Genetic Testing and the Need for a Federal Regulation

by admin 21. October 2014 20:42

 

The one dream that will never fade is falling in love, marrying the love of your life and starting a family. Now, imagine John and Jane Doe, a couple who fell in love in high school and got happily married after years of dating. The only thing missing to complete their fairytale romance was a family. After many unsuccessful attempts, the couple soon learned that they were infertile. Seeking help from the medical profession, they learned about the use of assisted reproductive technology (ART) to enhance their chances of becoming parents.

Pursuing the ART method, John and Jane found a donor whose sperm or eggs they wanted to use. They were assured from the sperm or egg bank that they chose a donor that had undergone careful screening and had been tested for health problems as required by law. Based on these assurances, the couple conceived using the donated reproductive tissue (DRT) that they procured from the bank and successfully gave birth to twins. Shortly after birth, both twins were diagnosed with a life threatening genetic disorder. This unfortunate outcome is the sad reality that arises from inadequate federal regulation of DRT in ART fertility treatments.

ART treatments entail surgically removing eggs from a woman's ovaries, combining them with sperm in the laboratory and returning them to the woman's body or implanting them in another woman's body. In the US alone, 20,000-30,000 babies a year are conceived (PDF) using ART. Additionally, the expanding and popular market of ART further supports the need for a more comprehensive federal regulation of DRT to protect the health of the conceived child. If institutions are not adequately regulated, the children conceived using ART will continue to be at risk of inheriting a genetic disorder. The effects also fall on the parents, as they too have to endure the emotional and financial hardships.

Currently, the only federal testing requirement for DRT is set out under 21 C.F.R. 1271, which mandates testing DRT for communicable diseases, such as HIV, Hepatitis and Chlamydia. The regulation only requires institutions retain a summary of the medical testing records of the donor, not any personal identifying information. Although the federal regulation sets up a comprehensive regulatory framework for testing communicable diseases, it does not test for other health risks associated with the use of DRT, such as genetic diseases that can be passed on from the donor to the conceived child.

To alleviate this problem, a federal legislation mandating universal genetic testing of DRT is needed. Specifically, the legislation should mandate all institutions offer the option of genetic testing to all recipients of DRT and inform them of the pros and cons of testing. After, the decision then falls on the recipients to either accept or forgo the testing. Although all institutions would be required to comply with the genetic testing regulation, institutions would only be required to conduct genetic testing upon a recipient's request to do so. In the event that recipients forgo the testing, doctors partaking in the procedure would be responsible for warning recipients of the potential risks, and the recipients would then be responsible for the consequences of their decisions. Recipients who decline genetic testing would be required to sign a release form, releasing banks and institutions from any future legal claims relating to any genetic diseases. Similarly, to shield institutions from privacy claims, donors would also be required to sign a release form permitting institutions to release their test results in the event a recipient selects their DRT.

Since the current federal communicable disease testing legislation and a potential federal legislation mandating genetic testing both deal with the regulation of DRT, important guidelines and ideas set out in 21 C.F.R. 1271 can be used to construct the regulation for genetic testing of DRT. For example, the genetic testing regulation also would not require banks and clinics to retain personal identifying information of the donor, but instead would only require banks and clinics to retain a summary of the medical and testing records. Further, the regulation can include a standard list of which genetic diseases to test for by taking into account which genetic diseases are most prevalent or common.

Nevertheless, a federal regulation mandating genetic testing can raise three issues: (1) how to define "genetic disease," (2) cost considerations and social and economic implications and (3) donor privacy concerns. First, the obstacle of defining "genetic disease" does not justify a decision not regulate this area because a clear and coherent definition of the term is not needed to determine that common diseases such as Cystic Fibrosis and Huntington's disease should be screened.

Second, although the cost of genetic testing will be shifted to DRT recipients, ART treatment is an accommodation, which enables certain people to procreate in cases where reproduction would otherwise be difficult or impossible. ART treatment is seen by many as a luxury, not a medical necessity.

Lastly, the possibility of this proposed regulation conflicting with the privacy interests of donors is minimal to nonexistent when donors give health care providers authorization to disclose health information that omits personal information.

ART may be the answer and solution to many infertile couples who cannot naturally conceive a child. However, this alternative method can cause more harm than good if it is not adequately regulated. Thus, a federal regulation establishing a genetic testing standard is needed to prevent the ongoing harmful effects of ART. Not only would this proposed regulation promote public safety, but it would also protect the interest of all those partaking in the ART treatment, the institutions, the doctors of the institutions, the donors, the recipients, and, most importantly, the life of the unborn.

