Category Archives: government

Days of Destruction

This book landed on my desk this morning – I am curious if other have read or heard of it?  It seems like an interesting representation of the lives of people in rural poor America, taken from interviews with people directly impacted by corporate policy.
From the back of the book “only corporate profit matters – has spread to outsource our jobs, cut the budgets of our schools, close our libraries, and plague our communities with foreclosure and unemployment….”  Sounds like it will be an interesting read, especially when looking at it from the American context…

Also – feel free to listen in: The Current CBC Radio Interview

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by | August 1, 2012 · 6:11 am

Update on withdrawn CIHR trials policy

In an only somewhat-overdue update (thanks to conference season interrupting my regular blogging activities – I do write on the road, but need to get sleep & give a read over before I can push “publish” on a post) the Canadian Instutites of Health Research (kind of the Canadian NIH, for US American readers) has put out a new message regarding the missing CIHR trials policy that we’ve been following since late March.

To backtrack a bit, while I was on the road and having fun with research and colleagues over the past month, there was more coverage of the CIHR trials policy disappearance, including Michael Geist’s blog and the National Post. Additionally, “rapid response” letters from around the world continued to roll in to the BMJ related to their article, some with great titles such as, “Canadians step back from the well of transparency while the World is thirsting for it” and “CIHR decides it must compromise my interests as a patient.”

Then, right around June 15 or so (I saw it on the 17th), CIHR President Dr. Alain Beaudet issued a “Message from the President – Policy on ethical conduct of research involving humans.” Go read it: http://www.cihr-irsc.gc.ca/e/43756.html. If you’re anything like me, you may need to read it a few times over, because it’s not the clearest statement ever made.

Here’s what I think it’s saying:

  1. That the March removal of the trials policy (“Registration and Results Disclosure of Controlled and Uncontrolled Trials”) was about “harmonization” and deference to the TCPS-2
  2. The TCPS-2 has some requirements for trial registration and public disclosure
  3. While the trials disclosure requirements in the TCPS-2 and the former CIHR trials registration policy were in the same spirit, the CIHR policy had more specific directions about what needed to be done
  4. CIHR will (at some unspecified point) be  integrating certain of these more stringent operational requirements as part of the terms and conditions of its “relevant programs.” These include: a) publication of the systematic review used to justify the trial, b) registration and compliance with WHO requirements for minimum data disclosure, and c) submission of final reports in CONSORT format.
  5. CIHR will propose 4 revisions to the TCPS-2 for “prompt consideration” (not clear on how soon this can/will happen): a) applying to all trials, not just clinical trials, b) requirement to update trial registration when the trial protocol changes, c) requiring that serious adverse events be reported in post-trial publications, and d) and a requirement to deposit aggregate data in an unbiased, publicly accessible database.
  6. In the interim, CIHR will specify that researchers have to “comply with all the requirements mentioned above” (not sure whether this means 4a-c or is also inclusive of 5a-d).

So, what does this mean? Are we all good now?

Well, we’re better than we were before the press coverage, I think. We’re not as better as we would have been, had the trials policy never been pulled.

Remaining questions:

  1. Really??? I’m still kind of skeptical that 3 months after the trials policy and the TCPS-2 came out, both of which had been in development for a looong time, someone suddenly just went, “Oh, gosh, you know what? It’s not okay to have both of these policy statements!” Why am I skeptical? Well, because it just doesn’t make sense. CIHR had a trials policy that wasn’t 100% the same as the TCPS-1. Tri-council funders have all sorts of different policies that are more stringent than the TCPS, and it’s not a problem (e.g., the beloved CIHR Access to Research Outputs policy). It’s just not adding up, and at this point the message seems to be that it doesn’t matter if it’s not adding up, CIHR is sticking to their story.
  2. When will the CIHR be implementing these new requirements for relevant grant programs, and how will this implementation be different from the trial policy rules?
  3. What’s the process for revisions to the TCPS, and how long does it take?
  4. When are we going to see the requirement to make individual-level/micro/”raw” data publicly available? The item listed above in 5d, which currently has no teeth, only requires aggregate data deposit. What does this mean? How aggregate? Does this have to include all adverse events? We need to be able to reanalyse this data to look for harms to specific groups. This is one of the most important parts of the scrapped trials policy, and there is no mention of it in the new statement from CIHR.

