17 January 2015

Next Generation Privacy?

'Next Generation Privacy: The Internet of Things, Data Exhaust, and Reforming Regulation by Risk of Harm' by McKay Cunningham in (2014) 2(2) Groningen Journal of International Law argues 
To many, the EU's 1995 Directive has failed. While the global trend toward adopting laws similar to the Directive suggests that many nations value privacy rights, commentators and empirical studies reveal significant shortcomings. The Directive is simultaneously over-inclusive and under-inclusive. It outlaws harmless activities while allowing exceptions that threaten to swallow the rule. Edward Snowden revealed a disrupting example showing that national governments enjoy wide latitude to collect and use personal information under the guise of national security.
The problem of protecting private information is exacerbated by technology that continues to leapfrog. Information privacy is made continually more difficult with each new app and innovation. The Internet of Things is more probable than speculative. Everyday objects — thermostats, garage doors, beer mugs — communicate with the Internet through sensors. Radio-frequency identification is a predicate to computer identification and assimilation of everyday physical objects, enabling the use of these objects to be monitored and inventoried by computers. Tagging and monitoring objects could similarly be accomplished by other technologies like near field communication, barcodes, QR codes and digital watermarking, raising the legitimate argument that informational privacy — at least as envisioned in the 1995 Directive’s absolute terms — is impossible.
Informational privacy cannot be accomplished by declaring it a fundamental right and outlawing all processing of personal information. To legally realize and enforce a privacy right in personal information, incremental, graduated, and practical legislation better achieve the goal than sweeping proclamations that have applications to actions unrelated to the harms associated with the absence of the right. With information privacy in particular, a capacious claim of right to all personal information undermines legal enforcement because the harms attending lack of privacy are too often ill-defined and misunderstood. This paper reviews the shortcomings of the EU Directive, reviews new privacy challenges posed by the Internet of Things, and posits a regulatory regime based on risk of harm.

Truthiness Again

Given my interest in survivor fraud (Wilkomirski, Head, DeFonseca, Khouri, Armstrong), memoir (Mortenson) and credulity I was interested to see the announcement by publisher Tyndale House that it will belatedly stop selling The Boy Who Came Back From Heaven: A Remarkable Account of Miracles, Angels, and Life beyond This World by Alex Malarkey and Kevin Malarkey.

The best-seller is an example of the 'heavenly tourism' genre in which a child recounts a visit to heaven - typically a postmortem visit, with the deity idiosyncratically allowing the tot to return to earth with good news. The visit is presented - breathlessly - as a matter of fact, rather than belief or allegory. Elsewhere I've cruelly described another example as a form of religious kitsch.

In this instance Alex's supposed visit took place while he was in a coma after a car accident that left him paralyzed. He supposedly saw his father (the co-author) get caught by an angel - presumably you don't need a seatbelt or airbags if an angel is looking after you - during the crash.

Revelations? The gates of heaven are "tall" and "looks like it has scales like a fish". He met Christ and Satan (the latter apparently making a special guest appearance after crash-site conversation with Alex). Angels are "big and muscular, like wrestlers" ("if you didn't know they were friendly, they would be scary").

Alex has now recanted, stating "I did not die. I did not go to Heaven". Quelle surprise.

Tyndale is reported as stating
We are saddened to learn that Alex Malarkey, co-author of ‘The Boy Who Came Back from Heaven,’ is now saying that he made up the story of dying and going to heaven. Given this information, we are taking the book out of print.
Devout consumers presumably won't be starting a class action.

16 January 2015

Exits and ethics

'Suicide Reporting Within British Newspapers’ Arts Coverage: Content Analysis of Adherence to Media Guidelines' by Alexandra Pitman and Fiona Stevenson in (2014) Crisis: The Journal of Crisis Intervention and Suicide Prevention 1-8 comments
Many suicide prevention strategies promote media guidelines on suicide reporting, given evidence that irresponsible reporting of suicide can influence imitative suicidal behavior. Due to limited resources, monitoring of guideline adherence has tended to focus on news outputs, with a risk of neglecting other journalistic content. Aims: To determine whether British newspapers’ arts coverage adheres to media guidelines on suicide reporting.
Method: Purposive sampling was used to capture current national practice on suicide reporting within newspapers’ arts coverage of exhibitions. Recent major UK exhibitions by artists who had died by suicide were identified: Kirchner, Rothko, Gorky, and Van Gogh. Content analysis of all UK national newspaper coverage of these exhibitions was performed to measure the articles’ adherence to widely accepted media guidelines.
Results: In all, 68 newspaper reviews satisfied inclusion criteria, with 100% failing to show full adherence to media guidelines: 21% used inappropriate language; 38% provided explicit descriptions of the suicide; 7% employed simplistic explanations for suicide triggers; 27% romanticized the suicide; and 100% omitted information on sources of support.
Conclusion: British newspapers’ arts coverage of exhibitions deviates considerably from media guidelines on the reporting of suicide.
The authors state that
Content analysis identified seven media guidelines that had been breached by any of the included articles (see Figure 1). These were assimilated into five codes:
  • Use of inappropriate language (including the phrases “to commit suicide” or “a successful suicide”) 
  • Explicit descriptions of the suicidal act (including suicide method, and quotations from suicide notes) 
  • Providing a simplistic explanation for the triggers for suicide 
  • Romanticizing or glorifying the suicide 
  • Omitting to provide sources of support for people affected by suicide
Content analysis showed that all 68 articles (100%) had breached at least one of these five media guidelines, with all 68 omitting to provide details of support available (see Table 1).
Practice outside the mass media is noncompliant with those guidelines. Some listeners presumably need trigger warnings - or would benefit from intervention by Dr Bowdler - before encountering 2 Kings 24 (two bears righteously disposing of 42 students), Judges 9:52-54, Judges 16:29-30, 1 Samuel 31:4-6 (esp 2 Samuel 1:2-17), 2 Samuel 17:1-29, 1 Kings 16:15-20 and 1 Kings 18:40.

Much of the art in national galleries features exemplary deaths - Sardanapalus, Lucretia, Ophelia, Socrates, Ajax, Cato, Cleopatra. Much art (for examples renderings of the Crucifixion by Gr├╝newald or of the dead Christ by Carracci and Mantegna) is disquieting, meant as an aid to contemplation rather than mere decoration. Presumably collections, rather than merely reports about artists, "may expose readers to potentially harmful influences on attitudes to suicidality" if we adopt the words of the authors.

The authors comment
Analysis of this sample of British newspapers’ arts coverage of exhibitions has shown poor compliance with media guidelines on the reporting of suicide, with 100% of articles omitting to provide information on sources of support. Even when using less stringent criteria, by excluding the expectation of providing information on sources of support, the majority (45, 67%) of articles transgressed any of the other four guidelines. Only one of the 68 articles was written by a news journalist, with the rest constituting the output of arts and features journalists. This sample therefore reflects one measure of the implementation of media guidelines beyond core news teams. Given existing evidence of the harmful effects of irresponsible reporting on suicidal behavior (Chen et al., 2013; Cheng et al., 2007; Pirkis & Blood, 2010; Pirkis et al., 2007; Sisask & Varnik, 2012; Stack, 2003; Zahl & Hawton, 2004), these results suggest that some arts coverage of exhibitions within British newspapers may expose readers to potentially harmful influences on attitudes to suicidality.
Comparison with other findings is not possible because no international studies have focused solely on arts output, and no UK studies have analyzed newspaper content. ....
Our findings suggest a need for further UK and international research to measure:
  • Awareness of media guidelines among reporters in each journalistic field; 
  • Journalists’ perceptions of whether guidelines are applicable to their field; 
  • The impact of suicide reporting within different journalistic and media content; 
  • The impact of irresponsible reporting of historical suicides; and 
  • The effect of interventions designed to encourage journalists across a range of fields and media channels to report suicide responsibly.
... The articles included in this analysis reported deaths occurring up to a century ago, while the majority of research on media effects has focused on contemporaneous deaths. Feedback from national seminars at which these results were presented indicated that media guidelines may be considered as less relevant to arts journalists because historical accounts of an artist’s suicide may have less influence on suicidal behavior than contemporaneous reports. However, there is no research evidence to refute the impact of irresponsible reporting of historical suicides, and media guidelines are intended for all branches of the media, including arts coverage of recently deceased and historically deceased individuals.
Seminar participants also suggested that culturally an artist’s suicide may be regarded as less newsworthy (and implicitly more acceptable) than the suicide of celebrities such as sports professionals, because of beliefs about mental health difficulties feeding artistic creativity. If these views, which reinforce the romanticization of artists’ suicides, are widely held, there may be a need for media work to challenge an apparently dangerous glorification. It is difficult to predict which types of high-profile suicides will have greatest resonance among those at risk of imitative suicide, and artists may take on the status of celebrities for literary and artistic professionals. While Wasserman’s 1984 study found a fall in suicides (observed minus expected) in the month after the death of Mark Rothko, the mythology that has grown around his death in subsequent decades may now contain strong personal significance to groups at risk.
The authors acknowledge that
The reductionist approach of content analysis, and its reliance on numbers, may be inappropriate for capturing nuances of meaning within articles of this kind.
They go on to state
However, the use of clear and established guidelines was intended to increase inter-rater reliability by increasing the likelihood of similar interpretations. Although the deductive analysis was theory-driven, an interpretive element was involved in coding texts, subject to inter-rater agreement. Our ╬║ value was high in comparison to similar studies (Machlin et al., 2012), but there remains the possibility that other researchers might make different inferences. This applies particularly to guidelines involving more subjective judgments of the language, tone, and structure used throughout each article in the context of the artist’s full biographical information. Individual appraisal of whether a suicide has been romanticized or sensationalized is particularly subjective (Machlin et al., 2012). Finally, despite best efforts, incomplete archiving may have led to some articles having been overlooked.

