Research ethics education needs assessment in Serbian medical researchers

ABSTRACT

The lack of formal education in research ethics is a significant issue for the ethical conduct of research in Serbia. We conducted a cross-sectional survey on a sample of researchers and ethics committee members in Serbia to evaluate their self-assessed competence and educational needs in research ethics. Results indicated that previous ethics education had a significant effect on respondents’ perception of their own competence in addressing issues like informed consent, authorship, and publishing. Respondents expressed a high motivation for further research ethics education. Moreover, the study revealed that researchers with different specializations and different research experience have different educational needs.

KEYWORDS:

• Research ethics
• ethics competence
• education needs
• curriculum development
• ethical review

INTRODUCTION

During the past several decades, the ethical conduct of research has become a pressing concern for scientists, funding agencies, politicians, and society as a whole (Shamoo & Resnik, 2015). Cases of scientific misconduct covered by the press and increasing interdependence of scientific institutions, industry, and business may jeopardize societal trust in science and scientists. These developments may also give rise to conspiracy theories related to clinical and public health recommendations (Goldenberg, 2023). Today we see distrust reflected in responses to pandemic safety measures, vaccinations, genetic testing, and climate change, among others. To address this concern, scientific research oversight agencies have focused increasingly on educating investigators and those charged with institutional research oversight, namely, members of research ethics committees (REC) or institutional review boards (IRBs) (Antes et al., 2009). Some funding agencies (e.g. National Institutes of Health) now require ethics training for all scientists applying for funding (Dalton, 2000). Biomedical science is an object of particular scrutiny, given its potential direct impact on health and the frequent involvement of human participants.

For these reasons, ethical review of research protocols has become a widely accepted requirement for initiating human and animal research. To adequately perform research review, however, members of RECs need highly developed understanding of the critical issues in the ethical conduct of research, and competencies in assessing studies involving humans or animals in particular. Yet, in many countries, one of the main obstacles to the RECs’ good performance is lack of training in research ethics (Tusino & Furfaro, 2022). Although each health institution in Serbia is mandated to establish a REC, members are not obligated to receive formal research ethics education (Republic of Serbia, 2019). Even though ethics committee members need deep understanding of ethical issues in clinical research, few reviewers have formal research ethics training. This lack of formal research ethics education is a significant limitation on ethical review in Serbia and other low- and middle-income countries (LMICs) (Abass, 2017). The need for educated REC members becomes especially important in the contemporary research context, particularly with rapidly developing technologies involving innovative study designs, biobanks, immunotherapies, artificial intelligence studies, genomics, “big data” and the like.

Some research ethics education is provided to Serbian biomedical researchers as continuing medical education, as courses within graduate training and as elective clinical research short courses. The training is not uniform, and the level and scope of courses can be minimal. At the same time, evidence suggests that formal ethics education for health care professionals can improve their confidence in addressing ethical problems (Sulmasy et al., 1993). Furthermore, competence in ethics is being recognized as a valuable element in medical education (Carrese et al., 2015; Savulescu et al., 1999). Ethics competence, consisting of knowledge, skills, and attitudes necessary for resolving ethical dilemmas, is typically considered part of professional competence (Robichaux, 2016) because it enables healthcare professionals to make complex decisions and justify them (Koskenvuori et al., 2019). In this way, ethics training helps to protect patient rights and promote quality care. It also assuages moral distress by providing clinicians and researchers with tools for navigating the moral dilemmas that they inevitably encounter in their professional activities (Rushton et al., 2016).

Recently in Serbia, several initiatives to establish formal research ethics training programs were launched. One such initiative is the NIH/Fogarty International Center project to establish a Master’s Program in Research Ethics at the Faculty of Medicine of the University of Belgrade. As the faculty for that program worked on developing its curriculum, we recognized the importance of learning about the needs of our potential students. We therefore undertook a study to assess the educational needs of Serbian biomedical researchers to inform shaping the curriculum. We also used the opportunity to identify novel research ethics issues that arise in the context of research in Serbia. We designed a study with a sample of Serbian biomedical researchers and REC members to elicit information about their previous education in research ethics, their self-assessed competence in research ethics, the issues that they wanted to learn more, and their motivation and preferences for research ethics education.

MATERIALS AND METHODS

Study design and sampling

Cross-sectional research was conducted from February 14 to March 25, 2022.

