PI Roles and Responsibilities

What is your role as the lead PI of a sponsored project? What legal responsibilities do you have and how do you navigate the murky waters of federal, state, and private award requirements? Levi O’Loughlin from the Office of Research Assurances (ORA) and Cheryl Dykstra-Aeillo from the Office of Research Advancement and Partnerships help you explore these questions and more.

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Cheryl Dykstra-Aiello: Thank you all for joining us. I’m Cheryl Dykstra-Aiello, I’m a research development specialist in the Office of Research Advancement and Partnerships, and this is the office that sponsors these information sessions. So today’s session will provide you with information about your post-award roles and responsibilities as a principal investigator. Levi will be presenting the last half of this information session.

Cheryl Dykstra-Aiello: Levi, do you want to introduce yourself?

Levi O’Loughlin: Yeah. Levi O’Loughlin. I serve as your university biosafety officer and head up the Research Safety Program, all within the Office of Research Assurances. So I can talk to all the things you’ve got to do to stay in compliance. One of the things, as I’ve given this talk in the past, it’s just helpful to know: are you guys PIs? Are you research administrators? Are you grad students? Are you post-docs? Are you… Who who are you, so that we know what kind of questions to answer and try to direct this to. Lisa, you’re a research admin.

Levi O’Loughlin: Thank you. Research admin. Okay, so you guys… We got the PI and co-I. Okay, good. So the research administrators are some of my favorite people to work with because they’re always trying to keep the PIs out of trouble. And then obviously PIs and co-Is are trying to keep themselves out of trouble. So this is helpful information.

Cheryl Dykstra-Aiello: Thanks

Cheryl Dykstra-Aiello: All right.

Cheryl Dykstra-Aiello: So, the role of the principal investigator. So first note that the responsibility for managing an award is shared, but the PI has the primary responsibility for the technical success of the project.

Cheryl Dykstra-Aiello: So that also means complying with all the policies and regulations, financial and administrative, that are associated with the award. And while the PI might have staff to help manage aspects of the project, ultimately the management of the award is the PIs responsibility. So exactly how is the responsibility shared then? Well, so there’s various pieces of the Office of Research, and here’s an organization chart and we are here to help from pre award through the Office of Research Advancement and Partnerships. Your post awards.

Cheryl Dykstra-Aiello: And that’s the offices of Research Support and Operations, Research Assurances, Research Integrity, etc. And this is a list of the administration processes for research and the roles and responsibilities that are associated with each. I’ve taken this from the from the website, the ORSO website and the processes that are highlighted in red are what we’re going to talk about today.

Cheryl Dykstra-Aiello: The the pre proposal, the first four steps I won’t be talking about at all and we’ll go down to compliance issues. The last process on this list that Levi will be talking about. So the list that I just showed you was accessible on the Office of Research Support and Operations website and the link is here on the slide at the bottom of the Research Administration process page.

Cheryl Dykstra-Aiello: So on this slide, I’ve taken two screenshots from that web link just to show you kind of the start of this. And you’re going to note that also the Office of Research Support and Operations Team doesn’t administer sponsored project and awards alone. They partner with other WSU units, which I showed you some of them on the Office of Research Organization chart previously, and they want to ensure the compliance with regulations and policies.

Cheryl Dykstra-Aiello: So below the the roles and responsibilities piece of the screenshot, you can see that the individuals and units that are involved in research administration and these are the the the shared responsibility partners for the for the PI. So the PI has roles and responsibilities as does the academic department chair, the dean, the chancellor or vice president, ORSO I’ve already mentioned, the Office of Research Advancement and Partnerships.

Cheryl Dykstra-Aiello: I’ve mentioned sponsor programs and services or SPS and the Office of Research assurances. And to the right of the slide is just a screenshot of one of the matrices that you can find that are attached to the list that I previously showed you. So let’s talk about then the roles and responsibilities associated with accepting the award. Most of the responsibility for this process lies with or so you’re going to note that there is a “see note four” on this screenshot of the matrix.

Cheryl Dykstra-Aiello: So it states basically that the the terms and conditions well and ORSO responsibility always involves the PI so that the PI is aware of any changes that are made and is in agreement with the changes. So the PI is still involved in the step and along with the award there’s some regulations and policies that need to be followed when the project is awarded and this is just a list with links to them.

