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Biobanking is a form of biological storage, used in research settings. From the 1990s onwards, biobanks have become instrumental in medical research, particularly in the fields of genomics and personalized medicine.

Biobanks allow researchers to collect and analyze vast quantities of data. The samples and data collected by biobanks are often used by researchers in multiple projects and settings, most significantly cross-purpose studies, often for the purposes of fighting and understanding diseases and how they are spread. Prior to the advent of biobanks, acquiring samples for these purposes was much harder than it is now.

Ethically, biobanks have raised questions on privacy, research ethics, and medical ethics. While viewpoints on these ethics are varied, the general consensus is that strong ethical guidelines and policies are needed for the purposes of operating a biobank, as failing to do so can be detrimental to biobanks themselves, as well populations that allow biobanks to open in their local communities.


Workflow model for the collection, storage, and distribution of samples in Biobanking [1]

Before the 1990s, scientists and researchers would themselves have to collect biological samples for each experiment they did. There was no unified system of sharing that was readily available to them. The effects of this could most easily be seen in the field of genetics, where scientists relied on prior research of a given sample to inform them of what areas to explore or tests to conduct regarding their own unique samples.

Eventually, this changed due to the realization that while diseases and disorders have genetic component, very few of them owe their manifestation to a single defective gene -- rather, they are caused by multiple genetic factors occurring on a multitude of different genes. As a result of this discovery, it was realized that it was necessary to perform genome-wide scans of a given biological sample vs the one-off genetic analysis of individual genes.

Around the time that this was happening, technological advances made it possible for the mass sharing of information. Thus, when data was collected, scientists doing genetic analysis found that they could coordinate their research efforts and have their work contribute to a larger body of knowledge in the field of genetics itself, thus allowing researchers the world over to access information derived from each other's work. Where before, genetics research was originally limited to a single laboratory or institution, now it was placed into unified and networked databases that the scientific community could access instantaneously with nothing more than an internet connection and computer. These were the world's first biobanks.

The development of these biobanks was far reaching. The sharing of the data derived from widespread sharing of genome-wide scanning led to the discovery of many single-nucleotide polymorphisms -- basically genetic variants. Indeed, in the ten years following the implementation of genome wide scans and the biobanking system, the number of discovered polymorphisms increased by a factor of fifty.

However, this didn't solve every problem. The first biobanks were storehouses for genetic information and research results. Another important area for biological research though, was that of phenotypic data. While genetic data can be gathered through a blood, saliva, or other biological sample, phenotypic data has to be collected through physical observation and examination of the subject that a given genetic sample can be derived from. This data includes information derived from interviews, physical assessment, review of medical history, or any other source of data that cannot be derived solely from a subject's genetic material.

Moreover, due to the nature of how phenotypic data is gathered, there were (and are) ethical considerations as to the rights of the subjects that data is derived from. These considerations became especially pertinent as biobanks began collecting phenotypic data and connecting it to genotypic data for the purposes of research and data sharing among scientists and institutions.[2]

By the late 2000s, scientists had stored more than two hundred and seventy million biological samples and specimens in biobanks in the United States alone, and had collection rate of twenty million new samples additions per year. However, this is a trend that goes outside the United States, and are reflective of similar setups around the globe. The development of this massive catelog of biological samples has lead to a massive paradigm shift in the way genetic research data is shared, as there has never before been a time in history when scientists in this field have had access to such a massive number of samples and data.

This access has not been without controversy however, and some of the challenges raised by the rise of biobanks have included: the fairness of collecting sample donations and data from vulnerable populations, providing informed consent 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 issues, researchers and policy makers began to require new systems of research governance.[3]

Types of Biobanks

Example of Tissue Biobank

The term "biobank" has connotated different meanings since its initial inception. Currently, the most widely used description is as "an organized collection of ... biological material and associated information stored for one or more research purposes". Collections of plant, animal, microbe, and other nonhuman materials can be included in the definition of a biobank, or it can refer exclusively to human-derived samples.[4]

Biobanks usually incorporate cryogenic storage mechanisms and facilities for their samples. These may range in size from individual refridgerators to entire warehouses, and are usually maintained by institutions such as hospitals, universities, nonprofit organizations, and pharmaceutical companies.[5]

In general, biobanks can be classified by their purpose or design. Disease-oriented biobanks usually have a hospital affiliation through which they collect samples representing a variety of diseases.[6] Population-based biobanks need no particular hospital affiliation because they take samples from large numbers of all kinds of people.[7] Most often, biobanks derive their samples and information from one or more of the following three institutions:[8]

1.) Virtual Biobanks -- these are storehouses for digital information that has been accumulated and uploaded from a variety of researchers (or institutions) and their projects.

