History, culture and social norms: implications for Ebola drug and vaccine clinical trials in affected region Morenike Folayan and Bridget Haire, Aminu Yakubu

Introduction The EVD epidemic precipitated debates about the appropriate methodologies for conducting clinical trials of drugs and vaccines during a major infectious disease outbreak.

Introduction - 2 While the research for EVD treatment and vaccines is important and urgent, research priorities cannot be allowed to leech funding from critical patient care and public health in resource limited settings.

Introduction - 3 Also, the ‘rule of rescue’ that supports the use of any plausible and available treatment to reduce mortality and morbidity has implications for the design of EVD clinical trials so that trials.

Introduction - 4 We highlight how social and cultural norms can inform the design and implementation of EVD clinical research; and the importance of community consultation to help shape the design and implementation of the research.

History, the State and its implications for EVD response Sierra Leone and Liberia have been affected by years of civil war, and Guinea has suffered many years of coups and political violence. These civil disruptions left political systems fragile with citizens being sensitive to signals of marginalization.

History, the State and its implications for EVD response - 2 The relationship of citizens with government is plagued with distrust, feelings of abandonment and frustration.

History, the State and its implications for EVD response - 3 There is also a history of distrust of foreign nationals promulgated by the government following the incursion of foreigners into domestic politics in the wake of humanitarian and refugee programs that followed the period of civil crisis.

History, the State and its implications for EVD response - 4 The conflict disrupted economic activities, reduced access to clean water and food, diverted resources from health care, resulted in breakdown of surveillance and communication systems and networks

History, the State and its implications for EVD response - 5 Post wartime, Ebola affected countries became accustomed to recurrent outbreaks of infectious diseases. The control depended on response and support of the international community.

History, the State and its implications for EVD response - 6 At the time of the EVD outbreak, “donor fatigue” had set in and the international community was engaged in setting up fledgling systems to reduce donor dependency. The fragile transitional systems were unable to handle the EVD outbreak, as it was outside routine healthcare management thereby delaying international response. Indigenous responses also required that changes be made to routine state performances with implications for political, social and economic changes. These changes take time and resulted in further delays in state response to the epidemic.

Culture, social norms and the implications for EVD research While there are biomedical perspectives about the science and ethics of clinical trial design, values that are rooted in culture and local moral traditions influence research participation.

Culture, social norms and the implications for EVD research - 2 Individuals in Africa view their participation in research as form of partnership between communities and researchers with the aim of achieving better health.

Culture, social norms and the implications for EVD research - 3 For this reason, it is an imperative for communities to have visible, meaningful local input in the design of EVD trials to ensure the research is humanely focused, and does not violate harmonious relationships within the society.

Implications for design and Implementation of EVD clinical trials There are 4 things to consider: ensure study protocols are developed in consultation with local researchers; ensure communities are engaged with the research design and implementation; ensure concrete plans are made for future access to EVD drugs; and foster investment in healthcare infrastructure

Study protocols Engagement of local researchers allow for in-country discussions on study specimen ownership, study specimen shipment process and data sharing prior to bio-banking. It also ensures the design of clinical trials is informed by local social, political and cultural perspectives. Acknowledging the legitimacy of cultural norms promotes exploration of alternative research designs that can produce desired outcomes with similar levels of scientific validity as with traditional designs.

Community engagement It promotes public dialogue to address misconceptions, equity and justice in participants’ selection, recruitment and retention strategies, and honest discussions about risks, benefits and future drug and vaccine access. It helps community advocates become knowledgeable about scientific aspects of proposed trials in order to contribute meaningfully to discussions about its design; and facilitates the design of culturally sensitive and politically appropriate trial processes.

Future drug access Trials cannot end with the determination of the efficacy or effectiveness of drugs and vaccines Concrete plans need to be made to ensure access to EVD drugs during future EVD outbreaks to avoid countries and citizens that have invested human resources in the EVD drugs trials being exploited. The Declaration of Helsinki and the CIOMS stipulate that research protocols must discuss post-trial access to experimental products.

Healthcare infrastructure While we do appreciate that it is the State’s responsibility to address health care provision for its citizens, we feel that research enterprises that conduct clinical trials in countries affected by EVD epidemics have a moral duty to invest in building healthcare systems and structures. Such efforts would contribute to long term human and infrastructural development for future research in neglected tropical diseases.

Conclusion Drug and vaccine clinical trials should not only be informed by science, but also by the history, politics, culture and social norms of the communities to be engaged in clinical trials. Trial design for EVD research should explore the suitability of alternative approaches to RCTs for conducting trials in EVD affected zones.