Category Archives: universities

Using personal data in research: all change….?

Pondering, as one does, the likely impact of the General Data Protection Regulation on one’s working life, this Blogger has been trying to figure out how simple it will be to use personal data for research purposes (especially research in healthcare) after 25th May 2018 – the day on which the GDPR comes into force.  Before you ask, whatever happens with Brexit, the timing is such that the GDPR will come into force in the UK.

The GDPR is similar and yet different to the present Data Protection Act.  Similar in that the use of personal data is still governed by a series of principles and that processing of personal data must have a lawful basis.  Different in the detail of the duties placed on data controllers and processors, the rights granted to individuals and the justifications available to show that data is being processed lawfully.  For now, this Blogger is focussing on the research use context.

20171014 Latitude

Oxford is 51.7520° N

The GDPR allows some latitude for research uses.  ‘Latitude’ is not the same as ‘get out of jail free’.  If research users apply appropriate safeguards and data minimisation (limiting any processing to the extent necessary for the particular purpose) then some of the individual’s rights may be excluded.  But the core principles of the GDPR still apply.

Today, consent is the researcher’s go to justification for processing personal data.  Under the DPA and the GDPR, processing is lawful if the individual has given consent.  However, GDPR consent is a different animal to DPA consent.  The GDPR sets higher standards in terms of information (specific uses and specific recipients should be listed) and record keeping.  The GDPR is clear that it must be as easy to withdraw as to give consent – potentially really troublesome for a research project.  The ICO’s draft guidance talks of obtaining granular consent that describes in advance all the proposed uses of the personal data and everybody who will have access to the personal data.  The consent will have to be specific and records comprehensive.  Under the DPA a researcher can be (fairly) comfortable with wording consenting to the use of personal data for a defined project ‘and other related research’.  Under the GDPR, the researcher will have to describe the project (ie the intended use) and list all those that will have access to the personal data and explain which other projects the personal data may be used for.  In effect, ‘if you’re not on the list, you’re not coming in’.  Thankfully, a pragmatic ICO recognises that not all future research uses can be specified in advance and the guidance allows some scope to ‘do the best you can’.

The result of these changes?  From the morning of 25th May2018, existing consents may be rendered inadequate. 20171014 Exclamation

Can you hear the sounds of the research based economy grinding to a halt?  Be afraid, but not petrified.  Other possible means of demonstrating that processing has a lawful basis may be available.

First possibility is legitimate interest: GDPR treats processing as lawful to the extent that it is necessary for the purposes of the legitimate interests of the data controller as balanced against the impact on the individual concerned.  An interest is the broader aim or stake that the controller has in the processing.  It does not need to be described in advance but it will need to fall within the reasonable expectations of the individual.

The problem for healthcare research is that sensitive personal data (classified under GDPR as a ‘special category’), can only be processed where one of a separate list of exemptions applies.  The special categories include data concerning health.  This separate list of exemptions does not include legitimate interest: the legitimate interest justification does NOT justify the use of health data for research purposes.

Second possibility is that processing a special category of data is permitted where it is necessary for scientific research conducted in accordance with appropriate safeguards and where use of the data is proportionate to the research aim.  Useful but the emphasis is on ‘necessary’, ‘appropriate safeguards’ and ‘proportionate’.

A third possibility is to use anonymous data.  Like the DPA, the GDPR only applies to data relating to an identified or identifiable individual.  Currently, individuals do not have to give their consent for their personal data to be anonymised.  So, anonymise the data and all your problems fall away.

20171014 Stig

Anonymous or not…?

Inevitably, it is not that easy.  How anonymous does the data have to be before it no longer relates to a living and identifiable individual?  Today’s test is whether the anonymization process is robust enough to be likely to defeat the efforts of the Motivated Intruder (about whom this Blogger has mused before).  The problem is that big data makes more things are possible.  More pieces of the jigsaw are available to be found and linked together.  The Motivated Intruder doesn’t have to try too hard.

Despite its difficulties, consent may still be a useful possibility.  The GDPR permits processing of special category data where the individual has given explicit consent for a specified purpose.  The granular nature of consent has already been considered: proposed uses must be specified in advance.  In addition, the consent cannot be coerced – an outcome cannot be conditional on consent being given.  This may be a problem for commercial providers (‘you can only use this service if you give me all your personal data’).

