A half-day experience-sharing training on reviewing research proposals for ethical clearance delivered to PSI Institutional Research Ethics Review Committee (IRERC) on June 19,2024.
Dr. Adamu Addissie, an esteemed Associate Professor of Public Health and Bioethics at Addis Ababa University, imparted invaluable knowledge on the process of ethically reviewing research proposals. The PSI Institutional Review Board(IRB) members also expressed their profound appreciation through robust applause.
Dr. Netsanet Jote, the Lead Researcher at PSI, Centre Coordinator of Research Development and Data Management and the Chair of the Institutional Review Board
During the opening session of the training program, Dr. Netsanet Jote, the Lead Researcher at PSI, Centre Coordinator of Research Development and Data management Centre and the Chair of the Institutional Review Board, addressed the attendees, stating that the primary aim of this training was to familiarize the PSI IRB committee members with the proper procedures for conducting IRB work, prior to the commencement of their official operations.
Dr. Adamu Addissie, Associate Professor of Public Health and Bioethics at Addis Ababa University
Dr. Netsanet explained that the PSI IRB members had previously undertaken various online courses from dedicated sources, and 20 senior PSI researchers had received face-to-face training on research ethics in July 2023. Additionally, PSI had undertaken the customization of the 29 standard operating procedures (SOPs) provided by the Ethiopian Ministry of Education, reducing them to a total of 26. She noted that this customization process had been time-consuming.
H. E. Prof. Beyene Petros, DG of PSI
Furthermore, Dr. Netsanet informed the attendees that PSI had applied for IRB certification to the Ministry of Education on March 24, 2016 E.C., and the Ministry had successfully awarded the certificate on April 4, 2026 E.C. She stated that PSI's IRB committee now comprises 9 members, 3 of whom are female, and it also includes a layperson who serves to ensure that the questionnaires are comprehensible to the study participants and that the clarity of the research proposal is maintained. The layperson also reviews the justice of the sampling methodology.
Dr. Beneberu Assefa , Lead Researcher at PSI and Dr. Ashagrie Gibtan, Lead Researcher at PSI(LR)
Dr. Netsanet further elaborated that the members of the PSI Institutional Review Board were drawn from a wide range of academic and professional fields, including engineering, biology, economics, and others. She stated that PSI has already allocated dedicated office space for the IRB committee, and the next step is to equip this office with the necessary facilities to support their operations.
Mrs. Hana Woldekidan, PSI Researcher
In closing, Dr. Netsanet expressed her optimism that the IRB will commence its critical work in the near future. She then invited H.E. Prof. Beyene Petros, the Director General of PSI, to provide the training participants with key lessons and insights they should take away from the training.
H.E. Prof. Beyene began by acknowledging that when he was assigned to lead PSI, there was no institutionalized system in place for conducting research ethics reviews. Recognizing this gap, he initiated the establishment of PSI's own Institutional Review Board (IRB).
Dr. Kaleab Kebede, Researcher at PSI and Dr. Mulugeta Getu, Lead Researcher at PSI(LR)
Prof. Beyene noted that prior to having the PSI IRB, many researchers had to seek ethical clearance from external institutions like the Ethiopian Public Health Institute (EPHI), incurring additional time and costs. Even the Young Lives research project hosted by PSI had to pay to obtain clearance from Addis Ababa University.
An Excellent AAU Portal for Comprehensive Information on IRBs and Research Ethics
Prof. Beyene strongly refuted the notion that social science research does not require ethical clearance. He shared a personal experience from his time as an advisor, where one of his MSc students in the Biology department at AAU had an excellent thesis on HIV patients rejected for publication due to a lack of awareness about research ethics procedures.
Inspired by this experience, Prof. Beyene dedicated much of his professional career to advancing research ethics. He served Addis Ababa University and other universities across the country, providing voluntary training and support to establish IRBs, including through EU-funded initiatives to provide computers and other facilities.
Prof. Beyene emphasized that the aim of today’s training is to ensure the PSI IRB committee becomes fully functional. He underscored that most funding agencies now require research proposals to undergo IRB review. To this end, he expressed pride these days in the expertise of Dr. Adamu Addissie and Prof. Yimtu Bezinash of AAU, and suggested that PSI may also invite other experts to contribute to the IRB's work. He noted that PSI has already been asked to provide ethical clearance for its DANIDA project.
