1. INSPIRING GREATNESS

2. Medical Education Partnership Initiative Research Ethics Capacity Building Portfolio (RESCAP 2011-2015) 2013 Contact Details : Singhn7@ukzn.ac.za/Singhn7@ukzn.ac.za/ +2733 2606165

3. INSPIRING GREATNESS RESCAP Team RESCAP Director/ Co-PI –Prof Doug Wassenaar (PhD) Project Manager –Ms Nivedhna Singh (MSocSci)

4. INSPIRING GREATNESS UKZN- MEPI Team MEPI PI: Prof Umesh Lalloo MEPI co-PIs: – Dr S Pillay – Prof R Bobat – Prof J Moodley – Prof DR Wassenaar –Prof P LaRussa (Columbia University) –Prof S Hammer (Columbia University) Management team: Dr Nisha Nadesan- Reddy

5. INSPIRING GREATNESS Purpose of the Presentation Describe our approach and our research ethics capacity-building (RESCAP) component of UKZN-MEPI. Review RESCAP outputs and participant evaluations to date.

6. INSPIRING GREATNESS Introduction Aim of MEPI: –Enhance medical training and training in the management of HIV and TB. Aim of RESCAP: –Develop and improve institutional research ethics capacity at UKZN, provincially and nationally.

7. INSPIRING GREATNESS Key Elements 1. On-line Research Ethics Module Development of a substantive online learning research ethics module – Based on SA Laws and SA DoH Research Ethics guidance. TRREE (Training and Resources in Research Ethics Evaluation– see http://elearning.trree.org/ TRREE training is free of charge to all users.http://elearning.trree.org/ Aim: to provide online learning, resources and information about South African research ethics ethical guidance. All UKZN REC members and ethics applicants (PIs) will be required to produce a TRREE SA certificate.

8. INSPIRING GREATNESS SA National Supplement

9. INSPIRING GREATNESS Key Elements 2. Research ethics training 2x intensive Masters-level research ethics modules offered by SARETI (South African Research Ethics Training Initiative See http://sareti.ukzn.ac.za/Homepage.aspx) http://sareti.ukzn.ac.za/Homepage.aspx (MEPI Scholarships to medical school staff and medical postgraduate and health science students).

10. INSPIRING GREATNESS Key Elements 2. Research Ethics Training (continued) Aim: for UKZN medical school staff and postgraduate researchers to gain theoretical and practical knowledge in the ethical review of complex protocols such as HIV prevention trials and in institutionalising research ethics review in their home institution.

11. INSPIRING GREATNESS Key Elements 3. Biomedical Research Ethics Committee (BREC) Fellowship Train UKZN PhD students in research ethics review. Aim: The aim of this fellowship is to provide training and allow the candidate to gain an understanding of the theoretical and operational aspects of research ethics review, and the roles and responsibilities of health- related Research Ethics Committees. Fellows shadow the BREC chair and do 96 hours of work, including reading, reviews and attendance of REC meetings.

12. INSPIRING GREATNESS Key Elements 4. NIH Grants Management Workshop Train UKZN staff members in NIH grant writing and management. The aim of this workshop is to provide training and allow participants to gain an in-depth understanding of NIH policies, funding opportunities, application processes, budgeting, management of awards and reporting and how these are applied and implemented at UKZN. Workshop run by NIH grants management experts and other key staff.

13. INSPIRING GREATNESS Key Elements 5. Training for RESCAP Project Manager Management of RESCAP is itself a capacity building opportunity: Aim is to provide internship opportunities for one emerging researcher in project management and research ethics Current intern (Nivedhna Singh) is receiving more research ethics training, is teaching research ethics at undergraduate and 4 th year level, and is writing a paper on RESCAP`s objectives, plans and implementation

14. INSPIRING GREATNESS EVALUATION

15. INSPIRING GREATNESS BREC fellowship The evaluation from the 3 PhD fellows were classified into 3 common themes: –Capacity development Enhanced Skills and Knowledge of Research Ethics Increased understanding of operational procedures and administration at RECs Increased ability to differentiation between scientific and ethical thinking

16. INSPIRING GREATNESS BREC fellowship 2 –Career development Enhanced development as scientist and bioethicist Potential career path in Research Ethics through PhD in research ethics –Personal development Enhanced networking and interaction with academics.

