- Court Blocks EPIC's Efforts to Obtain "Predictive Analytics Report": A federal court in the District of Columbia has blocked EPIC's efforts to obtain a secret "Predictive Analytics Report" in a FOIA case against the Department of Justice. The court sided with the agency which had withheld the report and claimed the "Presidential communications privilege." Neither the Supreme Court nor the D.C. Circuit has never permitted a federal agency to invoke that privilege. EPIC sued the agency in 2017 to obtain records about "risk assessment" tools in the criminal justice system. These techniques are used to set bail, determine criminal sentences, and even contribute to determinations about guilt or innocence. Many criminal justice experts oppose their use. EPIC has pursued several FOIA cases to promote "algorithmic transparency," passenger risk assessment, "future crime" prediction, and proprietary forensic analysis. The case is EPIC v. DOJ (Aug. 14, 2018 D.D.C.). EPIC is considering an appeal. (Aug. 16, 2018)
- EPIC To Congress: Require Transparency for Use of AI: In advance of a hearing on "Artificial Intelligence - With Great Power Comes Great Responsibility," EPIC told the House Science Committee that Congress must implement oversight mechanisms for the use of AI. EPIC said that Congress should require algorithmic transparency, particularly for government systems that involve the processing of personal data. EPIC said that Congress should amend the E-Government Act to require disclosure of the "logic" of algorithms that profile individuals. EPIC also said that the White House Select Committee on Artificial Intelligence should be open to public comment. EPIC has pursued several criminal justice FOIA cases, and FTC consumer complaints to promote transparency and accountability. In 2015, EPIC launched an international campaign for Algorithmic Transparency. (Jun. 25, 2018) More top news »
Genetic information about any organism is contained in the organism’s DNA (deoxyribonucleic acid) molecules. DNA is contained in all of the organism’s cells except mature red blood cells. Every cell has two pairs of chromosomes, composed of DNA, except gamete cells (sperm and egg), which have only one set. DNA provides exact instructions for the creation and functioning of the organism. DNA molecules of all organisms contain the same basic physical and chemical components, arranged in different sequences. The genome is an organism’s complete set of DNA.
What is DNA and how can it be used?
The current estimate is that humans have 24,000 genes. About 99.9 percent of the genome is the same in all humans. The arrangement of the remaining components is unique to most individuals. Only identical twins (or triplets, etc.) have identical DNA. Variations in DNA influence how individuals respond to disease, environmental factors such as bacteria, viruses, toxins, chemicals, and to drugs and other therapies. The interaction between genes and environmental factors is not well understood at this time and is the subject of intensive research.
Any properly stored tissue sample can be the source of DNA. ”Handbook of Human Tissue Sources”, published by RAND, estimated that in 1999 there were more than 307 million tissue specimens stored in the United States, and that the number was growing by 20 million per year. These specimens are collected and stored for research, medical treatment, law enforcement, military indentification, blood and tissue banking, fertility treatments and, increasingly, commercial purposes. However, not all tissue collections can be classified as DNA databanks. DNA databanks are composed of a set of tissue specimens, digital DNA profiles, stored in a computer database, and some form of linking between each specimen and the DNA profile derived from it. DNA databanks used in medical and research applications also include links to medical records and family history of individuals whose DNA is stored. Blood and tissue specimens can be preserved indefinitely, and DNA from these specimens can be tested multiple times.
Genetic data poses significant privacy issues because it can serve as an identifier and can also convey sensitive personal information about the individual and his or her family. As genetic science develops, genetic information provides a growing amount of information about diseases, traits, and predispositions. At the same time, smaller and smaller tissue samples are required for testing. In some cases tests can be performed with as little as the root of a single hair or saliva left on a glass from which an individual drank. The ability to derive more information from less and less material creates increasing challenges to privacy because it permits analysis of tiny traces that all humans leave behind unconsciously, such as cells left on computer keys or saliva left on a drinking glass.
The ability of genetic information to provide both identification and sensitive information related to health and other predisposition has led to a lively debate about appropriate privacy protections. Proponents of “genetic exceptionalism” claim that genetic information deserves explicit and stricter protection under the law. They base their argument on the special qualities of genetic material:
- Ubiquity, i.e., the ability to derive genetic profiles from small physical traces and the longevity of material from which genetic profiles can be derived
- Ability to reveal information not just about the individual but also about the individual’s family
- Predictive nature that can point to someone’s future health and traits
Opponents of “genetic exceptionalism” take the position that genetic information is much like other personal information and should be protected in the same way. They point to the fact that “genetic information” is difficult to define because it includes information like family medical history, which has been collected and used by doctors long before the sequencing of the genome. Therefore, they emphasize the importance of context in which genetic information is obtained and used. For example, if genetic information is obtained as part of health care research or treatment, it should be subject to the same privacy and anti-discrimination protections as all other health information.
The Genetic Information Nondiscrimination Act of 2008 protects individuals from genetic discrimination in health insurance and employment. The genetic information protected by the law includes family health history, the results of genetic tests, the use of genetic counseling and other genetic services, and participation in genetic research. In addition, protection of medical information under the Privacy Rule of the Health Insurance Portability and Accountability Act (HIPAA) provides protection for genetic information that falls within the HIPAA definition of “protected health information.” The Americans With Disabilities Act has been interpreted by the Equal Employment Opportunities Commission to include people with genetic predisposition. The Privacy Act of 1974 also protects genetic information in the same way as all other personal information that falls under the Act’s protection. States also provide protection against genetic discrimination: 48 states and the District of Columbia have passed laws preventing genetic discrimination in health insurance providers and 35 states and the District of Columbia prevent genetic discrimination in employment.
