Follow-up: CIHR trials transparency policy

Here is the official word from the CIHR on the clinical trials transparency policy that was so transparent that no one could see it:

According to  Dr. Ian Graham, Vice-President, Knowledge Translation, the new Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS-2) supersedes the Policy on registration and results disclosure of controlled and uncontrolled trials funded by CIHR.

The trials registration & disclosure policy page that was recently a 404 page is now a redirect page to the TCPS-2.

I find this response unsatisfying. Here’s why:

• I don’t understand why a policy would supersede another policy announced at the same time. Both policies were in development for years, but they didn’t notice until three months after they were simultaneously unveiled that they were redundant? Seems unlikely.
• It also seems odd that CIHR would send a KT Senior Advisor on a tour around the country educating people all about a new policy they would then suddenly decide was obsolete.
• While I have been assured that “CIHR is committed to transparency in clinical trials,” I have not gotten a clear answer as to whether or not all the exact requirements of the apparently-obsolete CIHR policy are included in the TCPS-2. (Am working on going through it with a fine-toothed comb, but it is >200 pages long and I have a head cold, so it’s slow going. ) I am particularly concerned about the preservation & disclosure of individual-level data and reporting of all adverse events in clinical trials.
• The TCPS-2 clearly states (Article 11.3) that “[Trial] registries, in addition to agency policies, editorial policies, ethical policy reforms, and revised national and institutional ethics policies and results disclosure requirements, contribute to a multi-faceted approach to eliminate non-disclosure.” It is concerning that CIHR apparently does not feel that the  CIHR policy facet of this “multi-faceted approach” is important.

If the TCPS-2 does ensure the same clinical trial reporting standards as the recently-retired-at-a-young-age CIHR policy, then this is possibly just an embarrassing right-hand-doesn’t-kn0w-what-left-hand-is-doing situation.

If, on the other hand (er, that would be the third hand in the middle, I guess?) the TCPS-2 is not as specific in mandate for clinical trial registration and reporting as the CIHR policy was, this is a great loss for open access, open data and public health and safety. Making detailed clinical trial data publicly available for third-party re-analysis is the best way we have to provide safeguards on drug approval, safety & effectiveness processes – processes that CMAJ rightly criticizes as opaque and secretive.

CMAJ has its own conflicts of interest, certainly, and I haven’t let them off the hook for that. But they are not the only ones. We must be vigilant not only about transparency in our scholarly publishing processes, but also about our government health agencies, including those that fund scientific research.

I would hope that CIHR’s relationship with, say, pharmaceutical companies (and their former employees), would never dictate their clinical trials policies. But I want the transparency to know that is true, for sure. And I’m certainly not getting it around this question right now.

If anyone has more info on this, I’m still looking for insight here, so please contact me.

-Greyson

Cached Copy: Policy on registration and results disclosure of controlled and uncontrolled trials funded by CIHR

For the record.

-Greyson

This is Google’s cache of http://www.cihr-irsc.gc.ca/e/42831.html. It is a snapshot of the page as it appeared on 17 Mar 2011 22:31:42 GMT. The current page could have changed in the meantime.

Policy on registration and results disclosure of controlled and uncontrolled trials funded by CIHR

Table of Contents

1. Preamble
2. Policy Objective
3. Guiding Principles
4. Application
5. Responsibilities of the Grantee
   • 5.1 Prospective registration of trials
   • 5.2 Public disclosure of trial information during trial
   • 5.3 Public reporting (disclosure) of trial findings
   • 5.4 Data retention
6. Monitoring and adherence
7. Policy Review

Appendix 1 – Additional information and resources

---

1. Preamble

CIHR‘s randomised controlled trial policy was announced in June 2004. This policy requires that all CIHR-funded randomised controlled trials (RCTs) be registered with an International Standard Randomised Controlled Trial Number (ISRCTN). The goal of the policy was to help ensure access to information about CIHR-funded RCTs.

 

Since 2004, a number of developments related to trial registration and results disclosure have occurred, including the development of International Council of Medical Journal Editors (ICMJE) and Ottawa Group statements, World Health Organization (WHO) International standards, expansion of existing registries and creation of new ones, development of the WHO network of primary registries, development of Standard Protocol Items for Randomised Trials (SPIRIT) elaborations of Consolidated Standards of Reporting Trials (CONSORT), CIHR‘s Policy on Access to Research Outputs, a dialogue on results disclosure – Public Reporting of Clinical Trials Outcomes and Results (PROCTOR), etc.

Currently prospective registration consists of submitting pre-defined controlled or uncontrolled trial protocol items to either one of the primary registries of the WHO or registry that is acceptable to the ICMJE prior to the recruitment of the first trial participant. The registry assigns an identification number (ID) and posts registered data on a freely accessible website. The assigned ID is meant to be used in all future communications including publications stemming from the given trial. Duplicate registration should be avoided.

2. Policy Objective

The objective of this Policy is to increase the transparency and accessibility of trials by improving their registration and disclosure of their results. Prospective public registration and disclosure of results are expected to help reduce publication bias, and fulfill ethical responsibilities to share knowledge gained from trials. It also complies with the WHO International standards, ICMJE requirements, and Declaration of Helsinki, thereby contributing to global initiatives to increase accountability of publicly funded health research.

3. Guiding Principles

In accordance with CIHR‘s commitment to the highest scientific and ethical standards and core values the following principles guide CIHR in promoting openness and transparency of all trials through prospective registration and reporting of results.

