Sage Journals: Discover world-class research

Abstract

This paper argues that specific individual informed consent and other forms of consent predicated on a right to autonomy may not in all circumstances be appropriate for the establishment and use of large data sets of health information. We suggest that there are inherent failings in such an approach, shortcomings that we analyse below. We argue that individuals share an obligation to contribute their data, as doing so is cost-free (however cost is construed) and benefits accrue to the population as a whole. Large health data sets can be considered public goods – goods that are non-rival in consumption (they are not depleted in being used, so others are not prevented from using them) and in some cases non-exclusive in use (e.g. when large datasets of non-identifiable information are publicly-accessible without cost, such as some Australian Bureau of Statistics data) – and contributing to these goods may be an obligation, the meeting of which allows citizens to invest in knowledge infrastructure. The approach argued for here is a variation of a communitarian ethic in which people have an obligation to contribute their data but have no correlative right to expect or receive an individual benefit.

Keywords

autonomy communitarian consent databanks health obligations

Introduction

Administrative datasets including education, community services and electronic health records are recognized for their value in discovery research (Whitehead, 2013). And by linking large databases to bio-repositories, there is even greater potential for researchers to contribute to the understanding of human disease and improve long-term health outcomes (Molster et al., 2012). But if current consent requirements persist, the potential to improve long-term health outcomes across communities may be limited. In this paper we ask whether consent is needed to include an individual’s information in large health datasets that are used in de-identified form for research purposes. We argue that although use of such data must be subject to approval by an appropriate human research ethics committee, no consent is needed for individuals’ information to be included and no consent is needed for de-identified information to be extracted from such data sets.

Autonomy and consent

Among the current controversies concerning population epidemiological studies using linked data and databanks has been a focus on the ethical principle of autonomy and specific individual consent, to which it is related.¹ Specific individual consent from participants has been the default position required of researchers since the 1970s, but we contend that such consent needs to be reconsidered because it is based on a premise that should not apply for research conducted on large data sets where there is no risk of personal identification and where population-wide benefits are to be reasonably expected.

Consent

Individual informed consent formally entered public consciousness in the 1957 US legal case Salgo v. Leland Stanford Jr University Board of Trustees (317 P.2.d 170) and has been primarily a legal concept since (Beauchamp, 2011; see also Dworkin, 1988: 101). It is a concept principally predicated on avoiding tortious negligence and on the presumption of a right of self-decision (Dworkin, 1988: 101; citing Nathanson v. Kline, 186 Kan. 393 at 406). In the 1970s, medical and research ethics began seriously to focus on informed consent and particularly on the patient or participant’s right to authorize or not a biomedical intervention (Beauchamp, 2011: 515). However, in an environment where large sets of health data can be analysed with increasing ease and efficacy in pursuit of public health objectives, should a form of consent predicated on the avoidance of tortious negligence continue to be the dominant form of consent? This is an especially relevant question considering that negligence, at law, protects against three types of harm: personal injury; damage to property and; economic loss. And for negligence to occur, three elements are needed: a (legal) duty of care is owed; there has been a breach of the duty owed; and damage was suffered as a result of the breach (Grant v. Australian Knitting Mills, 1935). In a case where health and other administrative data are compiled into large datasets and de-identified before being subjected to statistical interrogation, it would seem highly unlikely that personal injury might occur or that there might be negligence. So it is appropriate to consider whether consent is needed at all in cases where large health data sets are compiled and subsequently analysed (for research purposes) in a de-identified form or, if it is thought to be needed, what form the consent might take. It would also seem appropriate to ask whether the burden of obligation should continue to rest with researchers, or whether members of the community have an obligation to contribute their data.

If we are to retain consent, there are several models of consent we might consider in human research, each with advantages and disadvantages. There is, for example, explicit, implied, tiered, enduring, waived or opt-out consent, each with benefits and limitations specific to whether the research design is interventional, observational, or epidemiological and whether participants (or their data) are identifiable, potentially re-identifiable or not identifiable.