Use of DNA for Law Enforcement Identification
The Development of CODIS and Other Law Enforcement DNA Databases
The FBI maintains a national DNA database known as the Combined DNA Indexing System ("CODIS"). The pilot program for what became CODIS started with fourteen state and local laboratories. Today, there are over 190 public law enforcement laboratories. Additionally, all fifty states, Puerto Rico, the District of Columbia, the federal government, and the U.S. Army Criminal Investigation Laboratory participate in the CODIS program.
CODIS consists of three hierarchical tiers--local, state, and national--which operate in tandem as a nationally distributed database. The National DNA Index System ("NDIS") is the highest tier and makes it possible for all laboratories participating in CODIS to access and compare DNA profiles from across the country. NDIS contains the DNA profiles contributed by state, federal, and local participating forensic laboratories. The second tier is the State DNA Index System ("SDIS"). The third tier is the Local DNA Index System ("LDIS"), where DNA profiles are entered into the system by participating forensic labs throughout the country. The tiered nature of the system enables each state and local agency to operate its DNA database in compliance with state and local laws.
The FBI Laboratory's CODIS program allows federal, state, and local crime laboratories to store, search, and share DNA profiles electronically. NDIS accepts DNA data generated through PCR Stort Tandem Repeat ("STR") technology, Y chromosome STR technology, and Mitochondrial DNA technology. STR technology is used to evaluate thirteen specific regions, known as loci or markers, within DNA located in a cell's nucleus.
The Expansion of DNA Collection
As of March 2016, the NDIS contains over 12,253,681 offender DNA profiles, 2,292,478 arrestee profiles, and 690,220 forensic profiles. The number of profiles has grown rapidly from 460,365 total profiles in 2000. Originally DNA collection and profiling was only mandated for individuals convicted of a small group of Federal offenses. Congress increased mandatory collection for "qualifying offenses" in the DNA Analysis and Backlog Elimination Act of 2000 ("2000 DNA Act"), made it a misdemeanor to fail to cooperate with collection, and authorized the use of force to collect the sample, if necessary. The category of "qualifying offenses" was expanded after 9/11 in the USA Patriot Act of 2001, Pub.L. 107-56, 115 Stat. 272 (October 26, 2001). In 2004, Congress again expanded the category of qualifying offenses to include "any felony" and "any crime of violence." Justice for All Act of 2004, Pub.L. 108-405, 118 Stat. 2260 (October 30, 2004).
The collection of DNA samples from such broad categories of convicted offenders was not sufficient, and in 2006 Congress authorized the Attorney General to promulgate regulations for the collection of DNA samples from all persons arrested under federal authority. Violence Against Women and Department of Justice Reauthorization Act of 2005, Pub.L. 109-162, 119 Stat. 2960 (January 5, 2006). Congress also authorized the Attorney General to collect samples from all persons "facing charges," in addition to those "arrested" under federal authority. Adam Walsh Child Protection and Safety Act of 2006, Pub.L. 109-248, 120 Stat. 587 (July 27, 2006).
DNA Collection and the Fourth Amendment Generally
The Fourth Amendment ensures that "[t]he right of the people to be secure in their persons, houses, papers, and effects, against unreasonable searches and seizures, shall not be violated, and no Warrants shall issue, but upon probable cause, supported by Oath or affirmation, and particularly describing the place to be searched, and the persons or things to be seized." Kentucky v. King, 563 U.S. ___, ___, 131 S. Ct. 1849, 1856 (2011), quoting U.S. Const. Amend. IV. This Amendment was intended to protect the "sanctity of a man's home and the privacies of life," Boyd v. United States, 116 U.S. 616, 630 (1886), from searches under unchecked general authority.
The Supreme Court made clear in Schmerber v. California, 384 U.S. 757 (1966), that taking blood for alcohol testing constitutes a Fourth Amendment "search" and "seizure." Thus it is undisputed that DNA collection, whether by buccal swab or blood test, also constitutes a "search" under the Fourth Amendment. See United States v. Kincade, 379 F.3d 813, 821 (9th Cir. 2004) (en banc). Therefore when mandatory DNA collection occurs without a warrant, courts must determine whether the search is an unreasonable search under the Fourth Amendment. See Haskell v. Harris, 669 F.3d 1049, 1053 (9th Cir. 2012). In the context of searches of parolees or convicted offenders, the Supreme Court has applied a "totality of the circumstances" balancing test to determine whether a warrantless search is reasonable. See Samson v. California, 547 U.S. 843, 848 (2006) (whether mandatory search as a condition of parole violates the Fourth Amendment); United States v. Kriesel, 508 F.3d 941, 946-47 (9th Cir. 2007) (mandatory DNA collection from convicted federal felons).
In a historical line of cases involving suspicion-based searches of convicted offenders, the Supreme Court has balanced the (diminished) Fourth Amendment interests of the parolees against the states interest in rehabilitation, reintegration, and recidivism. See Samson v. California, 547 U.S. 843, 848 (2006); United States v. Knights, 534 U.S. 112, 122 (2001). This same test has been applied to the collection of DNA samples from convicted felons. See Hamilton v. Brown, 630 F.3d 889 (9th Cir. 2011); United States v. Kriesel, 508 F.3d 941 (9th Cir. 2007); United States v. Kincade, 379 F.3d 813 (9th Cir. 2004); Rise v. Oregon, 59 F.3d 1556 (9th Cir. 1995). However, it is unclear whether the same test should apply to the warrantless, suspicionless collection of DNA from a person who is not a convicted felon. United States v. Shavlovsky, No. 11-427, 2012 WL 652672 at 4 (Feb. 24, 2012). See Haskell v. Harris, 669 F.3d 1049, 1076 (9th Cir. 2012) (Fletcher, J., dissenting); United States v. Mitchell, 652 F.3d 387, 428-29 (3d Cir. 2011). But see Friedman v. Boucher, 580 F.3d 847, 862 (9th Cir. 2009) (invalidating the warrantles, forcible extraction of a DNA sample from a pre-trial detainee under the "totality of the circmstances" test).
