Dr. Allyson Hart, Leading the “Heart” of Ethical Research for Hennepin Healthcare

Allyson Hart, MD, MS, a Hennepin Healthcare Research Institute (HHRI) investigator and Hennepin Healthcare nephrologist, is surging through the summer in wonderful ways as she reaches the second year of her role as Chair of the Hennepin Healthcare Institutional Review Board (IRB).

IRBs are committees charged by the federal government to follow regulations that protect the rights and welfare of human subjects in research. Since the Hennepin Healthcare IRB’s inception in 1966, all research involving human subjects sponsored by Hennepin Healthcare and HHRI or conducted by its faculty requires IRB approval and ongoing oversight unless determined by IRB review to be exempt.

In August 2021, Dr. Hart stepped into her role, becoming the first woman to serve as the Hennepin Healthcare IRB Chair after her predecessor Dr. Craig Peine stepped down from the position. Dr. Hart said it’s an honor that at one time she couldn’t have imagined.

“If five years ago you had asked whether I would be chair of the IRB, I would have laughed really hard,” Dr. Hart said.

Despite being initially skeptical and uncertain about landing the position, Dr. Hart decided to apply for the Chair of the IRB in 2021 after receiving recommendations from several of her HHRI colleagues. As she envisioned what this critical role would encompass, Dr. Hart said she thought it would be interesting work. She also realized that landing the IRB Chair wouldn’t win her any popularity contests.

“You have to accept that nobody is ever really going to want to get an email again from you,” she said jokingly.

However, Dr. Hart said the position seemed very appealing as she looked deeper into the “heart” of what the IRB is charged with doing to protect the rights and welfare of human subjects. Because of this, as she reaches the two-year mark of her tenure, Dr. Hart said her role is very gratifying and something that she deeply and strongly believes in from both the IRB Chair and researchers’ points of view.

“Your whole job is to look at a research study from a lens of, is this conducted with as much transparency and with the highest level of ethics is actually really deeply satisfying,” Dr. Hart said. “Also, you want to make sure we’re not just stopping research in its tracks. Because research actually done well has the potential to benefit people who have been left behind, marginalized and harmed.”

Striking a Balance for Research

Dr. Hart said thanks to working with HHRI’s researchers who share similar ethical research standards it’s helping her strike a gratifying balance of having a critical lens while working to keep valuable research moving forward.

“I take the stance that a vast majority of investigators want to do the right thing and do high quality research,” Dr. Hart said. “As the IRB Chair, we want to build a framework that allows people to follow the regulations,” she added. “Sometimes you have to say no. Instead of just saying no, you say, no and here’s how can we help you work within the regulatory and ethical frameworks.”

As the IRB Chair, Dr. Hart said she opens the door to meet with any researcher who reaches out. She approaches her IRB duties by building an ethical framework that investigators can use to conduct their research within the federal and state regulations. These guidelines must be followed and can be complicated. Finding out what her colleagues want to accomplish is key for Dr. Hart to help researchers gain this awareness and understanding, allowing them to build great research studies which Dr. Hart said is like building a “very cool house.”

Receiving an NIH R01 Award for Her Research

When it comes to conducting her own research, Dr. Hart is building her own framework of a “very cool house,” so to speak. In April 2023, she received a three-year Research Project Grant Program (R01) award of almost $790,000 from the National Institutes of Health (NIH) and the National Institutes of Diabetes and

Digestive and Kidney Diseases (NIDDK) to study virtual coaching for potential kidney transplant candidates and their social support networks. The focus of this research pilot program is to improve access to kidney transplants for people of color who are facing glaring disparity numbers. The prestigious R01 award is the oldest grant mechanism used by NIH.

According to the National Kidney Foundation, although Black or African Americans make up 13.5% of the U.S. population, they make up more than 35% of dialysis patients. While kidney transplant is the optimal treatment for kidney failure, Black patients face barriers to access to this care, on average waiting a year longer than white patients.

Dr. Hart’s research will involve addressing existing kidney transplant disparities, including decreasing the progression of chronic, end-stage kidney failure in which Black Americans are three times more likely to require chronic kidney disease treatment compared to their White counterparts, half as likely to receive a kidney transplant and 73% less likely to receive a living donor transplant. Native Americans/American Indians, Hispanic Americans and Asian Americans also have high disparities for end-stage kidney failure.

Other social determinants of health disproportionally affect kidney disease risk factors for Black Americans as well.

Overall, these stark numbers indicate people of color face daunting challenges at every step of the process for kidney disease treatments, including being wait-listed to get a kidney transplant.

 Dr. Hart is interested in shrinking these disparities and finding ways to prevent the need for either dialysis or kidney transplants to treat end-stage kidney disease for all people which would be ideal.

“We need to find something that works and makes the process better for all people in need of treatment for kidney disease. The status quo is not acceptable,” Dr. Hart said.

Building Diversity in HHRI’s Research

Hennepin Healthcare’s IRB Committee is comprised of 12 members, including hospital and community representatives, scientists and non-scientists representing diverse groups and backgrounds. Increasing diversity in research at Hennepin Healthcare is an important impetus for Dr. Hart’s work. However, she reminds us that it’s also important for diversity to exist in an inclusive environment where all members are heard.

“A truly highly-functioning IRB committee is going to be one where anyone can respectfully say whatever they feel they need to say to be included,” Dr. Hart said. “I could recruit a massively diverse committee. But if one-third of them don’t feel comfortable speaking, that’s not accomplishing anything,” she added.

Hennepin Healthcare’s work to build its committee’s diversity is ongoing. Dr. Hart said if the IRB maintains an inclusive environment while improving its diversity it will lead to much richer discussions and discoveries. She said this will decrease the risk of research inadvertently harming community members. It’s also important for the committee to build back trust which is still an issue following medical research atrocities, including the 40-year Tuskegee Syphilis Experiment and the Henrietta Lacks saga, which are still painful reminders for some people in Black communities.

“I need to be able to go into our communities and say to any person there I can tell you exactly how and why something got through our committee,” Dr. Hart said. “I can explain it and it needs to be as transparent as we can make it,” she added. “I need to say we have all these perspectives and you can have members of your community on this committee, so you feel like research isn’t just being done on you. It’s being done with you.”

Dr. Hart said the IRB Committee is striving for its ultimate goal to have “community-based participatory research” where members of communities are members of a research team. “We at least need to say anyone in the community can come and hear how we review studies and feel they have access to be on that committee and review studies too,” Dr. Hart said.

As the IRB’s initiative to improve diversity is ongoing, Dr. Hart hopes to work with Hennepin Healthcare’s Community Advisory Board (CAB) to bring in more community members in general to help move studies forward. In the meantime, Dr. Hart also said there are other elements HHRI and Hennepin Healthcare need to do better as its IRB moves closer to its 60^th anniversary in 2026. This includes fundraising to support researchers who need additional grants for services, allowing them to add non-English speaking people into their studies.

At the “Hart” of HHRI’s and Hennepin Healthcare’s Research Horizon

As Dr. Hart enters her next year of being Chair of the Hennepin Healthcare IRB, she’s honored to break through the glass ceiling, becoming the first woman to be entrusted with the position. She also stresses that the board’s collective synergy is really driving the work.

“We work as a team in IRB meetings and intentionally discuss equity and community implications when reviewing studies,” Dr. Hart said. “This includes, opening conversations with researchers about how we can optimize IRB processes to balance the protection of individual participants and federal regulations,” she said. “We’re also partnering with leaders at Hennepin Healthcare to create a more clear and transparent process to determine whether a project is research or quality improvement.”

Dr. Hart’s hope is that in adding more community members to the IRB, both the researchers and community members can feel confident that clinical research at Hennepin is conducted at the highest level of ethical and quality standards.

She’s also driven to find remedies for kidney disease for all with her pilot research project.

“My goal is to pursue research that will help us create a system where all patients with kidney disease have access to the resources and information they need to be empowered to make decisions about their healthcare,” Dr. Hart said. “Our pilot clinical trial to improve access to kidney transplant is about meeting patients and their friends and family where they are, she added. “This will help them make sure they understand the very complicated process of trying to get a kidney transplant, and then empowering them to take the actions needed to get there.”

Dr. Hart is also working with the Scientific Registry of Transplant Recipients to develop partnerships with patients, donors, and family members to create better access to data, create tools that help providers make evidence-based care recommendations. She reminds us that, “All the data in the world won’t help anyone if it isn’t accessible and usable.”

Dr. Hart said she’s proud of her IRB team that’s fostering a culture to strive for and do the right thing, even when it gets hard.

She also acknowledges the support of the previous IRB chair, Dr. Craig Peine as well as former Vice-Chair Karen Heim-Duthoy, PharmD. “Dr. Peine spent a great deal of time giving me the resources I needed to prepare me for the role,” she said. “Karen was instrumental in supporting me after I took over the IRB Chair position.”

As HHRI continues to strive to close research disparities gaps, Dr. Hart is committed to forge HHRI’s mission forward into new horizons to improve patient care and the health of communities through research and education.

“I’m really excited to be in a place where it feels like most everyone is on board, changing the way we do things and opening up possibilities,” Dr. Hart said. “While I’m happy to celebrate that we are making strides to make leadership positions and committees more representative of the world we live in, I recognize this is an opportunity for me to help keep moving things forward, as we’ve got a ways to go yet.”