Week 11 PART A_ Ethics of Maternal Research
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Week 11 PART A: Ethics of Maternal Research
1. How do religious beliefs influence expectant parents in deciding if they consent to
participating in experimental procedures?
Religious views have a significant influence on the decisions made by expectant parents about
experimental procedures during pregnancy. They consider if they believe in a higher power and
how these practices align with their beliefs about the significance of life. Certain religions have
views on contemporary medicine as well. Considering the benefits and drawbacks, it's a difficult
choice, and the position of their religious group is important. Ultimately, the decision to undergo
experimental procedures during pregnancy is determined by the individual viewpoints and
opinions of each person (Colom & Rohloff, 2018).
2. Pregnancy involves numerous significant health risks to women & yet many researchers
and institutional review boards regard pregnancy as a near-automatic cause for exclusion
from research studies. Why?
Important research for the health of mothers and fetuses is hampered when pregnant women are
excluded from trials because of ethical concerns. Although immunity is not guaranteed during
pregnancy, 10% of women need treatment for major illnesses like diabetes or heart disease. Only
a few medications are approved because they lack safety data. Pregnant women who take
standard adult doses run the risk of either receiving too little or too much care, which could
endanger the unborn child. The majority of newly approved medications contain unidentified
dangers that take up to 27 years to find out (Lyerly & Faden, 2013).
3. Why is it necessary to research drug efficacy & safety in pregnant women as a distinct
patient population?
There are ethical and physiological issues with pregnancy. Due to a lack of studies, the
physiological effects of drug usage during pregnancy are poorly understood, and thorough
research across trimesters is required to determine appropriate dosage recommendations. Pregnant
women's and their fetuses' interests must be balanced ethically, and clinical experiments including
them must be included unless there are strong reasons not to (Kaye, 2019). Due to the fact that
medications have different effects on expectant mothers and fetuses, it is crucial to collect enough
information on safety and effectiveness.
4. Who was Chemie-Grunenthal?
The German pharmaceutical company Grünenthal gained notoriety for producing thalidomide, a
medication used in the late 1950s as an anti-nausea and sedative. Regrettably, thalidomide during
pregnancy caused severe limb abnormalities in the offspring of those moms. Thalidomide was
marketed under several names before its withdrawal from circulation in the early 1960s as a result
of dangerous side effects. Grünenthal's involvement in the thalidomide tragedy drew criticism and
legal action, but the company responded by paying restitution to people impacted and funding
pertinent initiatives.
5. Who was Frances Kelsey?
Physician and pharmacologist Frances Kelsey rose to prominence in the 1960s when she refused to
give in to pressure to approve the drug thalidomide, which was known to cause serious birth
deformities, at the speed of day. She received the President's Medal for Distinguished Service from
President Kennedy. Drug laws were reinforced by Kelsey's strict standards at the FDA, which
required businesses to demonstrate their products' efficacy and safety. She earned an M.D. and a
Ph.D., published articles in scientific journals, and cleared the path for women in medical research.
Drug safety laws are still affected by her activities today (
Kelsey, Frances Oldham | Women of the
Hall
, n.d.).
6. What is the specific molecular mode of action of thalidomide that causes birth defects in
the limbs of developing fetuses?
A unique molecular effect of thalidomide that results in birth abnormalities of the limbs is the
inhibition of vascular endothelial growth factor (VEGF), a protein essential to the development
of blood vessels. Malformations occur during the development of embryonic limbs as a result of
a disturbed blood supply brought on by thalidomide's inhibition of VEGF (Therapontos et al.,
2009). Babies exposed to the medication during pregnancy exhibit distinctive limb deformities as
a result of intricate biological pathways. In order to increase medication safety and awareness
during pregnancy, ongoing research attempts to expand our understanding of these complex
processes (Vargesson, 2015).