• Trial participants, the general public, decision makers, clinicians, public and private funders and sponsors, have a right to access the full information about ongoing and completed trials.
• Trial registration and results disclosure will enhance their openness and transparency which will in turn ensure accountability
• Prospective registration and disclosure of results of trials will contribute to the advancement of science, innovation, and strengthening of public trust in controlled and uncontrolled trials
• Academic freedom and the right to publish will be enhanced by prospective registration and disclosure trial results

These principles are aligned with international standards for trial registration developed by the WHO and endorsed by ICMJE and with principles defined by the Ottawa Statement.

4. Application

This policy supersedes the 2004 policy on registration of randomized controlled trials (RCTs) and it will come into effect for all competitions with application deadlines after December 31, 2010.

While Researchers awarded grants prior to this date are only obliged to adhere to the 2004 policy, they will be encouraged to adhere to the requirements of this policy.

5. Responsibilities of the Grantee

5.1 Prospective Registration of Trials

Grantees are required to:

1. register all CIHR funded trials following the 2006 WHO international standards prior to the recruitment of the first study participant by providing at least the WHO Trial Registration Data Set, ethics approval (one per country, generally for the main site), a reference to the systematic review that justifies the need for proposed trial, and other trial details, to any WHO/ICMJE endorsed registry.
2. register the trial in only one WHO primary registry or registry acceptable to ICMJE (such as ClinicalTrials.gov) following the WHO international standards for prospective trial registration. In instances when trial is registered in more than one registry, the grantee must provide cross-references to each registry including the identification number.
3. provide CIHR with the name of registry and the identification number issued by the registry. This ID should be used in all further communication with CIHR, publications, presentations, and on the trial website if it exists.

5.2 Public disclosure of trial information during trial

Grantees are required to:

1. update trial information in the registry at least once a year, usually following annual ethics review and re-approval.
2. report to CIHR and the registry major changes to the protocol such as the change of a primary or secondary outcome, or any other protocol amendment that requires ethics approval, upon approval by the ethics board, within 30 days.
3. report to CIHR and the trial registry early stopping or termination of a trial, within 30 days.

5.3 Public reporting (disclosure) of trial results

Grantees are required to:

1. submit, for RCTs, the CONSORT -based final report to CIHR within 12 months after the end of the trial, its early stopping, or termination regardless of the reason. CIHR considers this report public and has the right to publicly disclose it within 18 months of its submission. The grantee must follow the most recent CONSORT that corresponds to a design of his/her trial. For all other trials, the grantee must follow CIHR reporting guidelines.
2. comply with the CIHR Policy on Access to Research Outputs by publishing trial results in an open access journal or archive peer reviewed manuscripts in an open access repository (such as PubMed Central Canada).
3. submit trial results to a publicly accessible results databank such as ClinicalTrials.gov by completing all required fields (tables) within 18 months after the end of the trial.
4. post the aggregate (summary) data and micro (participant) level data on an unbiased freely accessible website.
5. report any severe adverse event or harm in the publication of the trial results following the CONSORT for harms.
6. submit any severe adverse event or harm to the trial registry along with the results if appropriate fields exist in the registry.

5.4 Data retention

Grantees are required to:

1. retain all trial information including original micro-level data and metadata data for twenty five years unless they are deposited in a freely accessible data repository (to align with the Health Canada requirements).

6. Monitoring and adherence

Grantees are reminded that by accepting CIHR funds they have accepted the terms and conditions of the grant or award as set out in the Agency’s policies and guidelines. In the event of alleged breach of CIHR funding policy, CIHR may take steps outlined in the Tri-Agency (CIHR, NSERC & SSHRC) Process for Addressing Allegations of Non-Compliance with Tri-Agency Policies to deal with the allegation.

7. Policy Review

As the area of trial registration and results disclosure is constantly developing and as there are no international standards for results disclosure and no acceptable trial data bank, CIHR will review and update this policy every two years or as needed.

Appendix 1 – Additional information and resources

Chan AW, Krleza-Jeric K, Schmid I, Altman DG. Outcome reporting bias in randomized trials funded by the Canadian Institutes of Health Research. CMAJ 2004 September 28;171(7):735-40.

DeAngelis C, Drazen JM, Frizelle FA, Haud C, Hoey J, Horton R, et al. Clinical trial registration: a statement from the International Committee of Medical Journal Editors. N Engl J Med. 2004;351:1250-1.

DeAngelis CD, Drazen JM, Frizelle FA, Haug C, Hoey J, Horton R, Kotzin S, Laine C, Marusic A, Overbeke AJ, Schroeder TV, Sox HC, Van Der Weyden MB. International Committee of Medical Journal Editors. Is this clinical trial fully registered? A statement from the International Committee of Medical Journal Editors. JAMA 2005;293(23):2927-9.

EQUATOR network

FDAAA

Krleza-Jeric K, Chan AW, Dickersin K, Sim I, Grimshaw J, Gluud C. Principles for international registration of protocol information and results from human trials of health related interventions: Ottawa statement (part 1). BMJ 2005; 330: 956-958.

Krleza-Jeric K, Lemmens T. 7th Revision of the Declaration of Helsinki: Good News for the Transparency of Clinical Trials. CMJ 2009; 50:105-10. doi:10:3325/cmj2009.50.105.

Krleza-Jeric K: Building a Global Culture of Trial Registration, (pp 59-82); in: Foote MA (ed): Clinical Trial Registries; A Practical Guide for Sponsors and Researchers of Medicinal Products. Birkhauser, Verlag, Basel, Switzerland, 2006.

