Webinar: COI – Management Basics and Best Practices

Transcript for COI – Management Basics and Best Practices

Giovanni Gallo: We’ll get started here. We’re gonna do a little bit of housekeeping so we can let people continue loading up. Hey, Dallas, Berlin, Germany, around the world. All right. So, today, we’re gonna be talking about conflict of interest management. We’re gonna be going over basics and best practices.

A few housekeeping things we wanna just let you guys know. You can relax and just soak in the learning today because we’re gonna send you these slides afterwards. Obviously, take notes if you want, but you’ll have all this information. We want this to be super valuable to you. We want to help elevate your understanding, help empower you to make changes in your organization, and also give you some actionable steps that you can take to move your compliance and ethics program forward. So we’ll be sending these slides to you. We’ll also be sending a recording of this so you can watch it every day if you want.

Also, like I mentioned, we’re active in the chat on these. Listen, we can’t be in person, but we want to make this as interactive as possible. Sarah and I and both of our teams have put this on because we want to serve you. We want to help make you a better ethics expert. So please tell us your questions. We’ll be looking at them as we go. If we can pause and jump into it, dive deeper, clarify something for you, we’ll be looking at that chat on an ongoing basis so that we can react to those. And also, we try to do some follow-up afterward. So if you asked a question that we didn’t get to, we may be able to follow up with you kind of generally or individually and help answer your question. Like I said, this webinar is here to help make you better. We want to serve you. We want to make sure that you are the best ethics expert that you can be. So please give us that feedback, give us those questions, and we’ll do our best to hit that target for you.

So without further ado, let’s jump into it. I’m Giovanni Gallo. I’m co-CEO of ComplianceLine. We run a range of services for caring leaders around the world, including whistleblower hotlines, case management, we do e-learning, we do sanction screening, and we do conflict of interest software. And I have the inestimable Sarah Couture with me today. She’s going to be guiding us through a bunch of the discussion around what are conflicts of interest, why they matter, challenges in managing them, and concepts and tips for developing a plan around this. Sarah, why don’t you kick it off? You can tell people about your background and then get us started. How does that sound?

Sarah Couture: Sounds good. Thanks, Giovanni, and thanks again for the invitation. Gio and I spoke not together but at the same event for the Health Care Compliance Association in Alaska. We connected a little bit beforehand, and afterwards, he said, “Hey, I really liked your COI session. We’ve got COI software. Why don’t we partner?” So we’re looking forward to being able to, hopefully, have some banter. We were talking about how it would be more fun if we could present this in person, just like you all probably wish we could all be, you know. Maybe like Jamaica, Bahamas, I don’t know. We can think about it. Giovanni, where would be the best place if we could ever do some live presentations? But we’re excited to share this with you today.

As Giovanni mentioned, I don’t work for ComplianceLine. I actually work for Ankura Consulting. I’m a nurse, by background, and I’ve been in compliance for the last 10 or so years. I got my start as the hospital compliance officer for a large academic medical center in the Midwest and have been with Ankura for the last seven years. I’m a managing director. I do a lot in the general compliance space, compliance program development, all of the elements. I do a lot of compliance program effectiveness assessment, risk assessment. Also, I’m very interested in clinical research building compliance, which, as you may know, is very technical, but I have a lot of fun. It’s really great to work with clients of all shapes, of all sizes, of all flavors, all around the country, and I’m just delighted to be able to have this dialogue today with Giovanni and with ComplianceLine.

As we’re getting started, first, we’re just going to kind of give some info material, and most of this content probably everyone here knows, right? What are conflicts of interest, and why do they matter? We hear about conflicts of interest not just in health care but really in a lot of different areas of our lives, I think even in our parenting, or in our interactions with our neighbors, or there are just various situations that come up where our professional judgment or our judgment on something is impacted by a secondary interest. So when that comes to medicine, we, a lot of times, think about taking care of patients, right? Like, patient care is our biggest goal. And certainly, in health care, we’re also doing a lot of clinical research, medical education, in our jobs, in our employers, whether that is a physician practice organization, or a behavioral health clinic space, or a physician practice group, or hospital, or academic medical center. Those that work for us, our physicians, our staff, our leaders, those in purchasing, their primary interests are to their employer, right, to make sure that we take care of patients the best, make sure that our research is above board, is accurate, there’s no fraudulent anything there, and to make sure that our medical education for the next generation…that everything is where it should be.

However, because we’re human, that’s the all-caps there at the bottom, it’s really hard for us to be able to separate our secondary interests, right? Like, we all need money. We all have to feed our families and put a roof over our heads. So if there’s a side gig or side hustle that we have that has money involved, that can influence our decision-making at work. Same with pursuit of professional advancement and recognition. I read an article a few years ago about a researcher, and for the sake of title and publishing, he had falsified a bunch of his research data. Really, everything that he published was inaccurate, but he was in pursuit of professional advancement and recognition. That was more important to him than the integrity of his data. We also have relationships, right, with friends, family, maybe with our students or our colleagues, and we want to be in good graces with them. That’s just part of being human. So we have to make sure that those secondary interests around money, around advancement, around, you know, our relationships don’t get in the way of our primary interests, which are taking care of our patients, having high-quality research, those things related to our job.

Giovanni, let me hit pause there, because I think this is a good spot for you to share some of your thoughts here.

Giovanni: Yeah, I appreciate it. So you know, I think it’s great, Sarah, that you have such a strong health care background, because I think health care has been pushing hard into compliance and ethics, you know, whether it was regulatory-driven or patient safety, for a long time. And I think a lot of industries are catching up to that. So you bring a really deep expertise on this concept of conflict of interest. But I just want to highlight that this is present in every industry, and it’s because humans are present in every industry. There’s a lot of psychology, if you look into behavioral psychology, where people…you know, when people do something questionable, very frequently, it’s tied to what group they’re tied into. And you can call it tribalism, you can call it the in-group, or you can call it just, you know, we are kind of a communal-type creature. But a lot of people, you know, because they have a family to take care of or, you know, they want that social status or whatever it is, it can lead them to kind of fall on the wrong side of some of these decisions. And I think part of what we want to do as ethics experts is not just kind of prevent regulatory enforcement and lawsuits but also make sure the right things are done.

