Biobank ethics

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Biobank ethics refers to the ethics pertaining to all aspects of biobanks. The issues examined in the field of biobank ethics are special cases of clinical research ethics.

Contents

Overview of issues

The following table shows many of the leading controversial issues related to biobanking. The table names an issue, then describes a point on which there is consensus and an aspect of that same point for which there is no consensus.

Biobank controversies [1]
issueconsensuscontroversynotes
Commercialization Different aspects of biobanks serve public, private, commercial, and noncommercial interests.How can policymakers set guidelines to fairly balance public, private, commercial, and noncommercial interests?
Who owns biological specimens and data derived therefrom?
When biobanks and related projects are publicly funded, the result will benefit private industry. To what extent is this outcome satisfactory? (Social Fairness). It may also undermine public trust in biobanks projects.
It may skew research agenda in favor of research projects which are more profitable and compromise necessary but not profitable research.
discrimination, including Genetic discrimination Biobanks should prevent donor communities from facing discrimination as a result of participating in a biobank projectResearch reveals private information and release of it may cause participants to face discrimination. What responsibility does the biobank have to mitigate the problem?
Participants may reveal their own information because of participation in a biobank and subsequently face discrimination. What responsibility does the biobank have to mitigate the problem?
informed consent Donors to biobanks need a consent process adjusted specifically to biobanks.What breadth of consent should biobanks have? [2]
Institutional review board It would be nice to have a robust governance system before biobanks are created.How will a good governance system be designed?
The oversight institution reviewing biobanks should be independent of the biobank.Where should checks and balances be?
An individual organization needs multinational support to do international research.Who should govern when research spans different countries with different legal and personal rights standards?
Privacy for research participants Donors should have their specimens sufficiently anonymized.A specimen by nature includes some data about donors - how much anonymizing is sufficient? [3] [4]
Donors have some right to return of results.How does one return results to anonymized donors? [3] [5]
Donors have a right to withdraw from research.Specimens can be destroyed, but to what extent should anonymized data which has already been shared be withdrawn? [5]
Data derived from specimens should be shared.Who gets access and how much? [3]
Changing technology makes it difficult for researchers to say how safe participant information is.What protections can be promised? [6]
Return of results Donors have a right to know the purpose of a biobank and what results it generatesWhen should all donors share general information and when does each donor have a personal right to personal information?
Public consultation Everyone wants the researchers and community to work together.What resources should be spent doing outreach, and how much involvement does the community want, and what role should the community have?
Communities should participate in writing laws, standards, and policies for research.How can communities be encouraged to participate, who represents the community, and how much involvement should there be?
Patients should be involved when there is research on diseases.When people are desperate because of a disease, to what extent can they participate fairly without feeling obligation to support research?
Communities which donate specimens to a biobank should have special involvement in their biobank.What kind of involvement?
Resource sharingResearch efficiency increases greatly when resources are shared.How should beneficiaries share costs? This is especially problematic when a biobank is a national resource and another country wants access to it.
Results of studies should go to the widest possible audience.When should this happen and in what way? Can results be released with commercial licensing for use?

Privacy for research participants

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, researchers balance the need for specimens to be anonymous or de-identified from protected health information with the need to have access to data about the specimen so that researchers can use the sample without knowing the identity of the donor. [7] In the United States, for example, the Office for Human Research Protections often promotes a traditional system wherein data which could identify a participant is coded, and then elsewhere stored away from the data is key which could decipher the identities in special circumstances when required outside of usual research. [8]

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. [7] Donor identities could become known if the data and decipher key are unsecure, but more likely, with rich datasets the identities of donors could be determined only from a few pieces of information which were thought unrelated to disturbing anonymity before the advent of computer communication. [8]

Among the concerns which participants in biobanks have expressed are giving personal information to researchers and having data used against them somehow. [9]

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. [10] This is because the historical methods of protecting confidentiality and anonymity have become obsolete when radically more detailed databases became available. [8] Another problem is that even small amounts of genetic data, such as a record of 100 single nucleotide polymorphisms, can uniquely identify anyone. [4]

There have been problems deciding what safeguards should be in place for storing medical research data. [11] 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. [3]

Ownership of specimens

When a person donates a specimen to a researcher, it is not easy to describe what the participant is donating because ownership of the specimen represents more rights than physical control over the specimen. [7]

