Bioethical Inquiry DOI 10.

1007/s11673-013-9503-2

RECENT DEVELOPMENTS

Investigating Research and Accessing Reproductive Material

Received: 8 December 2013 / Accepted: 15 December 2013 # Springer Science+Business Media Dordrecht 2014

The Markingson Case and the Ethics of Institutional Proceduralism Dan Markingson was acutely psychotic when University of Minnesota psychiatrists enrolled him in 2004 into the local arm of a controversial multisite CAF clinical trial,1
The CAF study compared three newer neuroleptic drugs (Zyprexa, Risperdal, and Seroquel) that in a previous study (the CATIE trial) had been found to be less effective and not better in terms of side effects than a traditional neuroleptic developed in the 1950s, perphenazine. The CATIE study was funded by the National Institutes of Mental Health (NIMH). It also was particularly unfavourable to Seroquel, AstraZenecas product. The CAF study, in which Seroquel was tested at a different dosage, was funded by AstraZeneca. Commenting on the CAF trial, Dr. Bernard Carroll, former chairman of the FDA Psychopharmacologic Drugs Advisory Committee and former chairman of the Department of Psychiatry at Duke University Medical Center, wrote: I am struck by how the entanglement with a commercial entity has influenced the scientific agenda of these academic investigators. There is little doubt that AstraZenecas participation shaped the study design and the reporting (Carlat 2010, under Comments). AstraZenecas use of other clinical trial reports has also been the object of much criticism and the company has been prosecuted in the United States for its promotional practices surrounding Seroquel, resulting in a US$647 million settlement (Feeley 2011). See the article by Carl Elliott (2010) in Mother Jones, which raises more general questions about the ethics of including research subjects in clinical trials that may amount to little more than marketing endeavours. T. Lemmens Faculty of Law, University of Toronto, 39 Queens Park Crescent East, Toronto, Ontario, Canada M5S 2C3 e-mail: [email protected] B. J. Richards (*) Law School, University of Adelaide, North Terrace, Adelaide 5005, Australia e-mail: [email protected]
1

an AstraZeneca-sponsored comparative study of three of the newer neuroleptic drugs. He had been repeatedly judged incompetent to make his own treatment decisionsincluding as late as two days before enrolling in the studyand was involuntarily committed after making delusional threats to his mother. But his commitment was suspended by a stay of commitment order from a district court judge that allowed him to leave the hospital under court-imposed conditions, a key condition being that he had to follow the treatment instructions of his treating psychiatrist, Dr. Olson. Shortly after the stay of commitment order, Dr. Olson proposed that Markingson participate in the clinical trial (of which Olson was the lead investigator at the Minnesota site). Markingson was surprisingly assessed as competent to consent to participate in this trial. Seventeen days after his enrolment in the trial, he moved to a halfway house. His mother, Mary Weiss, believing his condition was deteriorating, attempted repeatedly to get her son out of the study. Notes from a social worker and an occupational therapist also suggested that he was not doing well while in the trial. At one point, Weiss explicitly warned the research team that her son was in serious danger of killing himself. Her warnings were ignored. On May 8, 2004, Markingson committed a violent suicide. These are, in short, the facts of a case that has created turmoil in the bioethics and research communities, particularly in North America, since the St. Paul, Minnesota, Pioneer Press reported on it in 2008 in a series of articles. That the case never completely faded away in the 5 years following the first media report and continues to be the focus of heated debate is due to ongoing actions by Mary Weiss and her friend, Mike Howard, as well as the relentless questioning and reporting by Carl Elliott, a University of Minnesota professor of bioethics. After

