 And our last speaker for this morning's sessions is Mark Stein, who's a professor of psychiatry at the University of Washington School of Medicine, also a psychiatrist at Seattle Children's and the principal investigator in the Center for Child Health Behavior and Development. He received his PhD in clinical psychology from Southern Illinois University, Carbondale, and he's speaking to us today on the CTSA Research Ethics Consultation Project on Data Sharing. Mark, welcome back. Thanks. Thank you. It's great to be back here. I was a faculty member for 12 years in a fellow last year, and this always feels like home. I just wanted to acknowledge help for this talk from my new colleague, Ben Willfond, at Seattle Children's. I'm glad I had a disclosure slide. I do clinical research in ADHD, and these are some of my relationships. I'm going to talk about my experience with research ethics consultation and give you an overview of this project and some of the early results in 15 minutes. I guess to start a little bit about my history, I started at UIC in 2005, and I had a great deal of difficulty transferring some of my research grants in clinical trials, and I became very frustrated with the IRB process and contracts, and as a result of my frustration, they asked me to head a task force as to how to improve this for investigators. At the same time, there was the movement to develop clinical and translational science centers. UIC applied for one. Great. Thank you. We were funded in 2009, and what I did was direct the regulatory corps, and my focus coming in as an investigator was really to support investigators and was really focused on investigators and subjects. We had an external review in 2010, and it was right after this survey was conducted, which talked about the roles that CTSAs had in terms of research ethics consultation. The majority of CTSAs had a research ethics consultation service, but they were highly variable in terms of how busy they were, and they differed in terms of their approaches to confidentiality toward the investigators, toward the studies. Not surprisingly, the external review committee that came that year said, how come you don't have a research ethics consultation service? This was something that hadn't occurred to us when we were designing the corps. I immediately emailed Dr. Ross and Dr. Siegler, and we developed a collaborative program where we implemented a research ethics consultation service that was kind of an emerging program where UIC's program would provide clinical supervision and backup for the research ethics consultation service. At that time, I also began inquiring as to if I could become a fellow so that I could get training in clinical and research ethics, which I then did the next year. So just to review a little bit about research ethics consultations, this is a relatively new area. Some of the milestones, again, first use of the term was here following the studies of pediatric liver transplants in the Singer et al article. Another major milestone was the CTSA program, as we just talked about. You can also think about different studies that instigated the need for research ethics consultation services and where they are on this timeline. So what is a research ethics consultation? There are different definitions. This is one that Besko had. I think the important point is that it can occur at any point through the life cycle of a study, and it can involve many different stakeholders, you know, researchers, IRBs, sponsors. So this is a slide that Ben developed, and it sort of uses a parallel of research ethics consultations to clinical ethics consultations. You know, the main difference is the role of the IRB, and the dotted line is, you know, due to the confidentiality in terms of it's not a strict line, although it varies from institution to institution how that goes. So in general, consultation services are very general. They serve diverse clients. The topics are extremely broad, and they provide an in-depth discussion of fine grade concerns that often is not available to investigators or to IRBs. And as our science is getting better, there are more and more unresolved issues. You know, how do you address new frontiers? So again, there are multiple stakeholders, and it varies by program. At some places, many of the referrals come from IRBs, whereas at others, they hardly ever come from the IRBs. The questions are also extremely variable, from first and human studies, phase one trials, risk of harm, and studies, again, that there really is no consensus, you know, issues like incidental findings in genomic research or neuroimaging research. So one of the goals of the CTSA was to learn more about research ethics consultations. And under Ben's guidance, the project was started to systematically gather data on research ethics consultation services. The idea was to get standard information from each program and to be able to share it, and then to develop a system that we could evaluate its effectiveness. After numerous phone conferences, this was the form we developed, and I say we, this is a steering committee of people from 11 different sites. And there's a lot of discussion about what level of detail we should provide on the research ethics consult. So we wanted to be something that would be fairly efficient and easy for the investigator to enter, and something that would be helpful, again, for evaluating the project. So looking at, you know, what type of research activity, what stage the study is in, what's the primary ethical concern. That's actually what's hard to do, because oftentimes you look at one area and then you find out that there's another question. So secondary ethical concerns. And then some of the mechanics, how much time was spent, how