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Ethical Use of Student Data in Higher Education – Advancing the conversation1

 

In a 2016 conference paper discussing ethical use of student data I noted that there was a ‘disconnect between national and international perspectives of the importance of institutional policy and guidelines regarding ethical use of student data, and the perceptions of academics about these guidelines’ (Jones, 2016, p300). I suggested that one strategy for bridging this divide was for conversations to be held both within and between institutions with an aim of informing and enhancing learning and teaching practice and culture. This post provides an overview of some of the conversations that have occurred in this area in the last 12 months in Australasia, particularly through the Australasian Society for Computers in Learning in Tertiary Education (ASCILITE).

First though, my interpretation of the phrase ‘ethical use of student data’. To me, and I am sure many others, this is much more than applying for, and being granted, clearance from your institution’s Human Research Ethics Committee. Certainly, this is an important step if you are intending to disseminate your findings as research and publish, and is sometimes a step that academic staff can overlook if research in their discipline does not normally involve ethics approval, or they do not consider this as they are not directly researching students, just their data. Ethical use also considers:

  • Protection of student privacy
  • Conversations with students regarding reasons for collection and use of data
  • Ensuring that data is used for informing and enhancing practice and the student experience
  • Obtaining consent from students; or, at least, informing students how and why their data will be used

The ability for students to ‘opt out’ of any data collection is a sensitive issue as there are some circumstances, for example, research into online discussion forums where this could adversely affect the research if students were given this option. This is just one aspect that needs further conversations and development of policy and guidelines.

ASCILITE is considered a leading organisation in the southern hemisphere for staff working in tertiary education in ‘fields associated with enhancing learning and teaching through the pedagogical use of technologies’ (ASCILITE, 2014) and as such is well placed to be leading the cross-institutional conversation on ethical use of student data. In 2017 some of the ways these conversations were facilitated included

  • Learning Analytics Special Interest Group ran a series of webinars with one facilitated by Paul Prinsloo having the topic of Responsible Learning Analytics: A Tentative Proposal
  • The 2017 ASCILITE Conference included an Exploratory Panel Session discussing ‘emerging ethical, legal, educational, and technological issues surrounding the collection and use of student data by universities, and the impact these strategies have on student trust and privacy.’
  • The Learning Analytics SIG also held a panel session discussing scenarios for Utopian/Dystopian future in regards to Learning Analytics

However, there was only one submitted paper with reference to ethical use of data (Brooker, Corrin, Mirriahi & Fisher, 2017). Similarly for the upcoming Learning Analytics Knowledge conference (LAK18), only one paper has any reference to ethics in the title, and at the 2017 conference there was one session with 3 papers. This suggests that whilst national and international bodies are promoting the conversations, there is still a way to go before these happen widely within institutions. Are there other organisations that are facilitating similar discussions?

Whilst promoting these conversations is a useful first step, there is also a need to continue to develop guidelines and processes. These will help ensure that staff are submitting ethics applications and their work with student data is conducted in an ethical manner. Additionally, Human Ethics staff need to work alongside academics and Learning & Teaching support staff; journals and conferences need to ensure that appropriate ethics approvals have been obtained and institutions need to involve students in all facets of Learning Analytics. These strategies will promote more widespread adoption of ethical practices in use of student data to inform and enhance learning and teaching practice and culture, and, ultimately, the student experience. Hopefully initiatives such as those outlined in this post will continue to grow and spark the necessary conversations – who will join us?

References

ASCILITE (2014) About ASCILITE. Retrieved from http://ascilite.org/about-ascilite/

Brooker, A., Corrin, L., Mirriahi, N. & Fisher, J. (2017). Defining ‘data’ in conversations with students about the ethical use of learning analytics. In H. Partridge, K. Davis, & J. Thomas. (Eds.), Me, Us, IT! Proceedings ASCILITE2017: 34th International Conference on Innovation, Practice and Research in the Use of Educational Technologies in Tertiary Education (pp. 27-31). Retrieved from http://2017conference.ascilite.org/wp-content/uploads/2017/11/Concise-BROOKER.pdf

Jones, H. (2016). Ethical considerations in the use of student data: International perspectives and educators’ perceptions. In S. Barker, S. Dawson, A. Pardo, & C. Colvin (Eds.), Show Me The Learning. Proceedings ASCILITE 2016 Adelaide (pp. 300-304). Retrieved from http://2016conference.ascilite.org/wp-content/uploads/ascilite2016_jonesh_concise.pdf

Declaration of Interests

Hazel Jones is a member of the ASCILITE Executive Committee and one of the facilitators for the Learning Analytics SIG.

