Good Research Practice

The University of Cambridge's guidelines on Good Research Practice have been developed to emphasise the importance of integrity and rigour in all research carried out at, and in partnership with, the University.

The guidelines cover:

openness
supervision
training
intellectual property
the use of data and equipment
publication of research results
ethical practice

Good Research Practice Guidelines

The University of Cambridge's Guidelines on Good Research Practice have been developed to articulate the importance of integrity and rigour in all research carried out at and in partnership with the University. They are informative, rather than prescriptive. They offer assistance to researchers in helping them to determine how to apply the baseline standards set by ordinances and regulations of the University, as well as by wider legal and contractual requirements and ethical norms, to the concrete situations which face them in everyday practice of research.

The practice of research will require adherence to principles of ethics and integrity that may vary in their details according to the type of research undertaken. Thus, these general guidelines may need to be supplemented by other research-related policies, guidelines and principles. Links to additional guidance provided by funders, the University and other organisations are provided at the end of this document and in the relevant sections.

This policy will be routinely reviewed every three years unless earlier revision is required due to a major change in the legislation, regulations and guidance that govern good research practice.

The University welcomes feedback on the content of this document. Anyone with comments or suggestions regarding the guidelines is invited to send them to researchintegrity@admin.cam.ac.uk.

Introduction
Integrity
Openness
Leadership and Cooperation
Supervision
Training
Primary Data, Samples and Equipment
Dissemination and publication of results
Intellectual Property
Ethical practice
Patient and consumer involvement
Regulatory and compliance matters
Collaboration
Acknowledgements
University Policies and Guidelines
International guidance

1. Introduction

The University of Cambridge is committed to conducting its business in accordance with the seven principles identified by the Committee on Standards in Public Life:

selflessness
integrity
objectivity
accountability
openness
honesty
leadership

(Council's Statement on Corporate Governance contained in the Reports and Financial Statements for the year ended 31 July 2016, Reporter, No. 6448, 8 December 2016).

The University expects all those engaged in research to observe these principles, whether they are employees of the University, or students, and irrespective of the sources of their funding, or their area of research.

Researchers should make efforts to understand and meet the expected standards of integrity and good practice relevant to their work. To facilitate such efforts, this document provides guidelines on good practice in research. It is intended for all staff, including persons with honorary positions, and students carrying out research at or on behalf of the University. Research involving humans, human tissue, personal data and animals raises specific ethical issues, which are addressed in Sections 8.2 and 10.

1.1 Funder requirements

Research funders cannot be prescriptive about individual approaches taken by researchers to solving particular research problems. However, funders can reasonably expect the University to ensure that an adequate policy framework exists that promotes and promulgates good research practice, that emphasises integrity and rigour in research, and that facilitates the development of a culture in which the following general principles can be understood and observed. Such expectations are set out in Universities UK’s Concordat to Support Research Integrity which has been signed by the University’s leading funders, including UKRI and the Wellcome Trust. Compliance with the Concordat is a condition of receipt of funding.

Many funders have published their own policies, including UKRI’s Policy and Guidelines on the Governance of Good Research Conduct and the Wellcome Trust’s Policy on Responsible conduct of research. A list of relevant policies and guidance from various funders is provided at the end of this document. Researchers should ensure that they are aware of and abide by all policies and guidelines that apply to their research.

Research Councils and charities fund for public benefit, and in the case of charities within their charitable objects, and impose certain obligations and restrictions on the use of their funds, for example a requirement to disseminate research findings, and a proscription on funding research for the purpose of direct commercial or private gain. Researchers should be aware of these obligations and seek advice where required.

Researchers should report any significant changes in the direction of funded research to the funder or any other relevant body. Best practice would be to discuss any change in direction of the research with the funder prior to its implementation. Most funding agreements will provide a mechanism for handling this process.

The University's Research Operations Office can provide guidance on funder requirements and funding agreements.

2. Integrity

All individuals involved in research at Cambridge are expected to observe the highest standards of integrity, honesty and professionalism in respect of their own actions in research and in their responses to the actions of others.

The University is committed to upholding the commitments outlined in Universities UK’s Concordat to Support Research Integrity. This requires those involved in research to abide by national, European and international standards of research integrity and to embed good practice in every aspect of their work. A summary of the standards to which researchers are expected to adhere is provided in the University’s Statement on Research Integrity.

All researchers should be aware of their responsibilities under the Concordat. The primary responsibilities of researchers are:

Take personal responsibility for ensuring that you act in accordance with the principles of the Concordat
Understand and maintain the expected standards of rigour and integrity relevant to your research
Understand and comply with ethical, legal and professional frameworks, obligations and standards as required by statutory and regulatory authorities, and by employers, funders and other relevant stakeholders
Design, conduct and report research in ways that embed integrity and ethical practice throughout
Ensure that your research is subject to appropriate and active consideration of ethical issues
Collaborate to maintain a research environment that encourages research integrity
Declare conflicts of interest and act to manage them

The expectation to uphold the highest standards of integrity applies to the whole range of research work including, but not limited to: designing studies and experiments; generating, recording, archiving, analysing and interpreting data; sharing data and materials; applying for funding; presenting and publishing results; training new researchers, staff and students; and peer reviewing the work of other researchers (see sections 3-13). The direct and indirect contributions of colleagues, collaborators and others should be acknowledged (see Sections 8-10).