I think the international attention and public pressure on CIHR over the withdrawal of the new trials policy likely contributed to these developments, which seem like a step back in the right direction. However, without teeth in the current requirements, and a return of the publicly-accessibly micro-level data archivng requirement, it seems like 3 steps forward, 2 steps back at this point.

-Greyson

Previous posts on this topic, in case you haven’t been following along:

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Filed under democracy, ethics, funding, government, Health, OA, research

BMJ article about the CIHR trials policy disappearance

More follow up from these previous posts about the surprise disappearance of the Policy on the registration and results disclosure of controlled and uncontrolled trials funded by CIHR.

Thursday, the British Medical Journal (BMJ) published a News article by Ann Silversides, titled: Withdrawal of clinical trials policy by Canadian research institute is a “lost opportunity for increased transparency.”

For consistency’s sake I must note my dismay that this BMJ article about open data is not freely accessible online. Open access is as open access does; journals who live in glass open access houses should be cautious about criticism, folks.

Since some readers of this blog undoubtedly lack subscription access to the BMJ, here are a  few choice quotes from Silversides’ article, interspersed with my commentary:

“The CIHR [Canadian Institute for Health Research] policy
certainly was leading the drive towards increasing transparency,”
said An-Wen Chan, a scientist with the Women’s College
Research Institute in Toronto and co-author of the Ottawa
Statement on Principles and Implementation of Clinical Trial
Registration and Results Reporting

If the institute’s policy is permanently rescinded, the result
would be “a lost opportunity for a federal funding agency to
make a statement that increased transparency is important for .
. . ensuring that publicly funded research has maximal impact,”
said Dr Chan.

I don’t know Dr An-Wen Chan, but I agree entirely. The policy seemed to follow naturally along the progressive path forged by the CIHR’s 2004 RCT registration policy and 2007 research access (OA) policy.

Trudo Lemmens, of the University of Toronto law school, said
the decision to remove the policy “sends a bad message.” The
TCPS-2 requirements are more general and vague than the CIHR
policy, and it is not clear who will implement and enforce
TCPS-2, he said.

Again, I don’t know Dr. Lemmens, but I agree that the rescinding of the policy sends a “bad message.”

Silversides also reports that:

The CIHR has recently been “in discussions” with Rx&D, the
trade association for Canada’s brand name drug companies, on
renewing the CIHR/Rx&D collaborative research programme
(which funds awards, grants, and clinical trials) and finding
ways “to improve the clinical trial environment,” Rx&D
president Russell Williams stated in an email.

I suppose what is an improvement to the clinical trial environment depends on your point of view. Making clinical trials more transparent, and thus more likely to be audited, by more sets of eyes, for human safety issues, seems to be an improvement to me. But if my primary concern was the ease of bringing new technology/product from trial to market, my perspective would likely be different.

Professor Lemmens, who has published widely on transparency
and clinical trials, said that at an international level, the
pharmaceutical industry has been critical of trial registration
and requirements about having to give details of results. He
speculated that “maybe it is not pure accident” that the CIHR
policy, widely regarded as pushing for more transparency in
clinical trial reporting, has been withdrawn “when there is a
clear push (in CIHR) to promote collaborative research with
industry.”

And this possibility that the timing of the trials policy’s disappearance might not be “pure accident” is exactly what we don’t want to think about when it comes to our national health research funder, with a mandate:

“To excel, according to internationally accepted standards of scientific excellence, in the creation of new knowledge and its translation into improved health for Canadians, more effective health services and products and a strengthened Canadian health care system.”

-Greyson

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Details: TCPS-2 vs the CIHR trials policy of 2010

Thanks to a few days’ time and some help from people with more experience reading science policy, I now feel that I can expand on my previous post about the TCPS-2 “superseding” the Dec 2010 CIHR trials policy.

First of all, I note that I am putting “supersede” in quotes not merely because it is a really cool word to which I wish to draw attention (although it is) but because the TCPS-2 was officially launched before (not, as I had previously thought, simultaneously with) the new Trials Policy, and as such, would not likely have been intended as a replacement for another policy that had not yet been unveiled.