Physician-researchers employed as either full-time or part-time in public healthcare institutions in three Serbian cities, Belgrade, Kragujevac, and Novi Sad, were recruited via e-mail using institutional mailing lists. The research was conducted in Serbian, and we used the Survey Monkey platform to disseminate the online questionnaire, collect the data, and save the responses in a database.

Physician-researchers from all specialty areas, departments, and levels of experience were eligible to participate. The introductory section of the questionnaire provided participants with a brief description of the study and explained that all responses would be anonymous and treated as confidential. The participants were also informed that their participation was voluntary and that they had the right to skip any questions they chose not to answer and to withdraw from the study at any point.

Instruments

The original comprehensive questionnaire instrument developed for the purpose of this study was based on a qualitative study aiming to identify the most frequent and relevant ethical issues arising in the context of research in Serbia and to explore Serbian medical researchers’ and ethics committees’ perspectives on ethical dilemmas. The qualitative study included six interviews with REC members and three focus groups with clinical researchers. Categories of ethical dilemmas obtained by qualitative content analysis were the basis for the key constructs in this survey.

The instrument included the following sections:

Research Ethics Competence-General Self-assessment (REC-GS) is a short questionnaire measuring general confidence in the application of research ethics knowledge. It consists of five, 5-point Likert scale items (ranging from 1 “strongly disagree” to 5 “strongly agree”). The principal component analysis revealed one component accounting for 59% of the variance, with all item loadings higher than 0.60. The Cronbach’s alpha for the five items was 0.82. The total score was calculated by summing the responses and dividing the sum with the number of items (five). The total score ranged from 1 to 5, with higher scores denoting higher self-assessed general research ethics competence.

Research Ethics Competence-Specific Domains Self-assessment (REC-SDS) is a questionnaire measuring confidence regarding satisfactory application of the research ethics knowledge within specific domains. It consists of twelve, 5-point Likert scale items (ranging from 1 “strongly disagree” to 5 “strongly agree”), asking respondents to determine how confident they feel in relying on their theoretical knowledge of research ethics when solving the presented ethical problems. The Image Factoring analysis with Oblimin rotation revealed two factors accounting for 67% of the variance. The Cronbach’s alpha for the twelve items was 0.92. The total score was calculated by summing up the responses and dividing the sum with the number of items (twelve). The total score ranged from 1 to 5, with higher scores denoting higher self-assessed domain-specific research ethics competence.

Research Ethics Learning Motivation Scale (RELMS) is a short questionnaire measuring motivation for future education in research ethics. It consists of six, 5-point Likert scale items (ranging from 1 “strongly disagree” to 5 “strongly agree”). The principal component analysis revealed one component accounting for 63% of the variance, and Cronbach’s alpha was 0.87. The total score was calculated by summing up the responses to all items. For the purpose of calculating the total score, the responses on item 6 were reversely coded.

Ethical Issues Frequency Scale (EIFS) is a scale measuring the prevalence of specific ethical issues in previously performed research. It consists of twelve, 5-point Likert scale items (ranging from 1 “never” to 5 “always”) considering the ethical issues that are common for research practise. The principal component analysis with Oblimin rotation revealed two factors accounting for 69% of the variance. The Cronbach’s alpha for the twelve items was 0.94.

A check-list with research ethics topics was used to assess whether the respondents felt the need for further research ethics education. It consisted of a 12-item list of ethical issues. Participants were asked to indicate the topics for additional education.

Previous research experience was assessed by a single item measure, asking participants to provide the number of studies in which they had been actively involved, followed up by a question asking to mark the role they occupied in the studies, with four options provided (1) principal investigator, 2) research coordinator, 3) research associate, and 4) other (to add)

Prior experience in research ethics review and oversight was evaluated using indicators such as: 1) service on IRB measured by the question “Have you ever served as a member of an IRB?” with the binary (Yes/No) response

Previous research ethics education was assessed by the question “Have you had any education in research ethics?” with the binary (Yes/No) response, and the follow-up question for those who answered “Yes:” “What was the duration of the education,” with three possible options: 1) short course, 2) one semester, and 3) several semesters

Socio-demographic characteristic included six items: gender, age, education level, work status, work place, and specialty.