Contributor
Hazel Jones
PhD candidiate/Educational Designer | University of Southern Queensland | USQ Staff ProfileHazel.Jones@usq.edu.au

This post may be cited as:
Jones H. (2018, 22 February 2018) ‘Ethical Use of Student Data in Higher Education – Advancing the conversation’. Research Ethics Monthly. Retrieved from https://ahrecs.com/human-research-ethics/ethical-use-student-data-higher-education-advancing-conversation

‘Don’t mention the c word: Covert research and the stifling ethics regime in the social sciences’0

 

Covert research is associated with deliberate deception in social research and equated with harm and risk to the researcher, the researched, the institution and the field. It is a controversial and emotive tradition that runs counter to and violates the received orthodoxy and professional mantra of informed consent enshrined in various ethical committees, institutional review boards and professional codes of practice. It is a methodological pariah and last resort position that is frowned upon, submerged, marginalized, stigmatized and effectively demonized (Calvey, 2017) in the social sciences. Indeed, to some in that community, to even contemplate a covert move is a belligerent step too far, which displays a cavalier attitude and belligerent lack of ethics. This view of deliberate misrepresentation (Erikson, 1967) accurately represents the received tone of much of the debate around covert research for a lengthy period of time. For many, despite the growing critical literature on informed consent as ideologically idealistic and disconnected from field realities, this derogatory and simplistic characterization of covert research has not altered.

I call for a fairer reading of the covert tradition and, hopefully in turn, a greater appreciation and recognition of the disruptive and invigorating role that covert research has brought to the social sciences. By using covert research, one enters into an ethical labyrinth and moral minefield, saturated in ethical dilemmas and puzzles, but it does not automatically follow that covert researchers have no ethical conscience. Often what are displayed are complex ethical self-regulations and guilt syndromes. Ethics then becomes a situated matter of application as well as a textbook understanding. What is partly called for is a broader and more nuanced way of understanding research ethics in practice.

From my own covert ethnography of bouncers in the night-time economy of Manchester, I experienced a series of ethical moments around witnessing violence and gaining deviant knowledge, that I managed in the field. Part of my sustained passing in the setting was accepting and not altering their moral code and sensibility about events, even though I might have a different personal interpretation. After my lived experience of six months as a covert nomadic bouncer doing different doors in the city, I felt that I had a richer appreciation of their subcultural values and cultural realities. Part of my investigation was in debunking the moral panics and stigma around bouncing being by one of them from the inside.

The classic covert exemplars of Cressey and his study of sex work, Festinger et al and their study of religious cults, Goffman’s study of Asylums, Milgram’s torture and pain experiments, Humphreys’ study of  public sexual deviance and Rosenhan’s pseudo-patient study of psychiatric diagnoses are found in most ethics textbooks and are clearly seminal and instructive work with a significant ongoing scholarship about them, which tend to conventionally frame the field of covert research. However, these classics, or what I call usual suspects, can also limit and narrow our understanding of the covert diaspora, with many other covert gems staying submerged. Also, some might erroneously draw the conclusion that covert research is an older tradition that is not conducted anymore. Indeed, the contemporary covert diaspora, on further investigation, is very diverse in the social sciences and spans several topics and fields including, and not definitively, crime, education, health, leisure, politics, religion and work.

On further granulation, these covert studies are rarely purist and employ more mixed strategies involving gate-keeping and key informants. Some studies, moreover, involve more unwitting types of concealment, rather than being designed deceptively. The diaspora then is more akin to a continuum rather than a fixed state of deception. Because the field of covert research is not incremental, integrated, or cross-fertilized, some of the studies have a stand-alone status in their respective fields. This is also compounded by the dearth of dedicated literature on covert research.

There has been a revival of sorts in covert research, although it is ultimately still likely to remain a relatively niche position. This revival, in part, comes from the significant rise in popularity of autoethnography and cyber ethnography, particularly forms of online lurking. A significant amount of them have covert dimensions, both witting and unwitting. A diverse range of sensitive and controversial topics has been explored by both methods.

The classic ethical question of do the means justify the ends often trades on an ideal-type view of informed consentand an inflated and exaggerated view of the potential harm, risk, and danger of covert research.

The hyper-alarmist response to covert research is partly based on a caricatured picture of covert research as heroic. Related to this, the image of the covert researcher is also tied up with versions of undercover research from popular culture in the sense of filmic and television sources, which can give an overly romanticized and glamorized view of the field. Covert research has also been a long accepted and normalized investigatory strategy for a range of practitioners and professionals, particularly in the police, the military and investigative journalism. Some of these covert investigations have had significant impact and influenced reform and change.

