ACTA

'Lobbying and Lawmaking in the European Union: The Development of Copyright Law and the Rejection of the Anti-Counterfeiting Trade Agreement' by Benjamin Farrand in (2015) Oxford Journal of Legal Studies seeks

to examine the issue of ‘lobbying’ in the EU legislative process, using an interdisciplinary analysis of the development of copyright laws as a way of explaining why and how some lobbyists are more successful than others in having their preferences taken into account in legislation. As this article will demonstrate, the keys to successful lobbying in this field are information exchange, the ability to frame issues at an early stage in the legislative process (agenda setting) and the political salience of an issue. By assessing not only where legislative initiatives in copyright reform have been successful, such as the passing of the Information Society, Enforcement and Term Extension Directives, but also where legislative initiatives fail, as in the case of ACTA, it will be demonstrated that legislative success is not a simple case of ‘big business getting what it wants’, but of varying levels of political salience. Where the salience of an issue is low and voters consider that issue comparatively unimportant to other issues, industry representatives are able to effectively frame legislative outcomes. Where salience is high, and an issue important to voters, this ability is substantially reduced. By approaching copyright law development in this way, it is possible to reconceptualise the role of lobbying in the EU legislative process.

Farrand comments

As the last section demonstrated, copyright lawmaking in the EU is characterised by low political salience and influential industry representative organisations able both to set the legislative agenda and provide information pertinent to that agenda. To use Culpepper’s term, it is an area of policy defined by quiet politics, in which policymakers defer to industry expertise even where other expertise is provided. This does not suggest, however, that ‘big business always gets what big business wants’. As discussed, political salience is changeable, based on changing circumstances or even changing media coverage of an issue. To provide an example both of this changing salience, and of the ability to set the legislative agenda which did not result in successfully passed legislation, it is possible to use the example of the recent vote of the European Parliament on ACTA.

ACTA began as a series of informal talks between the USA and Japan in 2006 on the topic of counterfeiting and piracy in the context of international trade, with the discussion of a potential bilateral or even plurilateral treaty. By June 2008, these informal talks became a formalised negotiation between the USA, Japan, the EU, Canada, Australia, Mexico, Morocco, New Zealand, the Republic of Korea, Singapore and Switzerland. However, these negotiations were secretive, with each party held to a strict confidentiality requirement, to the extent that legislative bodies in each state were uninformed about the details of the negotiations. However, certain industry representative organisations had privileged access to the negotiation documents in the capacity of ‘cleared advisors’. These cleared advisors included representatives of the Intellectual Property Alliance (IIPA), IBM and Time Warner. According to Blakeney, these cleared advisors, such as IIPA, were active participants in the ACTA negotiations, suggesting considerable agenda-setting power on the part of these industry representatives. The public only became aware of the existence of the negotiations with a leak of a statement of initial positions released by WikiLeaks in May 2008. Substantive content came in the form of leaks by online activist organisations such as La Quadrature du Net (LQDN) of draft deliberations in 2009 and 2010, and the release of an interim draft by the EU in April 2010. Information contained in these deliberative drafts revealed that the intention of the Agreement was not only to bring in enforcement provisions to deal with counterfeit goods in transit between states, but also to apply to infringements of copyright committed online. According to Article 2.14 of this Draft, parties could impose criminal sanctions ‘at least in cases of wilful trademark counterfeiting or copyright or related rights piracy on a commercial scale’, which was intended to include wilful copyright and related rights infringements ‘that have no direct or indirect motivation of financial gain’. This appeared to extend substantially the scope of criminal liability for copyright infringement, making it a de facto criminal offence. ACTA began to be frequently criticised in academic literature, particularly over the secrecy of negotiations, and the deliberate attempt to sidestep both the World Intellectual Property Organization and World Trade Organization in order to prevent substantive input from countries such as China and India. The text of the Agreement was substantially modified following the publication of earlier drafts, with Article 23(1) stating that criminal sanctions should be applied in cases of copyright or related-rights ‘piracy’ on a commercial scale, intended to include ‘at least those carried out as commercial activities for direct or indirect economic or commercial advantage’. It was determined that these sanctions should apply in cases of infringement of copyright online under Article 27(1). Nevertheless, this Draft continued to be criticised, with concerns over the scope of possible criminal sanctions and enforcement136 as well as the possible impact on user privacy.