Laine C, Horton R, DeAngelis CD, Drazen JM, Frizelle FA, Godlee F, Haug C, Hébert PC, Horton R, Kotzin S, Marusic A, Sahni P, Schroeder TR, Sox HC, Van Der Weyden M, Verheugt FWA. Clinical trial registration: looking back and moving ahead. Ann Intern Med 2007 147:275-277

Moher D, Bernstein A. Registering CIHR-funded randomized controlled trials: a global public good. CMAJ 2004; 171(7):750-75.

Enquiries

Please direct enquiries about this policy to Dr. Karmela Krleza-Jeric, Senior Advisor, Knowledge Translation at karmela.krleza-jeric@cihr-irsc.gc.ca.

The mystery of the missing CIHR trials policy

Who stole the Canadian Institutes of Health Research’s trial transparency policy?

Canadian health researchers report that the policy, only four months old, went missing sometime in mid-March. The policy’s full name is Policy on the registration and results disclosure of controlled and uncontrolled trials funded by CIHR.

It was last seen in the vicinity of the CIHR/IRSC website, at http://www.cihr-irsc.gc.ca/e/42831.html. The policy is described as an expansion of a previous CIHR policy, aimed at increasing clinical trial transparency and reducing biased disclosure of trial results.

We have evidence that the policy was alive not long ago.

1) Canadian health researchers around the country have received the following announcement of this new policy via e-alerts and newsletters over the past few months:

CIHR announces new policy
Policy on the registration and results disclosure of controlled and uncontrolled trials funded by CIHR (http://www.cihr-irsc.gc.ca/e/42831.html)
In 2006 the CIHR endorsed, in principle, the World Health Organization (WHO) international standards for clinical trial registration. Consequently, CIHR has updated its policy effective 20th December 2010. The new Policy will apply to all competitions with application deadlines after 1st January 2011.
The new Policy requires researchers awarded CIHR funding to:
* Register a trial in one of the WHO primary registries or      ClinicalTrials.gov prior to participant recruitment;
* Regularly update the information during the trial;
* Report and publicly disclose trial results; and
* Retain all trial information for 25 years.

The updated Policy expands on the 2004 policy on RCT registration. This Policy complies with the WHO International standards, ICMJE requirements and the Declaration of Helsinki.The Policy will help ensure that clinicians, researchers, patients and the public have access to information about CIHR-funded trials. The aim is to increase transparency and accessibility of trials by their prospective registration and disclosure of results, thereby reducing publication bias and fulfilling ethical responsibilities.
The new Policy can be accessed via the CIHR Funding Policies web page (http://www.cihr-irsc.gc.ca/e/204.html)

2) The CIHR glossary refers to this policy (under “Results”).

3) There’s a nice archived abstract and PDF of the slides from a presentation explaining the origins, development and details of the new policy, “Towards Greater International Transparency of Clinical Trials – Short Term Efforts for Long term Benefits: CIHR Trial Policy 2010” given in February by Karmela Krleza-Jeric,MD, M.Sc., D.Sc.

But the policy hasn’t been seen in at least a week, possibly longer.

The URL to which the above sources refer as the policy document on the CIHR website is currently a 404 Error page.

At first, it might seem to be merely a website glitch. However, the policy is also missing entirely from the above mentioned CIHR Funding Policies web page, despite the fact that the other recently added policy on Gender and Sex Based Analysis is listed, and the page currently says it was last updated a week ago on March 28, 2011.

Whodunnit?

Policy wonks continue to search for the missing policy, last seen at least one week ago.

At this point, authorities can only speculate on motives for this disappearance. However, the spectre of institutional conflict of interest has been raised.  At this point, we are making an appeal to the public to please contact us with any information you may have about the policy’s disappearance.

Anyone with information on the current whereabouts of the CIHR Policy on the registration and results disclosure of controlled and uncontrolled trials is asked to please leave a comment below. We hope to see this young policy safely back at home again as soon as possible.

Thank you.

-Greyson

ETA – Cached copy of the policy text is now available here.

ETA2 – Follow up post here. And another here. Also here.

CMAJ and openness: audacity or ignorance?

I keep trying to figure out whether the CMAJ’s recent unofficial series of articles on various types of “open” is irony-aware or just pushing forward without realising what they’re doing.

Brief background: the Canadian Medical Association Journal is THE major Canadian medical journal. They’ve been around for 100 years, and become rather prominent in the English-language medical publishing world, ranking quite well in various impact rankings. CMAJ was an early adopter of a free-to-read-online access model.

Then, in 2006 there was a kerfuffle over editorial independence, leading to mass firing/resignation of journal editors (who went on to found Open Medicine, which styles itself as more open and more ethical/transparent than CMAJ). In January 2010, CMAJ became “no longer free for all” by restricting immediate free access to a portion of the journal’s contents.

The past week or so has seen a variety of CMAJ articles on open stuff: research, news items and commentary. I’ve been looking at some of these rather incredulously, unsure of whether the inherent irony and conflicts of interest here are editorially recognized or not.

What really caught my attention was the way that an article titled “The association between a journal’s source of revenue and the drug recommendations made in the articles it publishes”  was summarized in a commentary titled “Covert pharmaceutical promotion in free medical journals” (PDF, not freely available) and in the weekly CMAJ roundup as “Free journals may be biased.” This was then picked up my major news sources such as the Globe & Mail  “Free journals often promote costly or problematic drugs, study finds” and Reuters  “Widely read free medical journals hype drugs: study.”

Yes, you read that right. An article about how a journals’ acceptance of drug ads correlated with biased drug information in said journals was spun as “free journals are junk” a year after CMAJ – which incidentally accepts a whole bunch of pharmaceutical advertising – stopped being entirely free online.