Bases for an appropriate ethic

However, we need also to consider the basis on which an appropriate ethic might be developed as, in considering how best to manage consent in research involving large health-related datasets, an appropriate ethic may be developed on the basis of very different ideas: the principle of respect for individual autonomy and the responsibility to work for the common good (or in the public interest), for example. These two different ideas might best be characterized in terms of a distinction between a rights-based approach which has its origins in libertarian thought and legal precedent and an obligations-based approach with its origins in communitarian ethics. The rights-based approach has been the dominant form of bioethics for the past four decades, but it has had its critics in that time. For Daniel Callahan (1994), bioethics in its dominant form has two major deficiencies: it has ‘failed to pursue with sufficient imagination the idea of the common good or public interest on the one hand, and that of personal responsibility, or the moral uses of individual choice on the other’. He says that a ‘moral void’ has been created by reducing ‘the problem of the common good to justice and the individual moral life to the gaining of autonomy’ (p. 28). So how best to fill that void? Let us start by clarifying two key ideas: individual rights and the nature of a public good.

Individual rights vs the public good

Respect for autonomy or a right to autonomy?

Respect for autonomy has been the dominant principle underlying consent in health and human research since the publication of the Belmont Report (1979). The Report’s first basic ethical principle is Respect for Persons, but this is clarified as follows:

Respect for persons incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents, and second, that persons with diminished autonomy are entitled to protection. The principle of respect for persons thus divides into two separate moral requirements: the requirement to acknowledge autonomy and the requirement to protect those with diminished autonomy.

Broadly speaking, the principle of respect for autonomy is usually translated into a right to autonomy. However, autonomy over what is not entirely clear. The law presumes ‘each man is considered to be master of his own body’ and ‘has a positive right of informed consent which exists both in therapeutic and experimental settings’ (Dworkin, 1988: 101 citing Nathanson v. Kline, 186 Kan. 393 at 406), but having autonomy over what happens to one’s body does not fully satisfy one’s rights to autonomy. What of a person’s right to control information about him or herself, including information that affects reputation, financial well-being and capacity to enter into relationships and associations … and so on?²

Talk of the right to autonomy often presumes that the focus of discussion is a right to bodily autonomy, but the presumption risks effacing other possibilities. The presumption of bodily autonomy aside, staying with a legal definition has its own problems for, as Gerald Dworkin observes, ‘the law has specific features (such as the need to make a decision) that do not allow one to argue directly from a legal justification to more general normative conclusions’ (1988: 101).

Rights have come to dominate a lot of the discussion around the concept of consent, particularly the assertion that each human has a right to control what happens to his or her body. But rights themselves are problematic. They ‘are entitlements (not) to perform certain actions, or (not) to be in certain states; or entitlements that others (not) perform certain actions or (not) be in certain states’ (Wenar, 2011). More than a century ago Wesley Hohfeld noted that ‘the term “rights” tends to be used indiscriminately to cover what in a given case may be a privilege, a power, or an immunity, rather than a right in the strictest sense’ (Hohfeld, 1913: 30). This indiscriminate or ill-defined use of rights continues today. Using Hohfeld’s terms, we might ask: What privileges or liberties might a right to autonomy bestow? What am I free to do? What claim may I properly make against another on the basis of a supposed right to autonomy, and does the claim itself impose a duty on others? What power might I have to change the rules in respect of my rights, to change what I am free to do and what I can claim? And what immunity might I have to prevent others altering my privileges, claims or powers?

