Additional information

• CRediT statement
• Acknowledging the use of Artificial Intelligence (AI) tools
• Acknowledging the use of patient data
• Confidentiality and Anonymity
• Examples of data sharing statements
• Ethics statement
• Information Governance Statement
• Disclosure of Interest Statement
• Department of Health and Social Care disclaimer

CRediT statement

The NIHR uses the CRediT (Contributor Roles Taxonomy) system for recognising the contributions to our research and our publications. The CRediT system was developed in 2012 by the Wellcome Trust and Harvard University, with input from other academic, publishing and funding communities including members of the ICMJE. The aim is to ensure visibility and recognition of individual contributions in a consistent way.

CRediT uses 14 roles that represent typical roles played by contributors to research outputs, which describe each individual’s specific contribution to the scholarly output. The roles are described below:

The CRediT contribution statement should be provided as a subheading in the additional information section of your manuscript (See example below). This statement should list the full names of each contributor against each relevant role. Individual contributors can have multiple roles and individual roles can have multiple contributors. Optionally, you can provide the degree of contribution of each contributor, which are “lead”, “equal”, or “supporting”. This statement should be included in all manuscripts. In the threaded publication model, all articles require a CRediT statement and the synopsis’ CRediT statement should include all relevant contributors involved in the project. We also recognise there may be contributions that do not fit into this format (e.g. PPI contributions); therefore you may add a sub-heading “Other contributions” below to capture these if required. Please see an example of the CRediT statement format below:

Jan Jenssen: Conceptualisation (equal), Data Curation (lead). Fred Bloggs: Conceptualisation (equal), Formal analysis (lead), Writing – Editing and Reviewing (supporting). Sheela Patel: Conceptualisation (equal), Investigation (lead), Writing – original draft (lead), writing – editing and reviewing (lead)

The CRediT system is not a proof of authorship and contributors can be authors or non-author contributors, who were involved in your research project. In line with current ICMJE guidance, authors should ensure they have written permission from all non-author contributors acknowledged in this section. It is the responsibility of the corresponding author to assign roles and provide an opportunity for all contributors to review and confirm assigned roles, including seeking written permission where necessary. This system is currently not set up for the inclusion of group authors and therefore is limited to individuals. Individual ORCiD ID’s will be linked to next to their name, like the title page. All listed authors should be assigned a role.

For more information on CRediT, please follow the link to their homepage. The information recorded in the CRediT statement is the responsibility of the authors and anyone listed here should be made aware of this.

Acknowledging the use of Artificial Intelligence (AI) tools

We follow the ICMJE recommendations on authorship matters. See the ICMJE guidance on defining the roles of authors and contributors for more information.

Acknowledging the use of patient data

If your manuscript contains patient data which is routinely collected by the NHS, please include a subsection containing the following statement:

“This work uses data provided by patients and collected by the NHS as part of their care and support. Using patient data is vital to improve health and care for everyone. There is huge potential to make better use of information from people’s patient records, to understand more about disease, develop new treatments, monitor safety, and plan NHS services. Patient data should be kept safe and secure, to protect everyone’s privacy, and it’s important that there are safeguards to make sure that it is stored and used responsibly. Everyone should be able to find out about how patient data is used. #datasaveslives You can find out more about the background to this citation here: https://understandingpatientdata.org.uk/data-citation 

Confidentiality and Anonymity

For research involving samples or information from human participants, data must be managed and shared in a way that safeguards the confidentiality and anonymity of participants and is consistent with the terms of consent signed by participants. Data sharing does not necessarily mean public access. Data can be shared on request or via registration if deposited in an archive.

Examples of data sharing statements

Below are some examples of data sharing statements you might include in your manuscript. Please note these examples are indicative and that statements will be considered on a case-by-case basis. If you are unsure please contact the NIHR Journals Library team for guidance.

Primary research

• ‘All available data can be obtained by contacting the corresponding author.’
• 'All data requests should be submitted to the corresponding author for consideration.  Access to anonymised data may be granted following review.'
• 'We shall make data available to the scientific community with as few restrictions as feasible, while retaining exclusive use until the publication of major outputs. Anonymised data will be deposited here <link> to encourage wider use.’
• ‘The data will be made available via <link/corresponding author> within <x> months of publication, this is due to <insert reason>.’
• 'Due to <insert reasons>, there is no data that can be shared.’

Secondary research

• ‘This is a qualitative study and therefore the data generated is not suitable for sharing beyond that contained within the manuscript. Further information can be obtained from the corresponding author.’
• ‘Requests for access to data should be addressed to the corresponding author or to the data custodian (if known).’

