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There are over 1000 different guidelines on human research ethics (OHRP 2013). While they are not entirely consistent, nor comprehensive, there are a number of fundamental principles and requirements that are consistently upheld across guidelines. Some relevant examples are that participants must give valid consent to take part in research (with a very few carefully defined exceptions); participants’ privacy and confidentiality must be protected, and the interests of the individual can never be overridden in the interests of society. In addition, research must be reviewed by an appropriate ethics committee before it can be conducted.A recent exampleIn September 2012, a novel and dangerous strain of coronavirus was identified. While some strains of coronaviruses can be relatively low risk, causing conditions such as the common cold, others, such as SARS, carry a higher risk to the population. It is unsurprising then, that a novel strain with a 50% mortality rate, has been taken very seriously by health professionals and the media around the world, and especially in the UK, which has had one third of 12 identified cases. Thankfully, the strain appears to have very low person-person transmission rates, with the majority of the cases contracted after travel to Qatar or Saudi Arabia. However three clusters of coronavirus demonstrate person-to-person transmission within two families (one in UK and another in Saudi Arabia) and within a medical facility (an Intensive Care unit in Jordan) (HPA 2013).How should we respond to novel infections?Managing treatment of patients with novel infections is not straightforward (see for example the World Health Organization’s Interim Guidance published in February 2013). The route of infection and potential transmissibility of a new strain of a disease may not be clear, nor will the course the disease is likely to take or the effectiveness of potential treatments be known. Care of such patients will often involve very frequent testing and monitoring, and careful clinical judgement. With a small number of early patients, there may be requests to rapidly share patient data with national and international health organisations tasked with developing appropriate guidelines for management and treatment of the condition. In some cases clinicians may wish to go further and conduct research at the bedside, for example, trialling an antibiotic or anti-viral that has been shown to be effective against related bacterial or viral infections.Boundaries between research and healthcareConducting research in such circumstances raises some interesting ethical issues. One of the first is where the boundary of healthcare and research lies. If a clinician treats a patient solely using their clinical judgement (in consultation with colleagues) based on the limited information available, this is healthcare. What if, however, doctors wish to take additional blood samples not just to inform treatment of the patient, but to help to identify why some family members become infected but not others, or to sequence the genome of the new strain? In some cases it might be possible to go even further, and trial a potential treatment proved effective against related diseases. We can argue that both of these latter studies could potentially be very worthwhile and important. However, designing a research study and receiving ethical review generally takes months, which would mean that it would not be possible to conduct the study until after the infection rates had peaked. Review of the study may be able to expedited, but at a minimum this is still likely to take some weeks.Can we speed up the research design and review process?One way forward may be to develop draft protocols for primary research into emerging infections and have these reviewed by committees in advance. Specific features, such as information sheets and consent forms for the study, will need to be finalised once the specific infection has been identified. These aspects can reviewed via a special expedited process by the committee that has reviewed the principles in the earlier draft protocol. For example, a draft protocol may be developed for an epidemiological study. This may seek to identify standard categories of data that should be collected from all patients with a novel respiratory infection to enable collection of consistent datasets around the world for rapid and effective analysis. A more controversial example might be a protocol for a study of an anti-retroviral shown to be effective against one strain of a disease to be trialled when closely related strains are identified.Protecting patients’ interests: consent and confidentialityWhen healthcare is provided to a patient, when seeking to share their health data for secondary research it is often necessary (depending on the jurisdiction) to seek patient consent. It’s also often necessary to ensure that the data is anonymised or personal details are removed so it isn’t clear who data belongs to. Seriously ill patients may not be able to consent to having their data shared for research, particularly in the timeframe in which this needs to be done for research into an emerging infection. Additionally, when there are a small number of early patients and there is significant media attention, it will not be possible to conceal from secondary researchers who the data belong to. There can be significant pressure to publish results of early research as soon as possible, to aid treatment of others, and with secondary analysis of the medical records of small numbers of identifiable individuals, this may mean that aspects of individual patients’ health data become public.What do you think?Guidance on research ethics is very clear that the interests of the individual can never be overridden in the interests of society. In the case of novel, dangerous and easily transmissible infections, society has a considerable interest in ensuring that information about risk factors for the infection, means of limiting transmission and potential treatments are made available as soon as possible. In such cases can a case be made for allowing the use of participants’ relevant health data for secondary research without their permission or any guarantee that their privacy is protected? Can we imagine any circumstances in which we might argue a patient must participate in epidemiological research while their infection is being treated?