A right is effectively an entitlement that constrains behaviour (Mackie, 1977). The constraint on others can be an obligation to do something (the obligation resulting from a claim right, or welfare right) or an obligation not to do something (an obligation resulting from a liberty right). The constraint is, however, not general: the constraint is always on an individual to behave in certain ways toward the individual possessor of the right (Hohfeld, 1913: 17).³ If I have a right to X – whether it is a claim (welfare) right or a liberty right – then you are constrained through having a corresponding obligation to behave toward me in a certain way. If I have a welfare right there is an onus on you to assist me achieve X; if I have a liberty right, on the other hand, then all that is required of you is that you leave me alone to pursue the exercising of the right – there is no obligation to help me.

The right of a patient or research participant to exercise autonomy is generally held to be a form of welfare right rather than a liberty right. As such, there is an obligation on each health practitioner to ensure each of their patients can exercise autonomy and on researchers to ensure that each participant can exercise autonomy: the researcher or practitioner, as obligor, is compelled through such vehicles as regulation to meet their obligation through acquiring full, informed consent from the individual patient or participant.

The idea of autonomy as a right possessed by an individual has found its way into all areas of health and human research. From the World Medical Association’s Declaration of Helsinki (1996) through the Oviedo Convention (Council of Europe, 1997: 4. IV) to the UNESCO Declaration on Bioethics and Human Rights (2005), there is an underlying presumption that the interests and welfare of the individual are to be considered more important than the interests of science or society. This is best exemplified in the second item of Article 3 in the UNESCO Declaration: “The interests and welfare of the individual should have priority over the sole interest of science or society.”

Public good, public interest

In contrast to a presumed individual right to exercise autonomy (however that is defined) is the idea of public interest or public good. An ethic based on public interest in effect reverses the relationship between rights and obligations found in an ethic based on respect for (individual) autonomy. The focus is more on collective values, such as reciprocity – found prominently in Australia in the National Health and Medical Research Council guidelines on indigenous health research (National Health and Medical Research Council, 2003). In a public good or public interest ethics there is a presumed obligation to contribute to the good of the community. However, such a good should not be construed simply as the sum of individual goods but rather that the good of the community is something other than the sum of individual interests.

What we are proposing might be expressed as an extension of the idea of familial comity (Davey et al., 2006) and of Kozlakidis and Cason et al.’s (2012) discussion of the conflict between the rights of a person not to contribute samples to medical research and the future rights of those not yet born, but who stand to benefit from research relying on the samples. We have, in effect, extended the idea of familial comity to include the notion that an individual’s personal autonomy should be considered in relation to their responsibilities to others. This provides a useful counterbalance to the principle of autonomy as it is usually employed in justifying the need for consent, and supports a ‘joint account’ approach to the collection and use of large health datasets. Like Kozlakidis and Cason et al., we argue that donation of samples should be a societal obligation but, in contradistinction to them, not that the obligation is altruistic. We hold that there is reciprocity implied in that providing our data or samples has the potential to provide a benefit to the providers directly, to their extended families or to the communities in which they live. There may be no benefit directly to an individual provider of information, but that in itself does not make the provision of information altruistic.

The perceived obligation to contribute to the public good is often noted as being based in the idea – going back at least to Aristotle’s Politics (n.d.: Bk 1, Ch 2) – that we are firstly social animals and contingently individuals, that the state (or, more generally, society) is prior to family and individuals. Following from this, we miss out on something fundamental to our humanity if we conceive of ourselves merely as atoms or individuals, since the society we live in and help create is fundamental to our flourishing as humans. Building an ethic on communitarian lines honours social relationships and the obligations that we are under to maintain the social structure, rather than to consider as primary the rights of individuals. However, no matter that such a communitarian ethic might be built on a principle of benevolence in pursuit of a generalized benefit, we still need to protect against what John Stuart Mill (1860) called the tyranny of the majority. How we do that is a problem inherent in all democracies, and not easily solved. Below is an attempt to do so based in the notion of public goods.

Public goods and the public good

The Human Genome Organization Ethics Committee said in 2002 that human genomic databases are ‘global’ public goods from which humanity as a whole should be the beneficiaries (Sutrop, 2011: 536). So, should large databases of administrative data in general be considered public goods and, if so, should we change the way we regard research that employs them?

