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
This week’s Research Ethics Roundup looks at the ethical implications of inserting human brain organoids into laboratory animals, the need for deep brain stimulation researchers to think about the potential long-term ethical dilemmas involved in their work, the argument for classifying certain kinds of organ recipients as research subjects, and President Trump’s new pick to be the secretary of the Department of Health and Human Services (HHS). Read more
In collaboration with First Clinical Research, each month we share a new question and accompanying anonymous survey, designed to encourage critical thinking about questions in clinical research and highlight discussion generated by the prior month’s question.
This month's question:
Researchers have identified a previously unknown but fairly common viral disease in certain developing countries: infant maternalitis, in which an infant is born with a serious allergy to the mere presence of his or her mother. For reasons that are not understood, [...] Read more
Are you attending the 2017 Advancing Ethical Research Conference? Would you like to participate in a research study to discuss the risks and benefits of conducting record linkage studies during the conference? If so, please join us for lunch and discussions on Nov 5th (Sunday), 12:00-1:30pm in the Henry B. Gonzalez Convention Center Room 005 (on the River Level of the Convention Center.) Read more
This week’s Research Ethics Roundup looks at how researchers can learn about chronic traumatic encephalopathy (CTE) from living mixed martial arts (MMA) fighters, why scientists are increasingly providing research primates with cage-mates, how research misconduct is handled in Canada, and the argument for more Food and Drug Administration (FDA) oversight of stem-cell clinics. Read more
Last month, the Department of Health and Human Services’ (HHS) Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA) jointly released final guidance on meeting minutes for IRBs who oversee human subjects research under FDA and/or HHS regulations. The final guidance includes a few small changes from the draft released in November 2015. This is the first time the two agencies have jointly issued guidance in this area; the guidance summarizes how the agencies believe IRBs and institutions should apply the federal regulations as they pertain to the creation of IRB meeting minutes. Read more