Statistical analysis

Descriptive statistics were used to detail the sample characteristics and to summarize the variables. Internal consistency of the scale scores was evaluated with Cronbach’s alpha. To examine whether the prior education in research ethics had significant effects on general self-assessed competence and self-assessed competence within specific domains, a multivariate analysis of variance (MANOVA) with age as a covariate was conducted. In addition, a multivariate analysis of variance (MANOVA) was performed utilizing individual items of the REC-SDS as dependent variables, with prior education as independent. Bonferroni correction was used to adjust for multiple tests, and p < .025, namely p˂0.004 was considered statistically significant. To explore whether the frequency of ethical issues encountered in research practice was related to a medical specialty, analysis of variance (ANOVA) was conducted. To establish determinants of motivation to participate in research ethics education in the future, linear regressions were employed. In order to determine whether preferences for education in specific domains depend on certain socio-demographic variables and previous scientific experience, we conducted a series of bi-logistic regression analyses. All analyses were performed in Statistical Package for Social Sciences (SPSS) for Windows, version 25 (IBM Corp., Armonk, NY).

Ethical approval

On January 1, 2021, the Program for the Protection of Human Subjects (PPHS) office issued its determination that our study is exempt from human research as defined by Department of Health and Human Services (DHHS) regulations 45 CFR 46.101(b).

RESULTS

Socio-demographic characteristics

A total of 154 respondents, aged 24 to 64, participated in the research: 38.3% males and 61.7% females. All participants had earned an M.D (completed studies of medicine), more than a half of the participants (57.8%) had completed Doctoral studies, and 16.2% held Master’s degrees. The majority (68.8%) had clinical specialization (internal medicine, pediatrics, psychiatry, neurology, surgery, anesthesiology, gynecology), 20.1% had non-clinical specialization (forensic medicine, social medicine, epidemiology, hygiene, occupational medicine, basic science) and 11% were general practitioners. Almost half of them (48.1%) had previously taken a course in research ethics, but only 21.5% attended at least a one-semester course, while 26.6% attended a short course. A quarter of the respondents (25.3%) served as REC members at some point (Table 1).

Table 1. Socio-demographic characteristics of participants.

Socio-demographic characteristics	n	%
Sex
Male	59	38.3
Female	95	61.7
Level of education
M.D. (completed studies of medicine)	40	26.9
Master	25	16.2
Ph.D.	89	57.8
Specialization
Clinical	106	68.8
Non-clinical	31	20.1
General practitioner	17	11.0
Type of specialization
Internal medicine	45	29.2
Pediatrics	14	9.1
Physiatry	12	7.8
Neurology	9	5.8
Surgery	16	10.4
Anesthesiology	6	3.9
Gynecology	4	2.6
Forensic medicine, pathology	2	1.3
Institutional (social medicine, epidemiology, hygiene, occupational medicine)	21	13.6
Basic science (biochemistry, microbiology, immunology, pharmacology)	8	5.2
General practitioner/resident	17	11.0
Previous education of research ethics
Yes Short course One-semester Several semesters	74 41 30 3	48.1 26.6 19.5 2
No	80	51.9
Member of Ethical Board/Committee
Yes	39	25.3
No	115	74.7

Self-assessed research ethics competence

Biomedical researchers in our sample reported a higher level of self-assessed general competence to deal with research ethics issues in their research activities (M = 3.97 ± 0.67) as compared to self-assessed domain-specific research ethics competence (M = 3.76 ± 0.77). Both average total scores fell in the third quartile of the score range, which could be interpreted as moderately high self-assessed general and domain-specific research ethics competence. Domains in which our respondents felt most competent are responsible conduct of research (authorship and publishing (M = 4.12 ± 0.92), informed consent (M = 4.11 ± 0.91) and confidentiality (M = 4.10 ± 0.98)). They felt least competent to deal with issues of biobanking (M = 3.08 ± 1.25), international research (M = 3.47 ± 1.10), and commercial research (M = 3.55 ± 1.07).

After controlling for age, prior education did have a statistically significant positive effect on the participants’ both self-assessment of general competences (F (2, 148) = 5.655, p < .025, partial η2 = 0.07), and the self-rated competence on specific research ethics issues (F (2, 148) = 8,444, p < .001, partial η2 = 0.07) (Table 2). After controlling for age, previous research ethics education did have a statistically significant effect on respondents’ perception of their own competence to resolve dilemmas related to informed consent, vulnerable groups, biobanking, using placebo, and responsible conduct of research (scientific misconduct, authorship, and publishing, conflict of interest) (Table 3).