And I think a great element of this conflict of interest, kind of, point of engagement is that we can kind of get at some of those gray areas where someone might be, like, “Oh, I thought that was fine. You know, I think my brother runs a great company. I gave him the contract.” And we can point out, “Okay. Well, that’s not exactly right. We should do that a different way.” And I think the presence of humans in our heart and what we care about oftentimes clouds the judgment around this, and I think part of what makes a strong conflict of interest program so important is these are not all blatant fraud that someone is trying to rip everybody off and try to pull the wool over everyone’s eyes. Sometimes it’s someone just kind of making the wrong decision. And we can elevate their awareness and help them understand that, “Hey, the compliance team, the ethics team is here to make sure that everyone’s treated fairly and the right things are done, and let’s do that a little bit differently.” And I think that if you’re in an organization that has humans in it, whether that’s a technology company, an industrial company, you’re in retail, you’re in hospitality, or obviously, if you’re in health care, this is something that’s important, and the principles that we’re bringing to bear today are relevant to anyone who wants to manage these conflicts of interest through a program, through collecting, you know, surveys and information, and then taking action on them.

Sarah: Absolutely. I think that’s great. And really, with so many compliance internal controls that we put in place, which this is, right, a conflict of interest program in a plan is a type of internal control. And like Giovanni said, if you think about, you know, the compliance allegations that may have come through your shop over the last year, how many of them are truly people trying to be nefarious? For the most part, it’s a lack of knowledge or a lack of clear thinking, or they just didn’t put two and two together, or to Giovanni’s point, you know, they didn’t really think about the fact that doing this favor for their friend would really look bad. So these guard rails, these internal controls are helpful just to help people stay in the lines, right, color inside the lines, and it helps our organization certainly stay out of trouble, but I think it also just has for a cleaner…from a reputational perspective. As we know, conflicts of interest really can get an organization on the front page of a newspaper pretty quickly, as we’ve seen over the past few years.

So like Giovanni said, these are not all specific to health care. Some of them are, obviously, when we talk about clinical conflicts of interest, but conflicts of interest can really be in any industry. Certainly, we have financial conflicts of interest where someone has an investment or ownership or some sort of employment, some sort of financial relationship that could color their judgment. I do want to point out that the term FCOI or financial conflicts of interest is a defined term in the NIH grant world. So it does mean that specifically in NIH grants, but we’re talking generally, like conflicts of interest that are financially related. There can be clinical conflicts of interest, right? When we have some sort of, like, relationship maybe with a drug company, and we’re also writing patient prescriptions, so I think there can be conflicts there. Certainly, gifts and entertainment. You hate to say it, but business courtesies, which are very nice, honestly, even the DOJ Evaluation of Corporate Compliance Programs, in their 2020 update, pointed out that, like, business courtesies, you know, some people really focus on those and have a zero-tolerance, but, like, small business courtesies are just part of doing business. It’s the significant things, right? But if you have a vendor that’s taking your physicians out or taking your leadership out for thousand-dollar dinners or several hundred-dollar dinners, like, is that a business courtesy or is that an attempt to persuade, right?

We have these other things, board membership, consulting research, anything for a competitor. We, you know, think about board members and their fiduciary duties. Certainly, academic conflicts of interest, intellectual property. Foreign influence is something we’ve heard a lot about. So conflicts of interest can have a lot of different flavors, a lot of technical terms around them, but they still go back to what we said on the first slide, right, where a secondary interest, because we’re human, is impacting our primary duty to our employer, to our patients, etc.

Giovanni: Yeah. And just as we get into this, I think part of what I want to exhort everybody to look at is a great program here is going to go beyond the super obvious things. Listen, if someone got bribed, you know, $80,000 to give out a contract, and that’s a very clear conflict of interest, but doing a really great program gets you past that super obvious thing into some of these things that…you know, some of them are financially related and some of them are not, some of them are status or relationship, or something else. And a strong program, when you’re organized well, when you get through these best practices that we’re going to talk about, you’re going to be finding these other things that have potential to kind of gum up the works in your business and you achieving your mission, and that’s what I think we’re always trying to do as we’re moving toward a compliance 3.0 environment of “Let’s get past the obvious thing that we’re going to get sued for, and let’s do the right thing.”

So just briefly, Sarah, if I can pause us. I want to shout out Brazil, Thailand, and South Africa. Thanks for joining us. And we have a question. It might be jumping the gun, but I love when people ask questions. So the question is, when we get to gifts, travel, and entertainment, what is nominal value? I imagine that there’s not a bright line there, Sarah, but you know, how would you add some perspective to that?

Sarah: Well, there is a government document that talks about $15 per occasion and no more than $75 in a year. There’s actually a defined nominal value out there. Forgive me that I’m blanking on the spot. It’s either OIG or CMS. So we tend to recommend that when patients or, excuse me, clients are asking us, like, what should our nominal value be in our policies. If you want to shoot me an email, my email address is on that early slide. I can get that exact link to you so that you can have that. But there is a bright line. Now, that doesn’t have to be the only, right? Like, there’s wiggle room there, especially, depending on your industry, since that’s very health care specific.

Giovanni: Right.

Sarah: But if the government does make a suggestion, I think they’re nice to follow those. So that would be my…15 per occasion, totaling no more than 75 in a year.

Giovanni: Great. Thanks, Sarah. And thanks for the questions. Keep them coming, folks.

Sarah: So maybe this slide surprises some people. I think when we hear conflict of interest, especially in our country, especially in our culture, thinking about, like, our political climate and our news climate over the past few years, I think we’re, like, “Oh, gosh, conflicts of interest.” Like, we want nothing to do with that. But I think we need to remember, conflicts of interest are not necessarily bad, right? Like, just because a conflict of interest exists doesn’t mean it’s going to result in some sort of poor outcome. Just because a conflict of interest exists doesn’t mean that it shouldn’t exist, right? We must have industry and providers working together, or else we’re not going to have COVID vaccines that come to fruition that quickly, right? We’re not going to have new cancer treatments. We’re not going to have new drugs. There is a benefit when patients, health care organizations, and providers work with industry and others in health care to develop new treatments, to develop new ways of looking, excuse me, at issues and diagnoses. We become better with each other.

However, there are risks, right? You don’t want those relationships that need to exist for the sake of humanity and for the sake of progress in health care to call into question professional judgment or to create bias. You know, like we’ve talked about, we are human. There are biases that we have that we don’t even know. Like, I can’t imagine…if we could…I’m not a psychology major, Giovanni. I don’t know if you have that background or not. But, like, there’s entire fields of study around this, right? Like, we can’t help it. So what we want to do, again, is just put guard rails in to help…essentially, help our physicians, help our staff, help our leaders know what the lines are, create those guard rails, so that they don’t go outside of the lines even when they don’t need to. 

But just remember, just because it’s a conflict of interest isn’t bad. Certainly, the term has a super bad rap, but I don’t think it needs to. Really, the goal of COI management is just putting in guard rails that help protect reputation, right, help protect the integrity of professional judgment, make sure that patients don’t call into question, like, you’re a researcher for this drug company and then you prescribed a drug from that company, “Did I really need that or were you doing that because you had a financial relationship, right?” We don’t want our patients to think that.

