ethical aspects of open access in health research by dr amanda burls is licensed under a creative...

Ethical Aspects of Open Access in Health Research by Dr Amanda Burls is licensed under a Creative Commons Attribution-ShareAlike 3.0 Unported License.

Ethical Aspects of Open Accessin Health Research

Amanda Burls, Department of Primary Care Health Sciences

http://creativecommons.org/licenses/by-sa/3.0/deed.en_US



www.equator-network.org

• International group trying to improve access to, and the quality of, reports of health research

• Led by Doug Altman at the University of Oxford• Aim: Accuracy, completeness, transparency of

health research reporting and open access to it.



http://www.equator-network.org/


Lack of open access to health research breaches the principles of bioethics

• Non-maleficence– Creating barriers to knowledge about interventions proven to do

more harm than good

• Beneficience– Creating barriers to knowledge about interventions proven to do

be beneficial

• Justice– Paywalls differentially block those with most need

• Autonomy– Breaches implicit social contract with participants in health

research– Prevents informed choice




Implicit social contract with participants

• Study participants are denied the knowledge they contributed to




Probiotic yoghurt trial - finished

2005




Sent: 19 January 2010 15:45To: Dr Amanda BurlsSubject: RE: Yoghurt trial Dear Amanda,

The trial is not yet in press - this is in part due to the much longer than anticipated further analysis of the data at the funders request. In summary this was a negative trial - although both groups demonstrated benefit, those in the active product group did not show greater benefit and at times the difference actually favoured the control product….




Publication bias

• Negative research not published• Negative research that is published

– Less likely to be published in English– There is bias in the outcomes reported

(“statistically significant” ones preferentially cited instead of the primary ones in protocol)

• Chan et al CMAJ September 28, 2004 vol. 171 no. 7 doi: 10.1503/cmaj.1041086




Publication bias

• There is bias in the outcomes reported– “Statistically significant” ones preferentially

cited (OR 2.7; 95% CI 1.5–5.0) – Primary outcomes differed between protocols

and publications for 40% of the trials.

Dwan K et al. 2008 Systematic Review of the Empirical Evidence of Study Publication Bias and Outcome Reporting Bias. PLoS ONE 3(8): e3081. doi:10.1371/journal.pone.0003081

Chan et al CMAJ September 28, 2004 vol. 171 no. 7 doi: 10.1503/cmaj.1041086




Peter Gøtzsche

“It has been amply documented that the current situation, with selective reporting of favourable research and biased data analyses being the rule rather than the exception, is harmful to patients and has led to the death of tens of thousands of patients that could easily have been avoided.” http://www.allea.org/Content/ALLEA/SC%20Science%20Ethics/Prague%20-%20June%202011/att.9b.1-G%C3%B8tzsche-data-sharing.pdf




Implicit social contract with participants

• Research shows that many people enter into clinical trials and other health studies for altruistic reasons.




Altruism as reason for entering a trial

European Journal of Cancer CareVolume 14, Issue 2, pages 166-170, 14 APR 2005 DOI: 10.1111/j.1365-2354.2005.00535.xhttp://onlinelibrary.wiley.com/doi/10.1111/j.1365-2354.2005.00535.x/full#f1



http://onlinelibrary.wiley.com/doi/10.1111/ecc.2005.14.issue-2/issuetoc

http://onlinelibrary.wiley.com/doi/10.1111/j.1365-2354.2005.00535.x/full


Altruism most important reason for participants in HIV/AIDS trials study

M. W. Ross, K. Jeffords & J. Gold (1994): Reasons for entry into and understanding of HIV/AIDS clinical trials: A preliminary study, AIDS Care: Psychological and Sociomedical Aspects of AIDS/HIV, 6:1, 77-82http://www.tandfonline.com/doi/abs/10.1080/09540129408258027



http://www.tandfonline.com/doi/abs/10.1080/09540129408258027


Lack of open access breaches

• Non-maleficence

• Beneficence




The cost of ignorance“I recently met a physician from southern Africa, engaged in perinatal

