‘Except as required by law’: Australian researchers’ legal rights and obligations regarding participant confidentiality

Anna Olsen, Research School of Population Health, ANU

Julie Mooney-Somers, Centre for Values, Ethics and the Law in Medicine, University of Sydney

*Neither of us are lawyers and, as such, our interpretations are as social scientists and HREC members. Interested lawyers and legal scholars are encouraged to contribute!

Researchers’ promises of confidentiality are often easily and genuinely made. However, our experience in research ethics review (Julie through an NGO-run ethics review committee; Anna through formally constituted university and hospital human research ethics committees), in qualitative research and in teaching qualitative research ethics has led us to think about the limits of these promises.

Australian researchers generally rely on the National Statement (National Health and Medical Research Council, 2015) and Human Research Ethics Committees (HRECs) for guidance around ethical and legal conduct in research. For example, Chapter 4.6 in the National Statement notes that researchers may discover illegal activity and guides researchers and HRECs to consider what researchers might be obliged to disclose in a legal situation and how to best protect (and inform) participants of this threat to confidentiality.

The National Statement is currently under revision (National Health and Medical Research Council, 2016) and the review submitted for public consultation in late-2016 contains a proposal to include additional information on “Disclosure to third parties of findings or results” in Section 3 of the National Statement. Here the NHMRC explicitly state that: “There can be situations where researchers have a legal, contractual or professional obligation to divulge findings or results to third parties”. That is, researchers should concern themselves not only with the legal implications of revealing potential illegal activity, but any instance in which they may be asked to break participant confidentiality.

The recent review of the National Statement extends the NHMRC recommendations around potential data disclosure in a number of ways: it makes much more explicit that researchers (as opposed to HRECs or institutions) are responsible for understanding the risks to patient confidentiality: “researchers should be aware of situations where a court, law enforcement agency or regulator may seek to compel the release of findings or results”. Researchers are expected to anticipate legal risks to participant confidentiality by: identifying “(a) whether, to whom and under what circumstances the findings or results will be disclosed; (b) whether potential participants will be forewarned that there may be such a disclosure; (c) the risks associated with such a disclosure and how they will be managed; and (d) the rationale for communicating and/or withholding the findings or results and the relative benefits and/or risks to participants of disclosure/non-disclosure”. And, researchers should advise participants on legal risks to confidentiality and how they will be handled: “(a) have a strategy in place to address this possibility; (b) advise participants of the potential for this to occur; and (c) advise participants as to how the situation will be managed”.

For many researchers in health, legal risks are a very vague reality and legal intervention a remote threat. They may feel confident that their research does not and will not uncover illegal activity, or that their data would simply be irrelevant to a legal case. Or they may feel confident that they have taken sufficient steps to protect their participants’ confidentiality by following guidelines; researchers working in illicit drug use, for example.

Many Australian HRECs articulate the NHMRC guidelines on legal risks of disclosure to third parties by requiring that researchers inform participants that any data collected during research will kept confidential, “except as required by law”. In keeping with the ethical concept of informed consent, participants are thereby warned that researchers are not able to unconditionally offer confidentially. It has become clear to us that the intention of this phrase, to flag the legal limits of confidentiality, is not well understood by researchers (Olsen & Mooney-Somers, 2014).

The National Statement details some aspects of human research that is subject to specific statutory regulation however stresses that compliance with legal obligations is not within the scope of the National Statement: “It is the responsibility of institutions and researchers to be aware of both general and specific legal requirements, wherever relevant”. Moreover, in the document we are directed that it is not the role of a HREC to provide legal advice. It is relatively rare for Australian HRECs to provide explicit guidance on the relevant legal obligations for researchers, including: how they differ across jurisdictions; what protective strategies researchers could employ to better protect patient confidentiality; or how to best inform participants about the risks of legal action (Some useful HREC-produced resources are Alfred Hospital Ethics Committee, 2010; QUT Office of Research Ethics and Integrity, 2016) Criminology scholars have (unsurprisingly) considered these issues in their own field (Chalmers & Israel. 2005; Israel, 2004; Israel & Gelsthorpe, 2017; Palys & Lowman, 2014).

We believe there are real risks to participants, researchers and research institutions.

Recent international cases of research dealing with illegal activity becoming subject to legal action include The Belfast Project/The Boston Tapes (BBC News, 2014; Emmerich, 2016; Israel, 2014) and Bradley Garrett’s ethnographic work with urban explorers (Fish, 2014; Times Higher Education, 2014) (See also Israel & Gelsthorpe, 2017). On the whole, legal action was anticipatable in these cases as they involved illicit activities and the legal action was driven by law enforcement interest. In some instances, researchers took extensive steps to protect participant confidentiality. In other cases the promise of absolute confidentiality seems a little naïve (and in our opinion, perhaps negligent).

