Jan Hewett, J.D., B.S.N., Director of the HRPP
Today’s research landscape is hemmed in by requirements that can be both confusing and onerous. In order to promote the highest quality of clinical research and to help investigators meet the intensified demands of regulatory agencies, YCCI is increasing its offerings of educational programs regarding compliance as well as expanding its compliance support staff.
One such program is “Conducting Clinical Trials: Lessons Learned and Useful Tips,” a series of presentations on relevant research issues from the perspective of faculty members. The symposia features presenters from academic medical centers who have learned from firsthand experience with FDA audits, financial conflicts, and negative press related to clinical research. The series has been under way since October; its speakers have shared lessons learned and discussed the policies and structures they put in place to support best practices in research. The series kicked off with Emma Meagher, M.D., associate professor of medicine and pharmacology and associate dean for human research at the Perelman School of Medicine at the University of Pennsylvania, who spoke about Penn’s response to the 1999 death of Jesse Gelsinger during a clinical trial of gene therapy. These corrective measures included the development of a training and certification program for clinical research coordinators; creating standard operating procedures for investigators; developing risk-adjusted monitoring plans; making improvements in the IRB process together with a shift to a service-based culture; and instituting financial conflict-of-interest training for investigators.
Paul DeLuca Jr. , Ph.D, provost and vice chancellor for academic affairs at the University of Wisconsin–Madison, spoke on “Clinical and Translational Research: Lessons Learned at the University of Wisconsin Madison” on October 30. The school ranks among the top public universities in research expenditures. DeLuca presented four cases, illustrating problems and solutions put in place to handle conflicts of interest; privacy/security issues with manufacturers’ representatives; discerning whether the Family Educational Rights and Privacy Act (FERPA) or the Health Insurance Portability and Accountability Act (HIPAA) applies to the study; and safeguarding the security of protected health information (PHI) after an investigator had her smartphone stolen.
The series continued with Kara Morgenstern, J.D., associate general counsel at the University of Michigan, who spoke about FDA audits. The series will conclude on December 4 with Robert Califf, M.D., vice chancellor of clinical and translational research at Duke University, whose presentation is titled “Getting to the Truth: Research and the Learning Health System.”
To register, visit www.yale.edu/training; browse courses by course owner and select CTSA/YCCI; select clinical trials.
YCCI is collaborating with the Human Research Protection Program (HRRP) and the Office of Research Administration to develop well-rounded training programs and events. Efforts with the HRRP include designing a comprehensive training program for study coordinators, and the joint development of good clinical practice (GCP) training. GCP is designed to ensure the protection of human subjects as well as to preserve the accuracy and credibility of clinical trial data. Failure to comply with GCP requirements can lead to various consequences, including damage to individual or institutional reputation, disqualification, debarment, fines, and even incarceration.
In addition to the GCP training available on our website (see http://ycci.yale.edu/education/stafftrain/gcptraining.aspx), YCCI recently (and for the past several years) sponsored GCP training on the FDA’s GCP regulatory requirements. The training is led by Brian P. Bennett, who has 20 years of experience in clinical training and development. YCCI and HRRP have also been working on a FAQ document to answer questions about clinicaltrials.gov from a regulatory standpoint.
The HRRP recently completed a site visit with the Association for the Accreditation of Human Research Protection Programs (AAHRRP) in connection with Yale’s application for reaccreditation. About 85 interviews were conducted with investigators, study coordinators, and institutional leadership—an exhaustive effort that also involved preparation prior to the visit. Yale had only one observation out of 62 possible citations—an outstanding result, according to Jan Hewett, J.D., B.S.N., director of the HRRP. The HRRP is taking steps to correct this insufficiency, which had to do with knowledge of the regulatory definition of a UPIRTSO, or unanticipated problem involving risks to subjects or others. If the AAHRRP finds the remediation sufficient, Yale’s accreditation will be approved for another five years.
Susan Anderson, R.N., B.S.N., M.F.A., YCCI associate director for education and quality assurance
“Both YCCI and HRRP want to become more effective by working jointly across the institution,” said Hewett, noting that the relationship between the two programs is enormously collaborative. “Our aim is to integrate services where possible in order not to duplicate efforts,” said Susan Anderson, R.N., B.S.N., M.F.A., YCCI associate director for education and quality assurance. This approach is used increasingly often, as the institution seeks to identify high-risk areas and understand how programs may be able to overlap in monitoring and auditing research studies, in order to develop a more comprehensive university-wide compliance program.
Hewett pointed out that while institutional review boards (IRBS) are a fundamental component of the HRRP, they are only one unit under the organization’s umbrella. The HRRP also has substantial responsibilities for community outreach, education, and compliance. “We are here to drive the mission of research and be there for faculty,” she said. “An important part of our broader mission is the support and management of conducting research efficiently and in a compliant manner.”
In that sense, the HRRP and YCCI are aligned in their goals. YCCI is expanding its quality assurance staff in order to help investigators conduct high-quality clinical research, as well as understand and comply with regulations related to conducting research. LaToya Howard has assumed increased responsibilities that include supervising the administrative aspects of the scientific review committees under the auspices of YCCI and the Yale Cancer Center along with coordinating YCCI’s training programs for research staff. Howard has spent the last four years providing administrative support for these programs; she is knowledgeable about the challenges inherent in quality assurance for clinical research as well as ways to assist investigators and research staff in meeting those challenges. In her new role she will bring a wealth of experience in coordinating professional development for research nurses, coordinators, data managers, IRB staff, and other personnel involved in clinical research. “A robust clinical trials infrastructure is even more essential now in light of the increased volume of clinical trials at Yale and the complexity of conducting research,” said Anderson. “LaToya has been an asset for YCCI and I’m delighted that her role is expanding.”
Barbara Beckerman; LaToya Howard; Susan Anderson; Ariana Wiley; and Allison Gavaletz
Ariana Wiley, who was most recently a research assistant in the Clinical Trials Office, recently joined the Quality Assurance unit as an administrative assistant. Barbara Beckerman, MHSA, and Allison Gavaletz are two new compliance coordinators responsible for auditing clinical research throughout the School of Medicine. Beckerman has 25 years of clinical research experience and has worked with YCCI since 2008 as a clinical research associate/internal auditor for YSM and the Cancer Center. Gavaletz joins YCCI after more than 10 years as a regulatory/senior research coordinator at the Child Study Center. “I’m very excited to add these seasoned coordinators to our team,” said Anderson. “They bring a wide range of experience in a range of disciplines and will be an asset in terms of providing oversight and educating investigators and research staff.”