Part I - Informed Consent for Research: Operationalizing the Process
This talk will review the new common rule definition of vulnerable subjects including "individuals with impaired decision making ability." It will discuss why inclusion of this vulnerable population is needed in research studies, especially for diseases such as Alzheimer's research. Finally, it will review the ethical guidelines and discuss practical strategies for obtaining informed consent for subjects who may lack decision making capacity.
At the completion of the webinar, participants should be able to:
- Discuss the requirements for Informed Consent and HIPAA authorization for human subjects research.
- Recognize vulnerable populations and discuss ethical considerations and appropriate mechanisms for obtaining informed consent.
- Discuss strategies to ensure high-quality, high understanding in informed consent discussions.
Laura Holtz, MS, CCRP
Senior Research Manager
Laura R. Holtz, MS, CCRP, is a Senior Research Manager at Indiana University Center for Aging Research and Regenstrief Institute. Her experience managing multiple research trials includes projects with cognitively impaired seniors in the community and nursing facilities. Her coordination of the Indiana University Purdue University at Indianapolis (IUPUI) RESPECT Center annual conference includes facilitating continuing education focused on palliative and end-of-life communication. As a research staff advocate, Laura co-chairs the Indianapolis chapter of SOCRA, the Society of Clinical Research Associates which provides education opportunities for staff to become Certified Clinical Research Professionals (CCRP). She is a trainer on topics including: Informed Consent, research interviews, enrolling vulnerable populations, and research project management topics at Indiana University and Indiana Clinical and Translational Sciences Institute (CTSI). Her dedication to research education earned her seat on the SOCRA Board of Directors.