So when everything is very transparent, when everything is very up front, like Giovanni said, when you go beyond the checklist and you go into conversations in evaluation and really thinking through things, that’s the goal of COI management, right? So just remember, it’s not all bad. Like, it’s actually really good. We will have better organizations, better providers, when our providers are doing interesting things, like research and consulting sometimes, depending on what kind it is, right, and publishing. Those are all really good things. It’s just that we want to create guard rails so that those have a less of a chance of impacting our judgment.

Giovanni: Yeah. I think that point about you want to…conflict of interest management, not immediately rip out anything that might be a conflict of interest, and I think that’s why you need a thoughtful, well-managed program, because there’s a bunch of things in the gray area that are not the obvious malfeasance, but, “Okay, well, this is fine, let’s disclose it,” or, “Okay, let’s keep an eye on this and see if it progresses,” or we get deeper in with this vendor, or whatever it might be. And if you’re in finance, if you’re in technology, if you’re in hospitality, these types of things, the business consideration, you have relationships across the industry, you used to work somewhere else, wherever it is, it’s present, and I think if we raise our awareness that these conflicts of interest are present, they don’t all need to go away. You don’t, like, need to fire everybody who has one. But when you know about it, then you’re aware, and you can make a measured response of, “Okay, we need to separate from this relationship, and we need to manage this differently.” And that’s part of why this process gets so complex. That’s part of why you need a strong program, so you can manage through the volume of potential issues.

Sarah: So I’m not going to spend time here. They all end in question marks, as you see, right? Because there’s gray area here. There’s risk tolerance. There’s thoughtful conversations. So some of these, when you see them, you’re, like, “Yeah, we shouldn’t do that.” Note that speaker fees, like, is in quotes because, literally, OIG came out last year with some guidance there. Some of these, like, I don’t know. Do you think it’s appropriate? Do you think it’s not? Is it a conflict? Could it impact judgment? What about the dollar amount, right? Like, there’s a lot of considerations, and we’re going to spend some time talking about that.

I do want to point out quickly the open payments. So if you’re not familiar, the Physician Payments Sunshine Act requires pharmaceutical, medical device, biological, and medical supply manufacturers to report payments or transfers of value made to physicians or teaching hospitals. All of these are published. I will say, if you are working in a provider organization and you don’t know where to even start with COI, this is a good place to start. You can literally just put in this database, it’s called the open payments database, the name of one of your physicians, and you will see all of the payments that were made to that individual by industry in the last year. It’s super interesting, but that only applies to providers, right? If this doesn’t help you in your evaluation of COI for, like, managers, or leaders, or board members, just for physicians, but it is nice to point out that this resource exists. And a lot of people use this as part of their CON management processes.

Giovanni: Which is just another example of how progressed this conflict of interest management and oversight is in health care, which is, I think, a great way to kind of elevate any industry around, “Hey, health care has been doing this for a couple of decades. Here’s how you can implement it well.” Because a lot of the principles we’re talking about today are just how do you uncover, collect information, make decisions, and adjudicate them.

Sarah: So we’re going to spend a little bit of time just talking about challenges that I see working with various clients on their conflict of interest management processes, that Giovanni and his team have seen as they’ve worked to build a software. I really think one of the biggest ones, Giovanni, is just a poor understanding of COI risk, where leaders just don’t get it. Either they’re scared of it and they’re, like, “Oh, gosh, conflict of interest,” so they, like, put their head in the sand, or they think that maybe CON management has been overblown, and they want nothing to do with it, and they don’t want guard rails around their people. Really, somewhere in between is the most helpful.

Giovanni: Yeah. I think that’s true. And I think it’s part of what we, as a profession of compliance and ethics leaders, are moving toward is this ability to share our knowledge and develop our influence across the organization. So I think, as you look at this list here, you kind of have three levels of the organization, right? You have that tone at the top, right? You’ve got to get those leaders to understand what this is, and it’s a little bit nuanced, but it’s not completely, you know, always no or always yes. There’s that kind of mood at the middle. You need kind of your managers of your compliance program and maybe of divisions, you know, who have oversight on employees to understand what’s going on here. And ultimately, you need that groundswell of people on the front lines, you know, filling out these forms, understanding what’s relevant, and hopefully, you know, I think one measure of how strong your program is, is how engaged employees are in saying, “Hey, I want to give you a heads up about this. I think this might be a conflict. Let’s talk about it.” And that, you know, I think when you can do that, you get into this compliance 3.0 actually being effective, not just kind of trying to keep the boss out of jail. And you can have an effective dialogue. You’re no longer just, you know, the island of Dr. No, but you’re having conversations around, “Hey, you know what, let’s refine this a little bit. We can disclose it,” or whatever. But, yeah, I mean, I think you have to start with that tone at the top, because if your leadership doesn’t understand it, you’re not going to get, you know, the budget to run a program or the backing to say, “Hey, you know what, we’re serious about this.” And I think starting there is a great point.

Sarah: And, Giovanni, I love what you said around someone actually coming up to you, right? I think that points to the culture, right? If we have a culture of transparency and a culture where staff aren’t afraid to bring things up, you know, just like in patient safety where, back in the ’90s, like, all these safety events were happening. And we really moved as a country and as an industry to have this very transparent, a lot of transparency when it comes to safety, including ratting yourself out where, maybe 30 years ago, that wouldn’t have been a thing, right? But it’s the same thing here. You know you have an effective culture and an effective compliance program when people are going to bring something forward and they’re not nervous that they’re going to get in trouble or they’re not nervous they’re going to get the smackdown. They’re not nervous they’re going to be retaliated against, but, like, they want an open dialogue. So I think that’s a huge thumbs-up to your compliance program if you can create that kind of culture where people bring things to you, and not only, obviously, conflicts of interest, other things as well, but they want the dialogue there. Because there’s a lot that’s not black and white in compliance. There’s a lot that’s not black and white in health care. There’s a lot of gray. So you know, there is a lot to be said for conversations in risk tolerance and culture.

Giovanni: Yeah.

