 Marie just kindly showed the form up on the screen. Can everyone hear me? This is a big room. Put my mother's voice on. Marie just showed the proposal transmittal form up on the screen, but I've highlighted the bottom middle section, because what I'm going to talk about very briefly is IRB, and why am I talking about IRB? I'm not sure, but I have been on it for 12 years and I've reviewed a lot of proposals and I've also submitted a lot. So, please consider me your resource as you're developing, because I've done all the different types that are available. Well, you should also have a handout from me. It's called Grants and IRB Tips to Make Your Life Easier. I just went into the IRB site. They have a very nice website that has all the information you'd ever want to know, and I condensed it down to two pages. I passed it around the room. Everybody got one? Just slide in around the room, so everyone should have it. Okay. So, first tip on this sheet is that you should know what the granting organization's policy is. Do they require pre-IRB approval? Most do not, but the National Institutes for Health used to require that you had IRB approval in place. And those of us on IRB would get all these proposals to review because people were submitting a grant, and I think there was some pushback. And anyway, that's no longer required for NIH, but read the directions. I've written a lot of grants myself. Best piece of advice, read all the directions before you ever start. Know how to mark your grant proposal submission as far as human subjects. We, in extension, are kind of a different animal. I mean, we, the types of things we do, sometimes is research and sometimes is not. And we've had long discussions at our IRB meetings to determine if what we're doing is actually research or not. Well, my personal view on that is that if I intend to present, say, a statewide project, I'm gonna get IRB exemption or expedited review done because then I've covered all my bases. That's the easiest way to think about it. If you're simply asking your audience that you teach, did you like the coffee? Was it strong enough? Did some nutritionist put a bunch of healthy food on there and they don't like it? Not research, okay. So if you're looking at that kind of thing, don't worry about IRB. But if you intend to present it, go ahead and get the IRB. And another tip I also have on your sheet, I believe, I'll add it, don't be overwhelmed by the forms on IRB. There's a lot of paperwork, but often you only have to mark one thing and then you get to skip a bunch of categories and then go on to do it. So typically an exempt form usually takes me an hour or less to complete. They're pretty quick to do. Another tip, be sure that your training is up to date. Every three years you do need some training. One thing I run into all the time, particularly with county staff who you know, it's hard to keep track when you've had your three-year training done. It will get held up if the people listed as your research team have not had their training because that is checked. It will check on that. And if that person is not trained or up to date with their training, they'll stop it. And often I have to remove them from the research team until they get their training. So many of us in this room really rely on county staff to do our programming and our research-type projects across the state. So just something to remember for ourselves, keep our training up to date and also make sure staff know that. If you happen to be a thesis advisor, thought of this tip as I was sitting over here, I've also seen that if people do not realize that what they did was human subjects research, they will stop the thesis and I've seen chunks of a thesis having to be removed because they didn't have the proper documentation in place that what they did was research. And imagine getting your master's degree and suddenly you have to take a chunk out of your thesis. So be sure that you cover the basis. So again, some common delays for not getting your project or training documentation is not current. Information is incomplete or inconsistent. Don't have your required elements or your consent document. It's not printed on department letter again. That can stop things. And if it lacks some of the signatures that you are required to have. So just follow through all the different items. Don't be overwhelmed as I said by those forms. The exempt category is very simple to do and I would say for 90% of the sorts of things that we do in extension, we're gonna be exempt. Doesn't take long, very easy for you. If however you're doing some work with children outside of a school system, you might be in, you're very likely will be in the expedited or full board review. So just check with me, check with Terry or Christie and they're very, very helpful in determining what case you need to be in. So there you go, you can read the rest. I'm not gonna belabor all this, but. And let's see, one other tip, if I go back to the main sheet to the PDF form, use the current forms. They are subject to change regularly. And I have been guilty of grabbing an old form and updating it and suddenly I'm not on the right paperwork. So use the current forms and don't just put down a protocol because you have an IRB protocol for a similar project. Terry or Christie, someone over there will go and check that it matches and you'll get a letter. If you market pending, it's a nice one. If you market pending, you also will receive a letter because you cannot start your project until you have full approval. So if you market pending, you will get a little note unless you can spend money on the non-research. Yes, yes, so that's helpful. If you have some other preliminary things, maybe you're preparing materials and you're not gonna be engaged in research, then you can get going. So they'll make that available. So I'm happy to help you in whatever way I can. Don't be afraid of this process. If you've never done an IRB, it's not so bad. It seems like a lot of paper, but you do get to skip a lot of sections usually. You go on. Yes? The question is long for them. You had an Excel sheet at one point where people, when they were expiring, are you still keeping that up or someone? The Terry and Christie Shirley are kind enough to sort of keep almost a separate database for extension staff and help us with that. So they keep that now. And if their records show that you are expired, then that's what we go by and we have to do the training. Okay, and