In case you needed a little more conflict of interest with that irony, here’s a screenshot of the banner drug ad on the very page from which I downloaded the article:

Pot, kettle?

With their recent access model shift, the CMAJ of all journals should understand that access models are not the same as business models, and that free access to medical journal content may be supported by several different revenue streams, including association membership fees, advertising revenue, grants, reprint/offprint charges, and publication fees to authors.

Hmm, a drug ad on an article talking about drug funding for medical journals.…While I wouldn’t go so far as to imply that CMAJ is an industry-mouthpiece “fake journal” like some, this recent spin of “drug industry funded/biased” into “free to read” does make me wonder what’s up. Do they not realise that they’re incriminating themselves here?

CMAJ has followed this conflation of free access with pharmaceutical sponsorship with a bunch of coverage of open data – a current semi-hot topic (rapidly being eclipsed by non-confidence votes in parliament) thanks to Steven Harper’s March 18 “Open Government” strategy announcement.

First a news item alleged that “The systemic secrecy in which Health Canada shrouds data is “outdated” and “embarrassing” in comparison with the openness of other countries” , quoting co-author of the medical journal funding study Joel Lexchin as well as open government activist David Eaves. The next day, a news item lauded US President Obama’s Open Government Initiative. Just a few days later, CMAJ published an editorial titled “Will Open Government make Canada’s health agencies more transparent?”, which rightly criticizes the “black box” of Health Canada decision making, including the drug approval process.

While I’m glad the CMAJ is championing some forms of openness including more open government information, CMAJ’s own editorial decisions/independence (latter link to PDF), funding streams and potential pro-drug-industry bias are real elephants in the room here. Are the editors aware of this?

What do you think? Boldly sidestepping the issue of one’s own conflict of interest, or not being forthright enough to acknowledge it?

-Greyson

The metered Internet threat to innovation & access to information

Remember the early days of mass public access to the world wide web? Back when AOL was king, noisy dial-up modems were par for the course and having any graphics on a webpage was super-fancy? Remember in 1993 or so, when you’d connect to the Internet, download your email as quickly as possible, disconnect to read the text and write your responses, then connect and send your pre-written emails as quickly as possible? It’s the type of scenario today’s kids would find baffling and hilarious: clunky, unwieldy, expensive, and certainly not one that encouraged increased use of the technology.

Well, everything old is new again. The CRTC (Canadian Radio-television and Telecommunications Commission), Canada’s telecom regulator that brought us nearly-neutrality rules just a year ago, recently issued a decision on “usage based billing” or UBB (Telecom Decision CRTC 2011-44). And the meter on your Internet may well be back on – albeit measuring bytes rather than seconds this time around.

A lot of reaction to this decision is coming out, and more analysis will follow in the coming days, I’m sure. OpenMedia.ca has a petition up, Canadian news outlets are covering the decision (and reaction) widely, and online content providers are understandably furious.

I haven’t gotten a chance to comb through the decision in detail yet, and I have to take a couple of boys to the science museum shortly, but there are a few points I want to make right off the bat. I may be back later to comment further or clarify these quick notes.

1) UBB is not the same issue as net neutrality (unless #2 applies)

The reason usage-based billing sounds so appealing, so normal,  is that we do pay per item/metered amount for a lot of goods. We pay for utilities like hydro (hydro = electricity for you non-Canadians) on a metered basis, and many areas also meter water (although that is not without controversy). Frankly, the UBB idea is a brilliant example of big ISPs hearing the pro-neutrality argument that Internet should be treated like a utility and running with that concept, turning it to their advantage.

A lot of the same folk who were up in arms over net neutrality are upset about this UBB ruling. And they have good reason to be outraged. However, in strict sense, UBB is not in contradition with net neutrality (where net neutrality = slowing down of selected content en route to the consumer). My understanding of the CRTC UBB decision is that it is supposed to be content-agnostic, and only size-based. Now, this doesn’t make a lot of sense, policy-wise, anyway (as I will discuss below), but it’s not necessairly non-neutral.

However, metered use makes sense for goods for which we have  a finite supply, not for things like information, which do not require rationing. Economically speaking, information is a non-rivalrous good, meaning that my use of the good (say, a webpage, journal article or TV show) does not in any way prevent you from also using & enjoying the same good.

I know, I know, there’s that old argument about your pipes getting clogged because your neighbours are downloading too much big stuff all the time, but frankly Canadian ISPs have been given ample opportunity to show evidence of this overload, and none has materialised. In fact, the logs we did see during the net neutrality hearings showed the exact opposite of congestion, making it clear that this is just a cash grab. (I do want to make the point, however, that even if congestion were present – and eventually it may exist if ISPs fail to invest in their infrastructure – that does not mean that the correct response is to slow down Canada’s Internet in response. Other industries are required to upgrade their infrastructure over time as needs change or parts get old and fail.)

2) UBB is a potential neutrality workaround

While I think the intent of the CRTC  is allow metering of all Internet content equally within the same subscription plan, and to do otherwise is likely a violation of the still-untested CRTC net neutrality rules, there is a lot of scope here for ISPs to provide favourable conditions for content from which they benefit.

For example, an ISP may offer special promotional “exemptions” from UBB for content offered by their parent company – dinging, say, Netflix while exempting their own online TV/movie service. This isn’t throttling content in the “pipes” or charging a toll to content providers for content delivery, it’s charging a toll to users for content access. It’s throttling the consumer’s wallet.

3) UBB is a giant threat to access to information, and to innovation

Here’s where it gets really ugly. Imagine what it would (will?) be like when we are charged by the byte for information downloaded (and possibly also uploaded?) over our connections.

