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FACTORS INFLUENCING TURN-AROUND TIME OF ETHICS REVIEW IN TANZANIA: ASSESSMENT OF PROTOCOL REVIEW SYSTEMS.

FACTORS INFLUENCING TURN-AROUND TIME OF ETHICS REVIEW IN TANZANIA

Published onAug 14, 2023
FACTORS INFLUENCING TURN-AROUND TIME OF ETHICS REVIEW IN TANZANIA: ASSESSMENT OF PROTOCOL REVIEW SYSTEMS.
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FACTORS INFLUENCING TURN-AROUND TIME OF ETHICS REVIEW BY THE NATIONAL ETHICS REVIEW COMMITTEE.

DOI: https://doi.org/10.58177/ajb230003.

Abstract

Ethics review of health research protocols is paramount for the protection of the rights, safety, and welfare of research participants. The review of protocols is done by designated committees called Research Ethics Committees (RECs). In Tanzania, the National Research Ethics Committee (NatHREC) processes a large volume of protocols every year. Although the turnaround time of ethics review has been identified as a concern for stakeholders involved in the review process, there is a lack of comprehensive research on the specific factors that influence the duration of the review process by examining the research protocols themselves. While the long review timelines have significant implications for the timely commencement of research activities, as well as questions regarding the capacity of research ethics committees (RECs), the existing literature does not adequately address this aspect.

The study aimed to assess the factors that influenced the turnaround time of ethics review at the National Health Research Ethics Committee (NatHREC) for research protocols submitted between January 2018 and August 2019. This specific time frame was chosen to capture a substantial sample of protocols and provide a comprehensive understanding of the factors affecting the review process during that period and also because during this period the REC employed two different review systems for protocol review.

Several factors were identified as influencing the turnaround time of the ethics review process. Firstly, the review systems played a significant role as during the study period, the REC employed two different review systems; Precursor Protocol Review System (PPRs) and Improved Protocol Review System (IPRs) which proved to be more time-efficient. Secondly, the type of study being reviewed also had an influence on turnaround time as clinical trials had a longer review turnaround time than non-clinical trials. Additionally, the time taken for researchers to resubmit their protocols for review affected the overall turnaround time. If researchers took longer to make necessary revisions, it would naturally extend the review process.

By focusing on the NatHREC, which is a prominent and nationally recognized research ethics committee, the study aimed to explore the factors that are influential within a well-established and reputable review system. Understanding the specific factors that contribute to the turnaround time at this committee would provide valuable insights for other similar committees and research ethics bodies across the country. Overall, the study highlighted the importance of addressing factors that influence the turnaround time of the review process to improve the efficiency of the process. The findings suggest that implementing the IPRS can significantly reduce the time taken for ethics review, benefiting both researchers and research participants.

Keywords: Turnaround time, Review system, Reviewers, Researchers.

Background

Ethics review is a crucial step in the research process to ensure that approved protocols are both scientifically valid and ethically sound (Ness 2022). This process is carried out by Research Ethics Committees (RECs) with the primary goal of protecting the safety and well-being of study participants (Ness 2022) and ensuring that informed consent is obtained without influence and coercion (Gibbs Brown, 1998). With this regard, it is expected that the review process would take some time but the actual turnaround time of the review process exceeds the expected time.

Turnaround time of the proposal review process has been the most common concern all over the world and the expedition of proposals doesn’t seem to curb the issue. A study conducted in the United States found that the average time required to obtain ethics approval ranged from 12 to 15 business days in two institutions. Similarly, a study conducted in South Africa examined 53 research protocols and observed an average approval time of 14 weeks. The purpose of this study was to highlight the excessive duration of the approval process, which was attributed to bureaucratic hurdles and the complex nature of the review process (Ness 2022).

During the ethics review process, reviewers and researchers engage in multiple correspondences to address any concerns or queries regarding the research protocol. This iterative process continues until the reviewers are satisfied that the protocol is safe and scientifically valid to be conducted in the specified research settings (Ness 2022). Several studies have identified common concerns raised during the review of clinical trial protocols. These concerns typically revolve around the scientific design of the study, ethical considerations related to participant rights and welfare, compliance of researchers with ethical guidelines and the established procedures of the REC, and the adequacy of qualifications possessed by the researchers involved (Ness 2022; TMDA 2020)(Ness 2022; TMDA 2020). These concerns reflect the multifaceted nature of ethics review, which encompasses both scientific and ethical dimensions.

Research is often timebound and has deadlines for achieving the deliverables and milestones associated with the research. Hence, delays in the approval of the research can result in difficulties in achieving the deliverables of the research in the planned timelines (Ness 2022). Resource allocation is another aspect of research that can get negatively impacted due to delays in the review and approval of protocols which can lead to reduced feasibility of the research being done with the available budget (Ness 2022). Delays in the turnaround time of ethics approval can also affect the ability of researchers to collaborate in research as some grants require significant collaboration from many institutions, this also affects multicenter studies (Ness 2022). Also, delays in research approval can also impact the data collection for the research because researchers may want to speed up the process and in turn produce incomprehensive, inconclusive, or fabricated data (Ness 2022).

The REC in this study has Standard Operating Procedures (SOPs) that were established in 2014, that outline the specific timelines for the review process (Ness 2022). The ethics review process described by the SOPs details that when protocols are submitted for review, the REC administrators validate them and send complete applications to the assigned reviewers. This is done through the head of the secretariat. The reviewers then have a designated timeframe, as specified in the REC's SOP, to review the protocols and provide their comments. Once the reviewers submit their comments, they are forwarded to the principal investigator (the person conducting the research) for revision. The principal investigator is required to make the necessary revisions to the protocol based on the reviewers' comments. The revised protocol is then resubmitted to the REC for another round of review. The REC will either approve the protocol or request further revisions during the next committee meeting (Ness 2022).