Following Prof. Beyene's remarks, the trainer, Dr. Adamu Addissie, an Associate Professor of Public Health and Bioethics at Addis Ababa University, commenced the training session by asking the participants what they hoped to gain from the training. The trainees responded that they were seeking to deepen their understanding of how to effectively review research proposals from an ethical standpoint, the workflow involved in obtaining research ethics clearance, and the internal and external service modalities for the Institutional Review Board. By eliciting these expectations from the participants, Dr. Adamu demonstrated his intention to tailor the training content to address the specific needs and interests of the PSI IRB committee members in attendance, with the aim of providing the necessary knowledge and skills to equip the trainees for their upcoming responsibilities within the PSI IRB.
Next, Dr. Adamu began the training by providing a detailed explanation of the importance of the Institutional Review Board, covering key concepts such as informed consent, conflict of interest, confidentiality, and translation considerations for data gathering research instruments. He also walked the participants through the various IRB summary template formats, from protocol version one to four, along with detailed labeling and explanations of the template.
Furthermore, Dr. Adamu elaborated on the office arrangement of the IRB, stating that it should be staffed by a secretary to organize meetings, as well as archive experts, file organizers, and secure file boxes to maintain the confidentiality of all documents. He noted that Addis Ababa University, in particular, receives a high volume of applications from master's, PhD, and postdoctoral researchers, as well as university staff, all seeking IRB review, resulting in significant traffic and the need for the office to provide advice and address various issues.
Dr. Adamu also emphasized that once the IRB grants ethical clearance for a research project, it must continue to monitor the progress of the study. Typically, IRB approval is given for one year, and the board is responsible for reviewing the researcher's periodic reports to determine if the study should be allowed to continue or if the approval needs to be renewed.
Dr. Adamu noted that some researchers had previously chosen samples based on convenience, without clarifying whether the convenience was for the researchers or for the study participants. He stressed that every IRB member must sign a confidentiality agreement before beginning their work, pledging not to disclose any discussions or materials accessed during their committee membership.
Dr. Adamu highlighted that the IRB members often encounter novel ideas, new methodologies, and emerging research tools, and they must maintain the utmost confidentiality regarding all such information. Furthermore, he emphasized that the entire IRB ethical clearance process must be kept anonymous, and any correspondence between the committee and reviewers must be handled with the same level of care and confidentiality as a financial transaction.
Dr. Adamu explained that the Institutional Review Board at Addis Ababa University has transitioned to conducting its procedures digitally through a dedicated university portal. However, he emphasized that maintaining hardcopy records is still crucial, as external auditors like the World Health Organization may visit the IRB office every three years to assess the standard of their working procedures. He noted that while the research proposal approval process is important, the follow-up and monitoring of approved studies is equally vital.
Regarding the review process, Dr. Adamu stated that research proposals must be sent to reviewers two weeks in advance, and the IRB chair then convenes a monthly meeting where the two reviewers present their comments, and a layperson checks the translation and language aspects of the proposal. The committee then discusses the proposal based on the evaluation template, deciding on minor or major modifications, and incorporating the comments. The chair then sends official communication to the applicant, including the feedback and other comments. Once the researcher addresses the comments, the reviewers check if they have been included, and if so, the chair issues the IRB certificate with the official stamp.
Dr. Adamu stressed that all discussions and comments from IRB members must be anonymized in the meeting minutes, and the IRB must maintain a record of all communications sent to applicants to ensure timely responses. He also mentioned that in some cases, where the comments are minor, one reviewer can provide the feedback without waiting for the formal meeting, which is then presented and documented during the next meeting.
Dr. Adamu also discussed cases where research protocols may require expedited review due to an emergency, such as when requested by a grant provider or other extenuating circumstances. In these situations, the IRB may convene an extraordinary meeting to conduct an expedited review. If the research proposal is assessed to have low risk, it can be approved through this expedited process. However, if the reviewers determine that the proposal poses high risks, it must be referred to the full board procedure for a more comprehensive review. Dr. Adamu emphasized that the IRB committee must maintain its independence and not succumb to any pressure from higher-level institutional officials, even in cases where an expedited review is requested.
