Ethics & Regulatory Knowledge Core
Leigh Lamonica, JD, CIPP/US, CHC, CHRC
Regulatory Core Director
Pennington Biomedical Research Center
Contact this core
Email: ethicsreg@lacats.org
About This Core
The Ethics and Regulatory Knowledge Core (ERKC) provides a consistent approach to regulatory activities across the member institutions by streamlining, facilitating, educating, and training in the areas of ethics, compliance, and regulatory activities. The ERKC is a consultative resource to investigators, research staff and research coordinators on how to handle specific ethics or regulatory situations which may be essential to their research protocols. The ERKC operates under the guidance of a consolidated Ethics and Regulatory Working Group. This core is led out of Pennington Biomedical Research Center.
The ERKC team provides updated tools and information for study participants available on Research Participant Portal on the LA CaTS Center website. In addition, ethics advice will be provided to study participants in cooperation with the Community Engagement & Outreach Core.
Core Activities & Resources
ERKC has established a formal regulatory infrastructure across the LA CaTS Center by having personnel identified as “LA CaTS liaisons” identified at each institution’s IRB who oversee LA CaTS-related IRB issues.
More information can be found on the Regulatory & Ethics Tool page or by contacting the ERKC directly.
The ERKC regulatory specialist, based at Pennington Biomedical, offers valuable support services to investigators, including navigation to IRB liasions at each institution for IRB inquiries and submissions, pre-review of protocols, informed consent documents, coordination of regulatory submissions in multi-institutional projects, and advice on general regulatory matters.
Additionally, the regulatory specialist assists the LA CaTS Cores (e.g., Clinical Research Resources) in ensuring investigators submit the appropriate IRB documentation during the initial application process.
ERKC coordinates an ongoing education and training for the investigator and reseach staff. The ERKC participates in various LA CATS professional development & training programs, educating researchers on topics ranging from IRB and HIPAA compliances to sound ethical practices.
The education available is intended to compliment and streamline what is currently being done at the LA CaTS Member Institutions.
See the Regulatory & Ethics Tool webpage.
This group is led by the ERKC Director and meets regularly.
The purpose is for regulatory and ethics personnel at the LA CaTS Member Institutions (and others in Louisiana) to coordinate on applicable research projects. This group creates a forum to share regulatory challenges, participate in discussions on upcoming regulations and their implementation as well as institutional policies and procedures on how compliance with the regulations are handled.
Specific Aims
- To augment regulatory support through consultations by the Core leaders and institutional liaisons to 1) investigators and research staff, and 2) the Regulatory Review Committees (IRB and IACUC) at each LA CaTS institution, and 3) the ERK Working Group.
- To enrich ethics and regulatory resources for training and professional development of investigators at all LA CaTS institutions with a focus on enhancing how new investigators and Roadmap Scholars, including underrepresented minorities are trained on the ethical and responsible conduct of research and research integrity.
- To establish and support a research participant advocacy board, a subgroup of the ERK Working Group, which will act as a sounding board for potential research participants by serving as a human research participant advocacy resource.