7. Why is thalidomide an effective treatment for tumors & macular degeneration?
Thalidomide demonstrates several different modes of action. It stops cancer cells from
proliferating and dividing, which slows down the growth of the disease. It also prevents tumors
from growing their own blood vessels, which is necessary for their growth. Additionally,
thalidomide activates specific immune system cells to fight and target myeloma cells. Its variety
of activities makes it an effective treatment for some malignancies, especially multiple myeloma
(Cancer Research UK, n.d.).
8. What are 2 problems with relying only on “informed consent” as the pre-eminent test for
ethics of a research study? What else is required to ensure that the patient is not
succumbing to outside pressures to participate in the research?
There are disadvantages to relying only on "informed consent" for research ethics, such as
potential power imbalances and low participant knowledge. Independent evaluations, open
communication, continuous consent procedures, and outside assistance are essential to
guaranteeing that participants are not under duress. These safeguards go beyond the initial
permission agreement to protect participant rights and wellbeing.
9. a) What are the 4 principles of moral philosophy supporting the right to safe
motherhood ?
The right to safe motherhood is grounded in four moral principles (ACOG Clinical, 2007):
-
Autonomy (respecting individual choices)
-
Beneficence (promoting well-being)
-
Justice (ensuring equitable access)
-
Non-maleficence (preventing harm) (Nijhawan et al., 2013)
9. b) What would Immanuel Kant have said about the third principle, as discussed by
Professor Sandel in the video you watched for the first module of this course?
The 18th-century philosopher Immanuel Kant viewed justice through an understanding of his
political and moral convictions. He advocated the idea of universal moral norms and reinforced
the value of treating each person with inherent dignity. In accordance with Kant's categorical
imperative, fair deeds should be accessible to everyone and free from contradiction—this is
especially true of the idea of universalism. Also, his advocacy of people's inherent moral value
suggests a commitment to justice and equality. In terms of politics, Kant supported an
administration founded on the rule of law and democratic procedures (Nardin, 2017)
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References
ACOG Clinical. (2007, December).
Ethical decision making in obstetrics and gynecology
.
ACOG. Retrieved November 19, 2023, from
https://www.acog.org/clinical/clinical-guidance/committee-opinion/articles/2007/12/ethic
al-decision-making-in-obstetrics-and-gynecology
Cancer Research UK. (n.d.).
Thalidomide
. Cancer Information | Cancer Research UK. Retrieved
November 19, 2023, from
https://www.cancerresearchuk.org/about-cancer/treatment/drugs/thalidomide
Colom, M., & Rohloff, P. (2018). Cultural considerations for informed consent in paediatric
research in low/middle-income countries: a scoping review.
BMJ Paediatrics Open
,
2
(1),
e000298. https://doi.org/10.1136/bmjpo-2018-000298
Kaye, D. K. (2019). The moral imperative to approve pregnant women’s participation in
randomized clinical trials for pregnancy and newborn complications.
Philosophy, Ethics,
and Humanities in Medicine
,
14
(1). https://doi.org/10.1186/s13010-019-0081-8
Kelsey, Frances Oldham | Women of the Hall
. (n.d.).
https://www.womenofthehall.org/inductee/frances-oldham-kelsey/
Lyerly, A. D., & Faden, R. (2013). Mothers Matter: Ethics and Research during Pregnancy.
AMA
Journal of Ethics
,
15
(9), 775–778.
https://doi.org/10.1001/virtualmentor.2013.15.9.pfor1-1309
Nardin, T. (2017). Kant’s republican theory of justice and international relations.
International
Relations
. https://doi.org/10.1177/0047117817723064
Nijhawan, L. P., Janodia, M., Muddukrishna, B., Bhat, K., Bairy, K., Udupa, N., & Musmade, P.
B. (2013). Informed consent: Issues and challenges.
Journal of Advanced
Pharmaceutical Technology & Research
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4040.116779
Therapontos, C., Erskine, L., Gardner, E. R., Figg, W. D., & Vargesson, N. (2009). Thalidomide
induces limb defects by preventing angiogenic outgrowth during early limb formation.
Proceedings of the National Academy of Sciences of the United States of America
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Vargesson, N. (2015). Thalidomide
‐
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