III. Ethical Issues

IV. Legal Issues

V. Conclusion

 

Introduction

Examples of Human Gene and Tissue Banks

Gene Banks in particular, are systems in which the genetic composition of some population is identified (Gene Bank, 2005). In the case of Human Biobanks, the material being stored and identified are genes and tissue specimens and the composite population is Human. Human Gene and Tissue Banks are not a new phenomenon.

In Scandinavian countries, the healthcare system has been collecting human tissues and blood for decades (Maschke, 2005). In the United States and Europe , Human Gene and Tissue Banks took off in 1990 with the Human Genome Project’s effort to compile a map of all human genes. (Gene Bank, 2005)

There are many examples of Human Gene and Tissue Banks, but at least three have been developed that use genetic samples along with clinical and personal data on a large scale. These three are; The North Cumbria Community Genetics Project, The U.K. Biobank, and The Icelandic Collection of Iceland’s Health Records (Maschke, 2005).

The North Cumbria Community Genetics Project is a British Biobank set up in the North Cumbria Community. This Biobank has a database that stores umbilical cord blood and tissue from newborn babies (Maschke, 2005). The “U.K. Biobank” or U.K. Population Biomedical Collection is also set up in Britain and co-operated by The Medical Research Council, Wellcome Trust, and The National Health Service (NHS). This Biobank collects DNA, as well as lifestyle and medical information from people between the ages of 45 and 64 to distribute to commercial companies (Maschke, 2005). The Icelandic Collection received permission from its country’s parliament on December of 1998 to decode genetics obtained from the country’s health records. Their databases contain tissue samples and identifiable health data on individuals in the entire country (Maschke, 2005).

Potential Benefits of Human Gene and Tissue Banks

In this biotechnical age, the value of human tissue has soared. Artist have been known to use human body parts as mediums, cadavers are being emptied for medical or research purposes, and embryos are being harvested for stem cell research. These practices make one question if our population has any respect for the human body? Although using human tissue seems inhuman, there are many benefits of its uses. There are currently two areas of research that use human gene and tissue banking. These research fields are, Pharmacogenomics and Population Genetics (Williams & Schroeder, 2004).

Pharmacogenics

Pharmacogenomics uses the hypothesis that a patient’s response to medication can be found in that patient’s genetic make-up (Williams & Schroeder, 2004). The benefit this has for the population is obvious. Patients will no longer have to undergo therapies that may or may not have side effects. In addition, it will limit the high cost of certain medications because medication will not be wasted on individuals who will not benefit from it (Williams & Schroeder, 2004). The problem is that in order for Pharmacogenomics to achieve its goal human gene and tissue banks that collect personal and clinical data, would have to have enormous databases. The lifestyle and clinical data in these databases are then made available to certain institutions such as insurance companies, universities, and pharmaceutical companies.

Population Genetics

Population Genetics assumes that common diseases are linked to a complex interplay between “genetic predispositions and ‘life style’ or environmental factors” (Williams & Schroeder, 2004). This interplay allows researchers to identify certain genes that are susceptible to certain diseases like Alzheimer’s (Williams & Schroeder, 2004). It is the goal of Population Genetics to be able to give tailor-made advice, based on lifestyle and environmental issues, to people at risk for particular diseases. An additional benefit of Population Genetics would be to identify links between genes and diseases (Williams & Schroeder, 2004).

Ethical Issues

The use of human samples and medical records by institutions for research has raised many ethical issues. Among these issues are identifiability of donor subjects, cultural dilemmas, religious objections, and commercialization.

Identifiability of Subjects

The Federal Protection of Human Subjects Rule, or The Common Rule, was created by the World Medical Association in 1964. Under the Common Rule, a human subject is defined as “a living individual about whom an investigator, professional or student, conducting research obtains (1), data through intervention or interaction with an individual or through (2), identifiable private information” (Rothstein, 2005). In other words, all information must be clearly indicated in order to involve a human subject. A problem arises when gene and tissue banks must give up the donor’s identity, but in some cases the identity is protected until the donor is deceased (Rothstein, 2005).

The HIPAA Act (Health Insurance Portability and Accountability Act of 1996) initiated the Privacy Rule which applies only to individually identifiable health information (Rothstein, 2005). In order to determine if the information is de-identified, a statistical expert must determine if there is little to no risk of identifiability of the subject (Rothstein, 2005). Under this rule, specific types of information are removed, such as name, date of birth, and social security number. The HIPAA also limits the use of the research data set (Rothstein, 2005).There are recognizable differences between the Common Rule and the HIPAA’s Privacy Rule in their standards of identifiability. Although both rules cover individual identity, they do not protect groups that could be harmed by research data that still contain identifiers such as, race, ethnicity, and gender.

