Speaker 1  0:11  
Music. Hello and welcome to today's autumn webinar, mastering the balancing act of managing conflicts of interest. My name is Don vo Young. I'm a member of Autumn's educate team and today's staff host. All lines have been muted to ensure high quality audio, and today's session is being recorded. If you have a question for the presenter, we encourage you to use the Q and A feature on your zoom toolbar. Should you need closed captioning during today's session, the Zoom live transcript feature is turned on and available on your toolbar. Before we begin, I would like to acknowledge and thank Autumn's online professional development sponsor, Marshall garstein, we appreciate your ongoing support, and now I would like to introduce today's session moderator Dan benderly,

Speaker 2  0:57  
hi everyone, and thanks for joining us. First introduce myself and then our panelists. My name is Dan benderly. I'm an associate director of new ventures at workers University. I've been with the university about five years, first in a licensing role and then moving into new ventures as part of that role, facilitating the launch of new companies based on workers innovations in research. I've I kind of Sherpa those teams and our faculty members and students through our COI process that we're going to be talking more about today. I'd like to welcome our panelists. We have Hila Feldman Berger. She serves as the Assistant Vice President of Research Regulatory Affairs within the office research at Rutgers. At Rutgers, hilan and her team led the final stages of the hrpp accreditation for the hrpp program. Her experience spans institutional research, compliance, enterprise system development and university wide policy development. Rob marriage works for the office of Vice President for Research at the University of Virginia. He is the current chair of the UVA financial conflict of interest committee and sits in the UVA licensing and ventures group office prior to joining UVA in 2007 Rob worked as a commercial litigator and served as a legal counsel for two large publicly traded companies. Before I hand this off to Elon to kick off our section, our session, I'd like to start by noting that the views and opinions that we'll be sharing this webinar, webinar are our own, and based on our our professional experience and expertise, they do not necessarily reflect the official policies, positions or opinions of workers university or the University of Virginia. This presentation is for information and educational purposes only. So with that, Hila, I'm going to hand it to you to start, and then we'll get into what I hope will be an interesting discussion.

Speaker 3  2:53  
Great. Thanks so so much to Dan for agreeing to moderate for us today. And this really is a session that's going to rely on all of you to submit questions through the Q and A. Q A, please don't wait till the end to submit those questions. If something pops up for you that you would like to inquire more about, please enter those into the Q A portion of this session, and we have ample amount of time in our session outline for Q and A with our Moderator. So we're going to start off today, and just to give you a road map of what we'll be going through a really, really brief conflict of interest foundation. This is just to ensure that everyone's on the same page when it pertains to conflicts of interest, we'll go over the differences and similarities in our institutional disclosure processes based on the experiences that Rob and I both have at our institution, with disclosing overall and we'll talk a little bit about committee structures, and then focus in on topics such as conflict of commitment cases or startup conflict of interest cases. And so a little bit of time there for some of the experiences that we've had, managing conflicts of interest, and then we'll move into the Q and A portion of our session. And so we're really relying on our participants to submit questions. So just a really brief description of what is conflict of interest, a situation in which there is potential, it's not always real, but there is potential for an individual's personal financial interest to impair and potentially impair their judgment in the execution of their responsibilities to the university. And so if we were to dive a little bit deeper into that definition, I'm just going to share with you a little bit more about some foundational points related to conflict of interest. The individual could have a conflict of interest that is personal financial or other considerations like serving on a board that might compromise or buy. Is their professional judgment and objectivity in research education or decision making. And again, I want to lead some of these conflicts of interest are very much real, and some of them are the perception. Why is the perception really important? Because of that impact on public trust? So key areas of COI that I want you to be thinking about through this presentation in helping you facilitate, how do I recognize these conflicts of interest? How can I work with my counterpart? Parts in research compliance around conflicts of interest, if you encounter a situation that indicates personal financial gain for an individual so a faculty member that might have equity, a faculty member that might be receiving consulting fees or gifts from different entities. Those gifts could come in the form of equipment. Those gifts could come in the form of materials. Those are all personal financial gain time points where you want to be able to recognize that potential or perceived conflict of interest for a lot of institutions, that extends to the involvement of close family members, so research relationships that might impact close family members, such as a partner in the household, could also be an area of perceived conflict of interest. And then something that comes up quite frequently is dual roles of that faculty member, so the faculty member holding a position at the institution while also serving in some additional capacity with a private company. So those are all key areas of potential, either real or perceived conflict of interest that we all want to be familiar with. This is really important because of the high level of scrutiny on academia, we want to make sure that we're not undermining public trust. There's been a lot of pew data around the adult population in the US fully perceiving that scientists have and are regularly have conflicts of interest that may impact the research design, being able to talk about with the public, the fact that we have these conflict of interest management processes is really important for public trust. There are risks to biasing research outcomes if conflict of interest is not managed, and the integrity of the peer review process could be impacted without really transparent and full disclosure of any potential or real conflicts of interest. The impact on those individuals that work in the tech transfer space is your ability to partner with research compliance professionals such as myself, individuals that might chair conflict of interest committees or your partners in new ventures to help identify those cases where there could be potential or perceived conflict of interest, and helping facilitate a conflict of interest management plan that could be put into place To protect, again, ultimately, the public trust in research. Two federal regulations that I wanted to make sure as a foundation we are aware of is our public health service has 42 CFR Part 50, which mandates that significant financial interests that could potentially affect the PHS funded research are disclosed, and it requires the institution, any institution, accepting federal funding, to manage or eliminate the conflicts, to ensure unbiased research. The National Science Foundation has quite a similar policy as well. They're really specific on who they want your conflict of interests of policy to apply to. This makes it a little bit interesting. So their statement is principal investigators, co PI, senior personnel who are responsible for the design, conduct or reporting of research or any educational activities for a lot of institutions, it's kind of hard then to separate Well, is there anybody really who's working within the research that might not qualify in having to have disclosure and so you'll hear a little bit later on, as we describe our disclosure processes, sometimes it's simpler to cast a wider net than to say, well, this administrative person doesn't really do the research, but they might, you know, create a set of results reporting or create information around The results of the research so they're not really involved in the research. You know, I would think the safer and more conservative approach is to expand the disclosure requirements to ensure that anybody who has the potential to be involved in design, conduct or reporting to have a disclosure on on file, even if that's a null disclosure. And again, NSF requires institutions to have a COI policy to address conflicts in NSF funded research, and they've also expanded that to ensure that we are disclosing in other support, support from foreign entities as well. Okay. So a little bit about the Rutgers disclosure process, and then I'll hand it over to my colleague Rob to talk a little bit about the UVA disclosure process. And what it covers is to explain to you all that we use a ecoi web based system. It's a fully integrated data management system that provides comprehensive disclosure for actually, all of our employees at the institution, we leaned into what is a state requirement for disclosing outside employment, even a null statement of outside employment, meaning they don't have any outside employment. So every Rutgers employee actually completes a full disclosure in our ecoi system, and so it's required of all faculty, non faculty, students and any individual in the course of their association with the University, whether it's research that's funded or unfunded. So we have a lot of control points built into this disclosure process that really help us in terms of compliance. So for example, for those of you who have systems that administer your sponsored awards, through that sponsored award process that we have at our institution, we're also able to integrate a control point, meaning anybody that's listed as the PI or key personnel on that award must have an active disclosure in process. In addition to that, as required by our accrediting body, we also have that another control point built into our IRB reviews process, and so a letter of approval from the IRB cannot be released until each individual named in the protocol actually has a fully current active disclosure for that specific study. So a couple of control points that we've built in to ensure that we have a fully transparent disclosure process at the institution. So Rob, would you like to say a couple of statements and just summarize how this occurs at your institution currently?

