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. Author manuscript; available in PMC: 2024 Mar 8.
Published in final edited form as: J Empir Res Hum Res Ethics. 2019 Jun 6;14(4):372–382. doi: 10.1177/1556264619851351

Knowledge, Attitudes, and Practice Regarding Research Ethics Committees Among Health Care Faculty at Two Public Universities in Jordan

Nehad M Ayoub 1, Abeer M Qandil 1, J Allen McCutchan 2
PMCID: PMC10923338  NIHMSID: NIHMS1880964  PMID: 31169072

Abstract

Human research at Jordanian universities is increasing. This descriptive cross-sectional survey assessed knowledge, attitudes, and practices concerning the procedures and review process of research ethics committees (RECs) among faculty in health sciences in two major Jordanian universities. Most faculty reported having no training in research ethics in their current institutions. Although knowledge of RECs’ roles and functions was adequate, deficiencies were found regarding the advisory and monitoring roles for RECs raised in this survey. Faculty expressed concerns about levels of ethical training for members of RECs and potential conflicts of interest and bias in review process. RECs should provide ethics training for faculty, and future research should examine the functioning of the RECs in Jordan and other Middle Eastern countries.

Keywords: research, ethics, faculty, research ethics committees, knowledge, attitudes, practice, Jordan

Introduction

Clinical and biomedical research involving human subjects has increased in developing countries over several decades (Atallah, Moubarak, El Kassis, & Abboud, 2018; Chenneville et al., 2014). Jordan is an increasingly targeted biomedical research site in the Middle East and North Africa (MENA) region (Ahram, Othman, & Shahrouri, 2013; Shafout & Al Mahrouq, 2014). Many factors contribute to the increase in clinical research in Jordan, including the availability of highly qualified health care professionals, well-established and accredited health care organizations, and other resources. In addition, the country maintains high bioethics standards and a supportive regulatory body for human subject research (Shafout & Al Mahrouq, 2014).

In 2001, the Jordanian government issued the Clinical Research Law that became permanent in 2011 (Ramahi & Silverman, 2009). This law states that all clinical trials in Jordan should adhere to the Declaration of Helsinki and that one of the main duties of all local research ethics committees (RECs) is to ensure that the research team can conduct the studies in accordance with Good Clinical Practice (GCP) guidelines (Ramahi & Silverman, 2009).

The Ministry of Health (MoH) and the Jordan Food and Drug Administration (JFDA) are the highest governing authority of all types of clinical research in Jordan (Shafout & Al Mahrouq, 2014). JFDA protects the rights and safety of human subjects through visits, inspections, and monitoring of clinical sites and institutional review boards (IRBs; Shafout & Al Mahrouq, 2014).

RECs, also called IRBs, are committees of professionals responsible for protecting the rights, safety, and well-being of human subjects in research studies (Pandiya, 2011; Parvizi, Tarity, Conner, & Smith, 2007). Jordan uses local RECs/boards based within individual institutions without a central REC (Shafout & Al Mahrouq, 2014). There are 22 registered and approved RECs/IRBs in Jordan located in hospitals, private, and academic institutions (Al-Omari & Al-Hussaini, 2017; Shafout & Al Mahrouq, 2014). Among these, two institutional RECs/IRBs are located in leading public Jordanian universities: the Jordan University of Science and Technology (JUST) and the University of Jordan (JU). According to Jordanian law, the REC/IRB should consist of at least five members of both genders and must include at least one legal advisor and one member from the local community (Shafout & Al Mahrouq, 2014). Membership is valid for 2 years, renewable (IRB, JUST, & King Abdullah University Hospital, n.d.-b).

Increasing clinical and medical research in academic institutions and hospitals in Jordan has warranted a parallel expansion in the number and function of RECs/IRBs to review and assure ethical research on human participants. In 2006, JUST and its affiliated King Abdulla University Hospital (KAUH) established an IRB. The IRB chair and members are appointed by the JUST president. The IRB manual, a 35-page document, provides a detailed description of the composition, responsibilities, operations, and authorities of the IRB of JUST and KAUH (IRB, JUST, & King Abdullah University Hospital, n.d.-b).

There are currently 19 members of the JUST and KAUH IRB from different scientific backgrounds who review study protocols submitted by health care faculty at JUST and KAUH. All new IRB members are required to attend training sessions and orientation. Further research ethics training workshops and educational seminars are offered to members through the IRB administrative office when needed. The IRB chairman or designee can also invite internal and/or external consultants to provide ethics training to IRB members (IRB, JUST, & King Abdullah University Hospital, n.d.-b). In addition to convened meetings, REC/IRB of JUST provides exempt and expedited reviews of selected research proposals which meet standards and requirements that qualify them for expedited review.

