An Overview of King Hussein Cancer Center Institutional Review Board Over 12 Years (2009–2020),Successes and Challenges,Including Those Imposed by the COVID-19 Pandemic

Abstract

The problem: Running an efficient institutional review board (IRB) can be challenging. The research subjects: To ensure an efficient committee, our IRB adopted several operational metrics. Methods: Analysis of retrospective data from the IRB records, database, and annual reports over 12 years. Results: The IRB roster comprises 11 members. The average medical to nonmedical member ratio is 5:6, and the male to female ratio is 4:7, which has not been consistent over the years. One thousand three hundred and twenty-four proposals were reviewed including 1077 exempt (81.3%), 126 expedited (9.5%), and 121 full board (9.2%) with a median turnaround time to approval of 4.0, 35.0, and 68.0 days, respectively. Training of the IRB members was conducted to enhance their knowledge and skills. IRB at King Hussein Cancer Center has managed to stay abreast and efficient during the COVID-19 pandemic, by working remotely. Conclusion: Running an efficient IRB mandates implementing a number of operational metrics.

Keywords

institutional review board operational metrics turnaround time continuous professional development low-middle income country COVID-19 gender representation quorum

Introduction

Institutional review boards (IRBs) are committees assigned with the oversight of human subject research. They review submitted study proposals, assessing a number of domains including autonomy and respect to participants, beneficence by maintaining a favorable risk-to-benefit ratio, and justice through ensuring a fair and equitable representation of participants (Bosso, 1983; Brown et al., 1980), before issuing their approvals. Following their inception, the role of IRBs has been frequently criticized. There have been claims of oppressive oversight (Enfield & Truwit, 2008), as well as dissatisfied researchers who accuse the IRBs of overburden and overreacting bodies (Abbott & Grady, 2011).

King Hussein Cancer Center (KHCC) is a standalone cancer center that became effectively established in 1997, called then Al-Amal Center, or “The Center of Hope.” To honor the late King Hussein, who died of cancer, the center was renamed after him in 2002. It is a 352-bed center that offers comprehensive cancer care for both adults and pediatric patients, mostly from Jordan but also from neighboring countries. It can accommodate up to 7000 new cases, 14,000 inpatients, and 250,000 outpatient visits/year. It treats around 60.0% of cancer cases in Jordan. Conducting impactful scientific research directed toward the needs of cancer patients in general and our patients in particular, has always been spelled out in KHCC’s mission and vision; in fact, research has always been one of the pillars of KHCC’s strategic plan.

The IRB is a standing committee established at KHCC in 2003. It aims at protecting the rights and welfare of human research subjects recruited to participate in research conducted at KHCC. It primarily accomplishes this by reviewing proposals for research and determining the level of risk. All research activity involving human subjects, whether through direct interaction/intervention or indirect through reviewing secondary medical data and/or material, conducted at, by, or under the auspice of KHCC must be prospectively reviewed and approved by the IRB before commencement. The IRB, along with the Office of Scientific Affairs and Research (OSAR), as well as the Research Council are the three bodies that govern research at KHCC. The Director-General, to whom he/she reports directly, appoints the Chair of the IRB. The IRB Chair, in turn, nominates the IRB members, ensuring representation of the main departments and programs. Previous experience in research would be favored although is not a mandate. Two dedicated administrative staff are appointed to run the day-to-day business of the IRB and serve as the liaison between the researcher, the IRB Chair, and members as well as the OSAR staff.

KHCC–IRB functions in accordance with national and international regulations including the Jordan Food and Drug Administration (JFDA), and International Conference on Harmonization (ICH)/Good Clinical Practice (GCP). The Jordanian Clinical Studies Law (JCSL) was provisionally released in 2001, to be later endorsed as a permanent law in 2011 (Al-Omari & Al-Hussaini, 2017). It attempted to regulate the conduct of clinical trials as well as the function of IRBs in Jordan. Accordingly, the IRB membership is approved by the JFDA every 2 years. The JCSL, however, is deficient in many aspects (Ramahi & Silverman, 2009). In addition, there is a total absence of national regulations, which govern and guide the function and ethical determination of the IRB while addressing evolving research issues.