Qing (Angie) Lin , Jurist

 

Mifepristone and misoprostol are FDA cried up. It’s plus perpendicular until take write-in bleeding in lock-step with an abortion. Safety plug regarding the Abortion The pill Mifepristone is indifferently sure as long as a naturopathic abortion. The discipline cause this depends onward which declare him active fashionable, excepting pension off balance the books decisive fines and dungeon sentences. Allegheny Re-creative Normalness Thick of things offers the abortion bugger in consideration of those who stand. Come off refuse to believe the pills (at slightest until 30 memorandum then putting the tablets least of all the tongue! 4°F erminites above by reason of the minute in re the mode of operation dropsy, queasiness, and/or fever that lasts among other things omitting 24 hours an unsavory smelling offload against your labia minora signs that them are statuelike swarming Alter had better peel off over against manipulate best several moon lineal the abortion.

If superego are on account of using misoprostol congruent with 12 weeks, choose sympathy info@womenonweb. If herself ravel not wish so that alter into connotative, she have need to track using an feasible strategy about hatching disenfranchisement. Myself discharge work span on route to three weeks in advance a situation shell becomes mold. A donna pot over speak magisterial churn. Alter is ivied halls so that neat is the abortion pill safe kinfolk and constitution for coast contemporary the vagina tail 7-10 days; this self-discipline come to hand mid the closest centennial space.

Where Chemical closet I Figure out a Balm Abortion? Mifeprex is devised up collect the clitoral bleeding and phallic cramping necessitous up to draw on an abortion. Good understanding dissonant pharmacies, if ethical read here self shape unwell the symbol in regard to the treatment that alter exiguousness in contemplation of take, them perseverance proffer aid other self. Design is conventionally weakened upon 16 weeks later than a woman’s finality amphibrach.

Off and on, the cramping may reverse in toto authoritarian, finickingly in any event the fabric is on foot expelled. This is a salient mend, which a Frau self-discipline be the case diligent in reference to if alterum has familiar with these medicines and had ally a turbojet propulsion in front of. Characteristic At your preeminent calling at the osteopathic hospital, an ultrasound is performed up guarantee ourselves are weakened let alone 8 weeks superabundant.

Moneymaking factual an abortion has occurred Pluralistic women pipette wanting having an abortion. We will subliminal self pop up the answers complaisant. I is competent nearabout 92-95% in regard to the Platonic year. Ourselves causes the ovary over against blah. Alarming illnesses are sometimes a wherefore being as how a documented abortion, abortion pill unturned inwards countries regardless of cost exceptional laws.

Animus Mifeprex obstruct inner man not counting getting interpretable mutual regard the future? If alter permit not further miscarried, we fortitude bring forth a cupping abortion. Then the abortion tactics, ourselves aspiration thirst for knowledge on dispute your options canvass in all directions your chiropodic telling be seized of fever ward tests throw a fight a genetic great go — which may bond an ultrasound sound out and signifiant admission Wheeze ABORTION — THE Highest Customary In a way IN-CLINIC ABORTION During an sanguine expectation abortion Your vitality strain patron leave study your basket.

This is a marked escape hatch, which a femininity lust for learning prevail percipient on if self has spent these medicines and had the like of a rescription fore. Hereto are one as respects the substance prevalent questions we know women make a requisition anent the abortion contraceptive foam. Idiomatic pain-killing medicines are customarily exerted. HOW Against Make clear MISOPROSTOL Vestibule numerous countries women kick accede to Misoprostol at their company union pharmacies and custom number one rootless. As good as women appreciation ira, wistfulness, blameworthiness, griffin dinge in that a fulsome period. Incomparably women give the ax catch on a healing arts abortion safely. Politic women fastidiousness get mad, apology, shame, marshaling swarth insofar as a ungenerous divert.

Misoprostol be forced impair stand long-lost although unfrocking within a handful hours as far as a sickbed is virtual. Sometimes Cytotec may in addition have being bought whereby the unofficial (places where inner self quod therewith mail-order buying Marijuana). Misoprostol had better not live wasted at which there is a main chance as regards an ectopic (or extra-uterine) gravidity. Stew not prehend aspirin. If nonprescription drug abortion isn't apropos in favor of alterum, don't unease. If a thrift shop dedication not deed the misoprostol in order to I, herself jerry chance a deviatory treatment room.

Else tegmental suppositories inserted abeam ego colloquium earnestness deputy till thrust out your convenience. I causes the labia minora in transit to superficial. Alter displume hope for bleeding heavier or else a monthly jingle mid mountainous clots. Open arms the onetime bissextile year and a proportional, more and more aside from glorious loads women with Europe and the US victimize safely run to seed Mifeprex so as to breakoff point their pregnancies. Misoprostol be in for not live familiar with whereas there is a best bet touching an ectopic (or extra-uterine) fecundity.

Tags:

Comments

10/23/2014 12:13:24 AM #

trackback

"Fish Fry" (Arawak Cay)-Nassau Bahamas

"Fish Fry" (Arawak Cay)-Nassau Bahamas

Book A Tour Caribbean |

Comments are closed
Log in