Building an Infrastructure through Training: Best practices and Lessons learned from Nigeria

1. Building an Infrastructure through Training: Best practices and Lessons learned from Nigeria Clement A. Adebamowo Chairman, National Health Research Ethics Committee of Nigeria (NHREC), Director of Programs, West African Center for Bioethics http://nhrec.nethttp://www.westafricanbioethics.nethttp://adebamowo.com

2. Infrastructural Requirement for ethical research • Ethical researchers • Mentoring • Working environment that promotes ethical research and scientific integrity • Training on becoming a more ethical researcher • Institutional infrastructure in support of ethical conduct of research and promotion of research integrity • Integrity Officer • Protocols for dealing with suspected cases of FFP

3. Infrastructural Requirement for ethical research • Ethical review of research • Guidelines for ethical review of protocols • Informed consent • Ethics committees

4. What works- Single day training programs and seminars • Useful to increase awareness of research ethics • Particularly so in institutions/countries where the field is relatively new • They are easy to set up but have limited long term impact • Impact may be sustained if they are accompanied by within-institution continuing education programs • Participants do not develop core competency in ethical review of protocols • Systematic improvement in ethical standards of biomedical researchers who attend such programs cannot be demonstrated

5. What works – Short courses • Duration and course contents highly variable • One week long programs • Provide information about principles of informed consent • May not be enough to equip participants with minimum competence needed to adequately review protocols • Three weeks long programs appear ideal for provision of one university-course-equivalent of materials that covers e.g. informed consent and health research ethics committee composition, functions and management • We think at least 2 to 3 courses – (a) research designs (b) informed consent, ethics committee composition and management and (c) foundations of modern research ethics are minimum requirements

6. What works – Short courses • Short programs tend to be • Expensive • Logistically challenging • Probably most useful method for physicians-members of ethics committees who are unwilling to stay away from their practice for extended periods • In Nigeria, a diploma in health research ethics with course content equivalent to 2, 3-credit university courses and similar to CIP is being considered by National Health Research Ethics Committee

7. What works – short courses • Short programs • International faculty increases course uptake • Requires expensive and intensive advertisement • Careful selection to identify the right candidates • May consider targeting the course to individual institutional ethical committees • Joint training of members of same institutional health research ethics committee may promote collegiality and understanding of roles and responsibilities by members

8. What works – Short courses • Rotation of members off committees by institutional authorities provides a continuing need for this kind of program as new members require training • It may also address the potential issue of producing people with advanced degrees in health research ethics who have limited career and job prospects • Performance metrics difficult to determine but ethics committees in Nigeria are required to be registered and are being categorized based on such factors as qualification and training of members in health research ethics, mean duration of time taken to review protocols etc

9. What works – degree programs • Major investment required to train and mentor requisite local faculty • High demand for university education translates into high number of applicants but many are unsuitable and have limited career and prospects in ethics • Careful selection of candidates needed to ensure that program meets its objectives of providing manpower needed to populate ethics committees, teach research ethics, offer services and conduct research in ethics • High interest among researchers and physicians but long time away from work is a disincentive

10. What works – degree programs • This category of trainees are needed to advance the cause of health research ethics within countries, provide training, conduct research and provide specialist services that extend beyond review of protocols • Systematic creation of career opportunities and enhancement of the role of health research ethics within institutions needed for trainees of such programs to function effectively and realize return on training investment • Close relationship with the National Health Research Ethics Committee, Ministry of Health, Ministry of Education and Universities Commission helps to identify suitable candidates and supports the development of post-training career opportunities

11. What works – Online training • In collaboration with CITI, we offer online training in health research ethics, Good Clinical Practice and recently Responsible Conduct of Research • Uptake is lower than expected – 38 individuals have completed these courses this year • More uptake when online training is integrated with coursework • Should appeal to physicians who complain of lack of time • Requirement by the NHREC that researchers and ethics committee members undertake training in research ethics at least once every 2 years will increase demand

12. In summary • Mixed bag of training programs required because benefits are complementary and correlated disadvantages minimal • Working synergistically with local authorities and institutions • Ensures that training programs are aligned with country’s needs • Ensures that trainees are knowledgeable about local conditions – constitution, laws, regulations, competent authorities and the relationships between them • Supports evolutionary growth of health research ethics infrastructure • Helps to define, develop and expand career and job prospects for graduates

13. In summary • Trainees desire some sort of certification • Online training dependent on internet access which may be costly and inconvenient for some • Online training may need to be supplemented by some on-site training or be integrated into courses/seminars/workshops • CME credits are available largely in the medical professions but the requirement is not enforced

14. NHREC website

15. West African Bioethics website

16. Acknowledgment • Members of faculty and administrative staff of West African Bioethics Training Program – Ms Yemisi Ajibose (Program Administrator) • http://www.westafricanbioethics.net • Professor Adebamowo and the West African Bioethics Training Program are supported by NIH Research Grant No. D43 TW007091funded by the Fogarty International Center and the National Human Genome Research Institute.