Perhaps of more concern are cases in which legal action was instigated by interested others, not law enforcement. Of particular interest to us are recent cases of tobacco companies using Freedom of Information laws in Australia to obtain research data from Cancer Council Victoria on young people’s attitudes to and use of tobacco, and an earlier attempt to seek data on adults from Cancer Council NSW (McKenzie & Baker, 2015; Schetzer & Medew, 2015). As these cases do not involve illegal activity, it is much less likely that researchers could have anticipated the specific legal actions that undermined participant confidentiality. (The tobacco industry has taken these actions in other countries (Hastings, 2015; McMurtrie, 2002)).

Our point here is that the promise of confidentiality should never be casually made. Researchers have an ethical obligation to think through what “except as required by law” may mean for each particular research project. Although it has been argued elsewhere that as professionals, researchers should be provided the same participant confidentiality rights as doctors and lawyers (Emmerich, 2016), the current state of affairs is that research data is not (necessarily) safe from legal, contractual or professional obligation to divulge findings or results to third parties.

References:

Alfred Hospital Ethics Committee. (2010, Updated September 2016). Alfred Hospital ethics committee guidelines: Research that potentially involves legal risks for participants and researchers. Retrieved from https://www.alfredhealth.org.au/contents/resources/research/Research-involving-legal-risks.pdf

BBC News. (1 May 2014). What are the Boston tapes? Retrieved from http://www.bbc.com/news/uk-northern-ireland-27238797

Chalmers, R., & Israel, M. (2005). Caring for Data: Law, Professional Codes and the Negotiation of Confidentiality in Australian Criminological Research. Retrieved from http://crg.aic.gov.au/reports/200304-09.pdf

Emmerich, N. (9 December 2016). Why researchers should get the same client confidentiality as doctors. Retrieved from https://theconversation.com/why-researchers-should-get-the-same-client-confidentiality-as-doctors-69839

Fish, A. (23 May 2014). Urban geographer’s brush with the law risks sending cold chill through social science. Retrieved from https://theconversation.com/urban-geographers-brush-with-the-law-risks-sending-cold-chill-through-social-science-25961

Hastings, G. (31 August 2015). We got an FOI request from Big Tobacco – here’s how it went. Retrieved from https://theconversation.com/we-got-an-foi-request-from-big-tobacco-heres-how-it-went-46457

Israel, M. (2004). Strictly confidential? Integrity and the disclosure of criminological and socio-legal research. British Journal of Criminology, 44(5), 715-740.

Israel, M. (6 May 2014). Gerry Adams arrest: when is it right for academics to hand over information to the courts? Retrieved from https://theconversation.com/gerry-adams-arrest-when-is-it-right-for-academics-to-hand-over-information-to-the-courts-26209

Israel, M., & Gelsthorpe, L. (2017). Ethics in Criminological Research: A Powerful Force, or a Force for the Powerful? . In M. Cowburn, L. Gelsthorpe, & A. Wahidin (Eds.), Research Ethics in Criminology and Criminal Justice: Politics, Dilemmas, Issues and Solutions. London: Routledge.

McKenzie, N., & Baker, R. (15 August 2015). Tobacco company wants schools survey for insights into children and teens. The Age. Retrieved from http://www.theage.com.au/national/tobacco-company-wants-schools-survey-for-insights-into-children-and-teens-20150819-gj2vto.html

McMurtrie, B. (8 February 2002). Tobacco companies seek university documents. Chronicle of Higher Education. Retrieved from http://www.chronicle.com/article/Tobacco-Companies-Seek/6959

National Health and Medical Research Council. (2015). National Statement on Ethical Conduct in Human Research (2007) Retrieved from https://www.nhmrc.gov.au/printpdf/book/export/html/51613

National Health and Medical Research Council. (2016). Public consultation on Section 3 (chapters 3.1 & 3.5), Glossary and Revisions to Section 5: National Statement on Ethical Conduct in Human Research (2007). Retrieved from https://consultations.nhmrc.gov.au/files/consultations/drafts/ns-section3-public-consultation.pdf

Olsen, A., & Mooney-Somers, J. (2014). Is there a problem with the status quo? Debating the need for standalone ethical guidelines for research with people who use alcohol and other drugs. Drug Alcohol Rev, 33(6), 637-642. doi:10.1111/dar.12140

Palys, T., & Lowman, J. (2014). Protecting research confidentiality: What happens when law and ethics collide. Toronto: Lorimer.

