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PACE trial: fraud or incompetence?

Laelia

Senior Member
Messages
243
Location
UK
As I have been saying for years, you cannot demonstrate intentions without a paper trail or whistle-blower. This might well be the paper trail.

Yes. I gather that this has now become our most crucial piece of evidence demonstrating intent to deceive.

Scientific misconduct can be demonstrated without an intent to deceive, I think. Fraud cannot.

This is where I'm getting confused. I didn't think that scientific misconduct could be demonstrated without an intent to deceive? Sorry if I'm misunderstanding.

I wonder if we can directly lodge a complaint with the MRC? If not, then who could?

We should definitely look into this.

[Edit: The reason for my confusion was because the Medical Research Council (MRC) definition of scientific misconduct posted earlier in this thread is innaccurate. Please see here for the correct MRC definition:
http://forums.phoenixrising.me/index.php?threads/pace-trial-fraud-or-incompetence.50183/page-7#post-832589]
 
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alex3619

Senior Member
Messages
13,810
Location
Logan, Queensland, Australia
I didn't think that scientific misconduct could be demonstrated without an intent to deceive?

Scientific misconduct can occur just by doing things wrong. That does not have to be deliberately wrong. The paper you cited earlier by Gupta discusses this -
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3700330/#ref4

Misconduct may not be an intentional action, rather an act of poor management. It also includes failure to follow established protocols if this failure results in unreasonable risk or harm to humans.

Misconduct could also be due to innocent ignorance like backdating the subject's signature on a consent form because the subject forgot to date the form initially or discarding source documents after accurate transcription or even creating source documents from case record forms.

The most common types of misconduct in clinical research are: Failure to follow an investigational plan; inadequate and inaccurate records; inadequate drug accountability; inadequate completion of informed consent forms; failure to report adverse drug reactions; failure to obtain and/or document subject consent; failure to notify an Institutional Review Board (IRB)/Ethics Committee (EC) of changes/progress reports; failure to obtain or document IRB approval.

versus fraud -

Fraud is an intentional deception made for personal gain or to damage another individual, for instance, intentionally falsifying and/or fabricating research data, and misleading reporting of the results.

it does not include poor research unless this encompasses the “intention to deceive”

Falsifying data means altering the existing records. It is the deliberate distortion or omission of undesired data or results.
 

Laelia

Senior Member
Messages
243
Location
UK
The paper you cited earlier by Gupta discusses this -

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3700330/#ref4

Unless I'm going completely crazy, I don't believe I ever cited this paper. I have never seen this paper. Their definition of scientific misconduct seems to be a lot less strict than MRC definition. This would make it a lot easier to prove misconduct occurred in the PACE trial.

The second description of fraud that you posted is also what the MRC use to scientific misconduct which for me, is where the confusion lies.

[Edit: The reason for my confusion was because the Medical Research Council (MRC) definition of scientific misconduct posted earlier in this thread is innaccurate. Please see here for the correct MRC definition:
http://forums.phoenixrising.me/index.php?threads/pace-trial-fraud-or-incompetence.50183/page-7#post-832589]
 
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alex3619

Senior Member
Messages
13,810
Location
Logan, Queensland, Australia
I don't believe I ever cited this paper.
The fabrication, falsification, plagiarism or deception in proposing, carrying out or reporting results of research or deliberate, dangerous or negligent deviations from accepted practices in carrying out research. It includes failure to follow established protocols if this failure results in unreasonable risk or harm to humans, other vertebrates or the environment and facilitating of misconduct in research by collusion in, or concealment of, such actions by others. It also includes intentional, unauthorised use, disclosure or removal of, or damage to, research-related property of another, including apparatus, materials, writings or devices used in or produced by the conduct of research. It does not include honest error or honest differences in the design, execution, interpretation or judgement in evaluating research methods or results or misconduct unrelated to the research process. Similarly it does not include poor research unless this encompasses the “intention to deceive” (MRC, 1997).[4] [My bold]

Click on the 4. This is the quote you used earlier. You might not have followed the link in the quote, which is why it appears new.
 