Non-exhaustive list of differences between the TCPS-2 and the CIHR trials policy of 2010:

  • Unlike the TCPS-2, the CIHR policy required that the systematic review that justifies doing the trial be publicly cited.
  • TCPS-2 is specifically about clinical trials, whereas CIHR could be interpreted to apply to a wider scope of “controlled and uncontrolled trials.”
  • The CIHR policy required following the WHO international standards, whereas the TCPS-2 only requires that trials be registeres in registries that meet the criteria of WHO/ICMJE. Seems like a small distinction, but the difference is the minimum dataset required.
  • This one is kind of nitpicking/pointing out an oversight, but the CIHR required the name of the trial registry as well as the registation #, whereas the TCPS-2 only asks for the # (kind of useless without the name, and presumably they want the name too, but didn’t specify).
  • The CIHR policy took steps to prevent duplicate/multiple registration, whereas the TCPS-2 does not address this potential issue.
  • The TCPS-2 says that “Researchers should also promptly share new information about an intervention with other researchers or clinicians administering it to participants or patients, and with the scientific community – to the extent that it may be relevant to the general public’s welfare,” which does not require public disclosure. The CIHR policy required the data to be made publicly available to all.
  • Research design amendments (changes) require ethical approval under the TCPS-2. The CIHR policy required that amendments  to the research design be reported within 30 days after the ethics approval.
  • The TCPS-2 asks for “new risks” or “unanticipated issues that have possible health or safety consequences for participants” during the trial. CIHR policy did not ask for adverse event info until after the trial.
  • TCPS-2 asks for info that might merit or lead to early stopping of  a trial. CIHR policy wanted notification and public disclosure within 30 days of stopping a trial early.
  • The TCPS-2 tells researchers “to make reasonable efforts to publicly disseminate the findings of clinical trials in a timely manner by publications and by the inclusion of raw data and results in appropriate databases,” whereas the CIHR policy specified reporting guidelines (e.g., CONSORT for RCTs) and required reporting and public disclosure within 12 months of the end of the trial, building on the existing CIHR research access policy.
  • The TCPS-2 encourages researchers and institutions to publish results in a timely manner. The CIHR policy required public disclosure within 12 months and reserved the right to disclose the final report themselves within 18 months.
  • The TCPS-2 asks for “the inclusion of raw data and results in appropriate databases” whereas the CIHR specified what appropriate databases are and that both micro (aka “raw” aka “participant level”) as well as macro (aka “aggregate” aka “summary”) level data are necessary.
  • The TCPS-2 talks about ethics with regard to confidentiality clauses and PI access to trial data, whereas these issues were not addressed by the CIHR trials policy.
  • The CIHR policy talks about after-trial follow-up, including submission of any “severe adverse events or harm” to the publicly-available trial registry and a requirement to “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).”

Generally speaking, major differences are:

1) Insider vs public disclosure of information

TCPS-2 is concerned with sharing info with the research ethics board and “to other researchers or clinicians administering it to participants or patients, and with the scientific community.”

CIHR was concerned with reporting and disclosing info “to CIHR and the trial registry” – and the trial registry had to be openly accessible to the public.

2) Whether to specify how much should be reported, and how soon to report it

The TCPS-2 advises on ethical matters across disciplines. It makes few specific mandates as to timeliness or data specifics.

The CIHR policy was intended specifically for trials funded by CIHR, and similar to other funding policies could and did specify details of what kind of data should be reported (all, macro and micro), to whom (CIHR and a publicly accessible registry), and when (within 12 months of trial completion, or with some types of data 30 days of early stoppage of a trial).

TCPS-2  on its own vs. as part of a comprehensive approach

I’m not saying the TCPS-2 is bad. It’s pretty good, overall, and after years and years of collaboartive work and revision seems to do an admirable job of doing what it’s supposed to do – which is to set out general, interdisciplinary, national ethical guidelines, not details of practice requirements. Without specific procedural policies designed to instruct researchers in various disciplines, the TCPS-2’s appropriately limited scope leaves us with somewhat vague directions.