No one knows how much bandwidth they’re using so they minimize use, fearing fees. AJAX is no longer an asset; it is a liability and we disconnect from continuously refreshing websites to save bandwidth. The pressure is on for online content to be as compressed as possible, hitting the art community hard. Community wireless, such as building-wide wifi in co-op housing, becomes potentially pricey and hard to control.Schoolkids are no longer encouraged to post videos from the classroom to demonstrate and share learning. Employers start to police recreational Internet use more than ever. Coffee shops and other hotspots stop offering wifi all together, making life harder for freelancers, the self-employed, students and others without official workspaces.

Fearing the bandwidth limits on their personal subscriptions, the middle-class flock to libraries to do their downloading. Libraries cannot afford this. Libraries may not be able to afford current levels of bandwidth use, if metered, particularly academic libraries or those dealing with subject areas involving rich media (art, film, music…). I cannot over-emphasize the threat to public access to information via libraries here: libraries are currently THE places in society where anyone can access the Internet. If libraries have to limit this, ration it somehow, or lose this role, it will be a tragedy both for libraries and for the public who rely on library Internet. When public Internet access is limited or closed, public access to information, and therefore public participation in democracy, is seriously impinged. With the government increasingly moving to online-only forms, information, and dialogue with the public, how responsible is it to simultaneously move to meter Internet use?

We may move backwards in time, returning to network television for entertainment. Online course reserves could be pricier for the university than those old print custom course packages. We might actually revive the fax machine?!? Why would a country want to push its population back in time, when the rest of the world is jetting ahead with innovative multimedia content and new delivery systems? Hard to say. Just dumb policy-making? The cynic in my says it could be that those making the policy stand to benefit from old media technologies and fear the threat of the new. However we may drag our feet and try to slow things down within national borders, change and innovation are going to happen – if they need to happen elsewhere first, that will happen. Maybe the CRTC needs to attend Karen Schneider’s talk at MLA?

-Greyson

ETA – Well, that didn’t take long. The decision has already been appealed. Fasten your seatbelts!

Open access debate at CHLA/ABSC: not about OA at all

There was a lot of activity around the topic of open access at this year’s Canadian Health Libraries Association / Association des bibliothèques de la santé du Canada Conference in Kingston, ON:

• Our new Open Access Interest Group had its first meeting,
• I got to give a talk about where we are with OA in 2010 and what this might mean for health librarians,
• and then there was this really fun keynote presented as a debate over OA.

While the interest group meeting and paper presentation are probably pretty much what one might have expected from such events, the debate merits some special discussion, and I finally have a minute in which to do so. The two presenters were Dr. Udo Schüklenk & Dr. Sergio Sismondo.

The conference blurb about the event states:

Like many others in the academy, Udo and Sergio, both philosophers at Queen’s University, hold considered views on the question of the ‘open access’ versus ‘subscription’ models in academic publishing. As it turns out, they find themselves on opposite sides of the spectrum. Sergio thinks that ‘open access’ is ultimately the way to go, while Udo thinks that the ‘open access’ business model is fatally flawed. Unlike Sergio, Udo carries the baggage of a serious conflict of interest, being the paid editor of a monthly subscription based journal. The two of them have engaged in vigorous debates about the pros and cons of both models on various occasions. During our conference they will put their respective cases to the audience test. Each of them will talk for about 15 min, with a 5 min slot for a rejoinder available to both. Afterwards we will open up the debate to the floor. (emphasis mine)

The debate was lively and jovial, with this clearly not being the first time this pair had engaged in verbal sparring. Neither speaker hailed from a health or library background, and both said things that caused the audience to gasp audibly (e.g., the moment in which Udo said he couldn’t imagine why anyone would ever read the journal Social Science & Medicine!). More significantly, neither demonstrated a clear understanding of the distinction between access models and business models.

As Sergio identified from the start, Udo was intended to wear the “black hat” in the debate. Sergio made pro-OA arguments that might be considered overblown, advocating for the “OA system.” (Not sure what the “OA system” is…perhaps this is like the “gay agenda”?)

Udo, on the other hand, gamely played staunch defender of the possibly-dying print journal (and pointing to the recent JAMA article-revision kerfuffle as rationale), conflating OA with online publishing.

Both debaters tried to pin journals’ ethical transgressions on their access models. While both gentlemen were clearly experts in philosophical-ethical issues, it was evident that they were not experts in scholarly publishing, as they seemed unaware of initiatives such as LOCKSS as well as disciplinary trends in citation behaviour.

When the floor was opened up to the audience, I joined a few others in scampering up to the microphones. It was not long before Sergio had to concede that, no, OA will not change anything other than access. A moment later, Udo had to admit that not only would OA improve access, but he (the alleged anti-OA debater) archived all his publications under “green” OA.

And thus, our “OA debate” was suddenly revealed as a green OA vs gold OA debate.

I started this post claiming that the “OA Debate” at CHLA/ABSC 2010 was not about OA at all. Upon reflection, that’s not true. It was about OA, just not in the way we all expected. It was about how far we’ve come in the past decade+, that nowadays an OA debate is not about “whether OA” but rather “how OA.” Pretty awesome that “opposite ends of the spectrum” can now mean “believing in different OA futures.”

Thank you to all the OA movers & shakers who have been working on this issue since before I even knew it existed.

-Greyson

Internet Linking is Analogous to Citation

Everyone with whom I have discussed the issue of Internet linking agrees that Internet hyperlinks are a form of citation. But the subset of the population with whom I discuss these issues is not representative of the entire world, clearly. There are 2 schools of thought that I’ve encountered thus far that substantially differ from the above:

1. The folks who think you need to obtain permission to link to another website, and
2. The folks who think the author/owner/host/ISP of a webpage are responsible for any content accessible via hyperlinks on that site.

