Biobank
Encyclopedia
A biobank is a cryogenic storage facility used to archive biological samples for use in research and experiments. Ranging in size from individual refrigerators to warehouses, biobanks are maintained by institutions such as hospitals, universities, nonprofit organizations, and pharmaceutical companies.
to donors, the logistics of data disclosure to participants, the right to ownership of intellectual property, and the privacy and security of donors who participate. Because of these new problems, researchers and policymakers began to require new systems of research governance.
Many researchers have identified biobanking as a key area for infrastructure development in order to promote drug discovery
and drug development
.
Room temperature storage of samples is sometimes used, and was developed in response to perceived disadvantages of low-temperature storage, such as costs and potential for freezer failure. Current systems are small and are capable of storing nearly 40,000 samples in about one tenth of the space required by a -80 °C freezer. Replicates or split samples are often stored in separate locations for security.
One controversy of large databases of genetic material is the question of ownership of samples. To date, Iceland
has had three different laws on ownership of the physical samples and the information they contain. Current Icelandic law holds that the Icelandic government has custodial rights of the physical samples themselves while the donors retain ownership rights. In contrast, Tonga
and Estonia
give ownership of biobank samples to the government, but their laws include strong protections of donor rights.
taken by sampling
. Specimen types include blood
, urine
, skin cells, organ tissue, and other things taken from a body. The biobank keeps these specimens in good condition until a researcher needs them to conduct a test, do an experiment, or perform an analysis.
so that researchers can use the sample without knowing the identity of the donor.
Complications arise in many situations, such as when the identity of the donor is released anyway or when the researchers want to contact the donor of the sample.
Among the concerns which participants in biobanks have expressed are giving personal information to researchers and having data used against them somehow
Scientists have demonstrated that in many cases where participants' names were removed from data, the data still contained enough information to make identification of the participants possible. This is because the historical methods of protecting confidentiality and anonymity have become obsolete when radically more detailed databases became available.
There have been problems deciding what safeguards should be in place for storing medical research data. In response, some researchers have made efforts to describe what constitutes sufficient security and to recognize what seemingly anonymized information can be used to identify donors.
The specimens themselves have commercial value, and research products made from specimens can also. Fundamental research benefits all sectors, including government, non-profit, and commercial, and these sectors will not benefit equally. Specimens may be subject to biological patenting
or research results from specimen experimentation may lead to the development of products which some entity will own. The extent to which a specimen donor should be able to restrict the way their specimen is used is a matter of debate.
Some researchers make the argument that the specimens and data should be publicly owned. Other researchers say that by calling for donations and branding the process as altruistic the entities organizing biobank research are circumventing difficult ethical questions which participants and researchers ought to address.
is a part of this idea.
Returning results can be problematic for many reasons, such as increased difficulty of tracking participants who donated a sample as time passes, the conflict with the participant's right to privacy, the inability of researchers to meaningfully explain scientific results to participants, general disinterest of participants to study results, and deciding what constitutes a return of results.
If genetic testing is done, then researches may get health information about participants, but in many cases there is no plan in place for giving participants information derived from their samples.
Many people have the opportunity to donate samples to medical research in the course of their regular medical care, but there are ethical problems in having one's own doctor request specimens.
Researchers support biobanking despite risk to participants because the benefit is high, it pays respect to people's wishes to involve themselves in research, current practices and culture support this kind of research, and consensus is that the risk of participation is low.
Donors to biobanks frequently do not have a good understanding of the concept of a biobank or the implications of donating a specimen to one.
Background
In 2008 United States Researchers stored 270 million specimens in biobanks, and the rate of new sample collection was 20 million per year. These numbers are large and representative of a fundamental worldwide change in the nature of research between the time when such numbers of samples could not be used and the time when researchers began demanding them. Collectively, researchers began to act in interest of progressing beyond single-center research centers to a next-generation qualitatively different research infrastructure. Some of the challenges raised by the advent of biobanks are ethical, legal, and social issues pertaining to their existence, including the fairness of collecting donations from vulnerable populations, providing informed consentInformed consent
Informed consent is a phrase often used in law to indicate that the consent a person gives meets certain minimum standards. As a literal matter, in the absence of fraud, it is redundant. An informed consent can be said to have been given based upon a clear appreciation and understanding of the...
to donors, the logistics of data disclosure to participants, the right to ownership of intellectual property, and the privacy and security of donors who participate. Because of these new problems, researchers and policymakers began to require new systems of research governance.