Laelia

Senior Member
Messages
243
Location
UK
Would there be any point trying to crowd fund to pay for a lawyer with expertise in medical matters? (I have no idea how these things work. Hopefully someone else does.)

This seems to me to be worth considering. I don't have knowledge of how these things work either so it would be good to hear from someone that does.
 

Laelia

Senior Member
Messages
243
Location
UK
Bringing motivation and deliberation into it is more open to dispute and can distract from the central points: that PACE was a piece of crap, and if anything it showed that CBT and GET are ineffective. That does just as much damage to the principal investigators involved, and leaves the patients smelling like roses.
[My bold]

I disagree with you here @Valentijn. If the principal investigators were to be found guilty of deceitful intentions this would be far more damaging to them and could potentially bring about a much faster demise of the whole PACE fiasco.
 

Laelia

Senior Member
Messages
243
Location
UK
You're right about this @alex3619.

The MRC have this long document entitled:

MRC POLICY AND PROCEDURE FOR INVESTIGATING ALLEGATIONS OF RESEARCH MISCONDUCT

(See attached file)

In it they set out their full definition of research misconduct, which is as follows:

Appendix B- Definitions of misconduct

The MRC endorses the definitions of research misconduct and other unacceptable research behaviour identified in the RCUK Policy and Guidelines on Governance of Good Research Conduct
(February 2013). Unacceptable conduct includes the following:

Fabrication
The creation of false data or other aspects of research, including documentation and participant consent.

Falsification
The inappropriate manipulation and/or selection of data, imagery and/or consents.

Plagiarism
The misappropriation or use of others’ ideas, intellectual property or work (written or otherwise), without acknowledgement or permission.

Misrepresentation, including:

  • misrepresentation of data, for example suppression of relevant findings and/or data, or knowingly, recklessly or by gross negligence, presenting a flawed interpretation of data;
  • undisclosed duplication of publication, including undisclosed duplicate submission of manuscripts for publication;
  • misrepresentation of interests, including failure to declare material interests either of the researcher or of the funders of the research;
  • misrepresentation of qualifications and/or experience, including claiming or implying qualifications or experience which are not held;
  • misrepresentation of involvement, such as inappropriate claims to authorship and/or attribution of work where there has been no significant contribution, or the denial of authorship where an author has made a significant contribution.
A Breach of duty of care, whether deliberately, recklessly or by gross negligence:
  • disclosing improperly the identity of individuals or groups involved in research without their consent, or other breach of confidentiality;
  • placing any of those involved in research in danger, whether as subjects, participants or associated individuals, without their prior consent, and without appropriate safeguards even with consent; this includes reputational danger where that can be anticipated;
  • not taking all reasonable care to ensure that the risks and dangers, the broad objectives and the sponsors of the research are known to participants or their legal representatives, to ensure appropriate informed consent is obtained properly, explicitly and transparently;
  • not observing legal and reasonable ethical requirements or obligations of care for animal subjects, human organs or tissue used in research, or for the protection of the environment;
  • improper conduct in peer review of research proposals or results (including manuscripts submitted for publication); this includes failure to disclose conflicts of interest; inadequate disclosure of clearly limited competence; misappropriation of the content of material; and breach of confidentiality or abuse of material provided in confidence for peer review purposes.
Improper dealing with allegations of misconduct
  • failing to address possible infringements including attempts to cover up misconduct or reprisals against whistleblowers.
  • failing to deal appropriately with malicious allegations, which should be handled formally as breaches of good conduct.
So that "MRC" definition of scientific misconduct, originally posted by @adreno, and repeatly posted by me is flat out wrong! The bit where it says scientific misconduct "does not include poor research unless this encompasses the intention to deceive" is completely innaccurate.

Having seen the correct MRC definition, I believe we now have a much stronger case for misconduct against the principal investigators of PACE.

[Edit: added file attachment]
 

Attachments

  • Research Misconduct Policy.pdf
    309.3 KB · Views: 2
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Laelia

Senior Member
Messages
243
Location
UK
I should have put this in bold in my previous post!

"misrepresentation of data, for example suppression of relevant findings and/or data, or knowingly, recklessly or by gross negligence, presenting a flawed interpretation of data;"