NIH All About Grants Podcast: Responsible Conduct of Research and Training

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

David Kosub: Hello and welcome to another edition of NIH's All About Grants podcast. I'm your host, David Kosub, with the NIH's Office of Extramural Research. And today, we're going to be talking all about a very important topic that's Responsible Conduct of Research, and what one might be thinking about as they're putting together their application, and, you know, things for training and et cetera. You know, this conversation is going to be a little bit different from- we're not going to be discussing research misconduct, for instance, that's a different area. We're going to be talking about other parts of responsible conduct of research, and I'm glad to say that we have with us two guests today. We have Dr. Karen Wehner. She is the Director of Education and Integrity with the Department of Health and Human Services' Office of Research Integrity. I always have to take a breath when I say this, and a long title. And also, we have Dr. Ericka Boone. She directs the Division of Biomedical Research Workforce within the Office of Extramural Research, and I welcome you both to the show.

Ericka Boone: Thank you. Good morning, David. Good morning, Karen.

Kosub: So, Ericka, Karen, let's hear from both of you on this one. What is responsible conduct of research anyways?

Boone: Thank you for that question, David. Integrity and scholarship and research are fundamental values in science, and responsible conduct of research, or RCR, is the framework for not only thinking about but also personifying basic values in the context of day-to-day practice of good science. So RCR is essential for the preparation of future and early career investigators because it provides this basic framework for how we should live and breathe the day-to-day practice of good science as a process and not be thought of as just boring classes that you're forced to take every now and then.

Karen Wehner: I couldn't agree more. You know, always thinking about the responsible conduct of research as something that you do, something that you live, the way you actually conduct your research, I think it makes it much more practical and relatable and definitely less boring.

Boone: Yeah.

Kosub: I definitely like something that you do, something that you live. I like that. So for those who may not be too familiar, maybe we can spend just a couple seconds talking about like how the Office of Research Integrity within the Department of Health and Human Services works with us here in NIH. How do we view RCR? How do we work together on this?

Boone: Again, NIH establishes policies and guidelines regarding the structure, timing, and content that serves as the framework that can be utilized by institutions to implement RCR training. But Karen, I'll let you speak a little bit more about ORI's perspective.

Wehner: Thank you. So within ORI, we have sort of two main activity areas related to the responsible conduct of research, and one is derived from the regulation that we function under, the PHS policies on research misconduct. And that regulation calls for all institutions receiving money from the public health service for research to foster a research environment that promotes the responsible conduct of research and other related activities. And so that is independent of funding mechanism within NIH, independent of whether you're a trainee or a PI, it's everyone. And it's the institution's goals. Then within ORI, we work to support the institutions in those efforts. So whether it is helping them to more appropriately handle issues that arise related to research integrity, whether it is developing training resources that they might use in fostering that environment, so videos and case studies and other resources that they can use. But really, we're looking to move to develop practical resources that can be used by institutions and researchers as they really work to live that responsible conduct of research effort.

Boone: That was a good point, Karen, because if it's hard to implement, it's not going to be, so it won't be useful.

Wehner: Exactly. And you know, we want it to be something that is easy to adopt and implement in the research environment.

Kosub: Well, when you're talking about easy, we've got to talk about the policy, and get more into what exactly that means. So perhaps Ericka, since you mentioned the NIH policy earlier on, can you tell us more about what it is? Explain it to us, like what does it say?

Boone: Sure. So currently, NIH requires that all trainees, fellows, participants and scholars that receive any kind of support through NIH training, career development, awards, whether they're individual or institutional research, education grants and dissertation grants, must receive instruction in the responsible conduct of research.

Kosub: And what about the plan for one's responsible conduct of research in an application? Like, what does that actually entail? What does that look like?

Boone: So applicants are required to develop an RCR plan as a part of their application. And there are several basic elements that should be considered or addressed, including format of instruction, training subject matter, faculty involvement, frequency, timing, as well as duration of RCR training. So I'll speak a little bit more about those. So regarding the format of instruction, that's pertaining to whether it's face-to-face lectures, or discussion groups, or via video conferencing, all of these must foster discussion, active learning, engagement, and interaction amongst the participants. Next is the subject matter of RCR training. So there are at least nine topical areas that are listed in the notice. And David, I'm sure that you'll give them the links to that. And they include safe research environments, secure and ethical data use, policies regarding human subjects, and more. But we must remember here and understand that these are not the only topics that can be included. These are just baseline examples. Regarding faculty involvement or participation, training faculty and sponsors or mentors are highly encouraged to contribute both formally and informally to the instruction of responsible conduct of research. And lastly, frequency, timing and duration of RCR, which calls for RCR instruction to be undertaken at least once during every career stage and at a frequency of no less than once every four years, and for the duration, it should be at least eight contact hours. So as institutions consider how to best optimize the timing and delivery of instruction in RCR, they should definitely keep in mind the value of ongoing as well as discipline-specific training as individuals progress through their research careers.

