Implementation of research ethics training for postgraduate medical students – A learner-centered approach

INTRODUCTION

According to the World Federation of Medical Education document, research competency is essential for medical postgraduates globally.^[1] On similar grounds, postgraduate medical students in India are mandated to do research as a part of their curriculum to acquire first-hand learning experience and develop them as competent researchers.^[2] However, they face many ethical problems during their research, and no formal teaching of research ethics is incorporated into their curriculum.

In this regard, we tried to integrate interactive lectures, and for the first time, small group teaching with simulated ethics-based case scenarios to teach research ethics. Thus, the present study aims to determine the effectiveness of research ethics training based on a learner-centered approach for 1^st-year postgraduate students of a tertiary care teaching hospital in India.

PROCEDURE

This study was conducted after obtaining the institutional ethics committee approval. Written informed consent was obtained from all study participants.

At the outset, participants filled out a predesigned and validated pretest questionnaire containing 12 single-best-answer-type multiple-choice questions over 15–20 min. Correct and incorrect responses were scored “1” and “0,” respectively (maximum score = 12).

During the two-and-a-half-hour training, there were interactive PowerPoint presentations on “General principles of research ethics” and “informed consent process.” Furthermore, to develop ethical reasoning abilities, 10 fictional case scenarios were provided. They pertained to ethical issues relating to autonomy, beneficence and nonmaleficence, justice, privacy and confidentiality, research on a vulnerable population, therapeutic misconception, consent, assent, the Indian Council of Medical Research (ICMR) risk categorization, requirement of the Drug Controller General of India (DCGI) approval, and Clinical Trials Registry-India (CTRI) registration. They were developed based on common ethical concerns faced by the institutional ethics committee while reviewing postgraduate research. The pretest/posttest questions for evaluation of the training program were also based on the above mentioned ethical issues. The students discussed the case scenarios in small groups for 15 min. Later, they were encouraged to present the identified ethical issues to the other groups, and a moderator facilitated it.

At the end of the training session, the participants filled out the posttest form containing the same questions as the pretest.

Descriptive statistics were used to summarize the data. The frequency of correct responses before and after the training program was compared using McNemar’s Chi-square test. Wilcoxon signed-rank test was used to compare the total pre- and posttest scores. Subgroup analysis was done to assess the gender differences in pretest and posttest performances. Data were analyzed by the Statistical Package for the Social Sciences version 24. P < 0.05 was considered statistically significant.

RESULTS

Of the 60 participants attending the training, 57 completed the pretest and posttest. Their median (interquartile range) age was 25 (3) years, with a slight male preponderance (52.6%).

There was a statistically significant (P < 0.05) increase in the percentage of correct answers from pretest to posttest for all questions, namely those related to autonomy (24.6–68.4%), diminished autonomy (26.3–94.7%), vulnerable population and legally authorized representative consent (35.1–66.7%), verbal assent and parental consent (64.9–84.2%), justice and therapeutic misconception (31.6–77.2%), beneficence and nonmaleficence (43.9–78.9%)., ICMR risk categorization of research (19.3–96.5%), privacy and confidentiality (68.4–89.5%), autonomy, privacy, and confidentiality (35.1–73.7%), therapeutic misconception (7–71.9%), cost of research investigation to be borne by researcher/sponsor (50.9–75.4%), and requirement of DCGI approval and CTRI registration (14–78.9%).

Overall, the median (interquartile range) total scores on knowledge of research ethics rose from 5 (3) to 10 (4), after the training. This change was statistically significant (Z = −6.401, P < 0.001) by Wilcoxon signed-ranks test. Furthermore, there were no statistically significant differences in the pretest (5^[2] vs. 4 ^[4]; Z = −0.267; P = 0.79) and posttest scores (11.5 ^[4] vs. 9 ^[3]; Z = −1.694; P = 0.09) among males and females, respectively (by Mann–Whitney U-test). However, there was a significant increase (by Wilcoxon signed-rank test) in posttest scores compared to the pretest scores among both male (11.5 (4) vs. 5 (2); Z = −4.710; P < 0.01) and female participants (9^[3] vs. 4 ^[4]; Z = −4.377; P < 0.01).

DISCUSSION

Our study showed a significant improvement in the knowledge of research ethics among postgraduates after attending the two-and-a-half-hour interactive training. Their median test scores increased from 5 to 10 out of a maximum score of 12 points. Thus, our study provides evidence that even interactive short training sessions on research ethics effectively impart essential knowledge in research ethics among medical postgraduates.

A similar learner-centered approach in teaching research ethics through small group discussions on ethics-based case scenarios has been tried by other investigators.^[3–5] These studies prove that innovative short training sessions in research ethics improved the participants’ knowledge, attitude, and skills.

Limitations of the study include small sample size and a lack of a control group. Moreover, the application of the knowledge gained by the postgraduates in their future research-related activities such as designing, conducting, and publishing research was not studied.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.