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Elliott first learned about the case from the report in the Pioneer Press, he started to ask questions within the university and felt quickly stonewalled by his own institution. His further inquiries and investigations revealed additional uncomfortable components about the case. The university has maintained that this was a tragic, yet isolated and unavoidable, incident that was sufficiently investigated by various governmental and institutional units, which all concludedor so the university officials and legal counsel claimthat no one was to blame for what happened and that this was a unique, unfortunate event. Elliott (2010) and others (Heisel 2011; Stone 2012, 2013b; Davies 2013; Lamkin 2013), however, have continued to raise serious questions about this claim. In the course of their investigative reporting, using such means as access to information requests, commentators have unearthed additional ammunition to challenge the universitys position about the fact that there have been various detailed investigations. Recent testimony of another patient who claims to have been coerced into participating in clinical trials at the same psychiatric research unit further suggests that the Markingson case was not unique (Baillon 2013). I (TL) followed the case for some time from a distance. Then, earlier this year, I signed a petition (launched by Mike Howard) directed at the Minnesota governor and supported by more than 3,400 people, including many academic scholars, that asks for an external, governmentally mandated investigation of the universitys actions (Howard 2013). Being increasingly disturbed, however, by the ongoing refusal of the university to provide any reasonable response to the concerns raised and also worried about the isolation of University of Minnesota colleagues who continued to challenge their own institution, several like-minded colleagues (Raymond De Vries, Alice Dreger, Lois Shepherd, Susan Reverby, and Jerome Kassirer) and I drafted a letter to the University of Minnesota Senate (Lemmens et al. 2013). In this letter, we requested the establishment of an Independent Committee of Inquiry, with the mandate to evaluate what happened; what can be done to prevent similar events from happening again; whether and how university guidelines, policies, and procedures for research ethics review and monitoring of research can be improved; and how institutional responses can be improved when horrific events like Dan Markingsons suicide occur. More than 175 law, research ethics, bioethics, and medical scholars from various American,

Canadian, European, Australian, Asian, and African universities signed the letter. The idea of organising an independent academic inquiry run by outside scholars is well established. The Canadian Association of University Teachers has, for example, a long-standing tradition of setting up such inquiries to investigate controversies in Canadian institutions. Several of these inquiries, such as the wellknown Olivieri Inquiry (Thompson, Baird, and Downie 2001), have also focused on issues involving biomedical research and protection of research subjects and formulated specific recommendations for improved research governance practices. An independent inquiry appeared crucial for several reasons: The Markingson case reveals disturbing clinical trial recruitment practices affecting extremely vulnerable psychiatric patients; it indicates serious problems with research oversight at one of the top medical research institutes in the United States; and, last but not least, the universitys reaction to the case is a paradigmatic example of how institutions are able to exploit empty proceduralism in order to evade meaningful public deliberation of their moral obligations. Troubling Recruitment Practices and Conflicts of Interest in the Context of Research Subject Enrolment A key question is why Dan Markingson ended up being enrolled in this type of clinical trial in the first place. Markingson was actively psychotic and had been declared incompetent to make his own treatment decisions just prior to being enrolled in the trial. A psychiatric assessment used in the court proceedings that lead to his stay of commitment confirms the serious delusions he was under and his failure of insight in his own illness (Geister 2003). Yet, his treating psychiatrist, Dr. Olson, allowed him to enrol in the clinical trial he was running at the hospital, or, rather, participation became the recommended treatment option that Markingson could follow while under the stay of commitment. In other words, following the research instructions enabled a delusional, mentally ill patient to live and reside outside of the treatment centre. Standards of informed consent are generally identified as higher for research participation than for treatment options, the rationale being that the more complex and uncertain riskbenefit profile of experimental treatments and the complexity of randomisation are more difficult to comprehend. Similarly, people who are

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borderline competent will more easily be taken to be competent to make treatment decisions rather than competent for research participation. In the Markingson case, this logic seems to have been reversed. Not only his enrolment was problematic. In the course of the trial, the research coordinator, a social worker, also rejected repeated claims by Markingsons mother that he was deteriorating and in danger of killing himself. Although he was receiving antipsychotic medication in the trial, participation in the trial did not amount to standard treatment, since research subjects were randomly assigned to one of three arms and the research instructions encouraged investigators and the research coordinator to keep patients on the study medication. The fact that Markingson was not receiving standard treatment makes it particularly troubling that there were significant financial incentives, both to enrol him in the clinical trial and to keep him in one of the arms of the trial. The clinical trials unit of the university received significant payments from the study sponsor, while the psychiatrists involved also had long-standing consultancy relations with the study sponsor. The research contract with the institution included per patient payments of US$15,648, a substantial part of which was only paid if patients remained in the trial until the end. The research unit was also under pressure to recruit. Less than two years earlier, the contract research organization (CRO) in charge of organising the CAF trial had put the site on probation for failing to recruit a sufficient number of patients (Elliott 2010). In short, all the elements are there to suggest that this may very well be a case study of how pressures resulting from recruitment incentives can have a devastating outcome (Stone 2012), a concern that has been flagged in the past (Office of Inspector General 2000; Lemmens and Miller 2006). For Dr. Jerome Kassirer, a former editor of The New England Journal of Medicine and a signatory of the letter, [t]here was an overt conflict of interest, and there is reason to believe that the boys death was an indirect consequence of the financial inducements of the study (pers. comm.). In direct response to Dan Markingsons suicide, the Minnesota legislature recognised in 2009 that vulnerable psychiatric patients in Minnesota had to be better protected in clinical trials. It adopted more protective legislation, in principle excluding people who are civilly committed from being enrolled in a clinical trial (Minnesota Statute 2013, 253B.095 sub-div 1(d)(4)).

