Clinical Trial Transparency (for UAEM Global Health Ranking) Update Since 2018

The request was successful.

Dear University of Nottingham,

This FOI is being filed in order to allow Universities Allied for Essential Medicines UK (UAEM-UK) to gain insight into current clinical trial transparency policies and practices at selected UK universities, with the goal of informing the development of UAEM-UK’s forthcoming 2015-2020 Global Health Ranking of UK universities. Please find a background briefing to the project here: https://tinyurl.com/y9prgqcd

We sent a similar request in 2018 and in the request we are interested in changes in policies during this time period only (i.e. between 30th of April 2018 and 31st of May 2020).

The term “clinical trial” in the questions below refers to clinical trials as defined by the World Health Organization:
“[A] clinical trial is any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes. Interventions include but are not restricted to drugs, cells and other biological products, surgical procedures, radiological procedures, devices, behavioral treatments, process-of-care changes, preventive care, etc.”
https://www.who.int/health-topics/clinic...

The term “silent outcome switching” in Q3 below is defined as “adding, suppressing or switching a clinical trial’s outcome measures (compared to the pre-defined outcome measures set out at the beginning of the trial in the trial’s protocol and/or registry entry) when reporting a trial’s outcome in an academic journal without explicitly flagging such post hoc changes within the journal article”.

START FOI

Please respond to the following questions and provide us with electronic copies of the relevant documents:

Q1: Since the 30th of April 2018 has the university changed or created policy/policies regarding registration of clinical trials on clinical trial registries, by the university itself and/or by university staff? If yes, please provide a link to the policy/policies. If the policy/policies are not publicly accessible online, please provide an electronic copy of the policy/policies.

Q2: Since the 30th of April 2018 has the university changed or created policy/policies that require the posting of the summary results of clinical trials on clinical trial registries, by the university itself and/or by university staff? If yes, please provide a link to the policy/policies. If the policy/policies are not publicly accessible online, please provide an electronic copy of the policy/policies.

Q3: Since the 30th of April 2018 has the university changed or created policy/policies that prohibit its staff from silent outcome switching when they report clinical trial outcomes in academic journals? If yes, please provide a link to the policy/policies. If the policy/policies are not publicly accessible online, please provide an electronic copy of the policy/policies.

Q4: Does the university have time-specific plans to retrospectively post missing summary results onto trial registries for university-sponsored clinical trials completed in the past? If yes, please share a link to that document. If the document is not online, please provide a copy of the document.

Q5: Since the start of 2018 has the university made public an internal audit of trial registration and/or summary results posting performance? If yes, please provide a link to that document.

END FOI

Thank you for taking the time to address this and we look forward to your response. If you are expecting any delays due to the COVID-19 pandemic please do let us know. We would like to refer you to BIH QUEST’s recently published clinical trial reporting manual to improve clinical trial transparency at your university: https://tinyurl.com/y8p6z5bn

Yours faithfully,

Sarai Keestra

Br-Freedom-Of-Information, University of Nottingham

Dear Sarai,

Thank you for your request for your request for information on Clinical Trial Transparency. Your request was received on 22nd June 2020 and is being dealt with under the terms of the Freedom of Information Act 2000. The reference number of your request is 3806.

We will aim to respond to your request within twenty working days. Please note this is calculated from the following working day from receipt of your request.

Please be aware that due to the Covid-19 pandemic, and following Government advice, all University staff are working remotely, this may mean that access to some information held locally or on certain systems may not be readily available at this time.

Where it becomes clear that the information you have requested is not available due to the current situation, we will of course write to you and advise you of this.

I hope that this is of help. Please do not hesitate to contact me if you have any enquiries regarding this email.

Yours sincerely

Catherine Allin

Information Compliance & Quality Officer – Freedom of Information,
Registrar’s Department
Web: www.nottingham.ac.uk/freedom-of-informat...
Email: [University of Nottingham request email]

show quoted sections

Br-Freedom-Of-Information, University of Nottingham

3 Attachments

Dear Sarai,

 

I am writing in response to your request for information on Clinical Trial
Transparencies. After conducting a search of our electronic records we
have confirmed the information is held and our responses are below marked
in blue.

 

 

Please respond to the following questions and provide us with electronic
copies of the relevant documents:

 

 

 

Q1: Since the 30th of April 2018 has the university changed or created
policy/policies regarding registration of clinical trials on clinical
trial registries, by the university itself and/or by university staff? If
yes, please provide a link to the policy/policies. If the policy/policies
are not publicly accessible online, please provide an electronic copy of
the policy/policies. UAEM have already been provided with a copy of this
document, however, please find a copy attached.

 

 

 

Q2: Since the  30th of April 2018 has the university changed or created
policy/policies that require the posting of the summary results of
clinical trials on clinical trial registries, by the university itself
and/or by university staff? If yes, please provide a link to the
policy/policies. If the policy/policies are not publicly accessible
online, please provide an electronic copy of the policy/policies. As
above, UAEM have already been provided with a copy of this document,
however, please find a copy attached.