The existing research on ethics review turnaround time often focuses on general perceptions, attitudes, and experiences of stakeholders involved in the process. While these studies provide valuable insights into the overall concerns and challenges (Ness 2022), they do not specifically investigate the factors within research protocols that may contribute to the delays in the review process. Understanding these specific factors is crucial for identifying potential areas of improvement and implementing strategies to streamline the ethics review process.By assessing the protocols submitted to the REC within a designated period, this proposed study aims to bridge this research gap and shed light on the influence of different stakeholders on the review process. By examining the researchers, study design, and reviewers of research protocols, this study will provide a deeper understanding of the specific factors that contribute to prolonged review timelines. The findings will not only contribute to the existing body of knowledge but also inform research institutions, and ethics committees on potential interventions to expedite the review process and ensure efficient research initiation. Thus, this study will contribute to filling the gap in the literature by providing empirical evidence on the factors influencing ethics review turnaround time specifically at the NatHREC. The findings will not only be valuable for the NatHREC itself but also for other research ethics committees and stakeholders involved in the ethics review process, providing insights that can be used to optimize and expedite the review process, ultimately facilitating timely and ethically sound research.

Methodology

Study Design

This was a Cross-sectional Study; A cross-sectional study is a type of observational study that examines a population at a specific point in time or over a short period (Ness 2022). In this case, the researchers examined research protocols submitted to the National Research Ethics Committee (REC) during a specific time frame.

Data Collection was Retrospective, this means that the researchers gathered data from past records or events (Ness 2022). In this study, the researchers collected data on research protocols that were submitted to the National REC between January 2018 and August 2019. The data collection was conducted after this period had ended.

Study site

The study was conducted at the National Research Ethics Committee (REC) in Tanzania. This committee is responsible for overseeing and evaluating health research conducted in the country. Its main tasks include reviewing, approving, and monitoring research protocols to ensure ethical standards are upheld. The decision to conduct the study at the National REC was based on the fact that the committee receives a significant number of research protocols for review and approval on a daily basis. This high volume of protocols makes it an ideal location to undertake a study focused on the review process.

All protocols went through full board meetings, which were conducted twice a month. This implies that the protocols were presented and discussed during these meetings for review and approval. The pause time between these meetings was not considered in the determination of the turnaround time. Instead, it was embedded in phase 3 of the review process. This means that the time between meetings, when the committee was not actively reviewing protocols, was not factored into the calculation of the turnaround time. Additionally, the study noted that the meetings were conducted at specified times each month, indicating a regular schedule. This likely helped streamline the review process by ensuring that protocols were reviewed on a consistent basis and reducing delays caused by scheduling conflicts (Ness 2022).

Sample Size and Data Collection Process

Sample size

The researchers used purposive sampling to recruit protocols for their study. Purposive sampling is a non-probability sampling technique where researchers select participants based on specific criteria that align with their research objectives (Ness 2022). In this case, the researchers only included protocols that were reviewed and approved during the stated study period. To determine the sample size, the researchers employed the Yamane formula, which is a widely used formula for sample size estimation in survey research. The Yamane formula takes into account the population size and the desired level of precision. There were 200 protocols submitted to the REC during the study period. However, the number of protocols that were included in the analysis was 153.

Data collection

Data was collected from emails received by the NatHREC-secretariat for protocol review and approval. REC Administrators recorded the date of reception of the protocol, date of reception of reviewers' comments, date of resubmission, and date of protocol approval in a designated book which was also used to collect data on the timelines. A self-designed data collection tool was then used to collect and organize the data for ease of analysis.

The dependent Variable was the turnaround Time of Ethics Review which was the time taken for the ethics review process to be completed. The independent Variables included the review System used which encompassed the phases of review process; between 2018 and 2019, the REC employed two different review systems: the Precursor Protocol Review System (PPRS) and the Improved Protocol Review System (IPRS). The Precursor Proposal Review system (PPRs) was used by the REC ever since its establishment in 2002. The IPRs was introduced to improve the timeliness of the review process by improving the turnaround time in specific review phases. The timeline of the PPRs for receiving reviewers’ comments was 7 days from the day reviewers receive a protocol for review. On the other hand, the IPRs required that the reviewers send comments three days after receiving a protocol for review. Researchers were afforded 30 days in both review systems for re-submission of their protocols from the day comments were sent to them. Another independent variable was the type of Study; this was categorized as clinical trials and non-clinical trials; other independent variables include Reviewers whose qualifications, areas of expertise and initial comments were recorder; The researchers whose collaborators, qualifications and resubmissions were recorded; and the protocol validation time by REC’s administrators.

Data analysis and management

The study measured the time it took for a protocol to be reviewed and approved, and it divided the review process into three phases; - a) Phase 1: This phase measured the number of days from the reception of the protocol to the submission of initial reviewer's comments. It represents the time taken for the reception, validation and initial review of the protocol. b) Phase 2: This phase measured the number of days from the reception of initial reviewers' comments to the initial resubmission by the researcher. It represents the time taken by the researcher to address the reviewers' comments and make necessary revisions. c) Phase 3: This phase measured the number of days taken for a protocol to be approved after the initial resubmission. It includes the time required for subsequent resubmissions (if any) and the board meetings. The board meetings were held twice a month and were considered to take only one day for the purpose of analysis.

To analyze the data, the researchers used the Statistical Package for Social Sciences (SPSS). They calculated descriptive statistics such as mean, maximum value, minimum value, range and standard deviation values to summarize the data. Additionally, they conducted statistical tests by using an independent samples T-Test to determine the association between various factors and the turnaround time of protocol review. A p-value below 0.05 was used as the threshold for statistical significance, indicating evidence of a statistical influence of independent variables on the dependent variable (turnaround time of protocol review). Correlation of continuous variables was obtained through Spearman’s Rho which is a non-parametric test used to measure the strength of association between two variables (Ness 2022).