The two policies, the TCPS-2 and the CIHR trials policy of 2010, are clearly intended to complement with each other. As I noted before, the TCPS-2 specifically states 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.” (emphasis mine)

I continue to be very disappointed that the CIHR has apparently seen fit to retroactively withdraw their facet of this approach, and I do think that as a public agency they do owe the public a decent explanation of what happened here. What has been made publicly available thus far does not add up. As I have stated previously, there may well be valid reasons for killing the new policy on clinical trial data, but the lack of transparency around the policy retraction continues to be troubling.

-Greyson


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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

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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
  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.

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Evaluation, assessment, research & impact

Around the same time I noticed that a number of academic libraries were posting for new (or newish) “assessment librarians,” I went to a cool lecture by Dr. Eliza Dresang about a project teaming LIS researchers with children’s librarians to investigate impact of early literacy programming.

After the lecture, a local children’s librarian extraordinaire and I began a conversation – still ongoing – about assessment & impact research in public libraries. I’m a firm believer that in order to a) provide the best possible service to the community, and b) justify funding, libraries ought to be doing assessment beyond mere program evaluation.

Unfortunately, library school “research methods” courses seem generally weak, and there is limited professional development on research methods for professional librarians. Even excellent library programs often result in needlessly-biased evaluation reports that could have provided more valid evidence if only the methods have been stronger. Even senior librarians in public libraries confuse evaluation with assessment with research (yes there is ample grey area in there, but the terms are not synonymous), and fall into the trap of trying to demonstrate impact & value by counting things/measuring productivity.*

Adding to the challenge, few public libraries are intimately connected with professional academic researchers, and few librarians have the time to learn how to conduct unbiased program evaluations, let alone develop high-quality impact assessment skills.

In my mind, large public library systems should consider taking a page out of academic libraries’ new book and hiring internal research staff to demonstrate value and investigate impact. What’s more, government bodies that oversee libraries (e.g., the BC Public Libraries Services Branch) should be hiring staff to a) support library-based assessment & research, and b) coordinate, liaise with & conduct research on the value and impact of public library services.

I know that asking more more staff seems expensive, and there have been a couple of years of belt-tightening in a row at this point, but some of the best things the library sector could do to improve our ability to advocate for funding are to

  1. provide evidence of impact and
  2. ensure that services are relevant to the community

-Greyson

*To those nodding along with my concerns but unsure of how to move beyond these common problems, I recommend Markless & Streatfield’s Evaluating the Impact of Your Library, published by CILIP’s Facet Press. It does a great job of walking one through that process of mid-level assessment between basic program eval/library stats and full-fledged long-term impact research.

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Which is preferable: Invasive or Intrusive? (aka the Future of Canadian Census)

Back in July, when the kerfuffle over the long form census was fresh, I accused the Harper government of being disengenuous in their claims that changing the long-form census from mandatory to voluntary was due to privacy concerns over the invasiveness of the census form.

Recent permanent appointment of new Chief Statistician of Canada Wayne R. Smith (necessary due to the 2010 resignation of Chief Statistician Munir Sheikh over the census issue) and subsequent media coverage of Smith’s approach pretty much confirm that view.

Apparently Harper has asked Smith to “rethink” the census for 2016, specifically directing the Chief Statistician to look into how other countries conduct censuses. (Oh, you mean like this freely-available Sept 2010 article in Canadian Public Policy did?) The buzz that is arising from this directive is all about register-based methods that avoid mailing surveys to individuals at all. And this reinforces my assertion that the claims of concern over privacy are bogus.

Register-based censuses link administrative databases so that an individual’s profile can basically be mined for the answers to questions that would have been asked on a paper census. This is exciting for researchers and statisticians, because these registries are generally very accurate. However, for privacy advocates, giving the federal government carte blanche to link and mine federal databases is a matter of concern.

The Online Party of Canada is hosting a discussion on this topic in a  forum on their website. The original post notes:

At first glance, it would seem that most of the vital information collected by the Canadian long-form census questionnaire (2B) is already being collected, at least in part, via other governmental sources (i.e. federal, provincial, municipal, etc.):

●      Age (Q1), gender (Q2), date of birth (Q3) and most labour market activities (Q34-46) information can all be linked to our Social Insurance Number (SIN) and/or Canada Revenue Agency (CRA) data.

