The 3rd Annual Community Engagement Institute (CEI) drew participants from as far away as Nigeria, New York City, Virginia, Tennessee, and Mississippi to join Alabamians in exploring “The Journey to Justice: Expanding the Possibilities.” The daylong educational and training event took place on Friday, Oct. 14th, bringing together academic and community researchers, leaders, advocates, organizers, funders, and students to exchange ideas, build skills, and meet potential collaborators. Nearly 170 people filled the East Ballroom of the Birmingham Jefferson Convention Complex to hear from CEI’s first keynote speaker of the day, Kevin Powell. Political activist, writer, poet, and entrepreneur, Powell delivered a powerful presentation describing his personal journey to justice juxtaposed against four decades plus of tumultuous American history. Comparing 2016 to the civil rights watershed year 1968, he called for “courageous conversations” and greater “empathy and compassion” to get beyond the racist, sexist, and socioeconomic stereotyping underlying the violence in our country. “Justice,” he said, “must be inclusive of everyone’s culture.”
Representative Jeramay Anderson, who became the youngest African America ever elected to a U.S. legislative body when he won a seat in the Mississippi House of Representatives in 2013, explored the role of justice in “making America exceptional” in his keynote presentation at lunch. “Justice is giving every child a shot, no matter their zip code, because justice is not only the absence of oppression, but the presence of opportunity” he said. He noted that “with the $80 billion spent annually to keep people incarcerated in the U.S. we could have universal pre-k for every child in this country, when every dollar we invest doubles in value.”
The CEI breakout sessions provided opportunities for attendees to explore their personal biases; learn how to talk about social determinants of health and disparities without causing groups to polarize along political, socioeconomic, religious, or cultural lines; hear lessons learned from a program cultivating youth for social justice; and delve deeper into the causes of urban blight and brainstorm strategies to improve the health of those living in blighted neighborhoods.
This year’s poster session featured a mix of research findings, program evaluation, and professional skills development. Attendees networked with poster presenters and each other while learning about various public health topics, including cognitive programs for breast cancer survivors, social network analysis for evaluating community health collaboration, rural health initiatives for aging African Americans with heart disease, the impact of community health workers on an uninsured diabetes population, methodological advances in behavioral and community HIV/AIDS research, and HPV vaccination among college students.
Max Michael, MD, dean of the UAB School of Public Health, said he was encouraged by the broad range of organizations, disciplines, and backgrounds of this year’s participants, because “it reflects the communities we live in and must inform our discussions of justice and how to make meaningful changes that will improve public health.” He was especially heartened to note the number of millennials who attended, “bringing their energy, passion, and new ideas.”
CEI is hosted by the CCTS community engagement component, One Great Community (OGC), and the UAB Center for the Study of Community Health’s Jefferson County Community Participation Board. OGC Director Dr. Shauntice Allen noted “there is so much to do” but encouraged attendees to “please think about what you are able to do to move the needle on justice. I hope today has helped you to stretch your thinking.”
Dr. Keith McGreggor trains scientists to think like business people.“We are not here to turn you into a business person, you’ve trained hard to become a scientist. But we want to help you understand how business people think, especially when it comes to your discoveries.” So started Dr. Keith McGreggor, executive director and lead instructor, I-Corps™ South, Georgia Institute of Technology, one of several experts who spoke at the CCTS Bioinnovation and Commercialization Pop-up Course that took place in Auburn Oct. 6th. Designed for biomedical and engineering faculty, postdocs, and students, the three-hour training drew from the Lean Startup Methodology championed by the National Science Foundation’s (NSF) I-Corp™ program. Attendees were introduced to the Business Model Canvas approach that helps budding entrepreneurs determine the value proposition of their product, consider potential customers, create a start-up thesis, and then test it by interviewing potential customers.
“Applying the scientific method to business planning—generating a hypothesis about the commercial viability of your work, making predictions about who will want it, running experiments by actually talking to people, repeat, repeat, repeat—will help you eventually form the basis of a viable company,” said McGreggor.
Dr. Rachel Frazier, now a research engineer with the Alabama Institute of Manufacturing Excellence, but formerly a researcher at University of Alabama, shared how the I-Corp™ methodology helped her with the start-up of her company, Graphenics. “My research was in the growth and characterization of Group III-Nitride semi-conductors, so it was a challenge to convey the significance of bulk crystal growth development to device applications, let alone find customers,” she noted. The training, she added, “helped me look at my research in an entirely different way.”
Auburn University Associate Director of Commercialization Dr. Brian Wright discussed the top ten things university-based researchers need to know about intellectual property. He answered questions about patent applications, timing of public disclosure, licenses, freedom to operate, avoiding conflict of interest, and the roles of inventor vs. assignee.