Cheryl Dykstra-Aiello: There are federal policies, state policies and institution specific policies, and it’s always necessary to check agency guidance.

Cheryl Dykstra-Aiello: So this slide is very important to note that when an award is accepted, only an authorized signing official can sign and accept the award on behalf of W, WSU And these officials include the university president, vice president for research and Matt and Dan are listed in ORSO that they can…

Cheryl Dykstra-Aiello: That they’re authorized to sign. Common clauses in contracts that can cause problems include contracting limitations as a state agency. Confidentiality, liability issues, intellectual property and technology transfer, data rights and security obligations and publication restrictions. And I’ve got a big warning sign on this, because if a PI, who does not have authority signs the award or anybody who doesn’t have authority signs it, you can actually be liable for any damages that result from that.

Cheryl Dykstra-Aiello: So there are also contracts with industry and some of these include a sponsored project agreement or an S.P.A.. It has a set of standard terms and conditions that are frequently utilized by the university: full F&A costs apply. WSU retains ownership of the intellectual property that’s developed, but the industry partner has access to the results and they can obtain a license option.

Cheryl Dykstra-Aiello: There’s a broad industry project agreement or BIPA. It’s a simple, non-negotiable, one page agreement that provides a partner access to the results of the work. But there’s no option for the intellectual property rights. There are no F&A charges. Although the projects can incur a project fee, of which half of that returns to the lab for the lead faculty, and there’s a maximum of $40,000 for the project.

Cheryl Dykstra-Aiello: And then finally on this slide, there’s a contracting acceleration program or a CAP that allows industry sponsors and WSU researchers to choose from a variety of upfront licensing options for intellectual property that results from sponsored research projects. These agreements work best for highly applied projects in which the expected outcomes specifically benefit a sponsor or improve or refine a sponsored project product or offering.

Cheryl Dykstra-Aiello: There are also non-monetary agreements, and some of the common ones are listed here. I’m not going to read through the whole thing, but there are templates for these agreements on the ORSO website and the link is there. You can also email ORSO if you have questions about these. So once the award is accepted, it needs to be set up.

Cheryl Dykstra-Aiello: And here again there’s a matrix that is involved with this award set up where you can see who has the responsibilities for most of the administrative responsibility for this step involves SPS, Sponsored Program Services, but ORSO is also involved. They try to help SPS by recording the award information for tracking.

Cheryl Dykstra-Aiello: So once the award’s set up, then we talk about sub-recipient monitoring.

Cheryl Dykstra-Aiello: And again, there’s a matrix to show who is involved in which pieces of this process. And you should note that sub-recipient monitoring is a shared responsibility between the PI, ORSO, SPS, and the PI’s department and while the PI and the department take on the hands on piece of the task of monitoring the sub-recipient, ORSO and SPS, make sure that the monitoring procedures are compliant with regulations and policies.

Cheryl Dykstra-Aiello: So at the setup, the PI should work with the research administrator to prepare and submit a sub-award initiation sheet. And this is… there’s a link here on this slide that will take you to the template on the also website and that sheet along with a copy of the proposal document, should be sent to ORSO once the award has been funded.

Cheryl Dykstra-Aiello: The PI is the communication facilitator between ORSO and the sub-recipient PI and/or the grants office. And on the right side of the slide, you can see that the various forms, template forms that can be found on the ORSO website.

Cheryl Dykstra-Aiello: So as I mentioned, sub-recipient monitoring is a federal regulatory requirement. Again, I’ve got a link to that regulation.

Cheryl Dykstra-Aiello: So monitoring involves reviewing project task progress by the sub-recipient. So in some circumstances you might actually want to consider visiting the sub-recipient’s site. The PI is responsible for reviewing and approving the sub-recipient progress and final reports. The invoices. For invoices you want to work with the research administrator and SPS and if changes need to be made to the sub-award terms and conditions to work with ORSO.

Cheryl Dykstra-Aiello: So for instance, if there are time extensions needed or changes to the scope. You need to rebudget, then work with ORSO on these things. And if there’s ever a de-obligation, the PI should communicate first with the sub-recipient PI before any changes are made. And again, there’s a guideline through ORSO that I have provided a link here for you.

