Announcer: From the National Institutes of Health in Bethesda, Maryland, this is All About Grants.

Megan Columbus: From the Office of Extramural Research at the NIH, I’m Megan Columbus and welcome again to All About Grants. In today’s interview, we’re going to take a break from our current series and address a topic submitted by a listener: the NIH’s requirement for training in responsible conduct of research. We always welcome listener suggestions, so feel free to submit on the feedback form of our website. Rod has prior experience running research programs, as well as serving as associate dean of graduate programs at NYU Medical Center and University of Texas Southwestern in Dallas. So when we talk about responsible conduct of research, what is the actual requirement?

Rod Ulane: The actual requirement is for anyone who is supported by formal NIH research training dollars to receive instruction in the responsible conduct of research at least once every four years at each of their career stages in training.

Megan: NIH policy on responsible conduct of research applies to our training grant programs, and by those I assume we’re talking about career development, fellowship and training grants?

Rod: Yes. Any fellowship, training, individual career development, or any person who is on a training program, a T32 training program.

Megan: Even though ours only applies to those programs, I know that NIH is very interested in ongoing training in responsible conduct of research throughout a researcher’s career, would you agree?

Rod: Yes, NIH is, and I think everyone is. I don’t think only NIH is. I think the community is. And I think what actually happens is most faculty members participate. Faculty members who are involved in research training participate as the lecturers, course organizers for many of these programs. They benefit as much as the students do, because most of the instruction really involves discussion of nuanced issues in responsible conduct of research.

Megan: I‘d expect that continuing dialogue to be very important.

Rod: Absolutely. This is why the NIH insists that, at a minimum, to meet this requirement, there must be eight face-to-face contact hours, as opposed to an online course. I think most people in the community, most people who are involved in these responsible conduct of research courses would agree that the most productive time is spent in really examining issues face-to-face and discussing these issues.

Megan: You just mentioned that it has to be face-to-face training, but what might the training actually look like? What kinds of conversations or courses would that be?

Rod: Well, we give a suggested list of topics, for instance, authorship. Who determines and what determines a person’s name being placed on a paper? There are issues of reagent sharing. Can you share this reagent with your competitor or should you share this reagent with your competitor? Some of the answers to these questions aren’t black and white. I think in the process of discussing these issues, it just really raises everyone’s consciousness—just the kinds of sticky situations that anyone can get into.

Megan: What’s the appropriate place for people to be telling the NIH what courses they’ll be taking or what their plan is for training?

Rod: They are required in any formal training mechanism application to write out a plan as to exactly what that RCR training will consist of. It’s done in the application, and it’s done in the progress report also.

Megan: And so reviewers are actually looking at that training plan?

Rod: Yes, as a matter of fact, it’s a peer review issue. Reviewers look at the training plan, and, although the evaluation of the RCR training does not enter into the priority score, if the reviewers assess the plan as inadequate or insufficient, that is a block to funding that particular program even if it gets a high priority score until the applicant presents a remedy.

Megan: Rod, what happens if I have received RCR training right before applying for a fellowship? Does it count?

Rod: Yes, you could take the example of a graduate student who is not supported in her first year of graduate studies, but is applying for a fellowship, which is an NIH formal training program. And she may be receiving responsible conduct of research, as many graduate students do in their first year in graduate school. She can state this in her grant application, but she must, in detail, spell out what that training consists of.

Megan: What questions do you regularly get on this topic?

Rod: The questions of contact hours, the nature of contact hours and, as I mentioned, there is a minimum of eight face-to-face contact hours. Usually, over the span of a semester or one calendar year. There are special cases, although we insist on face-to face contact of a minimum of eight hours, there are some formal training mechanisms that support, for instance medical students, for only three months over the summer, short-term training programs. In these cases, there is a requirement for RCR instruction, but it doesn’t have to be eight hours. What many programs do is essentially have perhaps a two- or three-hour discussion some evening exploring some of these topics, like peer review, reagent sharing, authorship, conflict of interest, etc.

Megan: Eight hours, face-to-face, every four years.

Rod: Yes.

Megan: I think that summarizes it. Thanks for being here today.

Rod: Thank you.

Megan: For NIH and OER this Megan Columbus.

Announcer: To learn more about training in the responsible conduct of research, visit the OER website at grants.nih.gov and search for “responsible conduct of research.” That’s G-R-A-N-T-S dot N-I-H dot G-O-V.