Challenges to Mandatory DNA Collection from Convicted Offenders
Since the passage of the DNA Act in 2000 there have been a number of challenges to the warrantless collection of DNA samples from parolees and other convicted offenders. See, e.g., United States v. Stewart, 532 F.3d 32, 36-37 (1st Cir.2008); United States v. Kriesel, 508 F.3d 941, 950 (9th Cir.2007); United States v. Weikert, 504 F.3d 1, 15 (1st Cir. 2007); Banks v. United States, 490 F.3d 1178, 1193 (10th Cir. 2007); United States v. Amerson, 483 F.3d 73, 75 (2d Cir.2007); United States v. Hook, 471 F.3d 766, 773 (7th Cir. 2006); United States v. Conley, 453 F.3d 674, 679-81 (6th Cir. 2006); United States v. Kraklio, 451 F.3d 922, 924-25 (8th Cir. 2006); Johnson v. Quander, 440 F.3d 489, 497 (D.C.Cir. 2006); Nicholas v. Goord, 430 F.3d 652, 655 (2d Cir. 2005); United States v. Sczubelek, 402 F.3d 175, 177 (3d Cir. 2007); United States v. Kincade, 379 F.3d 813, 839 (9th Cir. 2004). Recently, in Boroian v. Mueller, 616 F.3d 60 (1st Cir. 2010), the First Circuit addressed the issue of whether the Government's retention of a former probationer's DNA profile in CODIS implicated the Fourth Amendment. The Court of Appeals held that the “FBI's retention and periodic matching of [the offender's DNA profile] against other profiles in CODIS for the purpose of identification” did not constitute an “intrusion on the offender's legitimate expectation of privacy and thus [did] not constitute a separate Fourth Amendment search.” 616 F.3d at 68.
The New Regime: Mandatory Collection of DNA Samples from Felony Arrestees and Detainees
Maryland v. King
In Maryland v. King, the U.S. Supreme Court considered the constitutionality of mandatory DNA collection pre-conviction. Alonzo King was arrested in Maryland for assault in April 2009. At the time of his arrest, pursuant to the Maryland DNA Collection Act, police collected a DNA sample from him using a cheek swab. The Act requires law enforcement to collect DNA samples from all individuals arrested for violent crimes. This sample was processed and profiled, then entered into a law enforcement database and compared to DNA profiles from unsolved "cold" cases. King's DNA matched a sample gathered from an unsolved sexual assault in 2003.
With a "hit" from the DNA database as the sole piece of probable cause against King, a grand jury indicted him on ten charges, including rape. The police obtained a search warrant to collect a second DNA sample, via buccal swab, from King to investigate these new charges. The second buccal swab also matched the DNA sample taken from the sexual assault. This new evidence ultimately led to King being convicted of rape and sentenced to life without parole.
In a 5-4 opinion authored by Justice Kennedy, the Supreme Court ruled that suspicionless collection of the DNA of those arrested for a serious crime did not violate the Fourth Amendment. The reasonableness of a search is determined by weighing the government’s interest in collection with the degree to which the search intrudes on privacy. The Court found that although swabbing an arrestee's cheek for DNA collection did constitute a search, the minimal physical invasiveness of the collection technique was important in evaluating the reasonableness of the search. Additionally, arrestees enjoy a diminished expectation of privacy. Kennedy found that the government's interest in identifying arrestees, including discovering one’s criminal history, weighed strongly in favor of collecting DNA samples, as this is a highly effective form of identification. The Court analogized to police practices of taking photographs or collecting fingerprints of arrestees, finding that the DNA collection merely served the same function more effectively. Ultimately, the Court weighed what it characterized as a minimal physical intrusion against the potential of DNA to provide law enforcement with valuable information about arrestees, concluding that DNA collection was a reasonable Fourth Amendment search.
Justice Scalia's four-Justice dissent argued that the Fourth Amendment categorically forbids suspicionless searches justified only by the government's interest in detecting crime. Scalia challenged the majority's assertion that the government’s interest in collection was identification of arrestees, arguing instead that the DNA collection was meant to detect crimes. Such a purpose made the search the type of indiscriminate, general search that the Fourth Amendment was meant to protect against.
Friedman v. Boucher
The United States Court of Appeals for the Ninth Circuit first considered the constitutionality of a warrantless, suspicionless, forcible extraction of a DNA sample from a pre-trial detainee in Friedman v. Boucher, 580 F.3d 847 (9th Cir. 2009). The Plaintiff Friedman was a resident of Las Vegas, Nevada incarcerated in Clark County Jail as a pre-trial detainee pending prosecution. Id. at 851. He had previously pled guilty to an unrelated sexual crime in Montana in 1980 and completed his sentence in 2001. Id. He was no longer a parolee, probationer, or otherwise under state supervision when he was arrested in Nevada in 2003. Id. A Nevada detective asked Friedman to provide a DNA sample, without a warant, court order, or individualized suspicion, and Friedman refused. Id. After obtaining authorization from the Deputy District Attorney, the detective forced Friedman's jaw open and took a buccal swab. Id. The District Attorney confirmed that the purpose of the search was to aid in the investigation of cold cases. Id. Friedman filed suit in federal court on March 10, 2004, alleging that the detective had violated his Fourth Amendment rights. Id. at 852.