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. [7]

Some researchers make the argument that the specimens and data should be publicly owned. [12] 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. [13]

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 participated so that they can check the extent to which their participation delivered beneficial results to their community. The right to justice in the Belmont Report is a part of this idea. [7] Despite the consensus that researchers should return some information to communities, there is no universally recognized authoritative policy on how researchers should return results to communities, and the views and practices of researchers in the field vary widely. [14]

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. [7]

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. [15]

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. [7]

A special informed consent problem happened historically with biobanks. Previous to the advent of biobanks, researchers would ask specimen donors for consent to participate in a single study, and give participants information about that study. In a biobank system, a researcher may have many specimens collected over many years and then long after the donors gave the sample, that researcher may want to conduct a new study using those samples but have no good way to give donors information about that study and collect their consent. This problem was first identified in widespread publication in 1995 [8] when an article on this topic was published. [16]

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. [17] Most participants are willing to provide consent for biospecimens and disease specific or related biobanks are favorable. [18] 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. [19] 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. [20]

Related Research Articles

Medical ethics is an applied branch of ethics which analyzes the practice of clinical medicine and related scientific research. Medical ethics is based on a set of values that professionals can refer to in the case of any confusion or conflict. These values include the respect for autonomy, non-maleficence, beneficence, and justice. Such tenets may allow doctors, care providers, and families to create a treatment plan and work towards the same common goal. It is important to note that these four values are not ranked in order of importance or relevance and that they all encompass values pertaining to medical ethics. However, a conflict may arise leading to the need for hierarchy in an ethical system, such that some moral elements overrule others with the purpose of applying the best moral judgement to a difficult medical situation. Medical ethics is particularly relevant in decisions regarding involuntary treatment and involuntary commitment.

The Human Genome Diversity Project (HGDP) was started by Stanford University's Morrison Institute in 1990s along with collaboration of scientists around the world. It is the result of many years of work by Luigi Cavalli-Sforza, one of the most cited scientists in the world, who has published extensively in the use of genetics to understand human migration and evolution. The HGDP data sets have often been cited in papers on such topics as population genetics, anthropology, and heritable disease research.

<span class="mw-page-title-main">UK Biobank</span> Long-term biobank study of 500,000 people

UK Biobank is a large long-term biobank study in the United Kingdom (UK) which is investigating the respective contributions of genetic predisposition and environmental exposure to the development of disease. It began in 2006.

Genetic discrimination occurs when people treat others differently because they have or are perceived to have a gene mutation(s) that causes or increases the risk of an inherited disorder. It may also refer to any and all discrimination based on the genotype of a person rather than their individual merits, including that related to race, although the latter would be more appropriately included under racial discrimination. Some legal scholars have argued for a more precise and broader definition of genetic discrimination: "Genetic discrimination should be defined as when an individual is subjected to negative treatment, not as a result of the individual's physical manifestation of disease or disability, but solely because of the individual's genetic composition." Genetic Discrimination is considered to have its foundations in genetic determinism and genetic essentialism, and is based on the concept of genism, i.e. distinctive human characteristics and capacities are determined by genes.

<span class="mw-page-title-main">Genetic Alliance</span>

Genetic Alliance is a nonprofit organization, founded in 1986 by Joan O. Weiss, working with Victor A. McKusick, to advocate for health benefits in the accelerating field of genomic research. This organization is a network of over 1,000 disease advocacy organizations, universities, government organizations, private companies, and public policy organizations. They aim to advance genetic research agendas toward health benefit by engaging a broad range of stakeholders, including healthcare providers, researchers, industry professionals, public policy leaders, as well as individuals, families and communities. They create programs using a collaborative approach, and aim to increase efficiency and reduce obstacles in genetic research, while ensuring that voices from the involved disease communities are heard. They also promote public policies to advance healthcare. Genetic Alliance provides technical support and informational resources to guide disease-specific advocacy organizations in being their own research advocates. They also maintain a biobank as a central storage facility for several organizations who otherwise would not have the infrastructure to maintain their own repository.

<span class="mw-page-title-main">Biobank</span> Repository of biological samples used for research

A biobank is a type of biorepository that stores biological samples for use in research. Biobanks have become an important resource in medical research, supporting many types of contemporary research like genomics and personalized medicine.

