This is a summary of the April 23 live Zoom update from Vice Chancellor for Research Penny Gordon-Larsen, Senior Associate Vice Chancellor for Research Andy Johns, and Director of the Office of Human Research Ethics Carley Emerson.
View the recording of this update here.
Introduction
Penny Gordon-Larsen, Vice Chancellor for Research
The Office of the Vice Chancellor for Research has spent the past year developing a Strategic Research Roadmap and through that process we learned that the research community would like more touch points with our office. OVCR Office Hours will allow that, and as we give the format a try, we’d be happy to hear feedback about what you find most helpful. (Email OVCRofficehours@unc.edu)
Andy Johns, Senior Associate Vice Chancellor for Research
For each of these sessions, we intend to select a particular topic to present on, and that topic will change depending on what is of interest to the campus research community.
We chose IRB for the first for this session because we know that a significant amount of our research on campus is human subjects research and therefore depends heavily on our IRB.
Carley Emerson joined us about a year and a half ago as director of the office, and we’re very grateful that she’s with us leading our efforts here. Prior to her joining the office went through a lot of transitions with staff departures and other challenges.
It has been a significant effort to rebuild and hopefully get to a point where we have a full staff that are well trained and knowledgeable. I’m very happy to say we’ve also been working to expand the office to make sure that it’s resourced appropriately to attend to the volume of our human subject that comes through our IRB.
We’ve also been looking very hard at our processes and rethinking where we can make changes to those processes with a focus on maintaining our compliance and protecting our human participants. We also try to make sure that we’re nimble and efficient and can process things as quickly as possible.
Presentation
Carley Emerson, Director of the Office of Human Research Ethics
The past year and a half a lot of work has been spent on looking at our processes and evaluating processes. In this next year our goal is to start doing a lot more outreach with our research community and hearing your feedback on where we can continue to improve things and build relationships with our research community.
See the Zoom recording of OVCR Office Hours starting at 5:50 for this presentation.
Penny Gordon-Larsen, Vice Chancellor for Research
I’ll provide some general updates about the research enterprise. First, we have been engaged in a process of strategic planning. We developed a Strategic Research Roadmap through a collaborative process and a lot of input from our research community.
We have three goals. One is around facilities, equipment and data. We have a second goal to promote growth and opportunity, which is about growing the research enterprise. And then we have a third goal about maximizing and communicating our value and impact of our research.
Those three goals are supported by two key operational imperatives. The first is to support and grow a talented research workforce, and the second is around efficient research, support, and compliance.
Our Research Roadmap will be intersecting with the Chancellor’s four areas of focus. He has pointed to enrollment, which relates to our workforce goal master plan. This all ties into our goals for facilities, equipment, and data. Applied sciences and generative AI relate to our growth and opportunity and to our research data goal in terms of treating data as an asset.
We’ll have more information about the strategic goals and the implementation that’s to come in the next several months.
We are also in the midst of planning for the Translational Research Building, and that planning is coming along really well. We’ll have more updates in the coming weeks and months on that. That’s going to be a several year plan and we will be breaking ground in the fall.
Our communications team has unveiled an interactive state map that helps to communicate the impact of our research in the state. When you hover over a county you can see statistics about the amount of research funding, the number of students who are engaged, residence employed, and more. It’s a helpful tool when you’re working with state agencies and legislators.
If your folks plan to engage with state or federal representatives and officials make sure that you contact Kelly Dockham from Federal Affairs, and Amy McConkey from State Affairs before engaging, so that they can provide guidance and really help ensure that your team can succeed.
Q&A
Penny Gordon-Larsen
As you know, research space is a limiting factor for many units across campus. Where are we pushing to increase new spaces and new buildings for research? Is this problem being escalated as a priority to the Interim-Chancellor as a major university need? Are there plans to retrofit/renovate the University-owned spaces on Franklin Street?
That really fits in well with our strategic plan for the Research Roadmap, and it also fits in with a key area in the master plan that the Chancellor has pointed to. This is going to be a topic that we’ll talk a lot about, and we’ll work hard on making those kinds of decisions that position us best for research growth in the future.
We’ll continue to have conversations with the research team and other leaders, the Provost, the Chancellor, and finance and operations about pressing needs as they unfold. We will have wonderful space available as we get the Translational Research Building online. But that’s going to be several years down the road. In the interim we’ll certainly be thinking hard about our research spaces and how we could make sure that the space on campus is fully leveraged for active research.
Carley Emerson
Is going to the OHRE website the best place to find/see updates to IRB/OHRE process?
Going to our page is the best place to find updates. So many of our policies and SOPs are now on the website and links to the TD client page, which is managed by the Office of Risk Management. They house a lot of policies. Make sure you’re also on our listserv so that you receive those updates.