Cheryl Dykstra-Aiello: So the award management and maintenance is actually the last administrative process that I’m going to cover before I hand it over to Levi, and he probably provide a lot more information than maybe I’m getting through here for you. But definitely if there are questions on anything that I have presented, reach out to ORSO. So award management and maintenance matrix.

Cheryl Dykstra-Aiello: So again, I’ve lifted this from the website, and as you can see, it’s much longer. It’s a much longer list. There are three different screenshots here showing the involvement between ORSO, SPS, the dean, PI’s department. So yeah, we’ve definitely got shared responsibility for these processes. So under this process is the PI and that there’s a responsibility for developing, designing, conducting the research program, completion and submission of necessary report, including continuation and renewal proposals, technical reports, financial reports and those… the last… financial reports you should definitely work with, the research administrator and SPS fo submission. Also work with research administrator and ORSO if you need to modify the award as I previously mentioned, PI is responsible for project management

Cheryl Dykstra-Aiello: and delegating where appropriate, but always maintaining adequate control. And the PI is responsible for dissemination of the results, including publications and presentations and continuing on with these responsibilities. PI is responsible for training everyone who’s involved with the project. So students, postdocs, other staff including the Responsible Conduct of Research training, that’s a requirement by many funding agencies, appropriate microbiological safety and clinical practices, training, safe and ethical conduct of research following university policies and federal regulatory laws.

Cheryl Dykstra-Aiello: And there is a CITI training that’s available for this. The PI needs to comply with shipping requirements for hazardous materials, infectious substances, diagnostic specimens, and recombinant DNA molecules. And finally, the PI needs to make sure that everyone who is involved is aware of the terms and conditions that are associated with the award, including such things as non-disclosure agreements, material transfer agreements, deliverables, etc..

Cheryl Dykstra-Aiello: And now I’m going to hand it over to Levi to talk about the PI’s roles and responsibilities with regard to compliance issues.

Levi O’Loughlin: Okay. Okay. So as we transition to the compliance aspect of this, I have a very serious question I wanted to ask you all: What do you call a fish wearing a bow tie? It’s soFISHticated! Nothing? Thanks. So my my half of these slides, I’ve got about 15 slides here, and these are just real brief overview of all of the things that a PI has to do to make their lab successful.

Levi O’Loughlin: Should they work with some of these, Some of them won’t apply. Right. So the first one there, IACUC: if you’re not working with animals, this doesn’t apply to you, but these are just the way we’ve set this up, as these are all the broad compliance things you likely would need to do. They won’t all apply to you, but some of them do apply to every person, so we’ll pop through these one at a time.

Levi O’Loughlin: This is just a broad overview of them. So the first one in our office, in the Office of Research Assurances is we house a number of presidential committees. So these are committees that are going to approve research. They’re typically made up of other faculty at the institution. Sometimes we have outside members based on the rules, if we have to, or community members, and they will review what the research proposal is and they can vote to approve or not approve certain research.

Levi O’Loughlin: And these committees have quite a bit of power. I don’t know if you know the structures of level one through four committees, but all of the presidential committees are two. So that means, you know, like at a college level committee, they can’t overturn this. So your dean can’t be like, “hey, we really want to do this research and the IRB said, no.” It really has to go through these committees.

Levi O’Loughlin: So the first one is IACUC. Cheryl?

Levi O’Loughlin: There we go. So the IACUC is the Institutional Care and Use program. They’re going to oversee all use of animals. It’s administered by the Animal Welfare Program. And so those four people on the slide there, they’re really just looking out for all critters. WSU fluctuates, but on average, we have about 70,000 animals that go through research.

Levi O’Loughlin: Most of those are zebrafish or rodents, but we have everything up to grizzly bears, right? Ensuring that they have good hibernation and nutrition studies. And so anybody that works with an animal, if it’s on this campus for more than 12 hours and it’s not client-owned, this doesn’t include like the vet teaching hospital, you have to write up a detailed plan of how you would work with this.

Levi O’Loughlin: And any of these people can help you. The links at the bottom there. And then Alan and his team will be able to assist with anything that comes in terms of where they’re kept, where they… what you’re doing with them, just making sure that the animal is healthy, happy and for all all of your research needs. So that’s the first one.

