trial may be ethically acceptable, even if an established therapy is available for a certain condition, under the following circumstances:
- The established treatment has never been demonstrated to be effective by evidence-based criteria; or
- Where for compelling and scientifically sound methodological reasons its use is necessary to determine the efficacy or safety of a prophylactic, diagnostic or therapeutic method; or
- Where a prophylactic, diagnostic or therapeutic method is being investigated for a minor condition and the patients who receive placebo will not be subject to any additional risk of serious or irreversible harm; AND
- There must be a robust mechanism for curtailing the trial if at any stage the treatment group is demonstrated (by adequate statistical methods) to be different from the placebo group.
- Patient consent for participating in clinical research (or permission of those authorised to act on their behalf) should be obtained in writing only after a full written explanation of the purpose of that research has been made, and any foreseeable health hazards outlined. Opportunity must be given for questioning and withdrawal at any time. When indicated, an explanation of the theory and justification for double-blind procedures should be given. Acceptance or refusal to participate in, or withdrawal from, a clinical study must never interfere with the doctor-patient relationship or access to appropriate treatment. No degree of coercion is acceptable.
- Boundaries between formalised clinical research and various types of innovation have become blurred to an increasing extent. Doctors retain the right to recommend, and any patient has the right to receive, any new drug or treatment which, in the doctor’s considered judgement, offers hope of saving life, re-establishing health or alleviating suffering. Doctors are advised to document carefully the basis for any such decisions and also to record the patient’s perception and basis for a decision. In all such cases the doctors must fully inform the patient about the drug or treatment, including the fact that such treatment is new or unorthodox, if that is so.
- In situations where a doctor is undertaking an innovative or unusual treatment on his or her own initiative, he or she should consult suitably qualified colleagues before discussing it with, or offering it to, patients. Doctors should carefully consider whether such treatments should be subject to formal research protocols.
- It is the duty of doctors to ensure that the first communication of research results is through recognised scientific channels, including journals and meetings of professional bodies, to ensure appropriate peer review. Participants in the research should also be informed of the results as soon as is practicable after completion.
- Doctors should not participate in clinical research involving control by the funder over the release of information or results, and should retain the right to publish or otherwise release any findings they have made. Doctors involved as principals in research should not participate if they do not have access to the base data. Negative as well as positive results should be published or otherwise made publicly available. Any dispute or ethical issue that may arise in respect of the research should be considered openly, eg, by consultation with the appropriate ethics committee.