The main responsibilities for the IRB of JUST and KAUH are to evaluate the scientific basis of the study proposals and assure safety and protection of human participants. The JUST IRB has Federal Wide Assurance (FWA) from the U.S. Department of Health and Human Services along with IRBs of the MoH and King Hussein Cancer Center (KHCC; Al-Omari & Al-Hussaini, 2017).

The IRB of JUST is located at the JU Hospital and requires that any study involving human participants be reviewed and approved (Office of Research, 2019). The IRB of JU hospital is accredited by JFDA and renewed every 2 years.

Publications in peer-reviewed journals are the most tangible product of research conducted by scientists in academic research institutions or industry (Edwards & Roy, 2017). Successful publication of research brings attention to scholars and facilitates their career progress. Academic promotion could be difficult without a good publication record (McGrail, Rickard, & Jones, 2006; Rawat & Meena, 2014). At the institutional level, publications may generate more funding for the institute, which has been increasingly used by administrators during recruitment (McGrail et al., 2006; Rawat & Meena, 2014). In addition, academic institutions frequently use the number of publications by scholars as a measure of competence (Rawat & Meena, 2014). Thus, faculties in developing countries face increasing pressure to publish and thereby generate increasing studies involving human subjects requiring REC review (Rawat & Meena, 2014). Thus, RECs must manage an increasing number of studies, but may lack fiscal and information technology (IT) resources, staff and academic personnel, and expertise to do so (Milford, Wassenaar, & Slack, 2006; Sleem, El-Kamary, & Silverman, 2010). Several studies conducted in the developing world, including the Eastern Mediterranean region, showed that RECs are increasing in number, but they often lack the above resources and training (Abou-Zeid, Afzal, & Silverman, 2009; Chenneville et al., 2014; Klitzman, 2012; Lansang & Dennis, 2004; Pandiya, 2011; Parvizi et al., 2007; Silverman, Edwards, Shamoo, & Matar, 2013). Several studies have also demonstrated problems in the functioning of RECs in developing countries (Chenneville et al., 2014; Silverman et al., 2015; Sleem, Abdelhai, et al., 2010). Ethics review systems in Egypt were found to have insufficient training in bioethics, limited resources, and inadequately diverse membership (Marzouk et al., 2014; Sleem, El-Kamary, et al., 2010). Multiple regulatory, economic/fiscal, logistical, and cultural barriers restrict health care research among faculty in the Arab world (Romani et al., 2016). Researchers from Qatar and Lebanon reported negative views and concerns regarding performance of RECs (Makhoul et al., 2014). Thus, RECs affect the advancement of biomedical research in Arab countries. In Jordan, data about the functioning and effectiveness of RECs/IRBs in academic institutions are lacking. Given these limitations of RECs in Arab countries, the knowledge, attitudes, and practices of faculty in health sciences concerning functioning of their RECs could identify deficiencies needing improvement.

Method

This descriptive cross-sectional study utilized a structured questionnaire based on surveys published in previous studies (El-Dessouky et al., 2011; Reddy et al., 2013) with additional items. A list of REC/IRB functions and activities was generated from our review of the REC literature and from REC documents of several institutions (Keith-Spiegel & Tabachnick, 2006; Matar & Silverman, 2013; Schwenzer, 2008). The study was approved by the IRB of JUST (research number 151/2016).

Sample and Data Collection Procedure

Convenience sampling was used to recruit faculty in JUST in Irbid, a northern city, and the JU in the capital, Amman. JUST, one of the leading research universities in the Middle East, was founded in 1986. JUST comprises 12 faculties in medicine, pharmacy, dentistry, nursing, applied medical sciences, engineering, science and arts, agriculture, veterinary medicine, architecture and design, IT, and graduate studies (JUST, n.d.; The World University Rankings, n.d.). JU, founded in 1962, has become a leading Jordanian university in research. It offers bachelor’s degrees in medicine, dentistry, pharmacy, nursing, rehabilitation science, agriculture, and other programs (The University of Jordan, n.d.).