20171014 Pencils

A simple answer: the Russians took a pencil…

It is less likely to be a problem in research world.  Does ‘you must consent if you want to participate in this clinical trial’ amount to imposing a condition?  Probably not.  Research is not the provision of goods or a service.  But the problem remains that it must be as easy to withdraw consent as it was to give consent in the first place.  Consent is not a simple answer.

Clearly, researchers (and their admin support!) will have to plan carefully to comply with GDPR.  That is not a Bad Thing: behind every data point there is an individual who deserves protection.  In any case, facing more detailed provisions is not the same as being prevented from performing research.  The GDPR is an intricate piece but, like eating an elephant, it can be dealt with in small chunks.  So, as a starting approach for those wishing to use personal data in their research:

First, establish what data it is that you wish to process.   Do you need to process all of it (data minimisation)?  Could you use anonymous data instead?

Second, establish whether it is a special category of data (eg health data) and if so, whether the intended use is permitted by any of the available exemptions:  including necessary for scientific research, consent (granular) or legitimate interest (but not for health data).

Third, if it is not a special category of data, or, if it is a special category but there is an exemption available, then check that the proposed processing is lawful.  Essentially that means demonstrating that Article 6 of the GDPR is satisfied.  That is worthy of a separate blog post in itself…

Simple.

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MPs’ report on TT: mostly practical, sensible advice

The House of Commons of the UK Parliament has a Science and Technology Committee. The committee has today released its report (HC755) on its Inquiry into Managing Intellectual Property and Technology Transfer. Disclosure: IP Draughts was one of 19 witnesses who gave oral evidence to the inquiry, and he gets a brief mention in the report, more on which below.

The terms of reference of the inquiry explained that it was taking place in light of two recent developments:

Dame Ann Dowling’s July 2015 Review of Business-University Research Collaborations commented that in universities “there is a tension between the desire to earn short-term income from their Intellectual Property and the need to deliver wider public benefit, and potentially greater long-term return on investment from this IP. The emphasis needs to shift towards the latter, and this must be reflected in Technology Transfer Office funding models and success metrics. … This area remains a major source of frustration for both academics and businesses.”

Our recent hearing on Graphene included discussion about the role of universities in the commercialisation of their research work. We now invite written evidence on how well this system works and what measures are needed to improve it.

The inquiry ranged across a number of aspects of university technology transfer (TT) and the commercialisation of IP. The final report of the committee focused on three areas:

  • how business demand for technology transfer might be increased
  • the geographical context of technology transfer [is it nearly all done in the ‘golden triangle’ of Oxford, London and Cambridge, and should it be encouraged in other places]
  • funding and support for technology transfer

Golden triangle. A=Oxford, B=Cambridge, C=London, X = Milton Keynes?

The report summarises the range of views that it heard when taking evidence on these topics and draws some sensible conclusions and advice for government. The main points that IP Draughts takes from the report are:

  1. Let’s move on to implementation. We’ve had enough national reviews of intellectual property and technology transfer (“at least 12 …over the last 15 years”). It’s time for the government to take action in several areas, outlined in the report. [Hoorah! IP Draughts and his colleagues on the Law Society’s IP Law Committee have spent hundreds of hours over the last 15 years submitting evidence to some of those reviews, including Gowers and Hargreaves, and have been disappointed by the quality of some of their conclusions.]
  2. Don’t scapegoat the TT offices. Dame Ann Dowling’s review expressed the frustration felt by some companies and academics about the process of negotiating IP issues with universities. The suggestion appeared to be that TT offices were the cause of this frustration. The present report gives a much more balanced picture, pointing out that some of the perceived difficulties may be down to (a) a lack of understanding of the complex issues involved, (b) the problems of valuing early stage technologies, and (c) the different interests of the parties. The report provides some welcome support for TT offices (“…situated in the middle of complex IP negotiations, balancing competing priorities, with varying degrees of support.”) [Hoorah! It is too easy to blame the TT office, which often has insufficient support from the university’s senior management, leaving other participants – whose interests differ from the university – with an easy target for cries of causing “difficulties”.]
  3. Focus on improving take-up by UK industry. Universities are good at generating technology; UK industry has a poor record of making use of it. Rather than continually focus on making universities better at serving UK industry, focus on improving the environment for industry to make use of university research and innovation. [Hoorah! Viewed globally, UK universities have a more impressive reputation than UK industry. Government policy should focus on the areas mentioned in the report, including tax policy on R&D credits, VAT and investment in technology.]