While an exception can be made, the very strict conditions under which enrolment remains possible seem to target explicitly some of the practices that were particularly problematic in the recruitment of Dan Markingson. A patient under a stay of commitment can only participate if the following conditions are met: The treating psychiatrist must testify or submit an affidavit that the patient may benefit from participating in the trial; other treatment options have to be provided for a reasonable period of time and must have been shown to be ineffective; and the court must also directly determine that, under the circumstances of the case, the patient is competent to choose to participate in the trial, that the patient is freely choosing to participate in the trial, [and] that the compulsion of the stayed commitment is not being used to coerce the person to participate in the clinical trial (Minnesota Statute 2013, 253B.095 subdiv 1(e)). Remarkably, the university never even conceded that enrolling patients like Markingson in the context of a stay of commitment could have been a problematic practice or that the recruitment pressures and financial incentives as they existed in that trial could raise serious concerns. Instead, the university insisted misleadingly that several institutional bodies, external agencies, and the courts had all cleared the university and researchers from any wrongdoing or errors. University administrators and the general counsel repeatedly suggested that detailed reviews by the institutions research ethics committee, a U.S. Food and Drug Administration (FDA) investigator, the court, and professional disciplinary bodies cleared them from any wrongdoing. A careful review of these claims, however, raises additional concerns, not only about the failure of regulatory and legal structures to respond when things have gone wrong in medical research but also about the disingenuous use of flawed procedures to shield institutions from their moral responsibility. Institutional Review Board Oversight or Lack Thereof? As has been argued more generally, there is already reason to be concerned about the reliance on internal institutional review boards (IRBs) to evaluate the potential impact of significant institutional financial interestsincluding financial interests of departmental decision-makerson research recruitment and other research practices (Liang and Mackey 2010; Lemmens and Freedman 2000). But there is more in this case. Carl

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Elliott revealed that the IRB that approved and was supposedly monitoring the study was itself affected by significant conflicts of interests: The IRB chair was the director of the Ambulatory Research Center that housed the clinical trial (Elliott 2013), and he reported in the Department of Psychiatry to Dr. Schulz, who was a coinvestigator in the study. The IRB chair also had significant financial relations with the company sponsoring the trial and with several other pharmaceutical sponsors. The universitys insistence that the IRB had properly investigated thus raised more troubling questions. The university also never produced concrete evidence that the IRB had investigated in any serious way the dramatic suicide. Minutes of one IRB meeting show that the case was discussed as an adverse event report, but nothing more than that (Stone 2013a). Moreover, in a sworn deposition in the context of court proceedings, the universitys IRB official even denied that the IRB conducted any review of the case (Stone 2013a; Elliott 2010).

Not surprisingly, the FDA report focused narrowly on procedural requirements and did not engage in a meaningful analysis of the core questions raised by the case. There is no detailed discussion of the use of civil commitment orders to induce someone to participate in a clinical trial, a practice the Minnesota legislature has since prohibited. The report simply accepts that Markingson was deemed competent to participate in the clinical trial and fails to identify the clash between several competency assessments prior to enrolment and the decision to allow him to participate in the trial. The report also fails to identify the conflict of interest problems of the IRB. It also missed some alleged serious issues with consent-related documents that were revealed subsequent to the FDA investigation and noted by the Minnesota Board of Social Work. The Limits of Professional Disciplinary Procedures The university has also frequently invoked the fact that the disciplinary body of the medical profession in Minnesota, the Board of Medical Practice, rejected Mary Weiss complaints against the two physicians supervising the clinical trial. However, the board clearly did not address any alleged institutional failures by the university. And while it is true that the board decided not to pursue any action against Drs. Olson and Schulz, this does not amount to an exoneration or to a detailed publicly accountable assessment of the facts. In an email dated June 19, 2013, the executive director of the Board of Medical Practice emphasised that it has no jurisdiction over the institution and that the failure to pursue any action against the physicians may mean that the Board did not find a violation of the Medical Practice Act but it also may mean that the Board could not find sufficient evidence of a violation to proceed with disciplinary action (Leach 2013, 3). Rather than taking the boards decision not to pursue any action as reassuring, there are again reasons to see the lack of action in this case as a paradigmatic example of how professional bodies do not easily hold their members publicly accountable for failure to live up to research ethics standards. It is worth contrasting here the medical boards decisions with the decision of the Minnesota Board of Social Work, which issued in 2012 a corrective action against the research coordinator of the clinical trial. The Board of Social Work concluded