Table 2. MANOVA: the effect of previous education in research ethics on the self-assessment of general competences and self-assessment of domain specific competences self-rating after controlling for age.

	Self-assessment of general competences			Self-assessment of domain specific competences
	F (2, 148)	p value	η^2	F (2, 148)	p value	η^2
Prior education	5.655	<0.025	0.07	8.444	<0.01	0.07

Table 3. MANOVA: the effect of previous education in research ethics on the self-rating perception of the specific competences after controlling for age.

Specific domains of ethical issues	F (12, 128)	p value	η^2
Eliciting informed consent	14.621	<0.001	0.08
Research involving the participation of vulnerable groups	5.996 9.527	<0.004	0.09
Research conducted on biological material stored in biobanks	7.085	<0.01	0.09
Commercial research	1.831	0.178	0.01
The process of recruiting participants	2.993	0.086	0.02
Justice	2.139	0.146	<0.01
Use of placebos	8.051	<0.01	0.04
Scientific misconduct	4.130	0.044	0.02
Authorship and publication	10.797	<0.01	0.06
Conflict of interest	5.947	<0.025	0.03
Confidentiality	1.465	0.221	<0.01
International research	0.017	0.897	<0.01

Motivation to pursue research ethics education

Overall, the respondents showed a high level of motivation to participate in further research ethics education (Mean = 24.19, SD = 4.92). A high percentage of physicians expressed an intrinsic motivation for studying topics in the field: 61.1% of the respondents indicated that their reasons for participating in (further) research ethics training were to expand upon their knowledge about already familiar topics, 81.2% indicated that it would fulfill their need to constantly improve professionally, and 63% specified that they would find reading the literature and discussing the topics interesting and challenging. The respondents also showed a high degree of extrinsic motivation: 64.3% reported that they would attend research ethics classes because doing so would enable them to participate in the projects requiring knowledge of research ethics. In addition, 72.1% indicated they would like to acquire additional knowledge in research ethics because that could enable them to do a better job in preparing research proposals for ethics review. Only 10.4% of participants stated they would never take additional education in research ethics because it would be useless (Table 4).

Table 4. Motivation to attend research ethic education, n (%).

	Responses on the scale
Statements	1 (Strongly disagree)	2	3	4	5 (Strongly agree)
I would like to take a course in research ethics because that way it would broaden my knowledge oftopics I find interesting.	3 (1.9)	12 (7.8)	45 (29.2)	32 (20.8)	62 (40.3)
I would like to acquire new knowledge of research ethics because it would fulfill my need to constantly improve professionally.	1 (0.6)	6 (3.9)	22 (14.3)	48 (31.2)	77 (50.0)
I would enroll in a course in research ethics because I find reading such literature and discussing such topics interesting and challenging.	3 (1.9)	17 (11.0)	37 (24.0)	41 (26.6)	56 (36.4)
I would take classes in research ethics because it would allow me to participate in projects that require that kind of knowledge.	4 (2.6)	14 (9.1)	37 (24.0)	39 (25.3)	60 (39.0)
I would like to acquire additional knowledge of research ethics because it would enable me to better prepare research proposals for ethicalreview.	1 (0.6)	11 (7.1)	31 (20.1)	38 (24.7)	73 (47.4)
I would never enroll in additional education in research ethics because I do not think I would benefit from it.	90 (58.4)	28 (18.2)	20 (13.0)	8 (5.2)	8 (5.2)

Linear regression revealed that age was the only significant predictor of the motivation to enter the research ethics course, with younger respondents’ being more motivated to participate in such education than older respondents (Table 5).

Table 5. Predictors of the participants’ motivation to enter the research ethics course: linear regression.

Predictors	B (SE)	β	p value
Previous education	−0.115 (0.797)	−0.012	0.886
Member of an IRB	−0.501 (0.915)	−0.044	0.584
Age	−0,093 (0.038)	−0.197	<0.05
Education level (Masters)	0.075 (1.246)	0.006	0.952
Education level (Ph.D.)	−1.631 (0.930)	−0.164	0.082
Participation in research	−0.051 (0.041)	−0.102	0.210

The frequency of research ethics issues

Research ethics issues most frequently encountered by our respondents are related to responsible conduct of research (authorship and publishing (49%)), informed consent (35.7%), and recruitment of participants (34.4%). The least frequently encountered issues are related to biobanking (20.1%) and justice (20.7%) (Table 6).