Cultural and Religious Issues

Susceptibility for certain mutations that cause disease may be found through research data that could affect one or more cultural groups. Health insurance providers have been known to use research records to deny coverage to particular cultural groups (Andrews, 2005). Research on tissues obtained from individuals belonging to a certain religious group may offend others in that same religious community. For example, the Orthodox Jewish community requires that the body must be buried whole. Thus, it is a direct violation to use body parts for research purposes (Andrews, 2005). Research on the bones of Native American Indians excavated from their graves outraged the Indian community. Many Indians believe that excavating the dead interrupts their spiritual journey causing the spirit to wander in limbo. The spirit is then free to wreak havoc on the living (Andrews, 2005). In both cases any information gained with or without an individual’s permission becomes an ethical issue.

There are many changes that have occurred with the use of tissues in research. Before, tissues were used only in order to improve a test that diagnosed a particular disorder (Andrews, 2005). Today these same tissues are being sold for thousands of dollars to the highest bidder.

Commercialization

In 1951, a 31 year old African American woman died of ovarian cancer. Her tissue was taken without her or her family’s consent. It was made into a cell line that has been valuable in cancer research and that is still sold today (Andrews, 2005). The institution has profited handsomely by the use of this woman’s tissue, while her family has not.

Gene patents are potentially worth over 2 billion dollars per year to the patent holder. Companies are now willing to pay millions of dollars to gene and tissue banks for access to their databases (Andrews, 2005). The American Society of Human Genetics opposes gene patents as “threatening medical advances and patient care” (Andrews, 2005). Moreover, a patent holder can deny access to the gene by other companies and researchers. The patent holder can also charge any amount for a diagnostic test for mutations in the patented gene (Andrews, 2005). The donor may or may not be able to afford the test that was created because of their donated tissue nor can they afford the treatment needed. Case in point, Myriad Genetics, a company who patented the BRCA1 gene, charges $1500 for the diagnostic test. Today, 1 in 4 laboratories no longer offer certain genetic tests because they are no longer affordable by their patients (Andrews, 2005). In the U.S., there are precedents for payment for the use of tissues. Sperm and egg donors are highly compensated for their samples. For example, a man marketed his sperm on the internet for $4000 a vial (Andrews, 2005).

Once a donor gives tissue to a Biobank, they are often not told for what research purposes their tissue will be used. It is argued that if donors are given this information, they will be unwilling to donate their tissue or would require some sort of monetary compensation if a gene is patented (Andrews, 2005). Today many patient donors are entering into agreements with patent holders and Biobanks in which they receive a portion of the royalties gained from the use of their tissue (Andrews, 2005).

Legal Issues

Most Human Gene and Tissue Banks are established solely for healthcare and research purposes. Although this may be the case for most Biobanks, they are still confronted with many legal issues.

Informed Consent

Many Biobanks use a general blanket of consent that applies to all future research (Andrews, 2005). This is problematic because most donors are relatively healthy when they are being recruited. Consent is given under less threatening and distressing circumstances, unlike individuals in the hospital who may find physicians and the healthcare system disconcerting (Andrews, 2005). In some cases a procedure done in a hospital requires the removal of certain human tissues. What exactly is being done with the removed tissue? One case in Liverpool dealt with the removal of tissue without the informed consent either of the individual involved or of the individual’s family. Alder Hey Hospital was the target of inquiry in 2001. Parents of children who died in the hospital discovered two years later that their children were buried without some or none of their internal organs. The Hospital was later charged with removing and retaining organs and human tissue samples from those deceased children without the consent or knowledge of their parents (Williams & Schroeder, 2004).

The regulation of informed consent varies by institution and government. The Common Rule requires that the benefits and risks of the research be given to the donor prior to obtaining informed consent. The FDA requires only written consent in a language understandable by both parties involved and The HIPAA’s Privacy Rule does not allow blanket consents to be used at all (Clayton, 2005).