Levi O’Loughlin: If you use animals, you have to do this. It is a contract. So once this gets approved, any changes have to go back through the IAB… or IACUC. IRB is the exact same way though, so IRB is going to be the next one. These are alphabetical. They look at human subjects and so similar to IACUC, anything you do with human research participants has to go through this board.

Levi O’Loughlin: The team will look at this and make sure that there’s respect for persons which is there. The research also has to benefit them and then that there’s a justice for all so that it wouldn’t just specific one group of people or any other. So they they’re guided by general principles. But both of these last two committees, they do have laws behind them.

Levi O’Loughlin: So Congress has worked to make sure that these committees are structured the same way as across all institutions throughout America, that they have the right expertise to review this. So diabetes is one of our biggest committees — it’s got to be one of the biggest at the institution. But they’re going to look at everything, right? If you are working with somebody in prisons, they have to have a prison expert, whatever it may be in.

Levi O’Loughlin: This includes surveys, it includes funded research, unfunded research. Their volume is greater than anybody else.

Levi O’Loughlin: Next one should be IBC… Ah, yeah, it’s Research Safety Program. So we combined a bunch of other things that ORA does into one unit called the Research Safety Program. And so this is going to have the IBC, Rad Safety, Export Controls, HAZMAT shipping, and then RCR in it.

Levi O’Loughlin: And so you have all the contact there. I’m going to be your contact for just as the program associate director in anything biosafety but really shipping is going to be Doug and Ryan and then radiation safety is going to be Ray McGehee. He’s our radiation safety officer for the institution. And then Braden, John assist him with the operations in the export controls.

Levi O’Loughlin: Doug is our export control officer in RCR. It’s kind of a shared program between us and ORSO. It’s just making sure you guys are trained every five years. Okay. So the next slide should be IBC. Yeah, there we go. So the IBC is a little bit different than those first two committees I talked about. They’re still made up of faculty members and community members that are going to look at biologicals, but there’s not law behind this.

Levi O’Loughlin: Congress didn’t do anything. So and that’s a good thing because scientists created this for other scientists to be able to review this. And what that allows us to do is make changes as new technology comes out. So as CRISPR-Cas9 came about, we were able to respond within months, whereas, you know, like FDA, the rules haven’t changed since the seventies.

Levi O’Loughlin: So because it takes a lot of effort to do that, whereas on something like this, it’s easier. So they’re mandated by the NIH guidelines. They are voluntary to participate. But what voluntary means is if you want NIH money, your institution has to participate. And we like NIH money because they give us hundreds of millions of dollars. So we we do this, all research would go through this with biologicals.

Levi O’Loughlin: And that’s going to be people always think bloodborne pathogens, but it’s more than that. It’s anything involving recombinant materials. So adding DNA, RNA, cloning, transgenics, intentionally genetically altered. Also, infectious agents, whether it’s to individuals like people or animals or plant pathogens, anything that could harm or modify what’s the acronym they always use. It’s a me, the sea, or a tree or something like that.

Levi O’Loughlin: Any of that would have to go through this committee. And all of these committees typically meet once a month. There are some various ways that you can navigate those without having to go through full board, right? IRB has an expedited or an exempt. IACUC has a designated member review, but this committee does meet once a month and as the slide shows, it’s really risk based.

Levi O’Loughlin: So the committee’s going to look at both containment and safe practices. So they’re going to make sure that the facilities we have, whether it’s a laboratory, a field, a studio space, that it’s appropriate for these kind of activities, and then that we’re working with it in a safe way. So, you know, if you need PPE, if you need a certain type of HVAC in that building or if you need some kind of containment for that, that those are all appropriate measures.

Levi O’Loughlin: And I think that brings us to our last committee. Ah no, I did Shipping, man! I organized these, I think all by alphabetical. So shipping is going to be the next one. So shipping shipping is interesting, about a decade ago, the university did not have a centralized shipping program and we had violations. And the violations where we could either pay money or we could invest money into a shipping program.

Levi O’Loughlin: So we invested in a shipping program. And so most of the shipping does occur on the Pullman campus. What we have is that number at the bottom there, you call that number, and it’s just a turnkey service. We’ll help you get it packaged up. We’ll help you get it shipped, we’ll get it sent out. Once it’s out of WSU, though, we don’t have control.