Sarah: Another thing that I see, and I think this kind of surprises me, but again, you know, organizations maybe are nervous. They don’t know what to do with COI. It’s like big and scary to them. When Giovanni and I were kind of preparing for this, I said, “Maybe we should have called the session Demystifying COI,” because I think a lot of people just hear the term and they don’t know what to do, because it’s super gray, right? There’s not regulations around all of it. There’s regulations around pieces of it. They don’t know what to do with it, and they’re scared of it. I don’t think you need to be scared. Like, it’s really just a matter of conversations, and a process, and a plan, an open dialogue, and then understanding risk tolerance. And that’s what we’re going to spend time on today. But I’m amazed by how many organizations don’t really know who’s in charge of COI management, who owns the process, who’s owning the disclosures, whose call is it to decide whether or not there’s a management plan, just a lack of operational ownership of, “Okay, who’s going to own COI? Is it going to be compliance? Is it going to be legal?” One place I worked with, it was actually the board. Like, the board itself handled COI management.

And then, you know, in addition to that, maybe your organization does know who handles COI, but you haven’t really communicated that. So your team doesn’t know, “Okay, well, what are we supposed to report? Like, what kind of conflicts should I be reporting? How do you report them? What’s the risk tolerance of the organization? How do I get help regarding COI?” Like, you would just be surprised to know how many places it’s super unclear. So if your organization hasn’t grappled with these things and you’re struggling, know that you’re not alone. These are very common challenges that I see.

Another one, and I think that maybe we could even call this kind of the bedrock, there’s not been good historical conversation in organizations really understanding and defining what is our risk tolerance, what are we comfortable with. And I think that is a foundation to conflict of interest management. Otherwise, once people start disclosing things, how are you gonna know what’s okay? How are you gonna know what your organization is okay with? So if you don’t have any COI processes in place right now or you’re looking to fine-tune them or looking to improve them, I would say, this needs to be one of your first steps. Sit down with your leaders, sit down with your board, sit down with your senior leadership and your CEO, and really define, what is our organization’s risk tolerance? What are we comfortable with? You’ll have to get into the weeds of what that means, depending…you know, if you’re a research organization, that’s going to look a little bit different than, you know, an organization that doesn’t do research. But, like, you really need to understand, what are we okay with? Are there some things that we’re, like, “Yes, every single time this occurs, we’re okay with it, but every single time this other thing occurs, we’re not,” right? Like, maybe that’s around the OIG guidance on the speaker fees or the speaker programs. So understanding your risk tolerance and then even being able to define will really help go a long way in COI management. Otherwise, every single disclosure, you’re gonna have to be, like, “Okay. I don’t know. What are we gonna do with this?” But if you can have your risk tolerance defined and understand what your organization is okay with, what they’re definitely not okay with, then you only have to deal with that gray area in between.

Giovanni: Yeah. And that gray area is really part of the challenge in conflict of interest management because part of the path here, if you kind of have a nascent program or it needs some clean-up, is you need to, first, get more information, right? You need to have more issues to review, and then you’re going to have this issue of, like, “Okay, I have a bunch of decisions to make.” And if you clarify that ownership of the process, what’s in and what’s out, which ones you’re okay with, which ones you want to monitor, which ones you want to put into an action plan, you can organize all of that, you know, with your plan, organize it in your software, and then stay on top of it. But that’s part of the challenge. As you do this better, you have more to review, and then you have to make decisions about those things.

So if I could pause for a second, Sarah, we have a couple of comments here. So thank you, Teresa, for jumping in. Teresa said, “Great point. Ownership of COI is very unclear in our organization.” You’re not alone, Teresa. So you’re in the right place. She said that HR owns the policy, but beyond that, it’s unclear, who needs to do what for it, you know. So I think that’s a common thing across organizations of, “Okay, well, we’ve defined what we need to do. It’s in our code of conduct,” whatever it is, but also, you know, we need to take the next step and figure out how to manage it. And stick with us because for the next half of this webinar, we’re going to be getting into some of those tactical things of what do you look out for, what decisions do you have to make.

So this other piece, and thank you, Khalid, for jumping in on this. Sarah, I think this is a question that a lot of employees on the front lines have and maybe some of the people who, you know, want to do a better job managing this. He asked, “What happens when I disclose a conflict of interest?” So I think that’s part of this process we need to go through of making sure everybody knows, “Hey, here’s what’s gonna happen.” You know, it probably is not, if you suggest something that might be a conflict of interest, you automatically get fired, but it’s probably something of, “Hey, we’re gonna review it,” and stuff like that. How can you give us guidance either on how to answer that question or maybe how to come up with an answer on what happens when something’s disclosed?

Sarah: Yeah. Well, how to come up with…what happens when something is disclosed is really the rest of our presentation. We’re going to talk you through what you need to put in place to build a COI program. At least, a lot of questions to ask and, like, your foundational concepts. But I will say, what happens when I disclose a conflict, you know, I think goes to the fact that, like, a lot of people, including physicians, including our staff, literally don’t know. So I think, just like transparency is key with disclosing conflicts, I think transparency is key from within an organization to say, “Hey, when you disclose a conflict, this is what it looks like.” So on your website, in your newsletters, like, however you are communicating around either your compliance program or your conflict of interest program, lay it out there. Let your constituents know, “This is what happens. So when you disclose a conflict, this is who reviews it. This is what we’re reviewing it against. These are how things are decided.” And just lay it out so that it’s not like a mystery. I think you had talked about the No Island, Giovanni. My favorite is a client actually said, when I interviewed them, about their organization’s compliance program, they said, “Compliance is where things go to die.” And I was, like, “Oh, my gosh, like, that’s kind of the worst thing you could say.” But…

Giovanni: Yeah, you need a rebranding at that point.

Sarah: I know, yeah. Yes, rebrand, don’t print t-shirts with “Compliance is the department where things go to die.” But I can see that when people bring something to compliance, be it COI or a report, and they never hear anything ever again, that’s the assumption, right? It went there to die. So if you can clearly communicate to your constituents, “This is what we want you to disclose. This is how you disclose it. When you disclose it, this is what happens on the inside, right? Like, this is who reviews it. This is how we’re reviewing it. This is how we’re making decisions, and this is when you’ll hear back from us, right?” That’s how you assure people know you’re gonna get back with them. So I think transparency, communicate, lay it out, make it clear, but like we talked about, it’s really hard to make something clear when everybody’s, like, “I don’t even know who owns COI in our organization. Like, what do we do? What’s a COI?”

So the last bullet point here, like, COI equals mystery, right? Who owns it? What do we do with it? What happens when I do disclose? So thank you all for bringing those questions, because that is what I hear in a lot of organizations. And it’s why Giovanni and I wanted to talk about this today.

Giovanni: Yeah. Awesome. Thank you, Sarah.

Sarah: Yeah. Do you have other questions? Anybody else?

Giovanni: Oh, we have some more, but I think we’re about to cover some of that. So let’s jump into kind of concepts and tips here.

