World Health Organization (2009) defines research with human subjects as any social science, biomedical, behavioral, or epidemiological activity that entails systematic collection or analysis of data with the intent to generate new knowledge. The human beings are therefore exposed to manipulation, intervention, observation or other interaction with investigators either directly or through alteration of their environment, and become individually identifiable through investigator’s collection, preparation or use of biological material or medical or other records.

History tells that health experiments made on humans during World war II (1939-1945), which were later collectively known as the Nazi Medical War Crimes (Nuremberg War Crime), which include high-altitude, incendiary bomb, freezing, sea-water, malaria, mustard gas, sulfanilamide, lice experiments etc. have been unforgettable tragedies committed by humans against humanity. This horror of unspeakable nature which continued with Tuskegee syphilis drug trial on Black Americans (1932-1972) to genetic study made on young Jesse Gelsinger that lead to his untimely death in 1999 are few among others. These incidences evoked public disobedience against such unethical research misconducts and became the basis for development of international codes and ethics guidelines like The Nuremberg Code, Declaration of Helsinki, Belmont Report, CIOMS Guidelines and ICH Guidelines.  To date, conducting research on humans requires strictly following ethical principles and adherence with international standards. All research involving human participants must be conducted in a manner that respects the dignity, safety and rights of research participants and that recognizes the responsibilities of researchers to perform following internationally accepted ethical principles of autonomy, beneficence and justice. Moreover, if a research is to be justified as ethical, it should have scientific and social values. 

For research to be ethical, all of the following eight criteria must be met:

  1. Ethical justification and scientific validity: The research must be rigorous in its methodology. For research to be ethical the methods must be valid and practically feasible, the research must have a clear objective, be designed using sound scientific principles, have sufficient statistical power, and be based on adequate knowledge of the scientific literature.
  2. Science and social value: The proposed protocol should demonstrate valid scientific basis/ground, enhance health or generalizable knowledge, and benefit individuals and the community where the research is conducted. However, the research participants’ rights and welfare outweigh any benefit to the society or gain in knowledge.
  3. Favorable risk-benefit ratio to research participants and their communities: Risks to subjects shall be minimized through using procedures that are consistent with acceptable research design and potential benefits enhanced. The maximum benefit should be provided at the lowest possible risk, and risks to research participants shall be reasonable in relation to anticipated benefits.
  4. Fair selection and enrolment of human subjects: “Scientific objectives, not vulnerability or privilege, and the potential for and distribution of risks and benefits, should determine communities selected as study sites and the inclusion criteria for individuals…” The justification for selection and the equitable nature of selection of research subjects should be described.
  5. Privacy: Privacy should be respected, confidentiality maintained, the opportunity to withdraw at any time or refuse any component(s) of the research should be available, and the well-being of research participants should be monitored, while information related to research participants should be kept confidential.
  6. Independent/IRB review: “Individuals that are not affiliated with the research must review the research and approve, amend, or terminate the research.” However, individuals involved in independent review with any conflicts of interest may be summoned to provide information to the IRB.
  7. Informed consent process: The information provided to research participants should be complete and appropriate to the participants’ level of understanding. The participant should be competent to give or refuse consent and research participants should provide their entirely voluntary informed consent without coercion, manipulation, undue influence, or intimidation.
  8. Community engagement: Research is quite often generalized to the community from which individual participants are drawn from. Such generalization can result in different positive or negative impacts to the community in terms of stigma, resource drainage, health outcomes, and more. Hence, researchers are encouraged to involve the community in decision making about the design and conduct of the study. Besides, investigators should consider the local customs, traditions, culture and religious practices of the community where the research is proposed to be conducted.

All researches being conducted by EPHI and other collaborating institutions are expected to adhere to national relevant laws and guidelines; and international codes, regulations and guidelines. To ensure that, Establishment and strengthening of ethical review committees is currently among the priority issues in health research that involve human study participants. 


Research ethics and publication office of EPHI is office of the secretariat for the institutional review board of Ethiopian Public Health Institute (EPHI) which reviews scientific validity and ethical acceptability of research project proposals in the area of health and nutrition, ensure scientific and ethical integrity of ongoing and completed research projects, organize scientific forums, serve as secretariat for the scientific journal (Ethiopian Journal of Public Health and Nutrition), which is published by EPHI, and provide capacity building training on research ethics and research methodology.


Institutional Review Board of Ethiopian Public Health Institute (EPHI-IRB) is established in order to provide independent guidance, advice, and decision on health and related research protocols. The IRB is mainly responsible to safeguard the dignity, rights, safety and wellbeing of research participants; and contribute in improving quality of research.

EPHI-IRB is mandated to review and decide on scientific validity and Ethical acceptability of research protocols. It is independent in its reflection, advice, and decision. It has working documents like term of reference (ToR) and standard operating procedure (SoP).


Version 01 – July 2017

Version 02 – Oct 2019


Version 01 – Jan 2017

Version 02 – Sept 2019

Version 03 – March 2022

The IRB is composed of members from both scientists and non-scientists which are appointed by director general of the institute with three years term which can be renewed for one more term. The board meets every two weeks regularly. Quorum is maintained when >50% of members are present. Decisions will be made on a consensus basis and/or simple majority vote.


Review Process

  • Exemption
    • Exemption notification letter, 10 working days
  • Expedited Review
    • Reviewed by two reviewers and determination by secretariat office, 20 W days
  • Full Board Review
    • Reviewed by two reviewers and determination by IRB, 45 W day 


  • EPHI-IRB is awarded the Strategic Initiative for Developing Capacity in Ethical Review (SIDCER) recognition for its compliance with international research ethics guidelines and standards, at 19th FERCAP general assembly in Penang, Malaysia on November 27, 2019.
  • Registered as Level A IRB based on the assessment made by Ministry of Education on 15 April 2022.
  • Renewed the recognition awarded by SIDCER for its compliance with international research ethics guidelines and standards during the 23rd FERCAP General Assembly in Kuala Lumpur, Malaysia on November 29, 2023.

The Ethiopian Journal of Public Health and Nutrition (EJPHN) is an internationally recognized and nationally accredited official journal of the Ethiopian Public Health Institute (EPHI). It has been published and distributed to the scientific community and other concerned bodies both in print and online media since 2016. The EJPHN is a multi-disciplinary journal of public health, traditional and modern medicine, health system, technology transfer and knowledge translation, biomedicine, biotechnology, human nutrition, food science and food technology aimed to address the community with evidence based information.