Ethics in Epidemics and Public Health Surveillance: Data Publication Guidelines

WHO Training Manual Ethics in epidemics, emergencies and disasters: Research, surveillance and patient care Learning Objective 5.1 Explain the conditions in which data gathered during public health surveillance or routine clinical management can be published as scientific knowledge

Outline 1. Introduction publication criteria 2. Reading 3. Role play presentation and discussion 4. Summary and conclusion Suggested time 0-15 (15 min) 16-35 (20 min) 36-40 (5 min) 41-60 (20 min) 61-75 (15 min) Activity Introduction Reading Role play and presentation Group discussion Summary and conclusion L.O. 5.1

Background Moral obligation to share and publicize relevant findings of knowledge generated in a public health crisis Data used in public health crises may be collected from routine clinical activities and surveillance Due to urgency there may be lack ethical oversight or individual consent Necessity to publish data of public health importance may outweigh absence of prior consent or ethical review L.O. 5.1

Declaration of Helsinki (2013) Researchers, authors, sponsors, editors and publishers all have ethical obligations with regard to the publication and dissemination of the results of research. Researchers have a duty to make publicly available the results of their research on human subjects and are accountable for the completeness and accuracy of their reports. All parties should adhere to accepted guidelines for ethical reporting. Negative and inconclusive as well as positive results must be published or otherwise made publicly available. Sources of funding, institutional affiliationsand conflicts of interest must be declared in the publication. Reports of research not in accordance with the principles of this Declaration should not be accepted for publication. L.O. 5.1

Publication clearance Criteria for publication clearance of routinely- collected data: a) Type of activity b) Relevance of data c) Scientific validity d) Confidentiality e) Risk minimisation f) Permission and partnerships g) Availability and accessibility h) Ethics approval L.O. 5.1

a) Type of activity Activities such as operational research may result in departures from standard ethics review processes Possible definitions of operational research: research carried out in the course of humanitarian operations (Balasegaram et al 2006) one among various domains of research to improve health systems (Remme et al., 2010) Must ensure researchers seeking post hoc approval are not using terms in a justificatory manner, rather than to describe specific circumstances L.O. 5.1

b) Relevance of data Data from routine activities such as public health surveillance or clinical monitoring often easiest and first collected in a public health emergency Decision to disseminate data must consider potential benefits Important in settings where work will continue, or where data may be used to promote change, e.g. modifying treatment protocols L.O. 5.1

c) Scientific validity Data collected during public health surveillance may not be as rigorous as data collected through formal research projects Where scientific validity of data collection activities might be open to debate these limitations must be explicitly acknowledged L.O. 5.1

d) Confidentiality Confidentiality ensures identifiable information is kept out of reach of others All identifiable information collected about individuals is subject to the duty of confidentiality and, as such, should be left out L.O. 5.1

e) Risk minimisation Communities, groups or individuals may be stigmatised if public health activities reveal higher prevalence of a condition linked to frowned upon practices Must minimise the risks where publication of data exposes such individuals Even when expected risks are minimal, they must be explicitly acknowledged by researchers L.O. 5.1

f) Permissions and partnerships National and local health authorities must be informed and agree to release of data if directly involved in its collection Pre-publication partnerships with local stakeholders must have been pursued whenever possible. E.g. engagement with a body representing the community and, if possible, authorship from a local authority or partner, should be sought. L.O. 5.1

g) Availability and accessibility Outcomes of data analysis must be made available to patients and communities in appropriate forms L.O. 5.1

h) Ethics approval If ethics approval not obtained for the conduct of the activity that led to the gathering of the data, post hoc ethics approval cannot be granted But if researchers decide to publish, they take the moral responsibility regarding the issues a-g above L.O. 5.1

Reading Balasegaram M, Harris S, Checchi F, Hamel C, Karunakara U. (2006). Treatment outcomes and risk factors for relapse in patients with early-stage human African trypanosomiasis (HAT) in the Republic of the Congo. Bull WHO, 84(10): 777-82. Read the paper, particularly the first two pages Imagine that the paper is in fact an advanced draft submitted to a journal, and consider whether it should be approved for publication. L.O. 5.1 (20 min)

Role play presentation Facilitator is the Technical Offer requesting ethics approval ahead of submission to a peer-reviewed journal L.O. 5.1

Group discussion Discuss the Technical Officer s request Decide if post hoc clearance for publication should be granted Summarize your discussions L.O. 5.1

Summary Grey areas exist when data gathered from public health surveillance or routine clinical management can be disseminated as scientific knowledge Proper informed consent may not have been obtained from patients-turned-participants Often a lack of a priori ethics approval Harm that might result from publication should be assessed against the expected benefits of dissemination List of criteria for publication clearance of routinely- collected data can be used to assist L.O. 5.1

Sources Balasegaram M, Harris S, Checchi F, Hamel C, Karunakara U. (2006). Treatment outcomes and risk factors for relapse in patients with early-stage human African trypanosomiasis (HAT) in the Republic of the Congo. Bull WHO, 84(10): 777-82. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2627495/?tool=pubmed Remme JHF, Adam T, Becerra-Posada F, D'Arcangues C, Devlin M, et al. (2010). Defining Research to Improve Health Systems. PLoS Medicine, 7(11): e1001000. http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1001000 Gollogly L. (2006). Ethical approval for operational research. Bulletin of the WHO, 84(10): 766. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2627493/pdf/17128348.pdf Calain P, Fiore N, Poncin M, Hurst SA. (2009). Research ethics and international epidemic response: the case of Ebola and Marburg hemorrhagic fevers. Public Health Ethics, 2(1): 7-29. Schopper D, Upshur R, Matthys F, Singh JA, Bandewar SS, Ahmad A, van Dongen E. (2009). Research ethics review in humanitarian contexts: the experience of the independent ethics review board of M decins Sans Fronti res. PLoS Medicine, 6(7): e1000115. L.O. 5.1

Acknowledgements Chapter author Calain, Philippe, M decins Sans Fronti res, Geneva, Switzerland L.O. 5.1