Levi O’Loughlin: So once it hits FedEx or UPS or anywhere else, it’s no longer WSU’s. We’ve passed it off to the courier. How this happens for other campuses, although you do have a shipping coordinator on the Spokane campus, every other campus has these. For the most part. There are some extension centers that don’t. So the Mt. Vernon Extension Center still drives things to Pullman to be shipped. And the the difficulty of this is the rules and regulations are really meant for manufacturers.

Levi O’Loughlin: So if you make one widget, one device. Think Dell computer, right? They have a couple of products that have lithium batteries and they ship them the same way. At a research institution, were shipping and all kinds of stuff. So I’ll reach above me because people always want to know, well, is there just a list of things? Here’s a list.

Levi O’Loughlin: This is what is regulated, shipped by air. And if you’re interested, it’s a slightly smaller book, but this is what’s regulated by roadway. So it’s really just navigating those rules and trying to help you do it. We can, in certain instances, train you if it’s a single item, right? If it’s always dry ice, we can train you how to do that.

Levi O’Loughlin: It’s always a lithium battery. We can train you how to do that.

Levi O’Loughlin: Yeah. And so some of the other locations, like Othello, we have a research station, so some of the places might have a trained shipper because it is somewhat cost prohibitive. Each course is a couple hundred bucks and training only last two years and you’ve got to recertify and redo it all.

Levi O’Loughlin: But yeah, if you have any questions, these people can help you get it right, get you the right packaging, labeling, all that kind of stuff, and then make it successful so that it actually does go out. And some of these packages are real simple. Some of them are very complicated, especially if they’re international shipments, because import rules of different countries are all over the place.

Levi O’Loughlin: Some things that we can ship really easy to Europe are very difficult to get into Canada and vice versa. So it’s nice having people that have done this for a couple of years. I think both Ryan and Doug have done this for at least half a decade, if not closer to a decade. And so they’ve seen a lot.

Levi O’Loughlin: All right. So next slide. If this is alphabetical, yeah export controls. Export controls is going to be any item that is exported or any deemed export, which means foreign national or the regulations call them foreign persons. So if you have an individual coming and joining your labs from a different country, there could be export control concerns based on what you’re working with.

Levi O’Loughlin: So what’s complicated about these regulations is three different federal agencies that oversee this, and they’re going to regulate the release of either the technologies, commodities, softwares, or the ideas of these the understanding of these items. So it’s not just physical items. It’s also going to be the research involved with them. And so we can work through that with you.

Levi O’Loughlin: It can be what you’re working on and it can be the country of origin of these individuals. So US and Canada, very good friends, easy to work with. US and, I don’t know, North Korea, those ones take a little bit more work because we want to make sure that the technology isn’t controlled, that the US hasn’t embargoed anything or limited involvement with those countries.

Levi O’Loughlin: And so we’re just working with that. Those collaborations based on… Our biggest is going to be what is called a deemed export. So it’s other individuals coming to WSU to do research, which is exactly what we want, right? We promote that. That’s part of our mission. But the export control rules have us do a couple of extra checks.

Levi O’Loughlin: So when you think there could be something there, contact us and there’s that link at the bottom there. What we’ll do is we’ll run them through a various screening tools we have. Sometimes we can develop a technology control plan. In most cases we can make it work or we can do just a portion of a project. So they don’t know in the entire project that they’re working on.

Levi O’Loughlin: There’s ways to do this successfully if you need. The other one is when you travel and give talks, if you ever give a talk and like an embargoed country. So last one, we had, we had a faculty member travel to Iran. The US and Iran don’t always see eye to eye on everything. And so there was we wanted to make sure that we weren’t bringing technology in there, that the US controlled

Levi O’Loughlin: And one of those technologies was anything Microsoft has built. So that was very complicated, right? So we ended up bringing in just a flash drive with a PDF of the PowerPoint on it. So there’s ways to do that when you travel again, once you’re off US soil, it gets a little complicated. So sometimes we can have have departments give a loaner laptop because you might not bring everything back with you that you think you’re going to bring back with you.

Levi O’Loughlin: And so it just kind of an education. We have a couple of modules that we can train on that there are some CITI trainings, there are some other trainings on exports, but they’re very complicated rules. And again, Doug can help you with this because he’s been our export control officer for, I think, eight years now. The average lifespan of most export control officers is three.

