Some key ethical questions that have arisen regarding biobanks have included:
- Can individuals consent to allow their samples and information be used for all sorts of research in the future? Initially, such “blanket consent” was critiqued by many experts, but it is now accepted widely.
Caulfield T, Murdoch B (2017) Genes, cells, and biobanks: Yes, there’s still a consent problem. PLoS Biol 15(7): e2002654. https://doi. org/10.1371/journal.pbio.2002654
- If biobanks sequence samples and have genetic findings that could be helpful to people who contributed samples, should that information ever be returned? That has mostly NOT been done, but some biobanks that standardly do genetic sequencing on samples do return very actionable findings.
- How do researchers protect donor information while researching connections between a person’s genes and their clinical outcomes? Researchers have a high incentive to identify genetic sequences that carry important implications for disease progression, drug metabolism, etc., but these sorts of studies also increase identifiability risks for donors.
Hansson MG. Ethics and biobanks. Br J Cancer. 2009 Jan 13;100(1):8-12. doi: 10.1038/sj.bjc.6604795. Epub 2008 Nov 25. PMID: 19034276; PMCID: PMC2634684.
- How do we ensure consistent tissue preparation and storage across biobanks and who should uphold these standards? Standardizing protocols are necessary for guaranteeing research is conducted with high quality samples, and the resulting outcomes are dependable and repeatable.
Heimo Müller, Georges Dagher, Martina Loibner, Cornelia Stumptner, Penelope Kungl, Kurt Zatloukal, Biobanks for life sciences and personalized medicine: importance of standardization, biosafety, biosecurity, and data management, Current Opinion in Biotechnology, Volume 65,2020, Pages 45-51, ISSN 0958-1669, https://doi.org/10.1016/j.copbio.2019.12.004.
- Who owns the biobank samples? There is debate around sample ownership and who has claim to the samples once they have been collected and stored in a biobank.
Yassin R, Lockhart N, González del Riego M, Pitt K, Thomas JW, Weiss L, Compton C. Custodianship as an ethical framework for biospecimen-based research. Cancer Epidemiol Biomarkers Prev. 2010 Apr;19(4):1012-5. doi: 10.1158/1055-9965.EPI-10-0029. Epub 2010 Mar 23. PMID: 20332272; PMCID: PMC2858050.
Biobanks play a crucial role in the recent development of precision medicine. Precision medicine seeks to identify genes responsible for developing disease to help dictate treatment and identify new targets for drug development. A large amount of data is needed to strengthen the connections between a person’s genes and their clinical presentation. Biobanks are well-suited for this task, given their role in storing and distributing biospecimens as well as associated health data.
IU Health and the IU School of Medicine are currently employing precision health techniques to improve outcomes in areas such as cancer, neurodegenerative disease, childhood disease, and chronic illness via their Precision Health Initiative. The Indiana Biobank, a part of the Indiana CTSI, makes possible the ongoing research into areas such as pharmacogenomics and disease risk assessment and is central to the success of the Precision Health Initiative. For more information on the Indiana Biobank visit here and for more information on Indiana University’s Precision Health Initiative follow this link.
Several IUCB researchers are published on this topic, including multiple collaborations within the center. Jane Hartsock and Mary Ott have focused their work on adolescent reconsent and consent waivers. Their work makes a legal and ethical case for incorporating anticipatory waivers into an adolescent’s assent and consent process for pediatric biobanks. T.J. Kasperbauer and Peter Schwartz have contributed to ethical and empirical discussions of participant understanding of biobanking and the role of trust in biobank enrollment. They have also worked closely with the Indiana Clinical and Translational Sciences Institute (CTSI) and IU Health to introduce biobank consent into the healthcare setting. Additionally, the IUCB has discussed biobanking as a part of their TREATs talk series. More information on the IUCB’s work on biobanks can be found below.