Category Archives: ethics

Fact-finding: Not an ethics-free zone

Hey folks – I’m popping back in here to guest-post today. Still doing the PhD student thing and still won’t be back around regularly. But here’s something I thought we in libraryland should be thinking about. -Greyson

Canadian author/storyteller Ivan Coyote recently published an article about the importance of respecting people’s preferred names and pronouns. The article opens with the following anecdote:

A couple of weeks ago I got an email from a young woman, a college student, who claimed that her professor had assigned her entire class a special little assignment, for extra credits, for students who could track down my legal name and bring it to class. This young woman had tried and tried, she said, to find it online, but couldn’t, and she really wanted those extra marks. Would I be so kind as to just tell her?

I took a deep breath. I was flabbergasted, skin crawling with chill fingers at how totally creepy this felt, an entire college English or writing or queer studies or whatever class assigned the task of violating my privacy for extra credit at school.

Go read the article, really. It’s good. But not what this post is about.

This post is about another article, “Teaching Students to be Rude,” that was written in reaction to Coyote’s column. In this response article, journalist Bert Archer does two noteworthy things that we need to discuss.

  1. Asserts that fact-checking (or, in LIS-speak, information seeking) is a nearly “ethics-free zone” and certainly impolite and invasive
  2. Argues that librarians are very useful because we can and will find anything

You may be wondering what the connection is between librarians and some alleged college student trying to find out Ivan Coyote’s birth name. The connection is Bert Archer’s mind. Although Coyote doesn’t say that the student was a library student (and, in fact, implies the contrary, as library science is a grad degree in North America), Archer assumes it.

Why would Archer assume that it was a library student doing this invasive information-seeking? Because, in Archer’s words,

“I think this sort of assignment is exactly what I expect from librarians.”

Think about that for a minute. Let it sink in. Teaching students to dig up people’s private personal information is “exactly what I expect from librarians.”

Scary.  

We may need some librarian PR here. But not the usual kind. Archer got the “not everything is on the Internet” memo. His experience as a journalist has taught him to value the information retrieval expertise of librarians. He knows that, even in the era of Google and Wikipedia, “Unsearchables remain.” He writes,

“Reporters at the Toronto Star, for instance, know how useful librarians can be. They can ask their in-house librarians anything, and get an answer back quick.”

I am flattered by Archer’s (only nearly true) assertion that librarians can find anything. However, librarians also have ethics and are both students and creators of information policy. Library associations have taken more than one major professional stand in favour of protecting personal privacy.

Skill without ethics is not my librarianship.

It’s not the American Library Association’s librarianship, either. Yes, “Access” is the first of the ALA’s listed Core Values of Librarianship, but it’s immediately followed by “Confidentiality/Privacy.” Also among the core values on the list are diversity, the public good and social responsibility – all items that might give pause to an information professional digging up the birth name of a gender variant individual just to feed the public’s curiosity. The Code of Professional Ethics for Librarians is also offered for guidance when values – e.g., the free flow of information and patron privacy – may conflict with each other.

Archer implies that, were he writing a biographical dictionary entry on Coyote, he could ask a librarian to find out Coyote’s birth name. Honestly, many librarians (especially given a decent research budget) probably could obtain nearly anyone’s birth name, medical histories, library borrowing history, and various other bits of private information. However, would we provide that information to be published? I’d like to think that most of us would not. I would sincerely hope that if Archer asked his librarian to find Ivan’s birth name to publish, the librarian would contact Ivan and subsequently let Archer know that it was inappropriate to include such information in the entry.

Digging up and/or publishing someone’s private personal information isn’t, as Archer states, “Rude.” It’s a violation of privacy. Rude is interrupting someone, or not saying “excuse me” after you belch. Librarians are not known for being rude. They’re particularly not known for violating people’s privacy. And I think it’s a matter of concern that Bert Archer, and now perhaps many people who read his column, think they may no longer be able to trust their librarian with that potentially-embarrassing health or legal question they have.

Let me set the record straight here. Dear world: If you disclose to your librarian, in her/his professional capacity, something private about yourself, we are duty-bound to keep your confidence. Even if you are a public figure, famous author or movie star.

Not because it would be “rude” not to. Because we have professional ethics.