Table 6. The frequency of encountering ethical issues, n (%).

Ethical issues	Never	Rare	Sometimes	Often	Always
Eliciting informed consent	18 (11.7)	41 (26.6)	40 (26.0)	38 (24.7)	17 (11.0)
Research involving the participation of vulnerable groups	26 (16.9)	40 (26.0)	40 (26.0)	31 (20.1)	17 (11.0)
Research conducted on biological material stored in biobanks	58 (37.7)	31 (20.0)	34 (22.1)	16 (10.4)	15 (9.7)
Commercial research	36 (23.4)	41 (26.6)	41 (26.6)	23 (14.9)	13 (8.4)
The process of recruiting participants	19 (12.3)	33 (21.4)	49 (31.8)	39 (25.3)	14 (9.1)
Justice	31 (20.4)	38 (25.0)	51 (33.6)	21 (33.6)	11 (7.2)
Use of placebos	35 (22.7)	42 (27.3)	38 (24.7)	23 (14.9)	16 (10.4)
Scientific misconduct	29 (18.8)	30 (19.5)	49 (31.8)	23 (14.9)	23 (14.9)
Authorship and publication	21 (13.6)	28 (18.2)	42 (27.3)	35 (22.7)	28 (18.2)
Conflict of interest	35 (22.7)	31 (20.1)	45 (29.2)	28 (18.2)	15 (9.7)
Confidentiality	39 (25.3)	33 (21.4)	38 (24.7)	28 (18.2)	16 (10.4)
International research	38 (24.7)	38 (24.7)	42 (27.3)	23 (14.9)	13 (8.4)

Analysis of variance showed that there were significant differences in the frequency of some research ethics problems among respondents by specialty (Table 7). Post hoc tests revealed that respondents with a clinical specialization reported encountering significantly more problems related to informed consent compared to general physicians (F = 3.116, p < .05). Respondents with clinical specialization also reported facing significantly more research ethics issues related to the use of placebos in research as compared to respondents with non-clinical specialization (F = 4.399, p < .05). The frequency of other ethical issues encountered in research practice did not differ among respondents with different types of specialties.

Table 7. The effects of the type of specialization on encountering different ethical problems: ANOVA.

Ethical issues	Clinical	Non-clinical	General practitioner/Resident	F	p value
Eliciting informed consent*	3.05	3.06	2.29	3.116	<0.05
Research involving the participation of vulnerable groups	2.96	2.61	2.35	2.346	0.099
Research conducted on biological material stored in biobanks	2.40	2.29	2.12	0.347	0.707
Commercial research	2.70	2.35	2.29	1.463	0.235
The process of recruiting participants	3.06	2.84	2.71	0.942	0.392
Justice	2.69	2.58	2.29	0.877	0.418
Use of placebos**	2.83	2.19	2.18	4.399	<0.05
Scientific misconduct	2.96	2.68	2.71	0.738	0.480
Authorship and publication	3.10	3.19	3.24	0.112	0.894
Conflict of interest	2.73	2.71	2.71	0.003	0.997
Confidentiality	2.74	2.65	2.29	0.832	0.437
International research	2.65	2.52	2.24	0.861	0.425

*Post-hoc test demonstrated that respondents with clinical specialization reported encountering significantly more ethical problems related to informed consent than general practitioners/residents (F = 3.116, p < .05).

**Post-hoc test demonstrated that respondents with clinical specialization reported facing significantly more research ethics issues related to the use of placebos in research than respondents with non-clinical specialization (F = 4.399, p < .05).

Preferences for topics within research ethics education

Nearly half of the respondents stated that they would like additional education in ethics issues in research involving vulnerable populations (45.5%), externally sponsored research, (44.2%) international research (41.6%), and recruitment of participants (39%). Approximately one-third of the participants expressed a desire for education in topics, such as informed consent (33.8%), biobanking (35.1%), justice (31.2%), and placebo (37%). Somewhat more than a quarter of respondents (27.3%) expressed interest in the subject of confidentiality. Regarding topics related to responsible conduct of research, half of the respondents (50%) expressed interest in ethical questions related to publication and authorship issues, while somewhat smaller proportions preferred additional education related to scientific misconduct (39%) and conflict of interest (33.1%).