We’ve tried to do other things to communicate out to our research community. We’ve been doing a lot of presentations through different groups on campus as well. We are also putting some updates in IRBIS now as well. You may have seen that you now get a pop up that tells you what was updated, and you must click through that popup before you can proceed in the system.
Andy Johns
Is there an update on the Research Data Management Core (RDMC)?
The RDMC is a new entity which was launched back in the fall of last year, after probably over a year plus of planning. It was launched to be part of our response to new requirements from NIH and other federal agencies mandating that every proposal be accompanied by a formal data management and sharing plan.
This alone served to be a pretty significant change in terms of a requirement that hadn’t necessarily been in place across most agencies prior and, in fact, had the potential to significantly affect our competitiveness for research funding. The RDMC was formed in part to not only be a service to assist with the compliance and submission of data management plans along with proposals, but to make sure that we could continue to be competitive with those data management plans that were being submitted.
This is an evolution. We have been on the forefront of leading efforts like this across the country, I think most of our peer institutions are trying to figure out how to best support data management requirements because this landscape is rapidly changing.
What has changed since we initially began planning is the rapid evolution of the use of AI and generative AI in research, and that has underscored some challenges that we face as a campus. If you don’t have good data, it’s difficult to take advantage of AI. And yet we have many faculty and staff who are interested in taking advantage of AI in their research. What we’ve learned is that you quickly hit a brick wall unless you have good, organized data.
The RDMC is going to be playing a very prominent role moving forward to help us craft a strategy around research data and begin to put in place infrastructure and support mechanisms that can be both consultative on the front end, but also on the back end of data collection that will hopefully allow us to really launch and support a broader strategy around research data that will position us to take advantage of AI and other technologies as they evolve.
In addition to the service offering, the funding model for the RDMC is also continuing to evolve. The NIH permitted us to launch a fee that’s levied against all sponsored projects that are involving research, and that was to help fund some of the infrastructure. The NIH continues to release and tweak their guidance, as do other agencies. We will be coming forward with some additional updates soon which will represent a change to the RDMC fee model. More than likely that fee will end up going down from what it was. The Office of Sponsored Programs is working right now to review some changes, and there will be guidance forthcoming very soon.
I keep being told that job descriptions are being redone/updated. This will allow for more accurate job descriptions and more equitable salaries across departments. Could someone elaborate on this? For example, are there timelines, what changes are being discussed, will these changes allow for career growth within departments?
The Office of State HR undertook an effort to update the compensation bands for all SHRA positions, and that update did just occur. Nearly all SHRA bands have been adjusted to compensate for market value and inflationary factors, and the bands have increased in terms of their upper range.
That’s great, because in some cases, we were not competitive, and we face challenges with being able to offer compensation for certain kinds of positions. Those increases in the bands do not automatically confer or convey salary increases. It’s still incumbent upon every individual departments to initiate actions like that through their local HR officers, which would ultimately feed up to the to the central HR.
While the Office of State HR is responsible for SHRA bands, the System office is responsible for the EHRA bands, and the System office similarly did release increases on the EHRA side as well. So, I think they’ve been good partners in trying to accommodate pressures that we’re facing for market forces, as well as increasing inflationary pressures as well.
If you have questions about that, I encourage you to reach out to your local HR officers, and they can probably provide you with information about those changes as well as options that you might consider.
I’ve been working on participant incentive logistics for a research study with human subjects, and as you know, there are a lot of logistics with human subjects research. I’m working with great people (including in the IRB), but we’re on 4+ weeks of trying to figure out the incentive options. What can be done to improve the understanding, efficiency, and transparency of the logistics process?
I would like to draw attention to a new initiative called our Research Navigation Hub. Paula Steele is the manager for that, and it is designed to assist faculty and staff on campus with a primary focus on clinical research, but you might also reach out if you have other questions about research and navigation issues. They are there to assist in not only helping you to understand where to go for a particular issue or question, but help you to navigate, especially in the clinical research space which is a complex environment because of all the regulations and other considerations. Their ultimate role is to assist you in helping to get your studies activated in a timely fashion.
To engage with the Research Navigation Hub, you can submit a ticket, which is their preferred method of engagement. But you also can send an email to their general inbox, and they will reach out to you to understand your need and then hopefully provide consultation and assistance with getting studies activated quickly.
Can you please confirm/clarify whether for UNC-CH subaward work which does not include human subjects, if the prime (overall) project includes human subjects, the IPF question “Is human research being conducted at UNC-CH” should still be yes and an IRB exempt determination is required. The IPF does not currently allow a yes response to the overall human subjects question with “no” to human research being conducted at UNC-CH.