I understand that I will likely differ from Archer on many questions of ethics, as he also thinks it’s just fine and part of the job for a journalist (or, presumably, a librarian) to “ask a heaving mother for a picture of her just raped and murdered child.”

I hope I don’t differ from the majority of librarians on such questions, though.

 -Greyson

Disclosure: Ivan Coyote is an acquaintance of mine. Don’t know if having met in person, or having overlapping social circles, makes a difference here, but there it is in case it does. 

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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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Niceness, Helpfulness & Ethics: Feedback edition

The Canadian Health Libraries Association/Association des bibliothèques de la santé du Canada has a mentorship interest group. While I can be skeptical about institutional “leadership training” and am in that awkward adolescent phase of my career in which I’m not exactly new anymore but not quite senior enough to be a mentor, the idea of being connected with an experienced Canadian health librarian seemed low-risk and potentially positive, so I signed up. Turns out that it’s actually been quite nice to be sent profession-related conversation topics on a monthly basis, and it’s been quite enjoyable to get to know my assigned mentor better (someone I might not have really connected strongly with otherwise, but with whom I have a surprising amount in common).

This month’s “check in” from the mentorship interest group is about “Compliments and criticism,” and refers readers to the recent Harvard Business Review blog post: “Don’t Be Nice; Be Helpful.” The jist of the article is that withholding constructive criticism may be “nice,” but it’s certainly not helpful to your colleagues.

I’ve written about “the dreaded librarian niceness” here before, and the email conversation with my CHLA/ABSC mentor brought up some points regarding criticism and niceness that I thought were worth copying to this blog.

There are two experiences, both of which I feel very fortunate to have had, strongly inform my approach to feedback giving/getting. The first is my classical music training, and the second is anti-racism organizing.

Classical Music Studies

The couple years before I trained in conservatory, when I was a high school student taking music lessons, I had an amazing music teacher who paired me with another student for double lessons. Not only did this give us extra lesson time, and create a bond between the two of us (who were necessarily also competitors at auditions all the time), but he taught us how to teach by having us constantly give constructive feedback to each other. I remember him early on telling us to think of 3 things the other person did well in the piece she just played, and then 3 suggestions you have to make it better. He modelled this type of feedback, and I still use this style with regularity.

What does this mean in practice? I try always to give positive feedback in at least as large a quantity as the negative, and to always lead with the positive, whether it’s giving feedback on a colleague’s grant proposal draft or student term paper comments. I don’t mean being disingenuous about how great something is; in my experience there are always some positive elements in any performance if you just look for them – and retaining the good parts is as important as improving the weak parts. When I went to conservatory and was exposed to the big bad world of the classical music industry, in which cutting, negative comments were depressingly the norm (one adjudicator’s comments on my first recital were, in totality, “The Beethoven was better [then the preceding piece], but still not good.” !!) I gained a deeper appreciation for the “civilized” and constructive way I had been taught to provide critique.

Anti-oppression Activism

Later on, I became very involved with anti-racism organizing, something I carry on to this day in various ways. This was yet another forum in which criticism could be very nasty. There are a lot of people dealing with a lot of hurt and anger and also guilt when you’re talking about societal structures of privilege and oppression.

As a person with white-skin privilege, it was really important for me to learn to self-criticize in a humane way (productively, not merely berating myself for past wrongs) and to learn to accept anger and negativity from people of colour about things I could not “fix.” Trying to be a white ally to people of colour in various contexts sometimes means hearing awful things, or being excluded for very good reasons that might nonetheless hurt my ego.

Learning to listen to people’s criticism, and even anger, toward me and the groups to which I belong, without immediately reacting, was a big thing for me. Even if I think the accusations hurled at me are unfair, I owe it to a member of a group I oppress (even if just by default, by being a member of a more privileged group) to really listen to what they say. And then consider later how I might respond.

This means suppressing the urge to immediately defend myself or my family or my school/work/co-op/etc., and the desire to “fight back.” Because the accusations weren’t really what I wanted to be fighting. Even if they were based in a misunderstanding or incorrect rumour, there was something important in them that could teach me about oppression and how to untangle it.

This is harder to explain, and to quantify, than the “3 positive + 3 negative comments” rule, but also really important and influential with regard to how I handle criticism. Even if a critique feels like an unfair attack, I try to listen to it and figure out what it’s really about, and what in the criticism is useful for my learning.