 For more information, please see our data sharing policy.

Ethics statement

NIHR-funded researchers are expected to have conducted their research in accordance with the World Medical Association Declaration of Helsinki. You should have sought regulatory approval for your research project and adhered to the highest standards of research governance. Ethics statements are important for demonstrating that your research has followed these standards and for providing accurate and complete reporting of the research.

Your manuscript should include an ethics statement in the additional information section. This should detail the ethics approval received for your research and should include the name of the ethics committee, date of approval and the reference number where appropriate.

If your study has been granted an exemption from requiring ethics approval, this should also be detailed (including the name of the ethics committee that granted the exemption).

If your research did not require ethical approval, a statement should be included detailing the reason for this. 

Information Governance Statement

This is a mandatory section, to be included as a separate heading as part of the 'Additional Information' of your manuscript if you are submitting a research article, synopsis or extended research article.

If you are submitting a Programme Grants for Applied Research (PGfAR) report, this would be included as part of the 'Additional Information' of your report.

NIHR-funded researchers are expected to have handled all personal information in line with the Data Protection Act (2018) and General Data Protection Regulation (EU GDPR) 2016/679. 

This should detail information on the data controller, data processor, Data Protection Act (2018) and the General Data Protection Regulation (EU GDPR) 2016/679. 

If your study did not handle any personal information, then a short statement should still be included detailing this.  

What an Information Governance Statement needs to include 

Information governance statements have to include certain statements and references, for which we consulted with NIHR’s Information Governance Manager to produce the below example. 

XXXX organisation/institution is committed to handling all personal information in line with the UK Data Protection Act (2018) and the General Data Protection Regulation (EU GDPR) 2016/679.  

Then 

Either (for organisations where the sponsoring body is also the Data Controller): Under the Data Protection legislation,  XXXX is the Data Controller, and you can find out more about how we handle personal data, including how to exercise your individual rights and the contact details for our Data Protection Officer here (provide website link) 

Or (for organisations where they are the Processor): Under the Data Protection legislation  XXXX is the Data Processor; YYYY is the Data Controller and we process personal data in accordance with their instructions. You can find out more about how we handle personal data, including how to exercise your individual rights and the contact details for YYYY’s Data Protection Officer here (provide website link). 

As an example, NIHR is a processor organisation and would put: 

NIHR is committed to handling all personal information in line with the UK Data Protection Act (2018) and the General Data Protection Regulation (EU GDPR) 2016/679. Under Data Protection legislation NIHR is the Data Processor; the Department for Health and Social Care (DHSC) is the Data Controller, and we process personal data in accordance with their instructions. You can find out more about how we handle personal data, including how to exercise your individual rights and the contact details for DHSC’s Data Protection Officer here. 

Disclosure of Interest Statement

The NIHR Journals Library adopts the International Committee of Medical Journal Editors (ICMJE) approach to disclosure of interest.

All authors are required to complete an ICMJE form. The form must be completed thoroughly and with full transparency detailing all potential conflicts of interest. (Please note, a disclosure represents a commitment to transparency and does not necessarily indicate a bias).

The completed forms will be uploaded along with the published report.

Disclosure of interest statement: A disclosure of interest declaration should be included in the additional information section (please include full first and last name). The statement should contain what you deem as primary conflict of interests. For example and not be limited to:

• All support for the present manuscript
• NIHR board/committee memberships
• Relevant financial activities outside the submitted work.
• Intellectual Property.
• Relevant Relationships not covered above.
• Details of other NIHR funding such as NIHR professorships and CLAHRC funding. (Please list the individual NIHR Funding reference numbers)

For example:

"Disclosure of interest: XXXX has received funding from the pharmaceutical industry to attend an influenza-related conference"

Or

"Disclosure of interest: None declared"

The editors will approve the final version of the statement prior to report sign off. For further information please see the ICMJE Disclosure of Interest form (.PDF).

Department of Health and Social Care disclaimer

This publication presents independent research commissioned by the National Institute for Health and Care Research (NIHR). The views and opinions expressed by authors in this publication are those of the authors and do not necessarily reflect those of the NHS, the NIHR, MRC, NIHR Coordinating Centre, the [insert programme name] programme or the Department of Health and Social Care.

If your manuscript includes verbatim interview quotes, please use the following Department of Health and Social Care disclaimer:

This publication presents independent research commissioned by the National Institute for Health and Care Research (NIHR). The views and opinions expressed by the interviewees in this publication are those of the interviewees and do not necessarily reflect those of the authors, those of the NHS, the NIHR, MRC, NIHR Coordinating Centre, the [insert programme name] programme or the Department of Health and Social Care.