Populations Requiring Additional Protections Track
2019 AER Conference
IRB review of research with children requires special consideration of commonly-accepted safeguards; however, the nuances of those safeguards often aren't well understood by IRB staff and members. This session will use case studies and presenter-facilitated debate to explore specific complexities in the IRB’s review of research involving children, those beyond the basics of categorizing risk and obtaining assent.
Specific attention will be paid to complexities of both biomedical and social behavioral research. Presenters will discuss the FDA's preferred component analysis method and consent challenges presented when engaging children in school-based research and online research. Speakers will do a deeper dive into ethical and regulatory complexities of conducting research with children and teens, including the IRB’s role in determining when one parent consent is sufficient, particularly when one parent is not reasonably available, discussion of children’s perspectives of the assent process, and innovative ideas for improvement of assent.
Before attending this session, attendees should have a foundation in the regulations that govern research with children, including knowledge of Subpart D requirements and considerations in making determinations regarding category of risk to children. During this double session, speakers and attendees will: