Tag: pregnant women

Bioethics Blogs

Research Ethics Roundup: Pregnant Women and Zika Vaccine Research, National LGBTQ Health Study Launches, New Mouse Study on Sexual Dimorphism, “The Bioethics of Remembrance”

This week’s Research Ethics Roundup looks at why researchers are not enrolling pregnant women in the early phases of Zika vaccine research, a new LGBTQ study that seeks to address participants’ health concerns, a new study that shows the sex of a mouse affects certain traits, and Dr. Susan Reverby’s case for making changes to a monument that fails to note how a prominent gynecologist used slaves in his experiments.

The post Research Ethics Roundup: Pregnant Women and Zika Vaccine Research, National LGBTQ Health Study Launches, New Mouse Study on Sexual Dimorphism, “The Bioethics of Remembrance” appeared first on Ampersand.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Ethical, legal and societal considerations on Zika virus epidemics complications in scaling-up prevention and control strategies

Much of the fear and uncertainty around Zika epidemics stem from potential association between Zika virus (ZIKV) complications on infected pregnant women and risk of their babies being born with

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics News

Pregnant Women Absent from Zika Vaccine Trials

August 15, 2017

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This uncertainty is a major reason behind researchers’ hesitancy to expose pregnant women to newer vaccines. Women do indeed get vaccinated while pregnant—against the flu or tetanus, diphtheria, and pertussis (Tdap), for example. But “the overall safety for flu and Tdap vaccines was established in very large populations prior to being administered to pregnant women,” says August.

Some vaccines—such as the flu vaccine—included pregnant women in clinical trials. And, notably, pregnant women were included in Phase 3 trials for the new respiratory syncytial virus (RSV) vaccine that prevents a devastating, potentially fatal infection that targets infants.

But recommendations for vaccination during pregnancy are not always backed by clinical trials. “Historically, many of the recommendations have relied on observational data,” writes Johns Hopkins bioethicist Carleigh Krubiner in an email to The Scientist. She, along with August, is part of the working group who wrote the Wellcome Trust-funded guidelines for Zika vaccine administration in expectant moms. In these cases, pregnant women were either intentionally or unintentionally given vaccines, then mother and child were observed.

… Read More

See also: PREGNANT WOMEN & THE ZIKA VIRUS VACCINE RESEARCH AGENDA: ETHICS GUIDANCE ON PRIORITIES, INCLUSION, AND EVIDENCE GENERATION

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The Scientist

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The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics News

Pregnancy Paradox

The dangers of not testing drugs on pregnant women. Pregnant women can get sick. And women with illnesses do get pregnant. Yet most drugs have never been tested for their effects during pregnancy

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Sterilization for Prisoners Is Not New and Shows That Studying History is Essential

by Craig Klugman, Ph.D.

In 1927, Supreme Court Justice Oliver Wendell Holmes ruled that Carrie Buck and her baby could be sterilized because of a perception that they were “mental defectives.” In the 20th century, 32 states had federally funded programs that sterilized “undesirable” populations. Approximately 60,000 people in the U.S. were sterilized without their consent or even knowledge of the procedure. This history made an unexpected reappearance last week when a Tennessee judge offered to reduce the jail sentences of prisoners if they underwent sterilization.

The inmates were offered vasectomies (males) or contraceptive implants (females) in exchange for him shaving 30 days off of their prison sentences. The offer was popular as 70 inmates signed up (32 women and 38 men). The inmates were convicted of drug offenses and Judge Sam Benningfield said he was offering them “an opportunity to take personal responsibility and give them a chance, when they do get out, to not to be burdened with children…This gives them a chance to get on their feet and make something of themselves.”

The primary purpose in this was to try to reduce the number of children born drug dependent or suffering the consequence of in vitro drug exposure…the number of children who would eventually wind up in foster care,” the Judge said in a statement. He claims that the offer was “strictly voluntary…no one is forced to participate…it is no way a eugenic program.” Of course, the Judge presumes that inmates have true freedom of choice in this matter.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Research Ethics Roundup: First Human Embryos Edited in US, Large Scale Wellness Studies, Seeing Pregnant Women as “Vulnerable” Research Subjects, Europe’s New Animal Research Transparency Efforts

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.

The post Research Ethics Roundup: First Human Embryos Edited in US, Large Scale Wellness Studies, Seeing Pregnant Women as “Vulnerable” Research Subjects, Europe’s New Animal Research Transparency Efforts appeared first on Ampersand.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics News

How Pregnant Women Are Sidelined By Science

July 26, 2017

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Pregnant women get bossed around by doctors‚ relatives and strangers dispensing advice on what’s best for their baby.

But a new study says the coercion of mothers-to-be — in particular their exclusion from clinical studies — is unfair and potentially harmful.

Doctors Carleigh Krubiner and Ruth Faden‚ from Johns Hopkins University in the US‚ said there was a desperate need to “protect women through research‚ not just from research”.

… Read More

Image: By Beth.herlin – Own work, CC BY-SA 4.0, https://commons.wikimedia.org/w/index.php?curid=46867814

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Sunday Times ZA

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The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

‘A bit of a compromise’: Coming to terms with an emergency caesarean section by Terena Koster

During the midwife-hosted antenatal class Cath attended in a private hospital in Cape Town, South Africa, where she would eventually give birth, pregnant women were encouraged to name the kind of birth they wanted. They were presented with three options: “natural all the way with no medication”, “natural but open to medication”, or “elective caesarean”. The ‘choice’ women were expected to make featured as an important point of concern in their antenatal care and in their preparations for birth.

Hannah, a participant in the class, recalls a particularly striking moment when the midwife went around the room and pointed at each of the participants and asked, “Who is your gynae”. She went on to predict diverse birth outcomes, irrespective of participants’ stated intentions to birth vaginally. For Hannah this was an “eye opening” experience. A first time mother, she was now invited into a highly politicised birthing environment. Hannah had been uncertain about what kind of birth she wanted, but at 8 months pregnant she had decided on a ‘natural’ birth as opposed to a ‘caesarean’, with the caveat that in the event that an emergency caesarean section was a likely outcome, she would proactively opt for an elective caesarean.

At 39 weeks and near the end of her pregnancy, she found herself sitting opposite her obstetrician who told her there was “a real threat of the umbilical cord wrapping around [the baby’s] neck as she … drop[s] down,” adding that because the baby was “so big” there was “a high likelihood of [Hannah] tearing”. For the first time, the obstetrician instructed her to make a birthing decision: to continue trying for a vaginal birth or to opt for an elective caesarean section.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics News

Zika Rewrites Maternal Immunization Ethics

July 20, 2017

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Ever since the shocking realization in 1961 that the morning sickness pill thalidomide caused shortened limbs in babies, doctors have been extremely wary of giving any medicine to a pregnant woman—and testing experimental drugs has raised even more concerns. But the recent discovery that exposure to Zika virus in utero can cause severe brain damage and other problems in children triggered an international effort to develop a vaccine for pregnant women. A new report written by an ad hoc group of prominent researchers, bioethicists, clinicians, and drugmakers concludes that pregnant women should be included in trials of Zika vaccines, once safety in animals and nonpregnant adults is demonstrated. The risk/benefit issues spelled out in the report also apply to experiments with maternal immunization for other diseases, which are winning increasing support.

Researchers have been too reticent to include pregnant women in clinical trials of vaccines, contends the working group behind the report. “Even for the vaccines we now recommend in pregnancy, pertussis and flu, the original trials did not include pregnant women,” says Carleigh Krubiner, a bioethicist at the Johns Hopkins Berman Institute of Bioethics in Baltimore, Maryland, who is part of the group, which was sponsored by the London-based Wellcome Trust. “This project is trying to be more proactive.”

The half-dozen Zika vaccine trials now taking place only enroll women of childbearing age who are on contraception or have a sterile male partner. That is appropriate, according to the risk/benefit analyses spelled out in the report, as these early studies assess only safety and basic immune responses.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics News

Excluding Pregnant Women From Clinical Studies Because They’re Classed As ‘Vulnerable’ Is ‘Harmful’

July 20, 2017

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Excluding mums-to-be from clinical studies is unfair and could be potentially harmful, researchers have said.

Pregnant women are often ruled out of participating in clinical trials because they’re classified as a “vulnerable” group, and this creates a knowledge void around the impact of drugs taken during pregnancy and “unfairly excludes” them from taking part in clinical studies, concluded researchers writing in the ‘Journal of Medical Ethics’.

“There is a desperate need to shift the paradigm to protect pregnant women through research, not just from research,” the researchers wrote.

… Read More

See Also – Commentary: Pregnant women should not be categorised as a ‘vulnerable population’ in biomedical research studies: ending a vicious cycle of ‘vulnerability’

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HuffPost UK

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The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.