Sarah: Perfect. So, hopefully, a lot of what is in this next section is, like, super practical things that you can do, especially if you’re in an organization where you’re, like, “I don’t know who owns it. I don’t know what it means. I don’t know what we do with it.” Like, COI management, a COI program, is not a one-size-fits-all. We are not suggesting that there’s only one way, but these are the concepts that every organization needs to grapple with and answer these questions so that they can build a conflicts of interest program that works for their organization. Just like a compliance program should be customized to the organization’s size, complexity, risk profile, and culture, you can say the same thing for a conflicts of interest program, right? It should be tailored to what is your organization’s culture, what are the types of activities that our staff are likely to be involved in. So while the concepts are very similar, the way it looks in your organization is going to be different, but hopefully, this provides at least a roadmap, a place to get started, a place to start conversations with your leadership.

So you know, just like with any issue, when we talk about root cause analysis, we start with a lot of questions. Like, we just start asking why, why, why, why. So I think you can make the same case here. You want to have a plan for COI. Maybe we should have put this slide at the very end after we talk about all the elements, or maybe here at the beginning and at the end, but your plan needs to consider the who, what, where, why, how, when, and any other question words that you can think of that I didn’t think of when I made this slide.

So, who’s going to have oversight of COI? Who’s going to own this? In our responsibility, like, if HR owns the policy, okay, does HR also own the review of the disclosure? Are they the ones who are going to be communicating? Who’s going to do that? So who has oversight and responsibility? Who’s going to educate the organization? Who needs to disclose? In some organizations, everybody discloses. In some organizations, they just have, like, board, physicians, and leaders, and managers disclose. What needs to be disclosed? Are there some things that you can say, “If you’re doing this, don’t even bother, or do you want everything disclosed?” And then, how will COI be disclosed? Some people have a paper and pencil process. Some have a home-grown software. Some get an outsourced software, like what ComplianceLine offers. But how will they be disclosed? And then, to the question we had a couple of minutes ago, when something is disclosed, who’s going to review it and then against what criteria? Who develops management plans? How are they developed? How often should COI be disclosed?

It’s definitely not a one-and-done. Just like exclusion screening, I can point to Giovanni for that too, right? If you only do it at hire, that’s not enough. It needs to be monthly for your staff and for your vendors. So, how often should COI be disclosed? It’s not one and done. Who’s going to audit? Who’s going to make sure that the things you put together are actually being followed? Anybody looking at open payments. And then documentation and tracking. You know, I’m a nurse. Like I mentioned, if you didn’t document it, you didn’t do it. Same here. If you’re not keeping a paper trail and for some reason something’s going to come into question, you want to make sure that what you put together, you are storing those documents and tracking.

Giovanni: Yeah. This is a great slide. Just as a reminder, everyone’s going to get these slides. This is a great slide to review some action plans and say, “Okay, this month, we’re going to figure out one of these questions. I have answers to four of these. I don’t have answers to the other five.” And you know, start getting on a continuous improvement process for your team and say, “Hey, you know what, let’s clarify this. This is one we can do quickly ourselves. This other one is going to take some, you know, kind of coalition building throughout the organization, and we can work on that next.” But this is some really actionable stuff that, if you don’t have clear answers to all of these, you’re not in trouble. It’s not terrible, or whatever, but you’re going to have more clarity. And what I like about it is when you answer these questions clearly, then your job’s going to be easier. You’re going to be less stressed and less wondering, “Oh, man, you know, this thing popped up. Now, I have to figure it out.” If you have a plan going into it, these are some things that you can beef up that plan with and then have it smooth sailing from there.

Sarah: And not knowing the titles and roles of those who are calling into the webinar today, but whoever you are, I think you can put a group together and start working through these, right? If you’re the compliance officer and you have a compliance committee, start working through these questions with your compliance committee. If you’re an operational leader, get some of the other leaders involved and develop, essentially, a little task force to say, “Hey, we’ve got an issue. Like, COI is not being managed. What are we gonna do?” But figure out who are gonna be your partners on this to even figure out your plan.

So let’s kind of walk into the water a little bit deeper, some of the more specific elements. So oversight. Like we’ve talked about, who’s got responsibility here? Who’s going to oversee the program? Who’s going to develop it? Who’s going to implement the COI program? Is it compliance? Is it a different administrative department? Is there a COI committee? Should there be a COI committee? There’s not a one-size-fits-all answer here. So think about what works at your organization. Regardless of the answer, you have to have leadership engagement and buy-in. So if you’re listening to this and, like, “Oh, my gosh, we need to go back. We need to work on this. We need to develop a COI program,” work with your leadership, talk to your CEO, make sure that they understand why this is important. As we know, if it doesn’t have executive-level buy-in, it’s not going to go well. So start there. You will need to collaborate to get…like, you know, we say in compliance, while we may be, like, the jack of all trades, we don’t know the details of every single risk like others in our organization do. 

So compliance shouldn’t function as a rock or an island, as our friend Simon & Garfunkel sang about. We need to collaborate. So you will need to involve legal, compliance, human resources, some of your physicians, if you have research, you need to involve research faculty, department management. So think about who needs to be involved even in the conversation for starting it up, and then, as you move forward, you’re going to need to collaborate with these folks to really understand the risk, understand the conflict, and think through what that means. Again, from, you know, like I mentioned earlier, if your organization has not defined risk tolerance and you don’t really know what’s acceptable, what’s not acceptable, you’re going to need to start there.

Giovanni: Yeah. And I just want to highlight that that collaboration is really important, because, listen, for better or worse, there’s not a universal 10-point plan for every industry of you exactly have to do these things, and then you’re fine. This is one of those things that we deal with a lot in compliance of you just got to make sure it doesn’t go wrong. So in that kind of big gray area that so many of us live in, well, don’t let a, you know, lack of clarity keep you from getting started. We’re giving you some things here that you can pick up and say, “Okay, I can clarify that. Okay, I can ask this division kind of what things would come up and start building this.” Because this is a management program, not a kind of, you know, one-and-done, fix-it program. And you can start, you know, taking steps to making this stronger, and part of it is gonna be you and your team have to figure it out. So let that freedom be something that pulls you into the process and say, “Hey, you know what, our best…what we can figure out for this is a great place to start, and we can figure out if something’s sticky or we need kind of a more formalized answer.” But step into this because there’s not a prescription, you know, there’s not some secret hidden treasure map of exactly how you need to do this. You need to figure out what’s right for your organization. 

But that’s what we, as compliance leaders, are meant to do, right? Galvanize the team, galvanize the organization, get the right people together so that we can make the decisions, and you can start stepping through some of these best practices and plan elements to build some more clarity for your program.

