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

November 6-7, 2017

Agenda

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.
 
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.
 
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.
 
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.
 
1:40 p.m.
 
1:50 p.m.
 
2:00 p.m.
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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