Faculty in health sciences at both universities were approached by a trained research assistant who explained the study purposes and procedures. Faculty who agreed to participate were requested to answer the questionnaire in the presence of the research assistant who could assist them in understanding the questions. Convenience sampling, which was used in this study, is believed to attain a high response rate and is efficient and simple to implement (Jager, Putnick, & Bornstein, 2017). Sampling was intentionally limited to a specific sociodemographic subgroup (i.e., faculty) which should provide a more accurate estimation of differences between universities (Jager et al., 2017).

Data Collection Survey and Variables of the Study

The study questionnaire was developed and administered in English. Face and content validity of the questionnaire were evaluated by five faculty members of Faculties of Pharmacy and Nursing at JUST. The 66 questions assessed four topics: (a) demographics and professional characteristics of participants, their (b) knowledge, (c) attitudes, and (d) practices regarding their institutional RECs.

Demographics and description of each respondent’s professional activities included highest academic qualifications, academic rank, college, number of funded research grants, and current academic activities. Knowledge regarding RECs was evaluated by 12 statements about the roles and activities of RECs. Possible responses are as follows: “True,” “False,” and “I don’t know.” Thereafter, each correct response was scored 1 point and each incorrect and “I don’t know” responses were both scored 0. The total score ranged from 0 to 12 points on knowledge of RECs. An average score of 7 points was considered the cutoff value for an adequate level of knowledge of RECs’ functions and activities.

Attitudes toward RECs were assessed by a 13-item Likert-type attitudinal scale, with 5-point responses ranging from strongly disagree to strongly agree. In the last section, faculty who had submitted grants to their respective RECs were asked to complete the practice assessment questions. Participants responded to 16 questions evaluating their experience of submitting research proposals to RECs with possible responses of “Yes,” “No,” and “Cannot decide.” The reliability coefficients (Cronbach’s α) calculated for attitude and practice items in this study were .61 and .79, respectively, which reflect adequate internal consistency reliability.

Data Analysis

Data analysis was performed using IBM SPSS statistical package (Version 21.0; IBM Corp., Armonk, NY, USA). Descriptive statistics were used to report study variables. Continuous variables are expressed as mean ± standard deviation. Categorical variables are presented as frequency and percentages (n, %). Pearson’s chi-square (χ2) test of independence was used to test associations between categorical variables. Independent samples t test was applied for comparing means between two groups. One-way ANOVA was applied for multiple-group comparisons. All p values were two-sided at alpha value of .05. Differences were considered to be statistically significant at p < .05.

Results

The survey was conducted over a 6-month period from September 2017 to February 2018. Of 160 questionnaires distributed to Jordanian health faculty, 129 (80.6%) of the questionnaires were completed.

Demographics and Professional Characteristics

Demographics and professional characteristics of the respondents, 80 from JUST and 49 form JU, are summarized in Table 1. Their average age was 39 ± 9 years (range, 23–52), and the majority were female (60%). Most (78%) had doctoral degrees and half (51%) were assistant professors (Table 1). Most respondents were recruited from colleges of pharmacy (41%) and medicine (20%). Although two thirds (66%) reported no training received in research ethics, the majority (80%) had conducted research including human subjects. Most faculty engaged in teaching (85%) and scientific research (75%), whereas less than half performed clinical (38%), community services (31%), or administrative activities (29%). Other demographic and professional data are shown in Table 1.

Table 1.

Demographic and Professional Characteristics of Participants (N = 129).

Characteristic n (%)
Age,a years 39.4 ± 9.4 (range, 23–52)
Gender
 Male 50 (40)
 Female 74 (60)
Marital status
 Single 28 (22)
 Married 97 (76)
 Divorced 1 (2)
 Widowed 1 (1)
University
 JUST 80 (62)
 JU 49 (38)
Highest academic qualifications
 BSc 11 (9)
 MSc 17 (13)
 PhD 99 (78)
Academic rank
 Full professor 9 (7)
 Associate professor 33 (26)
 Assistant professor 65 (51)
 Lecturer 21 (16)
College
 Medicine 26 (20)
 Pharmacy 52 (41)
 Dentistry 7 (6)
 Nursing 24 (19)
 Allied health sciences 19 (15)
Grants funded
 None 31 (25)
 External 5 (4)
 Internal 51 (41)
 Both 37 (30)
Received official training in research ethics at your current institution
 Yes 42 (34)
 No 81 (66)
Serving/served on REC on university level
 Yes 55 (43)
 No 72 (57)
Participation in research involving human subjects
 Yes 101 (80)
 No 25 (20)
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Note. JUST = Jordan University of Science and Technology; JU = University of Jordan; REC = research ethics committee.

a

M ± SD.

