This webinar will discuss new elements of the Rule impacting informed consent, including:
- Changes in the basic and additional elements of the informed consent
- New requirement that consent documents begin with a concise presentation of key information, presented in a manner that facilitates the subject's understanding
- New broad consent option for the collection, storage, and secondary research use of biospecimens or identifiable private information
- Changes in the criteria for waiver of informed consent related to screening/recruitment and research involving the use of identifiable biospecimens and/or data
- Clarifications regarding the determination of who is a legally authorized representative
- Increased clarity regarding requirements/methods for documentation of informed consent