The intent of that question is applicable to research that’s to be conducted here at UNC in the case of an incoming subaward. So, if another institution is the prime and they’re subbing to us, and the work that we are going to perform here is not going to include any human subjects research, then typically the answer to that question would be, “no.”
To clarify, if we’re the prime recipient of a grant and then we’re planning to sub to another institution, you would still be expected to indicate that the grant overall does include human subjects research, even if the portion that we’re doing does not. And if you’re intending to sub to another institution, you would still answer “yes” to that question but indicate that no human subjects research is going to occur at UNC.
If you have questions about that, I encourage you to reach out to your Office of Sponsored Programs representative and they can clarify that for you further.
Are there any initiatives underway to make it easier to work with community partners, for example, to improve the speed with which we can compensate them for engagement and research?
This is also something that is a huge focus on of our overall strategic plan. There are many benefits to being a state institution, but there are also downsides. Sometimes state laws which are written to broadly apply to state agencies make it more complicated for us to do certain things, and we have a group that is beginning to look at some rather innovative and creative options for how we might structure some parts of our organization in a way that allows us to be nimbler.
For example, when we’re working with community organizations that we so heavily depend upon for community-based research. Often these are small organizations that don’t have deep pockets and ultimately rely heavily on timely cash flow to meet their obligations. And we understand that as a large institution, cash flow may not always be a major concern of ours, but it is for our partner institutions.
We have some efforts underway that are designed to look at that and really think about novel solutions that could help us increase the ease with which we can work with our community partners moving forward. Hopefully, we will have some updates that we can share along those lines that will enhance our competitiveness.
Any updates on the Greenphire implementation?
Greenphire is a vendor-based product that is largely designed to simplify the process by which we compensate human participants in our clinical studies. By offering the ability to give them a pre issued credit or debit card, we can release funds to their pre issued card as they complete milestones or procedures on a study they’re enrolled in. That simplifies things dramatically for us.
Greenphire has been something we’ve wanted to move forward with ever since the Bank of America prepaid card solution went away. We have some interim solutions, but none of which are ideal. We’re deeply in the throes of that implementation with teams working on a variety of aspects.
Primarily, the integration between Greenphire’s vendor product and UNC’s financial systems is complicated, as you might imagine when we’re talking about the movement of reasonably large sums of money. There are a lot of financial and audit controls that must be put in place and attended to. The teams are currently working on those integrations to make sure that we can be compliant with both state and university auditor requirements.
We’re very anxious to get this live because we know how desperate folks are for this solution, which is the standard by which most institutions do compensate human participants. But we also must make sure we get it right and don’t end up rolling something out prematurely.
Can you provide an update on the IDS move?
The University relies on the UNC Health Investigational Drug Service (IDS) extensively for interventional drug and device studies. IDS is going to be moving to a new facility in Morrisville, and we are in conversations with the IDS and UNC Health leadership, because we are aiming to establish a hub locally in Chapel Hill that will hopefully streamline the issues and the logistics around making drugs and devices available for all our studies in Chapel Hill.
The other piece that we’re in negotiation with UNC Health on is to leverage the contract with MedSpeed to ensure at least hourly delivery to not just the Medical Center on campus, but also East Town and Hillsborough. If we can ensure at least hourly deliveries between the hours of 7 a.m. and 4 p.m. that should not impede any clinical research projects.
We’re very attentive to this issue and concerned about the potential impacts that the IDS move could have. And I will just shout out to our IDS colleagues and UNC Health, who have been great partners and working with us to explore all of these options to make sure that any move does not have any detrimental effects on our ability to do research in Chapel Hill, East Town, or Hillsborough. Just know that there’s a team working on this with the intent to make sure that we have solutions that mitigate any potential risks.
Are there any updates on the One UNC Clinical Research effort with UNC Health and the University?
That effort continues, and we have interim leadership in place right now. Laura Vierra has been working very closely with Michael Sledge in the healthcare system. We have a range of priorities that we have identified as major impediments that are currently being attended to. IDS is an obstacle, and so is communications, which is actively being worked on. And there are range of other efforts that are all focused, including the Research Navigation Hub.
There’s some short-term efforts that are underway to bring about relatively quick solutions to some items that have been identified as great challenges, but there is an overall effort and desire to provide for a more streamlined partnership between the University and UNC Health to be able to execute studies across the health system. That goal is still very much alive and moving forward with many conversations behind the scenes that are designed to help us navigate the complexities that go along with that.
There is a strategic plan underway by UNC Health that is connecting the University as well. There’s a sincere desire to make sure that we can address some of the longstanding impediments that have stood in the way for us to onboard other UNC Health sites for research.