November 2024 SOCRA Source Journal - Journal - Page 87
ONLINE EDUCATIONAL OPPORTUNITIES
Course registration fee - Member: Free (Non-member $75, includes one year membership)
Part 1: Informed
Consent for Research Operationalizing the
Process
Speaker: Laura Holtz, MS, CCRP
Part 2: Informed Consent
for Research - The
Importance of Quality
for Understanding
Decision-Making
Speaker: Laura Holtz, MS, CCRP
FREE FOR
MEMBERS!
This talk will review the new common rule de昀椀nition 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:
1. Discuss the requirements for Informed Consent and HIPAA authorization for human subjects research.
2. Recognize vulnerable populations and discuss ethical considerations and appropriate mechanisms for obtaining informed consent.
3. Discuss strategies to ensure high-quality, high understanding in informed consent discussions.
This presentation will review the new common rule de昀椀nition 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:
1.
2.
3.
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.
A Primer on
Clinical Research
Speaker: Patricia Beers Block, MDEd, BS, BS, CCRP
In this presentation, the speaker will introduce different practices and principles for how
new medical products are identi昀椀ed as safe and effective, and ultimately introduced into the
marketplace. How clinical research came to be and how professionals deal with proving that
products are safe and effective will be presented. Lastly, the speaker will discuss the evolving
research approaches used today.
Learning Objectives: At the completion of the webinar, participants should be able to:
1.
2.
3.
Discuss how new medical products might help to identify and mitigate the impact of COVID-19 on our health
Discuss different practices and principles for how products are identi昀椀ed as safe and effective for humans
Discuss how new products are introduced into the marketplace
Sponsor Responsibilities
Speaker: Amy Jo Jenkins, MS, CCRP
This presentation will provide an overview of the sponsor responsibilities for conducting clinical
research. The presentation will address sponsor responsibilities for regulatory submissions, site
selection, documentation, and monitoring. Safety and regulatory reporting will also be discussed.
As clinical trials expand throughout the globe, it is important to understand the regulatory and
ethical responsibilities of the Sponsor.
Learning Objectives: At the completion of the webinar, participants should be able to:
1.
2.
3.
Describe sponsor responsibilities for conducting clinical research
Discuss responsibilities for regulatory submissions, site selection, documentation and monitoring
Discuss safety and regulatory reporting
Institutional Review
Boards (IRB)
Speaker: Mtonya Hunter, MBA, CCRP
This presentation will provide a basic overview of the regulatory requirements and responsibilities
for an Institutional Review Board (IRB) review for Human Subjects Protection. Usual business
practices for most IRBs will be discussed including the required members of an IRB, required
documentation that must be submitted to an IRB, and the types of IRB reviews.
Learning Objectives: At the completion of the webinar, participants should be able to:
1.
2.
3.
Understand the role of the IRB
Discuss what documentation needs to be submitted to the IRB
Discuss the different types of IRB reviews
Additional Online
Courses are
available on our
website here:
SOCRA SOURCE © November 2024
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