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Well, it appears I clicked send before the reminder of what is in the Declaration of Helsinki (thanks Trish!). Patricia, I wonder if you wish to comment on how that squares with trainee human subjects research? It seems quite clear and doesn't make exceptions.
Rich

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From: [log in to unmask]
Date: Fri, 11 Mar 2011 13:03:39 +0000
To: <[log in to unmask]>
ReplyTo: [log in to unmask]
Subject: Re: unpublished research - is it ethical

I offer a clarification. While it is true that an ethics committee could require trial registration, trial registration generally occurs because of other reasons like drug approval agency requirements and journal editor requirements. Human subjects regulations and principles don't specify registration.

Perhaps more importantly, although some registries allow registration of observational studies, it is usually the case that a requirement for registration is limited to trials and not the vast amount of other human research. So in the end it is incumbent on the investigator to disseminate their work in some way or another, to at least make it available.

Best
Rich Saitz

Sent from my Verizon Wireless BlackBerry

From: Tamara Kredo <[log in to unmask]>
Sender: "Evidence based health (EBH)" <[log in to unmask]>
Date: Fri, 11 Mar 2011 09:08:11 +0200
To: <[log in to unmask]>
ReplyTo: Tamara Kredo <[log in to unmask]>
Subject: Re: unpublished research - is it ethical

Hi all,
I believe that the role of the ethics committee is to ensure that the proposed research be prospectively registered in an accessible/ search-able clinical trials registry such as www.pactr.org or clinicaltrials.gov.
In this way,  work that is not published (and there are many reasons for this), may be identified by others in a transparent process.
This helps in two ways - avoiding unethical duplication of research and the ability to share results and information amongst researchers. 

best wishes
Tamara

Dr Tamara Kredo
South African Cochrane Centre,
South African Medical Research Council
cel  +27 84 588 0388
tel   +27 21 938 0508
fax  +27 21 938 0836



On Fri, Mar 11, 2011 at 4:28 AM, Jordan Panayotov <[log in to unmask]> wrote:
Yes Richard, you are right.

However, this different direction is about something which is also important for everybody: academic & non-academic authors, users of the new knowledge, and tax payers who foot the bill in the end from both sides: (a) creating the knowledge (academic grants) and (b) the use of it for the benefit of the public (public health and healthcare).

What is the position of BMJ Group for acknowledging of original works from non-academics in the publications of BMJ Group?

Does BMJ Group leave this only to the conscience of the authors, or is it something actively required?

What happens if an author of earlier original work informs BMJ Group that his moral rights have been infringed by a later publication in BMJ Group?

All the best,


Jordan

********
Jordan Panayotov, MEc, MPH (Health Economics)
Director
Independent Centre for Analysis & Research of Economies
Melbourne, Australia
www.icare.biz
[log in to unmask]



----- Original Message ----- From: "Richard Saitz" <[log in to unmask]>

To: <[log in to unmask]>
Sent: Friday, March 11, 2011 12:02 PM
Subject: Re: unpublished research - is it ethical



Seems to me the issue here is not about publication in journals.

When research is done there are risks to participants. Those risks are only
justified if there are benefits (to them or to science). If the research
results are not available to anyone then they cannot benefit anyone (beyond
those in the study). If they cannot benefit anyone else, then the risk of
the study was not justified. (an internationally accepted ethical
principle).

One can make a solid case for peer review (not that it is perfect but it is
difficult to argue that zero review is a better system for vetting
scientific results).  But the issue here is not (in my view) publication in
peer review journals.  The ethical issue is making the results available
because if that is not done, the risk was not justified (and one could
ask--why was it done if not to share it).

One might imagine doing a study and telling participants---we will do this
study but we will never publish the results. Anywhere. Because we don't
think peer reviewed journals are good. We will keep them secret. Or, we wont
share them because we are too busy to write them down...

Would the participant agree? Should they? Is that ethical? And to return to
the focus of the listserve, what is the impact on systematic reviews that
try to determine the efficacy of interventions when such studies are not
reported? (they become either useless or unknowingly biased...)

Best
Rich Saitz



--
Dr Tamara Kredo

cel  +27 84 588 0388
tel   +27 21 938 0508
fax  +27 21 938 0836

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