Requirements and Resources for Training in the Responsible Conduct of Research

Responsible conduct of research (RCR) is defined as the practice of scientific investigation with integrity. It involves the awareness and application of established professional norms and ethical principles in the performance of all activities related to scientific research. RCR is an essential component of research training and active involvement in the issues of RCR should occur throughout a scientist’s career. NIH requires all trainees, fellows, participants, and scholars receiving support through any NIH training, career development award (individual or institutional), research education grant, and dissertation research grant to receive instruction in the responsible conduct of research. The Yale MD-PhD Program is funded by a T32 predoctoral training grant (T32 GM136651) from the National Institute of General Medical Science (NIGMS), and ALL students in the program are required to fulfill the RCR requirements.

The formal educational program in the responsible conduct of research is fully incorporated into the required first-year MD-PhD Program course (Cell Bio 600/601: Science at the Frontiers of Medicine) in the format of a 2-month “Rigor/Reproducibility (R&R) and RCR Bootcamp” at the beginning of the fall semester. A core group of outstanding physician-scientists have been selected to present the R&R and RCR Bootcamp lectures because aspects of their research and/or clinical practice are exemplary examples of RCR principles. Lecturers are asked to explicitly focus on established professional norms and ethical principles as they discuss their research programs. Their topics are mapped to the topics suggested by NIH for RCR instruction. CB600/601 meets every Thursday evening for two semesters; during the first two months of Y1 there are eight 1.5h R&R and RCR Bootcamp sessions, totaling 12 hours of instruction.

In the spring semester of the first year, MD-PhD Program faculty Associate Directors facilitate four to five additional stand-alone, in-person workshops on the responsible conduct of research. At each session, a group of 2-3 first-year MD-PhD students identify and present contemporary cases and a brief review of relevant RCR principles. The Associate Directors facilitate discussion with the entire group about best practices and potential pitfalls related to the topics and ensure that the students are introduced to Yale University resources and personnel available for consultation, advice or further in-depth training in RCR-related matters. The spring semester RCR workshops occur monthly, totaling 6-8 additional hours of instruction. MD-PhD students therefore receive a total of 18-20 hours of RCR instruction in the first year of their training.

Attendance at all RCR sessions is mandatory. Students with an excused absence must submit written essays on the cases/topics discussed. The Registrar of the MD-PhD Program maintains records of student attendance and posts completion of the RCR courses on student transcripts. For students that matriculate in the MD-PhD Program after first entering medical school, the RCR lectures must be taken in the year of matriculation. All of the topics suggested by NIH for RCR instruction are covered in this first year curriculum:

1. Conflict of Interest
2. Policies regarding human subjects, live vertebrate animal subjects, and safe laboratory practices
3. Collaborative research, including collaborations with industry
4. Peer review
5. Data acquisition and laboratory tools; management, sharing and ownership
6. Research misconduct and policies for handling misconduct
7. Responsible authorship and publication
8. The scientist as a responsible member of society, contemporary ethical issues in biomedical research, and the environmental and societal impacts of scientific research

All MD-PhD students are required to attend RCR refresher workshops in their fifth year in the program. Refresher RCR training is done in collaboration with each student’s home PhD program or department (8 hours of instruction) followed by an MD-PhD Program- specific workshop (2 hours) to discuss contemporary cases specific to the physician-scientist profession led by the MD-PhD Program Director and Deputy Director. For students in the MD-PhD program affiliated with a PhD program that does not offer a standalone refresher course, the MD-PhD Program Registrar identifies an appropriate substitute program within the Yale Combined Programs in the Biological and Biomedical Sciences (BBS). MD-PhD students therefore receive a total of 10 hours of RCR refresher instruction in the fifth year of their training.

The most important way in which students are trained in the responsible conduct of research is in their day-to-day experiences in the laboratory. We emphasize the critical need for faculty mentors to consistently review and enforce with their students core principles of rigorous experimental design and data analysis, to ensure that students are trained and monitored in data acquisition, analysis, sharing and management and to work closely with students on abstract and publication preparations.