Results

Demographics of the variables

The number of protocols analyzed in the study was 153. 78 protocols were processed through the PPRS and 75 protocols through the IPRS; 134 protocols were non-clinical trials and 19 were clinical trials; For the researchers qualifications, 4 protocols were submitted by researchers having an undergraduate degree, 68 protocols were submitted by researchers with a masters’ degree, and 81 protocols were submitted by researchers with a doctorate; 37 protocols had only local investigators and 116 protocols had involvement of at least one foreign investigator. Protocols assigned to reviewers with only Masters qualifications were 9, those assigned to reviewers with only doctorate qualifications were 57 and those assigned to reviewers with mixed qualifications were 87. 93 protocols were recommended after minor revisions, 57 protocols were recommended after major revisions and only 3 protocols were recommended as they were. 132 protocols were assigned to reviewers whose expertise matched the protocols’ study area, and 21 were assigned to reviewers whose expertise didn’t match the protocols’ study area (Table 1).

Phases of the review process

Phase 1

Phase 1 had an average turnaround time of 8.46 days, and a Standard deviation of 8.0; The range of the number of days for phase 1 was 39 (0-39). Spearman's rho value of 0.488 a moderate positive monotonic relationship between the variables. It indicates that as the values of one variable increase, the values of the other variable tend to increase as well, but not in a perfectly consistent manner (Table 9).

Phase 2

Phase 2 had an average turnaround time of 27.99 days, and a Standard deviation of 22.9; The range of the number of days for phase 2 was 110 (0-110). Spearman's rho value of 0.754 indicates a strong positive monotonic relationship between the variables. It suggests that as the values of one variable increase, the values of the other variable tend to increase in a relatively consistent manner (Table 9).

Phase 3

Phase 3 had an average turnaround time of 17.8 days, and a Standard deviation of 18.0; The range of the number of days for phase 3 was 90 (0-89) Spearman's rho value of 0.565 suggests a moderate positive monotonic relationship between the variables. Similar to the first case, it indicates that as the values of one variable increase, the values of the other variable tend to increase, but not as consistently as in Phase 2 (Table 9).

The review system.

The PPRS

Phase 1 had an average turnaround time of 13.3 days, and a Standard deviation of 8.6; Phase 2 had an average turnaround time of 31.95 days, and a Standard deviation of 22.9; Phase 3 had an average turnaround time of 25.4 days, and a Standard deviation of 6.9; and the overall review time had an average turnaround time of 70.71 days, and a Standard deviation of 32.7 (Table 2).

The IPRS

Phase 1 had an average turnaround time of 3.41 days, and a Standard deviation of 2.4; Phase 2 had an average turnaround time of 23.88 days, and a Standard deviation of 22.3; Phase 3 had an average turnaround time of 9.90 days, and a Standard deviation of 21.8; and the overall review time had an average turnaround time of 37.15 days, and a Standard deviation of 23.1 (Table 2).

Based on the analysis, Phase 2 of the review process in both systems had the longest turnaround time, accounting for up to 60% of the overall review. The range of number of days of the overall turnaround time for the PPRS was 173 (11-184), and the range of number of days of the overall turnaround time for the IPRS was 113 (7-120), A P-Value of 0.00 was obtained which showed statistical significance on the overall turnaround time of the review process.

Protocol validation time

The protocols were screened and sent to reviewers within two days after submission, indicating a prompt initial processing of the submissions. Also, the validation time for protocols remained constant for all submissions. This implied that the time taken for protocol validation was not a factor in determining the overall turnaround time of the review process.

Type of Study

Non-Clinical Trial protocols.

Phase 1 had an average turnaround time of 8.39 days, and a Standard deviation of 7.8; Phase 2 had an average turnaround time of 26.52 days, and a Standard deviation of 20.3; Phase 3 had an average turnaround time of 16.65 days, and a Standard deviation of 16.8; and the overall review time had an average turnaround time of 51.56 days, and a Standard deviation of 29.8 (Table 3).

Clinical Trial protocols.

Phase 1 had an average turnaround time of 9.0 days, and a Standard deviation of 9.4; Phase 2 had an average turnaround time of 38.37 days, and a Standard deviation of 35.3; Phase 3 had an average turnaround time of 25.89 days, and a Standard deviation of 23.8; and the overall review time had an average turnaround time of 73.26 days, and a Standard deviation of 46.4 (Table 3).

The range of the number of days for the overall turnaround time of review of clinical trials was 169 (15-184) while the range for the number of days for the overall turnaround time of non-clinical trials was 146 (7-153). Study findings revealed that Clinical trial protocols had longer review times compared to non-clinical trials. A P-Value of 0.02 was obtained which showed a statistically significant influence on the overall turnaround time of the review process.

Researcher’s highest qualifications

Researchers with an undergraduate degree

Phase 1 had an average turnaround time of 2.50 days, and a Standard deviation of 2.37.8; Phase 2 had an average turnaround time of 28.50 days, and a Standard deviation of 15.0; Phase 3 had an average turnaround time of 12.00 days, and a Standard deviation of 7.8; and the overall review time had an average turnaround time of 43.00 days, and a Standard deviation of 20.3 (Table 4).

Researchers with a Master’s degree

Phase 1 had an average turnaround time of 7.28 days, and a Standard deviation of 6.6; Phase 2 had an average turnaround time of 27.35 days, and a Standard deviation of 24.0; Phase 3 had an average turnaround time of 16.88 days, and a Standard deviation of 19.5; and the overall review time had an average turnaround time of 51.51 days, and a Standard deviation of 33.2 (Table 4).

Researchers with a Doctorate

Phase 1 had an average turnaround time of 9.75 days, and a Standard deviation of 9.0; Phase 2 had an average turnaround time of 28.52 days, and a Standard deviation of 22.4; Phase 3 had an average turnaround time of 18.85 days, and a Standard deviation of 17.1; and the overall review time had an average turnaround time of 57.11 days, and a Standard deviation of 33.2 (Table 4).