Speaker 4  11:56  
Yeah, sure. And I think for conflict of interest. It can mean different things to different people. To me, it's contextual. And so we're largely talking about research integrity when we're talking about the PHS and the NSF and all the other federal agencies, with the Public Health Service being sort of the gold standard for most r1 universities, as far as to having a financial conflict of interest, policy and sort of procedures, and so that's really designed to protect against research integrity. I also view it as to protect research participants, whether it's trainees being engaged in the research or if it's human subjects research the actual subjects. UVA is also a state agency. There's a different aspect we have. I We have a state statute that's really about self dealing. It has very little to do with the objectivity of the research or protection of participants. It's really about self dealing and so, and I know that attendees are coming from different universities. If you have any any sort of question about, well, what policy does my university follow? It will be pretty easy to find. These are all supposed to be publicly accessible, and so it's it's pretty easy. They're typically owned by either the vice president research or the provost, depending on the university we and I think Rutgers, has a homegrown system, right? Your conflict of interest system is developed on your own.

Speaker 3  13:29  
Well, it's a customizable product. I don't know if I'm supposed to mention the exact vendor during a webinar, but it's a product, yeah,

Speaker 4  13:38  
yeah. So we use, I think, a different vendor, and so, again, this is this, to me, it's interesting. You can have different approaches. My approach is, don't want anybody to take this the wrong way. But conflict of interest in these sort of compliance functions are somewhat like dosing of medicine. You know, we are looking for, you know, inappropriate, minimally effective dose. You know, some universities have, and there's not a necessarily a right or wrong answer. It really is, what is your sort of threshold for risk? At UVA, we have a disclosure system that is based on PHS, and so we would require disclosure of anything related to your institutional responsibilities that qualifies as a significant financial interest. And I think unlike how Rutgers is handling it, we're looking at we're looking at it in the context of sponsor, sponsored research, we don't really have a mechanism to catch it for internally funded or gift funded research, with one caveat, and so that is for human subjects research. Our IRB asks some very specific questions that are more detailed than what we ask to. Typical investigators in our system to complete. And so the IRB is always going to catch or cast a much broader net. And so I work with our IRB a lot on could be gift funded research coming out of our School of Medicine, or we do a lot of internally funded research at UVA. We have a strategic investment fund that funds research initiatives, if any of those involve human subjects. Again, our checkpoint would be the IRB. I think that's probably it. As far as the differences,

