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Xenon - a New Treatment for Out-of-Hospital Cardiac Arrest (Emergency Exception From Informed Consent Requirements)
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Henry E. Wang, MD
Informed consent is the process where the researchers share key facts about a research study with a person to help them decide whether or not to take part in the research study. Taking part in research is voluntary and people have the right to refuse to take part in a research study. In some emergency situations, people who are taking part in a research study are not able to give their consent due to their condition. The XePOHCAS study is a research study in which patients who have been successfully resuscitated after cardiac arrest may be included in the study without their consent. Henry Wang, MD, Professor Emergency Medicine at UTHealth will talk about the importance of planned emergency research in general and the XePOHCAS trial in particular.
Upon completion of this Seminar, attendees should be able to:
- Understand the FDA regulations (21 CFR 50.24) and FDA guidelines on research involving emergency exception from informed consent requirements.
- Apply the FDA regulations and guidelines to the XePOHCAS trial.
- Analyze whether the XePOHCAS trial meets the FDA regulations and guidelines for planned emergency research.
- Project Managers
- Regulatory Affairs/Compliance
- Data Managers (Site, Sponsor, CRO)
- Quality Assurance
Registration Cost: Free to attend
Contact hours: 1.0 contact hours have been applied for through ACRP.
Membership is not required for online registration of contact hours.
To receive contact hours: Purchase the contact hours, sign in at the event, and attend the program. Log on to the ACRP website then “Learning Portal” to complete the evaluation no later than 30 days following the event and obtain the online certificate.
Contact Hour Cost:
- $0 Chapter Members
- $15 ACRP Members
- $30 Non-Members
Refund Policy: Not specified
Level: Not specified
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