A Tumor Bank, A Tumor Bank is sometimes also referred to as a Tissue Bank, since normal tissues for research are also often collected. However, this function is distinct from a Tissue Bank which collects and harvests human cadaver tissue for medical research and education, and banks which store Biomedical tissue for organ transplantation.

Generation Scotland is a biobank, a resource of biological samples and information on health and lifestyle from thousands of volunteer donors in Scotland.

<span class="mw-page-title-main">Public Population Project in Genomics</span>

P3G (Public Population Project in Genomicsand Society) is a not-for-profit international consortium dedicated to facilitating collaboration between researchers and biobanks working in the area of human population genomics. P3G is member-based and composed of experts from the different disciplines in the areas of and related to genomics, including epidemiology, law, ethics, technology, biomolecular science, etc. P3G and its members are committed to a philosophy of information sharing with the goal of supporting researchers working in areas that will improve the health of people around the world.

DECIPHER is a web-based resource and database of genomic variation data from analysis of patient DNA. It documents submicroscopic chromosome abnormalities and pathogenic sequence variants, from over 25000 patients and maps them to the human genome using Ensembl or UCSC Genome Browser. In addition it catalogues the clinical characteristics from each patient and maintains a database of microdeletion/duplication syndromes, together with links to relevant scientific reports and support groups.

Return of results is a concept in research ethics which describes the extent of the duty of a researcher to reveal and explain the results of research to a research participant.

Privacy for research participants is a concept in research ethics which states that a person in human subject research has a right to privacy when participating in research. Some typical scenarios this would apply to include, or example, a surveyor doing social research conducts an interview with a participant, or a medical researcher in a clinical trial asks for a blood sample from a participant to see if there is a relationship between something which can be measured in blood and a person's health. In both cases, the ideal outcome is that any participant can join the study and neither the researcher nor the study design nor the publication of the study results would ever identify any participant in the study. Thus, the privacy rights of these individuals can be preserved.

<span class="mw-page-title-main">De-identification</span> Preventing personal identity from being revealed

De-identification is the process used to prevent someone's personal identity from being revealed. For example, data produced during human subject research might be de-identified to preserve the privacy of research participants. Biological data may be de-identified in order to comply with HIPAA regulations that define and stipulate patient privacy laws.

The right to withdraw is a concept in clinical research ethics that a study participant in a clinical trial has a right to end participation in that trial at will. According to ICH GCP guidelines, a person can withdraw from the research at any point in time and the participant is not required to reveal the reason for discontinuation.

CARTaGENE is a population based cohort based on an ongoing and long-term health study of 40, 000 men and women in Québec. It is a regional cohort member of the Canadian Partnership for Tomorrow's Health (CanPath). The project's core mandate is to identify the genetic and environmental causes of common chronic diseases affecting the Québec population. The overall objective from a public health perspective is to develop personalized medicine and public policy initiatives targeting high-risk groups. CARTaGENE is under the scientific direction of Sébastien Jacquemont, Ekaterini Kritikou, and Philippe Broët of the Sainte-Justine Children's Hospital University Health Center. Based in Montréal Québec, Canada, CARTaGENE is operated under the infrastructure of the Sainte-Justine Children's Hospital University Health Center and has seen funding from Genome Canada, the Canadian Foundation for Innovation and Génome Québec and the Canadian Partnership Against Cancer (CPAC) since 2007 among other sources. The program was initially founded by Professors Claude Laberge and Bartha Knoppers, and developed through two phases of participant recruitment under the direction of Professor Philip Awadalla as Scientific Director of the cohort from 2009 to 2015, who is now the National Scientific Director of the Canadian Partnership for Tomorrow's Health (CanPath).

Ellen Wright Clayton is an American academic specialzing in law and medicine. She is the Rosalind E. Franklin Professor of Genetics at Vanderbilt University and chairwoman of the Institute of Medicine Board at the Population Health and Public Health Practice. She was the 2013 recipient of the David Rall Medal.

