GENETICS AND PRIVACY

FAQ's

Many people are concerned about privacy issues regarding their DNA. This is for informational purposes, and is not meant to instill any paranoia in you. The theme should be that a well-informed consumer is a wise consumer. What you should understand is that y-DNA chromosome testing involves only noncoding regions of the y chromosome. Therefore, there are no possibilities of discovering genetic diseases. The privacy concerns that would apply to testing for medical diseases, such as the possibility of discrimination in the workplace, et seq., do not apply to this type of testing. Questions come to mind such as the following:

1) What happens to my DNA sample after a company is done?

First of all, swabs are sent out in kits to consumers. The consumer then swabs the inside of his or her cheek, capturing DNA found in buccal cells. Then the swab and the DNA on the swab are sent to the lab where all of it is used up in testing.

2) What happens to my DNA results after a company tests me and gives me a copy of the results?

The results are kept on file, in both computer and hard copy formats. DNA results should either go into a nonweb database with a number but no name, or could go onto a web database provided sufficient security precautions were taken.

3) Do my DNA results stay in a database, presumably for me to have other tested clans send in their DNA for comparison with mine?

This is an option. However, consent will have to be given if you would like your DNA used in comparison studies with other individuals.

4) Are these databases secure against hackers and other problems?

These databases are not accessible via the internet. No databases are 100 percent secure, but what helps is if the databases are either offline or on secure sites.

5) Does the company sell my DNA results or any other personally identifiable information?

The DNA and the DNA profile will never be sold or accessed by another party. Think about it for a minute. Companies are in business, and they get their business by referrals. If customers found out that companies sold their DNA data, the companies would not be in business very long. I would look for the company's privacy policy. State law may also regulate this area. Currently there is no federal (U.S.) statutory law, but there are regulations under the Department of Health and Human Services (45 CFR 46:101 et seq.) regarding privacy.

6) What other steps does the company take while testing to keep my DNA results and my identity separate?

The specimens as they arrive in the lab must be numbered. The number then would correspond to a name, and the actual tester would only have a sample with a number on it--never a name. Very few people would actually know who the customer is and what the results are.

7) Are any other tests, such as those looking for medical genetic diseases, being run on my DNA?

No tests other than DNA profiling will be done on the specimens. To analyze for genetic diseases, many tests would have to be run. That costs money to staff the lab, more supplies, more bookkeeping, increased overhead. Come on, now, businesses that did this would not stay in business very long!

8) Are there any laws that pertain to genetic testing that protect the consumer?

Yes, while there is no U.S. federal statute on the subject (attempts in 1992 and 1996 failed), the U.S. federal government has developed regulations (45 CFR 46:101 et seq.) to deter employers, insurance companies, or any other entities from discriminating against individuals based on their genetic makeup. There currently are also state laws (in the U.S.).

9) As genealogists, we want our results available to other companies so that comparisons can be made with our test results, and likewise, that those other companies share their results of those that they have tested. Let's take an example to show what I am talking about.  A goes and gets tested through Company A in the United States; B gets tested through Company B in France; C gets tested through Company C in Belgium; D gets tested in Germany.   It would appear that there is no way to compare the results since many companies are involved, not to mention laws of different countries and the European Union. Has anyone thought of a way to address this?

The transmission of the results of DNA identities can be handled much like medical records, but special consent would have to be obtained before results are shared between labs. Alternatively, results can be shared with labs by the individuals themselves, since they will have the profiles in their possession. On this note, we do not know if the labs have a procedure in place to handle a request from another lab or from a customer and what it would cost. Another approach would be to construct a huge database, or one common family tree. Those laboratories doing DNA testing for the public, especially in the Genetic Genealogy area, should lead the way. In their absence, maybe governments would like to lend a hand in the form of regulations to help the consumer.

10) Can drugs, medications or blood transfusions affect the test results?

Y polymorphism and mtDNA tests are not affected by drugs, medications or blood transfusions. Even patients who have had bone marrow transplants can still be tested because cheek cells, not blood, are being analyzed.

U.S. FEDERAL REGULATIONS

The genetic privacy issue actually consists of at least 3 sub issues: 1) genetic information as being private, 2) confidentiality of genetic information, and 3) the use of genetic information, even if authorized, can result in discrimination or stigmatization. Genetic privacy issues are not currently regulated by United States federal statute. While there are some U.S. Department of Health and Human Services regulations that regulate this area [see 45 CFR 46.101 et seq. (Code of Federal Regulations), most regulation in this area is at the state level. I will give you an example of state law, using selected parts of the Illinois law. If you would like to investigate further, then at least you have the statutory cites. There are some legal sites on the web where you can find federal laws and possibly state laws. But first, some links to proposed federal law:

U.S. Dept. of Health and Human Services regulations -- Applicability, 45 CFR 46.101; Definitions at 45 CFR 46.102; Research conducted or supported by any federal department or agency, at 45 CFR 46.103

HealthPolicy.com -- FDA Information Sheets, Guidance for Institutional Review Boards and Clinical Investigators, 1998 Update

HealthPolicy.com -- New proposed privacy regulations

Proposed U.S. federal statutes

Alliance of Genetic Support Groups/Consumer Policy Network

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