Study findings revealed that protocols whose researcher had an undergraduate degree had the least turnaround time, followed by protocols whose researcher had a master’s degree while protocols whose researcher had a doctorate had the longest average turnaround time. The range of the number of days of the overall turnaround time of the review process for researchers with an undergraduate degree was 45 (22-67), the range of the number of days of the overall turnaround time of the review process for researchers with a Master’s degree was 128 (9-137), and The range of the number of days of the overall turnaround time of the review process for researchers with a doctorate was 177 (7-184). A P-Value of 0.31 was obtained which meant that there was no statistical influence on the overall turnaround time of the review process.

Researchers’ collaborators

Researcher with all local investigators

Phase 1 had an average turnaround time of 6.38 days, and a Standard deviation of 8.0; Phase 2 had an average turnaround time of 25.54 days, and a Standard deviation of 19.4; Phase 3 had an average turnaround time of 15.16 days, and a Standard deviation of 11.8; and the overall review time had an average turnaround time of 47.08 days, and a Standard deviation of 27.1 (Table 5).

Researcher with at least one foreign investigator

Phase 1 had an average turnaround time of 9.13 days, and a Standard deviation of 7.9; Phase 2 had an average turnaround time of 28.78 days, and a Standard deviation of 23.9; Phase 3 had an average turnaround time of 18.64 days, and a Standard deviation of 19.5; and the overall review time had an average turnaround time of 56.54 days, and a Standard deviation of 34.4 (Table 4).

The average turnaround time for Phases 1,2, 3 and the overall review time was fairly similar between protocols having all local investigators and protocols having at least one local investigator. The range of the number of days of the overall turnaround time for protocols having all local investigators was 126 (8-134) and for protocols having at least one local investigator was 177 (7-184). A P-Value of 0.09 was obtained which meant that there was no statistical influence on the overall turnaround time of the review process.

Reviewers’ remarks after the Initial review

Phase 1 had an average turnaround time of 7.67 days, and a Standard deviation of 8.0; Phase 2 had an average turnaround time of 23.18 days, and a Standard deviation of 18.3; Phase 3 had an average turnaround time of 18.14 days, and a Standard deviation of 19.3; and the overall review time had an average turnaround time of 43.99 days, and a Standard deviation of 31.1 (Table 6).

Phase 1 had an average turnaround time of 9.70 days, and a Standard deviation of 8.1; Phase 2 had an average turnaround time of 36.35 days, and a Standard deviation of 27.2; Phase 3 had an average turnaround time of 17.68 days, and a Standard deviation of 16.1; and the overall review time had an average turnaround time of 63.74 days, and a Standard deviation of 34.5 (Table 6).

Phase 1 had an average turnaround time of 9.67 days, and a Standard deviation of 7.0; Phase 2 had an average turnaround time of 18.33 days, and a Standard deviation of 20.8; Phase 3 had an average turnaround time of 9.33 days, and a Standard deviation of 5.5; and the overall review time had an average turnaround time of 37.33 days, and a Standard deviation of 22.4 (Table 6).

The turnaround time of the review process for protocols that were recommended after major revisions had longer turnaround time than protocols that received minor revisions. Protocols recommended as they were had the shortest turnaround time. The range of the overall review turnaround time for protocols that were recommended after major revisions was 173 days (11-184), The range of the overall review turnaround time for protocols that were recommended after minor revisions was 130 days (7-137), and the range of the overall review turnaround time for protocols that were recommended as presented was 44 (18-62). A P-Value of 0.10 was obtained which meant that there was no statistical influence on the overall turnaround time of the review process.

Reviewers’ qualifications.

Protocols that were Assigned to reviewers with only master’s qualifications

Phase 1 had an average turnaround time of 3.33 days, and a Standard deviation of 1.0; Phase 2 had an average turnaround time of 22.56 days, and a Standard deviation of 15.1; Phase 3 had an average turnaround time of 7.67 days, and a Standard deviation of 7.4; and the overall review time had an average turnaround time of 33.56 days, and a Standard deviation of 20.5 (Table 7).

Protocols that were Assigned to reviewers with only doctorate qualifications

Phase 1 had an average turnaround time of 6.91 days, and a Standard deviation of 7.5; Phase 2 had an average turnaround time of 27.51 days, and a Standard deviation of 14.8; Phase 3 had an average turnaround time of 16.07 days, and a Standard deviation of 14.8; and the overall review time had an average turnaround time of 50.49 days, and a Standard deviation of 33.4 (Table 7).

Protocols that were Assigned to reviewers with mixed qualifications

Phase 1 had an average turnaround time of 10.1 days, and a Standard deviation of 8.4; Phase 2 had an average turnaround time of 28.87 days, and a Standard deviation of 23.0; Phase 3 had an average turnaround time of 19.98 days, and a Standard deviation of 20.2; and the overall review time had an average turnaround time of 58.86 days, and a Standard deviation of 32.8 (Table 7).

The turnaround time of the review process for protocols that were assigned to reviewers with Masters qualifications had the shortest turnaround time of review and protocols assigned to reviewers with mixed qualifications had the longest turnaround time of review. The range of number of days of the overall turnaround time for reviewers with masters was 53 (4-67), the range of number of days of the overall turnaround time for reviewers with doctorates was 177 (7-184), and the range of number of days of the overall turnaround time for reviewers with mixed qualifications was 144 (9-153). (P-Value of 0.54 was obtained which meant that there was no statistical influence on the overall turnaround time of the review process.

Reviewers’ area of expertise in relation to the assigned protocol.

Reviewers with expertise that matched the assigned study area of the protocol

Phase 1 had an average turnaround time of 9.02 days, and a Standard deviation of 8.2; Phase 2 had an average turnaround time of 28.39 days, and a Standard deviation of 22.5; Phase 3 had an average turnaround time of 18.05 days, and a Standard deviation of 17.9; and the overall review time had an average turnaround time of 55.46 days, and a Standard deviation of 33.2 (Table 8).

Reviewers with expertise that did not match the assigned study area of the protocol

Phase 1 had an average turnaround time of 4.95 days, and a Standard deviation of 5.9; Phase 2 had an average turnaround time of 25.52 days, and a Standard deviation of 25.4; Phase 3 had an average turnaround time of 16.19 days, and a Standard deviation of 19.2; and the overall review time had an average turnaround time of 46.67 days, and a Standard deviation of 31.2 (Table 8).