 

 

 

Q3: Since the 30th of April 2018 has the university changed or created
policy/policies that prohibit its staff from silent outcome switching when
they report clinical trial outcomes in academic journals? If yes, please
provide a link to the policy/policies. If the policy/policies are not
publicly accessible online, please provide an electronic copy of the
policy/policies. Please see the link provided  below.

Q4: Does the university have time-specific plans to retrospectively post
missing summary results onto trial registries for university-sponsored
clinical trials completed in the past? If yes, please share a link to that
document. If the document is not online, please provide a copy of the
document. Please see the link provided  below.

 

Q5: Since the start of 2018 has the university made public an internal
audit of trial registration and/or summary results posting performance? If
yes, please provide a link to that document

 

The University has published a [1]Code of Research Conduct and Research
Ethics which covers the behaviours identified in q’s 3-5.  This is
specifically referenced in a Research Ethics workshop run regularly for
School of Medicine researchers (The agenda challenges a variety of
inappropriate research practices and behaviours including p-hacking,
HARKing etc.). 

 

The University Code includes the following statement making it clear that
researchers are expected to demonstrate:

·         Honesty in all aspects of research, including in the
presentation of research goals, intentions and findings; in reporting on
research methods and procedures; in gathering data; in using and
acknowledging the work of other researchers; and in conveying valid
interpretations and making justifiable claims based on research findings.

·         Rigour in line with prevailing disciplinary norms and standards,
and in performing research and using appropriate methods; in adhering to
an agreed protocol where appropriate; in drawing interpretations and
conclusions from the research; and in communicating the results.

·         Transparency and open communication in declaring potential
competing interests; in the reporting of research data collection methods;
in the analysis and interpretation of data; in making research findings
widely available, which includes publishing or otherwise sharing negative
or null results to recognise their value as part of the research process;
and in presenting the work to other researchers and to the public.

·         Care and respect for all participants in research, and for the
subjects, users and beneficiaries of research, including humans, animals,
the environment and cultural objects. Those engaged with research must
also show care and respect for the integrity of the research record.

 

The Code goes on to say:

 

The University recognises that academic freedom is fundamental to the
production of excellent research. Therefore, the responsibility for
ensuring that no misconduct occurs rests primarily with the individual
researcher.

 

12.1 Research misconduct can take many forms, including:

12.1.1 fabrication: making up results, other outputs (for example,
artefacts) or aspects of research, including documentation and participant
consent, and presenting and/or recording them as if they were real

12.1.2 falsification: inappropriately manipulating and/or selecting
research processes, materials, equipment, data, imagery and/or consents

12.1.3 plagiarism: using other people’s ideas, intellectual property or
work (written or otherwise) without acknowledgement or permission

12.1.4 failure to meet: legal, ethical and professional obligations, for
example:

a) not observing legal, ethical and other requirements for human research
participants, animal subjects, or human organs or tissue used in research,
or for the protection of the environment

b) breach of duty of care for humans or animals involved in research
whether deliberately, recklessly or by gross negligence, including failure
to obtain appropriate informed consent where relevant.

c) misuse of personal data, including inappropriate disclosures of the
identity of research participants and other breaches of confidentiality

d) improper conduct in peer review of research proposals, results or
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 the
purposes of peer review

12.1.5 misrepresentation of:

a) data, including suppression of relevant results/data or knowingly,
recklessly or by gross negligence presenting a flawed interpretation of
data

b) involvement, including inappropriate claims to authorship or
attribution of work and denial of authorship/attribution to persons who
have made an appropriate contribution

c) interests, including failure to declare competing interests of
researchers or funders of a study

d) qualifications, experience and/or credentials

e) publication history, through undisclosed duplication of publication,
including undisclosed duplicate submission of manuscripts for publication

12.1.6 Improper dealing with allegations of misconduct: failing to address
possible infringements, such as attempts to cover up misconduct and
reprisals against the complainant, or failing to adhere appropriately to
agreed procedures in the investigation of alleged research misconduct
accepted as a condition of funding.

12.2 Honest errors and differences of opinion in, for example, research
methodology or interpretations do not constitute research misconduct.
Misconduct does not include honest errors and differences of opinion
related to the design, execution, interpretation or judgement in
evaluating research methods or result.

12.3 Allegations of misconduct in research will be judged by the standards
prevailing at the time that the behaviour under investigation occurred.

12.4 Allegations of research misconduct will be referred to the employing
or degree awarding institution at the time the alleged misconduct took
place.

 

 

I trust this meets your requirements

Yours sincerely

 

Catherine Allin

 

Information Compliance & Quality Officer – Freedom of Information,

Registrar’s Department

Web:    www.nottingham.ac.uk/freedom-of-informat...

[2]Logo_English_gif_blackEmail: [University of Nottingham request email]

 

 

 

 

 

 

 

 

 

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