Metadata

In a study sponsored by the US Office of the Director for National Intelligence (ODNI) the US National Research Council has argued that
No software-based technique can fully replace the bulk collection of signals intelligence, but methods can be developed to more effectively conduct targeted collection and to control the usage of collected data. Automated systems for isolating collected data, restricting queries that can be made against those data, and auditing usage of the data can help to enforce privacy protections and allay some civil liberty concerns
The study reflects Presidential Policy Directive 28 of January 2014 regarding  U.S. signals intelligence practices. The Directive instructed ODNI to produce a report within one year "assessing the feasibility of creating software that would allow the intelligence community more easily to conduct targeted information acquisition rather than bulk collection." ODNI commissioned the Research Council (ie the operating arm of the National Academy of Sciences and National Academy of Engineering)  to conduct a study.

Committee chair  Robert F. Sproull comments
 From a technological standpoint, curtailing bulk data collection means analysts will be deprived of some information,” said committee chairman former director of Oracle’s Sun Labs. “It does not necessarily mean that current bulk collection must continue. A reduction in bulk collection can be partially mitigated by improving targeted collection, and technologies can improve oversight and transparency and help reduce the conflict between collection and privacy.
The 86 page report [PDF] defines “collection” as the process of extracting data from a source, filtering it according to some criteria, and storing the results. If a significant portion of the collected data is not associated with current targets or subjects of interest in an investigation, it is considered bulk; otherwise, it is targeted. The report notes that the committee was not asked to and did not consider whether the loss of effectiveness from reducing bulk collection would be too great, or whether the potential gain in privacy from adopting an alternative collection method is worth the potential loss of intelligence information.

It should accordingly not be misread in relation to the often uninformed and highly polemical debate about Australian metadata retention proposals.

The Committee considers that a key value of bulk collection is its record of past signals intelligence that may be relevant to subsequent investigations. Other sources of information (for example, metadata held by third parties such as communications providers) might provide a partial substitute for bulk collection in some circumstances. Improving the relevance of collected information to future investigations could also be achieved with new approaches to targeting.
Rapidly updating filtering criteria to include new targets as they are discovered will help collect data that would otherwise be lost, and if done quickly enough and well enough, bulk information about past events may not be needed. However, targeted collection cannot substitute for bulk collection if past events were unique or if the delay in collecting the new information is too long. 
The Committee argues that
As an alternative to controlling the collection of data, automated controls on the use of collected data can help to protect the privacy of people who are not subjects of investigation, the committee found. The report describes three key technical elements required to control and automate usage: isolating bulk data so that it can be accessed only in specific ways; restricting the types of queries that can be made against stored data; and auditing the queries that have been done. The way these controls work can be made public without revealing sensitive data, so that outside inspectors can verify that the intelligence community has and abides by adequate procedures to protect privacy. While some of the necessary technologies to enhance targeted collection or improve automated usage controls require further research and development, some of the techniques are already in use in the intelligence community or in private companies, some have been demonstrated in research laboratories, and many are feasible to deploy within the next five years. Automating usage controls will be easier if the rules governing collection and use are technology-neutral and based on a consistent set of definitions.
 Given the Committee's charter the report unsurprisingly concludes
Ultimately, the decision to deploy any given technology is a policy question that requires determining whether increased effectiveness and apparent transparency are worth the cost in equipment, labor, and potential interference with the intelligence mission. Such discussions were beyond the scope of this report.

Paternalism

'Paternalism, Public Health, and Behavioral Economics: A Problematic Combination' by Wendy K. Mariner in (2015) 46 Connecticut Law Review 1817 comments 
Some critiques of public health regulations assume that measures directed at industry should be considered paternalistic whenever they limit any consumer choices. Given the presumption against paternalistic measures, this conception of paternalism puts government proposals to regulate industry to the same stringent proof as clearly paternalist proposals to directly regulate individuals for their own benefit. The result is to discourage regulating industry in ways that protect the public from harm and instead to encourage regulating individuals for their own good -- quite the opposite of what one would expect from a rejection of paternalism. Arguments favoring "soft paternalism" to justify some regulatory measures may exacerbate this trend. They can muddy the debate, narrow the range of reasons for regulating industry, and instead encourage harder paternalistic regulation of personal behavior.

Clinical Trial Data Sharing

The US National Academies Press has published a 280pp report on Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk.

The report is of particular interest to privacy specialists, research managers, and people such as myself who've been involved in the NHMRC clinical trials framework and TGA confidentiality consultations.

