The present research is the first to assess research ethics knowledge among medical students, residents and pediatric medical professionals in Azerbaijan by means of a structured questionnaire. We adapted the Azeri-version of the well-recognized TREK-P questionnaire to evaluate research ethics knowledge among medical students, pediatrics residents and pediatric medical professionals involved in children healthcare. The TREK-P test is easy to administer and can discriminate among learners of varying experience and expertise and identify content areas in which further emphasis is needed [6]. The use of the TREK-P is a novel application in the context of medical education in Azerbaijan, where there is a notable gap in research ethics education and where there are no medical education and residency training accredited requirements in ethics.
Clearly, broader emphasis on measures of attitudes, skills, and behaviors is needed in addition to general knowledge of ethical principles and the use of the TREK-P in Azerbaijan represents an initial step in development of benchmarks to evaluate research ethics training for medical students and pediatric residents, as well as continuing educational experiences in this area for practicing pediatrics professionals. It is important that the results reflect the current situation in settings involving students and residents at the AMU. The study can more broadly influence medical practice in Azerbaijan by improving the medical research education process. There are several reasons why we selected research ethics knowledge of pediatrics professional as a focus of the study. Children are a vulnerable population and need more protection during research. Pediatrics has been the topic of Fogarty/NIH research in the country (‘Optimizing prevention approaches for children reintegrating from orphanages in Azerbaijan’ by NIH 1R01HD099847). The decisions in clinical and research practice involving children and adolescents are complicated by many aspects such as involvement of third parties (parents, caregivers), different levels of capacity to consent depending on the age of the child.
In the original TREK-P report [6], performance on the test improved appropriately with degree of expertise with mean scores increasing with training levels, and residents performed significantly better than medical students. We expected that in our study residents also would score higher than the medical students, and that the pediatricians would score higher than residents. In the original study, the median score for medical students were 15 (range, 11–19), which was close to the scores of medical students in the current study (Table 2). The median score for pediatric residents in the original study was 19 (range, 14–23), which was higher than medical students in this study. Our findings are of interest in that we noted a reverse though non-significant tendency with lower median scores for pediatric residents compared to those of medical students. Furthermore, the practicing pediatricians scores were lower than that of residents showing a temporal improved trend or greater proximity to training. The Fogarty/NI fellowship group showed significantly better scores compared to the other three groups (Table 2). A positive aspect of the findings related to medical students at the AMU is that they performed comparatively favorably to students in the United States. This may reflect the inclusion of modern curricula in medical education at the AMU and greater awareness and idealism of the novice group in the service of the patients. Practicing pediatricians with greater experience were more defensive because they are not protected by approved governmental clear guidelines covering this area and they may be avoiding contradictory situations related to this area (e.g., stopping ventilators or nutrition for terminally ill patients). We believe that the results reveal that practicing pediatricians already used to avoid making decisions in situations have significant ambiguity and require a higher level of ethical responsibility, whereas the students took on a more idealistic common-sense stance on these ethical questions. Pediatricians were potentially more influenced by other parameters that may be underestimating their emphasis on research ethics but given that these practitioners represent the higher echelon of urban practitioners, the situation is likely to be worse in rural areas of the country. These findings suggest that just practicing medicine per se is not enough to improve knowledge of ethical principles. Active training is the key to develop solid understanding of ethics.
Given their stage of practice, we combined practicing pediatricians and fellowship groups to find out if other aspects of medical practice correlate with the TREK-P scores (Table 3). In our analysis, combining pediatricians who received medical education abroad and those who had previous experience of participation in research seemed to score higher, the comparative difference was not significant. The previous Fogarty/NIH training in research ethics was the only aspect that showed significant positive correlation with the TREK-P mean score. These findings support importance of R25 based postgraduate training on research ethics principles in Azerbaijan.
There are several possible explanations for the lack of correlation between performance on the TREK-P and degree of expertise in our study population. The TREK-P questions correspond to the statements on American Academy of Pediatrics Committee on Bioethics [6]. Though they reflect universal ethical principles, these principles haven’t been explicitly stated by similar bodies in Azerbaijan. Another obstacle is general deficit of ethical training for residents and practicing pediatricians. For example, questions related to ethical issues constitute less than one percent of all questions used in the pediatrics residency examination and the license examination for pediatricians in Azerbaijan (sample test questions are available at the website of the Certification Commission of the Ministry of Health: http://snsk.az/). There are also usually few sections and talks dedicated to ethical principles in programs of local conferences and seminars. Another factor that can contribute to relatively underperformance of practitioners is lack of medical research overall in the country involving human subjects as well as participation in human subject ethics review.
We compared the pattern of TREK-P questions that the participants in all 4 groups answered either correctly or incorrectly (Fig. 1). Such similarities in rate of incorrect answers, independent of participants’ background, may point to specific areas that need greater attention during research education process. Items Q3 (adolescent’s independent consent to therapy), Q8 (request for genetic testing of a 5-year-old by mother), and Q9 (request for genetic testing of a 5-year-old by mother after meeting with a genetic counselor) showed very low rate of correct answers in our participants, and there was a high rate of correct answers in the original report (Fig. 2). The answers to these questions might be significantly influenced by cultural differences (e.g., a parent-dominated decision-making approach in children’s healthcare), as well as local legislation (as in absence of emancipated minor concept) regarding research inclusion, as well as age of consent and assent involving pediatric populations. Item Q3 is about a 15-year-old with Chlamydia giving consent for treatment without involvement of the parents. According to Azerbaijani legislation the person must be 18 years of age to give consent, therefore the answers are dominated by established practicing rules, rather than by ethical considerations. On the other hand, the treatment of sexually transmitted disease in a teenage female without permission and involvement of her parents is unacceptable from a point of view of paternalistic tradition of Azerbaijan. Items Q8 and Q9 are about mother’s request to test her 5-year-old daughter. Most of the participants incorrectly answered that it is ethically acceptable to fulfil mother’s request. On one side this is appropriate from the point of the local legislation, on the other hand, the culturally accepted norm is that parents hold full rights over the little children. Interestingly, in item Q10 (request for genetic testing of a 17-year-old by mother against child’s wish) there was higher correct answers rate in all our groups as compared to the original report data. Item Q10 is similar to Q9, but here the child’s age is 17 and she expresses unwillingness to have the test. This suggests that our participants accept the younger age as a main determinant of judging of request as ethical, providing more autonomy to teenager and limiting decision-making rights of 5-year-olds in favor of her parents. Participants in all groups showed high rates of correct answers in item Q7 (disclosure to parents regarding their newborn child’s being a carrier for sickle cell disease) and item Q17 (administration of large doses of analgesics to a child with refractory metastatic cancer). These questions focus on topics that are less influenced by either cultural or legal environment.
In this study, questions most frequently answered incorrectly pertained to decision-making for minors. This is true for the last 4 items of the questionnaire that are designed as a separate domain, but also this hold true for other questions where participants incorrectly assigned full authority to decide to parents (Q3, Q8, Q9). Another domain that was difficult is end-of-life decisions, where some question particularly yielded very low rate of correct answers.