WHO Training Manual Ethics in epidemics, emergencies - PowerPoint Presentation

Slide1

WHO Training

Manual

Ethics in epidemics, emergencies

and disasters:

research, surveillance and patient care

Core competence 5

Ability to explain how publication ethics are related to public health surveillance or research in

emergencies

Corresponding learning objectivesExplain 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.

Data dissemination Gathered during public health surveillance or routine clinical management should be published as scientific knowledgeDeclaration 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.’

Types of research activityWhen 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

Publication clearanceCriteria 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.

Publication biasWhat is published and therefore what makes up the evidence base upon which decisions are informed has the potential to be biasedBias “[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)

Forms of Publication BiasPositive results biasPositive 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)

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

Data sharingSeminal 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

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)

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 researchincrease scientific progressproduce 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

Challenges and Barriers to Data SharingThere 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 journalsAn opportunity would be given to other researchers to publish from this data set, which might mean that data producers receive no (or diminished) benefit

Challenges and Barriers to Data SharingResearch, 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.

Conclusions Core Competence 5 Collected data during public health surveillance or routine clinical management should be published as scientific knowledge in a timely mannerPublication bias refers to publication that do not represent what is available to be publishedCommon 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

Sources World Medical Association (2013) Declaration of Helsinki. Ferney-Voltaire (http://www.wma.net/en/30publications/10policies/b3/). 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. 2006.

Sackett

DL. Bias in Analytic Research.

Journal of Chronic Diseases

, 1979;32: 51-63.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): 398-401.

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: 1667-1672.Mahoney MJ. Publication prejudices: an experimental study of confirmatory bias in the peer review system. Cognitive Therapy and Research, 1977;1(2): 161-75.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. 1996. 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.