Public goods have the qualities of being non-rival in consumption and non-exclusive in use. That is, my use of the good does not use it up in the way my eating an ice cream would use up the ice cream; and a benefit from the good is available to any person who wishes to receive it. A simple example of a public good in this sense is a street sign: my using it does not exhaust its use and any person in the street can get the benefit from it. Similarly, a large data set of health-related data may be accessed multiple times by multiple researchers (or even the public generally through web-enabled search portals) without the data being used up. And every member of relevant populations stands, potentially, to benefit in some way from information extracted from such data sets: no-one need be excluded. Large sets of health-related data should be considered public goods. And, just as we all contribute to the provision of street signs and the like without being asked individually, why should we be asking for individual consent before including people’s information in large health data sets?

For a population (including subsets of the population and individuals) to derive benefits from epidemiological research using databanks and health administrative datasets, a large proportion of the population – if not the whole – needs to contribute data. It has been argued recently that claims of consent bias in large data sets of health information have been overstated; that common statistical methods can obviate consent bias and that any residual effects of consent bias are ‘below an acceptable level of imprecision and constitute a reasonable social cost for conducting ethically responsible research’ (Rothstein and Shoben, 2013: 27). Whether this is so in all analyses of health datasets, it remains the case that Rothstein and Shoben’s study assumes that informed consent is necessary for research involving large data sets to be ethical. We argue that from an approach based in a person’s obligation to his or her community, informed consent is not necessary for the compilation and use of large data sets to be ethical. In addition, if the whole of a population (or a close approximation to it) is included in a dataset, there is no need for an ‘acceptable level of imprecision’ and no social cost for conducting research using the data.

From the perspective of a communitarian ethic, there is an obligation on each of us to contribute to large population databanks of health information. It is a cost-free contribution to the welfare of the community or society we live in; and requiring informed consent to be obtained from autonomous individuals is not necessarily consistent with the public good, where the public good is not simply an aggregate of individual private goods. So, what might be the options?

Opt-out consent

The Australian National Statement on Ethical Conduct in Human Research in Human Research (National Health and Medical Research Council, 2007) provides guidance in identifying information that needs to be disclosed to participants in research. Chapter 2.3 has two processes for when explicit consent is not feasible: limited disclosure, and waiver of consent, a decision on either of which must be made by a Human Research Ethics Committee. In 2013 the Australian Health Ethics Committee (AHEC) proposed a revision to Chapter 2.3 of the National Statement (National Health and Medical Research Council, 2013) which would allow the introduction of an opt-out process for low-risk research, including research using large data sets of unidentified information. The opt-out process proposed would require researchers to provide information to potential participants, who are allowed to decline to participate. If they do not decline, they are included. While the idea of an opt-out process for large health data sets is not new (see, e.g., Clark and Findlay, 2005) and there are recent strong proponents for it (see, e.g., Olver, 2014) we are reluctant to endorse such a process, particularly one in which researchers are required to contact and inform potential participants that they can opt out of a study they had not considered joining. It seems a lot of effort for researchers, with little justification of purpose or benefit, and places a burden on participants that they have had no choice but to bear: having been informed of their right to opt out, potential participants must then make a choice on an issue which many are likely to understand imperfectly, if at all. Rothstein and Shoben’s conclusions (2013: 27) notwithstanding (notably that common ‘statistical methods usually account for consent bias’), an opt-out provision could introduce significant biases into certain studies where data are analysed on a population basis. For instance, some birth anomalies, some cancers and zoonotic infections are so rare that complete ascertainment is the only way to identify and monitor clusters or epidemics. From these administrative datasets, researchers have reduced the impact of important health conditions such as spina bifida (Bower and Stanley, 1992) and other birth defects (Colvin et al., 2010). The AHEC notes that the opt-out approach provides less rigorous protection of a potential participant’s autonomy, but accommodates autonomy better than a waiver does.