Dr. Adamu emphasized that every research proposal seeking ethical clearance must go through a standardized template checklist, following the appropriate versions. He also stated that the IRB committee at the Population Services International (PSI) organization should undergo refresher training on ethical clearance procedures at least once a year. Regarding the administrative structure, Dr. Adamu noted that the IRB at the College of Science at Addis Ababa University is accountable to the Research Director's office of the college, and he advised that the PSI IRB should determine whether it should be accountable to the Research Development and Data Management Centre or the Director General's office.
Additionally, he recommended that the PSI IRB should discuss including both the IRB stamp and the signature of the IRB chairperson, as well as the stamp of the PSI Director General, on all their communications. Dr. Adamu stressed that every action of the IRB, such as the use of stamps, service payments for external users, and so on, must be clearly stated in the Standard Operating Procedures (SOP) document. He also advised that during each IRB meeting, the chairperson should have the SOP document available to reference and address any ambiguities that may arise. Finally, he noted that the SOP can be periodically updated, amended, and reviewed as necessary.
Dr. Adamu walked through the practical details of the IRB review process at the Health Science College of AAU. The process begins with a login portal that allows users to access the system as either a reviewer or a researcher. This portal showcases the workflow, checklists, and various document templates, including feedback forms and certificate templates.
The IRB committee provides services such as initial review, amendments, and renewal of research proposals. Dr. Adamu emphasized that no research is automatically approved - it must go through a review process and receive feedback before being approved. The purpose of the IRB is to improve the ethical aspects of the research, not just to reject proposals.
The portal also contains application forms, support letters from the researcher's institution, and assessment forms for reviewers, as well as template for meeting minutes. Dr. Adamu noted that if the research concerns national-level issues, it may need to be referred to the national-level IRB.
He also explained the key elements of the checklists, such as considerations for vulnerable groups (e.g., prisoners, children, mentally ill persons), benefit-risk ratio, level of protection, and risks. Dr. Adamu stressed that all research has inherent risks, even something as simple as an interview, due to factors like time taken from participants, sensitive questions, and interview logistics.
Regarding informed consent, Dr. Adamu stated that it can be obtained in written or oral form. He also advised against paying research participants directly, as this could be unethical, but suggested providing compensation for their time or refreshments.
Dr. Adamu recommended that the PSI IRB initially focus on providing services to internal researchers, and then expand to external users once they have developed sufficient capacity. He also suggested that the PSI IRB meet on a monthly basis.
During the training, Dr. Adamu Addissie shared several sample case studies, along with the sources from which these case studies were drawn, and provided specific questions for the participants to consider when examining the research protocols in detail. The sample case studies were intended to serve as part of the process for thoroughly reviewing and assessing research protocols, allowing the IRERC members to learn how to address key questions that arise during the protocol review process, such as the appropriateness of the study methodology, the need for phase-by-phase review and approval, the sufficiency of participant protections, and the potential elimination or modification of certain phases. This detailed case study examination enables the IRERC to conduct a comprehensive review of the research protocols and procedures involved in obtaining the necessary ethical clearance, and equips the members with the knowledge and tools to perform a rigorous and effective review of research proposals submitted for ethical approval.
All IRB documents related to Addis Ababa University college of sciences can be found at https://www.aau.edu.et/chs/irb/initial-submission/.The checklists used to evaluate research proposals cover a wide range of critical issues, including the subject matter of the study, potential risks, the appropriateness of the research methodology, the proposed interventions, and the anticipated benefits to the participants and the broader community.
Dr Adamu stressed that in the event that the Institutional Review Board identifies significant concerns or potential adverse effects on the study subjects, they have the necessary mandate and authority to stop the research project altogether. This safeguard ensures that the rights and wellbeing of research participants are prioritized and protected throughout the review and approval process.
The comprehensive nature of the evaluation checklists, combined with the IRB's ability to halt studies that pose unacceptable risks, demonstrates the rigorous and responsible approach taken to ensure the ethical conduct of research. This multilayered review process helps to uphold the highest standards of research integrity and participant safety.
Overall, the training provided by the renowned expert, Dr. Adamu Addissie, has equipped the PSI IRERC members with invaluable knowledge and tools to effectively review research proposals and uphold the highest ethical standards. By examining detailed case studies and considering critical questions related to study methodology, participant protections, and the phased approval process, the IRERC is now better prepared to conduct thorough and rigorous reviews. This training has been an important step in reinforcing PSI's commitment to ethical research practices and maintaining public trust in the organization's work.