Many researchers have identified biobanking as a key area for infrastructure development in order to promote drug discovery
Drug discovery
In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which drugs are discovered or designed.In the past most drugs have been discovered either by identifying the active ingredient from traditional remedies or by serendipitous discovery...
and drug development
Drug development
Drug development is a blanket term used to define the process of bringing a new drug to the market once a lead compound has been identified through the process of drug discovery...
.
Security and storage
Biobanks, like other DNA databases, must carefully store and document access to samples and donor information. The samples must be maintained reliably with minimal deterioration over time, and they must be protected from physical damage, both accidental and intentional. The registration of each sample entering and exiting the system is centrally stored, usually on a computer-based system that can be backed up frequently. The physical location of each sample is noted to allow the rapid location of specimens. Archival systems de-identify samples to respect the privacy of donors and allow blinding of researchers to analysis. The database, including clinical data, is kept separately with a secure method to link clinical information to tissue samples.Room temperature storage of samples is sometimes used, and was developed in response to perceived disadvantages of low-temperature storage, such as costs and potential for freezer failure. Current systems are small and are capable of storing nearly 40,000 samples in about one tenth of the space required by a -80 °C freezer. Replicates or split samples are often stored in separate locations for security.
One controversy of large databases of genetic material is the question of ownership of samples. To date, Iceland
Iceland
Iceland , described as the Republic of Iceland, is a Nordic and European island country in the North Atlantic Ocean, on the Mid-Atlantic Ridge. Iceland also refers to the main island of the country, which contains almost all the population and almost all the land area. The country has a population...
has had three different laws on ownership of the physical samples and the information they contain. Current Icelandic law holds that the Icelandic government has custodial rights of the physical samples themselves while the donors retain ownership rights. In contrast, Tonga
Tonga
Tonga, officially the Kingdom of Tonga , is a state and an archipelago in the South Pacific Ocean, comprising 176 islands scattered over of ocean in the South Pacific...
and Estonia
Estonia
Estonia , officially the Republic of Estonia , is a state in the Baltic region of Northern Europe. It is bordered to the north by the Gulf of Finland, to the west by the Baltic Sea, to the south by Latvia , and to the east by Lake Peipsi and the Russian Federation . Across the Baltic Sea lies...
give ownership of biobank samples to the government, but their laws include strong protections of donor rights.
Examples of biobanks
There are many active banks which have been created for many purposes by many organizations.Biobank specimens
The collection which a biobank protects are its specimensLaboratory specimen
In medicine, a laboratory specimen is a medical sample, that is, gathered matter of a medical patient's tissue, fluid, or other material derived from the patient used for laboratory analysis to assist differential diagnosis or staging of a disease process...
taken by sampling
Sampling (medicine)
In medicine, sampling is gathering of matter from the body to aid in the process of a medical diagnosis and/or evaluation of an indication for treatment, further medical tests or other procedures...
. Specimen types include blood
Blood
Blood is a specialized bodily fluid in animals that delivers necessary substances such as nutrients and oxygen to the cells and transports metabolic waste products away from those same cells....
, urine
Urine
Urine is a typically sterile liquid by-product of the body that is secreted by the kidneys through a process called urination and excreted through the urethra. Cellular metabolism generates numerous by-products, many rich in nitrogen, that require elimination from the bloodstream...
, skin cells, organ tissue, and other things taken from a body. The biobank keeps these specimens in good condition until a researcher needs them to conduct a test, do an experiment, or perform an analysis.
