Navigation Links
Bioethics scholars fault requirement that all women in clinical drug trials use contraception
Date:9/30/2010

(Garrison, NY) Research ethics review committees often require all women of childbearing age who enroll in clinical trials to use contraceptives to protect against a developing fetus being exposed to potentially harmful drugs. A mandatory contraceptive policy is often imposed even when there is no evidence that a trial drug could harm a fetus or when women have no chance of becoming pregnancy. This requirement is excessive and can safely be relaxed in many cases, according to a report in IRB: Ethics & Human Research.

Policies on contraceptive use in research should reflect the level of potential risk the study drug poses to the fetus, write Chris Kaposy, an assistant professor of Health Care Ethics at Memorial University of Newfoundland, Canada; and Franoise Baylis, professor and Canada Research Chair in Bioethics and Philosophy at Dalhousie University in Halifax. They point to the U.S. Food and Drug Administration's categories for prescription drug labeling for drug use in pregnancy as a helpful guide. The FDA has five categories, each with different degrees of evidence of risk to fetuses.

Category A, for example, indicates that "adequate, well-controlled studies in pregnant women have not shown increased risk of fetal abnormalities." And yet the policy of the University of Nebraska Medical Center's institutional review board which Kaposy and Baylis reviewed as a typical example of IRB contraceptive use policies permits researchers to petition the IRB to impose a mandatory contraception or abstinence requirement for trial participants in studies that use Category A drugs. However, the authors argue that an ideal policy for Category A drugs would not require contraception or abstinence.

The authors also say that contraception should not be mandated for women who have no chance of becoming pregnant while participating in a clinical drug trial. "Consider, for example, women who are not sexually active (e.g., nuns) or who are not sexually active in a heterosexual relationship (e.g., lesbians)," they write. Mandating contraception for these groups sends "a paternalistic message of mistrust" that undermines the normal practice of treating research participants as autonomous decision-makers.

"Our recommendations are an attempt to find an appropriate balance between the interests of potential fetuses and the autonomy and well-being of women," they write.


'/>"/>

Contact: Michael Turton
turtonm@thehastingscenter.org
845-424-4040 x242
The Hastings Center
Source:Eurekalert

Related medicine news :

1. "Consciousness" at 9th Annual International Bioethics Forum in Madison, Wisconsin
2. UofL student wins national minority nursing scholarship
3. ASP announces 2010 T. Franklin Williams Scholars
4. Angel MedFlight Worldwide Air Ambulance offers $3,000 scholarship for a student pursuing a career in aviation at an Arizona school
5. Fired Wal-Mart Employee Accepts Full Scholarship to The Medical Marijuana Academy
6. Students receive scholarships for public health systems research
7. NFL Wide Receiver Mike Sims-Walker Remembers His Father by Giving Out Scholarships
8. Quincy Bioscience Sponsors Multiple Sclerosis (MS) Scholarship Program
9. Celebrated Father Overcame Poverty and Mental Illness to Help His Son Earn a Scholarship to Harvard
10. High School Students Well-Schooled In Diversity: Teen Winners of Book Writing Contest Earn College Scholarships and Have Entries Published
11. Outstanding young gastroenterologists receive AGA Foundation 2010 Research Scholars Award
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/25/2016)... ... June 25, 2016 , ... "With 30 hand-drawn hand gesture ... said Christina Austin - CEO of Pixel Film Studios. , ProHand Cartoon’s package ... Final Cut Pro X . Simply select a ProHand generator and drag it ...
(Date:6/25/2016)... (PRWEB) , ... June 25, 2016 , ... On Friday, ... presented a Bronze Wellness at Work award to iHire in recognition of their exemplary ... part of the 7th annual Maryland Workplace Health & Wellness Symposium at the BWI ...
(Date:6/24/2016)... ... ... June 19, 2016 is World Sickle Cell Observance Day. In an effort ... holistic treatments, Serenity Recovery Center of Marne, Michigan, has issued a pain ... Disease (SCD) is a disorder of the red blood cells, which can cause episodes ...
(Date:6/24/2016)... ... June 24, 2016 , ... Dr. ... accelerated orthodontic treatment. Dr. Cheng has extensive experience with all areas of orthodontics, ... and accelerated osteogenic orthodontics. , Micro-osteoperforation is a revolutionary adjunct to orthodontic ...
(Date:6/24/2016)... ... June 24, 2016 , ... EB Medicine presented its first-ever ... Medicine conference in Ponte Vedra Beach, FL. The awards honor the outstanding work ... Practice and Pediatric Emergency Medicine Practice. , “With this award, we recognize ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... NAMUR , Belgium , ...  (NYSE MKT: VNRX), today announced the appointment of ... Board of Directors as a Non-Executive Director, effective ... the Company,s Audit, Compensation and Nominations and Governance ... Board, Dr. Futcher will provide independent expertise and ...
(Date:6/23/2016)... Research and Markets has announced ... Type (Organic Chemical (Sugar, Petrochemical, Glycerin), Inorganic Chemical), Functionality ... - Global Forecast to 2021" report to their ... global pharmaceutical excipients market is projected to reach USD ... in the forecast period 2016 to 2021. ...
(Date:6/23/2016)... 2016 Research and Markets has announced ... report to their offering. ... a favourable commercial environment for MedImmune to enter. The US ... will serve to drive considerable growth for effective anti-influenza medications. ... cap sales considerably, but development is still in its infancy. ...
Breaking Medicine Technology: