Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC)

November 6-7, 2017

Agenda

November 6, 2017
November 7, 2017

November 6, 2017

8:30 a.m.	Welcome and Opening Remarks Catherine Spong, MD
8:35 a.m.	Review and Approval of Minutes from August Catherine Spong, MD
8:40 a.m.	Introduction of Task Force Members
9:15 a.m.	Summary and Discussion of Work Products from Meeting 1 Identification of federal activities Recommendations for coordination of and collaboration on research related to pregnant women and lactating women Dissemination of research findings and information relevant to pregnant and lactating women to providers and the public
9:15 a.m.	Scientific Research and Federal Activities on Drugs, Vaccines, Vitamins, and Other Supplements for Pregnant and Lactating Women (PDF - 1.2 MB) Sarah Glavin, PhD
9:45 a.m.	Discussion
10:00 a.m.	Overview of Draft Section of Federal Activities for Secretary's Report (PDF - 554 KB) Catherine Spong, MD
10:45 a.m.	Discussion
11:15 a.m.	BREAK
11:30 a.m.	Public Comment Period
12:15 p.m.	LUNCH
1:30 p.m.	Ethical Issues Surrounding the Inclusion of Pregnant Women and Lactating Women in Clinical Research
1:30 p.m.	Overview of Pregnant Women in Research and Ethical Issues (PDF - 590 KB) Amina White, MD
2:15 p.m.	Discussion
2:30 p.m.	BREAK
3:00 p.m.	Panel: Federal and Local Requirements Related to Pregnant and Lactating Women Participating in Clinical Research
3:00 p.m.	Brief Overview of Presentations 3:00 p.m. Overview of 45 CFR 46 Subpart B and implications of the revised Common Rule proposal (PDF - 352 KB) Lisa Buchanan, MAOM, CIP 3:10 p.m. Consent requirements for both mother and father (PDF - 225 KB) Anne Drapkin Lyerly, MD, MA 3:20 p.m. IRB interpretation of 45 CFR 46 Subpart B (PDF - 67 KB) Karim Calis, PharmD, MPH, FASHP, FCCP 3:30 p.m. IRB interpretation of definition of "minimal risk" to the fetus (PDF - 301 KB) Maggie Little, PhD 3:40 p.m. Regulatory perspective (PDF - 247 KB) Tamara Johnson, MD, MS 3:50 p.m. Applicability to lactating women (PDF - 479 KB) Victoria Pemberton, RNC, MS, CCRC
4:00 p.m.	Panel Discussion Moderator: Ruth Faden, PhD, MPH Would the removal of pregnant women as a "vulnerable population" change research in this population? Many comments on the proposed Common Rule revisions recommend that pregnant women not be considered a "vulnerable population" but instead be considered "medically complex." Should NIH or others supporting research in these populations impose additional ethical restrictions beyond the Common Rule? How should the therapeutic benefit for the pregnant woman be weighed against risk to the fetus? What is the role of spousal/paternal consent? How do the ethics of conducting research with pregnant women change for lactating women, if at all?
4:30 p.m.	Q&A and Open Public Discussion
4:50 p.m.	Recap of Meeting, Action Items, and Charge to Group Catherine Spong, MD
5:00 p.m.	END OF DAY 1

November 7, 2017

8:30 a.m.	Recap of Day 1 and Outline and Goals for Day 2 Catherine Spong, MD
8:45 a.m.	Panel: Inclusion of Pregnant Women and Lactating Women in Research
8:45 a.m.	Brief Overview of Presentations 8:45 a.m. Reluctance to include pregnant women in clinical research to include physiologic changes and complexity (PDF - 583 KB) David Haas, MD, MS 8:55 a.m. Reluctance related to liability (PDF - 797 KB) Michael Greene, MD 9:05 a.m. Reluctance in vaccine research (PDF - 504 KB) Carleigh Krubiner, PhD 9:15 a.m. Impact on lactating women (PDF - 1.46 MB) Diane Spatz, PhD
9:25 a.m.	Panel Discussion Moderator: Marjorie Jenkins, MD, MEdHP, FACP What methods may alleviate or alter this reluctance to include pregnant women in research? How does lactation affect research? How would full inclusion affect research?
10:00 a.m.	Q&A and Open Public Discussion
10:30 a.m.	BREAK
10:45 a.m.	Panel: Ethical Issues of Specific Clinical Research Designs
10:45 a.m.	Brief Overview of Presentations 10:45 a.m. Observational studies and clinical trials (PDF - 34 KB) Jeanne Sheffield, MD 10:55 a.m. PK/PD studies (PDF - 698 KB) Steve Caritis, MD 11:05 a.m. Convenience studies (PDF - 68 KB) Amina White, MD 11:15 a.m. Issues of inclusion in clinical research (PDF - 438 KB) James Griffin, PhD
11:25 a.m.	Panel Discussion Moderator: Andrew Bremer, MD, PhD How has inclusion of other groups (pediatric, older populations) affected research design or study outcomes? Do specific study designs have less ethical impact for pregnant or lactating women? Does pregnancy or lactation provide new opportunities for research designs?
11:55 a.m.	Q&A and Open Public Discussion
12:15 p.m.	LUNCH
1:30 p.m.	Panel: Researcher, Industry, and Research Participant Perspectives
1:30 p.m.	Brief Overview of Presentations 1:30 p.m. Physician scientist - George Saade, MD (PDF - 1.2 MB) 1:40 p.m. Industry (large) - Robert Ternik, PhD (PDF - 347 KB) 1:50 p.m. Industry (small) - Kristi Lengyel (PDF - 392 KB) 2:00 p.m. Participant - Melissa Gorman, MSN, RN-BC, CCRN (PDF - 900 KB)
2:10 p.m.	Panel Discussion Moderator: Linda Lipson, MA Are there different approaches and/or concerns for research in pregnancy and lactation from the physician/scientist/researcher viewpoint, as compared with industry's? How does the participant play a role in research for pregnant or lactating women? Does the size or scope of industry affect interest in research for pregnant women and lactating women?
2:40 p.m.	Q&A and Open Public Discussion
3:15 p.m.	BREAK
3:30 p.m.	Discussion of Key Points Related to Ethical Issues Surrounding the Inclusion of Pregnant Women and Lactating Women in Clinical Research
4:30 p.m.	Recap of Meeting, Action Items, and Charge to Group (PDF - 107 KB) Catherine Spong, MD
5:00 p.m.	END OF DAY 2, ADJOURN MEETING

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