The Committee on Strategies for Responsible Sharing of Clinical Trial Data states
In response to 23 public- and private-sector sponsors, the Institute of Medicine assembled an ad hoc committee to develop guiding principles and a framework (activities and strategies) for the responsible sharing of clinical trial data. Responsible sharing of clinical trial data will allow other investigators to carry out additional analyses and reproduce published findings, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators.
At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to (1) protect the privacy and honor the consent of clinical trial participants; (2) safeguard the legitimate economic interests of sponsors (e.g., intellectual property and commercially confidential information); (3) guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health; (4) give researchers who put effort and time into planning, organizing, and running clinical trials adequate time to analyze the data they have collected and appropriate recognition for their intellectual contributions; and (5) assuage the fear of research institutions that requirements for sharing clinical trial data will be unfunded mandates.
With the goal of ensuring responsible sharing of clinical trial data to increase scientific knowledge and ultimately lead to better therapies for patients, the committee that conducted this study identified the following guiding principles for data sharing: (1) maximize the benefits of clinical trials while minimizing the risks of sharing clinical trial data, (2) respect individual participants whose data are shared, (3) increase public trust in clinical trials and the sharing of trial data, and (4) conduct the sharing of clinical trial data in a fair manner. The committee drew on these guiding principles in developing its recommendations and believes they will be useful in the future as circumstances change and unforeseen issues emerge.
In this report, the committee analyzes how key stakeholders (including participants, sponsors, regulators, investigators, research institutions, journals, and professional societies) assess the benefits, risks, and challenges of data sharing, and concludes that all stakeholders have roles and responsibilities in responsible sharing of clinical trial data. The report presents four recommendations designed to maximize the benefits and minimize the risks associated with data sharing:
 Those recommendations are -
R1: Stakeholders in clinical trials should foster a culture in which data sharing is the expected norm, and should commit to responsible strategies aimed at maximizing the benefits, minimizing the risks, and overcoming the challenges of sharing clinical trial data for all parties.
R2: Sponsors and investigators should share the various types of clinical trial data no later than the times specified in this report (e.g., the full analyzable data set with metadata no later than 18 months after study completion—with specified exceptions for trials intended to support a regulatory application—and the analytic data set supporting publication results no later than 6 months after publication).
R3: Holders of clinical trial data should mitigate the risks and enhance the benefits of sharing sensitive clinical trial data by implementing operational strategies that include employing data use agreements, designating an independent review panel, including members of the lay public in governance, and making access to clinical trial data transparent.
R4: The sponsors of this study should take the lead, together with or via a trusted impartial organization(s), to convene a multistakeholder body with global reach and broad representation to address, in an ongoing process, the key infrastructure, technological, sustainability, and workforce challenges associated with the sharing of clinical trial data.
The report
Responsible sharing of clinical trial data is in the public interest. It maximizes the contributions made by clinical trial participants to scientific knowledge that benefits future patients and society as a whole. Results from many clinical trials are not published in peerreviewed journals in a timely manner. Even when findings are published, large amounts of data remain unanalyzed. Data sharing makes data from clinical trials available to other investigators for secondary uses, which include carrying out additional analyses, analyzing unpublished data, reproducing published findings, and conducting exploratory analyses to generate new research hypotheses. In several highly publicized cases, independent investigators who have reanalyzed the data underlying published results of clinical trials have challenged the published results as invalid or incomplete. These allegations have sparked debates, additional analyses, and new clinical trials. Further, they have caused regulators to limit marketing of the products or led sponsors to withdraw them. This back-and-forth discussion, while complex and perhaps confusing to the public, is how scientific knowledge progresses, and has resulted in a broader evidence base for regulatory and clinical decisions.
Taken together, these are compelling justifications for sharing clinical trial data to benefit society and future patients. The challenge is to set clear expectations that clinical trial data should be shared and to agree on how to do so in a responsible manner that mitigates the risks involved. Stakeholders have concerns about data sharing. Clinical trial participants want assurance that data will be shared in a way that protects privacy and is consistent with informed consent. Sponsors want a quiet period for regulators to evaluate the entire body of evidence submitted to them, appropriate safeguards for intellectual property and commercially confidential information, and protections from invalid secondary analyses. Academic clinical trialists want time to analyze and publish the data they have collected and thereby gain appropriate professional recognition for planning, organizing, and running clinical trials whose data are subsequently used by other investigators. Research institutions fear that requirements for sharing clinical trial data will be unfunded mandates. Participant and patient advocates want clinical trial data to be widely available in order to advance the development of new treatments. If data sharing is to be broadly accepted and fulfill its promise, these concerns of key stakeholders will need to be acknowledged and addressed. Moreover, the sharing of clinical trial data needs to be carried out in a way that maintains incentives for sponsors and researchers to develop new therapies and carry out future clinical trials and that sustains patients’ willingness to participate in trials.
In addressing its statement of task (see Box S-1), the committee that conducted this study worked to craft a report that would be useful well into the future, as well as address specific issues that need attention in the short term. The committee acknowledges that no body or authority currently is capable of enforcing the recommendations offered in this report for all stakeholders; rather, the committee interpreted as its charge as helping to establish professional standards and set expectations for responsible sharing of clinical trial data. ...
The goal of responsible sharing of clinical trial data should be to increase scientific knowledge that leads to better therapies for patients. The committee formulated the following guiding principles for responsible sharing of clinical trial data:
• Maximize the benefits of clinical trials while minimizing the risks of sharing clinical trial data. • Respect individual participants whose data are shared. • Increase public trust in clinical trials and the sharing of trial data. • Conduct the sharing of clinical trial data in a fair manner.
These guiding principles need to be specified and balanced in the context of specific issues associated with the sharing of clinical trial data.
The committee determined that the public should benefit from the sharing of clinical trial data in the form of valid scientific knowledge and improved clinical practice and public health; at the same time, however, the legitimate interests of stakeholders—particularly their concerns about the potential harms and costs of data sharing—need to be recognized and addressed in a fair manner.
Key Stakeholders Involved in Data Sharing
In Chapter 3, the committee analyzes the perspectives of key stakeholders regarding the sharing of clinical trial data and their assessment of the associated benefits, risks, and challenges. No stakeholder can single-handedly create a clinical trial ecosystem in which sharing data is expected and the risks of sharing are minimized. But all stakeholders have crucial roles and responsibilities in creating a culture of responsible sharing of clinical trial data and in providing effective incentives for such sharing. The committee envisaged that different approaches to sharing clinical trial data will be developed and urges learning from experience with these approaches.
Recommendation 1: Stakeholders in clinical trials should foster a culture in which data sharing is the expected norm, and should commit to responsible strategies aimed at maximizing the benefits, minimizing the risks, and overcoming the challenges of sharing clinical trial data for all parties.
Funders and sponsors should
• promote the development of a sustainable infrastructure and mechanism by which data can be shared, in accordance with the terms and conditions of grants and contracts; • provide funding to investigators for sharing of clinical trial data as a line item in grants and contracts; • include prior data sharing as a measure of impact when deciding about future funding; • include and enforce requirements in the terms and conditions of grants and contracts that investigators will make clinical trial data available for sharing under the conditions recommended in this report; and • fund and promote the development and adoption of common data elements.
Disease advocacy organizations should
• require data sharing plans as part of protocol reviews and criteria for funding grants; • provide guidance and educational programs on data sharing for clinical trial participants; • require data sharing plans as a condition for promoting clinical trials to their constituents; and • contribute funding to enable data sharing.
Regulatory and research oversight bodies should
• work with industry and other stakeholders to develop and harmonize new clinical study report (CSR) templates that do not include commercially confidential information or personally identifiable data; • work with regulatory authorities around the world to harmonize requirements and practices to support the responsible sharing of clinical trial data; and • issue clear guidance that the sharing of clinical trial data is expected, and that the role of Research Ethics Committees or Institutional Review Boards (IRBs) is to encourage and facilitate the responsible and ethical conduct of data sharing through the adoption of protections such as those recommended by this committee and the emerging best practices of clinical trial data sharing initiatives.
Research Ethics Committees or IRBs should
• provide guidance for clinical trialists and templates for informed consent for participants that enable responsible data sharing; • consider data sharing plans when assessing the benefits and risks of clinical trials; and • adopt protections for participants as recommended by this committee and the emerging best practices of clinical trial data sharing initiatives.
Investigators and sponsors should
• design clinical trials and manage trial data with the expectation that data will be shared; • adopt common data elements in new clinical trial protocols unless there is a compelling scientific reason not to do so; • explain to participants during the informed consent process − what data will (and will not) be shared with the individual participants during and after the trial, − the potential risks to privacy associated with the collection and sharing of data during and after the trial and a summary of the types of protections employed to mitigate this risk, and  − under what conditions the trial data may be shared (with regulators, investigators, etc.) beyond the trial team; and • make clinical trial data available at the times and under the conditions recommended in this report.
Research institutions and universities should
• ensure that investigators from their institutions share data from clinical trials in accordance with the recommendations in this report and the terms and conditions of grants and contracts; • promote the development of a sustainable infrastructure and mechanisms for data sharing; • make sharing of clinical trial data a consideration in promotion of faculty members and assessment of programs; and • provide training for data science and quantitative scientists to facilitate sharing and analysis of clinical trial data.
Journals should
• require authors of both primary and secondary analyses of clinical trial data to − document that they have submitted a data sharing plan at a site that shares data with and meets the data requirements of the World Health Organization’s International Clinical Trials Registry Platform before enrolling participants, and − commit to releasing the analytic data set underlying published analyses, tables, figures, and results no later than the times specified in this report; • require that submitted manuscripts using existing data sets from clinical trials, in whole or in part, cite these data appropriately; and • require that any published secondary analyses provide the data and metadata at the same level as in the original publication.
Membership and professional societies should
• establish policies that members should participate in sharing clinical trial data as part of their professional responsibilities; • require as a condition of submitting abstracts to a meeting of the society and manuscripts to the journal of the society that clinical trial data will be shared in accordance with the recommendations in this report; and • collaborate on and promote the development and use of common data elements relevant to their members.
What data should be shared and when in the life cycle of a clinical trial 
In Chapter 4, the committee analyzes the benefits, risks, and challenges of sharing the various types of clinical trial data that are generated at different times during the clinical trial life cycle.
Data sharing can refer to various types of data, including individual participant data (i.e., raw data and the analyzable data set); metadata, or “data about the data” (e.g., protocol, statistical analysis plan, and analytic code); and summary-level data (e.g., summary-level results posted on registries, lay summaries, publications, and CSRs). Therefore, a clinical trial data sharing policy needs to specify what data will be shared, when, and under what conditions.
The committee recognizes that sharing the various types of data presents different benefits and risks.
• Sharing summary results helps protect against publication bias but does not enable new analysis. • Sharing the analyzable data set allows for reanalysis, meta-analysis, and scientific discovery through hypothesis generation, but this data set needs to be accompanied by metadata in order for secondary analyses to be rigorous and efficient, and sharing it could also lead to privacy risks and inappropriate analyses. • Sharing the CSR allows for better understanding of regulatory decisions and facilitates use of the analyzable data set, but the CSR may contain commercially confidential information or be used for unfair commercial purposes. • Sharing raw data is useful in certain circumstances, but is overly burdensome in most cases and also presents risks to privacy. • Summary results may be posted on public websites with few risks, but the risks of sharing individual participant data and CSRs are significant and may need to be mitigated in most cases through appropriate controls. • Explaining to trial participants what data will be shared during the informed consent process and making their own data available to them following study completion and data analysis helps uphold public trust in clinical trials.
The committee applied these considerations to clinical trial data for trials initiated after this report only, recognizing that sharing data from legacy trials may present greater risks and burdens, and so needs to be deliberated on a case-by-case basis. Sponsors and investigators are strongly urged to give priority to sharing of data from legacy trials whose findings influence decisions about clinical care.