QUT Office of Research Ethics and Integrity. (10 Novembeer 2016). Participants and illegal activities. Retrieved from http://www.orei.qut.edu.au/human/guidance/illegal.jsp

Schetzer, A., & Medew, J. (20 August 2015). Cancer Council spends thousands fighting big tobacco over children’s survey data. The Sydney Morning Herald. Retrieved from http://www.smh.com.au/national/cancer-council-spends-thousands-fighting-big-tobacco-over-childrens-survey-data-20150820-gj3nh7.html

Times Higher Education. (5 June 2014). Place-hacker Bradley Garrett: research at the edge of the law. Retrieved from https://www.timeshighereducation.com/features/place-hacker-bradley-garrett-research-at-the-edge-of-the-law/2013717.article

Contributors

Anna Olsen is a Senior Lecturer at the Research School of Population Health, Australian National University. She leads a number of qualitative and mixed methods public health research projects, teaches qualitative research methods and supervises post-graduate students. Dr Olsen is an experienced member of formally constituted university and hospital human research ethics committees. https://researchers.anu.edu.au/researchers/olsen-phd-am

Julie Mooney-Somers is a Senior Lecturer in Qualitative Research in the Centre for Values, Ethics and the Law in Medicine, University of Sydney. She is the director of the Masters of Qualitative Health Research at the University of Sydney. An experienced qualitative researcher, teacher and supervisor, she has taught qualitative research ethics and sat on a NGO-run ethics review committee for six years. http://sydney.edu.au/medicine/people/academics/profiles/julie.mooneysomers.php and http://www.juliemooneysomers.com

This article was originally published on Research Ethics Monthly. Read the original article.

This post may be cited as:
Olsen A, and Mooney-Somers J. (2017, 24 February) ‘Except as required by law’: Australian researchers’ legal rights and obligations regarding participant confidentiality. Research Ethics Monthly. Retrieved from: https://www.ahrecs.com/human-research-ethics/except-required-law-australian-researchers-legal-rights-obligations-regarding-participant-confidentiality

Propaganda or cost of innovation? The high price of new drugs

Narcyz Ghinea, University of Sydney; Ian Kerridge, University of Sydney, and Wendy Lipworth, University of Sydney

Ever wonder how much it costs to develop a new drug? The independent, non-profit research group, The Tufts Center for the Study of Drug Development, estimates US$2.6 billion, almost double the centre’s previous estimate a decade ago. But how accurate is this figure?

While the details of the study remain a secret, a press release, slideshow and background document on the Tufts website provide some insight into how this figure was calculated. Interestingly, only slightly more than half of this cost is directly related to research and development (R&D). US$1.2 billion are “time costs” – returns that investors might have made if their money wasn’t tied up in developing a particular drug.

As expected, these costings have attracted the attention of policymakers, consumer advocates and critics of big pharma. In the New England Journal of Medicine, Harvard University Professor of Medicine Jerry Avorn questions several assumptions underpinning the Tufts costing – particularly the unverifiable claim that up to 80% of compounds are abandoned at some point during development.

Avorn is also unconvinced by the Tufts assertion that an annual return on capital of 10.5% (which was used to calculate the “time costs” component) is needed to attract investors, noting that “bonds issued by drug companies often pay only 1 to 5%”.

More broadly, Avorn questions the Tufts claim that its US$2.6 billion figure related to only “self-originated” products and wonders whether this includes contributions from the public purse for underlying basic science. If the Tufts figure didn’t include public contributions to research, the real cost of drug development would be even higher.

Finally, Avorn notes that pharmaceutical companies could fund much of their research themselves with the hundreds of billions of their own (untaxed) capital held outside of the United States.

Avorn’s criticisms echo those of the Union for Affordable Cancer, which complains that the study’s figures are already being used as a propaganda tool to justify high drug prices, particularly for cancer.

Like Avorn, the Union suggests that the Tufts figures also ignore the significant public contribution to drug development, particularly for cancer.

Others have argued the Tufts figure is grossly over-inflated. Rohit Malpani, director of policy and analysis at Doctors without Borders notes drugs can be developed for as little as US$50 million, and at most, for US$186 million when failures are taken into account.

Even Industry heavyweights such as GlaxoSmithKline’s CEO Andrew Witty have undermined the Tufts claims by suggesting in 2013 that the US$1 billion dollar figure was a myth.

So why is this debate important and why does it matter whether or not these estimate are correct?

These costs are used to justify high drug prices. These prices increasingly have the potential to disable health-care systems, create enormous opportunity costs (as funds that could be spent on other goods and services are diverted to purchase more and more expensive drugs), and place medicines out of reach of all but the most wealthy individuals or governments.

