1

Building an Infrastructure through Building an Infrastructure through Training: Best practices and Lessons Training: Best practices and Lessons

learned from Nigerialearned from Nigeria

Clement A. AdebamowoClement A. AdebamowoChairman, National Health Research Ethics Committee of Chairman, National Health Research Ethics Committee of

Nigeria (NHREC), Nigeria (NHREC), Director of Programs, West African Center for BioethicsDirector of Programs, West African Center for Bioethics

http://nhrec.nethttp://nhrec.net http://www.westafricanbioethics.nethttp://www.westafricanbioethics.net

http://adebamowo.comhttp://adebamowo.com

2

Infrastructural Requirement for Infrastructural Requirement for ethical researchethical research

• Ethical researchersEthical researchers• MentoringMentoring• Working environment that promotes ethical research Working environment that promotes ethical research

and scientific integrityand scientific integrity• Training on becoming a more ethical researcherTraining on becoming a more ethical researcher

• Institutional infrastructure in support of ethical Institutional infrastructure in support of ethical conduct of research and promotion of research conduct of research and promotion of research integrityintegrity• Integrity OfficerIntegrity Officer• Protocols for dealing with suspected cases of FFPProtocols for dealing with suspected cases of FFP

3

Infrastructural Requirement for Infrastructural Requirement for ethical researchethical research

• Ethical review of researchEthical review of research• Guidelines for ethical review of protocolsGuidelines for ethical review of protocols• Informed consentInformed consent• Ethics committeesEthics committees

4

What works- Single day training What works- Single day training programs and seminarsprograms and seminars

• Useful to increase awareness of research ethics Useful to increase awareness of research ethics • Particularly so in institutions/countries where the field is Particularly so in institutions/countries where the field is

relatively newrelatively new• They are easy to set up but have limited long term impact They are easy to set up but have limited long term impact • Impact may be sustained if they are accompanied by Impact may be sustained if they are accompanied by

within-institution continuing education programswithin-institution continuing education programs• Participants do not develop core competency in ethical Participants do not develop core competency in ethical

review of protocolsreview of protocols• Systematic improvement in ethical standards of Systematic improvement in ethical standards of

biomedical researchers who attend such programs cannot biomedical researchers who attend such programs cannot be demonstratedbe demonstrated

5

What works – Short coursesWhat works – Short courses

• Duration and course contents highly variableDuration and course contents highly variable• One week long programs One week long programs

• Provide information about principles of informed consentProvide information about principles of informed consent• May not be enough to equip participants with minimum May not be enough to equip participants with minimum

competence needed to adequately review protocolscompetence needed to adequately review protocols• Three weeks long programs appear ideal for provision of Three weeks long programs appear ideal for provision of

one university-course-equivalent of materials that covers one university-course-equivalent of materials that covers e.g. informed consent and health research ethics committee e.g. informed consent and health research ethics committee composition, functions and managementcomposition, functions and management

• We think at least 2 to 3 courses – (a) research designs (b) We think at least 2 to 3 courses – (a) research designs (b) informed consent, ethics committee composition and informed consent, ethics committee composition and management and (c) foundations of modern research ethics management and (c) foundations of modern research ethics are minimum requirementsare minimum requirements

6

What works – Short coursesWhat works – Short courses

• Short programs tend to beShort programs tend to be• ExpensiveExpensive

• Logistically challengingLogistically challenging

• Probably most useful method for physicians-members Probably most useful method for physicians-members of ethics committees who are unwilling to stay away of ethics committees who are unwilling to stay away from their practice for extended periodsfrom their practice for extended periods

• In Nigeria, a diploma in health research ethics with In Nigeria, a diploma in health research ethics with course content equivalent to 2, 3-credit university course content equivalent to 2, 3-credit university courses and similar to CIP is being considered by courses and similar to CIP is being considered by National Health Research Ethics CommitteeNational Health Research Ethics Committee

7

What works – short coursesWhat works – short courses

• Short programsShort programs• International faculty increases course uptakeInternational faculty increases course uptake

• Requires expensive and intensive advertisementRequires expensive and intensive advertisement

• Careful selection to identify the right candidatesCareful selection to identify the right candidates

• May consider targeting the course to individual May consider targeting the course to individual institutional ethical committeesinstitutional ethical committees

• Joint training of members of same institutional health Joint training of members of same institutional health research ethics committee may promote collegiality and research ethics committee may promote collegiality and understanding of roles and responsibilities by membersunderstanding of roles and responsibilities by members

8

What works – Short coursesWhat works – Short courses

• Rotation of members off committees by institutional Rotation of members off committees by institutional authorities provides a continuing need for this kind of authorities provides a continuing need for this kind of program as new members require trainingprogram as new members require training

• It may also address the potential issue of producing people It may also address the potential issue of producing people with advanced degrees in health research ethics who have with advanced degrees in health research ethics who have limited career and job prospectslimited career and job prospects