Neither one of these perspectives makes a whit of sense to me, seeing as I conceive of hyperlinks as akin to footnotes or citations, not republication of the material to which the link directs. Republication would be copying content on one webpage and posting it (in a manner beyond that permitted by fair dealing/fair use) on another page.

Because I can’t really understand how a hyperlink could actually be considered republication rather than citation, I am dumbfounded by people who adhere to – and sometimes threaten legal action in accordance with – either of the above two viewpoints. I actually find myself a bit stymied when pressed to defend my stance that hyperlinking is citation, because the alternative is so ludicrous in my mind. I need to work on this, which is why I’m posting this here.

1. Permission to Link

I have encountered a few individuals who have adamantly insisted that their websites were their property and thus they had the rights to dis/allow linking to their web content. I have actually been threatened with legal action from a blogger (with a PhD – which led me to expect that she’d at least be able to research the actual law) who insisted that I not link to her weblog from a password-protected site, which I found incredible! (In this specific case, although I knew she didn’t have a legal leg to stand on, I removed the link because I liked her writing and didn’t really want to make her mad, and also because I didn’t want to sink energy into a fight, but stopped following her blog lest I accidentally post a link she didn’t approve again.)

Apparently U.S. Judge Richard Posner also did or does think that permission to link to a webpage should be the law. In this blog post from last year, he states that:

Expanding copyright law to bar online access to copyrighted materials without the copyright holder’s consent, or to bar linking to or paraphrasing copyrighted materials without the copyright holder’s consent, might be necessary

in order to save the newspaper industry (from the competition of free news aggregation sites). While I have great sympathy for the difficult times the newspaper industry is experiencing in this era of digitization, the above suggested curtailing of fair use/fair dealing is appalling.

My understanding is that nothing has been legally established in Canada about permission-to-link, but in the U.S. there is a bit of case law establishing that (in the absence of other factors such as defamation or violation of – in Canada – moral rights) as BitLaw states,

“there would appear to be no legal means for preventing someone from including a link in one page to another”

2. Liability of Link-maker

SO, the Supreme Court of Canada has apparently agreed to hear Wayne Crookes’ appeal of a 2008 BC ruling (an appeal that was dismissed from BC Supreme Court) that linking to websites that contain allegedly defamatory material is not in and of itself defamation. Vancouver-based Crookes has sued a bagload of folk for libel based not on things they wrote on their websites but on thinks written on sites they linked to, or sites those sites linked to.

Whoa. Similar to how ISPs should not be responsible for the content of their customers, web authors should not be held responsible for the content on pages they link to! Citing something, in traditional publication, is hardly the same thing as agreeing with it, let alone authoring it. Hyperlinking is like citing – a pointer, a reference.Hyperlinking is not – as I think I clearly distinguished above – republication of content.

Hopefully the Supreme Court of Canada has agreed to hear this in order to set precedent (in accordance with the BC courts decisions) and thus stop the free-expression chill that such SLAPPs create. The alternative is just too ludicrous, right?

Right?

-Greyson

CMAJ “No longer free for all”

I’ve been thinking about the Canadian Medical Association Journal (CMAJ)‘s decision to convert from being 100% free to read online to only partially so, come January.

Access Change

The Canadian Medical Association Journal (CMAJ) has been entirely free to read, online, since it first went digital in the mid-1990’s.

This is about to change.

Letters from the publisher and editor inform us that, beginning in January,

“Editorials, news, clinical images, abstracts and previously published articles will also remain accessible to all readers. Access to reviews, analysis, practice, commentaries, humanities and supplements will be restricted [to CMA members and journal subscribers]…although these items will become free of charge 12 months after publication.”

Funder OA Requirement Implications

Research – of key concern to any researcher holding funding from CIHR or the many other research funders who require OA to publications before a year’s embargo is up – will remain free to access. However, authors should be advised that publishing in the “Reviews” or “Analysis” sections will not meet the CIHR OA requirement – and there is no pay-for-OA option to remediate that.

Bucking the Trend?

The reason given for the CMAJ’s access change is that:

We must now adapt our business model to respond to current economic conditions and can no longer provide free access to all of our content.

I think this is interesting, given all the journals that have recently been deciding they cannot afford NOT at least offer an OA option. Is there some sort of OA “sweet spot” that is most profitable in 2009/2010? Or is CMAJ just panicking and hoping to get a bit more cash in a recession here?

I’m also curious as to why CMAJ decided to restrict access to readers, rather than charging publication fees to authors. Author-side fees seem to be the current dominant method for publishers attempting to move from subscription to free-to-read models in biomedicine. (Will this be a later phase for CMAJ, post re-institution of subscriptions, effectively making an early adopter of OA end up as also a late adopter of OA?) My guess is that CMAJ authors are generally better funded than the readers. If anyone reading this has insight in to why CMAJ decided to charge readers rather than authors, I’d love to hear it!

Institutions or individuals requiring immediate access to the entire online journal will need to purchase subscriptions unless they are CMA members. (Haven’t heard much buzz on the library wire yet as far as how this $690/yr is going to affect already-shrinking serials budgets in libraries…maybe there’s nothing to say?)

The journal is also planning to publish more frequently online, and less frequently in print, to speed up publication timetables and save on postage. Wish they could scrap the print all together, but I’m not intimately familiar with the reading habits of practicing Canadian MDs, so maybe there is a reason they haven’t done the obvious yet?

