The use of biospecimens in research is a vital tool in the development of knowledge and innovation in biomedical research. There are a number of established biobanks, local and international, that offer a rich resource of human biospecimens for research purposes. In most cases these resources are linked with genetic and/or other personal health information.
There is a vast amount of literature that comments on the ethical and legal challenges involved in biobanking, including the collection, processing and sourcing of biospecimens. This blog post addresses the types of information that Australian HRECs and researchers require to establish the ethical acceptability of research involving the use of biospecimens, particularly where the samples are sourced and imported from an international supplier.
In Australia, the National Health and Medical Research Council (NHMRC) National Statement on Ethical Conduct in Human Research, 2013 (National Statement), Chapter 3.4 on Human Biospecimens in Laboratory Based Research’, refers to human biospecimens as ‘any biological material obtained from a person including tissue, blood, urine, sputum and any derivative from these including cell lines‘ and outlines the ethical considerations for the collection, storage and use of biospecimens in research.
Specifically, for imported samples, Chapter 3.4.13 holds that ‘researchers must establish whether these human biospecimens were obtained in a manner consistent with the requirement described in the National Statement and relevant Australian legislation.’ Where it cannot be established that specimens were obtained in a ‘manner consistent with the requirements described in the National Statement and relevant Australian legislation the biospecimens should not be used for research in Australia.’
Determining whether the imported biospecimens were obtained in a way that satisfies the principles of the National Statement and conforms to Australian legislation requires information relating to the provenance of the biospecimen/s. Provenance is a broad term that generally means where something comes from, its origins and the ‘process or methodology by which it is produced‘.
Establishing the provenance of samples is important because it goes to the heart of understanding how samples were first obtained and from where they were derived, rather than merely how the current researchers obtained them; and because the laws and ethical guidance in different countries may differ from those applicable in Australia. These factors can reveal a potential conflict between the manner in which samples have been obtained abroad and the ethical principles set out in the National Statement. In addition, Australian laws and other national guidance prohibit the sale or exchange of human tissue, effectively calling in to question the use of samples sourced from an overseas supplier who may accrue profits from their sale or exchange.
In some cases, commercialisation of biospecimens by third party suppliers may include biobanks or biospecimen repository centres which may gain income from the manufacture, supply and distribution of biospecimens. In this circumstance, it is not always clear to what extent there has been a passage of responsibility for prior undertakings made with the donor to the wholesaler to ensure the type or quality of the activity subsequently conducted with the samples. This may not pose a problem for the researcher but may pose a problem for the host institution.
A further concern that is frequently unclear is whether the donor was aware of, or consented to, the use as proposed in the current research. Determining the nature of consent for collection, re-distribution and research use from such suppliers is difficult. Information may not be provided on the jurisdictional regulations applying to donation and subsequent research use. Instead the only indication of practice pertaining to specimen collection and when it occurred is generalities about compliance with such regulations, rather than the specifics of what they were at the time, and how they may concur with previous and current Australian guidance.
The following information relating to sample provenance can assist researchers and HRECs to determine if the biospecimens were collected in an ethically acceptable manner and that their proposed use is respectful of donor expectations:
- Evidence of donor informed consent for the use of their biospecimen/s is a paramount consideration for HRECs and is a primary indicator for how the biospecimen can be used in later research. Importantly, evidence of consent will indicate: whether the donors agreed to the scope and/or nature of subsequent research; how samples would be managed; and whether they were aware they would have no claims to any commercial gain from discoveries made by researchers or research organisations. In addition, such documents allow assessment of undertakings, if any, for researchers to feed-back findings that may be important for the donor’s blood relatives or community, particularly in the context of health research.
- Information relating to the approval for and level of oversight and custodianship of the original biospecimen resource (obtained from a commercial company, biobank or research colleague/partner), and how this is passed to researchers gaining access to samples. Ensuring that appropriate custodianship arrangements are in place for the biospecimen/s can provide assurance on the way in which the biospecimen/s were obtained.
Custodianship arrangements may include transparent policies for the maintenance of the privacy and confidentiality of research participants, protocols for the distribution of samples to researchers and records pertaining to the informed consent and the identity of research participants.
