1. Research and Innovation for Maternal and Newborn Health, Brussels – Square Meeting Centre, 8 th Dec 2015 Beyond Ethics in Outbreak Research NAS, Clinical Trials during 2014 Ebola Virus outbreak London, 22-24 March 2016 Carel IJsselmuiden

2. Beyond Ethics  Research Ethics – classical Protection against risk Fair distribution of benefits Largely directed at individuals – mainly participants – some extension into ‘community’  Research Ethics – more recent Social Value of Research www.cohred.org

3. Beyond Ethics www.cohred.org

4. Purpose of Ebola Outbreak Research  Immediate interventions Vaccine Other care Health System Improvements  Ability for Countries / Region to take over … Even if it may take another 25 years Ebola – 1 st case in 1976 Ebola (personal) – Johannesburg 1996 Basically no change in how, where, by whom research is done for 40 years ? – (not documented, at least) www.cohred.org

5. www.cohred.org

6. What happened since 2014/5  Vaccine development - perhaps IP held ‘up north’ Health System Improvements – not documented  But also More cases of Ebola New case of Lassa And of Marburg And of many other ‘research dependent’ conditions Without global response – as far as we can see  So – will we be status quo (again) in 25 years ? www.cohred.org

7. Yet, this is not (all) what Africa wants … www.cohred.org Main recommendations from the Dakar Forum: 5) Promote the strong and effective support of policymakers and various stakeholders, to develop the capacities of African scientists to conduct research and design interventions addressing the challenges related to the outbreak of Ebola as well as similar health threats; and 6) Strengthen the capacity of health, research, and governance bodies in the subregion.

9. Social Value of Research (ethical view)  Beginning to be defined in ethics guidelines e.g. forthcoming CIOMS guidelines Still very ‘timid’ – focused mostly on study participants with some extension to ‘local community’  Research Ethics does not yet know how to deal with ‘societal’ value of research Focus increasingly on ‘negotiating best deal’ But in absence of benchmarks of ‘fairness’ – is time- consuming, costly, causes conflicts, no way of knowing who gets the best deal …  Question is – how does it matter ? www.cohred.org

10. benefit sharing ?

11. the problem(s)

14. RFI ‘rationale’ : address diseases that matter to you Closing the R&D Gap in African Health Care. McKinsey. 2012 www.cohred.org

16. Capacity = Partnerships  Research funding  Technology transfer  Access to expertise  Institution building / system building  Wider access to grants – consortium approach  Greater links to business, venture capital  In other words: impact and competitiveness  But … only if partnerships work for ALL partners

17. www.cohred.org

18. FAIR RESEARCH CONTRACTING (FRC) Main focus areas covered under the FRC: Intellectual Property rights Data sharing Technology transfer Indirect costings Research contracts

19. Research Fairness Initiative – rationale  Raising Awareness e.g. Costello & Zumla (2000)  Establishing principles of best practice e.g. KFPE : 11 principles, 7 questions  Creating practical tools e.g. Fair Research Contracting (FRC)  Certification – Research Fairness Report e.g. the Research Fairness Initiative  Generating legal obligation e.g. the Nagoya Protocol

21. Development: How is the Research Fairness Initiative designed? COHRED’s Colloquium 4 – Wellcome Trust, London www.cohred.org

22. Development: How is the Research Fairness Initiative designed? COHRED’s Colloquium 4 – Wellcome Trust, London www.cohred.org Dr. Suresh Jadhav, Executive Director at Serum Institute of India Ltd. ‘It is global partnerships and collaborations in health that have played a significant role in the development of Serum Institute’s goals and objectives of developing quality, yet affordable, vaccines for the people who need them the most.’

24. RFI ‘rationale’ : key stakeholders

26. Martin Sepulveda, IBM Fellow & Vice President of Health Systems and Policy Research, IBM Corporation www.cohred.org ‘There is more information available today than there was before. At certain levels, this has been known forever; you can speak to any number of representatives from Sub-Saharan African countries at this meeting and they will tell you how disparate the benefits of health research are. There are now more data and information and communication technologies that are giving more visibility to disparities; and not just in health research, but in virtually every domain in our society.’

27. Institutional Endorsements www.cohred.org  The Nigerian Academy of Science  Turkish Academy of Sciences  Union of the German Academies of Sciences and Humanities  President of the University of the Philippines System (comprising component universities from Baguio to Mindanao, including the University of the Philippines Manila)  The Chancellor of the University of the Philippines Manila, the Health Sciences Campus of the University of the Philippines System  Forum for Medical Ethics Society (FMES), India

28. RFI Consultations Nigeria Academy of Sciences (April) Senegal Government Dept of Science Fiocruz – workshop for Brazil (May) South African MRC and Dept of Science & Technology Swiss National Science Foundation (May) Kenya, Ministry of Higher Education, Science & Technology (April) European Union (September) Guatemala – (November) Global Web-based Consultation – May 2016 Operational : from 1 July 2016 http://rfi.cohred.org www.cohred.org/frc