Category Archives: funding

How academic libraries annoy academics

Here’s a story I’m telling because I think libraries need more allies in the academy. As a librarian-slash-researcher-slash-professor I have these weird insider/outsider (or emic/etic) experiences with academic libraries from time to time. In these experiences (here’s one from last year) I can absolutely rationalise why libraries as institutions are behaving the way they are, yet I am also acutely aware of how these behaviours serve to irritate and even alienate academic faculty members based outside the library. The faculty members where I work my research-librarian job value librarianly expertise. They also pretty much never set foot in any of the libraries on campus, to my knowledge. I think this story exemplifies the reasons behind this behaviour.

A little while ago, I  got a revise & resubmit decision on a manuscript under review. As part of the revisions, I needed to find a couple of citations  for something I’d written. I knew what source I wanted to use, and checked the book’s availability in the OPAC. Its status was “available,” so I schlepped across campus in the rain (of course) to get it. However, the book was not on the shelf.

I logged into the nearby library computer terminal to verify that the book was still supposed to be available. This process took me 4 minutes of standing there waiting for the login to load, authenticate and update software. I checked the record. It still said “available.” I second-guessed myself and figured maybe I’d just missed it, so I decided to go back to the shelf and look again. In order to do this I had to log out of the computer to protect my private library account information that I’d had to input as part of the 4-minute process to check the book’s availability status. Back to shelf. Still not there. Checked all carrels and book trucks on the floor. Nowhere to be found.

So, in an attempt to be helpful, I logged back on to the computer terminal and eventually clicked the “report a problem” button on the record’s display. In the form provided, I explained that the book, while listed as available, was not on the shelf, and that given that I didn’t find it lying around anywhere on book truck/carrels or anything on the floor, it might merit placing a trace on the book so it could be found and/or be labelled lost/missing and replaced. I added that it’s was a fairly hot new volume, so I was sure I wouldn’t be the only one looking for it.

Then I logged out and left the library, of course getting caught by the gates on my way out because any public library books in my bag trip the academic library gates all the time and vice versa.

Got back across campus to my desk. Electronically, without leaving my seat, and using Google rather than a library database, I found an openly-accessible article or two that would suffice. Then I received an email from the library, thanking me for reporting the missing book and informing me that requests to have books traced have to be made in person at the circulation desk at the appropriate branch where the book should be located.

Are you kidding me?

I was feeling pretty patient, if disappointed, up until this point. But, first it’s raining (not the library’s fault!). Then, the book that’s supposed to be available isn’t there (these things happen…). Then the dinosaur computers suck 10 minutes of my time logging in and out to verify the status of the missing book and report it missing (okay, this is getting annoying and why does the library still use computers with floppy disk drives in them?). And now you want me to walk back across campus in the rain to go wait in line at the circulation desk to tell you the information I already reported to you? (This last bit is where I run out of rationales…um, perhaps someone frivolously made up and emailed fictitious trace reports once upon a time?)

I didn’t file the report. Sorry. Maybe the next person who fails to find this “available” book will do it. Not me. I have work to do. I’m on a schedule. I’ve already located two freely accessible substitute resources online and ordered a copy of the book I wanted from an online book retailer.

This is why people who have the means to do so avoid going into the library. Because the library is stuck in archaic systems that suck time. And those systems are presented as normal. When you’re grant-funded, or you’re racing the publications clock for tenure, time is money. Spending half an hour or more wandering back and forth around campus with nothing to show for it, all because electronic systems of communication aren’t yet in this century, is not normal to everyone. And it’s certainly not normal for the most productive faculty members on our campuses – those whose voices could be the most meaningful as allies.

I want my faculty colleagues to be advocates for our university library. So I do what I can to give them warm fuzzies about it, pointing out new acquisitions in their areas, noting that online access to the Journal of Important Stuff is brought to their desktop by the library, etc. But some days the library doesn’t make this easy for me. Some days I’m afraid to tell them too much about the library, in case they actually try to use it and have an experience like the one above.

I absolutely know there are budget constraints, time constraints, people-power constraints and bureaucratic time-suck constraints on academic libraries. I can explain why any given problem with the library systems might exist. But I can’t make archaic systems less frustrating and more worthwhile for people who have the option to avoid contact with the library most of the time. And those are the same people I really want out there speaking for the importance of the library. What a conundrum.

I’ve been sitting on this post, mulling it over for a while. I haven’t worked in a library in almost 5 years. Maybe I’m off-base here. Maybe academic libraries aren’t concerned with how the power faculty at their institutions perceive them. Maybe it’s all about the students and the have-nots of academia these days. Maybe it should be. I dunno. I do think libraries are missing out on opportunities to win powerful allies, but perhaps this is a deliberate move? Maybe you readers have insight to share?

-Greyson

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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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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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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.

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