Ethics of Surveillance Data Use
Developing an Ethical Framework for Research Using Surveillance Data in Resource Limited Countries
Data routinely collected as part of surveillance activities in public health (PH) is increasingly being used for research purposes. This occurs because activities such as the routine documentation of interventions and monitoring of epidemiological data, that characterize surveillance, offer representative or comprehensive data that can be used for later research. However, there is an increasing realization that because surveillance does not ordinarily warrant ethical requirements, the data gathered within it, which may subsequently be used for research, may not undergo ethical reflection either. There is also a conceptual challenge of differentiating between “research” and “non-research” in surveillance, so as to develop appropriate criteria for ethical distinctions. Questions on whether, which aspects and at what point research using surveillance data (RUSD) should fit in existing ethical frameworks, have also been inadequate. Currently, there is consensus that ethical reflection is important for all evidence-generating initiatives, whether or not they constitute formal research. However, questions on who is responsible for ethical judgments, and what processes are adequate for RUSD remain unanswered. Moreover, existing ethical frameworks that have been produced are either suited to PH initiatives or research but not to both, as is thought to be necessary in the case of RUSD. There is consequently, a dependence on extrapolations from research ethics frameworks and PH ethics guidelines for RUSD. The resultant imprecision of stakeholders’ interpretation, adaptation and implementation of ethical standards have potentially serious implications for research ethics goals and public accountability. The danger is that contemporary PH evidence generation and RUSD models in resource limited countries, such as Health and Demographic Surveillance Sites, may not be to meeting the right ethical standards, even when critical ethical issues are raised.
This study aims to conceptualize and distinguish PH “surveillance” and “research,” to examine issues arising from their overlap and how these issues challenge the effectiveness of research ethics frameworks for RUSD. To achieve this goal, the study’s objectives are to:
(1) Explore literature to distinguish “surveillance” and “research” so as to conceptualize RUSD
(2) Examine existing ethical frameworks (EEFs) including ethics guidelines, laws and regulations to understand the current knowledge base for guiding surveillance, research and RUSD
(3) Investigate ethics review mechanisms for surveillance activities and RUSD, and evaluate how different they are from other research
(4) Undertake an empirical study to explore PH professionals’ methods of distinguishing surveillance and RUSD
(5) Conduct a normative analysis to situate the empirical findings within ethical literature, to formulate where EEFs are inadequate or inappropriate, and (if feasible) develop an ethical framework for the future evaluation of RUSD.
A mixed methods approach will be used involving field work in Ghana, Tanzania and Uganda as follows: (i) review of literature on PH surveillance and research, in relation to international governance mechanisms (objectives 1 and 2); (ii) vignette-based questionnaire administration (n = 150 - 200) to HDSS team leaders and PH professionals, ethics committee members and committee administrators, to explore PH professionals’ methods of distinguishing surveillance and RUSD, and investigate ethical mechanisms and regulations for both activities (objectives 3 and 4); (iii) key informant face-face interviews with 30 experts in PH, RUSD and ethics to address objectives 2 to 4; and (iv) normative analysis/synthesis of empirical and theoretical findings to, if feasible, develop an appropriate framework for RUSD.
Six HDSS centres, one national and four local RECs that oversee HDSSs in Ghana and Tanzania, will be visited. The 2014 Annual General Meeting of the International Network for the Demographic Evaluation of Populations and their Health in Uganda will be attended to make contacts with heads of HDSS from Africa, Asia and Oceania, for interviews and questionnaire administration.