Speaker 2  15:36  
one kind of concept that has come up over the last few years, as we, you know, as Eli and I, have been revamping the startup COI process within Rutgers. The Attitude is not and cannot be to and the level go into more detail about it, but the attitude is, is not to avoid the conflict of interest, because when you think about a faculty startup, it's impossible to avoid that appearance of a conflict. It's inherent in the process. The attitude is, how do we make sure that those conflicts don't become problems? And that's been, from my perspective, sitting in the tech transfer operation, very key attitude to bring to the faculty members who are involved in this that's not it's protecting them as much as is protecting the university. So Elon, why don't you go back and kick off on

Speaker 3  16:34  
Absolutely. And I couldn't echo Dan's sentiment anymore, a large part of our role in compliance in general, is to help help the individual faculty members or key personnel understand what the purpose of and role and our why our function seeks to exist, and it's really to protect them and protect the integrity of the research, their reputation, their ability to translate what will hopefully transform something out in the public domain and be adoptable by those individuals that are that would be adopting that change or that policy or that technology. All of that feeds into this process quite significantly. And so we have, while we had a really comprehensive disclosure process overall for all of our employees at the institution, we just recently made significant updates to the way that we capture startup information. We were doing this a little bit ad hoc through a basic form, but it's now all integrated within our again, our comprehensive web based system where a faculty member is already logging into the ecoi system and now they have opportunity to do their startup disclosure right then and there. What we're leaning on with startup disclosures, because a lot of times our startups are happening outside of what might be a sponsored award record. So they don't necessarily come out of an NIH grant, or they're coming out of a sponsoring agency. They may have an existing award, MTA, or do you a somewhere at some point, but we're able to capture their startup disclosure right in the system. We're leaning on our tech transfer managers, our Innovation Ventures team members, to ensure that they're communicating that as they're having very preliminary conversations with faculty and individuals that might be engaging in startup activities, and so they're able to log in, and I will be sharing screenshots of the form. Dan and I are very comfortable sending out copies of the text and the questions for our startup certification, to any individual that wants to reach out to us, there'll be contact information for Dan and I after this. And so this form was integrated into the system. The form is then automatically routes to the department chair. This is really, really important from a position of transparency, if it doesn't wrap to a department chair, it can also route to a conflict or interest monitor. And so that element of ongoing monitoring is always a struggle, because you can set up a management plan, but if you don't have a team of professionals that are available for that ongoing monitoring of the management plan, you can lose sight of it. So the form automatically routes to either the department chair or COI monitor, and then from that point, it comes into our office, it's administratively reviewed, and then it's assigned to a startup committee meeting. So the system kind of follows that workflow that we've set up. It'll be assigned to a startup committee meeting. And our startup committee is uniquely different from our research COI committee, so we have two committees, while some of us hold dual roles on both those committees and the experience of managing conflicts of interest do overlap. Our startup committee meets once a month, and I'll talk a little bit about that committee structure and role in a little bit. And that system allows us to. Integrate with other systems across the institution. So if there's a management plan at the end of the day set up by the startup committee, it travels over to our sponsored Award Management System. Why is that really important? Because in that system, we're delivering contracts. Our contract services team is reviewing duas. MTA is could be reviewing other sponsored agreements. If you don't have the management plan moving on in the life cycle of those activities, then you could lose sight of certain elements that you build into the management plan. So we've have a lot of enhanced system integration, both after the issuing of a management plan out to our eirb system and our award management system, which is really key in this transparency element of things. So in terms of the and please don't worry about these screenshots, they're just in an effort to allow me to prompt some information and share with you all what faculty are sharing in their startup disclosure. We really wanted to make sure that we could ask all the questions that we need to be able to provide a really thorough management plan. So they're answering questions such as, when was a company founded? If it What hasn't yet been officially founded. Is there an intended date of company formation? A brief description, again, around the company, the name of the CEO. Why is that important? Because if at the time of startup setup, we have that dual role, we want to be able to assess that if there is no dual role, in other words, there's the CEO that is outside of our institution that helps to deal with some navigating some of those negotiations, a brief set of information around who else founded the company. Are there any other employees involved as founders of the company or have significant roles in the company? We want to know what their compensation in the company is, and we also want to have an idea of how significantly involved are they in the company? Now we happen to have at our institution a limitation in outside employment based on contract negotiations. Many institutions may have that we also want to make sure that faculty members that may not be aware of that cap on outside employment, that they have a strategy to address that we're asking questions around their equity ownership. If they own more than 1% they're going to let us know in what capacity do they have equity ownership. If they have a cap table, they're going to share that as well as any current investments in the startup company. So a lot, I do think it's a lot of information that we're asking for, and at any time, they can say TB to be determined or not applicable, because sometimes we're so early on in the startup formation, and that's okay. But the reason we ask these questions is we were finding in some of the precedent work that we were doing in conflict of interest plans, is that if you don't ask, sometimes there's not that full disclosure, and then you can't manage appropriately. So instead of having it come up in conversation, we created a pretty robust form for startup certification, and so our committee is structured with individuals from across the institution. First and foremost, you should have faculty representation. They're the ones creating startups. They're the ones understanding what it's like to engage in these relationships. So we have faculty members that serve on the committee. We have individuals from our new ventures team, individuals from research contract services. We have folks from our research compliance team. We also have individuals that serve from other administrative areas of the institution. And luckily, we have had pretty robust engagement in the committee. There's always an interesting startup to follow along and to follow their life cycle. We do a consensus voting. And again, our minutes indicate that the full committee agrees to any management plans that we put in place, the management plan is then uploaded into our system and can be updated at any time should the relationship change. And so anything else Rob that you might want to add about conflict of interest management from your institution's perspective?