The court noted that the collection of a DNA sample was a Fourth Amendment search, and that "[a] warrantless search is unconstitutional unless the government demonstrates that it 'fall[s] within certain established and well-defined exceptions to the warrant clause.'" Id. at 853 (citing United States v. Brown, 563 F.3d 410, 414-15 (9th Cir. 2009). The court rejected the Government's arguments that (1) the "special needs" exception applied, (2) a Montana statute authorized the search, and that (3) the search was "reasonable" under the circumstances. Id. The court stressed that only "important non-law enforcement purposes" can justify the special needs exception. Id. Gathering DNA samples for the purpose of solving cold cases was clearly a "law enforcement purpose." The court rejected the extraterritorial application of a Montana statute on several grounds. Id. at 854-56. The court also rejected the Government's argument that the search was "reasonable" due to the limited privacy rights of pre-trial detainees. Id. at 856-57. The court stressed that "neither the Supreme Court nor [the 9th Circuit] has ever ruled that law enforcement officers may conduct suspicionless searches of pretrial detainees for reasons other than prison security." Id. Ultimately, the court ruled that "[t]he warrantless, suspicionless, forcible extraction of a DNA sample from a private citizen violates the Fourth Amendment." Id. at 858.
United States v. Shavlovsky (and Tuzman)
The most recent DNA Act case to reach the Ninth Circuit is United States v. Shavlovsky, No. 11-427, 2011 WL 5513447 (E.D. Cal. Nov. 10, 2011). Defendant Tuzman was indicted for a mortgage fraud and voluntarily surrendered to the U.S. Marshals Service around September 30, 2011. Id. at 1. An Attorney General regulation, 28 C.F.R. § 28.12(b), promulgated in 2008 pursuant to the DNA Act, 42 U.S.C. § 14135a(a)(1)(A), required the Marshals Service to take Tuzman's DNA sample while it had him in custody. Id. Tuzman was on his way to be arraigned by a Magistrate Judge when his DNA sample was taken without a warrant, and he was later released on an "unsecured appearance bond." Id. at 8, 7. Tuzman moved for the return of his DNA sample pursuant to Fed. R. Crim. P. 41(g) and United States v. Comprehensive Drug Testing, Inc., 621 F.3d 1162 (9th Cir. 2010) (en banc) (per curiam), "arguing that it was taken pursuant to an unlawful search and seizure." Id. at 1.
The District Court drafted an opinion and order granting Tuzman's motion and holding that the "compelled, warrantless, suspicionless taking of DNA from Tuzman's body, based solely upon the mandate of the Attorney General's regulation violated Tuzman's Fourth Amendment rights." Id. However, the day before the court's opinion was published, the Ninth Circuit issued its opinion in Haskell v. Harris, 669 F.3d 1049 (9th Cir. 2012), and so the District Court ordered that Tuzman's motion be denied (but attached its drafted opinion). Tuzman appealed the denial of this motion under 18 U.S.C. § 1291 (collateral oder doctrine), and the case is currently being briefed.
EPIC has a longstanding interest in personal privacy, limiting the government's collection of personal information, and restricting the collection of genetic material. EPIC has filed several amicus briefs challenging DNA collection practices. In Maryland v. King, EPIC filed an amicus brief arguing that law enforcement's warrantless collection of DNA was unconstitutional. In 2004, EPIC filed an amicus brief in Maryland v. Raines, a precurser to Maryland v. King involving an incarcerated felon who was forced to submit to a DNA test. EPIC argued that the DNA Collection Act violated both the Fourth Amendment and Article 26 of the Maryland Declaration of Rights, Maryland's state constitutional equivalent. In Kincade, 379 F.3d 813, EPIC filed an amicus brief urging the Ninth Circuit to rule that a section of the DNA Analysis Backlog Elimination Act of 2000, 42 U.S.C. § 14135a, violates the Fourth Amendment by requiring the compulsory collection of DNA samples from parolees.
Now the DNA act regime applies not only to convicted offenders and parolees but also to certain arrestees. EPIC is particularly concerned about the continued expansion of DNA collection from increasingly larger populations; the CODIS database, which once contained only DNA profiles of sex offenders, has now been expanded to apply to mere arrestees. Furthermore, access to CODIS is not strictly limited, as all law enforcement agencies in the country, at the federal, state, and local levels, have access to CODIS for purposes of DNA matching. As CODIS expands, individual privacy rights are implicated, and not just for the individual whose DNA is added to the database; the ability to search for partial matches also implicates the privacy rights of family members whose DNA is a close enough match that the person is flagged in a CODIS DNA search.
EPIC is acutely concerned with evolving scientific knowledge and the way new scientific discoveries can further implicate privacy rights. Today's science shows that DNA reveals vastly more personal information than a fingerprint. The DNA markers utilized by CODIS are not "junk;" instead, these non-coding DNA segments can identify an individual's race, ethnicity, and heritage. Given that there is no statutory requirement for the government to discard the full DNA sample from which the DNA profile is obtained, the government indefinitely remains in possession of a person's full genetic makeup. As science reveals new ways in which DNA may be used, the potential for misuse by government entities increases the risk to individual privacy. Already, state governments have authorized law enforcement DNA samples to be used for non-law enforcement purposes, and EPIC has a vested interest in preventing such invasive uses.
Use of DNA for other forms of identification
Since the early 1990s, all personnel serving in the United States Armed Forces have been required to submit tissue samples to allow later DNA identification. The samples are stored at the Armed Forces Repository of Specimen Samples for the Identification of Remains. As of 2003, the United States military's DNA depository contains 3.8 million samples, including samples from active duty and reserve personnel. Civilian Department of Defense (DOD) employees and contractor personnel who accompany US forces on deployment may have their specimens included in the DOD DNA bank. DNA analysis of the specimens is not performed on demand. Retrieval and analysis is performed only when there is a requirement to identify human remains. Individuals have the right to request that their samples be destroyed when they conclude their relationship with the DOD (active duty, reserve duty and any other service).
