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Building on previous forums that explored the importance of trust and trustworthiness in research, the 2019 CCTS Bioethics Forum focused on new issues raised by the return of results in large population-based clinical and genetic studies. Leading PIs from the Alabama Genomic Health Initiative (AGHI) and the Jackson Heart Study shared lessons learned. A special panel discussion featured the experiences of several AGHI participants.

Leading PIs from the Alabama Genomic Health Initiative (AGHI) and the Jackson Heart Study shared lessons learned concerning RoR. Many revolved around unanticipated reactions to the process for returning results. Participants sometimes requested more information, such as the entire raw data set of their genetic results, than researchers were prepared to provide. Others balked at sharing even actionable results with their primary care physicians.

“What’s the sweet spot for sharing information about results with participants?” asked Dr. Bruce Korf, CCTS Director of Genomic Medicine and AGHI Principal Investigator (PI). “How much is too much, what is enough? It seems straightforward, but we have found with the AGHI the answers are quite nuanced,” he said. Decisions concerning how, when, and with whom to share results raise potential ethical dilemmas that challenge informed consent procedures. The AGHI informed consent document, for instance, is 13 pages long and requires an hour-long session with a study navigator to review prior to signing. A separate informed consent process is required for the return of raw data.

Dr. Mariko Nakano, Assistant Professor of Bioethics at UAB’s School of Medicine, led a session on other bioethical challenges in RoR, including expectations fueled by commercial products such as 23andMe. Participants sometimes expect clinical and genetic studies to return medically non-actionable results, carrier status, non-medical biological traits, and ancestry-related information.

Unlike commercial products, academic research studies have more constrained budgets and Hippocratic concerns about doing harm by confusing patients with results that may lack 100% scientific accuracy and clinical certainty. “Many genetic variants show incomplete penetrance, for instance, but this is a difficult genetic concept for the general public to understand,” said Nakano. [Editor’s note: Penetrance is the extent to which a particular gene or set of genes is expressed in the phenotype of individuals carrying it, as measured by the proportion of carriers showing the characteristic phenotype.] Genetic counselors are a critical part of the RoR process for those with actionable results, as they are trained in explaining such concepts.

A special panel discussion featuring several AGHI participants underscored the complexity of bioethical challenges in RoR with the variability of their experiences and perspectives. Although all four participants consented to sharing their results with their primary care physicians and with the biobank for future research, they differed on sharing results with family members, their preference for knowing when to expect results, how well they understood the informed consent process, and how anxious they felt after talking to a genetic counselor about a positive result.

Dr. Adolfo Correa, PI of the Jackson Heart Study, the largest single site, community-based study of cardiovascular disease among African Americans, agreed that one of the biggest challenges in RoR was how little is known about the impact on participants. “What are the health benefits? What are the risks, including psychosocial, financial, and familial? We need to do a better job of preparing participants for the return of their genetic information,” he said.

Tuskegee University Resident Bioethicist and Professor of Bioethics Dr. Stephen Olufemi Sodeke led the Forum’s final session, reminding the audience of the many historic reasons communities of color have for distrusting research and how fraught the RoR process is for eroding progress in trust. He conducted an exercise to brainstorm practical steps for promoting trust and trustworthiness among collaborating institutions and those volunteering for research. The top seemingly simple recommendation? Communication.

CCTS thanks our bioethical experts for their highly informative and thought-provoking Forum presentations and our Bioethics Forum planning committee (listed below) for developing an outstanding event. A special thank you goes out to our Training Academy Program Director Dr. Becky Reamey and Co-Director Dr. David Chaplin for their programmatic, logistical, and promotional support and to our AGHI participants for sharing their RoR experiences with our live audience.

Several sessions of our 4^th Bioethics Forum are available for viewing on the CCTS YouTube channel. To maintain the privacy of their health information, the panel discussion featuring AGHI participants was not recorded.

4^th Bioethics Forum Planning Committee

David Chaplin, MD, PhD
Bruce R. Korf, MD, PhD
Chiquita Lee, BS, MBA
Mariko Nakano, PhD
Becky Reamey, PhD
Stephen Olufemi Sodeke, PhD, MA
Clayton Yates, PhD

Slide Decks: Dr. Korf, Dr. Nakano

Dr. Robert BullardUAB School of Public Health Dean Dr. Paul Erwin (l) stands with Dr. Robert Bullard., Distinguished Professor of Urban Planning and Environmental Policy and former Dean of the Leland School of Public Affairs at Texas Southern University, founding Director of the Environmental Justice Resource Center at Clark Atlanta University, prolific author of 18 books, and climate policy expert, distilled 40 years of lessons learned in a powerful talk titled “Unequal Burden: Advancing Health Equity through Environmental, Economic, and Racial Justice” at the UAB School of Nursing last week.

Bullard reviewed the biggest battles of his venerable career, set against the background of the U.S. environmental movement, from its beginnings in the 1970s to today. Citing evidence showing people of color are more likely to live in zip codes near toxic waste dumps, with poorer air and water quality, and that are more vulnerable to severe weather events compared to zip codes that are predominantly White, he connected the dots to both the historical causes of neighborhood disparities and their associated negative health outcomes.

