Part II - Informed Consent for Research: The Importance of Quality for Understanding and Decision-Making
- Registration Closed
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.
LEARNING OBJECTIVES
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, PMP, CCRP, is a Senior Quality Specialist at Yale University, Yale Cancer Center, Clinical Trials Office. Previously, she was a senior project manager at the Indiana University Center for Aging Research on federally- funded randomized control trials and demonstration programs to provide care collaboration for patients with dementia and their caregivers in multiple care settings. She also coordinated an annual statewide conference focused on palliative and end-of-life communication and research. She shares her expertise in regulations, informed consent, decision making capacity, patient/caregiver interviewing, ethics, and research project management at numerous local and national conferences. Laura established the Indianapolis chapter of Society of Clinical Research Associates (SOCRA) and organizes education opportunities which provide pathways for staff to become Certified Clinical Research Professionals. She is a co-facilitator for the SOCRA Clinical Site Coordination/ Management and Good Clinical Practice (GCP) workshop and the Certified Clinical Research Professional (CCRP) and GCP Exam Prep course. As the SOCRA President, she contributes to the organization’s strategic objectives to provide research education, networking opportunities and professional credentialing for the research community. Laura has a Master of Science in Communications from Purdue University.
DISCLOSURE OF RELATIONSHIPS AND DECLARATIONS: CNE AND CME ACCREDITED SOCRA PROGRAMS
SOCRA adheres to the ACCME’s & ANCC’s Standards for Integrity and Independence in Accredited Continuing Education. Any individuals in a position to control the content of a CE activity, including faculty, planners, reviewers or others are required to disclose all relevant financial relationships with ineligible entities (commercial interests). All relevant conflicts of interest have been mitigated prior to the commencement of the activity.
SOCRA program content addresses regulatory issues and clinical research policies and procedures, no commercial therapies are discussed, no commercial (drug/device/biologic) products are discussed, and no commercial support is involved with SOCRA programs.
Planners and Speakers for programs have no undisclosed commercial relationships.