Dynamic consent is an approach to informed consent that enables on-going engagement and communication between individuals and the users and custodians of their data. It is designed to address the many issues that are raised by the use of digital technologies in research and clinical care that enable the wide-scale use, linkage, analysis and integration of diverse datasets and the use of AI and big data analyses. These issues include how to obtain informed consent in a rapidly-changing environment; growing expectations that people should know how their data is being used; increased legal and regulatory requirements for the management of secondary use of data in biobanks and other medical research infrastructure. The approach started to be implemented in 2007 by an Italian group who introduced the ways to have an ongoing process of interaction between researcher and participant where "technology now allows the establishment of dynamic participant–researcher partnerships." The use of digital interfaces in this way was first described as 'Dynamic Consent' in the EnCoRe project. Dynamic Consent therefore describes a personalised, digital interface that enables two-way communication between participants and researchers and is a practical example of how software can be developed to give research participants greater understanding and control over how their data is used. It also enables clinical trial managers, researchers and clinicians to know what type of consent is attached to the use of data they hold and to have an easy way to seek a new consent if the use of the data changes. It is able to support greater accountability and transparency, streamlining consent processes to enable compliance with regulatory requirements.

Genetic privacy involves the concept of personal privacy concerning the storing, repurposing, provision to third parties, and displaying of information pertaining to one's genetic information. This concept also encompasses privacy regarding the ability to identify specific individuals by their genetic sequence, and the potential to gain information on specific characteristics about that person via portions of their genetic information, such as their propensity for specific diseases or their immediate or distant ancestry.

DNA encryption is the process of hiding or perplexing genetic information by a computational method in order to improve genetic privacy in DNA sequencing processes. The human genome is complex and long, but it is very possible to interpret important, and identifying, information from smaller variabilities, rather than reading the entire genome. A whole human genome is a string of 3.2 billion base paired nucleotides, the building blocks of life, but between individuals the genetic variation differs only by 0.5%, an important 0.5% that accounts for all of human diversity, the pathology of different diseases, and ancestral story. Emerging strategies incorporate different methods, such as randomization algorithms and cryptographic approaches, to de-identify the genetic sequence from the individual, and fundamentally, isolate only the necessary information while protecting the rest of the genome from unnecessary inquiry. The priority now is to ascertain which methods are robust, and how policy should ensure the ongoing protection of genetic privacy.