Sarah: So once you have kind of figured out, “Okay, who’s going to own it?” right, like, oversight and risk tolerance, I feel like, are really your first things you need to establish. Once you have those in place, you can start talking about, like, these more fundamental things when we think about COI. So first of all, like, disclosure. You’re going to need to figure out who needs to disclose. As I mentioned, some organizations require everyone to disclose. Honestly, I kind of like that approach, because it’s just really clean and it’s really clear. But if you have a huge number of, you know, employees that may not be feasible unless you have a software system that can help you weed out those low-risk ones pretty quickly.

And then how to disclose. Like I mentioned, you know, there’s not a one-size-fits-all here, what works for your organization. I will say, a paper process, if you are very large, is going to become very onerous very quickly. So paper works well for smaller organizations. But once you get to a certain size, that’s going to become very challenging to manage. So you’ll want to think about some sort of software solution.

And then how often to disclose. Certainly, annually, you’re going to want to require an annual disclosure. I would say, at hire and annually for those who you’re requiring to disclose. And then really anytime an individual has a new circumstance that arises, if they get a new opportunity, if they start with some sort of new engagement, anytime there’s a circumstance that creates a potential for a new COI. You do want to build that into your program, because, otherwise, if you’re just doing annually, if you find out that somebody’s been doing something for nine months, and you didn’t know about it, and you didn’t prove it, like, that’s never a fun situation. You may even want to say that they need to disclose it 30 days before they start so that the potential conflict can be approved before they begin. So you want to think about that.

And then what to disclose. Again, you know, that’s something that you have a super vague answer here, right? Like, we didn’t tell you all the details, because that really needs to come from your organization, what type of organization, what type of activities, and then the risk tolerance of those in your organization. But I will say, clearly communicate expectations, and as much as you can, put a list of what types of activities you’re talking about that need to be disclosed, outside consulting, outside employment, any sort of work with industry, right, like a vendor, or a manufacturer, or a distributor. Some places want everyone to disclose their government involvement, like, if they’re reviewing government grants. Some people say, “If you’re doing something for the government, we don’t care. Don’t disclose it.” But you’ll need to figure out and give just really clear guidance and examples for what you want people to disclose.

Giovanni: Yeah. And it’s a great place to start. Can we pause on that disclosure piece?

Sarah: Yeah.

Giovanni: Because I want to bring up Q&A. But you know, a great place to start is how you think you should handle that. And you know, your organization can decide, and you can have, you know, a good faith effort toward this. Kathleen mentioned that, you know, what’s key in this process is transparency and confidentiality. So those are two great things to keep in mind. With that in mind, we have an anonymous comment, and we will preserve your confidentiality. But the question is, what are some of the best practices for communicating your conflict of interest program out to the broader organization and employees? How do you keep it top of mind? And I think a lot of that, you know, this is kind of the frontline effort to have the people who might be the sources of these conflicts make them aware of this, and I think that’s a lot around this disclosure piece. And I think that, you know, I’ll kind of jump in with some of my ideas, Sarah, and then you can round it out.

But you know, I think that this can and should be part of your broader compliance communications, your speak-up culture, with a specific focus on “Hey, these things are especially sticky issues and things we should have conversations about.” So they can, you know, go out in the emails that you send around. You know, we offer some, you know…you can do a conflict of interest kind of e-learning training, just like you do for your code of conduct. You can also send out reminders to people, you know, in video form or in kind of a quick burst that’s a, you know, 15-second to 2-minute video to get them to remember to think about this. And that should kind of be balanced with how frequently you want to hear about this, right? So if you’re only hearing, you know, about conflicts from your board of directors once a year, you probably don’t need a lot of effort around this. But if you’re trying to get all of your, you know, maybe hundreds or thousands of employees to kind of look out for these things, then you need to stay in front of them. That might be monthly or at least quarterly. But if you have them, you know, watch a 10-minute video once a year, I imagine that you might get into the situation that Sarah mentioned where, you know, you might go 9 months without someone disclosing something.

So I think it’s a best practice to kind of have a campaign, kind of annually, every twice a year, or quarterly, to ask people to disclose something, but also, you want to get that draw of making people aware of it so they say, “Hey, I’m about to enter into this agreement or this relationship. Let me check,” like Sarah said, “Let me check before I do it so that I’m not putting the organization at risk.” Do you have any other perspective on how you keep it top of mind or communicate this to your organization?

Sarah: Yeah. In addition to, you know, what should come out of your education and training plan and your communication plan, which are, like, “These are the things we need to be communicating,” right, from an education perspective as well as ongoing communication, like I mentioned, have it very clearly laid out. If you have a website on your intranet for your compliance program or for HR, whoever’s going to own this, map it out very clearly. Like, here is our COI program. Here is how we do it. Here’s who needs to disclose. Here’s what you need to disclose. Here’s what happens with your disclosure when you disclose it. Here’s how quickly you can hear back from us. But I think, you know, to the person…I think it was Kathleen mentioned transparency is key here, make sure that people understand what the expectations are. It’s really hard to say, “Hey, follow our expectations,” when we do a terrible job of telling them what those expectations are.

Giovanni: Yeah, yeah. Thanks for that, Sarah. It’s really key. There are kind of two elements, right? You want some awareness of this concept, and you want a place for people to say, “Hey, you know, what about this thing?” And that can be in your policies or on your intranet, or we have it baked into our forms, or someone can go to the forum and say, “Hey, you know, we have some FAQs. Hey, should I really report this?” And when you empower people with that information, when you kind of pull the veil back so that this is less of an opaque idea to people, then I think you’ll see people engaging better and be, like, “Okay. All right, I know what you’re talking about. I’ll keep an eye on that.”

Sarah: And you know, also, Giovanni, I think sometimes, in compliance, we put a lot on us. Like, what do we need to communicate, right? Think about what DOJ expects out of managers and leaders, right? They expect unambiguous communication around compliance. So, like, this is something where you can push this out to leaders and you can push it out to managers and say, “Hey, you know, this is coming. Can you please…you know, leaders, share this with your managers. Managers, share these with your staff,” you know, in your town hall meetings, in your department meetings. Leaders and managers can be talking about COI, and obviously, you know, that can be a lot more powerful than the person in the ivory tower over in compliance here, right, telling us what to do. But when we have our managers and our leaders saying, “This is important,” it protects our organization, and it protects you. So engage operational leaders and managers in this communication as well.

Giovanni: Yeah. And I think when you do that, if you can help them get an understanding of why this will benefit them, you’re going to get a lot more traction, not just “I’m forcing you to do this. I’m using the stick. You’re going to be in trouble if you don’t talk to your team about this. Hey, you know what, things are going to be smoother for your division if we can uncover these and negotiate them before we get caught in a trap.”