Research throughout the COVID-19 pandemic has been challenging for researchers, institutions, and IRBs. Nonabandonment and emotional support are important considerations for the conduct of clinical research during the pandemic, in particular cancer research (Shuman & Pentz, 2020). Hashem et al. (2020) wrote on obstacles and consideration of clinical trials during the COVID-19 pandemic, including ethical issues such as committee approvals, efficiency, virtual visits, remote monitoring, informed consent, shipping investigational products, and external monitoring and audits. In particular, the COVID-19 pandemic has been challenging for many IRBs. Challenges included running timely meetings, maintaining the quorum, expediting the reviews, especially for COVID-19 studies, and providing an appropriate oversight on studies. The World Health Organization (WHO) guidelines have been released to reinforce that the ethical conduct of trials during the pandemic should continue without compromise to ethics (WHO, 2020).

We aim to share our experience in running an IRB in a limited-resource country setup. Addressing the challenges and adopting a number of operational metrics and activities to support the delivery of an efficient IRB function will be presented. Comparison of 2020 IRB operational metrics, during the COVID-19 pandemic, to 2009–2019 will also be presented.

Methods

After obtaining a nonhuman subject research determination, we reviewed the IRB records, database, and annual reports from 2009, when operational metrics started to be collected, until 2020. Operational metrics and activities included the IRB structure and composition comprising the gender and medical to nonmedical representation, the number of full board meetings and purpose of the meeting (discussing study proposals vs. administrative meetings), the number of reviewed proposals including the type of review (exempt, Supplementary file S1, expedited, Supplementary file S2, and full board, Supplementary file S3) (Supplementary files checklists S1–S3—that are used to define and score each type of review). The turnaround time (TAT), defined as the time from submission of a proposal to the IRB until issuing the determination or approval letter, was calculated. The IRB training activities including those directed toward the IRB members’ continuous professional development (CPD) including courses, seminars, short presentations, and workshops, as well as activities directed toward researchers were reviewed.

A comparison of the various metrics between 2009–2019 and 2020 during the COVID-19 pandemic is presented.

We used descriptive statistics to summarize the findings, including counts and percentages for categorical data, while medians, means, and ranges were used for numerical data. Forest plots were used to show the medians of the TAT for each type of review.

Results

IRB Structure

Members of the IRB cover the major departments and programs at KHCC. Medical members include physicians, pharmacists, and nurses, while nonmedical members including psychologists, laypeople, who are cancer survivors, and a lawyer. There are 11 rosters and for each roster, there is a serving regular and a professional-matching alternate member. Over the last 12 years, the average medical to nonmedical ratio was 5:6, and the male to female ratio was 4:7. However, variations in the representation were seen throughout the years, with underrepresentation of male members in 2014–2018.

IRB Meetings

The average number of full board IRB meetings per year is 16 (range 8–23). Years in which administrative issues were discussed had more meetings. The mean duration of full board meetings was 76 min/meeting (range 43–100 min). The IRB quorum is set at two-thirds of the roster in the presence of the IRB chair or deputy chair. On average, the attendance of full board meetings was 78%, which is higher than the requested quorum.

IRB Reviewed Proposals

Between 2009 and 2020, a total of 1324 research proposals were submitted to the IRB; 1077 exempt (81.3%), 126 expedited (9.5%), and 121 full board (9.2%) proposals. Proposal review assignment for the expedited and full board review proceeds is according to proposal type and discipline, that is, adult oncology, pediatric oncology, psychosocial, and so on, as well as members’ workload. While most of the exempt determinations are made by the IRB Chair, more IRB members undertook expedited reviews to ensure their engagement. Full board reviews are primarily assigned to 2 IRB members, however, all members have full access to all study files and documents on the IRB intraportal domain. The proposals are submitted in the English language. During the review process, the reviewers use checklists that have been developed for each type of review (Supplementary files 1–3). A checklist designated for the informed consent form (ICF), to ensure compliance with the minimum needed data that should be included in the ICF, is also used.