Unknown Speaker  24:18  
Yeah. I mean, I think about one, one quick

Speaker 2  24:20  
question came, came in, and I thought it was, it was worthy of talking about. Now, when it comes to this startup interest form, do we get pushback on information being confidential to the startup, right? If people come to us that, oh, I don't want to share this information because it's proprietary information to the startup,

Speaker 3  24:39  
right? So I'm, you know, some of the items that I lean on is the fact that at our institution, we're all state employees, there's very little that can be at a need to know element of things. But if there's a private investor that cannot be disclosed, based on that agreement, that's we would probably allow for them to state private. Investor and then the amount that's invested. Should there be additional questions? We might do that offline and not within the system. Again, the startup forms are only accessible to the startup committee members or individuals that then need access to a management plan. So it's not that our startup forms are, you know, fully accessible to everybody that's in the ecoi system. So as of today, I don't know, Dan, have you gotten any pushback in terms of what's disclosed in the startup form? So

Speaker 2  25:33  
I've had some people express a little bit of discomfort, but I've been able to get them over that what you say, you know pretty much exactly what you're saying. You know what you're saying. So we haven't had fierce pushback. I've had a little bit of like, why'd you need to know this? And when I explain why they need to know it, they come around anyway. Sorry to interrupt the flow. Rob,

Speaker 4  25:57  
yeah, so, I mean, I think this is an interesting approach that Rutgers have, and it has, and I think it's a good one. We do it a little differently at UVA. And again, this is just philosophical differences on how you approach these I'm rolling something out like this. It's similar to it, but I'm I'm making it a voluntary I mean, when I say it's voluntary, some things you're going to have to disclose anyway. If you have equity in a startup company that's related to your institutional responsibilities, you're going to tell responsibilities. You're going to tell us anyway, do you need to tell me if you're going to be the CFO of the startup? Let's say you don't have any equity, or you're not being paid. Maybe not. However, what we're trying to roll out, what I'm going to roll out, is a voluntary program where, if you're an active participant in your startup. It overlaps, of course, with your otherwise, it's not an issue, but it's overlapping with your university activities. And you want to get a jump start on some of these things. I call it like it's a TSA Pre check. We will go through a voluntary sort of program. You'll make these disclosures, we will come up with what we call a management agreement. And I don't want to get into the semantics of it necessarily, but a management agreement in mind is different than a management plan. UVA, we have management plans that are unique to specific research projects. Your research project cannot continue, cannot start. You cannot spend any money at UVA if you have a financial conflict of interest until the management plan is in place. What I'm talking about is faculty come they have a startup. The research hasn't started yet, so there's really no technical requirement for a management plan, but we'll come up with a management agreement. I've seen this from a couple of faculty who come from other places, and I'm like, this is a really cool idea. We get this in place, we essentially get 90% of what we would need in a management plan attached already. When we actually need the management plan for a very specific research project, we'll do an implementation letter based on that. And you know, the reason I'm calling it TSA Pre check if you agree to do the work with us ahead of time, we promise we will get this through as quickly as possible. What I find, I used to work in sponsored programs, conflict of interest really becomes an issue for faculty when they can't get the research off the ground. You know, they can't get a spendable account until it's resolved. And so if you have a more complicated case, and nobody knows about it until the award is sitting here and like, Hey, you're ready to go. It may add another month to the process, so why not get it done ahead of time? So that's, I commend what you're doing at Rutgers. I think that's a good idea. We just have a different approach on it, because part of it is sensitivity to faculty not wanting to do it. And unless we can point to a requirement, some state law requirement, otherwise, we're not going to make them. But I'm trying to create a coalition of the willing. And so I think if you can, in exchange for doing this, you know, you will get expedited treatment. I'll see we haven't mandated it yet.

Speaker 3  29:04  
Thank you, Rob. I appreciate that insight, and I think it's so important for our attendees to hear that there are many ways within the confines of the regulations that we all have to abide by and the state rules that institutions could approach this. And I think what you know, the approach that UVA is taking resonates with me a little bit. It's a little bit more the freedom of the choice. And if you lay it out as this will be, this will allow us to better support you and your engagements. It sounds like that's also a really reasonable and fair approach. So lots of different ways to approach this that you might consider at your institution. One of the topics that comes up quite frequently is conflict of commitment, and how, when and in what capacity conflict of commitment can occur. And so I'm going to hand it over to Rob to talk a little bit about this, and then I'll chime in and and share a few dish differences, maybe from perspectives of kind. Conflict of commitment than I've seen at our institution, all

