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Revised Helsinki research guidelines include pre-registration for all research (not just RCTs)

Dolphin

Senior Member
Messages
17,567
The new guidelines are here: http://jama.jamanetwork.com/article.aspx?articleid=1760318.

I just read this blog on them by James C. Coyne


Revised Ethical Principles Have Profound Implications for Psychological Research

http://blogs.plos.org/mindthebrain/...ound-implications-for-psychological-research/

Extract:
One provision is that the design of every research study be preregistered in a publicly accessible place before the first research participant is even enrolled. The requirement is that investigators will have to commit themselves publicly to basic features of their designs, including numbers of research participants enrolled and the primary outcomes on which the efficacy of the invention will be evaluated. They are allowed to make subsequent revisions, but any revisions have to be recorded, along with a preservation of what was originally proposed.


Also (this is a quote from the revised Helsinki ethical guidelines themselves):
Paragraph 36 states
Researchers, authors, sponsors, editors and publishers all have ethical obligations with regard to the publication and dissemination of the results of research. Researchers have a duty to make publicly available the results of their research on human subjects and are accountable for the completeness and accuracy of their reports. All parties should adhere to accepted guidelines for ethical reporting. Negative and inconclusive as well as positive results must be published or otherwise made publicly available. Sources of funding,institutional affiliations and conflicts of interest must be declared in the publication. Reports of research not in accordance with the principles of this Declaration should not be accepted for publication.
 

alex3619

Senior Member
Messages
13,810
Location
Logan, Queensland, Australia
Let’s have no illusions. There are a lot vested interests in current editorial practices, but now we are better armed to challenge them, with an ethical code that declares that what we want is not only best practices, it is what is ethical. That in itself is a game changer.
 

Simon

Senior Member
Messages
3,789
Location
Monmouth, UK
Wow! Thanks @ Dolphin, James Coyne and those who produced the revised Helsinki declaration.


One provision is that the design of every research study be preregistered in a publicly accessible place before the first research participant is even enrolled....

Negative and inconclusive as well as positive results must be published or otherwise made publicly available.
...Reports of research not in accordance with the principles of this Declaration should not be accepted for publication.
That would wipe out almost all of the CFS literature if applied retrospectively. Hopefully it will improve things going forward.



 

biophile

Places I'd rather be.
Messages
8,977
Coyne said:
They are allowed to make subsequent revisions, but any revisions have to be recorded, along with a preservation of what was originally proposed.

Such as the recovery rates in the PACE Trial as originally defined? :)

Although on second reading, this probably means a record of the original protocol, not an analysis of the data.