Levi O’Loughlin: So WSU has one of the more senior individuals, which is great. All right. Next one is foreign influence. Yeah. So undue foreign influence is typically what we’re talking about. But foreign influences is going to be pressure any outside entity outside of the United States to interfere, to influence, to change our research purposes. So we as an institution have to run our collaborations through.

Levi O’Loughlin: We have to disclose who are collaborating with to sponsors. Often, if you’ve heard of the Mike Lauer letters, so a number of institutions didn’t have proper disclosures of these, and they just want to make sure that if we are working with other entities, which we often do, that that is fully disclosed and it’s transparent to both our funders, our regulators, and then for auditors as they come through WSU.

Levi O’Loughlin: So this is something that kind of the Office of Research does mostly on your behalf, but we do need the PI to disclose if they are working with outside entities. We often meet, I’d say quarterly with the FBI, they just check in with us and make sure that we don’t have any undue foreign influence. We’re aware or research of concern, so we’ll kind of talk through those things.

Levi O’Loughlin: If you are ever interested in this or have any questions about this, you can reach out to me. But we do typically bring our FBI contact through either research areas of concern or things that they’ve heard, and they might ask us questions. So questions are typically like animals or in engineering, especially if there’s going to be some kind of ballistics or anything like that.

Levi O’Loughlin: Those are the things they’re typically concerned about. It’s really not, you know, in plants or in the other areas. It could be precision agriculture, I think was the last one we had using drones, but it’s not necessarily in specific fields. Okay. Next one is tech transfer, right? Yeah. There you go. So tech transfer is going to be not in ORA, but this is going to be with the Office of Commercialization.

Levi O’Loughlin: If you’re a PI or even a research administrator and you see something really cool your college is doing, your department is doing, you want to talk to the tech transfer office. So talk to Office of Commercialization. It’s best that you can do this before you’ve publicly talked about your discoveries. So before you bring it to a conference or publish a paper or a poster on this and what they can do is they can help you patent this and commercialize it potentially.

Levi O’Loughlin: There’s a handful of things that WSU has done really well. I mean, Cosmic Crisp is one of those, right? So a great apple. It’s really helped the state, helped WSU, helped the PIs that came up with it. So there’s there’s ways to patent these and then there’s also a material transfer agreement. So if you ever want to ship strains or ship plasmids or isolates or things, Yeah.

Levi O’Loughlin: And you’ll get a copy of these slides. Steve you want an MTA for outgoing and incoming and we’ll review those to make sure. So I see the incoming MTAs to make sure that you have a containment lab if you’re getting like a strain of something. So I’ll look and make sure that you know, if you have biological were receiving that properly and other institutions want to do the same thing.

Levi O’Loughlin: So you want to transfer things with the MTA. There. Everything else is just resources. So part of the faculty manual and then the BPPM there. So next slide’s radiation safety. We do have a handful of people that work with radioactive materials. We have about 70 faculty members that have authorizations to work with either radiation producing materials or machines or radioactive materials themselves.

Levi O’Loughlin: A lot of these are rad chemists, some them are engineers, some of them are, you know, WSU Creamery has a X-ray machine to make sure that all the cheese has nothing but cheese in it. We oversee that to make sure that nobody’s getting a bad dose. So the principles for working with radiation safety is, again, just like the other committees, you would fill out a form, they would review it.

Levi O’Loughlin: You can disclose this in the eREX, much like Lisa talked about for the other one with IRB on surveys, you would disclose that you’re working with radioactive materials and then a committee of experts would look at this and really they’re going to make sure that you’re not going to dose that there’s time, distance and shielding. So you get what is known as ALARA: as low as reasonably achievable dose of radiation.

Levi O’Loughlin: And so we’ll badge you, we’ll shield you. We’ll make sure that everything that you’re working with stays in the lab and stays contained. And then that bottom right picture there, that’s the nuclear reactor in Pullman when it’s pulsed. So it’s kind of cool. If you guys have never done a reactor tour, it’s worth it. Next slide, EH&S.

Levi O’Loughlin: So our office has… of ORA. We have biosafety and rad safety. EH&S has all the other safeties, so they’re going to look for handling safety. Both lab safety, but also like campus safety. They’re going to be involved with chips… slips, trips and falls, making sure that facilities is removing snow in the right places, all the other safety environments. In a research setting, that’s going to mean that your lab is built for your research.

Levi O’Loughlin: If you are doing any kind of chemical work that you have a chemical hygiene plan. If you’re going to work with human participants, that it’s safe for the participants to come into those spaces. And so they’ll look at everything there. These are also the individuals that check food temps at Cougar football games. There’s a typo on that bottom on that oversee occ health, but they do have oversight of occupational health for the institution and so will contact them to make sure that people are working with animals if they need a respirator to do that, that they could be fit test on that or anything like that.

Levi O’Loughlin: So our office works pretty closely with EH&S just to ensure that research is successful. But they’re the principal ones in charge of your chemical hygiene plan. So reach out to them directly in the Pullman EH&S, much like our office, they do help other sites. So Olga, hopefully you’ve seen them. Lisa, hopefully you’ve seen Pullman EH&S helping you guys as well.

Levi O’Loughlin: The next one is financial conflict of interest. Thumbs up. Good, Lisa. FCOI is going to be anything that’s significant and if I remember right, significant means over $5,000. I don’t know, Cheryl, does that sound right to you? I think it’s all involvement over five grand.

Cheryl Dykstra-Aiello: I haven’t heard of a final amount. So. Okay.

Levi O’Loughlin: But this is if you have some kind of conflict of interest, you have to disclose this to both funders and the institution. And what they’ll do is they’ll do a conflict of interest management plan. And this just helps make sure that both your research at WSU and the research that the company is going to do or the product company is going to do is successful.

Levi O’Loughlin: So one of the examples I give is in CVM, one of the investigators came up with a really great antibody that made a really nice diagnostic tool to be able to screen dogs for a certain genetic phenotype. They went to commercialize and there wasn’t really a good place to do this commercialization. So now we just do it in-house through CVM.

Levi O’Loughlin: So we get samples shipped to us, they screen them for diagnosis and then back out and it’s a service center set up and it works really well for the investigator. Her product is out there. It works well for the institution because we’re able to fund positions and personnel doing this. You can think of the baseball bat lab. They do the same thing as a certified baseball bat.

Levi O’Loughlin: The MLB or whoever it is pays to have these bats certified and it funds positions. So there’s ways to do this and have everybody successful in within WSU’s facilities within these research spaces. So contact the FCOI, You got the two links at the bottom there. You can contact them if you have anything that’s good. And this also works really closely with the Office of Commercialization.

Levi O’Loughlin: So if you’re going to commercialize anything, anything, these two will go hand in hand and they’ll help you be successful at both. RCR Okay, so RCR is something that every person who touches research, whether you’re an administrator or a PI you have to do RCR and the way we do that is we log it through the MyResearch database, but it actually the slides are on CITI, which is a collaborative institute.

Levi O’Loughlin: Multiple institutions throughout America use CITI because we all have to have the same kind of training on research and RCR covers various topics. I think we have five modules in CITI. There’s going to be one for biomedical research, there’s going to be one for administrators and you just pick the one that based on title sounds closest to what you do.

Levi O’Loughlin: So administrators isn’t going to have anything on it about publication ethics, right? There’s they’re not really going to have any authorship. But if you’re a PI, you want to make sure that you’re trained in authorship, disputes and how to navigate those rules and regulations. So the modules change a little bit based on what you pick. The biomedical one has a little bit more on kind of recombinant materials and how that would work.

Levi O’Loughlin: And then I think one of them have the animals in it, but not all of them. Do you have to take these some places, do it a little bit differently. So the Spokane campus has a in-person course that once a month they meet and they go through and they do responsible conduct of research topics. I think it’s over a lunch period and in a year they cover everything and they just keep doing that on cycle.

Levi O’Loughlin: But that’s because certain grants require you to do it a little bit differently. So the rest of us have an RCR module and you’ll get reminded for this when you’re about ready to be due. It’s now logged in through Principio. We’re trying to make Principio work with all trainings. It’s slow going. When HRS changed into principio, there, there was a little bit of difficulty in understanding how how hard it would be to merge all the various trainings.

Levi O’Loughlin: But we’re aware of it. We’re trying to make it easier on you. Until then, you’ve got a couple of things you’ve got to log through, which is tough.