Flawed FDA Review Equally troubling is how an important independent federal agency that did conduct a site visit following Markingsons suicide failed to identify problems. An FDA inspector wrote up an establishment inspection report (EIR) based on a January 2005 site visit (Elliott 2011). The FDA investigator concluded that there was [n]o evidence of misconduct or significant violation of the protocol or regulations (U.S. FDA 2005, 1). Yet, an analysis of the report suggests that the inspection was (arguably very) superficial. It relied on a review of the paper records and interviews with members of the research team. But all of those directly involved obviously had an interest in downplaying any concern. The FDA inspector failed to interview Mary Weiss, Dan Markingsons mother, who was an important witness to the events even though her actions urging the research team to withdraw him from the study were clear from the records. The inspector also decided not to pursue any interview with Markingsons case manager (a social worker) and two other people more directly involved in Markingsons care while he was living in the community. In order to speak with these people, a consent form from a living relative (i.e., Mary Weiss) had to be obtained. There is no discussion in the inspection report as to why this was not pursued.

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on the basis of its detailed investigation that the study coordinator, a social worker who was overseeing Markingsons care and trial participation, had committed an alarming number of professional violations, including falsely initialling for the physicians on study charts and dispensing drugs without a license (Minnesota Board of Social Work 2012). Even if the corrective action imposed was very weak (additional education and the writing of a report), the detailed criticism voiced toward the coordinators actions makes it difficult to understand why those in charge of running the clinical trial and supervising this social worker were not held accountable for the serious transgressions. The Limits of Legal Proceedings The university also repeatedly suggested that it had been exonerated in a court of law, when a Minnesota district court ordered a halt to most legal proceedings launched by Dans mother against the university and the two researchers. This court had ruled in an interim judgment that there was no legal basis for Mary Weiss lawsuit against the university and its IRB because a university has statutory immunity for discretionary decisions in the context of research. An interim ruling of statutory immunity by a court is, however, not an exculpatory finding of fact. It is not a finding by the court that the university did nothing wrong. In the United States, statutory immunity for discretionary decisions exists in the context of research in part because there is a reliance on a well-functioning IRB and research governance system. The Markingson case raises precisely questions about that rationale. It is true that the court also rejected the claim against one of the physicians, but it did accept that a negligence claim against the physician most directly involved in Markingsons care, Dr. Olson, could proceed, thus at least identifying a basis for potential liability. The case against Dr. Olson was settled with a small US$75,000 payment to Mary Weiss. Following the interim ruling, the university filed a notice to assess costs against Dan Markingsons mother, requesting that she pay the legal costs of the university. It halted this procedure when Markingsons mother dropped her appeal against the interim decision. The use of such legal tactics against a mother who lost her son within the university setting raises questions about the universitys

willingness to engage in critical introspection about its core moral obligations.