The military’s DNA collection program has had its opponents. Two members of the United States Marine Corps were ordered to give DNA samples before being deployed to the Pacific in January 1995. They refused to do so and were charged with the violation of an order from a superior commissioned officer. The military court martial dismissed the charges, holding that the regulations underlying the DNA Repository program were not punitive and thus no disciplinary action could be taken for refusal to provide specimens. The two Marines sued the government in federal court, charging that the DNA collection program violates the Fourth Amendment protection against unreasonable searches and seizures. The district court found the DNA collection requirement to be valid. The court of appeals declared the case to be moot because by the time of the appeal the two Marines had been granted honorable discharges without ever having given samples of their DNA. Since that time two other members of the military have refused to give their DNA samples. One was sentenced by a court martial to 14 days hard labor and a two-grade reduction in rank. Another temporarily lost his rank and 40 percent of his pay, and was reassigned. He was later able to claim a narrow exception on religious grounds and was reinstated.
Paternity testing, fidelity confirmation and other uses of DNA identification
In the past few years there has been an emergence of DNA testing services and repositories created and controlled by the private sector. Companies are promising a variety of services, including individually tailored cosmetics, paternity testing, spousal fidelity confirmation, and genetic ancestry tracing. Some companies store samples for people in high-risk occupations, such as policemen and firemen, so that a loved one may have them identified after death, if needed.
Companies that collect and store genetic information promise confidentiality to their depositors. However, companies’ ability to change their privacy policies at any time raise significant concerns that genetic data can be misused, sold or stolen. Many of these companies use academic laboratories for genetic testing and abide by the same confidentiality standards that are mandated for those laboratories, but the companies themselves are not subject to oversight.
Because of the ubiquity of tissue samples from which genetic samples have been derived, there has been significant concern that samples can be taken and tested without individual knowledge or consent. Newspapers have published accounts of attempts by “genetic trophy hunters” to obtain tissue samples of famous people, such as Prince Harry of Britain. There have also been reports of surreptitious DNA testing in cases of disputed parentage or custody.
Using DNA for identification in uncontrolled circumstances raises complex issues and trade-offs that have not been examined and actively debated in the United States.
- Non-consensual testing: Since DNA profiles can be derived from cells all individuals leave behind in the process of living, it is possible to have genetic testing conducted without the knowledge or consent of the individual to whom the sample belongs. Many private genetic testing laboratories in the US do not question the source of the samples or request consent from individuals whose samples are submitted.
- Compromised family relationships: Many states consider a child to be a legitimate child of a marriage unless husband and wife were separated for a prolonged period during the time of the child’s conception. DNA testing that shows the child to be a product of an adulterous relationship can compromise the family and emotinally traumatize individuals involved.
- Privacy of sperm or egg donation; privacy of giving up a child for adoption: Many individuals donate sperm or eggs on the assumption that they will not be traced. Similarly, some young women give up their children for adoption on the assumption that they will have no future contact with the children. If DNA tests can link the donor to the child, the donor’s privacy is compromised in spite of his or her wishes to remain uninvolved in the child’s life. There are no easy trade-offs between the right of the child to know its biological parents and, possibly, the medical history of those parents, and the right of adults to give up a child or donate cells without having to be connected to the child in later life.
- Re-use of samples for other purposes: Companies have different policies with regard to preservation of specimens on which DNA testing had been conducted and of the resulting DNA profiles. Some companies destroy the specimens and the data when testing is completed and results reported to the requestor. Other companies preserve specimens and DNA profiles unless they are specifically asked to destroy or return them. When samples and DNA profile information are preserved, it is possible that they may be used for purposes such as research for which no consent had been given at the outset. It is also possible that companies will use the data to recruit individuals to participate in various research projects if they are known to possess characteristics of interest to the researchers.
Use of DNA for detection and treatment of disease
Genetics holds out the promise for more personalized medicine. This promise is expressed in two ways. First, there is hope that links between genes and disease will allow physicians to assess the risk of illness more accurately and to provide better preventive and treatment alternatives. Second, understanding links between genes and medication response may result in more accurate prescribing, particularly in cases where more than one drug exists for the treatment of a condition. Pharmacogenetics, or the study of links between a genetic profile and reactions to specific medications, is an important field of genetic research.
Links between genes and disease are not simple. Both genetic and environmental factors play a role in the development of disease. Some diseases are a result of a variation in a single gene. Single-gene disorders include cystic fibrosis, sickle cell anemia, Huntington’s disease, and hereditary hemochromatosis. Multifactorial or complex disorders are a result of a combination of mutations in two or more genes and environmental factors such as diet, lifestyle or exposure to specific chemicals or other environmental factors. These multifactorial disorders include heart disease, high blood pressure, Alzheimer’s disease, arthritis, diabetes, cancer, and obesity. Some genetic disorders, such as Down syndrome, are caused by abnormalities in gene-carrying cell structures such as chromosomes or mitochondria. Some genetic mutations are not present at conception but acquired later in life. According to the Human Genome Project Web site on genetic testing, over 900 genetic tests are currently available to determine whether an individual has one of the genes linked to a single-gene disorder and the number of tests is rapidly growing.
For multifactorial disorders, the links between genes and disease are not well understood. Generally, it appears that genetic information may provide some indication of vulnerability, but it is not possible to say whether or not a specific individual will develop the disease, when disease might develop, or how severe it will become. For example, the Washington Post reported that in 2003 researchers identified a gene responsible for the development of depression after exposure to stress. People with a variation in that gene are more than twice as likely as people with the normal version of the gene to react to a traumatic event by becoming depressed. Nevertheless, 57 percent of people with the mutated gene never became depressed and 17 percent of people without the mutation developed depression in response to similar crises.