This is a reminder that the real issue is not how much it costs to develop a drug, but whether or not these drugs are worth the high prices pharmaceutical companies charge for them.

While advocates of a completely free market might see “just” pricing and all forms of price control as “medieval”, “socialist” or as suppressing innovation, others worry that drug prices bear little, if any, correlation with actual clinical value.

Rewarding innovation is necessary, but allowing drugs to be priced according to whatever the market will bear, rather than according to their benefits and cost-effectiveness, leads to inefficiencies, inequities and dramatic global inconsistencies.

Knowing how much it really costs to develop a drug might make it easier to negotiate drug prices on a global level and make revenues more predictable. This would not only be beneficial for society but could also ensure more predictable returns for the pharmaceutical industry.

At the moment, however, the industry seems entrenched in free-market thinking and has so far countered efforts by US lawmakers to shine a light on how much drug development really costs. While secrecy of this type may benefit industry, at least in the short term, this is simply not in the public interest.

Until we know more about the actual cost of drug development, we are in no position to meaningfully critique the corporate model promulgated by the pharmaceutical industry, the drug costs put before regulators, or the claims of groups such as Tufts. Ultimately, that leaves health systems at the mercy of industry.

Narcyz Ghinea is Postdoctoral Research Associate, Centre for Values, Ethics and the Law in Medicine at University of Sydney.
Ian Kerridge is Associate Professor in Bioethics & Director, Centre for Values and Ethics and the Law in Medicine at University of Sydney.
Wendy Lipworth is Senior Research Fellow, Bioethics at University of Sydney.

This article was originally published on The Conversation.
Read the original article.

Genome editing poses ethical problems that we cannot ignore

Anthony Wrigley, Keele University and Ainsley Newson, University of Sydney

The ability to precisely and accurately change almost any part of any genome, even in complex species such as humans, may soon become a reality through genome editing. But with great power comes great responsibility – and few subjects elicit such heated debates about moral rights and wrongs.

Although genetic engineering techniques have been around for some time, genome editing can achieve this with lower error rates, more simply and cheaply than ever – although the technology is certainly not yet perfect.

Genome editing offers a greater degree of control and precision in how specific DNA sequences are changed. It could be used in basic science, for human health, or improvements to crops. There are a variety of techniques but clustered regularly inter-spaced short palindromic repeats, or CRISPR, is perhaps the foremost.

CRISPR has prompted recent calls for a genome editing moratorium from a group of concerned US academics. Because it is the easiest technique to set up and so could be quickly and widely adopted, the fear is that it may be put into use far too soon – outstripping our understanding of its safety implications and preventing any opportunity to think about how such powerful tools should be controlled.

There’s more to Pradaxa’s problems than meets the eye

By Wendy Lipworth, University of Sydney and Ian Kerridge, University of Sydney

Pharmaceutical companies don’t have a particularly good reputation, for some very good reasons. But we can’t let suspicions about the motives of such companies cloud our assessments of drug safety because patients may also suffer.

People with abnormal heart rhythms and other diseases that cause blood clots (thromboses) often require blood-thinning (anticoagulation) medications. For many decades, warfarin has been the most widely used such drug but it’s associated with a risk of bleeding (including fatal haemorrhage) and requires regular blood tests to monitor safety and efficacy.

So the advent of new oral anticoagulant drugs was heralded as a major advance by both patients and clinicians – principally on the grounds that they appeared as effective as warfarin, may be associated with a lower risk of serious bleeding, and are cost-effective because patients don’t need ongoing blood monitoring.

For these reasons, a number of these new drugs, including dabigatran (Pradaxa) and rivaroxaban (Xarelto) were fast-tracked through the regulatory approval processes in the United States and in New Zealand.

Academics on the payroll: the advertising you don’t see

By Wendy Lipworth, University of Sydney and Ian Kerridge, University of Sydney

In the endless drive to get people’s attention, advertising is going ‘native’, creeping in to places formerly reserved for editorial content. In this Native Advertising series we find out what it looks like, if readers can tell the difference, and more importantly, whether they care.

---

Academic medical researchers are hot property for companies marketing pharmaceuticals, complementary medicines, medical devices, fitness equipment, weight loss products, “health foods” and other health-related goods and services. Their opinions are highly respected by the general public, and their endorsement in the media of a product can help to ensure consumers and patients purchase it, or at least discuss it with their “health care provider”.

But this raises a question: why would an academic researcher choose to endorse a health-related product in the general media?

