Prospective Ethics Review in Infectious Disease Emergencies

299 Prospective Ethics Review in Infectious Disease Emergencies There is broad consensus worldwide on the elements of research ethics, which include prospective review or oversight by an appropriate research ethics committee (REC). While already a demanding task that often invites criticisms from researchers and academics, particularly the overly bureaucractic nature of the process, the management of ethics review becomes more complex during a public health emergency. For example, when an infectious disease outbreak caused by an unknown or novel pathogen reaches or is likely to reach an epidemic or a pandemic level, there is a need to design and implement research urgently to gather data on the disease and its risk factors, and to evaluate both medical and non-medical countermeasures. Time is of the essence for ethics review in such a situation because of the high costs of delay and missed opportunity to generate important knowledge and evidence-based approaches that can help address the ongoing outbreak, the possible next wave, or future similar outbreaks. Reducing knowledge gaps and the uncertainty of the effectiveness of each measure and their combinations also helps in determining proportionate measures in preparedness and response strategies. For example, quarantine of potentially infected individuals should not be imposed if it is shown to have no or little effect on containing spread in certain conditions, or when safe and effective vaccines become available. Infringement and unnecessary restriction of civil liberties and social disruptions are reduced when science and ethics work in harmony. The rules of the game may change for ethics review, however, during an infectious disease emergency. Review committees must take into account that perceptions of risks and benefits at the individual, community and societal level are likely to be affected, the extent of which depends on the contagiousness and severity of the disease and which may vary from place to place. As there is higher Asian Bioethics Review September 2009 Volume 1, Issue 3 299–303 U P D A T E P r o s p e c t i v e E t h i c s R e v i e w i n I n f e c t i o u s D i s e a s e E m e r g e n c i e s Vo o Te c k C h u a n A s i a n B i o e t h i c s R e v i e w S e p t e m b e r 2 0 0 9 Vo l u m e 1 , I s s u e 3 300 likelihood that research responding to a public health crisis will produce great social value, the exposure of research subjects to higher net risks than routine clinical research may become ethically permissible,1 as well as socially acceptable to the general populace. Perceptions of vulnerability and trust in authorities may also alter because of the recognition that we are all potential victims and vectors of infection. Organisational values like transparency and accountability are likely to connect more meaningfully with policy and individual decision-making as people strive to cooperate to deal with the public threat. Prospective review of such requirements may thus need to undergo appropriate procedural changes to meet public health and social needs during an infectious disease outbreak and other public health emergencies. WHO Technical Consultation on “Research Ethics in International Epidemic Response” Recognising the lack of guidance and forward thinking on this issue, which gains saliency with the emergence of influenza A H1N1/09, the World Health Organization’s Global Influenza Programme and the Ethics and Health Team jointly convened a technical consultation on “Research Ethics in International Epidemic Response” from 10–11 June 2009. (On the second day of the meeting, H1N1/09 was declared a pandemic.) Participants included experts from international organisations, government agencies and ministries, professional medical associations, academic and research institutions, and staff of various WHO departments and regional offices. The objectives of the meeting were (1) to identify and elucidate the ethical issues related to public health research and related activities during infectious disease outbreaks, and (2) to provide WHO, as well as public health practitioners...