Better at the Bench

Introduction to the training in the responsible conduct of research

In regards to research ethics, the NIH has been trying to transition from a focus on classroom lectures to conversations that frame ethics as a foundation for doing good science. If you would like to read more about research ethics training, here is a link to the NIH Office of Intramural Research.

For both F- and K-awards, a one-page document must be included that describes your plan to acquire instruction in the responsible conduct of research. This is a fairly easy document to generate (the definition of a sleepy writing activity), but remember to read through the instructions thoroughly and incorporate in all the details requested because your grant will not be funded without this document. In fact, the NIH grants policy clearly states that:

“Plans and past record will be rated as acceptable or unacceptable and the summary statement will provide the consensus rating of the review committee. Applications with unacceptable plans will not be funded until the applicant provides an acceptable, revised plan.”

What to include in your training plan

Thoroughly review the instructions when writing this document. However, here are a few highlights of what to include:

• History of training — Document prior instruction or participation in responsible conduct of research training during the applicant’s current career stage (including the date instruction was last completed).

• Future training plans — Propose plans to either receive instruction or provide instruction (i.e. participate as a course lecturer) to meet the frequency requirements of responsible conduct of research training. In describing these future training plans, the applicant must include the following five instructional components:

  • (1) Format — Describe the format of the instruction (example: face-to-face lectures, coursework, or discussion). A plan with only online instructions is not acceptable.

  • (2) Subject matter — Describe the breadth of the subjects addressed (example: conflict of interest, human subject and animal use, research ethics, etc).

  • (3) Faculty participation — Describe the role of the mentor and other faculty involvement in the instruction.

  • (4) Duration of instruction — Describe the number of contact hours of instruction and the duration of the program.

  • (5) Frequency of instruction — Reflection should recur throughout a scientist’s career and institutional training programs are strongly encouraged at all career stages. Instructions must be undertaken at least once during each career stage and at a frequency of no less than every four years. Individuals at the early career investigator level (aka. mentored K-awardees) must receive instruction in the responsible conduct of research at least once during this career stage. Document any prior instruction during the applicant’s current career stage, including the inclusive dates instruction was last completed.

MED255: Responsible conduct for medical research

Stanford designed a course that basically fulfills all NIH responsible conduct of research requirements. This course is called MED255. It is a one-day discussion focused class. I took it and was pleasantly surprised by how much I enjoyed it. Regardless of if you apply for a NIH grant, I would highly recommend you take this class. With the shelter in place still in effect, I don’t know what the status of this class currently is. However, you do not need to take this class prior to submitting your grant — just include it in your responsible conduct of research training plan as a future plan.

This is what I wrote about the MED255 class. Details may have changed since I took it two years ago, but you can see how I incorporated the five instructional components above (these components are underlined).

As a Postdoctoral Researcher at Stanford University I will continue to receive training in the responsible conduct of research by attending the class “MED 255: Responsible Conduct of Research” in the 2019 fall quarter. The format of the course is discussion-based, specifically designed to engage participants in thoughtful conversations about ethical issues that are commonly encountered by bench researchers. The course is a total of 9 hours of instruction long (all occurring on one day) and is comprised of 7 sections that will focus on the following subjects: authorship and inventorship, data integrity and information, conflicts of interest, regulatory basics, human subjects research, human biological materials, and societal responsibility. Over the entire duration of the course we will also focus on ethical topics that include stem cell research, bioweapons, and genetic testing. Prior to the class, participants must complete course work which includes watching a series of seven video lectures, reading assigned material, and completing study guide responses. Instructors for the class are all Senior Research Scholars at the Stanford Center for Biomedical Ethics and include Dr. Katrina Karkazis, Dr. Christopher Thomas Scott, and Dr. Sandra Soo-Jin Lee.

Additional components that I included in this document (non-class training)

In addition to the formal class training (MED255), I included in my responsible conduct of research training plan informal training opportunities which included: laboratory group meetings (where we discuss data analysis) and the use of drop-in statistic consulting services (provided by the Stanford Department of Statistics). I don’t know if it is required here, but in this section I also briefly mentioned some animal training (specifically the completion of the Animal Care and Use Training Program provided by the Stanford Veterinary Service Center), but elaborated on this further in the vertebrate section.