The AHEC consultation paper asserts that the integrity of research may be compromised in the absence of an opt-out consent process. This appears to be based on a presumption that the right to healthcare is linked to an obligation to contribute to those medical research activities that pose neither risk nor cost to the individual. We agree that a right to healthcare sits alongside an obligation to contribute to medical research, but think the AHEC would be better using a different principle. Under the principle of autonomy, which it cited, it is a matter of individual choice as to whether and how any obligation is honoured. We propose that a communitarian approach to ethics is better suited to the situation.

As Meslin and Cho (2010) have noted previously, for many years science and society have engaged in an informal ‘social contract’ – in which society accommodates and supports the scientific community to undertake important research, and the scientific community contributes knowledge that can be translated into community benefit. For example, society has accepted the allocation of significant resources to the Human Genome Project and has derived economic and health benefits – benefits that have been guided by ethical principles applied to the conduct of genetic research with human subjects.

Broad or open consent

Sutrop (2011) notes that in the use of population-based human genetic databases fully-informed consent is impossible, and the operating notion should be open (or broad) consent. Open consent is where ‘participants agree that their biological samples and data will be stored in the database and used for any future scientific research’ – research that has been approved by an ethics committee which is required to act in the participants’ best interests. She notes continuing debate as to whether open consent is genuine consent but claims that ‘the dominant view favors broad consent as the most efficient and economic approach’ (p. 537) to using human genetic databases.

Such an approach to consent, while now commonly used, does not operate from a principle of respect for individual autonomy, but is based on a communitarian understanding that citizens have obligations to their community and society (generally). But, care needs to be taken as we need to clarify whose community is to determine the common good or public interest (2011: 542) and need to remember that open consent does not obviate the possibility of consent bias, particularly in examples such as those noted above.

Moral obligations of patients and participants

We propose that medical research should not be regarded as something intrinsically dangerous, but that it is the best means for protecting against current and future disease. This change of perspective implies an emphasis on the collective responsibility of citizens and applies well to biobank research as well as to health database research generally. Both of these, in contradistinction to much medical research, offer a possibility to promote health and wellbeing at negligible or no individual cost or risk – no matter in what terms ‘cost’ is construed. Health database research and medical research using large-scale biobanks with coded samples should be thought of as a collective project to which each individual has an obligation to contribute. Failure to recognize such an obligation may be the result of confusion over the difference between research and clinical care.

The difference between research and clinical care

That the healthcare system is a product of much previous research and experience, without which there would be no healthcare, is often ignored, as is the realization that medical research is a slow process that cannot be expected to be of direct use if initiated only once the need is evident to all. Both healthcare and medical research offer a chance to keep up with the evolution – and treatment – of new and old diseases. However, the distinction between healthcare and medical research should be made clear so that individuals do not assume there should be a direct personal benefit from research, but rather they should recognize an obligation to contribute to the advancement of public health.

Research is a class of activity ‘designed to develop or contribute to generalizable knowledge’ (Belmont Report, 1979: Part A) that consists of theories, principles or relationships, or the accumulation of information on which they are based, that can be corroborated by accepted scientific methods of observation and inference. Clinical care exists primarily to benefit the individual patient. Not acknowledging the difference between research and clinical care is the basis of the therapeutic misconception, which is characterized by individuals wrongly attributing to research the goal (at least in part) of benefiting the research subjects individually (Henderson et al., 2007).