Levi O’Loughlin: Next one Research Misconduct. So obviously research is difficult, but any research you publish, it has to be truthful, has to be ethical, has to be good. So research misconduct is a program that every institution must have that receives PHS funding. There are some other rules and regulations. So USDA has their own version of this, but most of the policies are driven by PHS, and for research misconduct

Levi O’Loughlin: It’s really fabrication, falsification and plagiarism. They call it FFP. Almost always those are what the cases are. So fabrication is going to be making something up, right? You’re making a data, you fabricate it out of nothing. Falsification is going to be you manipulate it, you make the line look a little better, you make the blot a little clearer.

Levi O’Loughlin: You make the plant look a little bit better than it actually should. So it’s kind of manipulating that research record or highlighting only the good data and none of the outliers. And then plagiarism is going to be just taking another person’s idea. These three are the ones that WSU typically receives. I have some statistics on there. So, we probably have about five-ish cases a year that we talk about.

Levi O’Loughlin: Not all of them end up being RM. Some of them end up not, but we can help you evaluate that. And it doesn’t have to be published. It doesn’t have to be a faculty member doing it. I will say it’s a very process intensive organization or committee or structure. I guess structure is probably the right word. So most RM cases take at least six months, and that’s because we charge other faculty members who are subject matter experts to review this.

Levi O’Loughlin: There is a assessment phase. There is a inquiry phase, and then there’s an investigation phase. And so it’s process heavy because it’s got to be the same whether you’re a Regents tenured faculty member who’s been here for a couple of decades or you’re a grad student, it’s the same process that you have to go through. So if you can as a PI, a lot of these are resolved more easily within your own lab or your own unit.

Levi O’Loughlin: But if you need our assistance, we’re happy to do it. The last one there is serious deviation from accepted practices. PHS has one recorded case of this actually happening, you know, involved really people being the worst, being fairly abusive during research. So that can happen. But for the most part it’s FFP. HRS and CCR like me to highlight that WSU is equal opportunity and so that you got to train for any harassment, for bullying, for any of the bad things that people can do.

Levi O’Loughlin: We don’t like to do those things at WSU. So this training I want to say you have to do it annually to refresh your training. And then every five years you have to do the full slide deck. This was initially in-person training. Now it is a online modules that you complete. They have some quizzes afterwards. You kind of go through some scenarios.

Levi O’Loughlin: They’re good trainings and it just ensures that there is no harassment, discrimination or bullying at the university.

Levi O’Loughlin: Sharyl Kammerzell, again, our chief risk compliance officer, asked us to add public records and state records here. So the state of Washington is the second sunniest state in the Union following New Jersey. That means that everything we do should have some level of transparency.

Levi O’Loughlin: So I put a quote there. This is straight from the open government, the OPMA: Open Public Meeting Act and Open Government says that any public officials elected or unelected, for the most part, we’re all unelected, have an obligation to explain their decisions and actions to the citizens. So this is achieved… We would be in the administrative here designed to prevent corruption and ensure that public officials remain answerable and accessible to the people they serve.

Levi O’Loughlin: So because we take state funding, because we have state taxes and grants and awards that support, we try to keep everything fairly public. So if an individual requests a public record through our public records office, they can request all of your emails, all of your voicemails, all of your calendar. You turn those over to these people, they will redact what they can, but redaction’s fairly limited.

Levi O’Loughlin: If you’re a state employee, it really comes down to some contact information. If you’re a student, it’s much more protected because of FERPA. We can redact a lot of things, but just know if you’re using state resources, these can be requested to be reviewed elsewhere. So where this comes up often is every few months we get public records requests for everything we do with an animal at the institution.

Levi O’Loughlin: And so we would talk about what the animal welfare program does and we would try to keep everything that’s what they call intellectual property. So anything in a like IACUC form, those can be redacted, but otherwise and just be aware that that can happen.

Levi O’Loughlin: So state ethics at the bottom there after public records, this is just to ensure that all conflicts of interest are covered, that if you’re using state resources or you compensated for outside activities, that you’ve gone through that state ethics training.

Levi O’Loughlin: I think Adam Malcolm, one of our attorney generals, he he’s typically done this. I assume he’s still doing it, but you have to go through one of those trainings just so you don’t misuse any state resources. That was the last thing I needed to say there.

Cheryl Dykstra-Aiello: All right.