This study is the first of its kind in KSA, which assessed the compliance of Saudi IRBs/RECs compliance with international standards in terms of their structures and processes. The results identified areas where IRBs/RECs were performing well and where quality improvement was needed. The IRBs/RECs in this study scored a total of 150/200 of the allowable points on the self-assessment tool.
The mean score for the organizational aspect was 39.69 ± 13.27, which was 14 points short of the optimal score. This low mean score can be explained by the low percentage of IRBs/RECs who included prior training in ethics and prior publications in ethics as the criteria for chair selection. Communicating a decision (approval letter) had an excellent mean score of 4.15 ± 1.59, which was only 1 point short of the optimal score. A case study of two medical college IRBs/RECs was conducted in Western India utilizing the Research Ethics Committee Quality Assurance Self-Assessment Tool (RECQASAT), who scored 29 and 36 points for the organizational aspect, respectively. They both scored 3 points in the domain of communicating a decision (approval letter). Meanwhile, the total mean score was 123 and 133 out of 200 for each REC individually, which is less than the total mean score concluded in the current study (16). This could be an indicator that the IRBs/RECs in Saudi Arabia are performing better when compared to the two RECs in Western India.
According to the results obtained from a descriptive questionnaire-based study conducted in Lebanon (2018) where the total possible points was 175, the questionnaire mean score was 129.6 ± 22.3 out of 175, which was similar to the total possible score in the current study. This indicates an excellent adherence to international standards. Nevertheless, the organizational aspect was poorly scored deviating by 39 points from the mean. Quite the opposite, Lebanese RECs achieved the optimal total score for communicating a decision (approval letter) aspect (17).
A study conducted in Myanmar in 2020 showed the characteristics of the RECs and associated mean scores(18). In that study most of the 15 IRBs/RECs (93.3%) reported having meetings less than once a month. However, none of the RECs received an annual board meeting budget. Half of the IRBs/RECs with balanced gender representation reported a mean total score of 114.8 ± 15.3. While in the our study, 70% of the 25 IRBs/RECs who “had been running for less than 10 years” reported a mean total score of 152.23, the RECs that had been running for 10 years and above reported a lower mean total score (score = 140). Around a third of the IRBs/RECs used to have meetings less than once a month. Twenty-five per cent of the IRBs/RECs received a yearly budget, and they had a mean total score of 177.33. Only a third of IRBs/RECs had balanced gender representation.
According to another study conducted in low and middle-income countries (4), a slight majority of 64 IRBs/RECs reported having meetings at least once a month, while less than 40% stated they received an annual budget. Their total mean score was 137.7 ± 40.7 and 158.0 ± 19.2, respectively.
Turnaround time is one of the important indicators in the self-assessment tool. Our current study shows that the average turnaround time (TAT) from submission to approval for expedited research is 7 days, and 20.5 days for the full committee research. This average time is for committees that review up to 40 protocols annually. However, the benchmark turnaround time according to the Association for the Accreditation of Human Research Protection Programs (AAHRPP) (19) is 30.2 and 44.9 for expedited and full committee approval respectively, for an average of 39.8 protocol reviewed annually. This indicates the efficiency of the Saudi IRBs/RECs evaluating system. However, this could be due to the type of protocol being reviewed as well. For instance, the Saudi IRBs/RECs tend to review a higher number of observational and cross-sectional studies and a lower number of clinical trials annually which might be a factor in lowering the overall turnaround time.
More than half of the studied IRBs/RECs lacked gender-balanced representation. Nonetheless, Table 4 clearly demonstrates a better performance by gender-balanced IRBs/RECs in all individual domains, especially in the organizational aspect and review of specific protocol items. This finding supports the claim of the Myanmar study that lack of diversity is holding IRBs/RECs back from making scientifically sound decisions in developing countries(14). This could be due to gender segregation in the workplace that was effective until 2005 in Saudi Arabia, and it should be further monitored and improved to achieve women's empowerment goals for the Saudi Vision 2030 (9).
Limitation:
First, a potential limitation of the current study is the self-assessment tool, which might cause exaggeration or underestimation of the function of the IRBs/RECs. The non-probability sampling technique can also lead to a lack of generalizability. These results should be further compared to reports from the monitoring office of the Saudi IRBs for validation (20). Second, the low response rate was an issue due to the existing formalities and bureaucratic hindrance in some places(21). We faced different challenges and delays trying to approach IRBs/RECs, and many of them declined to participate without giving a specific reason for it. Ironically, others refused to participate because they insisted on a PI from the invited institution to be involved in the study in order to take IRB approval. We believe that these obstacles hinder improvement efforts by the NCBE and discourages the collaborations between institutions.
Challenges:
To overcome the suboptimal gender representation in IRBs/RECs, the following challenges should be addressed: the lack of financial incentives to attend IRB meetings, the current male-dominant situation in academia, and the lack of appreciation about the value that females can add to the decision-making process.
Furthermore, the high frequency of meetings in the older IRBs/RECs may indicate internal issues and difficulties, especially in terms of organizational aspects(22). Some of the main difficulties were the lack of a dedicated annual budget for IRBs/RECs and the lack of protected time for IRBs/RECs members to review proposals and attend meetings.
Recommendations:
Saudi IRBs/RECs need to be targeted for improvement with respect to balanced gender representation. Organizational issues might need closer investigation and guidance from the regulatory bodies. Moreover, training education and efficient support are required to maintain the key role of the institutions. These aspects need to be targeted for continuous improvement as well.