1. World Health Organization
13 April, 2018
WHO Training Manual
Ethics in epidemics, emergencies
and disasters:
research, surveillance and patient care
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2. World Health Organization
13 April, 2018
Core competence 5
Ability to explain how publication ethics are related to public health surveillance or research in emergencies
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3. Corresponding learning objectives
Explain the conditions in which data gathered during public health surveillance or routine clinical management can be published as scientific knowledge.
Explain what is meant by “publication bias” and how it might affect the response to emergencies
Explain the ethical obligations of researchers, public health practitioners and publishers regarding ownership of scientific data.

4. Data dissemination
Gathered during public health surveillance or routine clinical management should be published as scientific knowledge
Declaration of Helsinki, Paragraph 36 (World Medical Association, 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 affiliations and 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.’
2013 Declaration of Helsinki itself (paragraph 36)
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5. Types of research activity
When determining whether data obtained as part of an informal research project should be disseminated, the type of activity that resulted in data collection should be determined
2013 Declaration of Helsinki itself (paragraph 36)
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6. Publication clearance
Criteria for publication clearance of routinely-collected data:
Type of activity
Relevance of data
Scientific validity
Confidentiality
Risk minimisation
Permission and partnerships
Availability and accessibility
Ethics approval
Philip Calain, Schopper et al.
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7. Publication bias
What is published and therefore what makes up the evidence base upon which decisions are informed has the potential to be biased
Bias
“[a]ny process at any stage of inference which tends to produce results or conclusions that differ systematically from the truth” (Sackett, 1979, pg. 60)
Publication bias refers to what occurs when what is published is systematically unrepresentative of what is available to be published (Rothstein et al., 2005)

8. Forms of Publication Bias
Positive results bias
Positive results bias occurs when statistically significant positive results from a study are more likely to be published than results that support the null hypothesis or results that are inclusive (i.e. ‘negative’ results) (Hopewell et al., 2009)
Hot stuff bias / lack of interest bias
Bias occurs when a topic is popular (or not) within the scientific community or in the broader public domain, leading to an increased (or decreased) interest for publication on that topic
Confirmation bias
Can exist when the results of research tend to match or support the interests, expectations, or hypothesis of the researcher or study sponsor (Mahoney, 1977)

9. Methods to address publication bias
Making data (more) publicly accessible, while calling into question who owns the data, who should have access to them and who can make use of them
Making publications “open access”
Transparency in the publication process

10. Data sharing
Seminal documents on the ethical conduct of research on human subjects require that research have social or scientific value (Emanuel et al., 2002).
This requirement has been used to support in favour of data sharing, as restricting access to data can be seen as antithetical to research generating social or scientific value (Langat et al., 2011; Vanderpool, 1996)
Rapid data sharing is an ethical imperative in public health emergencies

11. Why Share Data?
“…when patients’ questions arise from unpublished — and inaccessible — study results, practitioners are in an impossible position. Unable to appraise the research, clinicians are left with an uncertain foundation for making decisions about patient care and, at best, can only echo what has been said publicly by others” (Stanbrook and Hébert, 2010)

12. Why Share Data?
Less restrictive data sharing practices in fields outside of public health (e.g. genomics) have demonstrated that data sharing can:
reduce the duplication of research
increase scientific progress
produce more career opportunities for researchers (Pisani et al., 2010)
Making data available and accessible can inform researchers of what data exists and where future research can be directed

13. Challenges and Barriers to Data Sharing
There may be less incentive for researchers to make relevant, time-sensitive research data or results available to the broader scientific community or the public, because:
Funding and promotion often requires researchers to publish original research and to publish in high impact journals
An opportunity would be given to other researchers to publish from this data set, which might mean that data producers receive no (or diminished) benefit

14. Challenges and Barriers to Data Sharing
Research, and perhaps especially industry-sponsored pharmaceutical research, might have commodity- driven interests to maintain data secrecy (Taylor, 2007)
Research data may be considered the intellectual property of researchers, requiring permission or payment if that data is to be accessed or used (Langat et al., 2011)
Concern may arise about maintaining confidentiality if data is shared.

15. Conclusions Core Competence 5
Collected data during public health surveillance or routine clinical management should be published as scientific knowledge in a timely manner
Publication bias refers to publication that do not represent what is available to be published
Common publication biases are positive result biases, Hot stuff/lack of interest biases, and confirmation biases
Rapid data sharing is required due to the social and scientific value attributed to scientific knowledge
Concerns about departures from normal review process
The challenge of departures from normal review processes is that they could possibly undermine the 11 important areas of research ethics review discussed in LO2.1. One source of concern is that variations in the review process of protocols could lead to the neglect of issues of exploitation. Because of their very nature, emergencies create vulnerability in certain individuals, while also exacerbating already-existing vulnerability of some social groups, such as may be the case with children, women, and impoverished communities and individuals (Sumathipala et al, 2010). Furthermore, health emergencies may deepen already existing disparities (both within societies and at the global level). It is important that variations to standard procedures of ethics review stay true to the goal of minimising exploitation.
Another aspect that must be considered is the possibility that variations to standard review might increase the risk for therapeutic misconception (see LO8.2). When research is combined with humanitarian aid or clinical care, there can be a lack of clarity as to whether the endeavour is part of routine care or is in fact part of research. This confusion might be particularly strong where the information provided to potential participants would be inadequate (e.g., no explicit mention of research, too much emphasis on a therapeutic intent of the project). The premise, then, is that even variations to standard procedures of ethics review ought to ensure that informed consent procedures should reduce the likelihood of participants mistaking research for therapeutic services.
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16. Sources
World Medical Association (2013) Declaration of Helsinki. Ferney-Voltaire (
Rothstein HR, Sutton AJ, Borenstein M. Publication bias in meta-analysis. In Publication Bias in Meta-Analysis: Prevention, Assessment and Adjustments, eds Rothstein HR, Sutton AJ, Borenstein M. John Wiley & Sons, Ltd: Chichester, UK
Sackett DL. Bias in Analytic Research. Journal of Chronic Diseases, 1979;32:
Hopewell S, Loudon K, Clarke MJ, Oxman AD, Dickersin. Publication bias in clinical trials due to statistical significance or direction of trial results (review). The Cochrane Library, 2009;1: 1-26.
Stanbrook MB, Hébert P. Disseminate time-sensitive research faster. Canadian Medical Association Journal, 2010; 182(1): 9.
Taylor PL. Research sharing, ethics and public benefit. Nature Biotechnology, 2007; 25(4):

17. Sources
Jefferson T, Jones M, Doshi P, Del Mar C. Neuraminidase inhibitors for preventing and treating influenza in healthy adults: systematic review and metaanalysis. British Medical Journal, 2009; 339: b5106.
Kaiser L, Wat C, Mills T, Mahoney P, Ward P, Hayden F. Impact of oseltamivir treatment on influenza-related lower respiratory tract complications and hospitalizations. Archives of Internal Medicine, 2003; 163:
Mahoney MJ. Publication prejudices: an experimental study of confirmatory bias in the peer review system. Cognitive Therapy and Research, 1977;1(2):
Emanuel EJ, Ezekiel J, Wendler D, Grady C. What makes clinical research ethical? Journal of the American Medical Association, 2002; 283: 2701–2711.
Vanderpool HY. The Ethics of Research Involving Human Subjects Frederick, MD: University Publishing Group.
Langat P, Pisartchik D, Silva D, Bernard C, Olsen K, Smith M, Sahni S,Upshur R. Is there a duty to share? Ethics of sharing research data in the context of public health emergencies. Public Health Ethics, 2011; 4(1): 4-11.