Dr. LaKami Baker, managing director, Lowder Center for Family Business & Entrepreneurship and associate professor, Dept. of Management, Auburn University, and Dr. Michael Chambers, assistant vice president, Research Innovation, University of South Alabama, described myriad initiatives for entrepreneurs at their respective institutions. Auburn will open several new resources between now and 2018, including a summer accelerator boot camp, an ideation lab, and a new innovation and entrepreneurship center. USA is launching a minority business accelerator, the Mobile Area Educational Fund for high school students, and a graduate course that will “take USA technology off the shelf and give it to life scientists and engineers to see what happens.”
In closing, attendees were encouraged to apply for a regional I-Corp™, such as the newly granted I-Corps™ South’s cohort, Atoms & Bits. Participation in a seven-session regional I-Corp™ training can help one gain entry into a national NSF cohort, which potentially offers more than $1 million in federal start-up grants. UAB Collat School of Business professor and Dept. of Management, Information Systems, and Quantitative Methods Chair Dr. Molly Wasko stressed the value of I-Corp training even for researchers who are not entrepreneurially inclined. “Seven weeks is a very small investment to make to ensure your research, which can take years and years, will have an impact in our communities,” she said.
Learn more at https://www.nsf.gov/news/special_reports/i-corps/index.jsp.
“Anyone can manage a team when everything is going well, but when a crisis hits, can you maintain your leadership?” So began UAB Senior Associate Dean for Faculty Affairs and Professional Development Dr. David A. Rogers’ exploration of conflict at the Sept. CCTS Training Interdisciplinary & Emerging Research Scholars (TIERS) meeting. Noting that scientists increasingly work in teams, he stressed the importance of developing conflict management skills, which he described as “leadership sustained through a challenging circumstance.”
Building from Rahim 2001’s definition of conflict as “a process of social interaction involving struggle over claims to resources, power, status, beliefs, and other preferences or desires,” Dr. Rogers divided the sources of conflict into two different types: tasks/processes and relational. The latter, he said, was the hardest to manage and the most likely to result in negative outcomes for a team.
Among the solutions for team conflict, Rogers ranked understanding one’s own tendencies at the top of the list. He listed several other important “soft skills” that are critical to stave off or better manage conflict, including learning to negotiate, listen strategically, modulate one’s language and emotions, suspend attribution, and apologize correctly. He also stressed the role of trust as a key ingredient in teams that function well.
In summary, he noted conflict on scientific teams is inevitable given they usually comprise “brilliant, passionate but underresourced academics.” Being able to recognize when conflict is likely, actively managing it when it occurs, and using each instance as an opportunity for leadership development was his recipe for building and maintaining successful science teams.
Join us for the the next CCTS TIERS meeting on Nov. 16, when Dr. Robert Rich, professor of Medicine, Microbiology, and Medical Education and former senior vice president and dean, UAB School of Medicine, will address Job Negotiation and Promotion in Academic Medicine. TIERS alternates monthly with the CCTS Journal Club, which will meet on Wed. Oct. 19 to discuss Comparison of Post-Hospitalization Function and Community Mobility in Hospital Mobility Program and Usual Care Patients with PI and lead author Dr. Cynthia Brown, director, UAB Division of Gerontology, Geriatrics, and Palliative Care, Department of Medicine. Both TIERS and CCTS Journal Club take place at the Pittman Center for Advanced Medical Studies (PCAMS) Building from 5-6pm.
In the September 2016 issue of “peer review notes,” the NIH Center for Scientific Review (CSR) shared what it has learned about implementing the new NIH rigor and transparency policies. Since the policies took effect in January 2016, there have been 525 peer review meetings with nearly 10,000 reviewers involved.
CSR trained peer reviewers to consider the four new criteria meant to enhance the reproducibility of studies: scientific premise, scientific rigor, consideration of relevant biological variables such as sex, and authentication of key biological/chemical resources. Although it found most reviewers “rose to the challenge” of applying these within the peer review process, “work remains.”
Some reviewers clearly kept the new policies in mind, but used “old language” in their critiques. Others confused “premise” with scientific significance or focused on whether hypotheses of studies were reasonable. NIH’s concept of premise, however, relies on reviewers to determine if studies or preliminary data leading to the proposed work are “scientifically sound.”
Reviewers raised several questions about the inclusion of sex as a biological variable that must be factored into research design, analyses, and reporting for all vertebrate animal and human studies, unless a compelling scientific argument can be made for not doing so. These included what is an adequate incorporation of sex into a study’s design; can inclusion of both sexes actually reduce scientific rigor by increasing physiologic variability; and if a disease predominantly affects only one sex, is that sufficient justification for a single sex study.
CSR noted, “There are no blanket answers to such questions at this point,” and called for reviewers to bring their best scientific thinking to the table to achieve the fundamental goal— “replicable, generalizable science.”
CSR trained peer reviewers to consider the four new criteria meant to enhance the reproducibility of studies: scientific premise, scientific rigor, consideration of relevant biological variables such as sex, and authentication of key biological/chemical resources. Although it found most reviewers “rose to the challenge” of applying these within the peer review process, “work remains.”
Some reviewers clearly kept the new policies in mind, but used “old language” in their critiques. Others confused “premise” with scientific significance or focused on whether hypotheses of studies were reasonable. NIH’s concept of premise, however, relies on reviewers to determine if studies or preliminary data leading to the proposed work are “scientifically sound.”
Reviewers raised several questions about the inclusion of sex as a biological variable that must be factored into research design, analyses, and reporting for all vertebrate animal and human studies, unless a compelling scientific argument can be made for not doing so. These included what is an adequate incorporation of sex into a study’s design; can inclusion of both sexes actually reduce scientific rigor by increasing physiologic variability; and if a disease predominantly affects only one sex, is that sufficient justification for a single sex study.
CSR noted, “There are no blanket answers to such questions at this point,” and called for reviewers to bring their best scientific thinking to the table to achieve the fundamental goal— “replicable, generalizable science.”
From certification in Good Clinical Practice (GCP) to reporting research results, the federal bar is being raised across the clinical trial lifespan. With its October Forum, the CCTS sought to prepare clinical trial teams across the partner network to “get out in front” of the wave of policy changes.
New GCP Requirement
Penny Jester, director of the CCTS Clinical Research Support Program (CRSP), discussed the new GCP training policy. By Jan. 1, 2017, all NIH-funded investigators and staff involved in conduct, oversight, or management of clinical trials must have documented proof of GCP training from a recognized clinical research professional organization. The goal, Jester explained, is to ensure the “safety, integrity, and quality” of clinical trials, consistent with the principles of the International Conference on Harmonization (ICH) E6. The training must be refreshed every three years.
Jester encouraged the audience to start with the basic course offered by Miami CITI, but noted “this is just the beginning. Pending changes implemented by the ICH will require enhanced training in the near future.” Additional training on 3rd party oversight, data security, risk management, and correction and prevention steps for non-compliance “are also on the horizon.” She announced that CCTS is already developing an enhanced training for clinical investigators and noted several other CCTS/UAB trainings that offer enhanced GCP material (the monthly UAB Research Orientation program, suitable for all clinical trial team members; the biannual CCTS Research Coordinator Training program for staff; and the bimonthly CCTS Research Seminar).
Addressing the impact on non-NIH trials, Jester emphasized that all human research, whether locally funded or industry sponsored, “ethically requires the same standards as that of NIH funded clinical trials.” Showing a slide of the Top Ten GCP issues cited by the FDA 483s (the FDA warning letter sent to research with compliance issues), she added, “this list demonstrates the need for GCP guidelines that protect the rights of study subjects and assure accurate and reliable collection of data in research.”
Reporting Results Requirements
Jester turned next to the new requirements for reporting results on ClinicalTrials.gov (CT.gov). The Department of Health and Human Services (HHS) has released a Final Rule, which the NIH has broadened and attached penalties to for non-compliance (see “Federal Reforms Will Reshape Clinical Trials,” CCTS Digest 30 Sept. 2016). The goal, Jester said, “is to increase transparency and accountability—to share results more broadly and rapidly for the benefit of the public we serve.” The new reporting rules will take effect Jan. 18, 2017.
One of the major changes, she explained, is that investigators will be required to upload their entire protocol and a statistical analysis plan. “What this means is NIH will be able to see if your primary and secondary endpoints agree up with what you set out to do in your protocol,” she said. Noncompliance with the new reporting requirements can result in loss of funding and fines, “as much as $10,00 a day.” Her slides listed the universe of different protocols that must be posted on CT.gov. She urged investigators to take advantage of CCTS research design and protocol development supports and to stay tuned as NIH continues to work on the CT.gov website.
Single IRB Requirement
The next speaker, UAB Interim IRB Director Leslie Cooper, discussed the rationale behind the move toward single IRBs of record for multisite trials. The goal, she said, is to “streamline review, improve efficiency, and reduce administrative burdens.” The final NIH policy on use of a Single IRB was released in June 2016 and applies to all competing grant applications (new, renewal, revision, or resubmission) with receipt dates on or after May 25, 2017.
Cooper reviewed the applicant responsibilities, including what grantees should do when a single IRB is not yet identified. One positive change she noted is that applicants, with appropriate justification, may request direct cost funding for the review of a multi-site study by a single IRB. In preparation of the new requirement, the UAB Office of the IRB is working to update and refine the IRB handbook and template for reliance agreements, educate the research community and IRB members, and create a single IRB section on the website.