The EU and 22 of its Member States signed ACTA in Japan at a formal ceremony in January 2012. It was assumed at this point that the EU ratification of the Agreement was certain. ACTA had the full support of the business community, and the Commission, which regarded the rapid conclusion and implementation of the Agreement as being ‘an important step in improving the international fight against IPR infringements’. Furthermore, the European Parliament had released a resolution in 2010 reiterating the need to ensure effective protection of intellectual property rights and considered ACTA a step in the ‘right direction’. This would appear to indicate that the legislative agenda had been set, and that activist organisations would be unlikely to prevent the ratification of the Agreement. However, by April 2012 ACTA was described as being ‘on its knees’. What had changed? A key development in the EU rejection of ACTA appeared to have originated in the USA. In October 2011, Representative Lamar Smith introduced a Bill in the House of Representatives called the Stop Online Piracy Act (or SOPA). This Bill contained a provision that would require ISPs to block access to websites used to infringe copyright or trademark through the use of a measure that would prevent a domain name being resolved to an IP address. Critics viewed this as draconian, arguing that it had the potential to be used for censorship. Major internet service providers in particular were concerned about their potential liability under the Bill. So concerned were certain providers that 18 January 2012 was a day of concerted and coordinated action by thousands of websites, including Wikipedia and Reddit, which became inaccessible, presenting a black background and text describing the potential effect of the Bill and providing information for contacting Representatives. Google also ‘censored’ its logo in protest. Due to the high profile of this action, on 20 January 2012, Representative Smith announced that the Bill would be postponed ‘until there is wider agreement on the solution’. The relation to ACTA reflects the nature of the internet as a global communications system—websites did not become inaccessible in the USA alone, but were also inaccessible in the EU. Given the high profile of the USA-based action, European citizens became aware of ACTA. When Donald Tusk, Prime Minister of Poland, announced his intention to ratify ACTA, declaring it a ‘success of the Polish EU Presidency’, an online campaign was initiated in Poland, including the creation of a Facebook page ‘Nie dla ACTA’, which received 100,000 views in less than 48 hours. Online activists coordinated offline action, culminating in ‘15,000 demonstrators in Krakow and 5,000 in Wroclaw’, and an increase in media attention in the rest of Europe. It has been argued that this political mobilisation began in Poland due to a combination of socioeconomic and historical factors, including the fact that copyright was used as a tool of political censorship by the government of Poland during the latter years of Communist rule. This concern translated into concerns over copyright overreach, negative implications for freedom of speech and concerns over process, as evidenced by a statement made by one of the organisers of the ACTA protests that ‘[t]hey promised debates—nothing. They promised openness—nothing. Democracy is being destroyed, the deputies don’t know what they are signing, and all this will lead to a situation when bloggers, scientists and entrepreneurs will be qualified as criminals’. As a result of domestic pressure, Tusk announced in early February that ACTA would not be ratified by Poland as it did not reflect ‘the realities of the twenty-first century’. Germany, Latvia and the Czech Republic announced they would delay, if not block, the ratification of ACTA and the Slovenian ambassador to Japan publicly apologised for signing, referring to it as an act of ‘civic carelessness… [there was] too little transparency’. Street protests continued throughout the EU, with a ‘day of action’ on 11 February, with reports of more than 25,000 protestors in Germany, 4,000 in Bulgaria and thousands more throughout France, the UK, Romania and other Member States, coordinated by activist organisations such as LQDN, FightForTheFuture.org and the Open Rights Group.

The success of civil society in raising awareness about an issue of concern is largely determined by the ability to disseminate information. According to Bennett and Toft, digital communications technologies such as social media platforms can help to coordinate (and blur the distinctions between) online and offline action, particularly when facilitating cross-border actions. The use of Facebook as a communications mechanism, and the spread of information through blogging activities and tweets, facilitated by organisers such as LQDN, can result in the swift mobilisation of political activists who can ‘spread the message’ and organise political activities. Actors such as LQDN then become key nodes in a network of activists, providing both communications infrastructure and information to other activists. What these activists ‘lack in terms of traditional organisational resources they often gain in networking capacities through the use of social technologies to facilitate the maintenance and activation of [ties between civil society activists]’. In this context, protest constitutes a form of ‘outsider’ strategy, a method by which concerns over a legislative policy can be voiced or questions raised as to the legitimacy of a policy through disruptive action. These strategies do not in themselves change legislation, but raise media (and therefore citizen) attention, increasing the salience of an issue. The more media attention an issue receives, the more likely it is that a population will see that issue as important. In this case, protests in Poland helped draw attention to the Agreement as well as frame ACTA as a threat to freedom and democracy due to the secrecy of its negotiation and overreaching internet copyright enforcement provisions. The outsider strategy of protest allowed for protestors to frame the media message as one of threat to citizen freedoms, and substantial media coverage discussing ACTA in the terms used by protestors further assisted in bringing the issue to the attention of the general public, and subsequently to the reporting of the protests in other EU Member States, helping to form the informational basis for civil society organisation. In the period from the initial announcement of the existence of ACTA up until December 2011, there were in total 25 stories about ACTA on BBC News and in the Guardian and Telegraph newspapers. In comparison, between January 2012 and the rejection of ACTA in July, there were 39 stories, almost double the number in six months than there were in the previous three years, and the majority of them negative. This raised the profile of ACTA as a political issue and the high-visibility public actions in the Member States was used as a way of generating additional forms of political action. LQDN created the ‘piphone’, which could make Voice Over IP (or VOIP) calls to MEPs, as well as providing a searchable database that users could use to identify their MEP in order to raise their concerns about ACTA. This proved to be a successful strategy, as LQDN coordinated EU citizens’ contacting of MEPs both during the committee stages of the European parliamentary process and again prior to the final vote. According to a press release by the European Parliament, there was ‘unprecedented direct lobbying by thousands of EU citizens who called on it to reject ACTA, in street demonstrations, e-mails to MEPs and calls to their offices’. As a result of these pressures, the Committees on Civil Liberties, Justice and Home Affairs, Industry, Research and Energy, Legal Affairs, Development and International Trade all recommended that the European Parliament reject ACTA. This recommendation was followed on 4 July, when ACTA was rejected by 478 votes to 39.

