Demand grows for chief research information officers as role evolves

There is no reliable data on how many health systems and medical schools employ a chief research informatics officer, or CRIO — sometimes called chief research information officer or something similar — but by all accounts, those with the right skill set are in high demand as organizations grapple with the exponential growth in and evolution of biomedical data.

Jeffery Smith, vice president of public policy at the American Medical Informatics Association, described CRIOs as "executives who are in charge of leveraging clinical data for research," including clinical trials. "They also use informatics related to the secondary research use of clinical data," including information from electronic health records and laboratory results, including genomic tests, Smith said.

No small factor in the explosion of data managed by CRIOs is the growth of whole-exome and whole-genome sequencing and the move into proteomics, metabolomics, and other molecular omics beyond merely DNA sequencing. "That kind of tricks my own thinking, because when I think we can see the plateau in how much data they need on genomics, now they are talking about genomics at the cell level," said Umberto Tachinardi, chief information officer of the Regenstrief Institute in Indianapolis, a health IT research organization affiliated with Indiana University School of Medicine.

Though his title is CIO, Tachinardi effectively serves as CRIO, and actually holds a dual appointment as dean of clinical research informatics at IU. He also was CRIO at a previous job at the University of Wisconsin-Madison's UW Health.

The CRIO role "means someone who is more concerned about innovation, use of data for research or generation of data of research, and implementation or innovation in the use of electronic systems, clinical systems, or innovations in EHR systems," Tachinardi said. "Usually this is what all of us have in common."

Smith has seen the role, scope, and prevalence of CRIOs expand greatly even in the last year or two. He said that no longer are only large academic medical centers and research institutes hiring CRIOs or the equivalent.

"Increasingly, larger community hospitals are going through similar maturity models to try and figure out how to better leverage the data that they create at point-of-care visits for research purposes," Smith said.

In 2017, members of the AMIA Clinical Research Informatics Working Group produced an article in Applied Clinical Informatics that reported results of a survey of CRIOs and equivalents.

That survey, conducted in 2016, had just 16 respondents of the 25 CRIOs or equivalents whom AMIA identified and reached out to. Titles of respondents included chief research informatics officer, chief research information officer, chief clinical research informatics officer, and chief research and academic information officer.

Of those 16, 88% were the first CRIOs their institution had ever hired, and 69% had been on the job for no more than three years at the time.

Firas Wehbe, CRIO of Northwestern Medicine in Chicago and director of the Applied Research Informatics Group at the Northwestern University Clinical and Translational Sciences Institute, said that there had been some "buzz" about CRIOs before the Applied Clinical Informatics paper appeared in 2017. But there were not many more than the 25 CRIOs nationwide that AMIA identified for that research.

Wehbe has been with Northwestern since 2015, but became CRIO at the beginning of 2018. Shortly thereafter, he was asked to help draft a CRIO job description not only for himself, but at a couple of other institutions that were considering adding CRIOs of their own, he said.

In writing his own job description, Wehbe took cues from upper management, which had an idea of what they needed. "But I think they also wanted my help in telling them what they needed but didn't know they needed it," he said.

The authors of the Applied Clinical Informatics paper said that Peter Embi became the first CRIO in the US when Ohio State University appointed him in October 2010. Embi, who is now president and CEO of the Regenstrief Institute, was one of the authors.

Three years after that article and a decade after Embi pioneered the job, Smith told GenomeWeb that Bethesda, Maryland-based AMIA has made a concerted effort in 2020 to recruit more CRIOs to its ranks. AMIA, an academic-heavy association for biomedical and health informatics specialists, is about as close as there is to a professional organization for CRIOs.

Smith said that an online CRIO discussion forum for AMIA members has grown to nearly 100 people. The Clinical Research Informatics Working Group, which is open to all AMIA members regardless of title or role, now has more than 525 members.

Smith has not only seen growth in the number of individuals fulfilling these responsibilities, but a diversification of titles and roles. "This follows a very similar path to what we saw with the growth of chief information officers initially within healthcare and then CMIOs," he said.