Next, the committee considered the timing of data sharing. The committee sought to balance several goals: (1) providing trial investigators a fair opportunity to publish their analyses; (2) allowing other investigators to analyze and use data that are otherwise not being published in a timely manner and to reproduce the findings of a published paper; and (3) reducing the risks of data sharing, including risks to participants and sponsors and the risk of invalid analyses of shared data. The committee appreciated that many clinical trialists feel strongly that, after years of effort carrying out a clinical trial, they should have the opportunity to write a series of papers analyzing the collected data before other investigators have access to the data. The committee concluded that after completion of a clinical trial, a moratorium of 18 months is generally appropriate before data are shared to allow trialists to carry out their analyses.
The committee paid particular attention to sharing of the analytic data set that supports a published paper reporting results of a clinical trial. Once the results of a study have been published, the scientific process is best served by allowing other investigators immediate access to the analytic data set supporting the publication so they can reproduce the published findings and carry out additional analyses to test the robustness of the conclusions.
In an ideal clinical trials ecosystem, the committee would favor sharing the analytic data set supporting a publication immediately upon publication. However, the committee recognized that there currently are many associated practical constraints and challenges that need to be addressed. The committee therefore has recommended a pragmatic compromise time frame of 6 months after publication at this time, with the expectation that the standard ultimately will become sharing the analytic data set simultaneously with publication. The committee hopes that the evolution of responsible sharing of clinical trial data will be guided by empirical evidence. At the same time, the committee recognized that there will be justifiable exceptions to its recommendations in light of the wide variation in clinical trials. The recommended time periods at which specific data are to be shared are not intended to be hard-and-fast, inflexible rules. For trials that are likely to have a major clinical, public health, or policy impact, the committee favors sharing the analytic data set supporting a publication sooner than the 6-month guideline.
The committee next considered clinical trials submitted to a regulatory agency.
Regulatory agencies review data from many trials and may carry out further analyses or require additional data. There are advantages to allowing regulatory agencies a “quiet period” to review the totality of evidence without being influenced by multiple analyses of just a portion of the data under review. However, if the sponsor publishes results from a trial prior to regulatory approval, the analytic data set supporting the publication should be shared as recommended, even if that occurs before the end of the regulators’ quiet period.
Turning to clinical trials of products that are abandoned, the committee distinguished situations in which the sponsor transfers rights to develop the product to another company from situations in which it does not. The committee also considered sharing of data with trial participants and the public, distinguishing summary results of a trial from results of measurements on individual participants made during the trial.
Drawing together these considerations, the committee formulated the following recommendation for what data should be shared after key points in a clinical trial. The committee believes that this recommendation will set professional standards and establish expectations that clinical trial data should be shared (see also Figure 1):
Recommendation 2: Sponsors and investigators should share the various types of clinical trial data no later than the times specified below. Sponsors and investigators who decide to make data available for sharing before these times are encouraged to do so.
Trial registration:
• The data sharing plan for a clinical trial (i.e., what data will be shared when and under what conditions) should be publicly available at a thirdparty site that shares data with and meets the data requirements of the World Health Organization’s International Clinical Trials Registry Platform; this should occur before the first participant is enrolled.
Study completion:
• Summary-level results of clinical trials (including adverse event summaries) should be made publicly available no later than 12 months after study completion. • Lay summaries of results should be made available to trial participants concurrently with the sharing of summary-level results, no later than 12 months after study completion. • The “full data package” should be shared no later than 18 months after study completion (unless the trial is in support of a regulatory application).
Publication:
• The “post-publication data package”  should be shared no later than 6 months after publication.
Regulatory application:
• For studies of products or new indications that are approved, the “postregulatory data package”1 should be shared 30 days after regulatory approval or 18 months after study completion, whichever occurs later. • For studies of new products or new indications for a marketed product that are abandoned, the “post-regulatory data package” should be shared no later than 18 months after abandonment. However, if the product is licensed to another party for further development, these data need be shared only after publication, approval, or final abandonment.
Access to clinical trial data
In Chapter 5, the committee analyzes how several risks associated with sharing clinical trial data (in particular individual participant data and CSRs) might be addressed through controls on data access (i.e., with whom the data are shared and under what conditions) without compromising the usefulness of data sharing for the generation of additional scientific knowledge. Arrangements for determining access to clinical trial data need to balance several goals: protecting the privacy of research participants, reducing the likelihood of invalid analyses or misuse of the shared data, avoiding undue burdens on secondary users seeking access, avoiding undue harms to investigators and sponsors that share data, and enhancing public trust in the sharing of clinical trial data.
The committee noted support for open and free access to scientific publications immediately upon publication, as well as the requirement of the U.S. Food and Drug Administration (FDA) to make a summary of clinical trial results available to the public. The committee believes that open access (to the public with no controls) is appropriate and desirable for clinical trial results, and in some cases, no or few controls on sharing other types of clinical trial data may be the preferred approach when all stakeholders involved in a trial (i.e., sponsors, investigators, and participants) are comfortable with this approach and believe the benefits outweigh the risks. In many cases, however, sponsors, investigators, and/or participants may have concerns about an open access model for certain clinical trial data, and may wish to place some conditions on access to or uses of the data.
In reviewing protections for privacy, the committee noted that while de-identification is commonly used to protect privacy, it has limitations. Different jurisdictions have different deidentification standards. Moreover, the risk of re-identification depends on the context in which data are released, the type of data, and the additional information that might be combined with the shared data. In the case of genome-wide sequencing data and “big data” analyses, for example, de-identification and data security alone may not provide adequate protection; additional privacy and security techniques are being developed for these cases.
The committee determined that data use agreements are a promising vehicle for reducing these risks and related disincentives for sharing clinical trial data. The committee reviewed a variety of provisions in existing data use agreements aimed at reducing risks to various parties, enhancing the scientific value of secondary analyses, and protecting the public health. The committee does not endorse all the specific provisions that were reviewed, but believes they should be considered as potential options. Although it is unclear whether and how data use agreements will be enforced, the committee believes these agreements have significant normative, symbolic, and deterrent value, setting professional expectations and standards for responsible behavior.
The committee considered the review of requests for data access and reached several conclusions. Access restrictions based on the composition of the secondary analysis team—for example, requiring a biostatistician with particular qualifications or excluding lawyers—would not further the goals of responsible sharing of clinical trial data. Review of research proposals could mitigate risks, but overly restrictive controls would inhibit valid secondary analyses and innovative scientific proposals. If the trial sponsor or investigator, rather than an independent review panel, reviewed data requests and made decisions regarding access, concerns about conflicts of interest could lead to mistrust. Representatives of communities and patient and disease advocacy groups could serve as useful members of such review panels. Furthermore, making the policies and procedures regarding access to clinical trial data transparent would enhance the trustworthiness of data sharing programs.
Finally, the committee concluded that the experience of early adopters of the sharing of clinical trial data will undoubtedly offer lessons and best practices from which others can learn. As sponsors try different approaches to data sharing, collecting empirical data that allow comparison of different approaches will provide crucial information on what does and does not work in various contexts.
In light of the above considerations, the committee formulated the following recommendation regarding data access:
Recommendation 3: Holders of clinical trial data should mitigate the risks and enhance the benefits of sharing sensitive clinical trial data by implementing operational strategies that include employing data use agreements, designating an independent review panel, including members of the lay public in governance, and making access to clinical trial data transparent. Specifically, they should take the following actions:
• Employ data use agreements that include provisions aimed at protecting clinical trial participants, advancing the goal of producing scientifically valid secondary analyses, giving credit to the investigators who collected the clinical trial data, protecting the intellectual property interests of sponsors, and ultimately improving patient care.  • Employ other appropriate techniques for protecting privacy, in addition to deidentification and data security. • Designate an independent review panel—in lieu of the sponsor or investigator of a clinical trial—if requests for access to clinical trial data will be reviewed for approval. • Include lay representatives (e.g., patients, members of the public, and/or representatives of disease advocacy groups) on the independent review panel that reviews and approves data access requests. • Make access to clinical trial data transparent by publicly reporting − the organizational structure, policies, procedures (e.g., criteria for determining access and conditions of use), and membership of the independent review panel that makes decisions about access to clinical trial data; and − a summary of the decisions regarding requests for data access, including the number of requests and approvals and the reasons for disapprovals. • Learn from experience by collecting data on the outcomes of data sharing policies, procedures, and technical approaches (including the benefits, risks, and costs), and share information and lessons learned with clinical trial sponsors, the public, and other organizations sharing clinical trial data.
The Future of Clinical Trial Data Sharing In A Changing Landscape
Chapter 6 presents the committee’s vision for responsible sharing of clinical trial data in the future. In this vision, all stakeholders are committed to sharing data responsibly, have modified their work processes to facilitate data sharing, and possess the resources and tools necessary to do so:
  • A culture of sharing clinical trial data with effective incentives for sharing emerges. 
  • There are more platforms for sharing clinical trial data, with different data access models and with sufficient total capacity to meet demand. The different platforms are interoperable: data obtained from various platforms can easily be searched and combined to allow further analyses. 
  • There is adequate financial support for sharing clinical trial data, and costs are fairly allocated among stakeholders. 
  • Protections are in place to minimize the risks of data sharing and to reduce disincentives for sharing. 
  • Best practices for sharing clinical trial data are identified and modified in response to ongoing experience and feedback. The sharing of clinical trial data forms a “learning” ecosystem in which data on data sharing outcomes are routinely collected and continually used to improve how data sharing is conducted.
Next the committee identified remaining key challenges to responsible sharing of clinical trial data, which include the following:
  • Infrastructure challenges—Currently there are insufficient platforms to store and manage clinical trial data under a variety of access models.  
  • Technological challenges—Current data sharing platforms are not consistently discoverable, searchable, and interoperable. Special attention is needed to the development and adoption of common protocol data models and common data elements to ensure meaningful computation across disparate trials and databases. A federated query system of “bringing the data to the question” may offer effective ways of achieving the benefits of sharing clinical trial data while mitigating its risks. 
  • Workforce challenges—A sufficient workforce with the skills and knowledge to manage the operational and technical aspects of data sharing needs to be developed. 
  • Sustainability challenges—Currently the costs of data sharing are borne by a small subset of sponsors, funders, and clinical trialists; for data sharing to be sustainable, costs will need to be distributed equitably across both data generators and users. 
The committee gave particular attention to the need for a sustainable and equitable business model for responsible sharing of clinical trial data and developed the following conceptual framework:
  • Responsible sharing of clinical trial data benefits the public and multiple stakeholders, including payers of health care as well as patients, their physicians, and researchers. 
  • As a matter of fairness, those who benefit from responsible sharing of clinical trial data, including the users of shared data, should also bear some of the costs of sharing. Additional sources of funding for responsible sharing of clinical trial data, such as private philanthropies, need to be identified. 
  • Policies on equitable distribution of the costs of responsible sharing of clinical trial data among stakeholders should be based on accurate information on the costs of data sharing for various kinds of clinical trials. 
  • The costs of responsible sharing of clinical trial data will decrease in the future if data collection and management are designed to facilitate sharing.
The committee concluded that a market analysis of the costs of sharing clinical trial data and an economic analysis of options for funding data sharing would provide an evidence base for developing sustainable and equitable models for responsible sharing of clinical trial data. 
Finally, the committee considered the ecosystem of responsible sharing of clinical trial data. Individual sponsors and trusted intermediaries can do a great deal to make sharing clinical trial data more responsible, effective, and efficient. For responsible sharing of clinical trial data to become pervasive, sustained, and rooted as a professional norm, however, many challenges need to be addressed in collaboration with other institutions and stakeholders. 
The committee recommends a next step to promote discussion and exchange of ideas among a wide range of stakeholders in order to forge agreement on best practices, standards, and incentives: 
Recommendation 4: The sponsors of this study should take the lead, together with or via a trusted impartial organization(s), to convene a multistakeholder body with global reach and broad representation to address, in an ongoing process, the key infrastructure, technological, sustainability, and workforce challenges associated with the sharing of clinical trial data.