Some genetic mutations that are associated with disorders are also associated with increased chances of survival in some environmental contexts. For example, sickle cell anemia is caused by a mutation in the hemoglobin gene, and is common among individuals from Africa and the Mediterranean area. However, being a carrier for sickle cell anemia gives the individual protection against malaria because carriers have abnormal red blood cells that die soon after being infected with the malaria parasite. Thus, the mutation gives a survival advantage to individuals who live in areas where malaria is endemic.
At present, genetic testing for disease predisposition is only minimally regulated in the United States. Under the Clinical Laboratories Improvement Act, clinical diagnosis may be made only on the basis of a test result from a laboratory that has been certified to conduct a particular genetic test. However, laboratories are permitted to perform genetic tests without certification. A few states have established regulatory guidelines for genetic testing.
In addition to genetic tests available through health care professionals, there has been significant growth of genetic testing kits marketed directly to consumers. Some see the availability of home testing kits as a positive development, allowing individuals to perform genetic tests privately and to make a choice about whether to disclose results to anyone. However, there are questions about the scientific validity of some tests on the market. There are also concerns that in-home tests do not provide genetic counseling for the interpretation of results, as is usually the case with tests offered through the medical community. Without help, individuals may not properly interpret genetic test results or understand their treatment and prevention options because even highly educated individuals are not always skilled at understanding opportunities and risks presented in terms of likelihoods or probabilities.
Growing research on identifying genes related to specific diseases poses several privacy and civil rights issues.
- The right not to know: While genetic testing for predisposition to diseases has been advancing, treatment has often lagged behind. In some cases it is possible to determine a genetic predisposition, but no treatments or only radical preventive measures are available. Thus, some individuals are deciding that they do not wish to find out that they are genetically predisposed to a condition. In practice, this “right not to know” may be difficult to maintain. Some diseases, like breast cancer, are known to run in families, so women may suspect their predisposition without formal genetic testing. In other cases, one family member may decide to test himself and reveal the result to the family, disclosing other family members’ predisposition by implication. It is not always possible to resolve the conflict between one individual’s right to know and another individual’s right not to know about a genetic predisposition.
- Discrimination in health insurance: The lack of clear connection between genetic make-up and disease has raised concerns about discrimination in health insurance in the United States. Health insurers claim that good business practices require them to charge higher rates or limit available insurance to people at higher risk of developing diseases, and that all known risk factors should be considered in the risk rating. In some cases, health insurers have treated genetic predisposition as a pre-existing condition and have denied or limited coverage on that basis. Opponents of such discrimination cite the tenuous connection between genetic predisposition and development of disease, the fact that many diseases can be treated, controlled or prevented through lifestyle changes and medical interventions, and the fact that health insurance is supposed to provide ill people with the means to pay for medical care. Some states have passed anti-discrimination laws applicable to health insurance. This type of discrimination is not an issue in countries that have national health care systems with universal coverage.
- Discrimination in life insurance: Life insurance applications generally require individuals to disclose information about themselves, their health and their lifestyles as a condition of obtaining coverage. Some life insurers have asked individuals to take genetic tests in order to determine whether they are predisposed to diseases that could make them greater risks. Genetic testing for life insurance was a subject of a Parliamentary hearing in the UK. Because of the uncertain connection between genetic predisposition and the eventual development of disease in any specific individual, life insurers agreed to a voluntary five-year moratorium on genetic testing with the exception of the test for Huntington’s Disease on policies that would pay out more than 500,000 Pounds.
- Discrimination in employment: The growth of genetic testing to determine predisposition to disease has given rise to concerns about discrimination in employment. Employers have strong economic incentives to hire and retain workers who are likely to remain healthy in the belief that such workers would exhibit less absenteeism. In the United States, where employers contribute a significant portion of the cost for employees’ health and life insurance, healthier employees are also favored because they incur lower health care and life insurance costs. In addition to testing for general predisposition toward disease, some employers have tested potential employees for genetic characteristics that would increase employees’ risk if they are exposed to certain environmental conditions during work. Employers have also claimed that if individuals with certain genetic predispositions are hired into positions that involve public safety, they may pose a threat to the public, and some courts have accepted that this may be a valid reason for limiting someone’s employment opportunities. The ability of employers to discriminate on the basis of genetic information has been held to be inappropriate in the US because the current state of knowledge does not allow a significantly strong link between genetic make-up and ability to perform a job or potential for developing illness. Some states have passed laws that prohibit employment discrimination on the basis of genetic information. President Clinton signed an executive order prohibiting genetics-related employment discrimination in the federal workforce.
- Involuntary disclosure of a condition: Increasing marketing of take-home DNA kits raises the risk that some people may be tested without their knowledge or consent. Discarded objects that contain DNA may be used by other members of the household or by outsiders for testing, violating an individual’s privacy even if done with the best intentions.
Pre-implantation testing and testing of newborns
Genetic testing can take place at almost any stage of human development. Couples that have babies through in vitro fertilization (IVF) can test embryos before they are implanted in a woman’s uterus. Babies can be tested in the womb by withdrawing small samples of their tissues. For many years newborns have been routinely tested for some diseases, although testing until recently has generally not involved DNA analysis.