2.) Tissue Banks -- these are storehouses for biological samples, which harvest and store human and animal tissue samples for transplantation and research.

3.) Population Banks -- these store biomaterial that is correlated with associated characteristics such as lifestyle, clinical and environmental data.

Ethics of Biobanking

There are many ethical considerations to biobanking. Most of the time, these arise due to a key cornerstone of biobanking itself: namely, when a researcher wants to collect a specimen for research. When this occurs, some of the major issues revolve around the following: right to privacy for research participants, ownership of the specimen and its derived data, 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. [9]

Regarding consent, the issues revolve around the fact that biobanks usually collect samples and data for the purposes of current and future research. As a result, it is unfeasable to obtain consent for every research instance that the sample or data may be used in. Within this context, broad spectrum consent forms have been discussed and utilized in various biobank and research settings. However, these consent forms have come under scrutiny, as they may not ultimately satisfy ethical and legal requirements. [10]

Some key ethical issues include[11] :

1. Participant autonomy

2. Informed consent

3. Return of results

4. Donor confidentiality and data privacy

5. Data storage

6. Diversity and equity

Privacy for Research Participants

The broad consensus is that once a specimen is donated for research, then the donor has a right to privacy thereafter. As a result, researchers have to balance the need for the donor's anonymity with the need for detailed information about the specimen they donate. In the United States, the Office for Human Research Protections promotes a system wherein data that could be used to identify a given donor is segregated from data that is made available to researchers. However, this data is coded in such a manner that if a special circumstance arises, such that the identity of the donor is ever needed, it can be deciphered using a separate system than the one that is made available via the usual research channels.

Unfortunately, this doesn't always work as intended, and situations can arise where the identity of the donor gets released despite the failsafes put in place to ensure their anonymity. Donor identities can become known if the keys to decipher their identity are themselves not secured properly. More often though, when multiple data sets are derived from a given sample, a donor's information can be inferred from the abundance of anonymized information, despite the removal of directly identifiable information such as names.

This ability to decipher a person's identity from anonymized information is a relatively recent problem as compared to before the advent of highly networked systems and data sets, such as those that biobanks provide. Traditional methods of ensuring confidentiality have become obsolete in the face of these rich and highly interconnected data sets, and new procedures and protocols to combat this issue have been slow to catch up and address this issue. This is compounded by the fact that the information being stored -- genetic material -- can uniquely identify a given individual, as each person's genomic makeup is unique.[12]

Ownership of Specimens

When a given specimen is donated to a researcher, ownership is hard to quantify, because the donor can be said (at least initially) to have as much of a right to the specimen as the researcher they donate the specimen to.

Specimens themselves have commercial value, as do the products made from specimens. As a result, benefits can be derived in a variety of public and private sector settings. In such cases where a given specimen is deemed to have commercial value, patenting of the biological sample, or the research and/or products derived from it, is another consideration. As a result, there is strong debate over whether or not a donor should be able to specify how their sample, or products deriving from their sample, should be able to be used.

Return of Results

The general consensus among researchers, as well as legal and ethical experts, is that any participant in clinical research has the right to be informed of the results of the study they participated in. This is done so that they can know any information that might apply to them, as well as any impact their participation had in the study and its intended target group, such as a person's local community.

Despite this general belief, there is no universally recognized authority group or policy on how this might be done. As a result, practices vary widely from project to project, and researcher to researcher.