Sarah: Totally. So let’s kind of jump ahead. When we think about risk, right, this is something that we’ve been talking about. Like, you should define your risk tolerance. Because if you don’t, when you get a disclosure, literally, you’re going to look at it and be, like, “Okay, is this okay? Is this bad? Is this good? Like, what should I do with this?” So some things to evaluate, and again, maybe you can take these bullet points, add some other ideas, and then, hopefully, turn this into something within your organization that even could be, like, your own risk matrix for how you use COI. The position and influence of the person disclosing. What type of outside entity are we talking about, and what kind of relationship? Is there remuneration involved, and how much is it? Is there any similarity between the role inside our organization in this kind of activity they’re going to be doing? What would be the risk of reputational harm if it went wrong? Think about the front page of the paper. Think about the internet, right? Think about the little daily news bites that we hear all day long. And then, how much time will be devoted? This is not an exhaustive list but hopefully just to help you think about what should we be considering when we’re talking about risk.

What I also recommend is, once you have that risk tolerance and you understand what that is with your organization, I recommend developing some sort of review criteria. Again, this is going to be very specific to your organization, to the kinds of activity that your teams may be doing from a conflict perspective, and also based on your risk tolerance. If you can define some limits and boundaries, again, like Giovanni talked about, like, there’s always going to be gray area. But as much as you can, if you can develop some review criteria that either helps you say, “Okay, low risk, we’re not going to worry about this,” or “Okay, this is in a medium risk bucket that we need to chew on or collaborate with those other folks that we talked about,” or if it’s, “Oh, gosh, this one’s a red light. We’re going to put this in our red light bucket. We’re going to get back to them today and get more information,” but if you can put together some review criteria, that’s really going to help you have consistency in evaluating COI and then, ideally, consistency also in managing COI.

And I want to just go ahead and move right into management, because, you know, based on the type of activity, hopefully, you can have some controls that are…I don’t mean templated in a bad way, but almost…think of an a la carte menu at a restaurant, “These are our a la carte 30 different options,” when somebody comes in with a certain type of conflict, right? Like, “Okay, they absolutely can’t do that,” or “They can do it, but this,” or “They need to notify committee members of this,” or “They need to notify patients of this,” or “They need to be monitored,” or “They need to be audited.” Again, the a la carte menu may not be complete. Like, you may have things that pop up that you need something outside of that list. But if you can go ahead and think through that, really, like, if organizations come up with a management plan template that has some stock information, so, like, across the board, we’re telling our people the same thing, right? Like, “We expect you to follow this. These are the expectations around disclosing to, like, those you work with or committees that you’re on. This is how often we expect you to report back to us and give us updates on what you’re doing.”

But also be very specific. I see a lot of management plans that, like, when you read it, it’s all written in legalese. It’s, like, “What is it even saying?” It doesn’t actually have any teeth. It doesn’t actually have any real, like, management to it. It’s just, like, stuff, and there’s no, like, “Okay, what am I supposed to do with this?” So you want some actionable things that the person can do, like, real controls that really do help mitigate the risk.

I do also want to say that not all COI can be managed. There may be something that comes in, and you’re, like, “Hey, I’m sorry. I don’t want to be the department of no,” or, “We, compliance committee, or we, leaders, don’t want to just say no, but, like, this is too risky. We just can’t tolerate it.” Like, and that’s a possibility. And in your clear, transparent communication to your organization, you need to say that. Like, not all COI can be managed, but we sure are going to work to manage as many as we can, because we know that most conflicts are really good for you and for our organization. But the big takeaway here, practical, implementable, and then try to be consistent over time so that, like, if this physician and this physician are each doing something similar, they shouldn’t get completely different management plans, right? Like, they should be consistent from person to person because you know they probably won’t talk about those. Probably, you know, you may have had a situation like that where they’re, like, “Well, he got this, and she got this.” They should be consistent.

Giovanni: Yeah. And that’s a big part about professionalizing your conflict management program because you could be exacerbating the risk in your organization by not handling those consistently. So having a plan for how you handle these and making sure there’s adherence to the plan, you know, we facilitate some of that through our software. You could do that by just having good training and having good checks and balances, and things like that. But if you give some consideration to this person and someone else in a protected class gets a worse treatment, and you don’t have…you know, because it’s not standardized, well, you’ve just turned a conflict of interest situation, potential conflict of interest management situation into a discrimination event. So having that standardization is important, and that’s part of why, you know, formalizing this program, getting your plan in place, and making sure that everyone’s doing the right things consistently is going to be really important for you.

Sarah: So auditing and monitoring. I think sometimes we think, “Okay, they disclosed. We gave them a management plan. We’re done.” Well, you’re not quite done, right, because there’s also risk in the fact that we say, “Hey, you had something that was kind of risky. We gave you a management plan,” but then that was it, right? You never reported back to us. We didn’t track it. We didn’t follow up. We didn’t make sure that you held up to your end of the deal as the person that has the management plan. So think about what should that look like. What should auditing and monitoring look like? And also enlist operations partners to help. 

Like, compliance is never going to have enough resources, right? We’re never going to have enough people. We’re never going to have enough time. So how can you use leaders and managers to say, “Hey, can you help me? Like, can you facilitate this conversation just to follow up on this management plan where appropriate?” You know, we would call that maybe monitoring. And then there may be some that are risky enough where, like, you do want more independent auditing. You do want an actual audit out of compliance, or from a third-party auditor, or from internal audit. But just think about what makes sense relative to the risk and do follow up, because what’s the point of saying, “You need to manage this,” and then we never make sure that you really did?

Giovanni, I think we’ve covered communication and education quite a bit. I think the key here is be transparent, be super clear, and get the word out. Really, this slide sums up so many of the Q&As that we’ve had. I do recommend putting a policy and procedure together to tie it all together. This should be part of your, you know, that website we talked about, with all of your different COI materials. But know that there are many public-facing COI policies available. So if you’re, like, “Oh, my gosh, I don’t even know where to start,” look on the internet. Look on hcca.net if you’re an HCCA member. Look at your professional organization if you’re outside of health care. See what’s out there, there are a lot of things, and compare ideas, and you should be able to come up with something.

Giovanni: So I can pick this up. This is kind of our ComplianceLine’s perspective on how to simplify your management of this program. So there are a bunch of things that Sarah’s been talking about, about getting your leadership on board, about getting your policy set, about, you know, collaborating with people in your organization. Those are a bunch of things that you can do. And you know, we can do some webinars like this and help you, but you know, you got to kind of do that stuff. As you get into managing your program, right, this is kind of distributing, you know, getting disclosures, and then, you know, managing and assessing your results. 