In order to determine whether specific preferences were related to socio-demographic variables (age, specialization), previous research experience (participation in a number of research studies), and prior experience in the research ethics field (service on a REC, previous research ethics education), a series of bi-logistic regression analyses were conducted (Tables 8 and 9). We found that none of these variables significantly affected interest in research ethics education regarding informed consent, vulnerable groups, biobanking, commercial research, recruitment of participant, justice, and responsible conduct of research (scientific misconduct, authorship, and conflict of interest). Still, there were different preferences for the topics such as placebo and confidentiality, depending on the type of specialty (clinical specialization vs. non-clinical specialization vs. general physicians). General physicians were 70% less likely to be interested in education concerning placebo (OR = 0.31, p < .05) and had almost 3 times higher chance of being interested in education concerning confidentiality (OR = 2.89, p < .05), as compared to those with clinical specialization. In addition, the respondents who participated in RECs were 70% less likely to be interested in education concerning international research (OR = 0.27, p < .05).

Table 8. The associations between certain characteristics of participants and their preferences for the future education: bi-logistic regression analysis.

	Eliciting informed consent	Research involving the participation of vulnerable groups	Research on biological material stored in biobanks	Commercial research	The process of recruiting participants	Justice
Predictors	OR (95% CI)	OR (95% CI)	OR (95% CI)	OR (95% CI)	OR (95% CI)	OR (95% CI)
Age	0.99 (0.97–1.03)	0.98 (0.95–1.02)	1.01 (0.97–1.04)	0.99 (0.96–1.02)	0.98 (0.95–1.02)	0.99 (0.96–1.02)
Specialization
Clinical	1.00	1.00	1.00	1.00	1.00	1.00
Non-clinical	1.82 (0.80–4.13)	0.58 (0.26–1.29)	0.78 (0.34–1.79)	1.36 (0.60–3.08)	0.76 (0.34–1.72)	0.86 (0.37–1.99)
General practitioner/Resident	0.92 (0.30–2.83)	1.91 (0.63–5.81)	0.70 (0.25–2.01)	1.23 (0.44–3.47)	1.51 (0.50–6.61)	2.20 (0.59–8.18)
Participation in research (continuous)	0.98 (0.94–1.02)	1.00 (0.97–1.03)	0.99 (0.95–1.02)	0.96 (0.92–1.01)	0.94 (0.90–0.99)*	1.01 (0.98–1.05)
Member of an IRB
No	1.00	1.00	1.00	1.00	1.00	1.00
Yes	1.20 (0.55–2.62)	0.59 (0.28–1.25)	0.61 (0.29–1.29)	0.63 (0.30–1.34)	1.61 (0.74–3.50)	0.98 (0.44–2.14)
Previous education on research ethics
No	1.00	1.00	1.00	1.00	1.00	1.00
Yes	1.60 (0.81–3.14)	1.19 (0.63–2.24)	0.99 (0.51–1.93)	1.48 (0.78–2.80)	1.52 (0.79–2.93)	1.14 (0.57–2.26)

Table 9. The associations between certain characteristics of participants and their preferences for the future education: bi-logistic regression analysis – continuing.

	Use of placebos	Scientific misconduct	Authorship and publication	Conflict of interest	Confidentiality	International research
Predictors	OR (95% CI)	OR (95% CI)	OR (95% CI)	OR (95% CI)	OR (95% CI)	OR (95% CI)
Age	1.02 (0.99–1.05)	0.98 (0.94–1.01)	0.98 (0.95–1.01)	0.98 (0.95–1.02)	1.01 (0.98–1.05)	0.98 (0.95.1,02)
Specialization
Clinical	1.00	1.00	1.00	1.00	1.00	1.00
Non-clinical	0.31 (0.12–0.83)*	1.10 (0.48–2.54)	0.79 (0.36–1.77)	0.78 (0.34–1.79)	2.88 (1.26–6.62)*	1.14 (0.51–2.58)
General practitioner/Resident	0.54 (0.18–1.65)	0.54 (0.19–1.51)	1.08 (0.39–3.02)	1.60 (0.49–5.27)	0.19 (0.02–1.52)	2.26 (0.80–6.42)
Participation in research (continuous)	1.01 (0.97–1.04)	0.99 (0.96–1.03)	0.99 (0.95–1.02)	1.01 (0.98–1.04)	0.99 (0.96–1.04)	0.99 (0.96–1.03)
Member of Ethical Committee
No	1.00	1.00	1.00	1.00	1.00	1.00
Yes	0.80 (0.38–1.68)	0.62 (0.29–1.35)	1.41 (0.68–2.93)	0.74 (0.33–1.63)	1.34 (0.58–3.13)	0.27 (0.11–0.64)*
Previous education on research ethics
No	1.00	1.00	1.00	1.00	1.00	1.00
Yes	1.31 (0.68–2.52)	1.70 (0.88–3.29)	1.23 (0.65–2.32)	1.34 (0.68–2.64)	1.17 (0.57–2.38)	0.88 (0.46–1.66)