many people were involved. So this is the volume data from 2012, and what you can see is there's a huge variation. NIH was the busiest center, and for many centers there were fewer than five. Our year at UIC, we had three that year. And I was really embarrassed to report that we only had three, and it was kind of reassuring to see this data that we weren't that much behind other places. Looking at the type of research ethics consults, they were done at all stages of research, but I think this is a very positive thing. Looking at the planning stage was one of the most common areas. Also in terms of translational phase, it occurred from T1 through T4. Looking at what the primary ethical concerns were, really heterogeneous group of reasons. The largest was informed consent issues, 22%. But you can see benefit-risk assessment is another area. In terms of categories, research ethics consults were done on a wide range of categories. Pediatric populations were the highest. So taking a step back and kind of looking at this process, what have we learned? Well, there are still questions in terms of how you measure research ethics consults. The quality is extremely variable, but how do you measure quality? Who should be the research ethics consults? What training should be required? One of the interesting things at UIC, we only had three research ethics consults, but we had 12 different consultants. And actually four of them had been fellows at the McLean Center. So I think the advantage of having more consultants are more likely to have people whose expertise overlaps with the consulting question. But also the more people you have, the more meetings, the more time, and you really don't want this to be another barrier. How do you measure the quality of advice? Which stakeholder do you ask? The investigator, the IRB? And the acceptability of the concept of research ethics consultation varies by institution. You know, science is very competitive. Some people, some places really emphasize speed and getting it done and may not want to share information, especially if that slows things down. As an investigator, you're very reluctant to add steps to what is already a large regulatory process. I'm on an IRB now, and I was going to ask for a research ethics consult, and I was surprised that people were saying, well, you may not need that because we have this person that does that. So again, the culture varies with the IRB in terms of their acceptability of this. And again, how do we measure it? I mean, I think this is a good first step in terms of developing this form. But I think there's a lot of work to be done on the psychometric properties of the measure, but most importantly, the validity of the measure. Utilization, just counting number of ethics consults, I'm not sure that's really optimal. Ratings, again, it depends on which stakeholder in terms of how they viewed it, but certainly investigators being satisfied with it I think is very important. Publications are good that you can count it, and I like the idea that Dr. Siegler suggested yesterday that we should count the number of lawsuits and if we can reduce lawsuits by doing more research ethics consults, that would be a very good thing. One of the thorny issues, again, is the confidentiality that you promised the investigator, especially if you're going to participate in a project like this where you're sharing information. Different consult services have different degrees of confidentiality and how they explain it. The biggest concern is if there's extreme misconduct or harm that needs to be reported. In summary, the main issues is the volume is highly variable between institutions. Again, we don't know is low use good, reflecting fewer ethical research dilemmas and learning from the past or bad in terms of people being reluctant to utilize what could be a very valuable service. One of the projects that the steering committee developed was an online forum for research ethics consultations, so people at different sites could post different questions and get response in a blind fashion online. It was a great idea, but no one used it and we thought it would be used. So why is that? We don't have good PR for this or what? One of the new concepts is to develop a national rec service for any CTSA so that you can provide a standardized service, protect confidentiality and ensure some uniformity in terms of training. And again, as I just talked about, how do you measure the effectiveness? One of the major benefits, I think, of the research ethics consultation service is a secondary effect and that's education of colleagues. As soon as we started the ethics consultation service at UIC, we had a dramatic increase in grand rounds on research ethics issues. More people interested in getting training, more people interested in reading about it. So I think figuring out a way to measure the secondary educational effects is really important. And then looking at the overall goals of the CTSA, by sharing experiences, are we building on each other's experiences and increasing our knowledge or are we still working in silos? And what can we do to enhance that? And I think that's the next step and the next deliberations. Thank you. Thank you, Mark. If you're willing, despite your voice, to take a question or two, we'll seek with you. I guess my personal view is I think there should be separation because you want to encourage investigators to use it first in the planning stages. And I just think that that takes down a major barrier. But I guess one of the unresolved questions is what to do after the consultation is done in terms of... Some institutions do give feedback to the IRBs, some don't, so it varies. Thank you. Thank you very much. Thank you. Let's thank our panel.