Knowledge of Health Care Faculty About RECs

Table 2 represents responses of participants regarding their knowledge of the roles and functions of RECs. Nearly all respondents (94%) responded correctly to the fact that all human subject research must be reviewed by RECs. Forty-six faculty (36%) responded incorrectly to the statement that “REC activities are restricted to initial reviewing and/or approval of research projects.” Regarding the reviewing process, less than half of faculty responded correctly to statements describing expedited and exempted reviews by RECs (Table 2). When asked whether “REC decisions to reject a research protocol can be overridden by another committee or local authority,” most participants either responded incorrectly with “True” (24%) or indicated “I don’t know” (32%). Less than half of the participants responded correctly to the false statement that “Investigators may change research protocol before receiving new REC approval.” Two thirds of the faculty (68%) responded correctly to the statement that “REC can revoke its approval of research protocols and halt a research study if they suspect a violation.” Responses of faculty to other items in knowledge assessment are shown in Table 2.

Table 2.

Knowledge of RECs Among Participants (N = 129).

Response
Knowledge statement Answer True, n (%) False, n (%) I don’t know, n (%)
All human subject research conducted must be reviewed by REC Correct 120 (94) 6 (5) 2 (2)
REC activities are restricted to initial reviewing and approval of research projects Incorrect 46 (36) 69 (54) 13 (10)
Full (convened) review is required for studies involving greater than minimal risk to research subjects Correct 100 (78) 12 (9) 16 (13)
Expedited review is suitable to studies implying only minimal risk to research subjects Correct 63 (49) 34 (27) 31 (24)
REC has the right to consider exemption from review for selected studies Correct 61 (48) 26 (21) 39 (31)
REC committees should regularly include community representatives who may be scientists or nonscientists Correct 95 (74) 10 (8) 23 (18)
REC decision to reject a research protocol can be overridden by another committee or local authority Incorrect 31 (24) 55 (43) 41 (32)
Any deviation from approved protocol needs to be reported to institutional REC Correct 112 (88) 5 (4) 10 (8)
Investigators may change research protocol before receiving new REC approval Incorrect 45 (35) 63 (50) 19 (15)
Clinical research protocols involving an intervention must include a written data safety monitoring plan Correct 108 (86) 4 (3) 14 (11)
REC can revoke its approval of research protocols and halt research if suspected a violation Correct 87 (68) 18 (14) 23 (18)
Observational studies requiring data retrieval from medical records, registries, or databases do not require REC review Incorrect 23 (18) 92 (72) 12 (9)
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Note. REC = research ethics committee.

Mean knowledge score was 8.0 ± 2.5 points (range, 0–12), and 78% of respondents had adequate knowledge of RECs’ roles and functions.

Attitudes of Health Care Faculty Toward RECs

Attitudes of respondents toward RECs are summarized in Table 3. The majority of participants agreed that the primary function of RECs is to protect the rights and welfare of human research subjects. Most faculty (66%) were either neutral or agreed with the statement that “Ethical reviews slow the progress of research.” Nearly half of respondents (45%) were neutral or agreed with the false statement that “RECs should not evaluate the scientific basis of research protocols.” More than half (57%) agreed to the false statement that “It is the responsibility of investigators to determine if their research needs revision and/or approval by REC.” Almost two thirds of participants (64%) were neutral or agreed with the statement that “REC is under pressure from sponsors and political powers,” and 44% agreed that “Reviewing procedures by REC may be subject to bias by committee members.” Responses to other attitude items are shown in Table 3.

Table 3.

Attitudes of Participants Toward RECs (N = 129).

Response
Attitude statement Strongly disagree, n (%) Disagree, n (%) Neutral, n (%) Agree, n (%) Strongly agree, n (%)
REC primary function is to protect the rights and welfare of human research subjects 18 (14) 6 (5) 4 (3) 32 (25) 68 (53)
Ethical reviews slow the progress of research 15 (12) 28 (22) 31 (24) 43 (34) 11 (9)
REC may suggest modifications of the protocol 3 (2) 4 (3) 22 (17) 67 (52) 32 (25)
REC should not evaluate the scientific basis of protocols 24 (19) 47 (37) 22 (17) 24 (19) 11 (9)
Ethical review of research is only necessary for clinical trials 37 (30) 68 (54) 10 (8) 7 (6) 3 (2)
Members of REC should receive training in research bioethics 4 (3) 3 (2) 5 (4) 34 (27) 82 (64)
All investigators should have training in research ethics 2 (2) 3 (2) 4 (3) 48 (38) 69 (55)
It is the responsibility of investigators to determine whether their research needs revision and/or approval by REC 11 (9) 29 (23) 13 (10) 43 (34) 29 (23)
Decision to exempt revisions should be made by REC 0 (0.0) 5 (4) 27 (21) 65 (51) 31 (24)
REC is under pressure from sponsors and political powers 15 (12) 30 (24) 42 (34) 35 (28) 3 (2)
Reviewing procedures by REC may be subject to bias by committee members 5 (4) 25 (20) 42 (33) 49 (38) 7 (6)
RECs lack transparency 15 (12) 50 (39) 43 (34) 18 (14) 1 (1)
Unequal treatment of applicants in REC review 15 (12) 33 (26) 51 (40) 24 (19) 4 (3)
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Note. REC = research ethics committee.