Some other recommendations in the report didn’t resonate with IP Draughts. Databases of university technology are unlikely to be of much use. Getting government agencies to look into training TT offices sounds like a bureaucratic solution. Encouraging regional specialisation in research and TT sounds like another top-down, dirigiste waste of time and money.

Overall, IP Draughts welcomes the report’s conclusions and the committee’s encouragement to government to implement TT-friendly policies.

And how could he not, when he is quoted at paragraph 69 (on the subject of whether TT offices cause problems in negotiations over IP):

Other witnesses suggested that the very nature of negotiations, together with the challenges posed by valuing new, early-stage technologies, can mean that a degree of delay and difficulty is unavoidable. As [IP Draughts] explained, “it is a negotiation: inevitably, there are going to be difficulties sometimes”.

Hardly an earth-shattering observation, but one that needed to be made in light of Dame Ann Dowling’s unbalanced conclusions on this issue.

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National reviews of IP are universally poor: discuss

radio-4Until a month ago, the closest IP Draughts had come to participating in national affairs was asking a question on the UK radio programme, Any Questions, in about 1981. The question he (neutrally) asked, which was whether a system of student loans should be introduced for UK students, provoked loud boos from some members of the audience, who were mostly fellow students at the University of Durham. As it happens (but nothing to do with IP Draughts’ intervention), a few years later the government introduced such a system, which is still in force today.

Last month, after 35 years of well-deserved obscurity, IP Draughts gave oral evidence on behalf of the Law Society to a House of Lords Public Bill Committee, which had been convened to consider the Intellectual Property (Unjustified Threats) Bill. The Bill was approved by the committee in its original form. It then proceeded to the Report stage, where the government proposed a few drafting amendments to deal with points that had been raised in committee by the Law Society, Chartered Institute of Patent Attorneys, and Professor Sir Robin Jacob, respectively. IP Draughts was pleased to see that the House of Lords voted in favour of the Bill with only these few amendments. We are now awaiting the third reading in the House of Lords, which should be a formality, before the Bill moves to the House of Commons for consideration.

commonsNext week, IP Draughts has another, unexpected public assignment. He has been asked by the House of Commons’ Science and Technology Committee to give oral evidence in relation to its enquiry into “managing intellectual property and technology transfer”. Details here.

As part of his homework for next week’s assignment, IP Draughts is re-reading last year’s Dowling Review of Business-University Research Collaborations, and  this year’s McMillan Review of University Knowledge Exchange Framework: good practice in technology transfer.

Dame Ann Dowling and Professor McMillan are giving evidence to the committee immediately after IP Draughts and his co-grillee, Daniel Nelki of Wellcome Trust.

Clearly, a great deal of work has gone into these reviews, and many of their comments seem sensible. But parts of these reviews, and of earlier national reviews of IP (Gowers and Hargreaves spring to mind), give the impression that they simply report views that have been expressed to them, or which appeal to their imaginations, rather than engaging in deep analysis of whether those views are:

  • objective, rather than promoting sectional interests
  • workable, in the views of experts who understand the subject
  • affordable and likely to be funded

Examples from (if IP Draughts remembers correctly) the Hargreaves Review were the ideas of having a national Digital Copyright Exchange or “hub” for making licences easily available, and of having standard IP licence agreements. The first soon died a death (a successor is still just about alive), while the latter resulted in the IPO forming a committee to work on licence agreements, of which IP Draughts was an inaugural member. At the first meeting, IP Draughts and one or two other members expressed strong doubts about the feasibility of this task, and the committee’s remit soon morphed into one of providing guides to licence agreements for SMEs.

Perhaps the review process doesn’t lend itself to, or have the budget for, this type of critical analysis. In the case of IP-related reviews, it is noticeable how rarely the composition of the review panels includes specialist IP lawyers, who might be expected to know something about the subject and have a degree of independence from the sectional interests who make representations to the reviews.

