15 November 2024 – Maribor
Direct-to-consumer genetic testing provides people with access to their genetic information without necessarily involving a healthcare provider or health insurance company in the process. The most popular tests:
- provide a limited set of genetic variations to make predictions about certain aspects of health,
- provide information about common traits,
- offer clues about a person’s ancestry.
Other names of direct-to-consumer genetic testing are DTC genetic testing, direct-access genetic testing, at-home genetic testing, at-home >DNA testing, ancestry testing. Direct-to-consumer DNA services are advertised via television, radio, print advertisements, or the Internet, and the tests can be bought online or in stores. After purchasing a test kit, customers send the company a DNA sample and receive their results directly from a secure website or app or in a written report. These genetic tests provide people access to their genetic information without necessarily involving a healthcare provider or health insurance company in the process.[1]
The demand for direct-to-consumer testing is growing, especially for the purpose of searching ancestry. Just five years ago, by the start of 2019, more than 26 million consumers had added their DNA to four leading commercial ancestry databases, according to estimates by MIT Technology Review, which may increase to 100 million within a few years.[2]
As more and more people are feeding DNA databases, searching for relatives is more likely to yield positive results. Users may give their consent to reveal their identity and to allow potential relatives to contact them. So, donor-conceived people can use these services to conduct a DNA test to search for their genetic parent. Recipient parents can test the child to identify the donor and any other half-siblings. Donors themselves can also take a DNA test to search for the offspring of their donations.
The condition for a successful search is that the donor and the donor-conceived siblings and other genetic relatives are in the database.
The procedure as such is simple and cheap. The curious person is sent a kit with the necessary tools. All he or she needs to do is put a saliva sample in a small receptacle, send it back to DNA test commercial provider, upload his/her information, pay as little as approximately 30 US dollars and wait for the result, which will indicate where the relatives are.
As the whole topic is presented in the context of donor-conceived children, a Dutch experience might be relevant. In the Netherlands, donor anonymity was waived in 2004. Approximately 40,000 donor children were born by 2004, most of them by anonymous donors. Due to the interests of both donor-conceived persons and donors, in 2010 the Fiom KID-DNA Database was established by the state, so that donor children and donors can search for each other. By the end of 2021, 846 donors and 2355 donor-conceived persons were registered in the database, and for 25% of the donors a link was found with one or more of their offspring, and 39% of the donor-conceived persons were linked to a donor profile.[3]
The Netherlands might be specific due to the social attitude toward the acceptance of the right of the child to know his/her origin and liberal social values that support various forms of families.
In traditional countries, the protection of the privacy of donors is considered to be extremely important for the motivation of donors. For example, In the Republic of Croatia, although the Act on Medically Assisted Reproduction 2015 allows heterologous assisted reproduction techniques, a gamete bank has not yet been founded due to a lack of interest of prospective donors, as there is no anonymity. The legislator gave priority to the right of the child to know his/her origin. Potential donors are discouraged from donating, as they primarily want to keep their privacy and not to establish any kind of link with the donor-conceived child (although there are no legal mutual obligations or connections between the child and the donor).
The motives of most donors to register in the database were child-oriented, as donors believe that their offspring are entitled to their physical and social details and/or they want to give their offspring a chance to contact them. Research also revealed other motives that are donor-oriented, such as the curiosity about the number of offspring, their well-being, and the desire to establish contact with the donor-conceived child (person).[4]
A survey using Donor Sibling Registry, the largest U.S. web-based registry (2009/2010) found that donor offspring would like to view the donor as a whole person, rather than as simple genetic material. They believe that the donor should act on his humanity and may want to control the decision about contacting their sperm donor in order to facilitate a bond between themselves and the donor that is separate from their relationship with their parents, also wishing to assure their parents that their natal families are primary and will not be disrupted.[5]
Another, more recent research on donor-conceived persons from Belgium, showed that“the average age of disclosure was 16.5 years of age, with notably later disclosure in heterosexual couple-parented households. A substantial 82.8% of donor-conceived individuals expressed a keen interest in obtaining non-personally identifiable donor information, while 69% were curious about personally identifiable donor data. Furthermore, 61.6% conveyed a desire for personal contact with their donors, and 26.6% advocated for the inclusion of the donor’s name on their birth certificates. Participants raised in lesbian two-parent families exhibited the lowest level of interest in donor-related information compared with those raised in other family structures. An overwhelming 90.1% wondered about the possibility of having half-siblings from the same sperm donor. The analysis of survey responses on DNA database registration revealed that 55.2% of donor-conceived offspring were already registered, with 68.8% discovering the same donor offspring and 30.4% successfully locating their donors. Compared to individuals from other family structures, those raised in heterosexual couple-parented households exhibit a less positive attitude toward their conception through anonymous sperm donation. About 61.6% of donor-conceived individuals reported experiencing distinct emotions compared to their peers, while 44.1% encountered psychological difficulties related to anonymous sperm donation, primarily attributed to late disclosure. The majority supported the idea of informing the donor about the number of children whose conception he facilitated. Lastly, the study highlighted that 21.2% of donor-conceived adults considered becoming donors themselves, and 31.3% expressed willingness to use an anonymous donor whenever faced with fertility challenges.”[6]
Giving a DNA sample is not without risk, so many companies performing this service assure consumers that their privacy is protected. Children may be endangered as well, especially if the check of the age of majority of the people providing a DNA sample is not performed properly. Considering the above survey, which showed that the average age of disclosure was 16.5 years of age, that should be taken seriously.