Covert research thus becomes a convenient scapegoat for those ethicists who quickly and strictly oppose it in any format, even if it could be used in a complementary way as part of a mixed or multiple methods approach. Covert work can be justified by providing a different type of insider insight, particularly in secretive settings and with illicit topics.

That is not to say that covert research can be zealously seen as a panacea. Nor is it the case that we no longer need robust ethical review processes and that ethical boards and committees are thus rejected and redundant. Such processes and organizations are useful and necessary but they need to refine, connect and adapt their policy sensibilities and mentalities to the messy nature of fieldwork realities.

In the current increasingly corporate climate of research, there has been what Hammersley (2010) cogently describes as creeping ethical regulation and the strangling of research, with covert research being particularly stifled. Miller (1995) described covert participation as the least used method and called for its reconsideration. Roulet et al (2017), in their more recent reconsideration of the value of covert research, argue that it has had a profound role in shaping the social sciences. Covert research can be a creative way, and certainly not the only way, to positively disrupt how we think about applied ethics. It offers an alternative way of doing situated ethics rather than being utterly devoid of them. Covert research is not to everyone’s taste, and will probably continue to offend some, but it should, nevertheless, be considered. Covert research will no doubt remain an object of both fear and fascination.

References

Calvey, D. (2017) Covert Research: The Art, Ethics and Politics of Undercover Fieldwork, London: Sage.

Erikson, K. T. (1967) ‘A comment on disguised observation in sociology’, Social Problems, 14 (4): 366–373.

Hammersley, M. (2010) ‘Creeping Ethical Regulation and the Strangling of Research’, Sociological Research Online, 15 (4) 16.

Miller, M. (1995) ‘Covert Participant Observation: Reconsidering the least used method’, Journal of Contemporary Criminal Justice, 11 (2): 97-105.

Roulet, T. J., Gill, M. J., Stenger, S and Gill, D. J. (2017) ‘Reconsidering the Value of Covert Research: The Role of Ambiguous Consent in Participant Observation’, Organizational Research Methods, 20 (3): 487-517.

Contributor
Dr David Calvey
Senior Lecturer | Manchester Metropolitan University | Staff profile | d.calvey@mmu.ac.uk

This post may be cited as:
Calvey D. (2017, 6 February 2018) ‘Don’t mention the c word: Covert research and the stifling ethics regime in the social sciences’. Research Ethics Monthly. Retrieved from https://ahrecs.com/human-research-ethics/dont-mention-c-word-covert-research-stifling-ethics-regime-social-sciences

What’s at risk? Who’s responsible? Moving beyond the physical, the immediate, the proximate, and the individual0

 

Building the Conversation

This month’s addition to the Building the Conversation series reflects upon how we approach risks beyond those that are physical, harm people other than a project’s participants and harms that are not immediate.

To some extent, when researchers reflect upon those harms associated with a project, they may well limit their assessment of risk to the here and now and to identifiable individuals. In addition, for projects in the medical sciences, those risks were long understood as predominantly physical in the form of injury, infection or disability and related to direct participants (e.g. persons who received an experimental pharmacological agent). This limited vision is not particularly surprising. One of the perverse consequences of requiring researchers to reflect on whether the potential benefits of research justify risk to participants is that some researchers are dissuaded from looking too carefully for risks and therefore avoid developing strategies for minimising these risks and mitigating possible harms. Even more perversely, this reluctance can trigger in human research ethics committees an unrealistic level of risk aversion.

It is vital that we remember that it is primarily the responsibility of researchers to identify, gauge and weigh the risk. Research ethics review bodies have the role of providing feedback to researchers to facilitate projects, not catch out researchers and chastise them for neglecting a risk. This is especially true if we do not have resource material to assist researchers with regard to this wider focus.

We need to improve our understanding of the complexity of risks, extending our vision to look beyond the physical, the immediate, the proximate, and the individual risks. At the same time, we need to review our understanding of on whom the responsibility for the identification, mitigation ad management of all of these risks should fall.

In recent decades, national human research ethics frameworks, such as the Australian National Statement on Ethical Conduct in Human Research (National Statement) (NHMRC 2007a) have augmented their original interest in physical harm with a much broader set of psychological, legal, economic and social harms. Documents such as the Australian Code for the Responsible Conduct of Research (NHMRC 2007b) cast this net wider still to include societal and environmental risks. However, the likelihood of incidence, the significance of the harm and the timing of such harms can be harder to predict, quantify and mitigate.

We are fuelling the potential for an adversarial climate (Israel et al., 2016) if we fail to provide researchers and our research ethics reviewers with guidance on how to approach such matters.

