Ethical Obligations of Researchers and Practitioners in Data Ownership

WHO Training Manual Ethics in epidemics, emergencies and disasters: Research, surveillance and patient care Learning Objective 5.3 Explain the ethical obligations of researchers, public health practitioners and publishers regarding ownership of scientific data

Outline 1. Introduction data ownership and sharing 2. Reading 3. Tamiflu video 4. Case study and debate 5. Summary and conclusion Suggested time 0-20 (20 min) 21-50 (30 min) 51-65 (15 min) 66-110 (45 min) 111-120 (10 min) Activity Summary and conclusion Introduction Reading Video and group discussion Case study and discussion L.O. 5.3

Background The availability and accessibility of research data can be an important factor in whether and to what extent that data can be utilized by public health researchers, practitioners, and decision-makers to promote and protect the public s health. L.O. 5.3

Background Making research data available during a public health emergency can have a significant effect on response capabilities (Langat et al., 2011; World Health Organization, 2007). a lack of access to data can hinder the abilities to respond effectively to a public health emergency. What are the ethical responsibilities of researchers, public health practitioners, and publishers regarding how to manage and share research data with the broader research community, health and government agencies, and the public? L.O. 5.3

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 when patients questions arise from unpublished and inaccessible study results, practitioners are in an impossible position.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 H bert, 2010). L.O. 5.3

Why Share Data? 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). L.O. 5.3

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 (Taylor, 2007). L.O. 5.3

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. L.O. 5.3

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. L.O. 5.3

Case Study Watch New doubts over Tamiflu here: http://www.channel4.com/news/articles/science_techn ology/new+doubts+over+tamiflu/3454737.html L.O. 5.3

Case Study In 2003, a paper was published eporting the results of a study sponsored by F. Hoffmann-La Roche Ltd. about the impact of oseltamivir (brand name: Tamiflu) treatment on influenza-related lower respiratory tract complications (LRTCs) and hospitalizations. The paper reported that oseltamivir treatment of influenza reduces LRTCs, antibiotic use, and hospitalizations both for at- risk and healthy adults (Kaiser et al., 2003). L.O. 5.3

Case Study This study involved the analysis of 10 separate phase three randomized control trials (RCTs) sponsored by Roche, of which only 2 have been published in peer- reviewed journals. In a subsequent Cochrane review it was claimed that, without including the data from the 8 unpublished studies included in the initial paper, there is insufficient evidence to answer the question about the effectiveness of oseltamivir in reducing LRTCs, antibiotic use, or hospitalization (Jefferson et al., 2009). L.O. 5.3

Case Study Irrespective of this, the original study s evidence has been used by public health decision-makers to justify recommending oseltamivir as a treatment option in combatting influenza, including pandemic strains of influenza (Godlee and Clarke, 2009). As a result, this has also led to the stockpiling of oseltamivir for use during an influenza pandemic. The authors of the Cochrane review conclude that, despite attempts to include all data for their review, they remained unable to access key data that purportedly supported the findings in the original Roche-sponsored study. L.O. 5.3

Case Study Questions What is the conflict in this case? What are some arguments for and against making the data in question available? What might be the effect of not having full access to all data about the effectiveness of oseltamivir both in terms of preparing for and responding to an influenza pandemic? L.O. 5.3

Case Study Questions To what extent should the following groups have access to all research data in this case? Should any of the following groups be limited in their access to all data? Why or why not? i. Researchers ii. Research institutions iii. Research sponsors iv. Publishers v. Practitioners vi. The public In your opinion, what responsibilities do each of the stakeholder groups listed above have with respect to data ownership and data sharing? L.O. 5.3

Case Study Questions If regulatory bodies, public health agencies, and other government bodies are responsible (to any degree) for the safety and effectiveness of a measure used in response to a public health emergency (e.g. oseltamivir), to what extent should they be obligated to base decisions about safety and effectiveness on all data? If not all data can be accessed, what responsibilities do these bodies have in making their decisions? L.O. 5.3

Questions for further discussion When considering whether a particular public health measure should be implemented to respond to a public health emergency, what data should be used? Should an effort be made to incorporate data that is unpublished or is tightly controlled by a researcher, study sponsor, or research institution? If research ethics boards/institutional review boards are meant to weigh the benefits and burdens of proposed human participant research, can they be said to have met this obligation if data ownership and data secrecy create a barrier to public benefit? Can public health research be said to have scientific and social value if it is not accessible by the larger research community and the public? L.O. 5.3

Questions for further discussion Do researchers, public health practitioners, and publishers have different responsibilities to share different types of data (e.g. raw data vs. cleaned data, qualitative observational data vs. quantitative experimental data)? If so, in what ways do these responsibilities differ? Consider the unique possible pathway(s) that different stakeholders might require in order to share data, given each stakeholder s distinct needs and constraints. Do research data generated during public health emergencies have a higher priority to be made available to other researchers and the public than data generated in non-emergency scenarios? Does a direct conflict exist between the requirement to publish and sharing data? Who should be responsible for developing protocols for data sharing? L.O. 5.3

Summary If research data is unpublished or is restricted this data will not be considered in public health decision- making Some argue data producers and publishers have ethical responsibility to share data generated in a transparent manner Additional responsibilities may exist to share data in pubic health emergencies to develop or implement effective and timely public health measures L.O. 5.3

Sources Emanuel EJ, Ezekiel J, Wendler D, Grady C. What makes clinical research ethical? Journal of the American Medical Association, 2002; 283: 2701 2711. Godlee F, Clarke M. Why don t we have all the evidence on oseltamivir? British Medical Journal, 2009; 339: b5351. 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. 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. Pisani E, Whitworth J, Zaba B, Abou-Zahr C. Time for fair trade in research data. The Lancet, 2010; 375: 703-705. Stanbrook MB, H bert 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. Vanderpool HY. The Ethics of Research Involving Human Subjects. 1996. Frederick, MD: University Publishing Group. World Health Organization. Avian and pandemic influenza. Best practice for sharing influenza viruses and sequence data. Available: http://apps.who.int/gb/ebwha/pdf_files/WHA60/A60_ID1-en.pdf. 2007. Accessed March 24, 2013. L.O. 5.3

Acknowledgements Chapter author Smith, Maxwell, Dalla Lana School of Public Health and Joint Centre for Bioethics, University of Toronto, Toronto, Ontario, Canada L.O. 5.3