2013 Webinar: Overcoming Obstacles to Research with Pregnant Women

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Overview

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 addressed the significance of conducting research with pregnant women and the protections that are in place for this vulnerable population.

Topics for discussion included:

  • 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.

Audience

This intermediate-level webinar was 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.

Faculty

Maggie Little, BPhil, PhD
Maggie Little is director of the Kennedy Institute of Ethics and a member of the philosophy department at Georgetown University. Her research interests include issues in reproduction, clinical research ethics, and the structure of moral theory. A fellow of the Hastings Center, she has twice served as visiting scholar in residence at the National Institutes of Health department of bioethics. She is a founding member of The Ob-Gyn Risk Research Group, which brings together experts from medical epidemiology, obstetrics and gynecology, philosophy, bioethics, gender theory, and medical humanities for research encompassing a wide variety of issues in reproductive health and clinical research ethics. Together with Ruth Faden and Anne Lyerly, she co-founded The Second Wave Initiative, which works to promote responsible research on the health needs of pregnant women.

Katherine L. Wisner, MD, MS
Katherine L. Wisner is the Norman and Helen Asher Professor of Psychiatry and Behavioral Sciences and Obstetrics and Gynecology and director of the Asher Center for the Study and Treatment of Depressive Disorders in the Department of Psychiatry at Northwestern University Feinberg School of Medicine. Dr. Wisner's main focus is research related to the psychiatric treatment of women of childbearing age. She is internationally recognized as an expert in the treatment of mood disorders during pregnancy and the postpartum period.  She has been the principal investigator on several National Institute of Mental Health- and foundation-funded research projects including the impact of medication use during pregnancy for unipolar and bipolar disorders, a randomized controlled trial of Estradiol for postpartum depression, screening for postpartum disorders, and the efficacy of bright light treatment for patients with bipolar disorder. Dr. Wisner received the Woman in Science Award from the American Medical Women’s Association in 2011; the Alexandra Symonds Award from the American Psychiatric Association in 2012 the Distinguished Mentor Award from the Institute for Clinical Research Education, University of Pittsburgh School of Medicine; in 2012; and the Marcé International Society for Perinatal Mental Health’s Medal for lifetime contributions to the field of Perinatal Psychiatry in Paris.

Certificates of Attendance

Certificates of Attendance for the Overcoming Obstacles to Research with Pregnant Women webinar were made available at the conclusion of the webinar. To access the certificate, you must first complete the online evaluation. Such certificates are useful for obtaining continuing education (CE) credits (not Continuing Medical Education credits) from professional associations. Note that guidelines concerning CE credits may differ, and you should consult the appropriate professional association representative for further guidance.

CE Credit for Certified IRB Professional (CIP®) Recertification
Webinar participants holding the CIP credential who wish to apply credits from Overcoming Obstacles to Research with Pregnant Women toward CIP recertification may submit the Certificate of Attendance they received upon completing the online evaluation as documentation of their participation. Participation in this 90-minute webinar counts as 1.5 CE credit hours.

For recertification by CE, CIPs must complete 30 documented hours of continuing education. At least 15 of the 30 hours must either carry credits issued by a recognized accrediting body or have received advanced recognition from the Council for Certification of IRB Professionals (CCIP). Credits from PRIM&R webinars have received such advance recognition, and may be counted towards these 15 hours.

Additional information about CIP recertification can be found here.