Clinical Trial Grant Submission Requirement
Dr. David Redden, codirector of CCTS Biostatistics, Epidemiology, and Research Design (BERD), addressed the rule requiring NIH grant applicants requesting support for one or more clinical trials to respond to clinical trial-specific funding opportunity announcements (FOAs). As of Sept. 27, 2017, NIH will no longer accept clinical trial applications submitted via a “parent” FOA. The new FOA mechanism for clinical trial grants will require specific information regarding study rationale, design, operational plans, and analysis plans. A new protocol template for phase 2 and 3 IND/IDE trials will also be rolled out. “It’s effort to write a solid protocol in a timely manner—but don’t forget, CCTS BERD is here to help.”
In case you were unable to attend, the Oct. Forum slides, handouts, and video are now available on our Monthly Forum page.
New GCP Requirement
Penny Jester, director of the CCTS Clinical Research Support Program (CRSP), discussed the new GCP training policy. By Jan. 1, 2017, all NIH-funded investigators and staff involved in conduct, oversight, or management of clinical trials must have documented proof of GCP training from a recognized clinical research professional organization. The goal, Jester explained, is to ensure the “safety, integrity, and quality” of clinical trials, consistent with the principles of the International Conference on Harmonization (ICH) E6. The training must be refreshed every three years.
Jester encouraged the audience to start with the basic course offered by Miami CITI, but noted “this is just the beginning. Pending changes implemented by the ICH will require enhanced training in the near future.” Additional training on 3rd party oversight, data security, risk management, and correction and prevention steps for non-compliance “are also on the horizon.” She announced that CCTS is already developing an enhanced training for clinical investigators and noted several other CCTS/UAB trainings that offer enhanced GCP material (the monthly UAB Research Orientation program, suitable for all clinical trial team members; the biannual CCTS Research Coordinator Training program for staff; and the bimonthly CCTS Research Seminar).
Addressing the impact on non-NIH trials, Jester emphasized that all human research, whether locally funded or industry sponsored, “ethically requires the same standards as that of NIH funded clinical trials.” Showing a slide of the Top Ten GCP issues cited by the FDA 483s (the FDA warning letter sent to research with compliance issues), she added, “this list demonstrates the need for GCP guidelines that protect the rights of study subjects and assure accurate and reliable collection of data in research.”
Reporting Results Requirements
Jester turned next to the new requirements for reporting results on ClinicalTrials.gov (CT.gov). The Department of Health and Human Services (HHS) has released a Final Rule, which the NIH has broadened and attached penalties to for non-compliance (see “Federal Reforms Will Reshape Clinical Trials,” CCTS Digest 30 Sept. 2016). The goal, Jester said, “is to increase transparency and accountability—to share results more broadly and rapidly for the benefit of the public we serve.” The new reporting rules will take effect Jan. 18, 2017.
One of the major changes, she explained, is that investigators will be required to upload their entire protocol and a statistical analysis plan. “What this means is NIH will be able to see if your primary and secondary endpoints agree up with what you set out to do in your protocol,” she said. Noncompliance with the new reporting requirements can result in loss of funding and fines, “as much as $10,00 a day.” Her slides listed the universe of different protocols that must be posted on CT.gov. She urged investigators to take advantage of CCTS research design and protocol development supports and to stay tuned as NIH continues to work on the CT.gov website.
Single IRB Requirement
The next speaker, UAB Interim IRB Director Leslie Cooper, discussed the rationale behind the move toward single IRBs of record for multisite trials. The goal, she said, is to “streamline review, improve efficiency, and reduce administrative burdens.” The final NIH policy on use of a Single IRB was released in June 2016 and applies to all competing grant applications (new, renewal, revision, or resubmission) with receipt dates on or after May 25, 2017.
Cooper reviewed the applicant responsibilities, including what grantees should do when a single IRB is not yet identified. One positive change she noted is that applicants, with appropriate justification, may request direct cost funding for the review of a multi-site study by a single IRB. In preparation of the new requirement, the UAB Office of the IRB is working to update and refine the IRB handbook and template for reliance agreements, educate the research community and IRB members, and create a single IRB section on the website.
Clinical Trial Grant Submission Requirement
Dr. David Redden, codirector of CCTS Biostatistics, Epidemiology, and Research Design (BERD), addressed the rule requiring NIH grant applicants requesting support for one or more clinical trials to respond to clinical trial-specific funding opportunity announcements (FOAs). As of Sept. 27, 2017, NIH will no longer accept clinical trial applications submitted via a “parent” FOA. The new FOA mechanism for clinical trial grants will require specific information regarding study rationale, design, operational plans, and analysis plans. A new protocol template for phase 2 and 3 IND/IDE trials will also be rolled out. “It’s effort to write a solid protocol in a timely manner—but don’t forget, CCTS BERD is here to help.”
In case you were unable to attend, the Oct. Forum slides, handouts, and video are now available on our Monthly Forum page.