The chief medical information officer (CMIO), which emerged in the 2000s and became mainstream in the healthcare world in the 2010s as EHRs became ubiquitous, started as a liaison between medical and IT staff. Now, many CMIOs have risen to the same level as the CMO and CIO on organizational charts.

Smith would not predict whether CRIOs would find themselves on a similar trajectory in the next few years.

Reporting relationships vary. In hospitals, the CRIO's boss might be the CIO or chief data officer, according to Smith. Some at academic medical centers actually report to deans rather than to a higher C-level executive.

Other titles he has seen in the last couple of years include director of research informatics, associate dean for informatics, assistant provost for data science, research CIO, chief research technology officer, VP of research technology for health, chief research technology officer, and CRIO for clinical research.

"There is obviously a lot of overlap with those titles referring to people in academic research organizations," said Tachinardi, one of the authors of the 2017 Applied Clinical Informatics article.

Often, political considerations go into the title. An organization with a CIO at the university or the medical school or the health system might not want to have someone with the same title for anyone else within the enterprise.

"Sometimes CRIO is a more specific term for people [who] support research with IT and an informatics background," Tachinardi said. "It varies a lot."

Some CRIOs or equivalents are closer to the healthcare systems than others, depending on the structure of the organization. When Tachinardi was at the University of Chicago a decade ago, the president of the university also was president of the healthcare system.

At Wisconsin, UW Health was legally separate from the UW School of Medicine and Public Health, but the dean of the med school was chair of the board of the health system, and thus had a hand in choosing leadership at both. Plus, revenue from UW Health helped fund education and research on the academic side.

There is more distinction at IU. "There is a friendship, but it's not a true marriage," Tachinardi said. "They share the building… but it's not a real, true connection."

Additionally, Regenstrief, which was founded in 1969, effectively serves as the departments of biomedical informatics or data sciences or biostatistics for four academic entities. In addition to the IU School of Medicine, Regenstrief has faculty from Purdue University, Indiana University-Purdue University Indianapolis (IUPUI), and the IU Richard M. Fairbanks School of Public Health at IUPUI.

Tachinardi's role is to serve the researchers at Regenstrief and at affiliated schools who rely on informatics as a resource.

"The clinical researchers or basic science researchers that we support campus are not true informaticians, but they need data. They need applications. They need analytics," Tachinardi said. "We give those things to them."

He has similar relationships with external partners, including drug developers Roche and Eli Lilly. "I oversee the team that provides resources and support to them," Tachinardi said.

Even in the year and a half that Tachinardi has been at Regenstrief and IU, he has seen his responsibilities expand.

Notably, researchers are demanding ever-larger datasets. "They want to play with a lot more variables than they used to play before," since they now have more advanced analytics tools at their disposal, particularly those driven by machine learning and artificial intelligence, Tachinardi said.

"They used to do more statistical analysis," he said. "But now with machine learning, they want everything all the time because the machine can analyze the data and figure out the signals in the data, patterns, and extract insights from the data."

Rather than just asking for information that can be extracted from EHRs, researchers are looking for data on socioeconomic determinants of health, familial connections, environmental factors, and geographical information, as well as genomic test results.

One job of the CRIO is to keep everything "connected to the patient," according to Tachinardi. "We are becoming more and more a data integration platform, which was not the case years ago."

This has necessitated more robust IT infrastructure to support the data requests. "We need to have more storage available. We need to have more CPUs and GPUs. We need to have more computing power, faster networks. Security is more complex today," according to Tachinardi.

A future goal for Tachinardi is to become sophisticated enough in managing genomic data so he does not have to make as many whole genomes available to all researchers. Tachnardi said that he does not expect to see a reduction in this number of variables in his lifetime.

The current complexity is particularly an issue in cancer because tumor genomes are fairly specific to a small number of cells. While the human genome can show predisposition to a disease, it is less helpful for diagnosis and treatment decisions, Tachinardi noted.