HIV prevention, whose primary access to information was abstracts

posted on the Internet. Based on a single abstract, they had altered

their perinatal HIV prevention program from an effective therapy to one

with lesser efficacy. Had they read the full text article they would have

undoubtedly realized that the study results were based on short-term

follow-up, a small pivotal group, incomplete data, and unlikely to be

applicable to their country situation. Their decision to alter treatment

based solely on the abstract's conclusions may have resulted in

increased perinatal HIV transmission.” Arthur Amman, President of Global Strategies for HIV Prevention cited in PLoS Medicine Editors (2006) The Impact of Open Access upon Public Health. PLoS Med 3(5): e252




Paywalls threaten distributive justice

• To read one article can cost 5 to 10 times the per capita annual health budget in some developing countries, like Uganda!

• Restricted access prevents evidence-based health policies and individual patient decisions

Yamey G. American Medical Association Journal of Ethics 2009 Vol 9 (7) 546-550




The Cochrane Collaboration is an international, not-for-profit, independent organisation, dedicated to making up-to-date, accurate, information about the effects of healthcare readily available worldwide.

We produce and disseminate systematic reviews of healthcare interventions searching carefully to try and find all randomised controlled trials to reduce bias.




From: Amanda Burls [mailto:[email protected]] Sent: 05 November 2010 18:11To: ORASubject: RE: Agreements with journals…Has the University considered making it a part of the employment contract that all research done within the University, or under the auspices of the University, should be published in public access journals or made available on the ORA? I think that, in the health sciences at least, it is becoming increasingly recognised that it is unethical not to make research methods and findings available to all. The University should take the lead on this so that, when the next generation look back in astonishment and ask “how could people have felt is was ethical to prevent free access to health knowledge” (as we do on the last generation, “how could they do trials on people without asking for informed consent?”), Oxford’s leadership role will shine forth! Best wishes Amanda_____________________________________________________Dr Amanda BurlsDirector of Postgraduate Programmes in Evidence-Based Health CareDepartment of Primary Health CareUniversity of Oxford



mailto:[email protected]


What universities should do?

Adopt strategies and processes to ensure

a. That research is of high quality

b. That all research is published

c. All research reports are complete, transparent and accurate

d. Research publications are open access

e. Research findings are further disseminated




What can universities do?

Adopt strategies and processes to ensure

a. That research is of high quality

b. That all research is published

c. All research reports are complete, transparent and accurate

d. Research publications are open access

e. Research findings are further disseminated




Bethesda (2003), Berlin (2003)

“…copy, use, distribute, transmit and display

the work publicly and to make and distribute

derivative works, in any digital medium for

any responsible purpose, subject to proper

attribution of authorship...."




Open access removes two important barriers

Price PermissionsGratis Libre




The majority of OA journals are no-fee

“… the discussion of OA journals has been harmed by a family of false assumptions: that all OA journals are fee-based; that all good OA journals must be fee-based; that author-side fees are "author fees" to be paid by authors out of pocket.”

Peter Suberhttp://www.earlham.edu/~peters/fos/newsletter/11-02-06.htm#nofee



http://www.earlham.edu/~peters/fos/newsletter/11-02-06.htm

http://www.earlham.edu/~peters/fos/newsletter/11-02-06.htm


Problem?: cost of publishing with OA

Solutions:

1. Include OA publication costs in grant application

2. Set up funds for publication costs– About 40 Universities worldwide have done so

• http://oad.simmons.edu/oadwiki/OA_journal_funds

3. No-fee OA journals– Most OA journals are no fee

• Suber and Sutton 2007 83%• Hooker 2007 67% (full OA journals in DOAJ)• Morrison 2009 90% (psychology journals in DOAJ• Sheiber 2009 70.3% (full OA journals in DOAJ)



http://oad.simmons.edu/oadwiki/OA_journal_funds


Two levels of OA

1. Gold – open access peer-reviewed journals

2. Green – deposition in open access repositoriesa. external repositories

b. institutional repositories




Growth in repositorieshttp://roar.eprints.org/




Finch Report June 2012http://www.researchinfonet.org/wp-content/uploads/2012/06/Finch-Group-report-FINAL-VERSION.pdf