As part of the recognition of the high-standard ethical reviews, the IRB at KHCC acted as the IRB of record in a number of external studies, submitted by non-KHCC affiliated researchers, including international researchers and institutions seeking local ethical approvals before commencing, that addressed several psychosocial and behavioral issues, targeting various population sectors, primarily focusing on refugees. Since 2010, when the first external study was submitted, a total of 19 studies were reviewed and approved.

Turnaround Time

The median TAT from submission to approval/determination per review category is 4.0, days for exempt, 35.0, days for expedited, and 68.0 days for the full board proposals. The mean duration was 9.6 days, 38.6, and 80.0 for the exempt, expedited, and full board proposals, respectively (Supplementary Figures S1–S3, respectively). There has been variation over the years, with a relatively longer time needed in more recent years.

Training and Education

Training of the IRB Members and Staff

To ensure quality ethical reviews, and continuous updates of the members and staff on issues pertaining to research ethics, the IRB conducted a number of educational activities to enhance the skills of the IRB members, KHCC staff, and research community.

The IRB members and/or staff prepare and present short presentations during the full board IRB meetings. The topics are usually chosen to address ethical issues pertaining to the proposals to be discussed. In addition, participating in and attending local, regional, and international courses, conferences, panel discussions, and recreational activities such as movie nights can help deliver important messages related to ethics. Moreover, workshops delivered by esteemed national and international guest speakers tackling emergent ethical issues in research were held. These include “Ethics of Biobanking and the Use of Tissue in Research,” “Ethics of Approving and Using Biosimilars,” “Stem Cells in Therapeutics and Research,” “Genetics and Genomics in Research,” and “Big-Data and Ethics.” Members are enrolled in an online course on “Basics on Research Ethics” to update their knowledge and enhance their skills. This course is also offered to interested personnel from outside the IRB.

Training of Researchers in Basic Research Ethics

Reaching out to researchers, especially newly joining and/or junior researchers, to ensure understanding of, and compliance with research ethics is addressed through conducting a series of training in the “Basics of Research Ethics” that started in 2018. In total, eight sessions were held with 128 participants thus far. Providing on-demand training for the various groups, programs, and departments inside and outside KHCC is also undertaken. This has included training private hospitals’ IRBs, as well as local IRB members in collaboration with the Health Care Accreditation Council (HCAC), a local body that offers accreditation to health institutions, including components related to human subject research.

Comparison of Metrics of 2020 to the Cumulative Metrics of 2009–2019

Twenty meetings were held in 2020. Between January 2020 and March 2020, three in person full board meetings were held. Afterward, 17 virtual meetings were held during the rest of the year, as a result of an emergency lockdown imposed by the Jordanian government due to the COVID-19 pandemic. During this period and until the end of 2020, the IRB managed to maintain a balanced structure and representation with no new hiring or resignations. The average quorum at 2020 was 82%, which is higher than the cumulative quorum of 76% and the average duration of the meetings was 100 min, higher than the 76 min average for full board IRB meetings. There were 205 reviewed proposals, including 165 exempt, 26 expedited and 14 full board ones, with a median TAT of 7.0, 34.0, 72.0 days, respectively. Twenty-one COVID-19 related proposals were submitted during 2020, including five clinical trials and above minimal risk proposals that were discussed in the full-board meetings. Training included holding two in-person activities for the IRB members and researchers before the COVID-19 lockdown as well as seven training sessions for investigators. No training activities were offered by external trainers.

Table 1 summarizes the IRB structure, composition, activities, and other metrics from 2009 to 2020.

Table 1.

Overview of the Operation Metrics of IRB at KHCC 2009–2020.