Speaker 4  30:03  
right. Well, so conflict of commitment, in my mind, is, you know, a topic that has maybe the most potential for faculty agitation. Nobody likes to be told what they can or cannot do and so, but the university has legitimate reasons to try to understand what our faculty are doing. Most universities have policies, whether it's a policy on consulting, maybe it explicitly says conflict of commitment, but it will say something along the lines of, if you want to engage in external consulting for pay that's typically, typically the for pay piece is included, and it's related to your institutional responsibilities, you can do so as long as the commitment does not exceed one day in seven or 52 days out of the year. That's for people who are on a you know, full time faculty at UVA, if you're in the School of Medicine, your consulting is approved in advance. If you're not at this if you're outside of the School of Medicine, you simply report it on your annual plan. I'm thinking of ways we can encourage people to report in advance. Many schools will say you have to get approval X number of days in advance before you you agree to engage in this activity. And I don't think that's unreasonable for certain things. It could be if you're going to be a startup. Let's take that as an example. If you're going to be the president of a startup company, some some institutions say you can do that for up to a year. Some say you can't do it at all. Others will just talk about they don't necessarily list the specific title, but they're say, if you have a fiduciary responsibility to an outside entity, you need to tell us about that, because that could create some form of a conflict. I know from the sponsor standpoint, NIH and some of the other federal sponsors are treating conflict of commitment almost like a non financial conflict of interest. And if you're really worried, I mean things I worry about from an institutional perspective, if you have faculty members who have labs outside of your university, particularly if they're in foreign countries, that is really going to be a recipe for disaster with your federal sponsors. You, you know, institutions have a legitimate need to know how much professional effort are you devoting that is outside of what we expect you to devote at the institution. I mean, at some point, if you're 90% grant funded, and you have all of this outside activity, it's just a real bad look. And so I'm sort of struggling with, how do we change our policies now to not prohibit anything, but just legitimately require some information up front, and it's the policy is not always owned by the I work for the Vice President for Research. A lot of these are owned by the Provost, because they're sort of faculty engagement policies. And so it's an interesting mix of, well, who do you who has to say this is okay or not? Okay? Sorry, hello. I'm not sure that answered the question.

Speaker 3  33:17  
No, you covered a lot of ground. And I think I just want to, I want to echo some of the elements that you mentioned. A lot of institutions require some level of disclosure with outside employment. We happen to have a pretty, again broad and really umbrella sized requirement that any outside employment, in fact, even appointments on unpaid appointments on on boards must be disclosed by every employee. Those always are intended to route to the department chairs or a supervisor, if that's a staff member. Currently, the negotiated agreement with faculty allows for 20% which is interpreted as, you know, one one day a week that could be, uh, utilized for outside employment. And I agree with you completely, and I'm so glad you mentioned the requirement of additional review and risk assessment when it comes to appointments abroad. So any foreign appointments, we actually have a small committee that takes in any time and outside employment comes in for a researcher that has a foreign appointment. We're doing some additional screening review of that potential, not only the conflict of commitment from their role at the institution, but screening in terms of export compliance and some of the other obligations that we have for data security. So that is a really, really important item that you mentioned that I think is often sort of an afterthought, but we've seen a number of cases at universities where there's been non compliance in the Institute. Has been fined, you know, and claiming we didn't know really isn't passing muster anymore, and a lot of institutions are seeing some fines related to that. So that disclosure, the the over, overly transparent disclosure, seems to be helping institutions kind of push forward on that oversight. But I also want to appreciate what you said. It's not about stopping the research. It doesn't mean that a foreign appointment is actually bad for the home institution. That is international collaboration can be really fruitful for the home organization. So we want to encourage that, but we want to have transparency, disclosure on what the relationship looks looks like, maybe a review by our intellectual property team to ensure that the appointment abroad does not infringe on intellectual property that's assigned to the institution home institution. So those are all considerations. So you can almost do more if you have more information, when you find out down the line of downstream that tends to create some problems. So I want to just push forward and briefly, I have two slides on a Template Management Plan. Again, this is another form Dan and I are very much willing to share. So I know the text is quite fine and small, but it's just again, to let you all know a little bit of a flavor of how we address and mitigate those potential or perceived or real conflicts of interest. So our management plan, again, the committee receives this outline filled in administratively based on the information that we have in our certification form, we're going to describe the potential conflict of interest that arises by any equity, by the sponsored research activities or current agreements, if there are any any equipment use that's in our default plan, because we want to know that that same equipment is available to others that might be interested in use of that equipment, not just to the startup. If there's space use, if there's an agreement, a rental agreement, for example, in place if there is going to be startup space use. We also want to be able to address and ensure that we've had our intellectual property taken a look at any of the terms and conditions in any current agreements if there are going to be any visiting scientists involved in that activity that may require additional screening, so we want to document that in the management plan. We also want to pay really close attention to our graduate students and postdocs. When they are involved, you're going to be recruited for involvement in that faculty member startup, because we want to ensure that we have some protections for them to be able to publish, and if there are restrictions, if that that we limit or minimize those completely, because our graduate students, our postdocs are here for a purpose of learning and sharing and contributing to the scholarly conversation. If they can't do that, that could really be problematic. So we want to understand and in addition to that, if you have a postdoc or graduate student and their ultimate the ultimate decision on as their dissertation chair is also also the startup founder and CEO and president, that presents a potential conflict. So we want to potentially have that student, have a secondary advisor. So that's something we would address in the management plan. If there's a clinical trial component. We also want to have really key information that travels back to the IRB to ensure transparency to participants around the relationship and then who's going to monitor the plan? So we document that in the management plan. Do we have a COI monitor that's local, whether that be the research Dean or somebody else who's pretty familiar with conflict of interest management? Again, being that Rutgers is so widespread, we don't serve as the COI ongoing monitor for all of our PIs that might have a startup. We designate that out, but check in with them annually if for some reason, the relationship is going to change in the next six months, we might say we want to come back to the management plan in six months. And so what's also really important again, not just that the management plan is then uploaded in our system so that it could travel its way out to the IRB and our sponsored award and contract services team members, but we make sure to copy our management plan to any relevant research teams that need to be aware of this engagement, so that that's a little bit about the template that we use. And again, we're very willing to share with anybody that reaches out to us relating to the startup template, if there are any final points or additional items that we want to monitor in the plan. We always add that in to the final document I didn't see. Dan, just want to make sure if there are any questions before we move into some case examples. And