Ethics and human sample biobanking
A common situation which arises in biobanking is when a researcher wants to collect a human specimen for research. Some issues which arise include the following: right to privacy for the specimen donor, who will own the specimen, the extent to which the donor can share in the return of the research results, and the extent to which a donor is able to consent to be in a research study.Medical privacy
There is broad consensus that when a person donates a specimen for research then that person has a right to privacy thereafter. To this end, donated specimens are made anonymousAnonymity
Anonymity is derived from the Greek word ἀνωνυμία, anonymia, meaning "without a name" or "namelessness". In colloquial use, anonymity typically refers to the state of an individual's personal identity, or personally identifiable information, being publicly unknown.There are many reasons why a...
so that researchers can use the sample without knowing the identity of the donor.
Complications arise in many situations, such as when the identity of the donor is released anyway or when the researchers want to contact the donor of the sample.
Among the concerns which participants in biobanks have expressed are giving personal information to researchers and having data used against them somehow
Scientists have demonstrated that in many cases where participants' names were removed from data, the data still contained enough information to make identification of the participants possible. This is because the historical methods of protecting confidentiality and anonymity have become obsolete when radically more detailed databases became available.
There have been problems deciding what safeguards should be in place for storing medical research data. In response, some researchers have made efforts to describe what constitutes sufficient security and to recognize what seemingly anonymized information can be used to identify donors.
Ownership of specimens
After a person donates a specimen to a researcher it is not apparent what the participant is donating.The specimens themselves have commercial value, and research products made from specimens can also. Fundamental research benefits all sectors, including government, non-profit, and commercial, and these sectors will not benefit equally. Specimens may be subject to biological patenting
Biological patent
A biological patent is a patent relating to an invention or discovery in biology. It can be a composition of matter, a method for obtaining or using one or more thereof, or a product combining such things...
or research results from specimen experimentation may lead to the development of products which some entity will own. The extent to which a specimen donor should be able to restrict the way their specimen is used is a matter of debate.
Some researchers make the argument that the specimens and data should be publicly owned. Other researchers say that by calling for donations and branding the process as altruistic the entities organizing biobank research are circumventing difficult ethical questions which participants and researchers ought to address.
Return of results
There is broad consensus that participants in clinical research have a right to know the results of a study in which they participant so that they can check the extent to which their participation delivered beneficial results to their community. The right to justice in the Belmont ReportBelmont Report
The Belmont Report is a report created by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Its full title is the Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research, Report of the National Commission...
is a part of this idea.
Returning results can be problematic for many reasons, such as increased difficulty of tracking participants who donated a sample as time passes, the conflict with the participant's right to privacy, the inability of researchers to meaningfully explain scientific results to participants, general disinterest of participants to study results, and deciding what constitutes a return of results.
If genetic testing is done, then researches may get health information about participants, but in many cases there is no plan in place for giving participants information derived from their samples.
Informed consent
Because donating a specimen involves consideration of many issues, different people will have different levels of understanding of what they are doing when they donate a specimen. Since it is difficult to explain every issue to everyone, problems of giving informed consent arise when researchers take samples.Many people have the opportunity to donate samples to medical research in the course of their regular medical care, but there are ethical problems in having one's own doctor request specimens.
Researchers support biobanking despite risk to participants because the benefit is high, it pays respect to people's wishes to involve themselves in research, current practices and culture support this kind of research, and consensus is that the risk of participation is low.
Donors to biobanks frequently do not have a good understanding of the concept of a biobank or the implications of donating a specimen to one.
Legal cases
Biobanks by their nature store specimens from human bodies. There have been cases when the ownership of stored specimens has been in dispute and taken to court. Here are some examples of such cases:- Moore v. Regents of the University of California
- Greenberg v. Miami Children’s Hospital Research Institute
External links
- Harvested Organs Revolutionize Medicine - 2007 PBSPublic Broadcasting ServiceThe Public Broadcasting Service is an American non-profit public broadcasting television network with 354 member TV stations in the United States which hold collective ownership. Its headquarters is in Arlington, Virginia....
/Wired ScienceWired (magazine)Wired is a full-color monthly American magazine and on-line periodical, published since January 1993, that reports on how new and developing technology affects culture, the economy, and politics...
report