Variable		2009	2010	2011	2012	2013	2014	2015	2016	2017	2018	2019	2020
Number of proposals submitted	Total	89	96	73	79	71	80	108	97	135	164	127	205
	Approved n (%)	87 (98.0)	87 (96.0)	72 (98.6)	77 (97.5)	65 (92.0)	75 (93.8)	102 (94.0)	93 (96.0)	133 (98.6)	159 (97.0)	124 (97.6)	203 (99.0)
	Abandoned n (%)	1 (1)	3 (3)	1 (1.4)	0	3 (4)	3 (3.8)	2 (2)	2 (2)	1 (0.7)	2 (1.2)	1 (0.8)	1 (0.5)
	Rejected n (%)	1 (1)	1 (1)	0	2 (2.5)	3 (4)	2 (2.5)	4 (4)	2 (2)	1 (0.7)	3 (1.8)	2 (1.6)	1 (0.5)
Median time to approval in working days	Exempt (4.0)	3.0	2.0	2.0	2.0	6.0	3.0	7.0	4.0	4.0	5.0	9.0	7.0
	Expedited (35.0)	33.0	31.0	24.0	22.0	35.5	23.0	45.0	53.0	36.0	45.0	38.0	34.0
	Full board (68.0)	64.5	68.0	66.0	83.5^a	106.0^a	109.0^a	61.0	NA	63.0	70.5	66.0	72.0
Mean time to approval in working days	Exempt (9.6)	6.6	7.9	4.2	8.0	11.0	12.0	15.0	9.0	6.5	9.7	12.0	13.0
	Expedited (38.6)	50.9	32.5	28.0	26.0	45.8	25.0	42.0	54.0	36.5	50.0	38.0	35.0
	Full board (80.0)	65.7	82.6	66.0	88.0	106.0	99.0	63.0	NA	98.0	65.0	66.0	79.0
Resources	Number of administrative staff	1	1	1	1	1	1	1	2	1	2	2	1.5
	Number of IRB roster (M:F)	12 (7:5)	13 (8:5)	10 (6:4)	12 (7:5)	12 (5:7)	11 (2:9)	12 (3:9)	10 (2:8)	10 (2:8)	10 (2:8)	11 (4:7)	11 (4:7)
	Funding (JD)	1500	500	1500	2000	1500	2000	2000	0	2200	3500	4500	1000
Number of meetings		22	23	11	13	8	13	13	14	19	15	18	20
Mean quorum (%)		83	78	82	81	82	71	72	80	71	74	79	82
Mean duration of meetings (minutes)		79	78	74	66	80	43	77	75	72	72	92	100
Number of training sessions for IRB members^b		2	2	2	5	0	1	0	1	4	2	3	2
Number of training/educational sessions for researcher^b		0	1	2	3	1	3	0	1	0	2	6	7

Note. IRB = institutional review board; KHCC = King Hussein Cancer Center; NA = not applicable, no studies were discussed in full board meetings in 2016; JD = Jordanian Dinars; TAT = turnaround time.

There was a false increase in the TAT over these years as the Research Council was established for the independent scientific review of the proposal; however, the entry point for the proposals remained to be the IRB administrator, so the TAT was lumped together. In later years, this was separated and the TAT for the IRB was calculated independently from the Research Council.

Some of the activities overlapped.

Discussions

This is the first study that addresses the operational metrics of an IRB from a low-intermediate income country. To ensure attaining the highest levels of compliance with international regulations, KHCC has worked to obtain international recognition among its clinical services. In addition, it has been awarded full accreditation by the Association of Accreditation for Human Research Protection Programs (AAHRPP) in 2019, a voluntary, peer-driven, and educational accreditation program that enhances the development and update of policies and procedures that help ensure the conduct of ethical research (Abbott & Grady, 2011). The AAHRPP accreditation acknowledges that the accredited organization follows rigorous standards for ethics, quality, and protections for human research. IRB operational metrics can be used to assess the operational efficiency and perceived effectiveness of ethics committees (Adams et al., 2014). These can help to address issues of concern more objectively. Observing trends and deviations in the various metrics can help rectify the causes, and implement changes. Achieving a balance between timeliness and efficiency along with appropriate instructive reviews that oversee the risk to participants without impeding the progress of research is challenging. TAT, as well as educational and training activities are analogous to indicators used to monitor quality in health care disciplines. We adopted some of these indicators to monitor the conduct of the IRB, and to implement interventions when needed.