• Performance metrics difficult to determine but ethics Performance metrics difficult to determine but ethics committees in Nigeria are required to be registered and are committees in Nigeria are required to be registered and are being categorized based on such factors as qualification being categorized based on such factors as qualification and training of members in health research ethics, mean and training of members in health research ethics, mean duration of time taken to review protocols etcduration of time taken to review protocols etc

9

What works – degree programsWhat works – degree programs

• Major investment required to train and mentor requisite Major investment required to train and mentor requisite local facultylocal faculty

• High demand for university education translates into high High demand for university education translates into high number of applicants but many are unsuitable and have number of applicants but many are unsuitable and have limited career and prospects in ethicslimited career and prospects in ethics

• Careful selection of candidates needed to ensure that Careful selection of candidates needed to ensure that program meets its objectives of providing manpower program meets its objectives of providing manpower needed to populate ethics committees, teach research needed to populate ethics committees, teach research ethics, offer services and conduct research in ethics ethics, offer services and conduct research in ethics

• High interest among researchers and physicians but long High interest among researchers and physicians but long time away from work is a disincentivetime away from work is a disincentive

10

What works – degree programsWhat works – degree programs

• This category of trainees are needed to advance the cause This category of trainees are needed to advance the cause of health research ethics within countries, provide training, of health research ethics within countries, provide training, conduct research and provide specialist services that conduct research and provide specialist services that extend beyond review of protocolsextend beyond review of protocols

• Systematic creation of career opportunities and Systematic creation of career opportunities and enhancement of the role of health research ethics within enhancement of the role of health research ethics within institutions needed for trainees of such programs to institutions needed for trainees of such programs to function effectively and realize return on training function effectively and realize return on training investmentinvestment

• Close relationship with the National Health Research Close relationship with the National Health Research Ethics Committee, Ministry of Health, Ministry of Ethics Committee, Ministry of Health, Ministry of Education and Universities Commission helps to identify Education and Universities Commission helps to identify suitable candidates and supports the development of post-suitable candidates and supports the development of post-training career opportunitiestraining career opportunities

11

What works – Online trainingWhat works – Online training

• In collaboration with CITI, we offer online training in In collaboration with CITI, we offer online training in health research ethics, Good Clinical Practice and recently health research ethics, Good Clinical Practice and recently Responsible Conduct of ResearchResponsible Conduct of Research

• Uptake is lower than expected – 38 individuals have Uptake is lower than expected – 38 individuals have completed these courses this yearcompleted these courses this year

• More uptake when online training is integrated with More uptake when online training is integrated with courseworkcoursework

• Should appeal to physicians who complain of lack of timeShould appeal to physicians who complain of lack of time• Requirement by the NHREC that researchers and ethics Requirement by the NHREC that researchers and ethics

committee members undertake training in research ethics committee members undertake training in research ethics at least once every 2 years will increase demand at least once every 2 years will increase demand

12

In summaryIn summary

• Mixed bag of training programs required because benefits Mixed bag of training programs required because benefits are complementary and correlated disadvantages minimalare complementary and correlated disadvantages minimal

• Working synergistically with local authorities and Working synergistically with local authorities and institutions institutions • Ensures that training programs are aligned with country’s needsEnsures that training programs are aligned with country’s needs• Ensures that trainees are knowledgeable about local conditions – Ensures that trainees are knowledgeable about local conditions –

constitution, laws, regulations, competent authorities and the constitution, laws, regulations, competent authorities and the relationships between themrelationships between them

• Supports evolutionary growth of health research ethics Supports evolutionary growth of health research ethics infrastructureinfrastructure

• Helps to define, develop and expand career and job prospects for Helps to define, develop and expand career and job prospects for graduates graduates

13

In summaryIn summary

• Trainees desire some sort of certification Trainees desire some sort of certification • Online training dependent on internet access Online training dependent on internet access

which may be costly and inconvenient for somewhich may be costly and inconvenient for some• Online training may need to be supplemented by Online training may need to be supplemented by

some on-site training or be integrated into some on-site training or be integrated into courses/seminars/workshops courses/seminars/workshops

• CME credits are available largely in the medical CME credits are available largely in the medical professions but the requirement is not enforcedprofessions but the requirement is not enforced

14

NHREC websiteNHREC website

15

West African Bioethics websiteWest African Bioethics website

16

AcknowledgmentAcknowledgment

• Members of faculty and administrative staff of Members of faculty and administrative staff of West African Bioethics Training Program – Ms West African Bioethics Training Program – Ms Yemisi Ajibose (Program Administrator)Yemisi Ajibose (Program Administrator)• http://www.westafricanbioethics.nethttp://www.westafricanbioethics.net

• Professor Adebamowo and the West African Professor Adebamowo and the West African Bioethics Training Program are Bioethics Training Program are supported by NIH supported by NIH Research Grant No. D43 TW007091funded by the Research Grant No. D43 TW007091funded by the Fogarty International Center and the National Fogarty International Center and the National Human Genome Research Institute. Human Genome Research Institute.