Children finding out the information following a DNA test may lack psychological assistance for themselves and their families, and there are no rules of contact between the donor and the child.
Considering that the right of the person that provides a DNA sample entails further issues, such as the right to privacy, MediPlus, a part the National Institute of Health (NIH), includes warning on their web page “How do direct-to-consumer genetic testing companies protect their customers’ privacy?”. MediPlus emphasizes that a customer should consider the following questions:
– What does the company do with a sample once it has completed the analysis?
– Will the sample be stored, shared, sold, or destroyed?
– Once you take the test, who owns the genetic data?
– How does the company safeguard genetic data and other personal information that you provide? Is it stored in a database that is protected from unauthorized access? What happens if the database is hacked or otherwise compromised?
- Can a customer delete his/her results from the company’s database if they wish?
- Does the company use information for internal research, advertising, or other secondary purposes?
- Will the company share your genetic data or sell it to pharmaceutical or biotechnology companies, academic institutions, or nonprofit organizations? If so, will the shared data include other information that could identify a customer (such as their name or date of birth)? For what purposes will the data be used? Will a customer be informed when data are shared or sold?
- If a customer does not want genetic data shared, sold, or used for research, can they opt out? What happens if a customer agrees to share his information but wants to opt out later?
- Will a customer be notified if the company changes its privacy policies?
- What would happen to the customer’s sample and genetic information if the company is sold or goes out of business?[7]
The donor’s right to privacy in the Council of Europe is protected by, as a soft law, Recommendation CoE 2156 (2019): Anonymous donation of sperm and oocytes: balancing the rights of parents, donors and children, which states that “the anonymity of gamete donors should not be lifted retrospectively where anonymity was promised at the time of the donation, except for medical reasons or where the donor has consented to the lifting of the anonymity and thus inclusion on the donor and donor-conceived person register. Donors should be offered guidance and counselling before they decide whether or not to agree to the lifting of anonymity” (Chapter 7.4).
Consumer DNA databases might help, in a way, to ensure the right to identity and personal development, the right to access information that would make it possible to trace one’s roots, to know the circumstances of one’s birth, and to have access to the certainty of parental filiation. But at the same time, their use is not regulated precisely enough. Nevertheless, they put pressure on the states that still maintain the principle of the gamete donor anonymity. Even in these legal systems the anonymity might be overridden, so it is important for the sake of keeping the family of a donor’s conceived child together, that parents are honest with the child about his/her origin.
[1] Help Me Understand Genetics, Direct-to-Consumer Genetic Testing, MedlinePlus [Internet]. Bethesda (MD): National Library of Medicine (US), https://medlineplus.gov/genetics/understanding/dtcgenetictesting/directtoconsumer/, accessed 9. 12. 2024.
[2] Regaldo, Antonio, More than 26 million people have taken an at-home ancestry test, February 11, 2019, online, https://www.technologyreview.com/2019/02/11/103446/more-than-26-million-people-have-taken-an-at-home-ancestry-test/, accessed 9. 12. 2024.
[3] Indekeu, A., Prinsen, C. F. M., & Maas, A. J. B. M. (2023). Lessons from 10 years’ experience running the Fiom KID-DNA database, a voluntary DNA-linking register for donor-conceived people and donors in The Netherlands. Human fertility (Cambridge, England), 26(5), 1164–1172. https://doi.org/10.1080/14647273.2022.2144772
[4] Ibid.
[5] Hertz, R., Nelson, M. K., & Kramer, W. (2013). Donor conceived offspring conceive of the donor: the relevance of age, awareness, and family form. Social science & medicine (1982), 86, 52–65. https://doi.org/10.1016/j.socscimed.2013.03.001
[6] Casteels, P., Nekkebroeck, J., & Tournaye, H. (2024). Perspectives on sperm donor anonymity: insights from donor-conceived adults in Belgium. Human reproduction (Oxford, England), 39(9), 2021–2031. https://doi.org/10.1093/humrep/deae160
[7] How do direct-to-consumer genetic testing companies protect their customers’ privacy? MedlinePlus [Internet]. Bethesda (MD): National Library of Medicine (US),
https://medlineplus.gov/genetics/understanding/dtcgenetictesting/dtcprivacy, accessed 10. 12. 2024.