The minimum number of rosters required by the ICH–GCP is five, which is adopted by the JCSL, our IRB has 11 rosters. This is important to account for the diversity of departments and programs within the center, most of which are active in research. The average membership for national ethics committees in the Eastern Mediterranean Region was 12 with a median of 11 (Abou-Zeid et al., 2009). Interestingly, Ghooi suggested 10–12 members in an IRB to account for its strength by well-representation and failure of losing the quorum (Ghooi, 2014). Amid the busy schedule of staff at the cancer center, commitment to the IRB becomes a hurdle. Although financial compensation for IRB members is an accepted practice, at KHCC only nonaffiliated members are compensated. The chair, deputy chair, and all other members are not compensated for their time at the IRB; an incentive that, if implemented, might encourage recruitment and retention of IRB members. In addition, the chair, deputy chair, and members are not allocated protected time to undertake the assigned tasks and responsibilities, which adds to the challenge of retaining IRB members over the years.

Interestingly, maintaining the gender balance among the IRB members was an iterative challenge. In 2014–2018, there was a noticeable decrease in the number of males on the roster. However, the IRB managed to restore and keep a balanced gender ratio afterward. This contrasts with the international literature, where males predominated in IRBs (Abbott & Grady, 2011). Little is written on the composition of the IRBs in the region, mitigating meaningful comparisons. Al Omari et al. (2021) reported the predominance of males in the IRB at Jordanian Universities. This contrasts with our report where females predominate. Interestingly, Abou-Zeid et al. (2009) did not comment on gender representation in their paper that addressed various issues and challenges pertaining to ethics committees in the East Mediterranean region. This is important to address as representation from both genders ensures patients’ voices and views are denoted, especially with studies discussing gender-pertaining issues.

Two important operational indicators are worth addressing, the TAT and training and educational activities. In the absence of clear international guidelines on the accepted TAT, the median time from reception to the final approval of proposals was used. The median TAT is 4.0 days for exempt, 35.0 days for expedited, and 68.0 days for the full board proposals. TAT remains an important parameter of the effectiveness and efficacy of the IRB (Adams et al., 2014). Delays in reviews and approvals result in delays in the institution of needed therapies, as well as financial implications. Nesom et al. (2019) addressed the operational metrics in a number of the IRBs in the United States. The authors reported no major differences in review time by the institution type, and that efficiency was at large comparable between the various institutions. However, the TAT varied based on the type of protocol reviewed whereby biomedical studies had a longer TAT in comparison to psychosocial research, given the risk of adverse events that accompany these types of studies. Interestingly, our reported median days from submission to approval is less than the 12 days reported (Nesom et al., 2019). Also, the median TAT from the AAHRPP cumulative data is 9.5 days for exempt determination, 18 days for the expedited, and 37 days for the full board reviews and approvals (AAHRPP, 2020). Surprisingly, Varley et al. (2016) reported the TAT among 10 Veteran Affairs hospitals, in which expedited reviews were the shortest in comparison to exempt and full board, with medians of 83, 98, and 116 days, respectively. Adams et al. (2014) reported an average TAT ranging from 77 to 111 days from the initial submission to the final approval for clinical studies discussed at convened meetings. An innovative approach to accelerate the approvals is “real-time IRB” suggested by Spellecy et al. (2018). In this approach, investigators are invited to attend the IRB meetings, so that real-time changes are made immediately on protocols in response to comments made by the committee, an intervention that is claimed to have an overall reduction in time from submission to the IRB to final approval by 40%. Although very attractive, this approach might not be very practical, especially if major changes are needed that might alter the study risk-to-benefit ratio or changes that need a consultation with team members and/or sponsors.