These thoughts are prompted by re-reading some of the Dowling Review’s recommendations. For example, recommendation 22 reads:

Innovate UK, in consultation with the IPO, should explore the establishment of an independent source of advice and expertise that SMEs could call upon for support in negotiating contracts with universities.

IP Draughts’ first reaction to this was that there is already such a source of advice: IP solicitors. Then he wondered whether the recommendation was more about getting advice on the commercial terms being proposed. Or getting free advice. Later in its report, the Dowling Review explains that it has in mind a kind of commercial mentoring service for inexperienced SMEs.

ipoWe have been there before. Following the Hargreaves Review, the UK IPO was tasked with finding inexpensive sources of IP advice for SMEs. 5 years ago, IP Draughts described that idea as half-baked and, as expected, it didn’t get anywhere. But the poor IPO spent time and taxpayer’s money in various initiatives, including the ill-advised promotion of a British Standard for Commercial Intellectual Property Services. It really isn’t part of the IPO’s skill set or function to set up new professions to provide cheap advice.

IP Draughts is left with a sense that these repeated IP reviews are being conducted on the basis that if they produce several dozen recommendations, at least a few of them will “stick” and prove useful. This is a terrible way of conducting public business. Please could we have a decent pause – say 10 years – before another national review of IP policy is conducted. And when the next review is conducted, could it be written into its terms of reference that it may not produce a report unless:

  1. The report has no more than 5 recommendations.
  2. Each of those recommendations has been reviewed by a specialist IP lawyer or IP contracts manager who advises in writing that he or she considers the recommendation to be workable.

 

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Why we need a Royal Academy of Innovation

raeSome readers may be aware that the British House of Commons has a Science and Technology Committee. Some of those readers may be aware that this committee is currently holding an enquiry that has the title “Managing Intellectual Property and Technology Transfer“. The enquiry has received both written and oral evidence, and is due to hear further oral evidence in December.

The enquiry appears to have been prompted partly by the publication of the Dowling Review. One paragraph in particular from its executive summary (how many people have read the full report?) seems to have caught the committee’s attention:

Universities have rightly become more aware of the importance of intellectual property and have significantly professionalised their knowledge exchange activities. However, there is a tension between the desire to earn short-term income from their IP and the need to deliver wider public benefit, and potentially greater long-term return on investment from this IP. The emphasis needs to shift towards the latter, and this must be reflected in technology transfer office funding models and success metrics. Notwithstanding the substantial work already undertaken to improve approaches to establishing contracts and IP agreements, this area remains a major source of frustration for both academics and businesses.

(emphasis added; only the bold text is quoted in the committee’s terms of reference)

raaSee also paragraphs 110 to 125 of the main report. Let’s unpick what, in IP Draughts’ view, the highlighted parts of this paragraph are saying.

  1. Universities shouldn’t be so concerned about making money from their IP, as long as there is a benefit to [UK?] society from its commercialisation.
  2. Universities shouldn’t judge their technology transfer (TT) offices on whether they make a profit.
  3. Academics and businesses are frustrated by the behaviour of TT offices in requiring complex agreements that give too much financial benefit to the university and take too long to negotiate.

IP Draughts’ reactions to these assertions (as reformulated by him) are as follows:

  1. Sometimes yes, sometimes no. IP Draughts would like to see technology transfer opportunities routinely triaged into (a) those which are worth investing in, and having detailed agreements for; (b) those which are best licensed for free or low cost, with a simple agreement, under an “easy access” type of model; and (c) those for which no commercial opportunity is identified, which the inventor(s) should be allowed to deal with as they see fit, with minimal university involvement. We should also be careful to avoid equating the benefitting of society with the interests of one company. IP Draughts has heard the benefit-to-society point being used in negotiations by a company that wants more favourable terms.
  2. Agreed. It is pure chance whether a commercially valuable technology crosses the TT officer’s desk, and very few TT opportunities make a significant amount of money. IP Draughts said as much to the project team on the Dowling Review.
  3. IP Draughts is highly suspicious of comments of this kind. Academics sometimes behave very badly in siding with the company to put pressure on the TT office to accept the company’s preferred terms. Often, the frustration arises through the company not understanding the university’s objectives, which may be very different to those encountered in business-to-business agreements. In particular, the company may not understand the university’s needs to ensure public benefit and avoid legal risk. It is also true that, sometimes, universities are their own worst enemies, through failing to have a clear “bottom line” or a clear hierarchy and process of decision-making on legal and contractual issues. There is also the issue that companies are not neutral observers of the process: their “frustration” with the university’s approach in resisting the terms that the company proposes is aligned with their desire to achieve the best commercial outcome for the company.