Pre-implantation testing of embryos has grown with the increasing use of IVF technology. The DNA of an eight-cell human embryo can be examined for genetic traits and abnormalities, allowing prospective parents to determine which embryos they wish to implant. Physicians involved with IVF see this as a positive development, permitting an increasing number of healthy births. They generally focus on the ability of people who carry a gene for a known disorder to choose an embryo that is free of that disorder. Some opponents of abortion even see pre-implantation testing as a way to make “choice” about a pregnancy before the pregnancy begins. However, the ability to “customize” babies causes concerns among ethicists, as they envision a future in which embryos are selected not only to minimize potential illness but to enhance competitive advantage and social status through traits such as height, eye color, musical talent, athletic ability or intelligence. Austria, Germany, Ireland and Switzerland have outlawed pre-implantation genetic testing on ethical grounds. France, Belgium, the Netherlands and United Kingdom have placed restrictions on the use of pre-implantation genetic testing.
Newborns of industrialized countries have been screened for many years to determine whether they have inborn errors of metabolism and some other genetic conditions. The newborn screening cards, generally known as Guthrie cards, contain blood samples and represent a large collection of specimens from which DNA can be derived. In addition, they contain personal information such as the mother’s name and address, hospital of birth, baby’s medical records number, and the name and address of the baby’s doctor. Different laboratories store Guthrie cards under different conditions and for different lengths of time. There is no general agreement about how long the cards should be kept. Some laboratories discard their cards after several weeks or months, when the cards are no longer necessary for quality control and similar purposes. Others keep Guthrie cards for years, enabling them to use the cards to help in investigation of babies’ deaths. In the UK, the Human Genetics Commission is working on a report that considers creating and storing genetic profiles of all newborns for future use in individualized medical treatment.
Although some laboratories have been keeping the cards for longer periods, others have discarded cards because of concern that the cards might be misused. There has been at least one case in which law enforcement officials have attempted to gain access to Guthrie cards as a source of DNA. When Guthrie cards were requested from a laboratory in Australia, laboratory officials destroyed the cards rather than provide access because such use of baby DNA was clearly not envisioned by the parents when they agreed to testing. There has been concern in the medical community that unless Guthrie cards are protected from re-use, parents will be reluctant to have their babies tested.
Genetic testing of embryos and newborns raises privacy issues.
- The right to privacy in family relationships: Scholars have recognized that privacy includes the right to maintain certain relationships confidential. If newborn screening were to include DNA testing and if test results are not kept confidential, others outside the family could learn about the genetic predispositions of the parents as well as the children.
- Re-use of samples for unauthorized purposes: When parents agree to have a fetus or a newborn tested for disease, they do not think about the possible use of the DNA in the sample for research or law enforcement purposes. Use of DNA for other than original purpose may violate individual privacy unless it is consistent with good information practices, including informed consent.
DNA and behavior
One of the more controversial areas of genetics research is the linking of genes and behavior. Researchers have made claims that genes influence such traits as alcoholism, homosexuality, thrill seeking, nurturing, and tendencies towards violent criminal behavior. These claims are based on indications that some behaviors are species-specific, can persist from generation to generation, and can change as a result of brain injury or other biological alteration. However, most human behaviors are complex and result from a life-long interaction between the genes and the environment. Certain genes are expressed only after an environmental trigger turns them “on.” An individual’s environment can also determine the extent to which behavioral predispositions are expressed. A recent review of genetic research by the Nuffield Council on Bioethics in the UK found that very little is known about the links between genes and human behavior.
Behavioral genetics involves several scientific difficulties. First, it is often difficult to define some behavioral traits. Intelligence is an excellent example of this, with many controversies that have arisen over the years. Second, even if a trait can be defined, it is not clear how to measure it or what constitutes the expression of the trait. For example, do people who like to ride roller-coasters engage in the same type or extent of thrill-seeking behavior as people who jump out of airplanes, and how can “thrill-seeking” be measured? Third, behavioral traits are often culturally defined. An individual who might be considered lazy in a culture that places primary value on work productivity may be considered a workaholic in a culture that values leisure and non-work-related pursuits. Finally, it is extremely difficult to determine the precise extent to which various genetic and environmental factors determine behavior.
Attempts to link genetics and behavior raise privacy and civil rights issues.
- Different treatment of individuals on the basis of genetic predisposition: If genetic links are presumed between specific genes and behavior, individuals who possess these genes may be singled out for different treatment even if they do not exhibit the behavior. For example, it is possible that someone who is found to have a predisposition to violence might receive a harsher criminal sentence for a non-violent offence because of a presumption that he poses a danger to society due to his genetic make-up.
- Discrimination in employment: Employers have claimed that they should be able to exercise some control or influence over employee behavior outside work. For example, many employers perform drug tests on employees and reserve the right to fire those who use drugs outside work hours, whether or not the amount of drugs present in the employee’s system during working hours may not be sufficient to influence on-the-job behavior. Genetic links to behaviors that employers might consider costly or undesirable can lead to discrimination against individuals who possess specific genes, whether or not these genes affect the employees’ ability to behave appropriately on or off the job.
Use of DNA for research
Finding connections between genes, lifestyle and disease requires databases that link the physical tissue sample (e.g., blood or saliva) with the DNA analysis of the sample and the medical and personal history of the individual. The links have to be maintained over time, particularly in cases where researchers are looking to track disease development. The need to maintain links between individual identity and highly personal, sensitive information in an easily searchable database creates privacy concerns. These concerns are amplified by the fact that it is not possible at present to envision all the research projects for which the collected genetic information will be useful, so the usual process of obtaining informed consent from participants may not always be meaningful.
Genetic research databases raise the following privacy concerns:
- Ability to assign individual characteristics through group membership: Whether or not individuals choose to participate in genetic research, they may be affected by the results of such research. For example, if research identifies an association between an illness and a particular ethnic group, all individuals within that group may be presumed to be affected, whether or not each of them had been tested. An individual’s privacy will, in effect, be violated simply through the existence of the link between the individual and the group.
