Thursday 18th September, 2014
8:00am to 5:00pm
This two-day seminar will provide the foundation for the application, concepts and theories of clinical research.
Protection of human subjects and everything relating to it is of paramount importance for those involved in or wanting to be involved in research dealing with human subjects or an individual's private identifiable information. For these individuals, professionals and companies, it is extremely important to understand that there are federal regulations that must be followed. There are also state statutes, institutional policies, federal guidance documents, and ethical codes that guide the conduct of the research. This is done to ensure that the research not only meets the regulatory requirements but also that it is conducted in an ethical manner containing adequate protections for the individuals who elect to enroll in the research or allow their information to be used for research.
However, the challenge that this position presents is that the guidelines –that also provide interpretation of the regulations –are not always as clear as they might appear upon first reading them.
This seminar will clarify on these regulations. The speaker will not only provide an introduction or refresher of the regulations; she will provide attendees with the opportunity to discuss and learn how these regulations, ethical codes and guidance documents get applied in different situations, as well. This information can then be used to help attendees in their day-to-day decision making when confronted with situations or questions regarding how to handle issues that do arise (e.g. a participant not showing for a scheduled appointment, an event that is unexpected occurs, someone who does not speak wishes to enroll in the study, a participate signed an outdated consent document, etc.) when conducting human subjects.
The learning acquired over these two days will help attendees learn about the historical evolution of research, and current regulations and guidelines including the Common Rule, FDA regulations and HIPAA. This session will discuss site and study staff responsibilities in the conduct and reporting of research, types of studies and the regulatory requirements that apply to different study designs. It will also discuss a variety of research including genetic, drug, device, and studies that use off-site or community partners. Current examples will be used and the audience will be invited to share their experiences and information.
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