The range of the number of days of overall turnaround time when reviewers’ area of expertise matched the proposals’ study area was 177 days (7-184), and the number of days when reviewers’ area of expertise did not match the proposals’ study area was 110 (15-125). However, a P-Value of 0.25 was obtained which meant that there was no statistical influence on the overall turnaround time of the review process.

Discussion

Understanding the factors that contribute to the review process duration at the NatHREC is essential for improving efficiency and addressing potential bottlenecks. By examining the protocols submitted during the designated period, this study sought to identify specific factors such as researchers’ qualifications and collaborators, reviewers’ qualifications and expertise, study design, and communication between the reviewers and researchers that may influence the review timeline. The factors that influence turnaround time were analyzed in categories of; review system, REC administrators, type of study, researchers, and reviewers. Results of the study showed that the review significantly system influenced review turnaround time, the PPRS had a longer average review turnaround time than the IPRS. Protocol resubmission turnaround time also proved to be the longest phase of the review process (Phase 2). The type of study being a clinical trial or non-clinical trial also significantly influenced the turnaround time of the review process. Some studies report lengthy review turnaround times from 14 to 42 weeks in some RECs (Ness 2022; TMDA 2020)(Ness 2022; TMDA 2020). In this study, the IPRS proved to have shortened the review turnaround time for all phases compared to the PPRS. In essence, results show that by implementing the IPRS, the NatHREC succeeded in increasing the efficiency of the review process. What was noted as the main factor that may have led to the shortened timelines of the review process was the difference in the number of reviewers for the two review systems; the PPRS employed three reviewers for the review of a single protocol while the IPRS employed two. And though the literature is short on the influence of the number of reviewers, it does note the importance of reviewers being qualified and well-trained in the review of health research protocols (Ness 2022; TMDA 2020)(Ness 2022; TMDA 2020). Also, the IPRS had a well-defined turnaround time for the first phase of the review process which was set to be completed within three days, we presume that this was one of the actors that encouraged researchers to make timely resubmissions because on average, through the IPRS researchers responded to comments a week earlier than in the PPRS.

The NatHREC granted 30 days for researchers to address comments, but sometimes researchers take too long to make resubmissions ultimately leading to a lengthy review time. In this study, this was evident based on the provided Spearman's rho values, Phase 1 and phase 3 indicate moderate positive monotonic relationships, while Phase 2 indicates a strong positive monotonic relationship between the variables under consideration. A study done in Tanzania pointed out that the non-compliance of researchers or sometimes the disregard of guidelines set up by RECs, the weight of comments provided by reviewers (Ness 2022), the lack of awareness of when to make resubmissions are the reasons causing protocols to have a lengthy review time or not complete the review process at all (Ness 2022). A study done at a South African academic institution suggested that protocols whose researchers had a master’s degree qualification or were seeking a master’s degree had longer review timelines than those whose researchers had higher qualifications (Ness 2022). A lack of experience in research or review processes could also lead to delays. Interestingly, the researcher’s qualifications and whether they were all local investigators or had at least one foreign investigator were not found to have an influence on the average review turnaround time. It was encouraging that more than half of the analyzed protocols had at least one foreign investigator. Even though studies expose challenges of collaborative research and multisite research in terms of the review turnaround time and the bureaucracy of the process, collaborative research is encouraged for knowledge and technology transfer and more importantly, capacity building (Ness 2022). Findings from this study did not indicate any statistical significance in the involvement of foreign investigators on the overall review time.

The influence of reviewers in the review process has been discussed in various articles and on various fronts. Studies reported that reviewers’ adherence to guidelines, training on ethics, availability when needed to review a protocol, qualifications, and expertise were among the reasons hindering reviewers from efficiently performing their duties (Ness 2022; TMDA 2020)(Ness 2022; TMDA 2020). Findings from this study also demonstrated that reviewers’ remarks after the initial review did lead to an increased turnaround time for protocols that were recommended after “Major revisions” compared to protocols that were recommended for “Minor revisions”. This is backed up by a study by (Ness 2022) who reported the influence of professionalism and qualifications of reviewers with regards to the comments they provide to researchers and how these remarks serve to improve protocols and adherence to ethical guidelines. There were instances where some protocols were assigned to reviewers who did not have expertise in that study area this could have been due to the workload on reviewers with the right expertise or availability of reviewers with the right expertise (Ness 2022). However, reviewers’ qualifications and whether the protocol assigned to them matched their areas of expertise were not found to have an influence on the average review turnaround time.

Clinical trial studies undergo a more rigorous review process compared to non-clinical trial studies due to the potential risks involved in the interventions being tested (Kimmelman, 2004). These studies involve interventions that may pose more than minimal risk to human participants(Ness 2022; TMDA 2020)(Ness 2022; TMDA 2020). The need for a stricter review process arises from the ethical and safety considerations associated with conducting research on human subjects (Ness 2022). In the context of the United States, the Food and Drug Administration (FDA) is responsible for overseeing and regulating clinical trials (Ness 2022). The FDA’s review process for clinical trial approvals typically takes a considerable amount of time, often up to 8 months (Ness 2022). This extended duration is necessary to ensure that all relevant aspects of the study, including participant safety and adherence to regulatory requirements, are thoroughly evaluated. Clinical trial protocols, which outline the procedures and methodologies to be followed during the study, have additional requirements compared to non-clinical trial protocols. Some of these requirements include the provision of investigator brochures, which contain comprehensive information about the investigational product being tested. Additionally, the protocols must include a list of members for the Data and Safety Monitoring Board, a group responsible for monitoring participant safety during the trial. Moreover, insurance coverage is an essential component to protect participants in case of adverse events or injuries resulting from the study. (Ness 2022; TMDA 2020)(Ness 2022; TMDA 2020). To ensure a comprehensive and accurate review of clinical trial protocols, it is crucial to appoint reviewers who possess expertise in the field of clinical trials (Ness 2022). These experts have the necessary knowledge and experience to assess the scientific validity, ethical considerations, and safety measures of the proposed study. Appointing clinical trial experts as reviewers helps maintain the integrity of the review process and ensures that all aspects of the study are adequately evaluated.