Assessment of Practice Among Health Care Faculty Toward RECs

Sixty-six faculty (52%) reported previously submitting research proposals for review by their institutional RECs. Most participants (77%) regarded the submission process as efficient. However, only a small proportion of respondents (29%) indicated that “REC members are knowledgeable about review procedures and research ethics.” More than half (54%) could not decide whether REC members allow personal biases to affect their evaluation of protocols or disclose potential conflicts of interests (57%). More than half of respondents indicated that RECs do not provide formal training in bioethics for new investigators (57%) or monitor progress of research after its initial approval (53%). Further items concerning REC practices are shown in Table 4.

Table 4.

Practice of Submitting Research Proposals to RECs Among Participants (N = 66).

Response
Practice statement Yes, n (%) No, n (%) Cannot decide, n (%)
Submission process is efficient 49 (77) 12 (19) 3 (5)
REC conducts comprehensive review of research protocols 28 (42) 16 (24) 22 (33)
REC members are knowledgeable about review procedures and research ethics 19 (29) 15 (23) 32 (49)
REC gives a complete rationale for any required changes to or disapprovals of protocols 24 (37) 16 (25) 25 (39)
REC is willing to reconsider its earlier decisions upon investigator’s appeal 21 (33) 7 (11) 36 (56)
REC invites investigators to explain their points of view when concerns about research protocols arise 42 (65) 10 (15) 13 (20)
REC members do not allow personal biases to affect their evaluation of protocols 20 (31) 10 (15) 35 (54)
REC discloses conflicts of interests among members whenever it is revealed 16 (25) 12 (19) 37 (57)
REC responds to investigators inquiries in a timely manner 35 (56) 20 (32) 8 (13)
REC review protocols in a timely fashion 38 (59) 20 (31) 7 (11)
REC effectively identifies the need for exempt or nonexempt review systems for submitted research protocols 19 (31) 12 (19) 32 (51)
REC provides formal training in bioethics for new investigators 9 (14) 37 (57) 19 (29)
REC maintains accurate records and data retrieval is efficient 24 (38) 7 (11) 33 (52)
REC provides consultation and opinion during design of research protocols 13 (20) 24 (38) 27 (42)
REC monitors the progress of approved research protocols 14 (22) 34 (53) 16 (25)
REC takes timely action if investigators violate its decisions 18 (29) 14 (22) 31 (49)
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Note. REC = Research Ethics Committee.

Association of Demographic and Professional Characteristics of Health Care Faculty With Knowledge of RECs

Table 5 represents an association analysis for selected demographic and practice characteristics with various items of REC-related knowledge. Academic rank was correlated with knowledge of expedited REC review (p = .003): 44% of full professors, 55% of associate professors, and 58% of assistant professors were able to recognize expedited revisions compared with only 14% of lecturers. Knowledge of exempt revisions varied by the university and college of respondents (p = .012 and p = .009, respectively). Fifty-four percent of JUST faculty responded correctly to the statement “REC has the right to consider exemption from review for selected studies” compared with 39% of faculty of JU. In addition, 13% of JUST faculty responded incorrectly to the aforementioned statement compared with 35% of faculty in JU. Faculty at colleges of allied health sciences, nursing, and pharmacy were aware of exempted revisions at a higher rate than faculty of colleges of medicine and dentistry. Serving on RECs was associated with respondents’ knowledge of the processes of approval (p = .005), rejection (p = .018), and modifications (p < .001) to research protocols.

Table 5.