Human research ethics committees, guided by the frameworks in which they function, focus on immediate risks directly to the participants in a project. For example, the National Statement requires committees to be satisfied that “the likely benefit of the research must justify any risks or discomfort to participants.” (NHMRC, 2007, 10). Committees can feel less equipped to tackle risks that can affect participants after the active phase of a project, such as harms to the reputation and standing of a group that can come from the research output that is distributed long after data collection and perhaps years after the research ethics review.

Harm can also impact upon populations and social/professional/community groups much wider than the actual participants. For, example, research into the academic performance of children from schools in a low socio-economic area if reported insensitively by researchers or, indeed by the media, can further stigmatise the kids, and harm the reputation of the schools and teachers. Again, work on the informal income of members of marginalised communities might be used subsequently by government to target tax avoidance by the already vulnerable. Lastly, research on the attitudes of residents in coastal communities to climate change and rising sea levels can detrimentally effect the value of surrounding land. Indeed, some review processes require researchers to consider the possibility of adverse findings (both medical and non-medical in nature). Although the National Statement, (NHMRC, 2007 p.13), recognises risks of this kind, it leaves unclear whose responsibility they are.

Focussing on the rights of individuals from a Western liberal democratic perspective is unlikely to be helpful in other contexts, such as an Aboriginal and Torres Strait Islander community, in a cultural context where a Confucian approach would be more appropriate (Katyal, 2011), or even in some organisational settings where accountability is partly achieved through openness to external scrutiny in the form of research and evaluation. As a result, there have also been prompts to consider risks to identifiable third parties, groups, institutions, communities (Weijer et al., 1999). Values and Ethics and the Guidelines for Ethical Research in Australian Indigenous Studies (GERAIS) do recognise such matters might be considered by some potential participant pools on a collective basis and perhaps with an knowledge of a history of research abuse and exploitation of their communities and this attention to collective interests can be echoed in other work on research ethics and Indigenous peoples around the world (Israel, 2015).

This is perhaps one of the reasons why some minorities have produced their own research ethics guidance documents (for examples, see Hudson et al. (2010), Nordling (2017) and Islamic Council of Victoria (2017)). The value of this kind of guidan this on some for the moments that it clarifies that it is on researchers that the important responsibility lies to foresee, mitigate and manage these risks.

Another example of deleterious impacts from research that might not be immediately obvious to researchers, research ethics reviewers or research office staff arises in the category of ‘dual use’ research (Miller and Selgelid, 2007). This where a technique, technology or an apparently non-military discovery can be used for military or terrorist purposes – sometimes with devastating effect. Initially, the concern of biomedical scientists, the issue has also troubled anthropologists, geographers, sociologists, political scientists and international relations experts in the face of overt or covert funding by military or intelligence agencies (Israel, 2015). One of the growing challenges for a significant proportion of such work (e.g. quantum computing, computer security/intrusion/hacking, smart materials, computer vision and energy storage) is the work will not typically require research ethics or any other form of independent review. The existing model of human research ethics review is initially attractive as a response, but some reflection will quickly show that ethics committees are not likely to possess the expertise/information to identify the dual use and the work may be occurring in disciplines that have not built their capacity to think through the ethics of working with human participants.

Australia has a strengthened export control framework with regard to security classification, Defence Department permits/approvals and other requirements (e.g. data security). Many Australian universities have established dedicated teams and processes for this particular area of concern. It remains an area of community concern (see Hamilton and Joske, 2017). Such controls involve balancing academic freedom, a commitment to open science and the value of scientific discovery against (inter)national security, trade and diplomatic interests. Such a balancing exercise is plainly beyond the capacity required for human research ethics review, so that the responsibility needs to rely on another mechanism.

The implications of all of this are not trivial. This all requires a change in thinking for researchers, institutions, funding bodies, learned academies and regulators. Our attention to the potential harms from a project needs to encapsulate research outputs, impacts upon communities, persons who were not direct participants in the project as well as national interests. At the same time, the consideration of a project vis-à-vis the ethical principle of research merit needs to include broader societal benefits and contributions to knowledge that might also involve a much wider group and a longer timeframe than the ones to which we are accustomed. However, in order to reach a more sophisticated analysis of the balance between potential harms and benefits, we need to more clearly allocate responsibility for such risks and devise mechanisms that reassure the community that these responsibilities have been fulfilled.

In our view, merely widening the scope of the responsibilities of human research ethics committees to address all these risks could not only exacerbate the propensity for risk aversion, but could also distort their important focus on the welfare of research participants. The current review system needs to find ways of working constructively with other processes that build the capacity of researchers and their institutions to work with these broader risks and benefits.