Speaker 2  39:56  
there are, there are some questions that have come up. Thank you for pause. Thing, can faculty members participate in the negotiation process with the tech transfer office? We're in the hat of the startup officer. So can they represent the company when negotiating with the tech transfer office for a license? And if you don't want to take that one, I can, I

Speaker 3  40:16  
think I can take it. But I really want to highlight that again, I'm sharing on behalf of my professional perspective, we do. We do not want to see people in those dual roles in a significant sort of capacity. So there should be someone selected on the company side that could do those term sheet and final contract negotiations, so that we don't have that issue and that inherent conflict, and in those negotiations, are they going to be aware? Sure? Are they going to have information? Yes, absolutely, they have an interest. But it's really important to have a different party on the startup side that is engaged in those conversations with our tech transfer manager. So I know that that's complicated when the individual creating the startup is the only person. So what do you do in those scenarios? Rob, have you ever had that where the startup faculty member is pretty much the only person that could be negotiated with? Have you ever had that come up,

Speaker 4  41:23  
you know, oddly, no, not in the context of the license. And so we have a state law that would kick in if, let's say that the startup was negotiating with the university. But we have ways around that. You know, our licensing adventures groups, a separate 501, c3, so they're not us. I, if I were asked, I would say, No, there's no prohibition about it. I mean, if it's a one person operation, and they are going to wear the hat of the you know, if they're representing the company, that's fine. You know, I've never had anybody in our tech transfer office ask me that I would defer to their judgment if they thought it was inappropriate. It would that's fine. It's not. It would not be, though, a university requirement to have a disinterested third party. I mean, I think it's the best practice. But, I mean, the reality is, a lot of them are just, I mean, which begs the question, you know, are they the best maybe? Are they the best licensee? However, they may be the only licensee, and you don't want to discourage them from doing it. So anyway, that's a this is a non answer, but I would say, you know, I could, I could see it coming down either way. It wouldn't be unreasonable to say, No, you have to have at least somebody else do this in name. But if you wanted to allow them to do it too, that wouldn't cause me any heartburn,

Speaker 2  42:41  
yeah, I mean, from my from my perspective, having sat in the check transfer office, we have a strong predilection against that. And we inform the faculty members very early on of that, and say, You go find somebody to to kind of conduct the negotiation, and oftentimes it can be one of their students or postdocs that wants to go and move into the company. And we'll consult with the with with the startup COI committee, about how best to handle that, because there's some conflict there, but it's not as much. Or sometimes it's a family member. It can be a spouse, a father or a parent, a child, or sometimes it's just a third party, you know, when an accountant or lawyer that takes on that role, but we think it's very, very important, both from the perspective of conflict of interest, and we have also have a state law that talks about that, as well as the kind of the inherent power imbalance right within the within the university, if you have a strong faculty member, and you know, coming up against a tech transfer officer, licensing manager can be very uncomfortable. So we really try very early on in the process to get somebody other than the faculty member, and from a business perspective, to reflect what Rob said, if indeed, it's just a faculty member that's going to be running this company, and there can only do it one day a week, you know, how successful is that company going to be? Right? You know, having been through a number of startups myself before I came to the university, it's an all consuming endeavor to be successful in doing that. So let me. Let me move on to some other questions. The this is a question that I think I'll take universities experience reluctance from the early funding sector in VCs to participate due to the PI mandates to provide compliance and disclosure measures. And I think the what I find is that the there's much more reluctance from the VCs over the university licensing terms than there is over over these compliance and disclosures if you have. VCs that are comfortable and aware and experience with universities. They understand, you know, kind of how the universities work. And this is not really a problem. We've actually had, quite the contrary, had people come out to us and reach out to us and say, Hey, we know that this is we're dealing with the university and that there's a PI tell us what the what the conflict of interest policies and procedures are, so we can make sure that they get done. They get they get done expeditiously. Bigger problem has to do with IP ownership. And you know when you know, once the startup is done and the that pi is working in the in the in the in the startup, that can be an issue, but that's something that's probably we don't have time to get into today too much. So here's, here's a question, Eli, I'm going to, I'm going to mix, mix two questions together, can a faculty member do sponsored research with a company in which he or he or she owns equity, and relate that also to the to STTR and SBIR is where that's usually what happens. The company will get an STTR and then subcontract back to the university. How does the universe? How does that pi kind of fit on but in that dual role situation,

