NIH Requirements for Instruction in the Responsible Conduct of Research

MED 255 is a necessary, but not always sufficient, component of training in responsible conduct of research. Please be sure to contact your funder to inquire about additional requirements beyond MED 255.

In general, however, the NIH requires several components of training in the Responsible Conduct of Research (RCR) including:

• The required MED 255 or 255C course;
• Refresher RCR instruction at each stage of training (e.g., graduate, postdoc, etc);
• Continuing informal or formal training in research ethics throughout the year; and
• The involvement of your departmental research faculty in supplemental and continuing instruction in research ethics.

Instructional Components

1) Instruction Format

The NIH requirements highly encourage multiple forms of RCR training, including formal courses (such as MED 255 or Med 255C), small-group discussions, and instruction by research training faculty members.

NIH applicants will need to describe the format for Med 255, which is described in the template PDF below.

Applicants will also need to describe the format they will use to provide continuing and ongoing training and instruction in research ethics/RCR (using their own faculty) throughout the year for each year of the trainees’ fellowship. These may be lectures, panel discussions, colloquia providing refreshers on topics covered in Med 255 (see Subject Matter), but they may also cover topics of specific ethical concern in the trainees’ field not covered by Med 255.

2) Subject Matter

The NIH lists several topics they strongly suggest RCR programs to cover, all of which are covered in MED 255:

• Conflict of interest
• Policies regarding human subjects
• Mentor/mentee responsibilities
• Collaborative research
• Peer review
• Data acquisition
• Research misconduct
• Contemporary ethical issues

3) Faculty Participation

In addition to the MED 255/Med 255C faculty, some training programs require that the department’s own faculty be involved in further RCR instruction. The NIH states, “Training faculty and sponsors/mentors are highly encouraged to contribute both to formal and informal instruction in responsible conduct of research.  Informal instruction occurs in the course of laboratory interactions and in other informal situations throughout the year. Training faculty may contribute to formal instruction in responsible conduct of research as discussion leaders, speakers, lecturers, and/or course directors.  Rotation of training faculty as course directors, instructors, and/or discussion leaders may be a useful way to achieve the ideal of full faculty participation in formal responsible conduct of research courses over a period of time.”  (see “Guidelines: Faculty Representation”)

Some institutes only require informal training by a faculty mentor, while others require actual formal instructor, preferably by faculty in training. If you participate in formal training, please include the names of the participating faculty members in your grant. Faculty and staff at the Stanford Center for Biomedical Ethics may also be available to assist by serving as additional panelists.           

4) Duration of Instruction

The NIH suggests training in RCR that spans across a longer interval of time in order to allow sufficient exploration and consolidation of the material. Instruction should also involve at least 8 contact hours between you and the participating faculty. The duration of instruction for Med 255 and Med 255C is covered in the PDF template below. Applicants will also need to describe the duration of instruction beyond Med 255 or Med 255C.

5) Frequency of Instruction

Some institutes require ongoing instruction throughout the year for each year of fellowship in addition to MED 255 or Med 255C, or may require retaking MED 225 or Med 255C at each stage of training. 

Template

We have created a Template that you may use as the basis of your grant. Please be sure to supplement the template with funder-specific requirements, and address all structural components mentioned above.

Course Policies

Course Information

In every class section there will be discussion sessions based on cases and dilemmas that will be distributed to participants. These discussions will draw heavily on the assigned pre-class videos and required pre-class assignment (MED255 Study Guide). Currently, only a single-day intensive format class is offered.  Multiple sections are offered in Autumn, Winter, and Spring Quarters. One section is usually offered in Summer Quarter. Please see the MED 255 schedule for the current Academic Year here.

Readings

Optional, but informative, reference readings for each class are available here. Participants are not required complete these readings. 

Dropping an Intensive Class

We have more people who want to take the intensive RCR class than available spaces. As a result, there are always students to fill extra spaces in these sections. If someone drops the course shortly before the class date, we cannot fill that space because no one can do the prep work in time. If you do not wish to remain in the class, please drop it as soon as possible to allow others to successfully enroll. Students who drop an intensive class within two weeks of the class date will not be allowed to register for the course directly next term.

Certification

Post-docs, faculty, staff, affiliates, and others who enroll through STARS and successfully completing the course will receive a certificate that can be used to demonstrate completion of research ethics training to fulfill NIH requirements. Graduate students who successfully complete the course will have certification of research ethics training on their transcripts.  If you have any questions please send an email to med255rcr@stanford.edu.