Under the Universal Declaration on Bioethics and Human Rights, each of us has a right to quality healthcare (UNESCO, 2005:, Articles 14 (2), 15 (1) b) but, following Hohfeld (1913), that right has a correlative duty or obligation. In the case of medical research that is of no risk or cost to the individual, and hence where there is no breach of Article 2 of the Universal Declaration, the correlative obligation is to take part. For example, once materials have been collected for clinical management of the patient, and used as planned, what is left over can be thrown away or used for research.⁴ In this case the patient has already benefited from the investigation as intended, and it is not obvious that he or she legitimately can claim a right to further direct gain. In this context, as with health administrative data entered subsequent to clinical care, contributions of left-over samples to the public asset of medical research are like taxation: the individual should have no expectation of any specific individual-only benefit, especially when research presents no risk or cost to the individual. Neither the common law nor Australian human tissue Acts acknowledge that the provider of tissue has property rights in human tissue removed in surgery or for diagnostic purposes (Australian Law Reform Commission, 2003). However, hospitals and others enjoy under the common law some proprietary rights in preserved samples. Such samples are oftentimes used for research with the proviso that the researcher’s right to make use of samples obtained in clinical practice does come with an obligation to make research results available to the healthcare system and to behave in ways consistent with ethical guidelines and the law. Notwithstanding common law proprietary rights, however, it is important to avoid situations such as those that arose at Alder Hey Children’s Hospital in Liverpool, UK (Hall, 2001).

A right to benefit, or an obligation to contribute?

It is sometimes argued that sample donors have a right to compensation (e.g. financial benefit or return of results) because researchers may also receive individual benefits. However, the donors have generally received a clinical benefit already and any benefit that can result from research is a product not of the samples or registries by themselves, but of the intellectual work done by the researchers. Proponents of a duty to return results often base their line of reasoning on autonomy and concomitant rights. It is claimed that individuals have a right to know what is known about them, so that they can lead their lives according to their life plans. Reporting the incidental finding of a brain tumour on a MRI to an individual who has volunteered to participate actively in a research project, and is easily identifiable and accessible to the researchers, would definitely seem to be the right thing to do. However, disclosing individual research results relating to factors thought to imply risk for a population may cause unjustified concern, especially if no relevant treatment or prevention modality to combat the investigated risk is yet available. An odds ratio expressing risk cannot be translated validly into an individual prognosis and attempts to do so may lead to unnecessary harms. Rather than basing an argument on autonomy and a putative right to ‘know what is known about me’, it may be better to see the issue in terms of a researcher’s obligations. As well as an obligation to respect persons and do no harm to individuals, the primary obligation of researchers using ‘public goods’ such as large public data sets and biobanks is to attempt to bring benefits to the wider society: there is no generalized obligation to provide benefit to individuals. Studies employing health administrative data sets or biobanks are not intended to find clinically-significant information for individuals, but to produce ‘generalizable’ knowledge for future research. Where clinically-significant information becomes available for an identifiable individual, decisions on what to do with the information need to consider the individual’s circumstances and take account of the justifiable concerns regarding the validity and the significance of such results. Further discussion of whether there is an ethical imperative to return clinically significant results is, however, outside the scope of this paper.

Conclusion

Here we have argued for a re-thinking of obligations and rights related to the inclusion of people’s information in large health datasets and biobanks. In particular, we have argued for what is in effect a reversal of the importance of the rights and obligations: members of a community or society have an obligation to contribute their information to large health data sets as these have the status of public goods, and it is not necessary to seek consent for that information to be so included.

Footnotes

Declaration of Conflicting Interest

The authors declare that there is no conflict of interest.

Funding

This research was supported by recurrent funds from the authors’ employers.

Notes

References

Ames

(1887) Purchase for value without notice. Harvard Law Review 1(9).

Aristotle (n.d.) The Politics: MIT Internet Classics Archive.

Australian Law Reform Commission (2003) Essentially Yours: The Protection of Human Genetic Information in Australia. Australian Law Reform Commission Report 96.

Beauchamp

(2011) Informed consent: Its history, meaning, and present challenges. Cambridge Quarterly of Healthcare Ethics 20: 515–523.

Belmont Report (1979) The Belmont Report: Ethical principles and guidelines for the protection of human subjects of research. DHEW Publication No. (OS) 78–0013. Washington, DC.

