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ICRISAT Global Planning Meeting 2019: Research Involving Humans by Michael Hauser

  1. Research Involving Humans: Principles and Procedures for the Protection of Human Research Participants.
  2. ‘Ethics is knowing the difference between what you have a right to do and what is right to do.’ Potter Stewart ‚Erst kommt das Fressen, dann die Moral‘, First the grub, then morals Berthold Brecht
  3. Research Ethics and its Importance Research Ethics are the principles and standards guiding research from inception through to publication. • A reflection of respect for those who are participating in research. • Has become the norm as an expectation for research purposes. • A critical requirement among an increasing number of donors. • Enhancement of ICRISAT’s reputation and credibility in the research community and among the public.
  4. Principles and Procedures
  5. CGIAR Centres Ethics Policies Centre Ethics Policy Bioversity Rely on partners' or external (e.g. Western Institutional Review Board) IRB processes CIAT IRB established in 2016 CIFOR Research Ethics Review Committee CIMMYT IRB in place CIP In the process of defining IRB procedures ICRAF Research Ethics Policy Guidelines; No IRB IITA IRB established in 2015 ILRI Institutional Research Ethics Committee in place IWMI IRB in place WorldFish Code of Ethics for Research Involving People updated late 2016 - beginning 2017 IFPRI Research Ethics Policy Guidelines and IRB in place
  6. Principles for Ethical Research • Researchers should consider power structures within communities and households. • The decision by participants to reject questions involving health, political and religious opinions must be respected. Principle 1: Examine and respect the culture, values, customs, beliefs of those involved in research, both on an individual or collective level.
  7. • The process of seeking consent should be context-specific and should take into consideration individual or community needs. • Before recording audio, video or taking photographs for research or any other use, verbal or written consent must be obtained. Principle 2: Obtain informed consent from participants before the commencement of research.
  8. Principle 3: Researchers have an obligation to ensure human participants are not subjected to harm or other sufferings. • The circumstances in which the research is conducted should provide for individual safety, emotional and psychological security, and wellbeing. • Researchers should justify that the potential benefits of the proposed research outweigh risks.
  9. Principle 4: Ensure confidentiality of information provided during research and a guarantee of anonymity • All personal information must be encoded or anonymized as far as possible and consistent with the study concerned. • If a digital technical device is used for interview recording, it must be password protected.
  10. Principle 5: Ensure research is designed, conducted and reported in a way that ensures its integrity, quality and contribution to scholarly knowledge. • Researchers should ensure honesty and reliability in the quality of research, from the design, methodology, analysis and use of resources. • Results should be reported in a manner that is reproducible and verifiable.
  11. Ethical Approval Process Proposal development PI submits proposal and ethics checklist to Program Director (PD) Approval granted? Commence research Commence research PD forwards documents to IRB for review Approval granted? Unsatisfactory review and/or decision not reached Amend and re-submit Yes No No Yes
  12. ICRISAT Institutional Review Board The IRB must protect the rights and safety of research participants and researchers. Composition • Chairperson – Director General (Research) • 1-2 ICRISAT Scientists • 1-2 Non-scientific staff with no affiliation to ICRISAT • One legal expert and/or explicit ethics expert • Both male and female genders should be represented. Training modules • Basic aspects of research design and methodology • Ethical considerations relevant to research involving humans and application of these to different types of research • Approaches and modes of ethical reasoning
  13. Next Steps 1. Appointment of ICRISAT IRB. 2. Development and implementation of a compulsory ethics seminar series for all current and newly recruited (national and international) staff. 3. Inclusion of specific training for all communications team members on the ethics in and usage of media material obtained from research. 4. Seminar programs to highlight contemporary ethical challenges in research and development. 5. Regular review of ethics document and adaptation through the IRB.
  14. References 1. United Nations Educational, Scientific and Cultural Organization (UNESCO) Universal Declaration on Bioethics and Human Rights (2005) http://unesdoc.unesco.org/images/0017/001798/179844e.pdf 2. World Health Organization (2001): World Medical Association Declaration of Helsinki http://www.who.int/bulletin/archives/79%284%29373.pdf 3. World Health Organization (2011): Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants http://apps.who.int/iris/bitstream/10665/44783/1/9789241502948 _eng.pdf?ua=1&ua=1 4. The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects Research (1979) https://videocast.nih.gov/pdf/ohrp_appendix_belmont_report_vol _2.pdf
  15. Thank You
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