During the first day of the 2019 Advancing Ethical Research Conference, I had the good fortune of hearing Janine Austin Clayton, MD, from the Office of Research on Women's Health, an NIH organization that was created with the goal of finding answers on why certain diseases affect women more than men. The data she shared on health gaps between men and women should spark a fire in all of us to encourage our government and employers to do more. Read more
Attending the 2018 Advancing Ethical Research (AER) Conference was a fantastic opportunity to connect with colleagues, hear renowned speakers address regulatory hot topics, and share ideas and best practices. Science and technology are expanding exponentially; as a result, our research community is becoming increasingly diverse and multi-center research is booming. While historically the regulations have remained relatively unchanged, in recent years the regulatory community has worked together to provide feedback on suggested major updates and new guidance which are greatly shifting the regulatory world. This year's AER Conference takes place November 18-20, 2019 in Boston, MA Read more
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
PRIM&R recently submitted comments in response to the Food and Drug Administration (FDA)’s draft guidance "Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials," which was published in the Federal Register on April 9, 2018.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gaps around the inclusion of pregnant women in FDA-regulated clinical trials and ultimately believes that the draft guidance will be of great benefit to relevant stakeholders, including industry, IRBs, and research subjects.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
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
