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


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


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