In my Current Work

I should note that both of these lessons about criticism are lessons I try to pass along in my classroom when I am teaching. At my current librarian-job workplace, the research team with which I am primarily affiliated works hard to create a constructive environment in which to workshop each other’s work. It’s not perfect – I think most of us are still a bit too hesitant to throw really rough ideas out there, which is likely a side-effect of the hierarchical structure of supervision (i.e. not wanting to look dumb in front of your boss), and a challenge of the interdisciplinary nature of the team (i.e. those from other disciplines might not understand my half-formed idea). But we do also have a fair bit of informal collegial workshopping and feedback as well – we edit each other’s papers all the time, for example.

The interdisciplinary nature of the team really highlights the different approaches to criticism. Economists, for example, can apparently be very nasty in criticism (not our economists, but ours are renegade economists who swap war stories of econ conference presentations)! In my experience, librarians (especially public librarians) tend toward being overly “nice,” but niceness is not the same as respecting a person’s rights and behaving in a just and equitable manner.

In a conversation with another blogger, Katie, here a few years ago, I wrote, “Nice is culturally based and thus culturally biased. Nice to me means exclusive to others who don’t share our cultural norms. Nice to my colleague means not challenging her when she says something racist in a meeting. Sometimes being ethical means having to be not-nice to people.” This still pretty much sums up  my problem with “the dreaded librarian niceness” and hits on some of our disciplinary challenges with constructive criticism.

-Greyson

recent Harvard Business Review blog post: “Don’t Be Nice; Be Helpful

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Filed under ethics, inclusion/exclusion, LIS education

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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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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Census Privacy is the Harper gov’t’s Girl-Power Barbie

I’m going to go ahead and assume anyone who’s reading this blog knows about the Canadian government’s recent decision to scrap the mandatory long-form national census, and attempt to replace it with a voluntary “National Household Survey” (NHS).

I’m going to assume you all know that the information from long form census is used for all kinds of governmental and non-governmental planning, including social programs, financial allotments for various uses, and, yes, library service planning.

I’m going to assume that readers all have the basic statistical proficiency (that the leaders of the Conservative party apparently lack) to know that a mandatory survey with near 100% compliance given to 20% of the population will almost certainly have greater validity that a voluntary survey of 33% of the population, because even if the absolute numbers of responses are the same under both surveys the response rate in the latter will almost certainly be lower and thus reflect self-selection/non-response bias. This, by the way, is a neat way to create policy-based evidence.

I’m also going to assume you know that the Tories are holding fast to their position, even in the face of the Chief Statistician of Canada’s resignation and overwhelming outcry from people who are not always allies on the issues.

Throughout this whole kerfuffle, the Harper government has insisted that the change is due to privacy concerns. They insist that the long form is too invasive. That people think the state should not be requiring that individuals report such personal information as the number of bedrooms in their dwellings and how we travel to work. Etc.

You probably also know that little evidence has been produced to back up the claim that many people are concerned about the invasiveness of the questions on the long-form (although in the most recent 2006 census there were refuseniks on the basis of the gov’t subcontracting census work to Lockheed, an issue that is going unmentioned today).

Privacy, eh?

Privacy, my foot! This change has nothing to do with privacy. Scrapping the long form does incredibly little to improve privacy of Canadians, and in fact may even make our personal data less private and secure.

Here’s some info about the long-form census, and voluntary StatsCan surveys, in terms of privacy. All of this is written to the best of my knowledge, so if anyone works with census data or has StatsCan connections and can clarify or expand on any of the below points, please do let me know.:

Public Release of Data

Full census data is normally released to the public after 92 years. Since the passage of S-18 in 2005, there has been an opt-in check box on the census, which must be checked in order to release that data after 92 years. Opt-in, while frustrating to researchers and genealogists who wanted opt-out instead, is a pretty high standard of privacy protection. Voluntary surveys are not released to the public, ever. Thus, it would seem that the NHS would be more private, 93 years from now, than the census. Or, rather, it would seem so if Tony Clement hadn’t assured us that they were changing things so the NHS will also be available after 92 years No word as of yet on whether the NHS will have an opt-in box.