There’s a lot of scalability that you can get through that, you know, disclosure oversight of the program and then taking action and remediation that can scale your efforts with some software. So our perspective on this is, like I said, there are a bunch of things that you and only you can do and you have to figure out. And when you have a great program in place, following a bunch of these best practices that Sarah has helped us illuminate, then you can get a simple, efficient, and comprehensive approach facilitated by software to handle the management of your program.

So you know, let’s draw a distinction between…you’re doing four paper reports from your board once a year, you probably don’t need a really full-blown platform for that, but if you have thousands of employees or hundreds of employees and you’re doing it monthly or quarterly, or something like that, well, then you’re going to quickly get buried. And there’s trouble when you get buried, it’s hard to follow up on it, and you’ve been told about a conflict that you haven’t followed up on. 

So if you get some software to help you manage the workload, what it allows you to do is you can get through a bunch of that administrative work that’s on the front end, and you can make that more efficient, so then you can focus your effort and your time on those, you know, I kind of call them two different tiers. There’s a kind of red flag of “There’s definitely a problem here, we need to remediate this,” and then there’s kind of the yellow flag of “Hey, let’s keep an eye on this, let’s have a conversation, and let’s manage this conflict,” rather than, you know, removing it.

So you know, your software can help you set up your form, distribute your questionnaire to hundreds of employees on a schedule, whatever it is, you can monitor and track those responses, you can summarize them as they come in, or weekly, or whatever it is. And then, ultimately, your software should facilitate you taking action on your concerns. This gets to that standardization that we talked about of making sure that, you know, things are handled in a timely basis, that the right questions are asked, you know, the right decision criteria are followed. And then, ultimately, this is really important if you want to be a continuous improvement compliance organization, you want to finalize your campaign or, you know, that effort to collect responses and then report on that and see how you did. So what the software can help you do, and you know, ultimately, this can make you less stressed, this can make you more confident in your program, and ultimately, make you more effective in moving this program forward. You can take that manual and time-consuming work and solve it with scalable forms and automation.

You know, if you have kind of disjointed policy and process and disclosure functions, you can streamline that all into your software where someone can see your policy, they can attest to the policy when they’re filling out the form, they can disclose standardized things, and an integrated policy attestation tool can just raise the protection and the standardization throughout your process. So everyone has seen that.

You know, kind of toward the bottom here, document retention, when you’re doing this at scale, can be a messy thing. It’s in your inbox. It’s in some PDFs on your drive. You know, you recorded some stuff in a spreadsheet. Well, if you have to go back and say, “Hey, we asked about this two years ago. We got this answer. We applied our policy consistently. We must have been told something that wasn’t true.” If you got to recover that from someone’s archives, in their Outlook, or something, that’s going to be really hard. But you can automate the tracking and the audit trail within your software. And ultimately, you know, like I said, you want to get to a point. This is going to help with that tone at the top, talking to your leadership about the benefit and the ROI that you got from this. When you can confirm the success of your campaign, you can get that real-time feedback and say, “Hey, we asked for all these disclosures. We got this many back. We got this many maybes, you know, those yellow flags, and we got these many red flags. And look at, you know, how we’ve helped our organization run smoothly and not trip over ourselves.” That’s the type of thing that you want to get to. You got to do the setup that we spent a lot of time talking about, communicating it, figuring out your policy, getting that collaboration across your organization, and then, ultimately, you can run a smooth, efficient program and not make this yet something else that buries you.

So ultimately, if you get to the point where you’ve done a lot of the things that we spent most of our time talking about today, you have your policy, you have your team, you have the right authority, and you know who’s running point on it, you can get a cross-platform, easy user interface so different people can help manage this work. You can customize those forms. Listen, everything you’re doing in compliance should be suited to what you and your organization has decided what’s best for you. You know, it’s really frustrating to me how some vendors will make you fit into, you know, their square hole when you’ve already decided this is what’s best for you. This stuff should be flexible to what you’re doing, have that single location for reporting. And you know, really after you report, the real work starts, right? You have to review those issues, “Hey, what’s important to me? Do I actually have to read 1,000 forms, or can my software help automate, you know, kind of find some hot spots and elevate these things?” And ultimately, that follow-up, “Hey, what am I doing with this case? Am I monitoring it? Is there an adjudication or rectification that we’re working towards?” And ultimately, are we closing out the issues, monitoring the relevant issues? And we have, you know, likely a bunch of forms that came back that didn’t have any problems.

Sarah: So kind of in summary, Giovanni and I both hope you’ve enjoyed this presentation. We’re obviously both happy to chat with you further. My email address is on, I think, slide two. You can contact Kate and Giovanni, you know, at the ComplianceLine address that this came from. But we hope this has been a really helpful session. We just put a few things, you know, concepts and implementation, things you really need to work through. And I do want to say before we’re done, like I mentioned, I work at Ankura Consulting, and we have a roundup series. Every single month, we have a health care compliance roundup, and then every other month, we alternate research compliance and privacy compliance as well. We’ve also been doing a COVID-19 each month just for, like, regulatory updates. So if that’s something that would be interesting to you, the link is provided here. We would love to hear from you. But you can submit our roundups for live CEUs for your certifications. So I do those quite often for my HCCA certifications, but I did want to make sure that you saw this opportunity for additional webinars. And thanks, Giovanni, so much for inviting me to come today. This has been fun. We’ll have to do it again. Again, hope it’s Jamaica or the Bahamas, but you know, if it’s the U.S. and virtual, I understand. But it’s been great, and I really appreciate the invitation.

Giovanni: Yeah. Thank you so much for joining us. I hope that the audience has gotten some benefit from this. Really, my hope is that the time that you shared with us today is beneficial to you and your team to help you get your job done, make your life easier, and make you more effective as an ethics expert. Thank you for joining us. I’m Giovanni Gallo, from ComplianceLine. This has been Sarah Couture from Ankura. We have some questions that we weren’t able to get to in the time, so we’ll try to follow up with you either individually or send some, you know, kind of Q&A around. And we might be covering some of this on a LinkedIn Live in the next couple of weeks. So follow me and/or Sarah on that, and you’ll get a notification for that. There’s a lot of work to be done here, but I want to encourage you all. You can do it. You can make progress on this. You have a lot of really actionable stuff that we’ve given to you in the slide deck. The slides and the recording will be coming out to you. And please get in touch with me, our team here at ComplianceLine, or Sarah and her team, if we can help you be a more effective ethics expert in running your conflict of interest program. Thanks for joining us.

Sarah: Thanks. Have a great day.

Giovanni: Thank you, Sarah. You are awesome.

Sarah: Have a good one.