- Lack of fully informed consent: Genetic science is now in its infancy. It is impossible to predict what projects will be done with the genetic data collected for research. Individuals may feel that they are unable to give fully informed consent because they may not wish to have their genetic material used for research projects which they find unacceptable.
- Benefiting from results of research: One of the inducements for participation in genetic research is the promise that the individual will benefit from therapeutics derived from the research. For example, Estonian physicians and consumers have cited the ability to get their own genetic profile and to take advantage of useful discoveries as an important reason for participation in the Estonian population database. This means that researchers must find a way of communicating research results to individuals who might benefit from them or to doctors who treat them. In some cases this may compromise an individual’s desire not to know about a particular genetic predisposition.
International genetic databases
Because links between genes and diseases or genes and behavior are statistical in nature, it is only possible to determine such links in a scientifically valid manner when a large number (potentially thousands) of people who exhibit a disease or a behavior are compared to a large number of “controls” who do not exhibit the trait. Statistical validity of the findings is further improved when unrelated variation is minimized by making comparisons on people who have common ancestry. This means that large national genetic databases are a highly desirable resource for genetic research. Several countries are developing such large databases, often in ways that seek to share risks and rewards with private sector companies.
In 1998, the government of Iceland passed the Act on Health Sector Database (HSD), which authorized the creation of a database that includes genetic information about the country’s entire population of 285,000 people. Because the population of Iceland has been relatively stable and isolated for over a thousand years, the database will be used to combine genetic, disease and genealogical data to identify genes linked to specific diseases, the proteins encoded by these genes, and drugs that can be used to treat the diseases.
The database, managed by a private company deCODE Genetics, includes genetic and medical information collected as part of Iceland’s national health system. The government of Iceland has the right to use the database for planning and policy purposes, but deCODE Genetics has an exclusive commercial license that gives it control over the database for 12 years. In exchange for commercial exclusivity, deCODE Genetics is obligated to provide the people of Iceland with free drugs and therapies that are developed as a result of research on the Icelandic population database.
At the start of the project, consent for the participation in the database was assumed to be implicit. The database was created from the available records and the project was initiated. After various groups, including the Iceland Medical Association, raised concerns about compulsory participation and possibly inadequate privacy safeguards, individuals were given the right to have their data excluded from the database by notifying their physicians. It has been reported that by June 2003 more than 20,000 Icelanders (more than 10 percent of the adult population) had opted out of the research plan. The Association of Icelanders for Ethics in Science and Medicine (Mannvernd) was formed to oppose HSD. The first lawsuit to test the validity of the Act was filed in 2001, with hearings still taking place in the beginning of 2003. As of the summer of 2003, deCODE Genetics is still redesigning database structures to improve privacy protection. At the same time, the company is publishing well-regarded research conducted on a separate database in which 80,000 Icelanders have chosen to participate.
The former Soviet state of Estonia is developing a population-wide genetic database. The database is expected to include samples from about one million of Estonia’s 1.4 million people. The database is being developed by the Estonian Genome Project Foundation, created by the government of Estonia within the jurisdiction of the Ministry of Social Affairs. The Foundation owns the database and is responsible for privacy protection of the participants. Research and commercialization of results will be carried out by Egeen International, a commercial company located in California and given the exclusive commercial license to the database. Egeen raised its first round of private financing in November 2002. Profits derived from the commercialization of results are to be shared between investors and the Estonian Genome Project Foundation. The main focus of the Estonian database is pharmaceutical research, starting with research that correlates genetic make-up, lifestyle and environmental factors with response to particular anti-depressant medications.
Unlike the Icelandic database, participation in the Estonian database has been voluntary from the start and based on explicit consent of the individual. Individuals have a right to access their data, can give permission to their physicians to obtain their information, and can request to be notified of any relevant tests or treatments developed from the database. Although there is no organized opposition to the project, concerns have been raised because physicians are being paid about five times their normal hourly rate to recruit patients for participation. This might provide inducement to physicians to present participation in a more favorable light than they would if they were not given heavy incentives.
The United Kingdom is working on assembling a large genetic research database. UK Biobank, a joint venture of the Medical Research Council, the Wellcome Trust and the Department of Health. UK Biobank plans to collect 500,000 samples from men and women, aged 45 to 69. Genetic information will be combined with environmental and lifestyle information in order to study interaction between genetic, environmental and lifestyle factors in disorders such as cancer, heart disease, diabetes and Alzheimer’s disease. UK Biobank plans to start recruiting participants in 2004.
The UK Biobank project has been controversial not only because its high cost is perceived as detracting from other worthwhile projects, but also because of privacy concerns as biotechnology and pharmaceutical companies access the data to create new diagnostics and therapies. UK Biobank’s founders responded to various criticisms by setting up an independent oversight body to monitor how data and results will be used. They have provided assurances that participating companies, insurers and employers will not be able to get individually identifiable information, and that police will be given information only if required by court order.
A large-scale Swedish biobank is managed by UmanGenomics, which was created in 1999 in order to commercialize the large population based Medical Biobank in Umee. Originally established by a group of scientists, the Biobank contains detailed medical information for the relatively homogenous population of Vesterbotten in Sweden. The Biobank contains DNA, plasma samples, and biochemical and lifestyle data from more than 66,000 individuals and is linked to high quality disease registries. It is regulated under the Swedish Act on Biobanks, which came into force on January 1, 2003.
Several other national databases and large research projects are being carried out.
Canada: Genome Quebec is a not-for-profit organization that is promoting genetic research on Quebec?s population. The funding is provided by the Canadian federal government, the Quebec Ministry of Research, Science and Technology and the private sector.
United States: Several large research projects are under way, including a project at Howard University that will use samples from 25,000 individuals to look for genetic factors in diseases that are disproportionately prevalent in people of African descent.
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