Slum and Rural
Health Initiative
Peer-to-peer Research Training
Ethics in Research
Kehinde Fatola
Introduction
Ethical concerns in research are the sum
of principles and code of conduct that
must be adhered while conducting
research.
Research ethics involves the application
of fundamental ethical principles to
research activities which include the
design and implementation of research,
respect towards society and others, the
use of resources and research outputs,
scientific misconduct and the regulation of
research.
Objectives
To understand the;
● Ethical principles
● Ethical Guidelines
● Institution Review Board / Health Research Ethics Committee
● Review Process
● National Health Research Ethics Committee
● Other Regulatory Bodies
Ethical Principles
• Voluntary participation
• Informed consent
• Anonymity
• Confidentiality
• Minimal potential for harm
• Results communication
Ethical Guidelines
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Social or scientific value
Scientific validity
Fair selection of participants
Valid attempts to minimize risks and maximize health-related benefits
Independent review
Informed consent
Respect for potential and enrolled participants
Trust relationship
Interest of stakeholders must be protected
Good clinical and laboratory practices
Institutional Review Board / Health Research Ethics Committee
• Protection of research participants
• Protect the right of researchers
• Request completion of agreements indicating ownership and rights of
access to data, resources, intellectual property and infrastructure
Review & Approval Process
Basic Requirements
• Research protocol (proposal) including
consent form – with translations if
necessary, information sheets, prompts etc.
• Materials used for advertisement of the study
including brochures, posters, discussion
prompts, radio jingles and video etc.
• Brief curriculum vitae of the investigators
• A one-page plain language summary of the
proposed research.
• Copies of all questionnaires, case report
forms and study instruments to be used in
the research.
• Previous decision if previously reviewed by
another HREC
• Copies of all agreements, for example
Materials Transfer Agreement, Clinical Trials
Agreement Insurance certificates, etc.
National Health Research Ethics Committee (NHREC)
• Nationwide coverage or involving more than three sites in the
country
• Referred to the NHREC by HREC(s) or in institutions with no
HREC
• Protocol complexity e.g., magnitude of risk involved, national
security, controversial issues
• Exclusive areas e.g., phase 1 clinical trials
• Responsible for updating, revision and modification of the
National Code of Health Research Ethics
• Arbitrates disputes arising from appropriate interpretation of the
Code
• Establishes the categories of HRECs
Other Regulatory Agencies
• National Agency for Food and Drug
Administration and Control (NAFDAC)
• Institutional Bio-safety Committees (IBC)
• Data and Safety Monitoring Boards
(DSMB)
• Community Advisory Board (CAB)
Practical
Examples and
Quiz
QUESTION
FURTHER READING
Differentiate between
ethical principles and
ethical guidelines
Nigerian National Code of
Health Research Ethics
DISCUSSION
https://drive.google.com/file/d/19
hfKT5oZspdDdeP3cuzwKXIgxEd
5wdBX/view?usp=drivesdk
Specific institutional IRB/HREC
protocols
Available at
THANK YOU!