ramStanding back from these issues, it seems to IP Draughts that there are human factors that need to be considered:

  • Vice chancellors and their teams. Universities are primarily concerned with research and teaching, and TT activities take second place to these priorities. Senior management of universities tend to understand research and teaching and not to understand TT.
  • Academic researchers. Academics tend to be concerned solely with their research and its funding, and not to be so concerned with the larger institutional interests of the university, including those which come into play when negotiating commercial contracts.
  • TT and contracts staff. TT and research contracts offices tend not to have high status within the university, and their staff are sometimes thought of as support workers rather than leaders of the university.
  • Business representatives. As mentioned earlier, companies sometimes lack understanding of the institutional, legal and other drivers of university behaviour. Often, it is not a case of the TT staff being “difficult”; rather, their behaviour is perfectly logical if you understand the context in which they are working.

So, what can be done to increase mutual understanding among the actors in TT, to raise the status of innovation and creativity as a discipline, so that it is no longer a “poor relation” of the university’s research and teaching activities, and to provide a focus for national policy initiatives in this field?

IP Draughts would like to suggest the formation of a Royal Academy of Innovation and Creativity (RAIC).

rsRoyal or national academies are a tried-and-tested way of developing a discipline, encouraging professionalism, and promoting the discipline at a national level, all for the benefit of society. Their core activities seem to vary across disciplines. Some of the science-based academies have a strong focus on academic research (eg the Academy of Medical Sciences or the Royal Academy of Engineering). Some of the arts-based academies seem to be more like national conservatoires, focussed on excellence in teaching (eg the Royal Academy of Music).

Drawing on the common features of some national academies, IP Draughts would like to see a Royal Academy of Innovation and Creativity that (adapting the words of Wikipedia’s article on national academies):

  1. is a voluntary, non-profit body with which government has agreed to negotiate, and which may receive government financial support while retaining substantial independence.
  2. has a core membership of “fellows”. The fellowship is elected, on the basis of excellence, by existing fellows. The number of fellows is restricted either to a total number or to a rate of accretion.
  3. has a governance structure that is democratic and “bottom up”. The fellowship is the ultimate source of the academy’s authority.

One of the functions of national academies is to bring together diverse bodies representing different aspects of a discipline, with a single national body. In the case of UK TT activities, there are bodies representing parts of the community, from PraxisUnico/AURIL for university TT and research contracts managers, to the British Inventor’s Society for individual inventors, as well as scientific and professional organisations.

The RAIC would provide a national focus for policy, education, research and excellence within the fields of innovation and creativity. It would raise the status of innovation and creativity in the academic and business communities, and provide an authoritative voice when dealing with government. It would be cross-disciplinary, in the sense of including among its members eminent representatives of academia, industry, TT leaders, investors and, dare one suggest it, professional advisers.

For this initiative to get off the ground, suitable individuals would need to act as midwives and perhaps form the first batch of fellows. Possible candidates, if they are interested, might include:

Academia: Professor Anthony Finkelstein (UCL, and Chief Scientific Adviser for National Security), Professor Sir Tim Berners Lee (MIT)

Industrial inventors and creators: Jonathan Ive (Apple), James Dyson (Dyson)

Industrial managers: Sir Howard Stringer (Sony), Malcolm Skingle CBE (GSK)

TT community: Jeff Skinner (London Business School), Alison Campbell OBE (Knowledge Transfer Ireland)

US National Academy of Inventors

US National Academy of Inventors

No doubt, others can think of different names. Does this idea have legs? Should the House of Commons’ Science and Technology Committee be pushing it as a way of improving the development of national policy and mutual understanding in university/industry relations and technology transfer?

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