17. INSPIRING GREATNESS Research Ethics Training Evaluation from the MEPI- SARETI students: –Career development Improved ethical aspects of own PhD research Improved ethics knowledge about research in African context Join UKZN research ethics committee as reviewers

18. INSPIRING GREATNESS Research Ethics Training 2 –Capacity development Improved professional application of ethics in research. Greater understanding of ethics review process and pitfalls Sharing of knowledge from modules with other colleagues at the home institution. –Overall Well structured, comprehensive Shorter time-frame for modules

19. INSPIRING GREATNESS NIH Grant Management workshop Day1 –Introduction –Grant writing –Finance Day 2 –Management –Reporting –Role of UKZN –Above average Excellent overall, Request for more group work, Presenters well prepared and experienced –Above average Appreciation for including research office and legal services

20. INSPIRING GREATNESS NIH Grant Management workshop Overall Satisfaction –Above average Most useful aspects of the workshop: –Group work, Sharing experiences, topics are relevant. Least useful aspects of workshop: –Too much reading, too heavy focus on administration and compliance, delay with computers, presentation from research office and legal services was weak, presenters should highlight important points.

21. INSPIRING GREATNESS Project Manager Qualifications –M SocSc (Research Psychology) Internship –Project Management –Training in research ethics Evaluation –Enhanced professional/career development –Personal Growth – international travel, networking and collaboration, grants management, project management skills, presentation skills, preparation of publications.

22. INSPIRING GREATNESS Challenges TRREE Online Ethics Module –The module is undergoing the final edit await decision from TRREE director about the national supplement –Conflict between local module authors and international reviewers regarding what is relevant to SA setting; many more iterations than expected –Dispute about legal vs ethics emphasis –Final version expected to launch in Q3 of 2013

23. INSPIRING GREATNESS RESCAP Achievements TRREE –Module has been reviewed by several experts and is undergoing its final edit. –Launch hopefully Q3 of 2013 BREC fellowship –3 PhD fellows have been trained –2 undergoing training

24. INSPIRING GREATNESS RESCAP Achievements –NIH grants management 20 UKZN Staff members have been trained Further 20 candidates will undergo training in August 2013 –Research Ethics training (SARETI) 15 UKZN staff and students have successfully completed 2 Masters-level SARETI research ethics modules 10 more students will register in September 2013

25. INSPIRING GREATNESS RESCAP Achievements RESCAP Project Manager –1 project manager has been trained – ongoing. Has completed masters degree and internship is underway pending registration with Health Professions Council of South Africa; attended fellowship at Univ. of Neuchatel, Switzerland and draft paper underway. Several presentations completed; teaching undergraduates and junior postgraduates.

26. INSPIRING GREATNESS Expected Outcomes Impact of RESCAP –Completion due 31/01/2016 1 Trained personnel (Project Manager) TRREE module developed, launched & accredited for UKZN/national/international use, possibly for academic and CPD credits – unlimited use, no cost to user – statistics are kept on all TRREE certificates issued for each module and national supplement. SARETI : 54 Students completing 2 research ethics modules.

27. INSPIRING GREATNESS Expected Outcomes 2 BREC Fellows: 9 PhDs will have done 96 supervised hours in aspects of research review PhD dissertations : 2-4 ethics PhD students in REMETH UKZN Staff members trained in NIH grants management and grant writing: ~80 Staff members

28. INSPIRING GREATNESS Conclusion/Summary RESCAP decreases the ‘gap’ in research ethics training – brings research and ethics closer together Self-sustaining –Each activity provides a basis for further/advanced training Collaborates with other international projects (SARETI, TRREE) –Cost effective, avoids duplication of resources and efforts

29. INSPIRING GREATNESS Acknowledgements We would like to thank –UKZN MEPI PI Prof Umesh Lalloo –UKZN MEPI Steering Committee –UKZN MEPI Project coordinators –MEPI Symposium Organisers

30. INSPIRING GREATNESS Thank you! Questions?? 30