Conclusion

The findings of the study revealed several issues, and implementing certain strategies proved effective in reducing the review turnaround time. Specifically, two interventions were successful: reducing the number of reviewers assigned to each protocol and setting shorter timelines for the different review phases. By decreasing the number of reviewers assigned to a single protocol, the review process became more streamlined and efficient. This approach likely allowed for better coordination and communication among the reviewers, facilitating quicker decision-making. Additionally, setting shorter timelines for the review phases helped expedite the overall process. By imposing stricter time limits, the review stages were completed more promptly, reducing delays and ensuring timely completion of the ethics review.

The study also emphasized the importance of various stakeholders in improving the turnaround time. The REC administrators, reviewers, and researchers all played vital roles in enabling and enhancing the efficiency of the review process. The administrators of the REC hold a significant responsibility in managing the workflow and resources of the committee. By implementing strategies such as optimizing reviewer assignments and establishing efficient protocols, administrators can contribute to reducing the review turnaround time. Reviewers, on the other hand, are responsible for evaluating the protocols and ensuring their compliance with ethical standards. By actively participating in the review process and adhering to the prescribed timelines, reviewers can facilitate faster decision-making and contribute to shorter review durations. Finally, researchers submitting protocols for review also have a role to play. They can support the process by promptly resubmitting their protocols after addressing any queries or concerns raised by reviewers. The involvement and cooperation of REC administrators, reviewers, and researchers are crucial in improving the overall efficiency of the ethics review and lessening the burden on all parties involved.

Overall, there is a need for more empirical research that directly examines the research protocols themselves to identify the specific factors that influence ethics review turnaround time. Such research will help fill the current gap in understanding and provide actionable insights for stakeholders seeking to enhance the efficiency and effectiveness of the ethics review process. The findings will help inform NatHREC and other ethics committees about potential areas for improvement, allowing them to streamline their processes, reduce delays, and enhance research initiation timelines.

Figures and Tables

Table 1: Demographics of the factors influencing turnaround time of ethics review.

Variables

Sub variables

Frequency (n)

Review system

PPRS

78

IPRS

75

Type of Study

Non-clinical trial

134

Clinical Trial

19

Researcher qualifications

Master’s degree

68

Doctorate

81

Undergraduate degree

04

Type of collaborator

Local

37

Foreign

116

Reviewers’ remarks after the Initial review

Major

57

Minor

93

Approved as is.

03

Reviewers’ academic qualification

Masters-Masters Pair

09

Doctorate- Doctorate pair

57

Doctorate-Masters pair

87

Reviewers’ area of expertise in relation to the assigned protocol.

Match

132

Mismatch

21

Table 2: Turnaround time of the review process in relation to the review system.

Stage of review

Review system

Mean

Std. Deviation

Range

Minimum – Maximum

P-value (ORT)

Phase 1

PPRS

13.32

8.612

IPRS

3.41

2.366

Phase 2

PPRS

31.95

22.883

IPRS

23.88

22.331

Phase 3

PPRS

25.44

21.793

IPRS

9.85

6.986

Overall Review Time (ORT)

PPRS

70.71

32.764

173

11-184

0.00

IPRS

37.15

23.181

113

7-120

Table 3: Turnaround time of the review process in relation to the type of study.

Stage of review

Type of study

Mean

Std. Deviation

Range

Minimum – Maximum

P-value (ORT)

Phase 1

Non-clinical trial

8.39

7.890

Clinical Trial

9.00

9.404

Phase 2

Non-clinical trial

26.52

20.324

Clinical Trial

38.37

35.307

Phase 3

Non-clinical trial

16.65

16.851

Clinical Trial

25.89

23.893

Overall Review Time (ORT)

Non-clinical trial

51.56

29.884

146

7-153

0.02

Clinical Trial

73.26

46.468

169

15-184

Table 4: Turnaround time of the review process in relation to the Researcher’s qualifications.

Stage of review

Researcher’s qualification

Mean

Std. Deviation

Range

Minimum – Maximum

P-value (ORT)

Phase 1

Undergraduate degree

2.50

2.380

Masters

7.28

6.682

Doctorate

9.75

9.012

Phase 2

Undergraduate degree

28.50

15.022

Masters

27.35

24.066

Doctorate

28.51

22.411

Phase 3

Undergraduate degree

12.00

7.874

Masters

16.88

19.541

Doctorate

18.85

17.107

Overall Review Time (ORT)

Undergraduate degree

43.00

20.347

45

22-67

0.31

Masters

51.51

33.248

128

9 -137

Doctorate

57.11

33.261

177

7-184

Table 5: Turnaround time of the review process in relation to the type of collaborator.

Stage of review

Protocol researchers

Mean

Std. Deviation

Range

Minimum – Maximum

P-value (ORT)

Phase 1

All Local

6.38

8.050

At least one Foreign

9.13

7.985

Phase 2

All Local

25.54

19.474

At least one Foreign

28.78

23.914

Phase 3

All Local

15.16

11.880

At least one Foreign

18.64

19.570

Overall Review Time (ORT)

All Local

47.08

27.149

126

8-134

0.09

At least one Foreign

56.54

34.445

177

7-184

Table 6: Turnaround time of the review process in relation to the reviewers’ remarks after the initial review.

Stage of review

Initial reviewers’ remarks

Mean

Std. Deviation

Range

Minimum – Maximum

P-value (ORT)

Phase 1

Major revisions

9.70

8.100

Minor revisions

7.67

8.045

Approved as is.

9.67

7.024

Phase 2

Major revisions

36.35

27.259

Minor revisions

23.18

18.302

Approved as is.

18.33

20.841

Phase 3

Major revisions

17.68

16.163

Minor revisions

18.14

19.378

Approved as is.