Speaker 3  46:19  
right? So I'll take a stab at this one. First, we want to ensure that the PI has a current conflict of interest management plan that highlights that there is going to be a potential for sponsored research agreement, or it's in negotiation if they are going to be serving under a sponsored agreement that the company is sending over to the institution. What we're looking for is actually, actually, whether it be the COI monitor, an additional individual at the department level that can both verify any invoicing or results reporting, so that that pi is not serving in all capacity. So it's an intermediary, we don't want to stop the sponsored agreement from coming back to the institution, because clearly, our PI is the most qualified and invested to be able to provide that service. We want to ensure that that service does not preclude that maybe that piece of equipment, or those pieces of equipment or that lab from being utilized by other interested parties. That's a really important element that will highlight in the management plan, again, almost like an additional services monitor, so that it's not only the PI saying, Yes, I did all this work, and I have invoice for the full sponsored agreement, and nobody else has verified those services. We want to make sure that somebody else has verified those services and that the COI monitor is fully aware of the sponsored agreement. So we have many of these in place where the company, where the PI has equity, then wants to engage in a sponsored research agreement. It's really important to just have the management plan in place, have your contract services team aware of the management plan, so that they can integrate those terms into the negotiations of the sponsor agreement. So, yeah, really important not to, you know, set this up as this is not possible. This is possible, but it's about having additional, you know, transparency and disclosure with a couple additional control points that, in the end, protect the PI from someone claiming that the you know, the work wasn't conducted under some level of conflict of interest management. And I want to dovetail back Dan, yet there have been now several times where VCs or investment parties come back and say, share a copy of your conflict of interest management plan. We actually don't do that directly. We ask the pi if they feel a level of comfort sending that conflict of interest management plan to any interested VCs. We just don't preclude them from from doing that if they if they need to share some of that information. So

Speaker 2  49:01  
it goes back, I think, to the attitude of, you're not avoiding conflicts. You can't, you can't avoid conflicts, right? If you have a faculty startup, they will want to contract back to the university to do work that's, that's that, that's, you know, not only unavoidable, but desirable. How do you make sure that conflict is managed and doesn't become a problem deadline.

Speaker 3  49:25  
The other piece of that is that if you have postdocs, lab members, anybody who's going to also be engaged in that sponsored research agreement, that the conflict is transparent to those individuals, so that they are aware that there is a management plan and that the faculty members not just giving up their lab for their company. That's kind of the storyline we don't want to create. We want to make sure that we can we have a little bit more shift in the narrative that we're engaging in the in shared research activities for the greater goal of success of this this. Work that you're involved in. So Rob, anything else to add in there?

Speaker 4  50:07  
I would say it's going to be a little more difficult to be the PI on the on the university side and on the small business concern side if it's an SBIR, because there's some requirements about employment. I look at it a little differently. I mean, I get asked this a fair amount, and it to echo what you and Dan had said, yeah, the answer is generally this, there are ways to make this happen. But I just ask people some philosophical questions. I mean, are you diverting funding from that should be coming to your home institution, to your company? That's a hard I mean, it's an easier one with an STTR SBIR, because whole program is designed to have money go to the company. Fine. Are you using university resources to benefit your company? Well, if this is a virtual company, I'm going to look at the scope of work, and it's like, if this all requires the wet lab space, and you have no wet lab space, obviously somebody's going to be concerned that you're just going to be doing it on our nickel in our space. That cannot happen, right? And so you just sort of ask these questions, okay, what are you doing? And do you have the space? Are you using University time to engage in the activity? You know, that's part of, you know. What's your commitment to the company? You have to have something, you know. So if you've said on the CFO or the CEO or something, there has to be some, you know, time commitment you put down that goes towards your one day and seven. So we know what the obligation is. We worry about the university subsidizing the research, and so we look at the budgets. Hitler, I think you mentioned this before. You can't have, I can't be the PI on the UVA side approving invoices from the pi, which is me from the company side, right? And so, but we can, we can set somebody else to do that. So there are ways to sort of make all this work, but I try to explain it to people in ways that allow and have the decision, frankly, made. You know, are we diverting resource research funding? Is it? Are you are the is the facilities of the university benefiting the company, those sorts of things, uh, time commitment. I mean, I try to defer somewhat to the department chair. I mean, they hired this person to work there, so they should have some say into whether they're comfortable with them doing this or not. And the one thing we didn't talk about is intellectual property. And I know Dan, that opens a whole nother case of can of worms. But I think you have to address it in cases like this, because if you're actually engaged in research outside, you know, as the PI at the company, and you don't say anything, the university is going to be That's great. We own it all right, because a lot of the policies are we own it if, if it's related to your institutional responsibilities, or, I think Rucker says, if it's in the scope of your employment, UVA uses similar terms. That doesn't mean you're actually at UVA working. It just means it's related to your job. You could be doing it in the company's facilities. And so that's why I always want to ask the faculty member, okay, you've signed this patent agreement that gives everything to the university. Maybe we need to do a rider to that, that sort of carves out in this particular instance. If you're going to have a company that has space, you know, and there's some commitment, if your chair is on board, everybody else is on board. Let's just agree that this bucket of IP might fall into a different category. Because I think if you don't, and this gets back to consulting too, which is a different topic, but I think if you ignore the IP, you do so at your own peril. It's never going to be a problem until money is at stake, and then it becomes a real problem. It's so easy to in my personal opinion, it would be so easy to address it when there's not a lot of money at stake, because people don't act weird, then,