●      Citizenship (Q10-11) via Citizenship and Immigration Canada;

●      Place of Birth (Q9) and parents’ POB (Q25) via Provincial Birth Certificates or country of origin under the Immigration Act;

●      Mobility (Q23-24) via Canada Post (theoretically);

●      Education (Q26-32) via Provincial Departments of Education, School Boards and Post-Secondary Institutions;

●      Only a few questions related to: Activities of daily living (Q7-8), Household Activities (Q33), Language (Q13-16), Commuting (Q47) and Dwelling (QH1-H8) could not presently be answered from other sources.

But then asks:

How would Canadians feel about this alternative?

No more census. Save millions in tax dollars. More accurate data.

But our personal information would have to be linked and completely centralized. What types of mechanisms would we need to implement in order to insure confidentiality and protect ourselves from government misuse or abuse of data?

Now I’ve never heard of the OPC before, but these questions are right at the heart of the matter. The only thing  I can think of that they leave out is the question of whether inconvenient questions – questions not represented in official data and also those asking things the current government might not wish to collect – things such as self-reported ethnic identity or unpaid work hours – would be scrapped under a register-based census plan. Given that the unpaid work hours question was already scrapped (much to the chagrin of feminists), I expect this is not a large concern of the current government.

So, How do we feel? How would you feel about your medical records being linked to your tax filing and your hydro bills and your school records  and your motor vehicle records and your vital stats records and your address as listed with Canada Post and…a bunch of other things? How would you feel about a law requiring you to register all address changes with the government? Denmark astutely points out that registering your address with one central body is highly efficient. But do we trust our government the way Danes trust theirs?

The researcher in me loves the idea of the high-quality data we could get with a registry-based system. (The researcher in me is also skeptical that Canada could pull together anything like that for 2016!) However, there would have to be some serious safeguards (including updated ethical review and data stewardship processes) put in place for the privacy advocate in me to feel comfortable with it. I’d also have to feel assured that the increased data infrastructure would be available for non-governmental researchers as well as internal government use.

Last year Harper supposedly changed the census due to its invasiveness. But that’s not the right word. A lot of us were using the wrong word, because it appears that perhaps he’d like to entertain the idea of a more privacy-invasive process, as long as it would be less intrusive into our lives. No pesky, visible forms taking up our time. No census takers knocking on our doors, asking us annoying questions, making sure the population is well aware of what info the census is aiming to collect. Instead just a quiet government data-mining operation. Invasive (possibly more invasive than now), but not so intrusive.

-Greyson

ps – Incidentally, if you’re interested in reading it, the Globe & Mail has published a transcript of their whole interview with Mr. Smith, and it’s pretty enlightening. For example, until reading that I had no idea StatsCan is assuming there would be only a 50% response rate to the voluntary survey that replaced the long-form census. In this fascinating read, Smith says amazing things, including:

“The one thing we know with absolutely certainty is the response rate going to fall from making the survey voluntary.”

and

“But there is no guarantee this data will not be usable. There is no guarantee it will be subject to major non-response bias beyond the levels we’ve traditionally seen in the census.”

He also denies that there is *any scientific reason* to expect non-response bias from groups such as Inuit, non-English speakers, or immigrants.

Wow.

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Online consultation on metered internet: Need we say more?

Now that the NDP, the Liberals, Green Party and Conservative Party(including the PM’s office and Minister of Industry) have all suddenly come out against the CRTC’s usage-based billing ruling, the CRTC has announced that they will be reconsidering and are seeking comments/submissions. Online.

It almost feels like I could end this post there, as conducting an online consultation about whether the public should be rationing their Internet usage is irony enough, is it not?

But I suppose I should post the consultation details:

  • Notice #2011-77 is here
  • It asks specifically for comments about the billing practices for wholesale residential high-speed access services, so they’re concerned here about the impact on small ISPs who get their bandwidth from the big guys, not necessarily on the impact on the public/consumer, libraries, Internet cafes, Netflix or innovation in Canada
  • In order to comment you have to register by Feb 22 and submit commenst by March 28.
  • This is what they’re looking for, in their own words:

Comments are invited on:

i.   How best to implement the following principles with respect to large incumbents’ wholesale services used by Small ISPs;

a.   As a general rule, ordinary consumers served by Small ISPs should not have to   fund the bandwidth used by the heaviest retail Internet service consumers.

b.   It is in the best interest of consumers that Small ISPs, which offer competitive alternatives to the incumbent carriers, should continue to do so.

ii. Whether the Commission should set a minimum threshold level for the sale of bandwidth by large incumbent carriers to the Small ISPs and, if so, what should it be;

iii. Whether it is appropriate to hold an online consultation as part of its review; and

iv. Whether it is appropriate to hold an oral public hearing as part of its review.