15 January 2015

Cruelty and commerce in family law

'A History of Cruelty in Australian Divorce' by Colin G. James at the 2006 Australian and New Zealand Law and History Society Conference, Waikato, examines 
the concept of matrimonial cruelty in Australia during the twentieth century. Cruelty was a matrimonial offence in Australian statutes and grounds for judicial separation or divorce until 1975. Most allegations of cruelty were by wives against their husbands. Judges often espoused on men's role as husbands, their use of power and the nature of hierarchy within marriage. I examine the background of matrimonial cruelty as it developed within English common law in the Australian colonies until Federation. While claiming to be doing justice, the courts used the grounds of cruelty in a strategy to preserve hierarchy in the marriage-based family by silencing women and empowering men. The theory was that men were 'naturally' superior to women in ways that were good for the family and ultimately for social stability. Until the 1970s, the Australian man had a legal duty to control his wife as much as a wife had a duty to obey her husband. The legal endorsement of patriarchy over decades reinforced misogynist attitudes in men as much as it provoked ultimately successful feminist demands for reform. Cruelty was abolished with all matrimonial offences by the Family Law Act 1975 however the controlling attitudes remained, to materialise in a new regime of domestic violence.
'Wife Sales' by Peter Boettke, Peter Leeson and Jayme Lemke in (2014) 1 Review of Behavioral Economics 349-379 comments
 For over a century, English husbands sold their wives at auctions. We argue that wife sales were an institutional response to an unusual constellation of property rights in Industrial Revolution-era English law. That constellation simultaneously required most wives to obtain their husbands’ consent to exit their marriages and denied most wives the right to own property. In doing so it precluded direct Coasean divorce bargains between spouses that could dissolve inefficient marriages when wives’ valuation of life outside their marriages was higher than husbands’ valuation of life inside them. To overcome this problem, spouses used wife sales to conduct divorce bargains indirectly. Wifesale auctions achieved this by identifying and leveraging “suitors” — men who valued unhappy wives more than their current husbands, who unhappy wives preferred to their current husbands, and who had the property rights required to buy unhappy wives’ right to exit marriage from their husbands. The resulting transactions enabled unhappy wives in inefficient marriages to exit those marriages where English law otherwise prevented them from doing so.