There are four criteria that limit informed consent under the Common Rule law, these are as follows; 1. The research involves little to no risks to the subject, 2. The waiver will not affect the rights and welfare of the subject, 3. The research could not be carried out without the waiver, and 4. The subject will be provided with additional information after the participation (Clayton, 2005). The HIPAA’s Privacy Rule uses the first three criteria but the FDA waiver requirements do not apply to any Biobanks within the U.S. (Clayton, 2005). The process of asking for consent not only protects the individuals involved, but it also acknowledges the individuals as well. Acknowledgement of the individual involved is healthy and beneficial, but can it also be a double edged sword. Can a person be acknowledged while at the same time maintaining confidentiality?

Confidentiality

Today researchers are facing a new dilemma. They want to recruit subjects on the basis that no personal or medical information will be used, but they also know that using anonymous samples greatly restricts the samples utility in their research (Clayton, 2005).

In a telephone interview survey, 1,796 individuals were asked how willing they would be to participate in genetic research under these four conditions: 1. research would be anonymous, 2. research would involve linking genetic test results to their medical records, 3. research would involve de-identified information that would be shared nationwide with other researchers, and 4. the research might lead to the development of treatments (Clayton, 2005). Older, white individuals with higher incomes and more years of education were found to be more willing to participate overall, but anonymity and confidentiality decreased in all demographics with age (Clayton, 2005). For those individuals over 50, anonymity and confidentiality was the most important. It was ascertained that the information sharing provides the most conflict among individual potential donors.

Another issue with Biobanks is that information is shared in a unidirectional order (Clayton, 2005). This means that it goes from subject to Biobank then to research companies and never the other way around. Many organizations have come up with ways to make information sharing bi-directional. The subject could be informed through an annual or more frequently distributed newsletter or website about the progress of the research which involves their donated sample. Subjects could also be asked if, when, and how they want to be informed about new discoveries (Clayton, 2005). Of course, there would be some difficulty in enforcing information sharing between all parties involved in publicly and privately owned Biobanks.

Public and Private Biobanks

There are many legal issues concerning public and private Biobanks. In the U.S. , there is no legal requirement for companies to protect human subjects. (Maschke, 2005) When a private Biobank goes bankrupt, what happens to the information stored in their databases? In Fremont , California , a company went bankrupt in 2003. Eighteen thousand donor samples and their information were included as assets and Genaissance Pharmaceuticals in New Haven , bought them for $1.3 million (Maschke, 2005).

There are also no regulations addressing the issues of research goals, strategies, and methods for private Biobanks. Some private Biobanks have established ethics advisory boards to accommodate the lack of regulations. They are also being held responsible and accountable for their actions by their respective boards of directors and shareholders (Clayton, 2005).

Public Biobanks are very controversial because they are funded and created by the public. (Clayton, 2005) Although many issues are discussed when creating a public Biobank by all parties involved, there is still a need for ongoing commitments to the research goals, strategies, and methods of Biobanks and their affiliated researchers (Clayton, 2005). Only then will a Biobank’s credibility and the trust of the population be maintained.

Conclusion

Biobanks have existed for decades. They have involved clinical and research uses to improve our day to day lives. With the availability of information such as personal lifestyles and medical history and the increase of human gene and tissue banks, the legal and ethical issues must be acknowledged and adequately addressed. While we develop regulations that protect the individual, we also must consider the public’s greater interest. Not only is the public interested in protecting individual’s rights, but it is also interested in finding new ways of preventing, treating, and ultimately curing diseases effectively. Therefore it is in the best interest of all that the custodians of Biobanks actively promote the benefits, avoid all harm, and earn the respect and trust of the human population it in which it samples.

 

References

Andrews, L.B. (2005). Harnessing the Benefits of Biobanks. Journal of Law, Medicine, &

Ethics, 33(1), 22-30

Clayton, E.W. (2005) Informed Consent and Biobanks.

Journal of Law, Medicine, & Ethics, 33(1), 15-21

Gene Bank (2005) Book Rags Biology Study Guide. Retrieved October 31, 2005 , from the World

Wide Web.http://www.bookrags.com/sciences/biology/gene-bank-enve-01.html

Maschke, K.J. (2005). Navigating an Ethical Patchwork-Human Gene Banks. Nature Biotechnology, 23

(5), 539-45

Rothstein, M.A. (2005). Expanding the Ethical Analysis Of Biobanks. Journal of Law, Medicine, & Ethics, 33(1), 89-99

Williams, G. & Schroeder, D. (2004). Human genetic Banking: Altruism, Benefit, and Consent.

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