TAG ARCHIVES FOR pregnant women

3
Aug2018

This edition of Research Ethics Roundup covers African-American participation in DNA testing, difficulties recruiting participants for Alzheimer's trials, even when results are promising, the deaths of eleven babies born to mothers in a Dutch drug trial involving generic Viagra, and a call for research misconduct investigations across Britain by the United Kingdom’s House of Commons science and technology committee. Read more

18
Jun2018

PRIM&R recently submitted comments in response to the Food and Drug Administration (FDA)’s draft guidance "Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials," which was published in the Federal Register on April 9, 2018. PRIM&R suggests a few areas for further clarification, but generally applauds the agency for taking this important step to fill current regulatory gaps around the inclusion of pregnant women in FDA-regulated clinical trials and ultimately believes that the draft guidance will be of great benefit to relevant stakeholders, including industry, IRBs, and research subjects. Read more

20
Nov2017

If you have ever reviewed a research study as a member or administrator of an IRB that included or involved pregnant research participants, you may be eligible for a new study on the enrollment of pregnant women in clinical research. As a practicing obstetrician-gynecologist, bioethicist, and the study principal investigator, I hope you will consider participating in a 20 to 25 minute online survey on IRB views and experiences reviewing research involving pregnant women. Read more

12
Sep2017

In this post, I continue my closer look at a few select areas of the revised Common Rule, which was published January 18, 2017 of this year, and is scheduled to go into effect January 19, 2018. One set of changes that has not gotten very much attention is that around the definition and categorization of “vulnerable” research subjects. In this post, I explain what those changes are and reflect a bit on their significance. Read more

28
Jul2017

This week’s Research Ethics Roundup looks at the first known US-based attempt of changing the DNA of embryos with CRISPR, the results of a large-scale wellness study, why researchers are challenging the notion that pregnant women are a “vulnerable” research population, and why European researchers are choosing to be transparent about their research with animals. Read more

Page 1 of 212