Implementing a Responsible Conduct of Research Curriculum for an Undergraduate Summer Clinical Research Program in Quantitative Sciences.

Objectives: Instilling the principles of ethical and responsible medical research is critical for educating the next generation of clinical researchers. We developed a responsible conduct of research (RCR) workshop and associated curriculum for undergraduate trainees in a quantitative clinical research program.

Methods: Topics in this 7-module RCR workshop are relevant to undergraduate trainees in quantitative fields, many of whom are learning about these concepts for the first time. These topics include: (1) research collaboration and mentoring, (2) human subjects and privacy, (3) rigor, reproducibility, and responsibility in data analysis, (4) data safety, security, and sharing, (5) responsible authorship, peer reviews, and conflicts of interest, (6) research misconduct and whistleblowing, and (7) social responsibility and contemporary ethical issues. The workshop adopts an active learning approach and is intended to encourage peer-to-peer learning through a critical review of case studies and contemporary media reports. Workshop materials and discussions are designed to address experiences relevant to undergraduate trainees. For example, for the discussion on human subject protection, trainees are asked to review their own university's policies for engaging students as research subjects. Student perceived knowledge and understanding of research ethics were obtained from pre- and post-workshop surveys, with responses ranging from 1 (low level of understanding) to 5 (high level of understanding).

Results: Survey responses from 38 trainees across 4 years demonstrated marked increase in perceived knowledge and understanding of research ethics, from 64% in pre- to 96% in post-workshop responses with scores of 3 and up. Trainees noted the effectiveness of the active learning format of the workshop and relevance of the topics on their own research projects.

Conclusion: Intentional instruction is vital to help trainees discern between good and bad science in research. The presented RCR curriculum can be adapted by other programs designed for trainees engaged in medical research and education.