"There is this variation between what genome are we talking about. Are we talking your germline genome or are we talking a genome of certain diseases?"

He sees more challenges on the analytics side, making sense of ever-more-complex data. "We are also starting to move in the direction of returning actionable information in the hands of the clinicians," Tachinardi said. "That's the big informatics challenge, and CRIOs are directly involved with that."

Tachinardi said that his ultimate focus is on creating "actionable" data. "CRIOs, our end goal is not to manipulate data. Our end goal is to provide value at the end of the line, which is the clinical setting," he said.

Tamara Winden joined the University of Kansas (KU) Medical Center as CRIO a little more than three years ago. Prior to that, she had similar responsibilities at a manager level at Allina Health in Minneapolis. While not an academic health system, Allina does have a substantial research organization.

Winden said that her current job is quite diverse.

"My role at KU, they brought me in really as a bridge between the university and the health system," Winden said. In fact, half of her salary comes from each of the two entities.

Northwestern's Wehbe also called himself a "bridge" between the health plan and the university.

Wehbe has two reporting lines. He reports directly to the vice dean for research of the Feinberg School of Medicine. While he is not a direct report to the CIO of Northwestern Medicine, the health system. Wehbe said that he is treated like one. However, Wehbe said that he now saves meetings with the CIO for high-level topics rather than specific questions about imaging or security issues or grant reviews.

Wehbe also is a member of an internal working group that evaluates technologies tested in the medical school or engineering school before deploying them on the clinical or operational side.

According to Winden, the KU medical school wanted to use the health system's EHR for research purposes, necessitating collaboration between the two sides.

"My role didn't and still doesn't necessarily include a lot of the data resources," Winden said. While someone else manages that at KU, she knows that CRIOs elsewhere are responsible supporting all research information systems, including the building and management of a research data warehouse.

Winden instead is focused on adapting KU Medical Center's Epic Systems EHR to support researchers in participant recruitment, study administration, and data capture. "[I am] really embedding clinical research into the clinical care workflows toward KU becoming a learning health system," Winden said.

Considering that so much of what she does has to do with putting research elements into Epic, Winden works closely with several other IT leaders, particularly KU Health's CMIO.

"I'm collaborating and working with him to get buy-in and leadership support on the health system side to do what we have done already and are planning on doing, embedding more research into the EHR," Winden said.

The university and the health system each have their own CIOs and CSOs or equivalent, however. Winden said that she does not have a reporting relationship with any of these officers, but she does meet will all of them regularly with regard to IT infrastructure issues.

"I have been intersecting more and more with the health system with regards to data use for research purposes," she noted. That means working closely with the CIO and related staff on that side of the house.

Winden, a former laboratory technologist with a background in sequencing for a transplant program, said that genomics is "on the roadmap" at KU. The organization has not set a timeline, though.

"When I came on board here, my role was supposed to be more of a global ecosystem for translational research, basic science all the way to the bedside," she said. Her first three years largely focused on the front end of the EHR for research.

However, KU, like so many other institutions, has been looking to embed more and more genomic data into the EHR and other clinical repositories to inform analytics. "It hasn't been something I've been focusing on yet, but it's coming," Winden said.

The research data warehouse now includes anonymized EHR data, demographic information from the KU Health System, and billing claims, particularly from Medicare. Lab tests are imported into the EHR and eventually funneled into the research data warehouse. "There is a movement towards incorporating more genomic data there," Winden added.

"I see that data warehouse growing in the future to be more inclusive of data based on what the current research of the day is," Winden said. Obviously, that is COVID-19 now, so she is taking advantage of KU's participation in the National Patient-Centered Clinical Research Network (PCORnet) to add COVID-19 resources from the US National Institutes of Health to the warehouse.

Most of the records go into the warehouse as discrete data, not as flat PDF files, so researchers can apply natural-language processing, machine learning, and other analytics technologies to the information.

Winden's team has built a self-service tool so researchers can query the data warehouse to locate potential subjects for clinical trials and find datasets for analysis. They also can go on PCORnet to run queries across multiple organizations.