Association Between Study Variables and Knowledge Items Among Participants (N = 129)

Knowledge statement Gender Academic rank University College Training in research ethics Serving on REC
All human subject research conducted must be reviewed by REC 0.856 0.133 0.293 0.514 0.425 0.442
REC activities are restricted to initial reviewing and approval of research projects 0.668 0.216 0.262 0.092 0.771 0.005 *
Full (convened) review is required for studies involving greater than minimal risk to research subjects 0.058 0.060 0.192 0.031 * 0.174 0.671
Expedited review is suitable to studies implying only minimal risk to research subjects 0.306 0.003 * 0.599 0.069 0.610 0.345
REC has the right to consider exemption from review for selected studies 0.570 0.794 0.012 * 0.009 * 0.361 0.383
REC committees should regularly include community representatives who may be scientists or nonscientists 0.126 0.838 0.949 0.083 0.371 0.258
REC decision to reject a research protocol can be override by other committee or local authority 0.185 0.145 0.158 0.022 * 0.641 0.018 *
Any deviation from approved protocol needs to be reported to institutional REC 0.357 0.673 0.509 0.568 0.312 0.530
Investigators may change research protocol before receiving new REC approval 0.336 0.004 * 0.248 0.027 * 0.493 <0.001 *
Clinical research protocols involving an intervention must include a written data safety monitoring plan 0.751 0.729 0.323 0.180 0.230 0.206
REC can revoke its approval of research protocols and halt research if suspected a violation 0.534 0.194 0.035 * 0.085 0.864 0.266
Observational studies requiring data retrieval from medical records, registries, or databases do not require REC review 0.964 0.300 0.201 0.008 * 0.261 0.080
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Note. Table represents p values generated by chi-square analysis of independence between categorical variables. REC = Research Ethics Committee.

*

p < .05.

Figure 1 represents knowledge scores about RECs among participants according to demographic and professional characteristics. Mean knowledge scores did not differ significantly by our participants’ gender, prior ethics training, or service on RECs (Figure 1a–1c). Knowledge scores differed significantly between respondents according to their academic rank, but not their college (Figure 1d and 1e).

Figure 1.

Figure 1.

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Knowledge of RECs among healthcare faculty based on demographic and professional characteristics. * p < .05

Discussion

We assessed the knowledge, attitudes, and practices of health care faculty toward their institutional RECs in two major Jordanian universities. Most respondents held doctoral degrees, were at least assistant professors, and had conducted research with human participants. Despite the fact that most faculty who participated in this study had not received training in research ethics by their respective RECs, the majority generally had adequate knowledge of REC functions and activities. However, deficiencies that need to be remedied include inadequate knowledge of expected roles and services provided by RECs, negative views about RECs, and concerns regarding research submission and the review process. Almost all of our respondents endorsed the requirement that RECs oversee human research, but many believed that ethics review need not consider scientific validity and scientific merit of proposals and believed that such review slows the rate of progress of research.

Most participants were unable to identify the monitoring role of RECs and assumed that REC functions were restricted to initial approval of research projects. Prior studies have reported concerns and deficiencies in REC review and approval (Rothstein & Phuong, 2007). Thus, the lack of knowledge about this function may reflect inadequate monitoring of studies by these RECs. Most of our participants recognized that local RECs must approve human research projects and that their decisions cannot be overruled by local institutional or other external committees (Breault, 2006; Schwenzer, 2008).

In this study, a majority of respondents lacked adequate understanding of approval procedures applied by RECs. Half of respondents were unaware that RECs require that investigators seek approval for changes to their protocol (Schwenzer, 2008). About one third (32%) of faculty were unaware that RECs can revoke their initial approval and stop research projects (Schwenzer, 2008). We also found inadequate awareness of the concepts of exempted studies and expedited reviews. RECs may unnecessarily send for full committee review research projects that could be reviewed by the REC staff (Conforti, Hess, Ross, Lynn, & Holmboe, 2012). An example of such research projects include research conducted in educational settings (Sullivan, 2011). Education of faculty and REC staff on procedures for approval of minimal risk studies might focus resources on higher risk studies (Conforti et al., 2012).

Attitudes toward RECs were generally positive, with the majority of faculty agreeing that members of RECs and investigators should be trained in bioethics, but some misunderstood the necessity of some level of review of all research with human participants. Nearly half of respondents (45%) were neutral or agreed that it is the responsibility of principal investigators to determine whether their research proposals are subject to ethics review. Despite the positive attitude of faculty toward their institutional RECs, lack of adequate training and education regarding activities and authorities of RECs may hinder effective communication between investigators and RECs.