ACT Speed Cameras

Last year's Speed Cameras in the ACT Performance Audit Report by the ACT Auditor-General comments
The ACT is unlikely to have the right number of speed cameras in the right places. The effectiveness of speed cameras in the ACT has not been established. Speed camera reliability is poor.
After noting that those deficiencies have  no effect on the validity of infringements issued the report offers specific comments over some 110 pages
Siting of speed cameras conclusions (Chapter 2)
There is no strategic basis for making decisions for integrating the use of the ACT’s speed camera systems as the ACT Government does not have a speed camera strategy and its draft ACT road safety camera strategy (September 2013) is ‘not a strategy’. Over the last fourteen years, the use of speed cameras in the ACT has grown incrementally without a strategy that covers the whole road network, or the contribution each camera system makes towards long-term road safety goals.
Problems and uncertainties exist with each of the four speed camera systems in use in the ACT:
  • Mobile speed camera coverage is limited compared with that envisaged by the ACT Government in 2005, and mobile camera operations are overt which means it is unlikely that the ACT Government is achieving its desired ‘anytime, anywhere’ approach. 
  • Speed and red light cameras may not be located at the highest priority sites as their effectiveness and relative priority, compared with intersections with traffic lights where there are no cameras, has not recently been evaluated. The last evaluation occurred in 2003 and it was for three sites only. 
  • There are too few mid-block speed cameras to achieve the Government’s aim of having a general effect on speeding across the road network, and the siting of these cameras does not take account of crash data as is the practice in other Australian jurisdictions. Mid-block cameras are unlikely to be sited to achieve the best road safety results. 
  • The siting of point-to-point speed cameras in the ACT is experimental as there is little or no evidence from elsewhere to support their use in an urban environment, for such short sections of road, or for the purpose of reducing speeding beyond the sections of road between the pairs of cameras. There is no evaluation plan to determine the effectiveness of the ACT’s point-to-point speed cameras.
Effectiveness of speed cameras conclusions (Chapter 3)
There is a persistent speeding problem in the ACT, according to survey and infringement data, which calls into question the effectiveness of the ACT Government’s speed camera systems.
Evaluations of speed camera systems, particularly the mid-block speed cameras and the recently implemented point-to-point cameras have not been undertaken. Furthermore the value for money of the two point-to-point camera installations is questionable. It is likely there has been a three-fold increase in the cost per km of road treated from the initial design stage through to implementation.
While the speeding problem in the ACT is persistent, its extent is unknown. Residents report high levels of speeding, but this cannot be confirmed with any accuracy. The use of infringement data from camera sites is an unreliable indicator of speeding behaviour across the road network and speed surveys have not been designed to be representative. As a result there is limited information on whether the problem of speeding is increasing or diminishing on the road network.
Limitations in data used in the development of the ACT’s speed camera systems are not identified to decision makers. The planning and coordination of data collection is not effective. Information on camera effectiveness has not been routinely made public. The administration of requests for the disclosure of vehicle images is inadequate.
Speed camera reliability and operations administration conclusions (Chapter 4)
Reliability problems, particularly with mobile cameras, have led to escalating maintenance costs, limited camera availability, and a greater number of rejected infringements when checked by adjudicators prior to issuing. This compromises the effectiveness of the Government’s speed enforcement activities as fewer speeding motorists receive a Camera Infringement Notice, despite speeding occurring at camera sites. In 2013-14 the Government funded ($1.55 million) the replacement of most of its speed camera equipment that is more than ten years old.
The Government’s administration of Camera Infringement Notices with respect to the verification of infringements is robust thereby reducing the risk of issuing invalid infringements. However, the relatively high rejection rate of potential infringements indicates inefficiencies. The Traffic Camera Office is aware of the limitations of its adjudication system which will be the subject of an options evaluation in 2013-14.
All fixed speed cameras receive routine checks with planned maintenance currently meeting requirements. While this is the case, the current maintenance cycle for these cameras may be too frequent in some instances. This needs to be investigated as savings may be able to be realised if cameras are being over serviced.
Although the Government has provided funding in 2013-14 for existing equipment replacement and maintenance, there is no documented strategy to guide how best to program and integrate these activities.
The planning and review of the sites scheduled for mobile speed van operations is inadequate. This makes strategic forward planning difficult and presents the risk that these cameras are not being used effectively.
The Auditor-General's key findings are -  
Siting of speed cameras --  The development of speed camera systems in the ACT . Since speed cameras were introduced in 1999 the ACT Government has not developed a speed camera strategy that: supports its road safety strategies and road safety action plans; adopts a network-wide approach; identifies a target contribution from speed cameras to the overall reduction in fatalities and injuries; and integrates systems and actions.
Budget proposals have been the basis for expanding speed camera systems in the ACT. Many have had a focus on adopting a new technology. Budget proposals have been inadequate as there has been no explanation for the scale of funding requested, proposals do not state what the funding requested will achieve in terms of road safety results and what the relationship is between the level of funding sought and the long-term expansion of camera systems.
At no time in the fourteen years of the development of speed camera systems in the ACT has there been a Government commitment to, or policy position for, the extent of the camera coverage in a timescale beyond the budget round at the time. Expansion has been a stated aim but it has not been defined.
The ACT Government in 2011 recognised the need for an overarching speed camera strategy in its Road safety action plan 2011-2013 in stating that an ‘overall strategy and guidelines for gradual expansion will be prepared’. A draft ACT road safety camera strategy (September 2013) has been prepared.
Professor Max Cameron, the road safety subject matter expert engaged to assist in this audit, advised that
‘The ACT road safety camera strategy (draft) is not a strategy. No goal is stated and its specific objectives for achieving a reduction in road trauma in the ACT are not given. The four types of camera system represent the elements of the system, but it is unclear what principles for the deterrence of speeding are their basis. No estimates of the speeding and crash reductions likely to be achieved by the camera systems, alone and in aggregate, appear to have been made in developing the strategy. Hence the ACT Government will have no idea whether its road safety camera program will contribute substantially to achieving the ACT and National strategic goals of 30 per cent reduction in serious road casualties by 2020, or not at all’. 
The lack of an adequate speed camera strategy presents the risk that the ACT’s speed camera systems, collectively and individually, will not achieve desired road safety objectives, funding will not be targeted, and decisions to invest in specific speed camera systems will result in poor value for money.
The ACT Government has agreed to adopt the National road safety strategy 2011-2020 which seeks to have jurisdictions consider the issue of hypothecation by the end of 2013. According to an Austroads report (2013) there has been a partial or full hypothecation of revenue from speed enforcement activities directly back to road safety in Victoria, Queensland, Tasmania and Western Australia. The ACT Government’s position on this matter has not been stated. 
Mobile speed cameras -- Mobile speed camera sites were initially selected based on, amongst other things, data relating to speed-related crash history and speed surveys. In 2005, the Government committed to assessing all 649 arterial and collector roads in the ACT with a view to expanding the number of sites for its mobile speed camera operations, and achieving a greater compliance with speed limits across the whole ACT road network.
The expansion of mobile speed camera operations is taking considerable time to achieve as after nine years, mobile speed camera vans are only able to be used on 147 roads, which is 23 per cent of the ACT’s 649 arterial and collector roads. This is because not all of the 649 roads have been assessed and therefore cannot be added to Schedule 1 of the Road Transport (Safety and Traffic Management) Regulation 2000 to facilitate the use of mobile speed cameras. 
Furthermore, since 2005, at least 77 per cent of sites added to Schedule 1 were initially identified from public complaints. In most cases, during the site assessment process, there was limited consideration of other site selection criteria, such as accident history and traffic density. Therefore Schedule 1 may not reflect the most appropriate sites according to a balanced consideration of all site selection criteria.
The ACT Government mobile camera operations are overt as the vans used in the ACT are white with a sign on the van roof stating ‘your speed has been checked’. This makes the vans identifiable to road users on their approach to the mobile speed cameras. While an overt approach is used, there is no evidence to suggest that a covert or a combined overt and covert approach, as happens in some other jurisdictions, was considered in the decision-making process.  Given the relatively limited number of sites where mobile camera vans may operate, and that operations are undertaken in an overt manner, the ACT Government is unlikely to achieve its desired ‘anytime, anywhere’ approach. 
Speed and red light cameras -- At the time of the introduction of speed and red light cameras in 2001, twenty intersections had been identified and prioritised from the analysis of crash data from the previous four years. The circumstances surrounding each crash at the twenty intersections were considered. As with mobile camera sites, each intersection was required to be added to Schedule 1 of the Regulation.
The ACT Government’s road safety strategy action plans (2003-04, 2005-06) identified the need for the ‘review of current intersection crash data to ensure most efficient allocation of red light cameras’. No such review has taken place since 2003, and the 2003 review related to the first three sites selected for speed and red light cameras.
Mid-block speed cameras -- Between the time at which the budget proposal was agreed in 2006 through to April 2008, there was a change in the Government’s stated purpose for the mid-block cameras: from one of achieving a local effect at ‘dangerous locations’ to that of achieving a general effect to improve speed compliance across the whole road network.
Professor Max Cameron advised that: … a signed, conspicuous fixed-spot speed camera system cannot achieve [a general deterrent or general effect], unless there is a high density of cameras e.g. at least 1 per 4 km.