Institutions must have resource materials for researchers and research ethics reviewers that have the primary objective of resourcing reflective practice and building expertise in risk assessment and mitigation. Researchers must recognise these matters as their primary responsibility and research ethics reviewers must focus upon facilitation not enforcing compliance. We have written about how institutions can implement such an approach (Israel and Allen, in press).

In short, we cannot afford to ignore these challenges. Instead, we should take innovation seriously and seek constructive solutions.

References

Allen, G. and Israel, M. (in press, 2018) Moving beyond Regulatory Compliance: Building Institutional Support for Ethical Reflection in Research. In Iphofen, R. and Tolich, M. (eds) The SAGE Handbook of Qualitative Research Ethics. London: Sage.

Hamilton, C. and Joske, A. (2017) Australian taxes may help finance Chinese military capability. The Australian. http://www.theaustralian.com.au/news/inquirer/australian-taxes-may-help-finance-chinese-military-capability/news-story/6aa9780c6a907b24993d006ef25f9654 [accessed 31 December 2017).

Hudson, M., Milne, M., Reynolds, P., Russell, K. and Smith B. (2010) Te Ara Tika. Guidelines for Māori Research Ethics: A Framework for Researchers and Ethics Committee Members. http://www.hrc.govt.nz/sites/default/files/Te%20Ara%20Tika%20Guidelines%20for%20Maori%20Research%20Ethics.pdf (accessed 29 December 2017).

Islamic Council of Victoria (2017) ICV Guidelines for Muslim Community-University Research Partnerships. http://www.icv.org.au/new/wp-content/uploads/2017/09/ICV-Community-University-Partnership-Guidelines-Sept-2017.pdf (accessed 29 December 2017)

Israel, M. (2015) Research Ethics and Integrity for Social Scientists: Beyond Regulatory Compliance. London: Sage.

Israel, M., Allen, G. and Thomson, C. (2016) Australian Research Ethics Governance: Plotting the Demise of the Adversarial Culture. In van den Hoonaard, W. and Hamilton, A. (eds) The Ethics Rupture: Exploring Alternatives to Formal Research-Ethics Review. Toronto: University of Toronto Press. pp 285-316. http://www.utppublishing.com/The-Ethics-Rupture-Exploring-Alternatives-to-Formal-Research-Ethics-Review.html

Katyal, K.R. (2011) Gate-keeping and the ambiguities in the nature of ‘informed consent’ in Confucian societies. International Journal of Research & Method in Education 34(2): 147-159.

Miller, S. and Selgelid, M. (2007) Ethical and philosophical consideration of the dual use dilemma in the biological sciences. Science and Engineering Ethics 13: 523-580.

NHMRC (2007a) National Statement on Ethical Conduct in Human Research. http://www.nhmrc.gov.au/guidelines-publications/e72 (accessed 29 December 2017).

NHMRC (2007b) Australian Code for the Responsible Conduct of Research. http://www.nhmrc.gov.au/guidelines-publications/r39 (accessed 29 December 2017).

Nordling, L. (2017) San people of Africa draft code of ethics for researchers. Science, March 17. http://www.sciencemag.org/news/2017/03/san-people-africa-draft-code-ethics-researchers (accessed 29 December 2017).

Weijer, C., Goldsand, G. and Emanuel, E.J. (1999) Protecting communities in research: Current guidelines and limits of extrapolation. Nature Genetics 23: 275-280.

Contributors
Dr Gary Allen
Senior consultant | AHRECS | Gary’s AHRECS biogary.allen@ahrecs.com

Prof. Mark Israel
Senior consultant | AHRECS | Mark’s AHRECS biomark.israel@ahrecs.com

This post may be cited as:
Allen G. and Israel M. (2018, 1 February 2018) What’s at risk? Who’s responsible? Moving beyond the physical, the immediate, the proximate, and the individual. Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/whats-risk-whos-responsible-moving-beyond-physical-immediate-proximate-individual

Use of Imported Human Biospecimens in Research0

 

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[1]. 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[2]. 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‘[3].

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[4].

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[5].

Notes

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>.

Contributors
Ms Anne Walsh,
Manager Research Ethics and Integrity,
Office of Research Ethics and Integrity,
Division of Research and Commercialisation,
Queensland University of Technology
Anne.Walsh@qut.edu.au

Adjunct Professor Conor Brophy
Chair, University Human Research Committee (UHREC)
Division of Research and Commercialisation
Queensland University of Technology
Conor.brophy@qut.edu.au

Dr Conor Brophy
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.

Ms Anne Walsh
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.

Acknowledgments:
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

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