Hiding Behind a Procedural Veil The troubling circumstances surrounding Markingsons suicide should already be a sufficient reason for a public institution to investigate what happened, with recent reports that this may not have been an isolated case providing additional ammunition. The universitys claims about proper prior reviews notwithstanding, this is also a case of systemic failure of research ethics governance and a paradigmatic example of how institutions can conveniently hide behind a veil of flawed procedures. It has become a tale of how, in a country with arguably one of the most elaborate research governance systems, research ethics review and adverse event review procedures amount to little more than paper tigerswhich institutions subsequently employ to shield themselves from further ethical reflection and public accountability. As mentioned earlier, critics have provided a detailed rebuttal of the University of Minnesotas claims that the Markingson case has been sufficiently investigated. Yet, the university continues to make these claims, simply refusing to engage in any further reasoned discussion. The mere existence of an IRB structure and the fact that there has been somealbeit limitedassessment by a federal regulatory agency (the FDA) have helped the institution and the researchers to stick to the party line that there is nothing more to be done. The simple fact of some procedural mechanisms becomes an argument to evade further moral responsibility, without any serious reflections about the limitations of these procedures. In the same vein, university administrators themselves are no longer responding when academic scholars, including in their own institution, ask questions. When we sent our letter to the chair and vice chair of the University Senate, we received a short quasistandard letter from the universitys legal counsel, indicating that no further inquiry was needed. It is worth noting that it is the universitys president who chairs the Senate and that he has repeatedly rejected claims to investigate the case. The university leadership has, in other words, retreated from the debate and relegated governance questions that touch on the moral integrity

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of the institution to the status of procedural and legal liability issues to be dealt with by legal counsel. In his quest for justice for Mary Weiss and Dan Markingson, Carl Elliott tried to mobilise other federal agencies to look into the case and the lack of proper action by various entities. But here, too, he faced the limits of bureaucracies: When he sent a complaint to the Office of Inspector General of the Department of Health and Human Services, his complaint was forwarded to two other agencies, including the Office of Human Research Protection (OHRP), an agency that promotes the protection of the rights, welfare, and well-being of research subjects but that deals specifically with federally funded research. But the OHRP declined to look at it. In fact, Elliott had already complained to the OHRP before, and the agency had then forwarded the file to the Food and Drug Administration, even though part of the complaint was about problems with the FDA review process. Since the bureaucracies set up to promote human research protection have clearly failed to act, one has to hope that people involved in the governance of the university itself will take the moral obligation of academic institutions seriously and pressure university administrators to convene an independent inquiry. One faculty member of the University of Minnesota, Leigh Turner, recently reminded members of the Board of Regents of their potential legal liability if they knowingly fail to intervene when serious incidents of misconduct are brought to their attention. In a letter, he drew comparisons with the high-profile criminal prosecution and lawsuits against several Pennsylvania State University administrators for their alleged failure to act following reports of sexual abuse by a football coach (Turner 2013). Supporting an independent inquiry would certainly indicate that the university is finally willing to evaluate more seriously what went wrong and to look at how research governance can be improved. It should help to protect other extremely vulnerable patients from being coerced and potentially seriously harmed in the context of clinical trials. But the academic community should also reflect critically on how this case and subsequent interactions between Markingsons supporters, the academic community, and the institution reveal that research subject protection mechanisms can easily become procedural window dressing. While well intended, many of our existing research ethics review procedures may result in superficial assessments that

institutions can easily employ as a protective shield. Instead of promoting better ethical standards in research, they may sometimes become tools to hide abuse. Trudo Lemmens Authors Note: University of Minnesotas Senate has since voted (67 in favour, 23 against) to ask the university to conduct a review of the recruitment and protection of participants in clinical trials. The university president has indicated he will follow the Senates recommendation. However, there are reasons to be concerned that this inquiry could function as yet another shield. The president has already explicitly stated that the inquiry would not cover the Markingson case. We, therefore, wrote a follow-up letter, reminding the University Senate that we identified two key components as being crucial for a meaningful inquiry: a wide mandate, allowing a review of past and current research practices on the ground, and a committee member selection process that would not be controlled by those who have been criticised in the context of the Markingson case. See the next issue of the Journal of Bioethical Inquiry for a report on the further developments.

Posthumous Reproduction Posthumous reproduction raises a number of ethical and legal difficulties, not the least of which is initial access to the reproductive material. There have been a series of decisions in Australia in which wives and partners of either newly deceased or soon-to-be-deceased men have sought access to their sperm for later use in reproductive treatment. These decisions have not been consistent in their outcomes and have moved from outright rejection of the application through approval and even recent developments that have seen a Supreme Court retreat from the question and refer to the Human Tissue Acts that were introduced (in an example of rare state cooperation) to cover retrieval and donation of human tissue. It is this final decision that provides the focus for this brief note.2
Earlier related decisions include (but are not limited to): MAW v Western Sydney Area Health Service (2000) NSWLR 231, AB v Attorney-General for the State of Victoria [2005] VSC 180, In the matter of Gray [2000] QSC 390, Jocelyn Edwards; Re the estate of the Late Mark Edwards [2011] NSWSC 478, and Baker v State of Queensland [2003] QSC.
2

