Institutional review boards in Saudi Arabia: the first survey-based report on their functions and operations

Abstract

Background Institutional review boards (IRBs) are formally designated to review, approve, and monitor biomedical research. They are responsible for ensuring that researchers comply with the ethical guidelines concerning human research participants. Given that IRBs might face different obstacles that cause delays in their processes or conflicts with investigators, this study aims to report the functions, roles, resources, and review process of IRBs in Saudi Arabia. Method This was a cross-sectional self-reported survey conducted from March 2021 to March 2022. The survey was sent to 53 IRB chairpersons and the administration directors (or secretary) across the country through email after receiving verbal consent. The validated survey consisted of eight aspects: (a) organizational aspects, (b) membership and educational training, (c) submission arrangements and materials, (d) minutes, (e) review procedures, (f) communicating a decision, (g) continuing review, and (h) research ethics committee (REC) resources. A total of 200 points indicated optimal IRB functions. Results Twenty-six IRBs across Saudi Arabia responded to the survey. Overall, the IRBs in this study scored a total of 150/200 of the points on the self-assessment tool. Relatively newer IRBs (established less than ten years ago) conducted meetings at least once in a month, had annual funding, had more balanced gender representation, tended to score higher than older IRBs. The organizational aspect score was the lowest among all items in the survey (14.3 score difference, p-value < 0.01). The average turnaround time for expedited research from proposal submission to final decision was 7 days, while it was 20.5 days for the full committee review. Conclusion Saudi IRBs performed generally well. However, there is room for focused improvement with respect to extra resources and organizational issues that require closer evaluation and guidance from the regulatory bodies.

Behind the scenes of research ethics committee oversight: a qualitative research study with committee chairs in the Middle East and North Africa region

“…Participants did not express the need for continuous training for their members who were assumed to be knowledgeable because of their seniority which overlooks the pivot of keeping REC members in line with emerging research ethics topics, such as gene editing or arti cial intelligence. This inconsistency of requiring ethics training has been documented by research in the region by (6) in Jordan and (11) in Sub-Saharan Africa showing that it is not seen to be necessary; while other research studies in Saudi Arabia describe proper training mechanisms and guidance for RECS (7). REC members in Saudi Arabia are required by law (Law of Ethics of Research on Living Created by the National Committee of Bio-Ethics NCBE) to complete training on ethics and regulations in order to be registered (7), which could explain the attention to this training initiative there.…”

“…This inconsistency of requiring ethics training has been documented by research in the region by (6) in Jordan and (11) in Sub-Saharan Africa showing that it is not seen to be necessary; while other research studies in Saudi Arabia describe proper training mechanisms and guidance for RECS (7). REC members in Saudi Arabia are required by law (Law of Ethics of Research on Living Created by the National Committee of Bio-Ethics NCBE) to complete training on ethics and regulations in order to be registered (7), which could explain the attention to this training initiative there. If such policies and laws that require continuing education for RECs and researchers, were to be developed and enforced then all parties involved in research and research oversight would bene t.…”

Awareness of Medical Professionals Regarding Research Ethics in a Tertiary Care Hospital in Riyadh, Saudi Arabia: A Survey to Assess Training Needs

“…On average, the IRBs review 40 protocols of clinical trials annually, and the duration of each meeting is around 45-120 min. The average number of days taken for the full committee review is 20.5 days [40]. This might be the reason that researchers are reluctant to have the full board review every project.…”

“…Also, researchers had the least positive attitude toward the statement that "the IRB should have an unaffiliated member (non-medical person)" (47.92%). In a survey by Al Fattan et al (2022) [40], it was reported that only 30.7% of the members of the IRB in Saudi Arabia were non-scientific members. In a survey conducted among non-affiliated IRB members, 88% agreed that having nonscientist IRB members is one of the reasons for making research more accountable to the public [41].…”