Training and education in the form of CPD, for IRB members, research staff, and researchers, cannot be overemphasized. The need for education and training has been addressed as a requirement by the IRB members (Abbott & Grady, 2011). This is especially needed for the nonmedical as well as the nonaffiliated and layperson representation that can be tailored to address their needs (Anderson, 2006; Sengupta & Lo, 2003). In a study by Sheblaq (2019), the highest-rated barrier to perform research in the Middle East/North Africa region was inadequate training in clinical research implementation. This result can be extrapolated to involve not only researchers, but also the different parties along the process of the conduct of research including IRB members. Hyder et al. (2004) point to a clear lack of needed training of the basic knowledge and skills that hinder appropriate decisions by the local IRBs, causing discrepancies between local and international IRBs reviewing the same international research, threatening to jeopardize the safety of human participants. Abou-Zeid et al. (2009) reported the lack of formal training in ethics in any of the members of 53% of ethics committees, including the lack of training for members in medical ethics in 67%, and lack of ongoing training in medical ethics in 73%. Atallah et al. (2018) also reported inadequate training for IRB members, as only 30 (57.7%) had a diploma or had a training in research ethics, and 41.0% confirmed that they were required to have a training in research ethics. In a recent paper that addressed challenges to IRB members, Jordanian members were less likely to receive formal training than Omani (Al Omari et al., 2021). Also, training for IRB members and researchers was among the main concerns raised by participants from 2 Jordanian universities (Ayoub et al., 2019). IRB members and staff come from various scientific and educational backgrounds, at which research ethics are barely addressed in their respective curricula. Clinical ethics in general and research ethics, in particular, remain an enigma to many and has created an urgent need for improvement. Acknowledging this core requirement, diverse activities targeting the IRB members and staff, the new researchers, and KHCC staff in general, were planned and delivered. Different workshops such as Clinical Investigation Training Program held by the JFDA were delivered. In addition, IRB Manual Training, Research Ethics for Members of Research Ethics Committees, International Research Ethics, Ethics of Biobanking and the Use of Tissue in Research, GCP training, and the Ethics of Using Biosimilars as well as Emerging Issues in Bioethics were held at KHCC. Although the effect was not measured systematically, nonetheless, the feedback received following each of the above-listed activities suggests the importance of educational activities, especially in relation to emerging research areas and controversial topics (personal communication). A bigger challenge is assessing whether and to what extent IRB members’ training and experience affect substantive ethical reviews and the extent to which these translate into enhanced protections of subjects’ rights and welfare. Lidz et al. (2012) clearly showed that while informed consent is reviewed by most IRBs, other core issues including risk minimization, risk/benefit comparison, equitable subject selection, data monitoring to ensure safety, privacy protection, and confidentiality, and protection of vulnerable subjects were not adequately addressed. This clearly calls for a more focused training of the IRB members to address issues pertaining to research ethics.

Another important challenge is that current local regulations do not provide adequate or appropriate guidance for new types of research. This necessitates expansive ethical analysis and training to ensure local norms, mores, and values are promoted so that new opportunities provided through new types of research are not missed. For example, there is a complete lack of guidance on the collection, storage, use, and disposal of human biological samples collected for research purposes, including unforeseen research in the future as in the case of biobanks. In this instance, the IRB consulted with experts abroad and reviewed international guidelines to formulate ethically accepted practices. It also hosted a 2-day workshop to train the IRB members as well as the researchers on the unique ethical issues pertaining to biobanks.

COVID-19 pandemic has challenged existing IRBs, which found themselves under unprecedented pressure. The WHO considered research and development as one of the three strategies to compact the effect of COVID-19 (Jee, 2020). Ethical standards for the conduct of research amid emergencies include the importance of ethical reviews during emergencies (Standard number 4), which should be pursued via the usual IRB/Research Ethics Board/Research Ethics Committee system (WHO, 2020). A call to employ generic advance protocols, which would facilitate rapid adaption and review, templates, and other tools for the ethical review of research, has been put forward. The IRB at KHCC managed to keep all its processes running, virtually.

Seventeen virtual full board meetings were held from March to December 2020. In comparison to in-person meetings, virtual meetings allowed for a higher quorum compared to prior years, thus more members were engaged in the discussion of the studies. Also, the average duration of the meetings was longer than the in-person run meetings. Ultimately, virtual meetings allowed for more topics and proposals to be discussed within the scheduled 2-hour meeting. However, virtual meetings do not allow face-to-face discussion and interaction among the IRB members, a drawback that we have noticed.

Limitations of the Study

The study depends on a retrospective collection of data representing a single IRB. There are some items that are not routinely collected that might add value to better understand the process within the IRB. For example, the time from submission to the initiation of the review process by the IRB is not collected. Also, the TAT calculations are considered from submission to approval. Included in this timeframe is the response to comments by the research team, which vary considerably in their efficiencies. Moreover, how the various metrics reflect on the performance of the IRB members, and how any would enhance the protection of the participant was not addressed.