“Repositories … provide access to some version of papers

either before they are submitted for publication in a journal

or at some point after they have been published, usually

subject to an embargo period. Most universities in the UK,

and in many other countries, have established repositories,

but the rates at which published papers have been

deposited in them so far has been disappointing.”



http://www.researchinfonet.org/wp-content/uploads/2012/06/Finch-Group-report-FINAL-VERSION.pdf

http://www.researchinfonet.org/wp-content/uploads/2012/06/Finch-Group-report-FINAL-VERSION.pdf


Registry of Open Access Repositories Mandatory Archiving Policies - Worldwide 2012

http://roar.eprints.org/




Total Mandates to Date

Institutional Mandates (156) Proposed Institutional Mandates (4)

Sub-Institutional Mandates (34) Proposed Sub-Institutional Mandates (3)

Multi-Institutional Mandates (3) Proposed Multi-Institutional Mandates (5)

Funder Mandates (53) Proposed Funder Mandates (7)

Thesis Mandates (93)





32 UK Academic Institutions (~10%)1. Aberystwyth University (09 Feb 2009)

2. Aston University (14 Jul 2009)

3. *Birkbeck College (13 Jul 2011)

4. Brunel University (02 Feb 2010)

5. Coventry University: Department of Media

and Communication (17 Jul 2009)

6. Cranfield University (11 Jun 2009)

7. Loughborough University (20 Oct 2010)

8. Napier University (09 Dec 2008)

9. Northumbria University (22 Feb 2012)

10. Queen Margaret University (29 Apr 2008)

11. Roehampton University (22 Jun 2009)

12. *Royal Holloway (15 Feb 2010)

13. *St George's (19 Aug 2012)

14. Teesside University (13 Oct 2010)

15. *University College London (02 Jun 2009)

16. University of Abertay Dundee (16 Dec

2009)

17. University of Bath (14 Jun 2011)• This list was generated on Sat Oct 6 01:07:55 2012 BST.

17. University of Birmingham (12 Jun 2009)

18. University of Bradford (12 Jun 2009)

19. University of Edinburgh (07 Mar 2009)

20. University of Glasgow (09 Oct 2008)

21. University of Leicester (27 Jul 2009)

22. University of Lincoln (06 Apr 2010)

23. University of Nottingham (15 Oct 2010)

24. University of Reading (16 Feb 2012)

25. University of Salford (17 Oct 2009)

26. University of Southampton (04 Apr 2008)

27. University of St Andrews (12 Jun 2009)

28. University of Stirling (09 Apr 2008)

29. University of Strathclyde (01 Feb 2010)

30. University of Surrey (26 Aug 2010)

31. University of Westminster (24 Jul 2009)

32. University of Westminster (13 Oct 2010)





Registry of Open Access Repositories Mandatory Archiving Policies for UK Oct 2012





Oxford could…

• Pro-actively identify and deposit copies of all journal articles published by staff, and all approved dissertations by graduate students, in their institutional repository.

• Require deposition of all research in the ORA.• Make it a requirement that we cannot give away

copyright.




In conclusion, lack of open access to health research breaches the four principles of bioethics

• Non-maleficence– Creating barriers to knowledge about interventions proven to do

more harm than good

• Beneficience– Creating barriers to knowledge about interventions proven to do

be beneficial

• Justice– Paywalls differentially block those with most need

• Autonomy– Breaches implicit social contract with participants in health

research– Prevents informed choice



ethical aspects of open access in health research by dr amanda burls is licensed under a creative...

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health research amanda

unported license publication

reports of health research

negative research

dr amanda burls subject

yoghurt trial dear amanda

negative trial

informed choice slide