9.33

5.508

Overall Review Time (ORT)

Major revisions

63.74

34.553

173

11-184

0.10

Minor revisions

48.99

31.112

130

7-137

Approved as is.

37.33

22.480

44

18-62

Table 7: Turnaround time of the review process in relation to the reviewers’ qualifications.

Stage of review

Reviewers’ qualifications

Mean

Std. Deviation

Range

Minimum – Maximum

P-value (ORT)

Phase 1

Masters-Masters Pair

3.33

1.000

Doctorate- Doctorate pair

6.91

7.517

Doctorate-Masters pair

10.01

8.438

Phase 2

Masters-Masters Pair

22.56

15.101

Doctorate- Doctorate pair

27.51

23.818

Doctorate-Masters pair

28.87

23.070

Phase 3

Masters-Masters Pair

7.67

7.433

Doctorate- Doctorate pair

16.07

14.842

Doctorate-Masters pair

19.98

20.225

Overall Review Time (ORT)

Masters-Masters Pair

33.56

20.507

53

4-67

0.54

Doctorate- Doctorate pair

50.49

33.497

177

7-184

Doctorate-Masters pair

58.86

32.845

144

9-153

Table 8: Turnaround time of the review process in relation to the Reviewers’ area of expertise in relation to the assigned protocol.

Stage of review

Reviewers’ expertise vs protocol’s study area

Mean

Std. Deviation

Range

Minimum – Maximum

P-value (ORT)

Phase 1

Match

9.02

8.266

Mismatch

4.95

5.599

Phase 2

Match

28.39

22.542

Mismatch

25.52

25.490

Phase 3

Match

18.05

17.901

Mismatch

16.19

19.268

Overall Review Time (ORT)

Match

55.46

33.224

177

7-184

0.25

Mismatch

46.67

31.210

110

15-125

Table 9: Turnaround time of the phases of the review process and correlation to overall review turnaround time.

Stage of review

Mean

Std. Deviation

Range

Minimum – Maximum

Overall Review Time (Spearman's rho).

Phase 1

8.46

8.061

39

0-39

0.488

Phase 2

27.99

22.900

110

0-110

0.754

Phase 3

17.80

18.040

89

0-89

0.565

Figure 1: Phases of review time and their description

Figure 1: Displays the description of phases of the review process. - a) Phase 1; the number of days from reception of protocol to submission of initial reviewer’s comments; b) Phase 2; the number of days from reception of initial reviewers’ comments to initial resubmission by the researcher; and c) Phase 3; the number of days taken for the protocol to be approved after initial resubmission. This phase includes the number of resubmissions. since board meetings were conducted twice a month, time pauses between one meeting and another were not included in the analysis as meeting deliberations always took only one day.

References

Abbott, L., & Grady, C. (2011). A systematic review of the empirical literature evaluating IRBs: What we know and what we still need to learn. Journal of Empirical Research on Human Research Ethics (pp. 1984–1984).

Baldwin, J. R., Pingault, J. B., Schoeler, T., Sallis, H. M., & Munafò, M. R. (2022). Protecting against researcher bias in secondary data analysis : challenges and potential solutions. European Journal of Epidemiology, 37(1), 1–10. https://doi.org/10.1007/s10654-021-00839-0

Black, N., Van Rooyen, S., Godlee, F., Smith, R., & Evans, S. (1998). What makes a good reviewer and a good review for a general medical journal? Journal of the American Medical Association, 280(3), 231–233. https://doi.org/10.1001/jama.280.3.231

Burmeister, E., & Aitken, L. M. (2012). Sample size: How many is enough? Australian Critical Care, 25(4), 271–274. https://doi.org/10.1016/j.aucc.2012.07.002

Cancer Research UK. (2022). Types of clinical trials _ (p. 4). https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/what-clinical-trials-are/types-of-clinical-trials

Chambers, J. D., Thorat, T., Wilkinson, C. L., & Neumann, P. J. (2017). Drugs cleared through the FDA’s expedited review offer greater gains than drugs approved by conventional process. Health Affairs, 36(8), 1408–1415. https://doi.org/10.1377/hlthaff.2016.1541

Cho, K., Schunn, C. D., & Charney, D. (2006). Commenting on writing: Typology and perceived helpfulness of comments from novice peer reviewers and subject matter experts. Written Communication, 23(3), 260–294. https://doi.org/10.1177/0741088306289261

Cipriani, A., & Barbui, C. (2010). What is a clinical trial protocol? Epidemiologia e Psichiatria Sociale, 19(2), 116–117. https://doi.org/10.1017/s1121189x00000804

Clarke, D. L. (2014). Auditing the process of ethics approval for Master’s degrees at a South African university. South African Journal of Bioethics and Law, 7(1), 23. https://doi.org/10.7196/sajbl.301

dLaerd Statistics. (2018). Spearman’s Rank-Order Correlation - A guide to when to use it, what it does and what the assumptions are. In Lund Research LTD (pp. 1–2). https://statistics.laerd.com/statistical-guides/spearmans-rank-order-correlation-statistical-guide.php

Emanuel, E. J., Wendler, D., Killen, J., & Grady, C. (2004). What makes clinical research in developing countries ethical? The benchmarks of ethical research. Journal of Infectious Diseases, 189(5), 930–937. https://doi.org/10.1086/381709

Gibbs Brown, J. (1998). OFFICE OF INSPECTOR GENERAL Institutional Review Boards: A Time for Reform. https://oig.hhs.gov/oei/reports/oei-01-97-00193.pdf

Hirshon, J. M., Krugman, S. D., Witting, M. D., Furuno, J. P., Limcangco, M. R., Perisse, A. R., & Rasch, E. K. (2002). Variability in institutional review board assessment of minimal-risk research. Academic Emergency Medicine, 9(12), 1417–1420. https://doi.org/10.1197/aemj.9.12.1417

Howe, E. G. (2018). Balanced Ethics Review: A Guide for Institutional ReviewBoard Members. Psychiatry (New York), 9(2), 2016. https://doi.org/10.1080/00332747.2018.1492854