AMIA's Smith noted that EHRs are evolving in ways that make research with clinical data — including lab data — easier. He gave particular credit to the Fast Healthcare Interoperability Resource (FHIR) standard, which features an add-on genomics module.

"I think that is going to be a tremendous boon not only to research, but to the role of the CRIO because it's going to greatly expand the universe of data and hopefully improve the standardization of those data available to do research," Smith said of FHIR.

While conceding that there are "legitimate challenges" with adapting FHIR to research, he said that the continued uptake of the standard is helping make clinical, lab, and genomics data more widely available for research purposes.

"I think the actual scope of the role is dependent on the institution," Winden said, adding that the EHR at KU is "very mature" now, so a new CRIO could jump right in and begin working on some other focus area.

Wehbe is in a similar situation at Northwestern, which also has a consolidated data warehouse that serves both the med school and the health system. He has 21 people who report to him, including those who maintain the research data warehouse and analysts who help investigators extract pertinent data from the EHR.

Some of his responsibilities include managing data for regulatory oversight purposes and making sure researchers follow protocols of the institutional review board and of the health system's privacy officer.

"It's a critical mass of informatics professionals who support various research functions," he said.

"I think my role is to be a collaborator," Wehbe said. He said that other faculty often approach him to write the informatics components of grant applications. "I know there are CRIOs that maybe don't have that expectation, but I help with that for sure," Wehbe added.

Northwestern has a large high-performance computing infrastructure, as well as many geneticists, genomic experts, and bioinformaticians.

Wehbe often reviews the plans of departments, centers, and labs under the Northwestern Medicine and Feinberg School umbrellas to make sure that projects are suitable for the organization's HPC infrastructure and regulatory environment. "I can also either draft letters of support myself or help them get letters of support from the health system's CMO or the health system's CIO or speak to my leadership in the dean's office to say that we're going to support this initiative," Wehbe said.

Wehbe said that he increasingly sees himself working in regulated areas such as CAP/CLIA-certified next-generation sequencing labs, both in house at the health system and with third parties including Foundation Medicine, Guardant Health, and Tempus.

"Because we're an academic medical center, we're interested not just in receiving the reports and the interpretations, but we in some cases also work with them to receive raw sequence-level data," he explained.

When Wehbe arrived at the Chicago campus nearly three years ago, he said that Northwestern Medicine was grappling with the issue of whether clinical NGS data could be repurposed for research. For privacy reasons, clinical data cannot just be sent over to the university side without proper safeguards such as data stewardship and IRB approval, so Wehbe is helping the health system archives the NGS data in a way that serves the needs of both sides of the house.

"In terms of clinical research, there will always be separate provenance of the data, but in our case, they are tightly integrated … in our data warehouse," Wehbe said. The EDW contains information from more than 100 clinical and ancillary information systems, as well as about a dozen research systems, including the IRB, a biobanking system, and a clinical trial management system.

"I think it's not completely integrated, but I would say it's better than other places, and there's still a lot ahead for us."

In the future, he would like to see research informatics be described in more precise language. For example. "clinical trial management system" seems monolithic and perhaps in need of specialization in terms of functions, according to Wehbe.

"I'd rather be speaking more about data capture or consent management or regulatory data management. Where do we store our consents? Are our systems validated for FDA studies?" Wehbe explained.

He said that this kind of specialization would also improve the definition of the CRIO role in more contexts, both in the academic and clinical institutions.

"If you are at an institution that's a powerhouse in imaging, then the CRIO role could be defined based on the specific research informatic competencies that are missing and that need to be lit up by a dedicated CRIO," he said.

Many large academic medical centers like Northwestern have multiple CMIOs now, with many associate CMIOs specializing in disciplines such as pathology informatics, imaging informatics, and outpatient chemotherapy, according to Wehbe.

"I think that's where the CRIO may be either subsumed or have a global role, like an umbrella role that has specialized subcomponents under it," he said.

This story first appeared in our sister publication Genomeweb.