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The decision of interest here is Re Section 22 of the Human Tissue and Transplant Act 1982 (WA) [2013] WASC 3, 2 January 2013. In presenting his judgment, Edelman J explained why he had formed the view that a proper approach to these issues was to apply the legislative regime as opposed to the previously accepted judicial approval. In referring to these issues, his Honour was considering the request of a newly widowed woman for the retrieval of her husbands sperm. The applicant and her husband had been trying to conceive for two years and had commenced in vitro fertilisation (IVF) treatment but, sadly, her husband, who had a history of mental health problems, committed suicide before conception was achieved. In explaining his reasoning as to why this was a question to be answered under the Human Tissue Act as opposed to the State Supreme Court, his Honour placed great emphasis on the urgency of the application (see [11] where he refers to extreme urgency and again at [22] and [10]) and clearly felt that a new approach to requests for posthumous retrieval of sperm was warranted. In reaching this conclusion, Edelman J explored the accepted approach to such requests and took the time to identify the flaws in the established source of power in the Supreme Court to make such decisions. It is appropriate to briefly explore this challenge to the application of the Supreme Court Rules, which highlights the complexity of the problems raised by requests to posthumously retrieve sperm. In Western Australia, the relevant source of power has been identified as the Rules of the Supreme Court, O52 r3, which empowers the Court to make decisions regarding the dispersal of property. Clearly this raises the ongoing debate regarding the status of reproductive tissue and whether or not it falls within the definition of property. His Honour referred to the ongoing debate regarding the status of tissue removed from a living body and emphasised that the principle that a human body cannot be the object of a property right does not apply in relation to tissue or body parts once they are removed from the human body but also noted that there are a different set of considerations with regards to deceased persons and the established principle that there is no property in a corpse ([6][9]). His Honour concluded that there were a number of problems raised by the application of this Rule to decisions concerning the posthumous retrieval of sperm, most of which turn on the characterisation of sperm as property, but given the urgency of the application he did not, at the original hearing, have the time to consider

these in detail. Similarly, in presenting his judgment he declined to pursue the inquiry beyond highlighting the, in his view, problematic nature of the application of the relevant Rule in these circumstances. Rather, he preferred to focus on the simpler legislative route open to applicants in these situations and it is this simpler legislative route that warrants consideration. The relevant provision is Human Tissue and Transplant Act 1982 (WA) s 22 (all other jurisdictions have equivalent provisions). This section clearly sets out the power of the designated officer of a hospital to consent to the removal of tissue after death for the purpose of transplantation of the tissue to the body of a living person or for the use of the tissue for other therapeutic purposes or for medical or scientific purposes. His Honour concluded that the retrieval of sperm came under the ambit of the legislation because: 1. The deceaseds body was brought into the hospital, 2. The purpose of storage for later assistance for another person to become pregnant falls within medical purposes, 3. The definition of tissue in s3 includes spermatozoa in the relevant part of the Act, and 4. There is no evidence of objection or reasonable grounds to believe that he would have objected to the retrieval ([16]). This conclusion is consistent with earlier decisions. An interesting partner to this decision can be found in Jocelyn Edwards; Re the estate of the Late Mark Edwards [2011] NSWSC 478, which, whilst having a clearly different factual matrix ([79]) addresses many of the key issues and, interestingly, considers whether a failure to comply with the provisions of the relevant Human Tissue Act when authorising posthumous retrieval of sperm can impact on later access to, and use of, the subsequently retrieved and stored material. The facts of this case are simple and tragic. Jocelyn and Mark Edwards had ongoing fertility issues and had considered accessing assisted reproductive treatment (ART) for up to two years. They commenced their tests and were scheduled to attend an appointment at the clinic on August 6, 2010, but Mark Edwards was injured and died at work on August 5. At that point in time, when Jocelyn asked for retrieval of Marks sperm, she was advised to seek an order from the Supreme Court. An urgent application was made and Simpson J made the order for extraction and storage pending a further court order. The State Coroner was also approached and