Joppi, R., Bertele, V., Vannini, T., Garattini, S., & Banzi, R. (2020). Food and Drug Administration vs European Medicines Agency: Review times and clinical evidence on novel drugs at the time of approval. British Journal of Clinical Pharmacology, 86(1), 170–174. https://doi.org/10.1111/bcp.14130

Kashyap, S. (2023). What Causes Project Delay and How to Avoid Them with 6 Tips (p. 10). https://www.proofhub.com/articles/project-delays

Kimmelman, J. (2004). Valuing risk: The ethical review of clinical trial safety. Kennedy Institute of Ethics Journal, 14(4), 369–393. https://doi.org/10.1353/ken.2004.0041

Landau, P. (2023). What Is Resource Allocation? How to Allocate Resources for Projects (p. 6). https://www.projectmanager.com/blog/resource-allocation

Liberti, L., Bujar, M., Breckenridge, A., Hoekman, J., McAuslane, N., Stolk, P., & Leufkens, H. (2017). FDA facilitated regulatory pathways: Visualizing their characteristics, development, and authorization timelines. Frontiers in Pharmacology, 8(APR), 1–6. https://doi.org/10.3389/fphar.2017.00161

Lynch, H. F., Abdirisak, M., Bogia, M., & Clapp, J. (2020). Evaluating the Quality of Research Ethics Review and Oversight : A Systematic Analysis of Quality Assessment Instruments Evaluating the Quality of Research Ethics Review and Oversight : A Systematic Analysis of Quality Assessment Instruments. AJOB Empirical Bioethics, 0(0), 1–15. https://doi.org/10.1080/23294515.2020.1798563

Mamotte, N., & Wassenaar, D. (2009). Ethics review in a developing country: a survey of South African social scientists’ experiences. Journal of Empirical Research on Human Research Ethics : JERHRE, 4(4), 69–78. https://doi.org/10.1525/jer.2009.4.4.69

Mrisho, M. (2021). Understanding constraints and enablers of turnaround time for ethics review : The case of institutional review boards in Tanzania.

Ness, E. (2022). Protocol Development , Review and Approval Process Planning a Clinical Trial. Center for Cancer Research National Cancer Institute, 84.

NIMR. (2014). STANDARD OPERATING PROCEDURES FOR THE NATIONAL INSTITUTE OF MEDICAL RESEARCH. NIMR, 2, 94.

Nxumalo, B. C. (2017). An examination of timelinesss in the expedited ethics review process at the University of KwaZulu-Natal, biomedical research ethics committee (Doctoral dissertation).1. Nxumalo BC. An examination of timelinesss in the expedited ethics review process at th. University of KwaZulu-Natal, 58.

Page, S. A., & Nyeboer, J. (2017). Improving the process of research ethics review. Research Integrity and Peer Review, 2(1), 1–7. https://doi.org/10.1186/s41073-017-0038-7

TMDA. (2020). GUIDELINES FOR APPLICATION TO CONDUCT CLINICAL TRIALS IN TANZANIA. 63(March). chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://www.tmda.go.tz/uploads/publications/en1672900058-CLINICAL TRIAL GUIDELINES - 2020.pdf

Toto, N., Douglas, E., Gmeiner, M., Barrett, L. K., Lindblad, R., Makhaza, L., Nedi, W., Phulusa, J., Quinnan, G. V, Sawyer, L. A., Thole, H., Voorhis, W. C. Van, & Tam, P. I. (2020). Conducting clinical trials in sub-Saharan Africa : challenges and lessons learned from the Malawi Cryptosporidium study. 1–8.

Tsoka-Gwegweni, J. M., & Wassenaar, D. R. (2014). Using the Emanuel et al. Framework to assess ethical issues raised by a biomedical research ethics committee in South Africa. Journal of Empirical Research on Human Research Ethics, 9(5), 36–45. https://doi.org/10.1177/1556264614553172

Wang, X., & Cheng, Z. (2020). Cross-Sectional Studies: Strengths, Weaknesses, and Recommendations. Chest, 158(1), S65–S71. https://doi.org/10.1016/j.chest.2020.03.012

Weinger, M. B., Slagle, J., Jain, S., & Ordonez, N. (2003). Retrospective data collection and analytical techniques for patient safety studies. Journal of Biomedical Informatics, 36(1–2), 106–119. https://doi.org/10.1016/j.jbi.2003.08.002

Wolzt, M., Druml, C., Leitner, D., & Singer, E. A. (2009). Protocols in expedited review: Tackling the workload of ethics committees. Intensive Care Medicine, 35(4), 613–615. https://doi.org/10.1007/s00134-008-1343-x

Acknowledgments and author contributions

The authors worked together to compile this manuscript; D.M. collected, analyzed, and interpreted the data. He also wrote the first draft of the manuscript. M.A, R.J, P. K and M.K. supervised data collection commented on the analysis and interpretation of the data, and were major contributors in writing the manuscript. All authors read and approved the final manuscript.

Ethics Approval and Consent to Participate

This study was reviewed and approved by the REC of the Muhimbili University of Health and Allied Sciences (MUHAS-REC-03-2021.517) dated 08th March 2021. Approval for data collection (NIMR/HQ/R.8a/VOL II of 2020/111) was obtained from NIMR on 25th March 2021. A waiver of informed consent was requested from the respective ethics committee as no interview was conducted in this study. Proposals were only used for timeliness data analysis no identifiers were used and anonymity of proposals was observed. This study was done under the supervision of MUHAS supervisors and staff of the national REC.

Disclaimer:

The study was conducted at the national REC that hosts the national research ethics committee. The results obtained are not representative of the situation of other RECs in Tanzania. The PPRS and IPRS were employed only for full board reviews, the results do not represent other review processes. However, the findings of the study can serve as the basis for further research into factors influencing the turnaround time of ethics review and as a basis for the creation of review systems that will shorten the review turnaround time.

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