Ethics & Regulatory Knowledge Core
Leigh Lamonica, JD, CIPP/US, CHC, CHRC
Regulatory Core Director
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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. ERKC will work to harmonize IRB and other regulatory processes among the LA CaTS institutions to put in place other processes that effectively reduce or remove impediments between collaborating institutions.
ERKC will strive to streamline regulatory activities while continuing to assure the highest levels of protection for human participants in clinical and translational research. It will provide hands on guidance and assistance to investigators submitting IRB proposals, including COBRE/INBRE researchers. ERKC will coordinate an ongoing education and training for the sites and their staff, with specific emphasis given to the special needs of investigators as part of the COBRE and INBREs of the state. This program will be geared for a wide range of users from physicians and senior researchers to COBRE, INBRE and other investigators, study coordinators, and support staff. Existing programs at the institutions will be expanded to include programs ranging from IRB compliance to HIPAA compliance. ERKC education and training programs will be designed and implemented in conjunction with the training in clinical research offered through the Education Core.
The Ethics and Regulatory Knowledge Core operates under the guidance of a consolidated Regulatory Affairs and Ethics Advisory Committee. Direct information for study participants will be made available through the LA CaTS Center web portal. In addition, Ethics advice will be provided to study participants in cooperation with the Community Engagement Outreach Resource.
The Ethics resource will be directed by bioethicist Richard Culbertson, PhD. The ethics program will provide consultation, guidance, and analytical resources in clinical ethics to enhance research conducted by participating organizations. This goal will be achieved through:
- Integration of clinical research ethics into the research process by consultation and training on ethical issues.
- Establishment of an Ethics Advisory component in cooperation with the Community Engagement Resource.
- Review on request of research protocols for sound ethical practices.
Advance participant safety through education and public outreach through:
- Providing information on clinical trial opportunities, participant rights and safety, in particular for low literacy participants, the underserved, and at risk/vulnerable potential participants.
- Special informational communications to the minority community through organized events and media outlets.
- Ongoing evaluation of the impact of ethics outreach on the community, study participants, health care providers, and researchers.