Kosub: You can definitely count on me providing all those links, Ericka. So you mentioned a lot of players in that response. You know, I'm just wondering, you know, could y'all talk more about, say, like what are their different perspectives? How does, you know- how do institutions, you know, see responsible conduct of research? You know, how is it, you know, perceived from, you know, principal investigator, or a researcher, or a grad student? You know, maybe y'all could talk about that.

Wehner: You know, I'll take that one to start with. I think that frequently, it's perceived as a compliance checkbox that must be checked. But I think that that can make the effort related to the responsible conduct of research training less effective. I think it's important to think about, you know, as I said at the beginning, what's practical, what is actually going to help foster that environment where research integrity and the responsible conduct of research are the norm, and we have high quality research that can be built on and relied upon. And so thinking from those practical steps, what is going to help make the research stronger? What is going to help the researchers as they're conducting their research make the best decisions they can for the future of the research and for the research they're conducting? And for the institutions, what is it that they want as far as the quality and integrity of the research that's coming out of their institution? And how can they support that? It's not about checking a box should somebody come and ask. It's about really achieving that level of integrity and quality that they're all searching for

Boone: Day-to-day.

Wehner: Every day. You know, and I loved what Ericka said about ongoing and discipline-specific, because those are key as well, so that it's always at the forefront of your mind and it is delivered in a way and relevant to the groups that are participating in the training.

Kosub: So let's say we've gone and listened to this podcast, we've read all the materials, we've thought about it from all these different perspectives. We've actually put our thoughts on the paper, we've written our application. Now it's the peer reviewer's time. You know, like what are they looking at? Like, how can we get, you know, an insight into how they're reviewing these parts of the application related to the responsible conduct of research?

Boone: I think that I'll answer this question in just a slightly different way or perspective than what was asked. So as I stated previously, there are several basic areas regarding RCR that have to be addressed within an application. But with that being said, while RCR plans are rated as acceptable versus unacceptable, I would definitely caution investigators not to underestimate the value and the importance of RCR training and how it's discussed within the application in and of itself. So just as one with detailed future research plans within a research application, applicants should address or develop future, like, beyond like right now plans regarding RCR. RCR plans can address the evolving needs as trainees and scholars bridge from one career stage to the next career stage. So this can be a chance for how they're translating the fundamentals of RCR training into action. So for example, how you may be preparing as a mentor to ensure that your mentees will learn best practices regarding RCR, how your understanding of human subjects' regulations goes beyond just checking off boxes of regarding requirements, and how you'll ensure how your future lab will be organized from the beginning to foster an ethical research environment.

Kosub: Well, this has been very great. You've given us a lot of things to think about as it relates to RCR. Any final thoughts, any, you know, burning issues that haven't been touched on already or something you'd like to reinforce related to topic of responsible conduct of research?

Boone: Karen, you want to go first?

Wehner: You know, I think we've touched a lot on making it relatable, making it practical, making it something that is the way you live your life in the research environment and the way you conduct your research, and keeping that in mind, I think, whether you are developing training to deliver it or whether you're participating in it, I think will go a long way towards making it more effective.

Boone: I think that I just want to build upon what we've been talking about and establishing this theme around RCR that is not just a policy that includes a list of topics that must be strictly adhered to, but rather than that, it's consistent communication and education around RCR and infusing that into the research and educational experiences of trainees, of fellows, of scholars, that helps to foster trust within the research environment. And this enables scientists to work better together, and ultimately, this all helps to promote public confidence and scientific knowledge and its applications to protecting public health.

Kosub: anything we can do to enhance the trust of the research that we're conducting and supporting, I'm all in favor. Well, Ericka and Karen, greatly appreciate this time to learn more about, you know, responsible conduct of research and what people might be thinking about as they're putting together an application or thinking about RCR more generally. You know, for those interested, please do check out the resources we have available on our NIH grants site. There's a lot of information there to go through, so we encourage you to check it out. This has been David Kosub with the NIH's Office of Extramural Research's All About Grants. Thank you.

Boone: Thank you.

Wehner: Thank you.