Speaker 2  53:40  
yeah, I agree completely that you need to deal with the IP issue question up front. And we actually spend a lot of time talking to our PIs as we go through the startup process and making sure that they understand the university policies up front and that they can design the way their company is going to operate based on, you know, based on what those policies say the but you know, not withstanding that, the piece of advice that I give to the PIs is, you know, do what's right for the business. We all want the business to succeed. We want the technology to succeed and to and to have an impact in the in the outside world, and change people's lives. Don't, don't, don't forsake that outcome based on, you know, the IP policies of the university. So yes, you have to, we have to make sure that that, you know, kind of put in the proper context they need. But they do need to completely understand what that is up front, otherwise it can and has caused, you know, problems down the road.

Speaker 3  54:40  
Yeah, yeah, I agree. And this can even impact visiting scientists agreements, you know, other agreements that might be put in place in that facility or lab. I wanted to address one of the questions that I often get is, at what point are you asking folks to make this startup disclosure, and would you consider how. Having a management plan? What if there are no investments, they don't even know their equity status? You know, is it too soon at some point to have a management plan? You know that that isn't it's a very insightful question. You want to reduce the amount of perceived oversight that you're taking, but in negotiating the management plan. And I failed to mention that when we develop a management plan as a committee, we actually send it back out in like near final or draft form to the PI. Why? Because we want to ask and check in with them if there's any terms of the management plan that we might have created that would prohibit the pursuing that activity and are willing to bring it back to the committee for any tough points of renegotiation. We haven't had too much pushback in that space, but it really allows them to say, you know, I'm not sure that I understand this part of the management plan. Or can you explain this further? And it's in those conversations, especially with the really early on scenarios, that we're treating this as almost an educational opportunity, because one of the biggest challenges that we're finding, and I'm sure you were going to ask this question, Dan, is some of our pre existing startup or COI management plans that maybe didn't have a fully fleshed out framework, so things were left open ended, or, you know, they weren't really laid out or discussed with the PI and so we're having to, you know, it's potentially that you're kind of cleaning up scenarios that might have been, not been discussed with startups that might have, you Know, had an engagement that was different than our current process for management plans. So it is, it is partially an evolution. And you know what the perspective from the top is on startups, and how supportive you want to be of entrepreneurialship, but also how transparent you want to be of any potential or perceived commerce. So it's never really too early, and maybe in the very early, early stages of patent pending, you know, but it's probably never too early to start talking about the elements of a management plan.

Speaker 2  57:12  
So I'm going to, I'm going to segue from there to to a closing question, because we have, in our last three minutes, sitting in a tech transfer kind of seat, many tech transfer professionals end up feeling a conflict of interest themselves, between the imperative of supporting the commercialization of the technology, the relationship with the with the innovator on the one hand, and the fiduciary responsibility to the university and to the state and to the laws on The other hand, and it's, you know, how do you how do you conflict it? Can you kind of give in like, one minute each thoughts about how the tech transfer professional should think about it and approach it. What role should they play in this process?

Speaker 4  57:58  
Rob, you go first. Yeah. Okay. I mean, I think this might largely depend on the expectations that the university has for the tech transfer function. I mean, many of these functions are outside of the formal, you know, confines of the university, whether they're separate, you know, legal entities or not. At UVA, we have an operating agreement or a memorandum of understanding that lays out what the expectation is, from the University side, making money is nice, but that's, you know, of the list of eight or nine things. It's pretty far down the bottom. I mean, we want to recoup our funds. It'd be great if we made money, but the tech transfer function at UVA is a faculty engagement function. We want entrepreneurial faculty. We want to give them an outlet to get, you know, interesting ideas to be commercialized. And so, if there's a, you know, a tension between, am I making a lot of money, or am I going to enable the you know, this activity to go on? You know, the the money in my mind, piece is, is sort of secondary, so, but that, but that, you know, really, your institution may have a different opinion, right? I mean, it would very difficult, I think if you're the tech transfer office and you only get to spend what bring in, I mean, talk about tension. I mean, that would be the worst case in my mind,

Speaker 3  59:11  
yeah. And since we're very, very short on time, I just want to throw out, I mean, currently, the way that we operate as compliance professionals in in general, is partnering with the research faculty really ensuring that that we can give them the tools, techniques and with uphold the utmost of integrity and all that they're doing. So if, if that's your underlying approach, then you can come through and really facilitate pretty much nearly all areas and strategies that your research faculty are taking on. So we really want to be there to support that really engage them in their pursuit of scholarly excellence. So I'm just going to leave it at that, since I know we're wrapped up at time and hand it over to Don Val and thank you to my colleagues and to autumn for allowing us to take part in this webinar. Appreciate it. Thank.

Speaker 1  59:59  
On behalf of autumn, I would like to thank our presenters for the informative presentation today, and thank you again to our online sponsor, Marshall Gerstein. A recording of this webinar will be available for viewing in the autumn Learning Center within a week of this event and is included in your registration. Please be sure to complete the webinar evaluation, which will open immediately when you sign off the session and thank you for being a part of today's presentation. Thank you again to our speakers and have a great afternoon. Everyone. You.

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