^*p < .05.

DISCUSSION

This study provides insights into the research ethics education experiences and the educational needs of biomedical researchers in Serbia. As evidenced by studies of several other Fogarty research ethics education programs conducted in countries across Eastern Europe, Central Asia, Africa, the Middle East, and Latin America, one of the main challenges identified in designing curricula was to make it relevant to the local needs and culture of trainees (Matar et al., 2014). Several findings of this study are noteworthy, and they have implications for the curriculum development of the Master’s program.

This study demonstrates that nearly half of Serbian biomedical researchers had some kind of research ethics education during their professional life, but only a fifth attended an education lasting one semester or longer. Respondents with prior research ethics education assessed their general research ethics competence as higher, and felt more competent to deal with issues of informed consent, vulnerable groups, biobanking, using placebo, and responsible conduct of research (scientific misconduct, authorship and publishing issues, conflict of interest), than respondents with no prior research ethics education. High confidence in one’s research ethics competence does not necessarily imply objective knowledge or skills. A study of REC members’ knowledge in Croatia showed that, although the majority of REC members were highly confident in their knowledge and competency, the level of actual knowledge was less than satisfactory. Their knowledge, however, was significantly improved after an interventional course (Borovečki et al., 2006). These findings imply a need for a more systematic approach to research ethics education, with strictly defined objectives and content, based on the reported needs of Serbian researchers.

Our respondents felt most competent in dealing with issues of responsible conduct of research (authorship and publishing), informed consent, and confidentiality, and least secure in resolving dilemmas related to biobanking, international, and commercial research. Similar findings were observed in a study of the perceptions and experiences of Bolivian health researchers. They felt most knowledgeable in research ethics related to informed consent, while they had the least knowledge in international research ethics (Sullivan et al., 2015). These findings are relevant given that most of clinical studies conducted in Serbia are international commercial studies sponsored by multinational pharmaceutical companies and funding institutions from high income countries. There is an increasing trend of conducting clinical studies in Eastern-European countries (Bartoszkiewicz et al., 2022; Filipovic, 2021). Several reasons explain this phenomenon. LMICs in Eastern Europe have a large pool of patients who are treatment-naïve to the newest therapies. More than 90% of the clinical studies being conducted in Serbia involve innovative therapies. Since participation in clinical studies is often the only way for many patients to access new treatments not covered by insurance, they are eager to take part in these studies (Rankovic & Mijatovic, 2016). In addition, an increasing number of studies conducted in Serbia are based on stored biospecimens (European Commission, n.d.). The development of legislation regulating this field in detail is still ongoing. In addition, public awareness on data and biospecimen protection is still quite low, thus making research opportunities less restricted than they might be elsewhere.

Our respondents were highly motivated to pursue education in research ethics, expressing high levels of both intrinsic and extrinsic motivation. Younger researchers are more motivated to engage in research ethics education. High motivation for education in research ethics indicates a good chance for successful recruitment to our research ethics Master’s program.

The ethical dilemmas most frequently encountered by our respondents were related to responsible conduct of research (authorship and publishing), informed consent, and recruitment of participants. Clinical researchers often encountered problems with informed consent and placebo whereas researchers with non-clinical specialization and general physicians rarely did. This finding is not surprising given that clinical researchers are typically involved in research with human participants, and therefore face dilemmas related to informed consent. Ethical issues related to use of placebo are also more prominent in clinical studies. This finding is in line with the results of a national survey of United States internists’ experiences with ethical dilemmas where physicians encounter different types of ethical dilemmas depending on their specialty (DuVal et al., 2004). Another finding suggests that general practitioners were less likely to be interested in education regarding placebo than specialist researchers but were more likely to be interested in studying ethical aspects of confidentiality. The issue of data confidentiality is gaining increasing attention, especially in the era of “big data,” so it is not surprising that general practitioners are aware of the issue and interested in additional education.

