Pediatric subjects participating in HHS-funded or FDA-regulated studies are afforded additional protections not codified in subpart A of the Federal Policy for the Protection of Human Subjects (the Common Rule). Subpart D—additional protections for children—introduces new terms like assent, parental permission, minor increase over minimal risk, prospect of direct benefit, and one and two parent signatures.
When assessing risk for pediatric studies, an IRB must evaluate all procedures and interventions against four categories of research. To make this determination properly, the IRB has to decide on two inconsistently defined concepts: 1) is there prospect of direct benefit? Or 2) does the research present minimal risk or a minor increase over minimal risk? During this webinar, speakers will address such questions and more.
- Overview of pediatric subpart D regulations
- Approvable research categories
- Prospect of direct benefit
- Minimal risk and minor increase over minimal risk
- Interactive case studies for the IRB
What will I learn?
After attending this webinar, you will be able to:
- Identify the criteria for pediatric approvable research
- Compare and contrast minimal risk with minor increase over minimal risk
- Evaluate if the interventions or procedures in a protocol hold the prospect of direct benefit
Who should attend?
IRB staff and members will benefit from attending this webinar. No prerequisite knowledge is required, but those who have wrestled with issues of risk determination in pediatric studies will benefit in particular.