Pollution Takes a Heavy Toll on the Health of People of Color
A 2017 Harvard University study found African Americans are nearly three times more likely to die from exposure to airborne pollutants than other Americans. According to the CDC, African Americans are almost three times more likely than whites to die from asthma related causes; African American children are 4 times more likely to be admitted to the hospital for asthma, as compared to non-Hispanic white children; African American children have an asthma death rate ten times that of non-Hispanic white children. Dismantling institutional racism would go a long way in closing environmental health disparities in the United States. It’s time for this immoral, unjust and illegal pollution dumping to end. –Dr. Robert Bullard

Drs. Robert Bullard and Shauntice Allen, CCTS Community Engagement Program Manager.Bullard also discussed the much later emergence of the environmental justice movement and the challenges it still faces, even among progressives. He called for intersectoral collaboration and exhorted the standing room only crowd of students, faculty, and community advocates to remember the difference between equity and justice—“We are not trying to distribute environmental poisons equally among our neighborhoods, but rather making sure nobody is doomed to poor health and a shorter life expectancy because of where they happen to live.”

In case you missed it, Dr. Bullard’s April 2, 2019, blog captures the major points of his presentation. Many thanks to CCTS Community Engagement Program Manager Dr. Shauntice Allen for her role in organizing the event and to event sponsors, including the UAB School of Public Health, Lister Hill Health Policy Center, Institute for Human Rights, Office of Sustainability, College of Arts and Sciences Anthropology Dept. and GASP.

 Dr. Bullard saved the last 20 minutes of his presentation time to answer student questions. The audience was inspired by Dr. Bullard’s career achievements, which he characterized as a “marathon relay race, with folks like me passing the torch to your generation to continue the struggle for environmental justice.”

For the second year in a row, Forte Research Systems has selected UAB, the CCTS Partner Network Hub, as the Top Performer among national OnCore organizations. Two research organizations —the Cancer Institute of New Jersey and the University of Kentucky Markey Cancer Center—tied for Most Improved.

The Top Performer in Clinical Research Operations Award recognizes the site that achieves the highest overall score, determined by comparing percentile rankings on benchmark categories against those of peer organizations. Metrics focus on study start up and implementation, including cycle time for IRB, PRMC, Open to Accrual to First Patient, % Target Enrollment Met, and SAE Reporting timelines. 

"This award reflects the dedication of our OnCore users, who work hard to keep their data complete and accurate," said UAB OnCore Initiative Team Lead John C. Sandefur.

CCTS applauds the UAB OnCore implementation team for its successful enterprise-wide rollout of the powerful clinical trials management system, including a planned upgrade to Version 15 and the ongoing training and support of the UAB research community. To honor their achievements and a second Forte Award for Excellence in Clinical Operations, CCTS is hosting a celebration on Wednesday, April 17, at 4:30pm--we welcome the UAB research community to join us at PCAMS in commemorating this milestone of success for the CCTS Clinical Trials Initiative. 

To learn more about how Forte is transforming the clinical research industry, catch the highlights from its 27^th Onsemble conference, which took place in Dana Point, CA, March 26-29, 2019: “Forte Unveils New Data Exchange and Analytics Features at its Industry-Leading Customer Conference.” 

Dr. Joel Tsevat, Director of the Institutional Clinical and Translational Science Award (CTSA) KL2 program at The University of Texas (UT) Health Science Center, Director of the Center for Research to Advance Community Health (ReACH), and Professor of Population Health and Medicine at UT Austin Dell Medical School, shared findings from a national survey of KL2 alumni at our March CCTS Forum. The standing room only crowd included many early stage investigators curious to know more about the benefits of becoming a KL2 scholar.

Demographics

The survey went to ~1800 former KL2s, with 756 responding, representing every stage of translational research. The median time on a KL2 was 2 years (range 1-5 years), and the median time since KL2 support had ended was 4 years (range <1-10 years). More than half of the respondents were female and 23% were from underrepresented minorities. Of the 80% who had become assistant or associate professors, nearly half reported having an administrative or leadership role.

Findings

The survey results indicate becoming a KL2 scholar positively impacts one’s career progression and opens the door to a wide array of training and research opportunities, with protected time the most highly valued. Respondents also reported high levels of intrinsic measures of success, such as meaningful work (more than 93% agreed or strongly agreed). Most felt the program enabled them to have an impact on their research goals, including changing the paradigm in understanding the pathophysiology of a disease; developing or disseminating a novel methodology with impact on human health; and influencing health policy or clinical guidelines.

Below we share additional highlights from the survey.

Funding Success: More than 47% reported their salary was supported by grant funding, followed by clinical activities, institutional funds, and teaching. Only 15% (115) indicated they have zero grant funding. More than 80% applied for extramural grant funding during their KL2, with a roughly equal number most successfully targeting a K, VA or foundation grant mechanisms. Between 13-15% reported having an R01, R21, or R03.

Training Opportunities: Many of the respondents took advantage of learning opportunities while in their program, especially the mentorship (formal and peer) that is a hallmark of the KL2. Research collaborations, as well as didactic training in clinical and translational competencies, grant writing groups, mock reviews, and Individual Development Plans (IDPs), were also frequently utilized.

Caveats

The survey results offer a glimpse into the relationship between the KL2 and success in clinical and translational research. But Tsevat cautioned attendees that the survey results may not be generalizable to all KL2s. The analysis also did not take into account how variables such as length of KL2 award (2 years vs 5) and look-back period (<1 year vs 10 years) may have influenced scholar outcomes.

Even with the strong foundation that a KL2 provides, a high percentage of respondents reported it is challenging or very challenging to be a clinician or teacher and a researcher. “Individuals need to look in the mirror and decide if they need more support for training or if they are ready to strike out for an R01 on their own,” Tsevat concluded.

If you are a junior faculty member with a passion for translational research, visit our CCTS Deep South Mentored Career Development (KL2) program page to learn more. 

A pdf of Dr. Tsevat’s slide deck is available on the CCTS Monthly Forum page. To watch his talk, visit the CCTS YouTube channel.