Respondents who had experience as REC members were less likely to be interested in education regarding ethical aspects of international research, whereas those who had participated in smaller number of studies were more likely to be interested in additional education, especially related to participant recruitment. The largest percentage of respondents are interested in education regarding responsible conduct of research (authorship and publication issues and scientific misconduct), participant recruitment, vulnerable populations, commercial research, and international research. Topics of responsible conduct of research (e.g., authorship, publication issues, scientific misconduct), as well as issues related to human participants (e.g., informed consent, recruitment) are the most frequently encountered issues, and also the preferred subjects for additional education. Similarly, in a study conducted with REC members in Cameroon, Mali, and Tanzania, respondents identified the issue of informed consent among the top five ranked research ethics training priorities (Ateudjieu et al., 2010).

In contrast, dilemmas associated with international and commercial trials are issues our respondents feel least competent to address. This evidence from our study should be utilized in guiding future research ethic education to meet the needs of researchers in countries like ours which also conduct international and commercial trials. Also, the low level of confidence among Serbian researchers for addressing ethical issues associated with biobanking is particularly informative. There is an urgent need to provide adequate education for educators of trainees with similar needs to establish and cultivate ethical awareness and confidence in dealing with these ethically complex fields of research.

Strengths and limitations

To our knowledge, this is the first study examining the research ethics education needs of biomedical researchers in Serbia. We noted, however, several limitations of our study. Convenience sampling could have omitted some groups and left us with a sample that was not ideally representative of the population of Serbian researchers. We included biomedical researchers from three large University centers in Serbia, so additional research is needed to engage more representation from public and private hospitals, clinics, and universities, and to involve researchers other than clinicians, who could provide unique perspectives on the problem

The use of an online platform for questionnaire dissemination probably resulted in a lower response rate than an in-person study. This problem has been documented in previous studies (Leece et al., 2004; Whitehead, 2011). We decided to employ online dissemination because of our time constraints. We needed the information to support our curriculum development, while COVID-19 physical distancing measures made directly approaching participants too difficult. Since we used an open-access link for the questionnaire allowing participants to share the survey freely with their colleagues, it was not applicable to make the estimation of the unique audience reached and calculate the response rate.

Limitations of self-reported inquiring include the possibility of social desirability bias (Fisher & Katz, 2000). As the study was based on self-reported data, there may have been some over- and under-reporting of some particular experiences and behaviors. For example, the finding that ethical issues related to authorship and publishing were among the issues respondents felt most competent to deal with, and at the same time were among the topics for which they expressed the highest educational interest suggests the effect of possible social desirability bias in responding to items regarding self-assessed competence.

CONCLUSION

Respondents in our study expressed strong motivation for future education in research ethics. This suggests that comprehensive systematic education in research ethics for biomedical researchers in Serbia is needed. Results of this study indicate that issues related to responsible conduct of research (e.g., authorship, publishing issues, scientific misconduct) and human participant research (e.g., informed consent, recruitment) are those that Serbian biomedical researchers feel most competent to deal with and encounter in their research practice most frequently. Surprisingly, they are also among topics they are most interested in studying further.

Ethical issues related to international and commercial research and biobanking are issues biomedical researchers in Serbia feel least confident to address. They are also among the highly preferred topics for additional education. Researchers with different specialization and research experience have relatively different educational needs, a finding that should be taken into account when tailoring research ethics curricula to a specific learner population.

DISCLOSURE STATEMENT

No potential conflict of interest was reported by the author(s).

SUPPLEMENTARY MATERIAL

Supplemental data for this article can be accessed online at https://doi.org/10.1080/10508422.2024.2382402.

DATA AVAILABILITY STATEMENT

The data that support the findings of this study are available from the corresponding author, [IM], upon reasonable request.

Additional information

Funding

This work was funded by the National Institutes of Health/Fogarty Center under Grant [3R25TW008171-08S1].