I encourage you to submit something. And to keep a copy, in case it gets lost the way my copyright consulatation submission did, because if you keep a copy it can get found the way mine did, too. Here’s the first example I’ve seen of someone (Jason Koblovsky) posting their UBB submission.

Technically you can submit comments via mail as well, but you have to dig to find out where & how. “Regular” people who might want to comment will presumably go the website and click on the “submit” button, fill out the online form, and be done with it. I wouldn’t be surprised if the CRTC went ahead with point iii above and held a full-on online consultation process, complete with streaming video from Nik Nanos et al.

Fortunately, you don’t have to worry about how much bandwidth uploading your submission will eat up. Yet.

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A Day in my Life, with Census Data

To follow up on my last post about census data, and a great conversation with some local librarians a couple of weeks ago, I decided to try to brainstorm the ways census data impacts my daily life. I’m not talking about how I or my colleagues might use it in research, but actual, concrete people, places and things in my day-to-day that would not be the same without good data from the long-form census. The hyperlinks below track to news articles or open letters to the government about the importance of the long-form census for specific reasons. Some of these links are PDFs.

I wake up in my housing co-op (built with support of gov’t programs for affordable housing, informed by data on income and housing).

Wave to my hearing-impaired neighbour and her service dog (supported by disability advocacy based on the census and the census-based Participation and Activity Limitations Survey).

Bike to my bus stop, on bike routes planned with information from the census.

Take transit to work – on an express route planned based on commuting time/mode data and housing density information.

If I arrive a few minutes early, I might stop by a coffee shop on my way in to the office. The store’s business plan was informed by census data, which helped the business owners know they had a market in that neighbourhood.

Arrive at work, which for me and over 12,000 others at my institution alone, is at a University.Universities rely on long-form data for planning programs and projecting enrollment.

Over lunch, read the news. Reporters frequently use publicly-available data from the long form census, as they did in this article this weekend.

Perhaps on the way home I visit some sort of health-care provider. It’s not unheard of. Health services planners and health care provider professional associations use census data to help plan efficient and community-responsive services and care. Medical researchers also rely on census data.

Pick up child at (French language) school and take him the public library (which has a convenient storefront location and services tailored for our community based on the census community profiles)

On our way out of the library/community centre, admire the new mural put in by local artists. Cultural councils and government arts programs rely on census data to provide information about cultural workers in Canada, who are often non-traditionally employed and under-represented in other types of counts.

Arriving home, say hi to our neighbours and admire their new foster-baby. They are foster parents, and the social work system depends on census data to identify and respond to community needs.

After dinner, attend a co-op meeting at which we discuss our federal grant application for energy-efficient upgrades to our building. Such programs for home renovations are generally informed by data about home repair needs and community housing needs.

Your day is different from mine. Perhaps during your day you interact with census data by visiting your religious institution. Perhaps you participate in an immigrant settlement program. Perhaps you are job-seeking or retraining after a layoff. Maybe you do unpaid work to care for an elder in your community or volunteer or eat at a soup kitchen.

To sum up, without good census data:

  • My house might not exist, or
  • might not be getting the needed repairs to the building envelope.
  • Disability advocacy would be set back.
  • I might not have bike routes or
  • convenient public transit in my neighbourhood or connecting to my workplace.
  • Local businesses would have less accurate business plans and thus be more likely to fail.
  • Universities would have a harder time planning for the future.
  • News reporters would lose an accurate source of information.
  • Health services would be less well-planned for my community’s needs.
  • Medical research would be set back.
  • We might not have so many French-language public schooling options in our predominantly-anglophone province.
  • Library planning would be a challenge.
  • Artists and cultural workers would be even less well supported than they already are.
  • Our social work system would be weakened.

And that’s just the things I can think of in one day of my little life.

What things in your life are impacted by census data?

-Greyson

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