so the second question, you did one time with kind of our telephone. Are you doing that again? We cannot do it by phone. I mean, I cannot do it anymore. It must be Terry or Christie Shirley who does the training, but if you're in a bind, like you really need to have somebody get through this or a couple people, there is the online version. It's painfully long, but they have been very kind again to say, okay, if you've got a group of four or five, we'll set something up, we'll work with them. So they're very accommodating as much as they can be, but occasionally, if it's just a single person, we have to make them go online and do the online version. One more tip on the online version. Be sure you do the right one. Yeah, because I've got some of the students who work for me who's helped us with some of our research. They have to go through that. I've got some do the wrong modules and they end up spending hours on it. So we have to do the right modules. Is everybody gonna do it up on the conference again? Yes, every year at Fall Conference, we offer it. And that way, new staff consistently have an opportunity. And then every year, there seems to be at least one other time that somewhere along the line, we build up this need. Last year was the three years since we first did it. We had a massive group who needed to recertify. And so I anticipate three years from now, there'll be a massive group again. It's just kind of how we started it. But we try as best we can to get the opportunities out there. We do it at new staff orientation, try and catch all new staff there if they don't happen to make it, Fall Conference. Hey, kindly ask me to stop by. I'm Josie Hayden, I'm the Research Compliance Administrator for the IACUC, or the Institutional Animal Care and Use Committee on campus. So what I'm passing around is just, it's the NDSU policy because the NDSU policy supersedes all federal regulations in that some of your funding agencies may not require you to have IAC approval, or if you're depending on what type of research you're doing, there's one federal regulator that will say if you're doing biomedical, you need IAC. Another one is dependent on the funding you have to have IAC. The NDSU policy says if you are working with a live vertebrate animal for research, teaching or testing, you need to have IAC approval. So that's why I have that policy on the sheet there. Also what I have on there is the link to our website. So, what? Here, there's more coming this way. And on the bottom of that sheet are the contact information for myself, for Dr. Walden, the attending veterinarian here on campus, and for Dr. Neil Dyer, who is the IACUC chair. Quickly to go back to the PTF form, you're gonna check yes, if anywhere on your proposal it mentions the use of live vertebrate animals, even if you yourself are not gonna touch them or they're not going to be anywhere on an NDSU facility or they're not NDSU animals. If you are working with a collaborator who is doing all of the animal work at their facility, you still wanna check yes on that PTF. And the earlier you contact the IACUC, the faster it's gonna make your project go along. Because what I'll do at that point is start working with that facility's IACUC or whatever their oversight committee is to make sure they have it in place on their site. We have to follow the money. So if the money's coming through you to do animal work elsewhere, the IACUC here is still responsible for following that money and making sure there's oversight at that facility. So that's my tip to you. As the earlier you contact the IACUC office, the better it is and we're willing to work with you. Some agencies want something right away. I know the American Quarter Horse Association always wants something that you've at least submitted a protocol. And so I've worked with investigators in the past where we kind of just have a framework and we have a number and that's satisfied them. And then we follow up on the if it's funded. And I had five minutes, so I'm making it quick, quick. Does anyone have any questions for me before I sneak out? How many of you in here have worked with IACUC? So I know we don't have as many staff, but we do want to make sure that everybody understands how it fits. So thanks, Joseph. Thank you. Hello everybody. I think I know most of you. My name is Marsha Mazzone. And I'm here to talk a little bit about probably the newest compliance issue for those of you receiving government grants. And it's probably a compliance issue that we still have a lot to learn about, at least in agriculture. And so what I'm talking about is out of handout being passed out to you. I sent out an email on May 9th to all ag. So all of you should have received a copy of this requirement. But in mid-April, SPA or Sponsored Programs was notified that NIFA, National Institute of Food and Agriculture is also going to require a compliance with responsible conduct and research training. Previously it was only required for those receiving NIS and, excuse me, NIH and NSF grants. So this is something new that came down. And Terry Gross from SPA informed Charlie Hall and Jane Hsu, because each of those individuals had been responsible for some of the training or responsible integrity in research prior to their current positions. And so they told me about it. And I sent out that email on May 9th. And it was probably a good thing I sent out the email because I got a lot of good questions. So in the email it said, for recipients, new recipients of NIFA grants, they would be expected to have this training. So those of you that already have grants, my understanding is you don't have to apply. Or you won't be asked to give documentation that you've had that training. And so if you were a new recipient of a grant, there would be two options available at this time. You could either take an online training program called CITICITI program, and I've given the website. NDSU pays for this training. Again, they are already paying for it, so you could take it free. Or if you're on campus you could take a course that's taught in the fall. It's a team taught course. Jane Xu is one of the teachers at Glendorsen. And it's called Scientific Integrity. And you could take it as your one free course as a staff member. So looking into this requirement a little bit more, and I was not familiar with it, the city training online course has four areas, biomedical research, social and behavioral research, physical science research, and