Pregnant women have historically been excluded from participation as subjects in biomedical research, but there is increasing recognition in the research community of the importance and of the vast potential benefits to allowing their participation. This webinar will address the significance of conducting research with pregnant women and the protections that are in place for this vulnerable population.
Topics for discussion will include:
- Importance of conducting research with pregnant women
The first part of the presentation will address the benefits of involving pregnant women as subjects in research and the shift in perception of such research from protecting pregnant women from research to protecting them through research.
- Subpart B of 45 CFR 46: Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research
This part of the presentation will feature an analytical breakdown of the relevant regulations, including duties of IRBs, in connection with research involving pregnant women, and, specifically, research that presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of pregnant women that is not otherwise approvable.
- Myths and misinterpretations
With references to specific cases, this part of the webinar will focus on the studies that have been initially denied, and will segue into a discussion on understanding risk, minimal risk, and benefit in this population. Examples will focus on problem solving to move projects forward with balanced justification.
- New approaches and summary of key points
Presenters will discuss strategies for addressing issues that arise during the approval process, including novel study designs and approaches to negotiating with IRB members in order to gain approval allowable by regulations.
This intermediate-level webinar may be of interest to anyone involved in the conduct and review of research with pregnant women, including IRB members, chairs, administrators, and staff, as well as researchers
Please contact us via email or telephone at 617.423.4112, ext. 118. Thank you!
Tuesday, April 9th, 2013, 1:00 – 2:00 PM ET
Registration and Fees can be found here.