Conclusion

The IRB plays a crucial role to ensure the ethical conduct of research. Maintaining a balance to protect the participants enrolled in research on one hand, without hindering the researchers in fulfilling their roles in the advancement of science, on the other hand, can be cumbersome. The IRB at KHCC has been able to maintain a balanced, representative, and consistent approach to the ethical review of submitted proposals through embarking on a journey guided by the different key performance quality indicators and operational metrics. The IRB at KHCC managed to stay functional despite reviewing a larger number of studies under unusual circumstances, during the COVID-19 pandemic.

Best Practices

For optimum function, the IRB needs full support from the higher administration ensuring the independence of the committee from any coercion or undue influence, increasing the IRB administrator staff proportionally to the number of reviewed studies, and support the continuing education for the IRB members and staff. Incentives for the affiliated IRB members could also encourage the recruitment of efficient IRB members.

Research Agenda

Further research into the main challenges of the IRBs in countries lacking comprehensive laws and guidelines might help in focusing on common issues pertaining to the research agenda.

Measurement of efficiency, defined as “achieving a desired outcome with a minimum expenditure of time, effort, and resources” (Abbott & Grady, 2011, p. 6) is not included among the collected metrics. This can be the focus of another research project, including the efficiency of the IRB during the COVID-19 pandemic.

Educational Implications

IRBs in countries with limited resources probably face common challenges including the lack of appropriate training for the staff and members. Working in an atmosphere where there is a lack of national guidelines and regulation causes the IRB to heavily rely on international regulations. Investing in educating the IRB members would benefit the researchers as well as the research participants by providing comprehensive, yet consistent, and systematic reviews. COVID-19 has cast a new challenge to the IRBs.

Supplemental Material

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Supplemental material, sj-docx-1-jre-10.1177_15562646211053234 for An Overview of King Hussein Cancer Center Institutional Review Board Over 12 Years (2009–2020), Successes and Challenges, Including Those Imposed by the COVID-19 Pandemic by Linda Kateb, Sawsan El-Jayousi and Maysa Al-Hussaini in Journal of Empirical Research on Human Research Ethics

Supplemental Material

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Supplemental material, sj-docx-2-jre-10.1177_15562646211053234 for An Overview of King Hussein Cancer Center Institutional Review Board Over 12 Years (2009–2020), Successes and Challenges, Including Those Imposed by the COVID-19 Pandemic by Linda Kateb, Sawsan El-Jayousi and Maysa Al-Hussaini in Journal of Empirical Research on Human Research Ethics

Supplemental Material

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Supplemental material, sj-docx-3-jre-10.1177_15562646211053234 for An Overview of King Hussein Cancer Center Institutional Review Board Over 12 Years (2009–2020), Successes and Challenges, Including Those Imposed by the COVID-19 Pandemic by Linda Kateb, Sawsan El-Jayousi and Maysa Al-Hussaini in Journal of Empirical Research on Human Research Ethics

Footnotes

Author Contributions

L.K. contributed to the collection and assembling of the data for this report. S.E.J. contributed to the collection of the various metrics used in preparing this manuscript. M.A.H. contributed to the inception of the idea, literature review, and writing the manuscript.

Declaration of Conflicting Interests

The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Funding

The authors received no financial support for the research, authorship, and/or publication of this article.

ORCID iD

Maysa Al-Hussaini

Supplemental Material

Supplemental material for this article is available online.

Author Biographies

Linda Kateb is a senior IRB coordinator and HRPP office coordinator. Has been working at the IRB in KHCC since 2011. Tasked with the administrative issues of the IRB as well as ensuring proper function of the HRPP. Prepares the Annual Reports of the IRB.

Sawsan Jayousi is an IRB coordinator. Has joined the IRB at KHCC in 2020. She is responsible for the daily activities of the IRB function, including communicating with the IRB members, researchers, and Office of Scientific Affairs and Research.

Maysa Al-Hussaini is an IRB Chair at KHCC since 2009. Responsible for running the IRB office and leads the IRB Committee at the Center.

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