Regulatory involvement in human research has resulted from various historical research events. Some of these issues are highlighted in the University of Nevada’s History of Research Ethics. As a result, research involving humans is governed by a number of guidelines. These ensure that both participants and researchers are protected by compliance with international, national and local requirements. A research protocol describes how the research complies with these standards.
Where researchers, including student researchers, are intending to undertake research involving human subjects, they must obtain final ethics approval from the relevant committee before commencing the studies. This normally require an application form plus a study protocol, participant information sheets and consent forms to be submitted to the reviewing Human Ethics Committee.
Some studies may be designated as involving only low or negligible risk to participants and researchers. For studies which meet the criteria for this definition, the ethics approval process is likely to be somewhat simpler and easier, usually only requiring completion of a brief institutional form. Evaluation of health services, quality improvement projects, audits, benchmarking studies, and so on, do not usually require ethics approval if the data is to be used only internally within the organisation and not published, however individual organisations may have their own policy on this.
Applications for ethics approval are usually required to include a well developed research protocol outlining methodology, participants, data collection, analysis and any ethical considerations. It is important to allow sufficient time when planning research in palliative care to prepare for, and receive, ethics approval. The processes of ethics approval may take some time especially in multi-site research, where each site may have its own procedures.
A complete set of templates for participant information and consent forms have been developed by the NHMRC. For new researchers these templates provide a guide to the issues that need to be addressed in their own study documentation.
Ethics and Palliative Care
Human Research Ethics Committees (HRECs) can sometimes be very cautious when reviewing ethics applications for studies using palliative populations. The following points can help in seeking ethics approval:
- Focus on benefit versus burden within the protocol. In many studies, the participants themselves will be unlikely to benefit from changes to care informed by findings from the research. In these cases, a persuasive argument needs to be made that the benefits to the patient (and sometimes general) population outweigh the burden on the small number of individuals taking part. The risks and burdens of participating will need to be clearly stated on the patient information sheet so people can make a balanced decision about whether or not to participate.
- Ensure that ethical considerations are clearly and well explained to assist the reviewers in considering the protocol.
- There are specific issues to consider in relation to research with Aboriginal and Torres Strait Islander people; NHMRC guidance is available to assist with this:
A review of specialist palliative care practitioner-reported ethical challenges noted that these issues were far broader than those covered by many textbooks and ethics guides. The Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) checklist covers key ethical considerations for clinical trialists.
Having received ethics approval, researchers need to fulfil the requirements of their ethics approval, which involves secure storage of data and consent forms for the stipulated period, protection of participant confidentiality, notifying the ethics committee of any changes to the protocol or study materials or adverse events affecting any participants, and reporting on progress as requested (usually annually).
Regardless of whether a study needs ethical approval, all research must be conducted in an ethical way, to ensure the integrity of the findings. Many journals will require ethical clearance or evidence that this was not required prior to publication.
Managing during COVID-19
Research processes during a pandemic have become more complex. The Australian Health Ethics Committee of the National Health and Medical Research Council (NHMRC) has developed a guide Decision-making for pandemics: an ethics framework. It is designed to support ethical health and medical related decision making and ethical policy development during a pandemic.