References

  1. ↑ Cambon-Thomsen, A.; Rial-Sebbag, E.; Knoppers, B. M. (2007). "Trends in ethical and legal frameworks for the use of human biobanks". European Respiratory Journal. 30 (2): 373–382. doi: 10.1183/09031936.00165006 . PMID   17666560. adapted from table 2, which includes a list of issues
  2. ↑ Karp, D. R.; Carlin, S.; Cook-Deegan, R.; Ford, D. E.; Geller, G.; Glass, D. N.; Greely, H.; Guthridge, J.; Kahn, J.; Kaslow, R.; Kraft, C.; MacQueen, K.; Malin, B.; Scheuerman, R. H.; Sugarman, J. (2008). "Ethical and Practical Issues Associated with Aggregating Databases". PLOS Medicine. 5 (9): e190. doi: 10.1371/journal.pmed.0050190 . PMC   2553818 . PMID   18816162.
  3. 1 2 3 4 Malin, B.; Loukides, G.; Benitez, K.; Clayton, E. W. (2011). "Identifiability in biobanks: Models, measures, and mitigation strategies". Human Genetics. 130 (3): 383–392. doi:10.1007/s00439-011-1042-5. PMC   3621020 . PMID   21739176.
  4. 1 2 Lin, Z.; Owen, A. B.; Altman, R. B. (2004). "GENETICS: Genomic Research and Human Subject Privacy". Science. 305 (5681): 183. doi:10.1126/science.1095019. PMID   15247459. S2CID   53909556.
  5. 1 2 Caulfield, T.; McGuire, A. L.; Cho, M.; Buchanan, J. A.; Burgess, M. M.; Danilczyk, U.; Diaz, C. M.; Fryer-Edwards, K.; Green, S. K.; Hodosh, M. A.; Juengst, E. T.; Kaye, J.; Kedes, L.; Knoppers, B. M.; Lemmens, T.; Meslin, E. M.; Murphy, J.; Nussbaum, R. L.; Otlowski, M.; Pullman, D.; Ray, P. N.; Sugarman, J.; Timmons, M. (2008). "Research Ethics Recommendations for Whole-Genome Research: Consensus Statement". PLOS Biology. 6 (3): e73. doi: 10.1371/journal.pbio.0060073 . PMC   2270329 . PMID   18366258.
  6. ↑ Lunshof, J. E.; Chadwick, R.; Vorhaus, D. B.; Church, G. M. (2008). "From genetic privacy to open consent". Nature Reviews Genetics. 9 (5): 406–411. doi:10.1038/nrg2360. PMID   18379574. S2CID   836309.
  7. 1 2 3 4 5 6 7 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.
  8. 1 2 3 4 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.
  9. ↑ Kaufman, D. J.; Murphy-Bollinger, J.; Scott, J.; Hudson, K. L. (2009). "Public Opinion about the Importance of Privacy in Biobank Research". The American Journal of Human Genetics. 85 (5): 643–654. doi:10.1016/j.ajhg.2009.10.002. PMC   2775831 . PMID   19878915.
  10. ↑ Ohm, Paul (17 August 2009). "Broken Promises of Privacy: Responding to the Surprising Failure of Anonymization". UCLA Law Review. 57: 1701. SSRN   1450006.
  11. ↑ Lee, L. M.; Gostin, L. O. (2009). "Ethical Collection, Storage, and Use of Public Health Data: A Proposal for a National Privacy Protection". JAMA: The Journal of the American Medical Association. 302 (1): 82–4. doi:10.1001/jama.2009.958. PMID   19567443.
  12. ↑ Rodwin, M. A. (2009). "The Case for Public Ownership of Patient Data". JAMA: The Journal of the American Medical Association. 302 (1): 86–8. doi:10.1001/jama.2009.965. PMID   19567445.
  13. ↑ Andreas Brekke, O.; Sirnes, T. (2006). "Population Biobanks: The Ethical Gravity of Informed Consent". BioSocieties. 1 (4): 385–398. doi:10.1017/S1745855206004029. S2CID   144943584.
  14. ↑ Haga, S.; Beskow, L. (2008). "Ethical, Legal, and Social Implications of Biobanks for Genetics Research". Genetic Dissection of Complex Traits. Advances in Genetics. Vol. 60. pp. 505–544. doi:10.1016/S0065-2660(07)00418-X. ISBN   9780123738837. PMID   18358331.
  15. ↑ Avard, D.; Knoppers, B. (2009). "Genomic medicine: Considerations for health professionals and the public". Genome Medicine. 1 (2): 25. doi: 10.1186/gm25 . PMC   2664958 . PMID   19341496.
  16. ↑ Clayton, E. W.; Steinberg, K. K.; Khoury, M. J.; Thomson, E.; Andrews, L.; Kahn, M. J.; Kopelman, L. M.; Weiss, J. O. (1995). "Informed consent for genetic research on stored tissue samples". JAMA: The Journal of the American Medical Association. 274 (22): 1786–1792. CiteSeerX   10.1.1.465.863 . doi:10.1001/jama.274.22.1786. PMID   7500511. This is the article which first discussed the issue
  17. ↑ Lurie, N.; Fremont, A. (2009). "Building Bridges Between Medical Care and Public Health". JAMA: The Journal of the American Medical Association. 302 (1): 84–86. doi:10.1001/jama.2009.959. PMC   3747986 . PMID   19567444.
  18. ↑ Ewing, Altovise T.; Turner, Arlener D.; Sakyi, Kwame S.; Elmi, Ahmed; Towson, Michele; Slade, Jimmie L.; Dobs, Adrian S.; Ford, Jean G.; Erby, Lori H. (2020-09-25). "Amplifying Their Voices: Advice, Guidance, and Perceived Value of Cancer Biobanking Research Among an Older, Diverse Cohort". Journal of Cancer Education. 37 (3): 683–693. doi:10.1007/s13187-020-01869-0. ISSN   1543-0154. PMC   10286728 . PMID   32975747. S2CID   221917485.
  19. ↑ Barr, M. (2006). "'I'm not Really Read up on Genetics': Biobanks and the Social Context of Informed Consent". BioSocieties. 1 (2): 251–262. doi:10.1017/S1745855206060029. S2CID   143367372.
  20. ↑ Hofmann, B. (2009). "Broadening consent--and diluting ethics?". Journal of Medical Ethics. 35 (2): 125–129. doi:10.1136/jme.2008.024851. PMID   19181887. S2CID   23555894.
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