Finding information relating to the provenance of samples for some overseas suppliers can be difficult and is generally limited to information accessible on supplier websites. Often it is not always obvious or clear how suppliers have obtained biospecimens. Often a Materials Transfer Agreement (MTA) is all that exists. This may contain provisions restricting how the biospecimen/s are used and for what purposes, and are generally understood as being indicative of the custodianship arrangements put in place to protect donor expectations.
In the absence of any information relating to the provenance of imported samples, HRECs and researchers may consider the use of biospecimens under a ‘Waiver of consent’ (National Statement, 3.4.12). This generally applies to situations where it is at least known that samples were collected during clinical procedures and stored in pathology facilities. Because no prior consideration was given to research use, no consent has been obtained from donors. Under such circumstances, because of the time since collection, and the numbers of samples, it may be impracticable to return to patients to inform them of the potential research use and to gain consent. The HREC must satisfy itself that the conditions for a valid waiver from the requirement for consent apply. This is a judgement based on the level of risk for, and reasonable expectations of, the original donors, management of samples and data, the merits of the study and potential benefits for others such as the community at large from undertaking the research.
Establishing the ethical acceptability of imported biospecimens is challenging for researchers and HRECs. Until such time as there is harmonisation of global biobanking standards, greater engagement of donors in understanding the community benefits accruing from biospecimen research, and increased awareness of the ethical issues underlying the collection and transfer of samples, all available information relating to sample provenance must be provided for scrutiny by reviewing HRECs.
1. An example of a list of international biobanks can be found at http://specimencentral.com/biobank-directory/
2. See for example, 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 and Don Chalmers et al. (2016) ‘Has the biobank bubble burst? Withstanding the challenges for sustainable biobanking in the digital era.’ BMC Medical Ethics 17:39 https://bmcmedethics.biomedcentral.com/articles/10.1186/s12910-016-0124-2.
3. The Australian National Data Service (ANDS) defines ‘Data Provenance’ as ‘to document where a piece of data comes from and the process and methodology by which it is produced’. <https://www.ands.org.au/partners-and-communities/ands-communities/data-provenance-interest-group>.
4. See Transplantation and Anatomy Act 1979 (Qld) s 40(1) and cognate state and territory legislation and discussion in the now revoked NHMRC, ‘Ethics and the Exchange and commercialisation of products derived from human tissue’ (Background and Issues Paper, NHMRC, October 2011) https://www.nhmrc.gov.au/_files_nhmrc/file/health_ethics/ethcial_issues/e103_ecpd_humantissue_111019.pdf.
5. See example of donor awareness at HTA Human Tissue Authority The Regulator for human tissue and organs, Donating your tissue for research FAQs < https://www.hta.gov.uk/faqs/donating-your-tissue-research-faqs>.
Ms Anne Walsh,
Manager Research Ethics and Integrity,
Office of Research Ethics and Integrity,
Division of Research and Commercialisation,
Queensland University of Technology
Adjunct Professor Conor Brophy
Chair, University Human Research Committee (UHREC)
Division of Research and Commercialisation
Queensland University of Technology
Dr Conor Brophy Ms Anne Walsh
Conor has been a member of human research ethics committees in UK and Australia for 20 years. She chairs the Mater Misericordiae Ltd HREC and the Queensland University of Technology HREC, reviewing human research from all faculties. She has degrees in medicine, bioethics and clinical research and previously worked in health and pharma research and clinical governance.
For 15 years, Anne has worked in a number of roles relating to clinical and research ethics and research governance and integrity. She has been a member of human research ethics committees in the public and private health sector. Anne has degrees in science, philosophy and law. She is currently a PhD scholar in the Law Faculty, QUT.
Dr Conor Brophy
Ms Anne Walsh
Thanks to Dr Jane Jacobs, Director Office of Research Ethics and Integrity and
Dr Nicola Pritchard, Research Ethics Coordinator, Office of Research Ethics and Integrity, for review and input.
This post may be cited as:
Walsh A. and Brophy C. (2017, 1 February 2018) Use of Imported Human Biospecimens in Research. Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/use-imported-human-biospecimens-research