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Ethics in Research.pptx
- 1. Peer-to-peer Research Training Ethics in Research Kehinde Fatola Slum and Rural Health Initiative
- 2. 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.
- 3. To understand the; ● Ethical principles ● Ethical Guidelines ● Institution Review Board / Health Research Ethics Committee ● Review Process ● National Health Research Ethics Committee ● Other Regulatory Bodies Objectives
- 4. Ethical Principles • Voluntary participation • Informed consent • Anonymity • Confidentiality • Minimal potential for harm • Results communication
- 5. Ethical Guidelines • 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
- 6. 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
- 7. Review & Approval Process • 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. Basic Requirements
- 8. 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
- 9. 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)
- 10. QUESTION Differentiate between ethical principles and ethical guidelines DISCUSSION Specific institutional IRB/HREC protocols Nigerian National Code of Health Research Ethics Available at https://drive.google.com/file/d/19 hfKT5oZspdDdeP3cuzwKXIgxEd 5wdBX/view?usp=drivesdk FURTHER READING Practical Examples and Quiz
- 11. THANK YOU!
Editor's Notes
- Factors that must be uphold Voluntary Participation: Your participants are free to opt in or out of the study at any point in time. Informed consent: Participants know the purpose, benefits, risks, and funding behind the study before they agree or decline to join. Anonymity: You don’t know the identities of the participants. Personally identifiable data is not collected. Confidentiality: You know who the participants are but you keep that information hidden from everyone else. You anonymize personally identifiable data so that it can’t be linked to other data by anyone else. Potential for harm: Physical, social, psychological and all other types of harm are kept to an absolute minimum. Results communication: You ensure your work is free of plagiarism or research misconduct, and you accurately represent your results.
- Conditions the study must fulfill Harmonized Tripartite Guideline for Good Clinical Practice and Clinical Investigation of Medical Devices for Human Subjects*
- All institutions in Nigeria involved in the conduct of health research must have a registered institutional health research ethics committee The authority of any institutional HREC is limited to the geographical boundary of the institution that established it or wherever any of its permanent members of staff conducts research. HRECs are registered established and caegorized in line with the regulations of the NHREC, and registration is renewed every 2 years Protect the right of researchers to own their data and research products, publish their findings without hindrance and ensure that they are not exploited or put under undue pressure Request completion of agreements indicating ownership and rights of access to data, resources, intellectual property and infrastructure generated in the course of the research in order to protect Nigerian researchers and institutions and prevent their exploitation
- Research submitted to the ethics committee can only be registered as being properly submitted and accepted for review by the ethics committee if a complete set of all required documentation has been provided. The minimum requirements are: HRECs have the powers to review prescribed application materials and have authority to approve, require modifications in (to secure approval) or disapprove any health research activities and notify the investigator within three months of submission
- The National Health Research Ethics Committee (NHREC) is the apex body responsible for the provision of and ensuring adherence to guidelines that govern ethical research practice in order to ensure the protection of human research participants in Nigeria. Reviews that could not be completed within three months of submission is to be referred to the NHREC
- National Agency for Food and Drug Administration and Control (NAFDAC) This agency gives permission for the conduct of clinical trials to test the efficacy and safety of newly finished products for sale or use as food or drugs in Nigeria. Such clinical trials that would be conducted in Nigeria must however conform to the guidelines issued by National Health Research Ethics Committee and other regulatory bodies. Institutional Bio-safety Committees (IBC) The IBC provides bio-safety review of research involving the use of classified hazardous substances of physical or biological nature (like pathogens, radioactive materials, application of recombinant DNA techniques and processes, etc.) with the overall objective of minimizing potential human and environmental risks Data and Safety Monitoring Boards (DSMB) This is an independent group of experts (comprising individuals with appropriate training and scientific knowledge in all aspects of research with adequate medical, pharmaceutical, scientific, bio-statistical and clinical trial experience as well as ethics qualifications) assembled before the commencement of specific research by the study sponsors to review safety data during the clinical trial CAB: The multi-ethnic, cultural and religious diversities of the Nigerian nation and their influence on ethical issues in research demand community participation from the pre-research stage to avoid conflicts and frictions during and after the research. The role of community “gatekeepers” in the successful implementation of research in Nigeria underscores the importance of the CAB.