CMAJ will continue to participate in the HINARI and AGORA initiatives to bring free or low-cost access to low-income international readership. They’re also giving “media” free access, and while I am really glad CMAJ’s not planning to limit journalists to lousy “press-release journalism,” I’d be interested to know who qualifies as “accredited” media in 2010.

Effect on Journal Impact?

CMAJ is one of the only Canadian biomedical/health journals to be a serious competitor in the Impact Factor rankings (ISI Journal Citation Reports). Since 1997, it’s IF has grown from 1.6 to 7.5, placing CMAJ within the top 10 general medical journals. This stellar climb in a non-U.S.American journal has frequently (but controversially) been associated with it’s wide availability – particularly since other OA journals – such as PLoS Medicine – have made similar sharp climbs. While research articles (upon which the IF formula is based) will remain free to read, it will be interesting to see whether the journal maintains its high IF ranking or slips in the years following this change. My guess is that it would take a long time to slip, if at all, because it is now fairly widely known internationally, compared with a decade ago.

Open vs Free

A couple years ago, back in July 2007, the editors of CMAJ published a commentary congratulating the editors of Open Medicine (OM) on establishing a new journal. While this congratulatory note was interesting in light of the historic editorial schism at CMAJ that gave birth to OM, the letter itself looked nice and innocuous enough. In said letter, CMAJ wrote:

Like CMAJ, Open Medicine is an open-access journal, available free to all who wish to read it and free for all who wish to contribute to it. As open access remains disappointingly rare among general medical journals (Table 1), this is both commendable and of great significance. The birth of Open Medicine thus provides us with a valuable opportunity to remind our readers why open access to the medical literature is important and necessary.

OM’s editors responded a few days later with their own letter, which struck some as less than gracious. In it, they wrote:

Although the endorsement by CMAJ’s editors of open access medical publishing is welcome, we would like to take this opportunity to clarify several points raised in their commentary.1 First, there is an important distinction between open versus free-access publication. Open Medicine has not only adopted the principle of free access, that is, making content fully available online, but endorses the definition of open access publication drafted by the Bethesda Meeting on Open Access Publishing.2 This definition stipulates that the copyright holder grants to all users a free, irrevocable, worldwide, perpetual right of access to, and a license to copy, use, distribute, transmit and display the work publicly and to make and distribute works derived from the original work, in any digital medium for any responsible purpose, subject to proper attribution of authorship. Given that CMAJ holds copyright and charges reprint and permission fees, it is not in fact an open access journal.

It’s significant to note that these letters were written before the Suber-Harnad agreement on the terms gratis OA and libre OA to indicate free-to-read/access vs free-to-read/access/reuse/redistribute. There was more talk about what was and wasn’t “real” OA just a couple years ago. Even taking into consideration the context of the day, though, the OM response could be read as a bit snitty.

However, in light of this recent “Access change” by CMAJ, the OM letter suddenly seems more relevant, almost prescient. Another difference between gratis, free-as-in-no-money OA and libre, free-as-in-freedom OA emerges when journals highlight their ability to take their toys and go home. CMAJ is not saying they’re moving anything that is currently freely available back behind subscription barriers, and they are currently planning to make everything free to read 12 months after publiciation, BUT…we are reminded that CMAJ’s articles are CMAJ’s articles. Whereas Open Medicine’s articles are ours.

-Greyson

Privacy vs. Data: Electronic Medical Records (EMR)

My province, British Columbia, is one of many jurisdictions currently in the process of implementing eHealth, which is (in part) basically a large scale, provincially-coordinated  implementation of the Electronic Medical Record (EMR).

And I’m gonna come out and say it: I’m a privacy advocate who is pretty much in favour of government-administrated EMRs.

(Of course, there is a catch…)

I work with health data. I mean, I don’t actually lay my own grubby librarian hands on most of it, but I work in a data-rich environment and with researchers who are analyzing lots of health system data. This stuff is highly privacy sensitive. There are parts of my office I’m not even allowed in without an escort, passing a security cam, and signing a log. And that is how it should be.

I sincerely appreciate the tension between

a) the researchers who want data access and linking in order to do good research and improve health and healthcare, and

b) data stewards and privacy officers who want to protect our privacy first and foremost.

Sometimes the privacy laws and regulations make it harder to do good research, but that’s part of the process.

For example: here, we’re not allowed to identify subpopulations with particularly diagnoses anymore, to survey them, because that’s considered invasive of their privacy. Fair enough – I wouldn’t necessarily want to be subject to lots of survey requests from people who somehow found out I had disease X. However, this also understandably makes it harder to research disease X, when we can’t just pull a representative sample (or all patients) to survey/study.

Both sides – the research/access and the privacy protection side – need good advocates in order to find the best (or at least an appropriate) balance. And I do believe in that balance.

It’s kind of like how in domestic violence shelters there’s often a staff member advocating for a mother who is in shelter, and another staff members advocating for the mother’s child. Usually what’s best for mum (the primary shelter client) is best for the whole family, and there’s no apparent need for the child’s advocate. But sometimes that’s not the case, and both mum and child deserve a strong advocate who is primarily concerned with their welfare, in order to strike a balance and find a solution that is in the best interest of most people.

I’m not a perfect privacy advocate.  I do not believe the government having any information on me is necessarily a bad thing. Sure, there are days when I dream of living off the grid and having babies who never get social insurance/social security numbers. Mostly, though, I think of myself as a realist whose goal is to help the government find an appropriate balance of privacy and data.