Some respondents believed that RECs are subject to institutional pressure that can result in biased reviews. RECs are supposed to function independently and in collaboration with other committees of their institutions (Schwenzer, 2008). RECs in low- and middle-income countries may be under pressure to approve research protocols by external sponsors because of financial benefits to their institutions (Bodenheimer, 2000; Coleman & Bouesseau, 2008; Rothstein & Phuong, 2007). In Jordan, most research projects are funded through internal grants provided by local institutions, which may reduce external pressures on RECs. Nevertheless, almost half of academics in this study questioned the neutrality and transparency of RECs. Decisions of RECs are ideally independent of political, institutional, or commercial influences (e.g., pharmaceutical industry) (Kerrison & Pollock, 2005; Laurence, 2006). However, the level of independence of RECs from hospitals, medical schools, government, or pharmaceuticals has been a subject of concern, especially in developing countries (Milford et al., 2006).

A potential reason for questioning transparency of RECs’ review process could be explained by strict confidentiality of proceedings and lack of justifications for decisions made by RECs (Ashcroft & Pfeffer, 2001). Klitzman described much of the IRB work “occurs behind closed doors” (Klitzman, 2011). Minutes are kept private and are not publicly accessible along with all correspondence (Klitzman, 2011). Attempts to disclose proceedings to investigators to a reasonable degree that maintains IRB operations and procedures could enhance transparency and improve perceptions of RECs/IRBs among researchers (Klitzman, 2011).

Conflicts of interest for REC members are another source of bias in ethical review, but policies to regulate conflicts of interest may be insufficient (Rothstein & Phuong, 2007). The IRB of JUST and KAUH provides clear policies for handling conflicts of interest for IRB members who should declare potential financial or other conflicts of interest regarding a particular research proposal, and in such case that member is not allowed to vote on that particular study (IRB, JUST, & King Abdullah University Hospital, n.d.-b). Clearly, most respondents in this study were unsure whether board members actually disclose potential conflicts of interest or personal biases during the review of research proposals despite the availability of clear regulations in this regard.

These concerns could be explained, in part, by the lack of understanding of the regulations governing REC/IRB functions and operations in academic settings from the investigator side. In the same time, RECs/IRBs are requested to take an active role in sharing these regulations with faculty and assure the proper handling of any potential cases of personal bias or conflict of interest during the review process. Concerns regarding the quality of REC/IRB reviews have been described in several studies from developing and developed countries.

Dissatisfaction with the IRB system has been reported by investigators criticizing the review procedure as being dysfunctional and overburdened (Adams et al., 2014; Burman, Reves, Cohn, & Schooley, 2001; Fost & Levine, 2007; Grady, 2015). A systematic review of empirical studies evaluating IRBs in United States revealed multiple concerns among investigators, including inconsistencies, delays, and inefficiencies about review process and procedures. In particular, clinical investigators perceived IRB review process as inefficient, resulting in unnecessary delays in their research. Furthermore, the review identified potential variations in practices and decision making among IRBs, which led investigators to call for less variation and more efficient reviews (Abbott & Grady, 2011). Collectively, issues of transparency, independence, bias, and disclosure of conflicts of interest are critical concerns by faculty that need to be addressed by institutional RECs. Thus, RECs must educate faculty about the review process and regulations to enhance their confidence in the review process.

No widely accepted tool to evaluate the performance of RECs is available (Chenneville et al., 2014; Feldman & Rebholz, 2009; Silverman et al., 2015; Sleem, Abdelhai, et al., 2010). Evaluating the effectiveness of RECs has been conducted through standardized self-assessment tools (Silverman et al., 2015; Sleem, Abdelhai, et al., 2010) and applying special IRB metrics (Adams et al., 2014). Nevertheless, performance evaluation of RECs could be challenging and may vary depending on the perspective of investigators, committee members, or research participants (Feldman & Rebholz, 2009).

In Jordan, little is known about how effectively RECs function and how investigators who use their services perceive them. Thus, assessment of RECs’ performance from the perspective of health care faculty could reveal how researchers evaluate their efficiency and function. Efficiency, which is determined by achieving a desired outcome with a minimum expenditure of time, effort, and resources, is an important aspect of the submission and revision process by RECs (Abbott & Grady, 2011). Although most respondents indicated that the REC review process was efficient, many respondents were unsure about REC procedures and the expertise of REC members. Given the wide scope of human research, RECs should have an appropriately diverse membership with respect to expertise and experience in research methods (Blunt, Savulescu, & Watson, 1998), but the perceptions and/or reality may not meet those standards. Other REC practice deficiencies that our respondents identified were a lack of ethics training for new investigators, unawareness that minimal risk studies were exempt from full REC review, lack of postapproval monitoring of approved research projects, and lack of consulting or advisory roles for investigators from their RECs.