There was no evidence that the ACT Government had planned a mid-block speed camera system with sufficient camera sites to potentially achieve a general effect across the whole arterial road network. The arterial network in the ACT extends to around 290 km on which there are only nine locations with thirteen mid-block speed cameras.
Furthermore, crash data was not included in the criteria for determining the siting of the mid-block cameras. The ACT is the only jurisdiction where crash data has not been used to prioritise mid-block camera sites.
Point-to-point speed cameras -- The ACT Government has implemented two point-to-point installations, one on Hindmarsh Drive and one on Athllon Drive. The Territory and Municipal Services Directorate has indicated that the purpose of the ACT Government’s point-to-point camera system is twofold: to have a general effect across the network, that is, an effect beyond the length of road between the pairs of speed cameras, and to have a local effect.
Professor Max Cameron advised that: ... there is no research to support the aspiration that the system will have an effect beyond the section covered by the pair of cameras, that is, a local effect over the treated length.....beyond that it is unclear and ambitious.
In relation to the use of point-to-point in an urban setting, Professor Max Cameron advised that it is: ... unprecedented outside the ACT ... [and that there are] doubts about its suitability in urban areas except for long lengths of urban freeway ...
The cost effectiveness of the installations on the two sections of road (Hindmarsh Drive, 2.8 km and Athllon Drive, 3.7 km) covered by the point-to-point cameras in the ACT is compromised since each section is shorter than: o the minimum length of sections in the two other jurisdictions (Victoria 7 km, and Queensland 14 km) that have installed point-to-point cameras for speed enforcement of all vehicles; o the minimum length initially proposed (5 km) by the ACT Government’s advisors in the Forward Design Study: Introduction of Point to Point Speed Cameras in the ACT (July 2010) in order to be the most cost effective option; and o the minimum length recommended by advisors (10 km) to two other jurisdictions considering the introduction of point-to-point systems.
While there are currently two point-to-point installations in the ACT, the initial forward design study (2010) identified ten or potentially more being implemented in a phased approach following a pilot. However, there is no evidence that advice has been sought or received as to the extent to which the current two installations or the initially proposed ten installations, as part of the phased approach, would provide a general effect across the network, or a local effect on the road lengths between the pairs of cameras.
The pilot of the point-to-point speed camera system in the ACT does not have a supporting evaluation plan that would ensure learnings from this experiment are maximised. Evaluating the pilot is important in order to determine if this type of system is providing value for money and should be further deployed in urban areas. 
Effectiveness of speed cameras (Chapter 3)
Infringements -- Infringement rates for fixed speed cameras in the ACT are around 0.06 to 0.12 per cent over the long term, i.e. approximately one vehicle in one thousand is issued an infringement notice for speeding at camera sites. Infringement rates are of limited use in determining the extent of speeding. These rates are likely to grossly understate the level of speeding above the speed limits across the whole ACT road network as: o camera detected infringements are only issued for speeding offences that are significantly above the speed limit; and o the overt nature of fixed speed cameras and signs in the ACT provides road users with ample warning to slow down approaching camera sites.
The National road safety strategy action plan 2007-08 outlines measures for best practice including adopting ‘tight enforcement tolerances’. The ACT Government agreed to review the discretionary speed enforcement tolerance in the ACT in 2007-08. However, there is no a documented rationale for the ACT’s enforcement tolerance.
Community attitudes -- The National Survey of Community Satisfaction with Policing surveys shows that the ACT has a speeding problem as over 60 per cent of drivers surveyed each year from 2009-10 to 2011-12 stated that they had driven 10 km/h or more above the speed limit. This is higher than the Australian average and other jurisdictions in Australia, except for New South Wales in 2011-12 and Western Australia in 2010-11 where reported speeding was similar to that in the ACT.
Public perceptions of crime problems are also considered in the National Survey of Community Satisfaction with Policing surveys. Survey data suggests that ACT residents had the second highest level of concern for speeding as nuisance behaviour in residential neighbourhoods compared to residents in other Australian jurisdictions in 2011-12.
Attitudes of ACT residents, as identified in surveys, are difficult to reconcile. When compared to residents of other jurisdictions, ACT residents: o are more likely to see poor driving skills as a contributory factor in crashes; o are less likely to link speeding with the incidence of crashes; o have the strongest support for more speed enforcement activity; o feel they are less likely to get caught speeding; and o are more likely to agree with the speed limits. It is not clear in the draft ACT road safety camera strategy how community attitudes are influencing speed camera systems in the ACT. 
Speed surveys -- The ACT Government conducts and annually publishes the results of a large number of roadside speed surveys. In the last fourteen years there have been 3 644 surveys which show that free-flow traffic speed is greater than 5 km/h over the speed limit for approximately 50 per cent of the survey sites and ranges from 41 and 65 per cent.
While this identifies the extent of the speeding problem at specific locations this data does not provide an accurate indicator of speeding across the network. This is because the selection of survey sites is not a representative sample of road types and conditions of the ACT road network. Sites are generally identified for surveying as a result of perceived problems.
Speeding infringement rates, community surveys and roadside speed surveys indicate there is persistent speeding in the ACT. Since there is no network representative roadside speed survey or any other speed monitoring system, it is not possible to determine whether this problem is increasing or diminishing across the whole road network.
Evaluation -- Over the past fourteen years, the Government has planned but not undertaken evaluations for many aspects of its speed camera operations. Two camera systems (mobile, and speed and red light cameras) were evaluated but this was over ten years ago, and neither was conclusive. There is no overarching evaluation framework to gauge the effectiveness of speed camera activity across the whole ACT network despite the adoption and siting of camera systems in the ACT that is either contrary to prevailing research or where there is an absence of accepted practice.
The draft ACT road safety camera strategy recognises that formal evaluations of the effect of ACT road safety cameras have been limited and proposes options for the evaluation of effectiveness of the Government’s speed cameras. However, there is no commitment in the strategy to a forward program of evaluations. In November 2013 the Government committed to undertaking an evaluation of the ACT’s speed cameras in the first half of 2014.
No evaluation plan has been developed to guide the assessment of the pilot of the point-to-point system in the ACT. Such a plan is important to determine if this type of system is providing value for money and should be further deployed in urban areas.
The value for money of the point-to-point system pilot is likely to have been compromised by changes to the lengths of road covered by the two installations. The reduction in the length of the road between the pairs of point-to-point cameras, combined with the increase in actual costs (compared to the estimated cost) of installing this system, has led to a three-fold increase in the cost per km of road treated.
Data collection -- National road safety strategy action plans advise that the collection of speed data should be done independently of the data generated by enforcement activity at speed cameras sites. This is achieved in the ACT since the Traffic Data Unit in the Territory and Municipal Services Directorate provides such data to Legislation, Policy and Programs in the Justice and Community Safety Directorate, that is, the Directorate that leads on road safety policy and enforcement. However, the planning and coordination of activities between these sections is not fully effective.
The siting criteria for speed camera systems currently used in the ACT have relied on data which is primarily sourced from surveys of road speeds and traffic conditions, management information from camera operations such as infringement rates, and information on crashes. File records identify that many data sources used in the siting methodologies are imperfect as they are often incomplete or imprecise. There is a risk that decision makers are asked to make decisions on recommendations without knowing the robustness of the data.
Data utility is improving as the Territory and Municipal Services Directorate has been able to plot crash sites more accurately since 2011, using precise coordinates rather than attributing crashes to long sections of roads. Also a larger number of traffic light-controlled intersections can now be monitored for red light running, which can be a very useful predictor of potentially dangerous intersections.
Camera operations data -- The draft ACT road safety camera strategy identifies the need to improve the public availability of camera siting information, but the strategy does not identify a need to improve the availability of camera effectiveness information. Information on camera effectiveness has not been routinely made public. Other jurisdictions are considering publishing or have already published information on the effectiveness of camera operations.
Protecting and disclosing images of vehicles -- Disclosure of images from speed camera operations is permitted if it is ‘reasonably necessary for the enforcement of criminal law’. The point-to-point installation on Hindmarsh Drive takes images of an estimated 900 000 vehicle movements a month. ACT Policing has made 22 requests for images since January 2012. No other agencies have made requests.
The Traffic Camera Office’s administration of these requests is an area where procedures, practice and record keeping should be improved in order to provide assurance that camera image disclosure is ‘reasonably necessary’.
Speed camera reliability and operations administration (Chapter 4)
Speed camera reliability -- Annual reports show that the Government’s target level of fixed speed cameras being ‘in use’ for 95 per cent of the time has been achieved in six of the last seven years.
The Justice and Community Safety Directorate target of 43 shifts per week for mobile speed camera operations was not achieved in the last three years. Operational availability fell markedly in 2012-13 with fewer than 40 per cent of 43 shifts per week being possible in three of the four quarters of the year. This was due to equipment failure, which has resulted, at times, in only two of the five camera vans being available.
The number of reactive maintenance work requests has increased in the last three years by 109 per cent, from 114 in 2010-11, to 174 in 2011-12, and to 238 in 2012-13. An estimated two per cent of mobile camera detected potential infringements had to be rejected during adjudication due to camera errors in the two-year period to June 2012.
