Biobank ethics

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.

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]
issue	consensus	controversy	notes
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 project	Research 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 generates	When 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 sharing	Research 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]

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.[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]

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.[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]

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. 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. 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.
5. 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.
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. 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.
14. 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.
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. Hofmann, B. (2009). "Broadening consent--and diluting ethics?". Journal of Medical Ethics. 35 (2): 125–129. doi:10.1136/jme.2008.024851. PMID 19181887.
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.