Knowledge, awareness, and attitudes (KAP) regarding RECs and research ethics have been surveyed in health care academics from several low- and middle-income countries. For example, most dental faculty members at two universities in Saudi Arabia and Egypt accepted the role of RECs and endorsed availability of training in research ethics (El-Dessouky et al., 2011). However, like ours, almost half of their faculty viewed REC review as a source of delay in performance of research (El-Dessouky et al., 2011). Similarly, knowledge regarding RECs among dental faculty in India found sufficient knowledge and positive attitudes toward RECs (Reddy et al., 2013). Researchers in Lebanon and Qatar complained of delays, rigid and insensitive requirements, and ineffective communication with researchers by their RECs (Makhoul et al., 2014). Jordanian faculty shared these concerns about performance and objectivity of their RECs. All of these studies are similar to our findings that faculty members are generally knowledgeable about the roles and procedure of RECs, but concerned about their competence, flexibility, and integrity.

We acknowledge that our study has several limitations. Self-reported data and the small sample size may inaccurately reflect actual KAP. Convenience sampling was applied to recruit participants as it provided advantages of expedited data collection from readily available participants. However, a limitation of convenience sampling is selection bias which limits the generalizability of results. However, our study achieved a high response rate (80%) that mitigates this potential bias.

Best Practices

Among Jordanian faculty, we found that knowledge was generally adequate but defective in respect to some roles of RECs, such as monitoring and full versus expedited review based on risk level and potential harm to participants. Moreover, some health care faculty doubted the integrity and competence of their RECs. These findings are relevant because of the current expansion of human research in Jordan and many other developing countries. Better training in ethical and regulatory aspects of research for current or potential investigators could enhance research performance and promote higher ethical standards.

Research Agenda

Future research should objectively assess the current operations of RECs in developing countries to assess the views of REC members and administrators about their limitations and best practices. In addition, clearly identifying barriers facing RECs could improve efficiency of the review process. Future research should also be directed to assess the impact of REC review process on protection of human subjects and advancing medical and clinical research in developing countries.

Educational Implications

Based on the results from this study, RECs should establish training programs for faculty utilizing RECs. Institutional RECs are required to conduct regular educational workshops or seminars to faculty to discuss functions of RECs, objectives, goals, expectations, and outcomes of the review process. Effective communication between faculty and REC members is highly recommended.

Although RECs/IRBs in Jordanian universities do not provide regular training in research ethics to faculty, in 2015, the Research Ethics Program in Jordan was launched as a project led by the University of California San Diego (UCSD) in collaboration with JUST (Research Ethics Program in Jordan, n.d.). The goals of this project are to train and mentor researchers to enhance the research environment in Jordan and eventually the Arab region. The program involves 12 months of graduate-level course work and a practicum. A team of 32 faculty members are involved, including four leading instructors and four advisory experts from the United States, to prepare researchers to carry out research with high ethical standards (Research Ethics Program in Jordan, n.d.). The expertise and awareness engendered by this program should improve the function of Jordanian RECs.

Acknowledgments

The authors thank the participants for their participation in this study.

Funding

The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: Work on this project was supported by grant # 5R25TW010026-02 from the Fogarty International Center of the U.S. National Institutes of Health on behalf of the Research Ethics Program in Jordan.

Biographies

Nehad M. Ayoub, PhD, is an associate professor in the Department of Clinical Pharmacy at Jordan University of Science and Technology (JUST). Her research interests include cancer research and ethics. She contributed to the conception of the study, statistical analysis, and writing the article.

Abeer M. Qandil, PhD, is an assistant professor in the Department of Community and Mental Health Nursing, Faculty of Nursing, JUST. Her research interests include community health nursing, health care policies and quality, and health promotion. She contributed to the conception of the study and statistical analysis.

J. Allen McCutchan, MD, MSc, is a professor emeritus of medicine at the University of California, San Diego, where he chaired the institutional review board for 10 years and currently teaches courses in study design and in ethics and regulation of human research to graduate students in a master’s program in clinical research methods. He provided advice on interpretation of the study results and contributed to writing the article.

Footnotes

Declaration of Conflicting Interests

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

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