The most worrying explanation is that the academic is being employed by the company to speak favourably about its product. Such commercial relationships are rarely made transparent and rely on a public perception that academics are objective observers and commentators. For the most part, however, this is unlikely to be the case.

A far more likely explanation is that any academic endorsement occurs in the context of a long and mutually productive relationship with the company concerned. Academics are frequently targeted by companies on the grounds that they provide authority and act as “key opinion leaders” who are able to influence the opinions, beliefs and behaviours of others in both professional and public arenas.

This relationship with industry is frequently one of many. Academics who comment on products have frequently partnered with the company in its clinical trials of the product; put his or her name to the resulting academic publications; provided strategic advice on how to have the product regulated and perhaps subsidised by the government; or given talks to other academics and clinicians about the research (if not the product itself).

Abandoning clinical trial safeguards won’t boost local industry

Paul Komesaroff, Monash University; Colin Thomson, University of Wollongong, and Ian Kerridge, University of Sydney

CLINICAL TRIALS – Human clinical trials are an important last hurdle in the development of new drugs and therapies. Today, The Conversation takes a closer look at this vital scientific endeavour with three articles that look at different aspects of the process.

---

Testing new drugs in clinical trials is a billion-dollar industry in Australia, with most of the money coming from international pharmaceutical companies. But as investment grows in India, China, and other emerging competitors, some people argue we need to make Australia more attractive to such investment. One of their solutions is to water down the ethics approval process.

Responding to these concerns, the Coalition’s election policy on medical research promises to “move swiftly” with reforms to the ways in which clinical trials are conducted, by developing:

a nationally consistent approach to ethical standards to reduce complexity, speed up the process and where possible, rationalise the number of ethics committees to reduce the large number that currently exist.

Before major changes are introduced, however, it is important to remember that ethics committees are the very bodies that ensure the safety of clinical trials and maintain public confidence.

Developed in response to concerns about the untrammelled power of medical institutions in the 1970s, as well as reports of egregious excesses by researchers in the United States and elsewhere, the ethics committee system has become highly refined in both its processes and in the substance of the issues it addresses.

In Australia, it is also remarkably devolved and democratic, drawing in thousands of men and women from different walks of life across the country to engage in conversation, for no personal gain, about ethical issues in health care and research.

Established by hospitals and universities, the panels review research proposals and ensure they’re ethically acceptable. Their deliberations cover potential risks and benefits to both individuals and the wider society and issues relating to consent, confidentiality, privacy, conflicts of interest and protection of vulnerable participants.

China’s pharma scandal and the ethics of the global drug market

Wendy Lipworth, University of Sydney and Ian Kerridge, University of Sydney

China is in the midst of conducting a series of corruption investigations of pharmaceutical companies that have been operating in the country.

It all started with the investigation of officials from pharmaceutical company GlaxoSmithKline, who were reportedly engaged in “bribery and corruption” in China. The officials apparently used travel agencies to funnel illegal payments to doctors and government officials.

That was in July. In August, Associated Press reported French drug company Sanofi was being investigated for bribing Chinese doctors in 2007.

And late last week, South China Morning Post reported that German pharmaceutical conglomerate Bayer had joined the ranks of companies being investigated by the Chinese. That report mentioned pharmaceutical companies Eli Lilly, Novo Nordisk, H Lundbeck, AstraZeneca and UCB had also been contacted by Chinese investigators.

This wide-ranging, ongoing scandal highlights the many regulatory and ethical challenges of globalised drug development.

Of mice and men: role of mice in biomedical research questioned

Christopher Degeling, University of Sydney and Jane Johnson

A study recently published in the peer-reviewed journal PNAS (Proceedings of the National of Academy Sciences) shows that mice are poor models for human inflammatory diseases. The paper, which focused on sepsis, burns and trauma, raises questions about the fundamental role of mice in biomedical research.

Bodily responses to burn injuries and acute infections look similar in mice and humans, but the study authors found they’re driven by fundamentally different genetic and molecular mechanisms. They spent ten years examining which genes in human white blood cells are activated during infection. Data from 167 patients suggested there are particular patterns of genomic change associated with acute inflammation.

After having their paper rejected by several journals, the researchers decided to redesign their study. Apparently, one objection from reviewers was that the results had not been validated by mouse studies. But when the researchers looked at the genomic response to different forms of inflammation in mice, they made a number of startling discoveries:

1. The relatively uniform gene changes found in human patients were not found in mice.
2. Genomic changes in mice were completely different to humans, and there was no discernible pattern of gene modification.
3. None of the mouse models for sepsis, bacterial blood poisoning, trauma or burns predicted the magnitude or direction of inflammation in humans.

These findings have significant ramifications.