The rejection of ACTA can be explained in terms of political salience. As was seen with the examples of the three Directives, copyright law is generally an issue of low salience that does not register with the average European voter. For this reason, industry representatives are able significantly to influence the passage of legislation. In comparison, ACTA became a politically salient issue, generating protests in Europe that were then covered by the media, leading to more widespread protests and inducing citizens to contact the European Parliament, a body that has a historically weak connection to voters. In particular, media coverage referred to the concern of protesters that the Agreement represented a threat to democracy and freedom of speech. This discourse in turn was reflected by MEPs. In April, rapporteur and MEP David Martin stated that the ‘intended benefits of this international agreement are far outweighed by the potential threats to civil liberties… the European Parliament cannot guarantee adequate protection for citizens' rights in the future under ACTA’. The European Parliament, constituting a body of elected representatives, is susceptible to pressure by voters. Where interest in a particular issue is low, it is likely to vote according to the information provided by expert bodies or lobbying organisations. Where the salience is high, however, and citizens demonstrate their interest in, and preferences concerning, a particular policy then they are more likely to listen to the public on that issue. This would appear to indicate that where an issue becomes ‘high profile’, the usual tactics of quiet politics are ineffective. As the media coverage was unfavourable, and represented the views of protestors rather than industry, the ability to mould public perception of the issue was also lost. ACTA had become a high salience issue. Nonetheless, it is important to state that, although ACTA was of high salience, it does not mean that copyright more generally has become a high salience issue. Speaking after the rejection of ACTA, David Martin stated that ‘this was not an anti-intellectual property vote. This group believes Europe does have to protect its intellectual property but ACTA was too vague a document’. European Parliament President Schulz also indicated that the key issue in the rejection of ACTA was the question of transparency and democratic participation rather than intellectual property law, stating:

The decision to reject ACTA was not taken lightly. It followed an intensive, inclusive and transparent debate with civil society, business organisations, national parliaments and many other stakeholders … All over Europe, people were engaged in protests and debates. The mobilisation of public opinion was unprecedented. As the President of the European Parliament, I am committed to dialogue with citizens and to make Europe more democratic and understandable.

This would appear to indicate that while ACTA was a high salience issue, the decision to reject the Agreement cannot be considered as representing a shift in intellectual property policy at the EU level. The success of the ACTA protests and resultant media coverage was in providing a simple and effective framework for considering the impact of the Agreement, namely that of freedom and democracy. However, in doing so the subject of dispute became ACTA specifically and the threat posed by this one document rather than any perceived threats resulting from overly broad copyright protection. Activists therefore petitioned for the rejection of ACTA by the European Parliament and the European Parliament responded by rejecting ACTA. It did not act as a catalyst for rethinking copyright, its aims or the appropriateness of its enforcement mechanisms. It is submitted that copyright lawmaking will continue to be an issue dominated by quiet politics and, as a result, industry organisations will continue to be successful in having their preferred outcomes taken into account. Passing a resolution on the negotiations between the USA and EU on the Transatlantic Trade and Investment Partnership, the European Parliament stated that ‘intellectual property is one of the driving forces of innovation and creation and a pillar of the knowledge-based economy, and that the agreement should include strong protection of precisely and clearly defined areas of intellectual property rights’. It would appear, then, that despite the very visible conflict and, indeed, change in legislative policy over ACTA, the legislative approach to copyright law issues in the EU ultimately remains unchanged.

'Who's Afraid of Wikileaks? Missed Opportunities in Political Science Research' by Gabriel J. Michael in Review of Policy Research (Forthcoming) argues

 Leaked information, such as WikiLeaks' Cablegate, constitutes a unique and valuable data source for researchers interested in a wide variety of policy-oriented topics. Yet political scientists have avoided using leaked information in their research. This article argues that we can and should use leaked information as a data source in scholarly research. First, I consider the methodological, ethical, and legal challenges related to the use of leaked information in research, concluding that none of these present serious obstacles. Second, I show how political scientists can use leaked information to generate novel and unique insights about political phenomena using a variety of quantitative and qualitative methods. Specifically, I demonstrate how leaked documents reveal important details about the Trans-Pacific Partnership negotiations, and how leaked diplomatic cables highlight a significant disparity between the U.S. government's public attitude towards traditional knowledge and its private behavior. 

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.

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 Grünewald 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 κ 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.