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gave permission for extraction. This case was seeking a further court order to the effect that Jocelyn Edwards was entitled to possession of the sperm so that she could take it from New South Wales (NSW) to the Australian Capital Territory (the ACT) where she would access fertility treatment. She originally sought orders for release and use but, given the clear legislative prohibition of posthumous treatment, she changed the application and merely sought release. (These facts are drawn from the judgment, [6][24].) The significance of this decision to the present discussion is that it acknowledges the relevance of the Human Tissue Acts, considers whether or not a failure to comply with the provisions of the relevant Act impacts on any later decisions regarding access to and use of the reproductive material, and, importantly, demonstrates that inquiries such as these deal with issues of considerable complexity ([24]). With regards to the Human Tissue Acts, his Honour referred to the relevant provision, Human Tissue Act 1983 (NSW) s 23 that mirrors the Western Australian provision discussed above, and was satisfied that the removal of sperm for reproductive purposes could fall within the category of medical purposes ([32]). However, in this particular instance, whilst the State Coroner was consulted the designated officer was not and the authority was provided by the Supreme Court. This approach was, according to Hulme J, taking the decision outside of the hands of the appropriate decision-making authority. This is an interesting conclusion given the fact that the vast majority of decisions regarding posthumous retrieval of sperm are made by the relevant Supreme Court through the application of property law principles3 and in Re Section 22 of the Human Tissue and Transplant Act 1982 (WA) looked to the Human Tissue Acts as providing a new and preferable approach to the accepted one. The fact that the Human Tissue Acts were overlooked in the earlier proceedings did not impact on the present decision, however, as the coroner was consulted and it was concluded that the designated officer would have approved the retrieval ([37]). The key point of interest from this decision is not, however, the application (or not) of the Human Tissue

Acts. It is the fact that it clearly demonstrates the multifaceted and complex nature of what occurs after the sperm is retrieved. There is absolutely no guarantee that the sperm can be used in any reproductive treatment. There is a clear prohibition on the use of reproductive material from a deceased donor (unless the donor had expressly consented to such use whilst alive) in four jurisdictions and a strong cautionary note sounded in the others (through the application of the NHMRC Guidelines introduced above). The mere possession of appropriately stored sperm is not sufficient to support access to treatment. At best, there will be series of further legal disputes4 and, at worst, a denial of access and subsequent destruction of any stored material. I suggest that the most recent decision does not provide a final solution; rather, it simply adds to the complexity of these disputes. Bernadette Richards

References
Baillon, J. 2013. Side-effects of drug study? Fox News Minneapolis-St. Paul, November 17. http://www. myfoxtwincities.com/story/23994239/investigators-sideeffects-of-drug-study. Carlat, D. 2010. Was the CAFE study manipulated by AstraZeneca? Maybe not. The Carlat Psychiatry Blog, August 26. http://carlatpsychiatry.blogspot.ca/2010/08/wascafe-study-manipulated-by.html. Davies, E. 2013. Investigating the fallout of a suicide. British Medical Journal 347(October 8): f6039. http://dx.doi.org/ 10.1136/bmj.f6039. Elliott, C. 2010. The deadly corruption of clinical trials. Mother Jones, September/October. http://www.motherjones.com/ environment/2010/09/dan-markingson-drug-trialastrazeneca. Elliott, C. 2011. How the FDA got the Markingson case wrong. Bioethics Forum, March 3. http://www.thehastingscenter. org/Bioethicsforum/Post.aspx?id=5147&blogid=140. Elliott, C. 2013. Getting by with a little help from your friends. Bioethics Forum, October 18. http://www.thehastingscenter. org/Bioethicsforum/Post.aspx?id=6582&blogid=140. Feeley, J. 2011. AstraZeneca resolves most Seroquel suits for $647 million. Bloomberg Businessweek, July 28. http://www.

See, for example: AB v Attorney-General for the State of Victoria (2005) 12 VR 485, Baker v State of Queensland [2003] QSC 2, and the extensive discussion of this in Re Section 22 of the Human Tissue and Transplant Act 1982 (WA) [2013] WASC 3, 2 January 2013.

4 Jocelyn Edwards had at least three applications before the Courts and there is the series of cases represented by AB v AttorneyGeneral for the State of Victoria [2005] USC 180 and YZ v Infertility Treatment Authority [2005] VCAT 2655 which dealt with a series of applications by a woman who wanted to access stored sperm and remove it to the ACT where she believed she could obtain treatment.

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