This is at least partially due to the nature of the donation/participation process. Returning results can be complicated by issues such as tracking an individual participant down after the study has reached its conclusion, typically measured in years (if not decades). Other factors include potentially violating a participant's right to privacy, general lack of interest on the part of the participant, lack of sufficient scientific knowledge on the part of the participant to understand the results, as well as defining exactly what constitutes a proper return of results.[13]

Informed Consent

Informed consent acknowledges an individual's right to decide whether or not their information and body can be used in data and research. This notion of consent goes through many difficulties in large-scale biobanks. A sample can be used over many years with evolving research and knowledge. The main ethical issues of informed consent is the level of completeness from the given information, individual consent for each use of the information, and who will make the decision on the issue. Usually, minors or individuals unable to give consent are at risk of this ethical dilemma. Most of the concern regarding informed consent comes from confidentiality issues. Several other topics of concern have risen such as broader consent for long-term research, right to withdraw, and advance consent given to re-contacting patients for other studies [14].

Donating a specimen to a biobank carries with it many issues that need to be considered. Each donor will have different levels of understanding, and corresponding expectations, of what they are doing when they donate a sample. Because of this, it can be challenging to explain each and every issue to everyone involved. As a result, the issue of informed consent can be difficult to properly address.

Historically, this has been one of the biggest issues facing biobanks. Prior to the establishment of biobanks, researchers would ask donors for consent in participating in a single research study or program, and would then provide each participant with information about that study. With biobanks, samples that were originally used in a single project may end up having their data used in a future and unrelated project. Because a given data set is usually anonymized, tracking down donors each time a new research project wants to use their historic data is usually unfeasible. As a result, gaining informed consent for each project is usually impossible.


Working with genetic information frequently has the potential of revealing the individual who is donated the sample and also individuals to them. Anonymity cannot be guaranteed since identification is still possible when samples are being compared to a database. The risk of identification grows as the number of databases increases. Even though there are many efforts made to anonymize data and protect privacy in large-scale biobanks, unintentional identification is always possible [15].


  1. Coppola, L., Cianflone, A., Grimaldi, A.M. et al. Biobanking in health care: evolution and future directions. J Transl Med 17, 172 (2019).
  2. Greely, H. T. (2007). "The Uneasy Ethical and Legal Underpinnings of Large-Scale Genomic Biobanks". Annual Review of Genomics and Human Genetics 8: 343–364. doi:10.1146/annurev.genom.7.080505.115721. PMID 17550341.
  3. Haga, S.; Beskow, L. (2008). "Ethical, Legal, and Social Implications of Biobanks for Genetics Research". Genetic Dissection of Complex Traits. Advances in Genetics 60. pp. 505–544. doi:10.1016/S0065-2660(07)00418-X. ISBN 9780123738837. PMID 18358331.
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  8. Labant, MaryAnn (Jan 15, 2012). "Biobank Diversity Facilitates Drug & Diagnostic Development". Genetic Engineering & Biotechnology News 32 (2): 42,44. doi:10.1089/gen.32.2.21. ISSN 1935-472X. Retrieved 1 February 2012.
  9. Hawkins, Alice K.; Kieran C. O'Doherty (7 October 2011). ""Who owns your poop?": insights regarding the intersection of human microbiome research and the ELSI aspects of biobanking and related studies". BMC Medical Genomics 4: 72. doi:10.1186/1755-8794-4-72. PMC 3199231. PMID 21982589.
  10. Hoeyer K. Trading in Cold Blood? Trust in Biobanking 2012; 21-41.
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  12. Greely, H. T. (2007). "The Uneasy Ethical and Legal Underpinnings of Large-Scale Genomic Biobanks". Annual Review of Genomics and Human Genetics 8: 343–364. doi:10.1146/annurev.genom.7.080505.115721. PMID 17550341.
  13. Haga, S.; Beskow, L. (2008). "Ethical, Legal, and Social Implications of Biobanks for Genetics Research". Genetic Dissection of Complex Traits. Advances in Genetics 60. pp. 505–544. doi:10.1016/S0065-2660(07)00418-X. ISBN 9780123738837. PMID 18358331.
  14. Cambon-Thomsen, A., et al. European Respiratory Society, European Respiratory Society, 1 Aug. 2007, Trends in Ethical and Legal Frameworks for the Use of Human Biobanks
  15. Widdows, H., Cordell, S. The Ethics of Biobanking: Key Issues and Controversies. Health Care Anal 19, 207 (2011).