Why? Well, because I do have some faith in evidence based practice, despite the somewhat flawed way that medical evidence (the EBP “gold standard”) has been implemented. So I do want the government to have some data on me, because I certainly don’t trust private companies more than I do public institutions, and without data, there is no evidence.

So, when I think of EMR, I think first of the good that can come of it.

Yes, there is the clinical potential: possibly reducing adverse drug reactions/interactions, and the like. Yes, likely improving communication between docs working with the same patient. But beyond those (mostly unproven) claims of the potential of the EMR, the potential for research is phenomenal, really. Even the potential for a patient to finally have access to their own, fairly complete, medical records is pretty awesome.

THEN come the “buts”: the caveats, the necessary policies and procedures to ensure optimal stewardship of this type of linkable – and in some cases already linked – data.

I have to say, up front, that there is absolutely the risk of significant breach of privacy with EMRs.

BUT most of this risk already exists. We already carry electronic data. Several existing individual databases that will combine to form the EMR in this province are already personally identifiable and potentially incriminating. Take PharmaNet, for example. PharmaNet tracks every prescription dispensed in the province. It’s made possible some research in BC that hasn’t been done anywhere else (e.g., this cool stuff that some of my colleagues are doing). However, there is certainly a need for good data stewardship, as there’s a chockload of sensitive information in that database (and there have been some noted breaches – e.g. in this .doc from FIPA).

Combining multiple database may raise the ease of identification, and give more information, but what my real concern is isn’t the linking and interoperabilityof the datasets (because, really, if PharmaNet shows an AZT script, does anyone really need corroborating doctor records to out you as HIV+?), but the privacy and security policies and procedures of the data stewards. This is the same concern today as it will be once the EMR is implemented in my province.

So no, I don’t want to Opt Out. Call me deluded, but I want all health care professionals who treat me to have access to appropriate data on my health history. I want the ER staff, when I arrive on a stretcher the day a crazy driver finally plows into my bicycle, to know about my life-threatening medication allergies ASAP.

And I’m not alone. Heck, there are people who want an EMR badly enough that they are trusting companies like Google and Microsoft with their medical information! I certainly can’t claim to fully trust my government, but I’ll take the Ministry of Health over a publicly traded company any day, when it comes to my health care and private information!

HOWEVER, I do want a Real Dialogue and some transparency about the handling of the EMR, as well as other government data. Because while I’m not signing on the Opt Out bandwagon, I do think the concerns about:

• lack of government transparency,
• lack of a publicly-available privacy policy governing EMR data sharing,
• selection of a US based company managing/holding the information,
• and lack of clarity regarding who will have access to which modules/portions of the EMR

are very valid and legitimately alarming.

We have some pretty good models of data stewardship here. Let’s learn from them, and listen to our privacy advocates and commissioners, as we move toward the inevitable EMR.

-Greyson

Caron’s LAC Modernisation message: huh?

(aka the blog post wherein I probably blow any and all future chances of working in government…)

Making the rounds of Canadian LIS (and presumably archives) listservs today has been Librarian and Archivist of Canada Dr. Daniel Caron’s “Message from the Librarian and Archivist of Canada: Modernization.”

As far as messages go, it’s kind of an odd one.

The message begins by promising to share the course for LAC he has charted, and ends by saying LAC should do what it was set up to do. Truly radical. Maybe some of this makes more sense to people with more inside knowledge of LAC? To me it sounds rather like the teacher from the Peanuts cartoons. (“Wa wah wa wa…”)

On my first skim through I was numbed by all the vague references to generally-unspecified issues, challenges, harmonizing and togetherness. The “today is the tomorrow you worried about yesterday” business in the middle was somewhat amusing, and the reiteration of LAC’s mandate (repeat after me: acquire, preserve, access; lather, rinse, repeat) and praise for LAC’s “brilliant past” were a nice acknowledgment.

On my second read through I realized that Dr Caron must be reeeally worried about LAC being seen as “relevant.” I mean, he mentions this concern no fewer than 4 times in the 9 paragraphs (which is, incidentally, the same amount of times he used the word “library” in the message):

1.      “Today, digital technology has radically changed our practices and expectations and, to remain relevant, we will need to tackle the issues, communicate and collaborate more than ever before with others who share our goals.” (para 1)

2.      “Our relevance in the medium and long term is also called into question in this new environment.” (para 3)

3.      “How do we remain relevant in an increasingly fragmented and to a certain extent uncontrollable environment?” (para 5)

4.      “…our relevance depends on our ability to implement the best work procedures and marshal the most effective and efficient combinations of available expertise.” (para 8 )

(all above emphasis mine)

What’s weird is that exactly the things he seems to see as threatening LAC’s relevance (digitization, preservation challenges, information overload, social media…) are the exact things that I see as making the case for the relevance of information professionals.

Nu? This is really the man in charge of our national library & archives?

I accept that I am of a different generation, cultural background, and academic discipline than Dr. Caron. I, for example, don’t feel “condemned to live in both worlds, analogue and digital, at the same time,” (<-emphasis mine; and I would say something more like privileged to live at this time of straddling the aforementioned worlds); nor do I feel especially burdened by the “daily challenges” of unspecified “social transformations” (unless by that he means corporate globalization? I do feel kind of daily challenged by neocolonialism, come to think of it…).

However, I do know a fair number of librarians and archivists from backgrounds pretty different from my own, and when they send me messages, I generally feel like I have a decent clue what they’re trying to communicate.

This, well, what can I say? It’s a totally weird message. Maybe Caron’s trying to prove that he really does get libraries and archives,  while just totally missing the mark?

…or at least that’s what I’d like to think, since the alternative would seem to be that he’s basically paving the road for privatization of LAC…

-Greyson