humanities research. And I really struggled trying to figure out how I as a pathologist would fit into those areas. You know, if you are doing microbiology work or work with animals, maybe you could do biomedical research module. But currently those are the four choices. And I think Jane Xu, of course, she took the biomedical research module. Are others going to be developed specifically for some of our other areas of interest? I don't know yet. Terry Gross from SPA has an inquiry into NIFA to see if she can get some more answers about how NIFA is going to implement this program. So that was one question I had. I just didn't think the modules fit very well. But there's also other universities approaching this problem, and the University of New Hampshire has developed modules that I thought were a little more apropos for us, but I think I asked Terry and she asked Kaye if we would be able to use something like this and I don't think we know yet. Yeah. And then the other part of this requirement, if you looked at the language, it sounded like everybody involved in the project had to be receiving this training. And so that was a question I had specifically from our research extension centers. You know, like the guys that feed my animals have to do it, do my summer help have to do it. And Terry had some information from the University of New Hampshire and their approach was that only those directly participating in the research, directing studies, collecting and analyzing the data, planning and conducting the experiment. And they did not feel that people that were peripherally involved would have to be trained, but that is still something that isn't completely clear. So currently, and I don't know if Kaye would agree with this, my advice would be that if you are applying for a grant, right now you don't have to do this training until you are awarded the grant and then if you are awarded a new grant, hopefully we will have some more answers for you by this fall. We have a new vice president of research being hired. That person hasn't been, I don't know who it is yet, I don't think we do. And once they are on board, we also hope that we can get some more clear guidelines and perhaps a new research integrity officer will be appointed and will provide more information. And Kaye, if you have anything to add, she is going to be developing some training seminars that perhaps will be supplemental to this information, but yeah, we're just talking about beginning a new seminar series that would be focused on research excellence and would cover some of the topics that have been identified, authorship, things like plagiarism, conflict of interest, and of course the IRB, IACUC issues, all of these would be potential topics. So it's all in discussion stage. So grad students? I think grad students would be required because they would be involved with research. How long does it take to go to the online class or of course experience with them? Somebody, I think Jane's shoe told me six hours. Yes? So it's only for new ones and we're like in year five? No, you don't have to. We don't have to. That isn't the way that the document reads new, basically. Well, so we have a formula for every year? Is that new or re-examined? It's not a myth of that. Oh, it's old. It's only for a myth of that. That's formula. So now if research area is outside of these four areas, so still they have to go through that training or only? No, everybody has to go through a training if you are a new recipient. It's just that those are only the four research modules that are available currently on this online program. Now, I think Kay and Terry and others, Ona and I, we would like to get together and talk about are there other opportunities, other modules such as the University of New Hampshire that would be available for us to take as well that I thought were more fitting for those of us in agriculture or in our disciplines. But so I hope we don't have anybody that's gonna be out of compliance between now and in the next few months. I don't think so. I know Frayne is asked about one of the questions. He has a grant. He's applying for it. He has a number of collaborators. He wants to know if they all need to be trained now before they get the grant. No. Find out if you get the grant and then we'll go for it. So if you write a grant and you put the participants or the PIs, co-PIs, and then later on you hire a graduate student that's not originally listed on the grant. Do they have, will they have compliance just to come back and see if you've added a new personnel or how do you know yet? I don't have experience with that. I don't know what they've done with NIH. My guess is that when we, at least IRB-wise, anytime that you change, you are responsible to see that those people are trained. Right. That's what I'm like. That's how it would be with IRB. I would, my guess would be the same with the year. So if I'm the PI and I bring someone new in to it, I'm responsible to see that they're trained too. And I do know respect to NSF and IH, again, I'm not with much at the NIFA, but those federal agencies reserve the right to come back to the institution, you know, and more specifically than, you know, look back at the departmental level on who has been trained and when, you know, that that is supposed to be tracked. I think my, my, my, this is all new to all of us, okay? But my thinking is based on what's happened in the past, our compliance people have been so good about helping us to get what we need. I mean, we don't have every extension agent doing the city training for IRB, which is three, four, five hours long either week. She comes and does the one hour for us. I mean, my perception is that we're going to be able to figure something out here, just bear with us and be aware, don't get caught that we don't, you know, do what we're supposed to do. But I have confidence that they're gonna work with us. Yeah, I kind of thought, after I sent this out that maybe I shouldn't have, but I really got good questions that made me think about it too, so. Marcia just has a follow-up. I know on that, that nymphogram that I just submitted, they actually included language in RFP to cover this. Oh, good. Because I looked at last year's application in the RFP versus this year's. It's essentially, they did add, you know, half a page discussing, yes, and I'm just kind of trying to make a requirement. Okay, so now you know about it. Yeah, so it's showing up in the RFP. Okay, thanks.