Commercial Interest Intervention

Commercial firms do not have access to the census planning process. Commercial firms as well as non-profit researchers may purchase modules  for many voluntary surveys from Stats Can (e.g., the Canadian Community Health Survey), however. Should the long form census remain a voluntary survey, I would not be surprised at all if business were eventually granted access to this survey too. In fact, I would expect it, if the survey loses the “sacredness” of the National Census.

Privacy Safeguards

While we might never be fully confident that stewards of any data could never possibly misuse it, the census is subject to privacy safeguards above and beyond other surveys. Disclosure for any purpose prior to the 92-year blackout period would be subject to fines and penalties under the Statistics Act, which requires StatsCan employees working with this data to be sworn to secrecy. Unlike other StatsCan surveys, the Census is not available to researchers outside StatsCan as a full microdata file. It is also not eligible to be linked with other databases, unlike other data sources including other StatsCan surveys. Again, should the long-form census turn into and assume the norms of a voluntary survey, these safeguards will likely be lost.

The Short Form & Privacy

The still-mandatory short form, which nobody appears to be speaking out against, provides plenty of information on which to base discrimination (name, age, sex, marital status including whether partner is same or opposite sex, first language learned). Sexual orientation is pretty personal and invasive to ask everyone to disclose on a mandatory basis, if you ask me — perhaps more so than many of the questions on the long-form. First language-learned gives a lot of ethnicity & immigration information, even without the long form asking about where your ancestors came from.

As comment poster LindL on the Worthwhile Canadian Initiative blog writes, of the move to scrap the long form but retain the short form,

“If it’s wrong, it’s wrong. What you’re arguing is equivalent to ‘Stealing is wrong. So I’m not going to steal a car, instead I’ll just steal a bicycle’.”

Harper’s Privacy = Girl-Power Barbie

The Harper government is using privacy as a red herring here. Calling these changes to the census good for privacy is like calling a “girl power Barbie” feminist – in other words disingenuous cooptation of a real issue in order to improve market share. I fear that to take the Harper/Clement argument at face value – that this change is about privacy – is to play right into their hands.

What is the Harper government’s interpretation of Census privacy? Well, apparently that applies to the government need/ability to make private and unseen the concerns of Canadians regarding the census changes! The long-form census, although second top rated issue by participants in the recent digital economy econsultation, was buried on the site(Although I wouldn’t vote for this very specific issue to be the top concern of Canada’s digital economy, I am quite impressed that it got so many votes, continuing to add votes and hold second place *even after it was buried* on the site and could only be accessed via a direct URL.)

As a privacy and social justice advocate, the long-form census is not what I am worried about. There are a lot of less secure sources of data out there, with less redeeming social value to worry about. For me, the benefits of  responsible, privacy-sensitive data collection and stewardship sometimes outweigh the risks, but I can respect opposing opinions.

It’s one thing if you oppose any government collection of personal data. That I can respect. I think it’s a perspective that usually comes from a position of privilege, and I don’t take this stance myself, but I can respect it if you think the long form should be scrapped along with a whole bunch of other things, on principle. But THIS? Only scrapping the long form? That is not about privacy. If you want to campaign for the end of all government information gathering, fine, but the census is really not the place to start. And don’t think for a moment that the Conservative government is on your side  an end to government information-gathering

However, in a practical sense, this change is not improving the privacy of Canadians in any measurable way, and is in fact eroding the privacy of those who answer the voluntary survey as well as hurting those who don’t by virtue of providing a skewed and unreliable demographic profile of Canada.

Silver Lining?

On the upside, if they do go ahead with this plan to convert the long-form to voluntary National Household Survey, I think it’s likely that whoever is in power in 2016 will change it back. In that case, while we’ll lose the 2011 data for planning and research purposes, it will be interesting to see how and to what extent making a survey voluntary creates deviations from trends (i.e., we may be able to tease out which subgroups will & won’t respond to a voluntary survey). A natural experiment in the making!

-Greyson

ps – For whatever it’s worth, I agree with Sandra Finley that the census software etc should not be subcontracted to Lockheed Martin – much like I do not think the BC MSP data should be with Maximus. But that’s another kettle of fish.

pps- Tracey over at datalibre.ca has been researching the census as part of her PhD research and has been chronicling this recent debacle quite comprehensively.

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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:

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

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