Maintenance of speed camera equipment -- The current and previous maintenance contracts covering the period August 2009 to date have a requirement for fortnightly planned maintenance for fixed speed cameras. This was not achieved in 2011 or 2012 but was met in 2013. While this is the case, it may not be problematic as in Victoria planned maintenance for fixed camera devices is specified to be undertaken on a monthly basis. It was not evident why fortnightly maintenance inspections are necessary in the ACT, rather than monthly. The estimated additional cost to the ACT of requiring fortnightly rather than monthly planned maintenance is $120 000 a year.
For the management of reactive maintenance, the Traffic Camera Office has improved its ability to track and confirm the responsiveness of its contractor. However, there remain areas for further improvement.
The Government agreed on 4 June 2013 to fund the replacement of six of its eight speed and red light cameras that are over ten years old and all its mobile cameras, costing $1.55 million. Once implemented, this will ensure all except two cameras in use on ACT roads are less than ten years old.
While the Government is funding the replacement of older speed cameras in 2013-14, there is no documented strategy that sets out the rationale and the program for speed camera maintenance and replacement.
Speed camera accuracy -- In considering the accuracy of speed measuring devices for the period 2010 to 2013, the Audit Office identified a lack of a master inventory of devices. In addition there is no readily accessible record system that identifies whether speed measuring devices are either in or out of use, or their location or certification dates.
Justice and Community Service Directorate officers acknowledge the desirability of such a system, and advised that the use of an electronic diary for annual certification reminders, introduced after the February 2010 audit, was a stand-in measure until a new adjudication system was introduced that would incorporate the means to monitor annual certification. This system has not been designed or implemented.
There is no verification process for when test certificates are received by the Traffic Camera Office to check that their key content is correct, such as device details, test and signatory dates. 
Mobile speed camera operations  -- Based on a walk-through of systems and procedures by an audit officer on 24 September 2013, the assessment of records and a review of other documentation, it is considered that operational practices are aligned with legislative requirements and internal standard operating procedures regarding initial mobile camera operator training, and associated operator approval.
Auditing mobile camera operators, once approved, is an area where the record keeping, and potentially practice, is not in accordance with the internal standard operating procedures. The internal standard operating procedure for this indicates this should comprise one, two and three-month audits, as well as a number of unannounced audits and the evaluation of traffic camera operator effectiveness. There was no documented evidence of this audit process occurring.
In planning the shift schedule for mobile camera operations, the Traffic Camera Office takes limited account of site by site infringement history, that is, whether previous camera van shifts at the same site identified a high number of infringements and therefore evidence of a continuing speeding problem.
There was no evidence that demonstrated that the Traffic Camera Office periodically assesses road accident statistics to ensure that sites that are statistically significant are allocated mobile speed camera coverage, as the ACT Traffic Camera Office Mobile camera unit site selection criteria states should happen. There is no routine analysis of the results of mobile speed camera operations. 
Infringement validity -- The ACT Traffic Camera Office has a relatively high rejection rate of potential infringements due to adjudication. Between 18 and 43 per cent of all potential infringements per year over the last fourteen years have been rejected during adjudication. Rejected infringements are deemed to have not met evidentiary requirements. Professor Max Cameron advised that other Australian states typically achieve a lower than 20 per cent rejection rate as a result of adjudication, with one state managing an improvement from 25 down to 10 per cent over a fifteen-year period. He further advised that the percentage that is rejected is something that can be reduced, given effective systems.
Officers in the Traffic Camera Office identified that the existing adjudication database introduced in 2000 has many monitoring and reporting limitations due to its age and design. This makes it difficult to systematically focus on process improvements that may lead to reducing the infringement rejection rate. For example, officers advised that it is not possible to identify trends in the reasons for rejecting cases, the identity of previous adjudicators or the reasons for changes.
As a result of a 2013-14 budget proposal from the Justice and Community Safety Directorate being supported by the Government, funding of $50 000 has been allocated to evaluate adjudication system replacement options. This is currently being undertaken.  In the 60 infringement cases reviewed by an audit officer, there was sufficient evidence to re-adjudicate the case and the same conclusion could be derived as that made in the original adjudication.  
An analysis of the supervisory control sheets showed that there was disagreement between the first adjudicator and the cross checker in 0.3 per cent of all cases adjudicated for the most recent twelve-month period. This indicates that adjudicators, for a very high percentage of infringements, are consistent in their decision making regarding an infringement’s validity.
Training and development is effective in enabling new staff members to develop the skills and knowledge necessary to undertake the adjudication role and to be approved as competent. However, there is no independent training provided to the adjudicators, and there is no documented procedure for the adjudication training process. The Office is heavily reliant on the corporate knowledge of a few key members of staff with learning occurring through the sharing of experience.
Infringement administration -- Thirty case studies were assessed by an audit officer with respect to the three matters of: extension of time to pay ‘out of time’ applications, withdrawal of Camera Infringement Notices, and unknown drivers. The assessment identified inadequacies in procedures and their implementation, and in record keeping, since: o internal standard operating procedures were not up to date; o while there were internal standard operating procedures, at least in part, for each of these three matters, these were not always followed; o there was insufficient evidence in rego.act of the actions taken to understand why some decisions were made; and o the identity of the administrator approved to take a particular action was not available in every case.
The ACT Government has issued around 60 000 Camera Infringement Notices a year in the past three years, and collected around $10 million a year in fines. At any time over this period there is around $2 million to $3 million in uncollected fines. The value of uncollected speeding fines has grown from $448 528 as at 1 July 2001 to $2 939 455 as at 1 July 2013.
In June 2013 the Government legislated and implemented arrangements to enable people in receipt of infringement notices, who are having difficulties, to seek an extension of time, and to pay off fines according to an agreed plan. Long-term or high-level debtors are being encouraged to use the new arrangements. A priority group of road users with $4.8 million in debt have been contacted. Plans have been agreed for over 1 700 road users which account for $2.5 million in debt.
Limited management information is routinely drawn from the rego.act system to provide assurance as to the effectiveness of the system, for example, in terms of the transparency, consistency and fairness of administration of Camera Infringement Notices.
The report notes that the Auditor-General made 16 recommendations
R1 -- The ACT Government should develop and implement a speed camera strategy that: a) includes a goal and measurable objectives for achieving a reduction in road trauma on ACT roads through the use of speed cameras and related speed management actions; b) takes a long-term perspective (to 2020 or beyond) and addresses speeding and speed related crashes across the whole of the ACT road network; c) establishes, using leading practice from elsewhere, options for the development and integration of speed camera systems that will collectively achieve the targeted reductions in road trauma; and d) includes a sensitivity analysis, to support future budget proposals, which shows how varying levels of investment and the phasing of implementation will affect short, medium and long-term road safety.
R2 -- The ACT Government should develop and implement a mobile speed camera plan which: a) specifies the extent of the ACT road network where mobile speed cameras may operate, and the time by which this is to occur; and b) identifies the effect of different levels of operational intensity (i.e. the number of vans and shifts, and siting priorities), and mode of operation (i.e. overt, covert) on road safety goals as coverage of the road network is expanded.
R3 -- The  Government should review the purpose and siting of its existing thirteen mid- block speed cameras to determine if they need to be removed, relocated or expanded.
R4 --  The  Government, for its two existing point-to-point speed camera installations, should: a) review and state the purpose of the system; b) develop and implement an evaluation plan to assess their effectiveness in reducing speeding and road trauma; and c) determine their value for money compared with other speed management treatments to inform future decisions.
R5 -- The  Government should develop and implement a ‘relatively large, network- representative, speed monitoring system’ in order to determine changes in the extent of speeding on ACT roads.
R6 -- The  Government should develop and implement an ACT speed camera evaluation and data collection plan.
R7 -- The  Government should routinely publish information on the effectiveness of all its speed camera systems according to the stated purpose of each system.
R8 -- The Justice and Community Safety Directorate should document its procedures, and maintain comprehensive records, for its administration of requests for the disclosure of camera images.
R9 -- The  Directorate should align its speed camera maintenance practices, internal standard operating procedures and contractual requirements.
R10 -- The ACT Government should develop and implement a speed camera maintenance and replacement strategy (This could be part of the speed camera strategy which is the subject of Recommendation 1).
R11 -- The Directorate should develop and maintain a master inventory of speed camera devices and use this to verify the key content of new certification against primary and / or secondary sources.
R12 -- The  Directorate should undertake and document audits of approved mobile speed camera operators in accordance with its internal standard operating procedures.
R13 -- The  Directorate should strategically plan its mobile speed camera operations by fully applying the principles in the Mobile camera unit site selection criteria guide and as set out on its speed camera web-pages.
R14 -- The  Directorate should improve its recording of adjudication information so that this can be used to target improvements for reducing the infringement rejection rate.
R15 -- The  Directorate, in its administration of infringements in the rego.act system, should: a) update its internal standard operating procedures; b) align practice with procedure; and c) maintain comprehensive records for all manual interventions.
R16 -- The  Directorate should monitor the transparency, consistency and fairness of the administration of Camera Infringement Notices in the rego.act system by conducting qualitative and / or quantitative reviews.