Bower

Stanley

(1992) Periconceptional vitamin supplementation and neural tube defects; Evidence from a case-control study in Western Australia and a review of recent publications. Journal of Epidemiology and Community Health 46: 157–161.

Callahan

(1994) Bioethics: Private choice and common good. Hastings Center Report 24: 28–31.

Clark

Findlay

(2005) Attaining adequate consent for the use of electronic patient records: An opt-out strategy to reconcile individuals’ rights and public benefit. Public Health 119: 1003–1010.

Colvin

Slack-Smith

Stanley

. (2010) Linking a pharmaceutical claims database with a birth defects registry to investigate birth defect rates of suspected teratogens. Pharmacoepidemiology and Drug Safety 19: 1137–1150.

10.

Council of Europe (1997) Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine. Oviedo.

11.

Davey

Newson

O’Leary

(2006) Communication of genetic information within families: The case for familial comity. Journal of Bioethical Inquiry 3: 161–166.

12.

Dworkin

(1988) The Theory and Practice of Autonomy. Cambridge: Cambridge University Press.

13.

Richard Thorold Grant v. Australian Knitting Mills, Ltd, et al. (1935) UK Privy Council.

14.

Hall

(2001) Reflecting on Redfern: What can we learn from the Alder Hey story? Arch Dis Child 84: 455–456.

15.

Henderson

Churchill

Davis

. (2007) Clinical trials and medical care: Defining the therapeutic misconception. PLoS Med 4: e324.

16.

Hohfeld

(1913) Some fundamental legal conceptions as applied in judicial reasoning. The Yale Law Journal 23: 16–59.

17.

Kozlakidis

Cason

Mant

. (2012) Human tissue biobanks: The balance between consent and the common good. Research Ethics 8: 113–123.

18.

Mackie

(1977) Ethics: Inventing Right and Wrong. Harmondsworth: Penguin.

19.

Meslin

Cho

(2010) Research ethics in the era of personalized medicine: Updating science’s contract with society. Public Health Genomics 13: 378–384.

20.

Mill

(1860) On Liberty. Cambridge, MA: Harvard Classics.

21.

Molster

Maxwell

Youngs

. (2012) An Australian approach to the policy translation of deliberated citizen perspectives on biobanking. Public Health Genomics 15: 82–91.

22.

National Health and Medical Research Council (2003) Values and Ethics: Guidelines for Ethical Conduct in Aboriginal and Torres Strait Islander Health Research. National Health and Medical Research Council.

23.

National Health and Medical Research Council (2007) National Statement on Ethical Conduct in Human Research. Canberra: Australian Government.

24.

National Health and Medical Research Council (2013) Public Consultation on the Revision of the National Statement Chapter 2.3.

25.

Olver

(2014) Opting in for opt-out consent. Medical Journal of Australia 200: 201–202.

26.

Otlowski

(2013) Australian reforms enabling disclosure of genetic information to genetic relatives by health practitioners. Journal of Law and Medicine 21: 217–234.

27.

Rothstein

Shoben

(2013) Does consent bias research? American Journal of Bioethics 13: 27–37.

28.

Sutrop

(2011) Changing ethical frameworks: From individual rights to the common good? Cambridge Quarterly of Healthcare Ethics 20: 533–545.

29.

UNESCO (2005) Universal Declaration on Bioethics and Human Rights.

30.

Wenar

(2011) Rights. In: Zalta

(ed.) The Stanford Encyclopedia of Philosophy. Available at: http://plato.stanford.edu/archives/fall2011/entries/rights/ (accessed 10 June 2015).

31.

Whitehead

(2013) 360° of health data: Harnessing big data for better health. Association of the British Pharmaceutical Industry – National Institutee for Health Research, Research and Development Conference. London: ABPI-NIHR.

32.

World Medical Organization (1996) Declaration of Helsinki (1964). British Medical Journal 313: 1448–1449.

Revisiting consent for health information databanks