The University expects research results to be checked for accuracy and consistency by the researchers responsible for them before being made public. Researchers must be able to explain and justify how results were reached.

Further guidance on the University’s expectations for integrity in research is provided by the University Research Integrity web pages.

2.1 Research Misconduct

Allegations of misconduct in research are rare but the University takes them very seriously. The University is committed to ensuring that allegations of misconduct in research are investigated with all possible thoroughness and vigour.

All members of the University, and individuals permitted to work in University institutions, have a responsibility to report any incident of misconduct, whether this has been witnessed, or is suspected. Those participating in or running investigations into allegations of research misconduct are expected to act in good faith and according to University policy.

The University's definition of research misconduct and approach to managing these issues is described in detail in the University’s policy on Misconduct in Research.

2.2 Conflict of interest

Researchers should declare and manage any real or potential conflicts of interest, both financial and professional. The University's Financial Regulations contain further information on the declaration of personal interests.

Researchers should ensure that they abide by any conflict of interest requirements of funders or that are otherwise relevant to their research. In particular, researchers should be aware of EU terms and conditions and the specific requirements of the US Public Health Service (which includes the National Institutes of Health).

2.3 Professional Guidance and Legislation

All researchers should be aware of the legal requirements that regulate their work, including the legislation related to research that involves:

humans, including human tissue, and personal data (see section 10.1)
animals (section 10.2)
security-sensitive material and export control (section 12.1)
non-human genetic resources that originate from overseas (section 12.3)

Detailed information is available from the University's Safety Office and Information Compliance web sites regarding health and safety legislation, the data protection legislation and the Freedom of Information Act.

Where available, the University expects researchers to take into account the standards of research practice set out in guidelines published by scientific and learned societies, and other relevant professional bodies.

3. Openness

Whilst recognising the need for researchers to protect their own intellectual property rights

(IPR), the University encourages researchers to be as open as possible in discussing their work with other researchers and with the public. The aim in disseminating charity-funded or University research is to increase knowledge and understanding: its purpose should not be primarily to seek publicity for the researcher, for the University or for the funder.

The University is committed to disseminating research and scholarship as widely as possible, whilst affirming academic freedom to choose the location and nature of publication. In keeping with this commitment, the University supports its staff in making their research available through Open Access. Where research funders include Open Access requirements as a condition of grant funding, researchers are expected to ensure that they comply with such requirements.

Once results have been published, the University expects researchers to make available relevant data and materials to other researchers, on request, provided that this is consistent with any ethical approvals and consents which cover the data and materials, confidentiality considerations, and any intellectual property rights in them. Many funders will have data sharing policies that must be abided by where appropriate. Funders recognise that publication of the results of research may need to be delayed for a reasonable period pending protection of any intellectual property arising from the research. Any such periods of delay in publication should be kept to a minimum and this should normally be no more than three months. Restrictions on publication may be longer for PhD theses, see the University’s Scholarly Communication webpage for details.

Researchers should be especially careful when discussing work that is not complete or has not been published, particularly if it has not undergone peer review.

4. Leadership and Co-operation

Heads of institutions and their senior colleagues should ensure that a research climate of mutual co-operation is created in which all members of a research team are encouraged to develop their skills and in which the open exchange of ideas is fostered.

Efforts should also be made to foster an environment where research is conducted in accordance with good research practice and to ensure that all those involved in research are made aware of these guidelines and related policies and guidelines (see section 13). Senior researchers should make particular efforts to help new members of the scientific community understand and adopt best practice. Within a research group, responsibility to ensure that good research practice is maintained throughout the research process ultimately lies with the group leader.

5. Supervision

The University wishes to ensure that appropriate training and direction of research and supervision of researchers is available. Training in supervisory skills is provided as part of the University's overall staff development programme.

The University also provides guidance for supervisors and the Code of Practice for Research Students clearly sets out supervisor responsibilities.

Supervisors should supervise all stages of the research process, including outlining or drawing up a hypothesis, preparing applications for funding, the design of experimental or research protocols, data recording and data analysis, and writing the thesis.

6. Training

The University offers many courses to enable students and new researchers to understand and adopt best practice in research as quickly as possible. Supervisors should encourage students and colleagues to attend relevant courses as part of their overall career development. Lists of courses are available on the Personal and Professional Development web site and relevant courses are increasingly available as part of the University's teaching programme. Researchers should also be aware of training offered locally by their School or Department.

7. Primary Data, Samples and Equipment

7.1 Ownership and responsibilities

There should be clarity at the outset of the research programme as to the ownership and use of, where relevant:

data and samples used or created in the course of the research
the results of the research
patient questionnaires
equipment paid for by funders

The responsibilities and procedures for the storage and disposal of data and samples (including compliance with the requirements of any ethics committee) should be made clear at the commencement of any project. Any research collaboration agreement relating to the research should contain clauses describing any necessary arrangements.

7.2 Research data

Research data should be generated using sound techniques and processes and accurately recorded in accordance with good research practices by those conducting the research.

When collecting personal data, researchers must comply with data protection legislation.

Full guidance for researchers on compliance with data protection legislation in academic research can be found in the University’s guidance for Academic Research Involving Personal Data. More general guidance on data protection is available from the University’s Information Compliance Office.

All research data must be managed and curated effectively throughout its lifecycle to ensure integrity, security and quality and where possible to support new research and research data sharing. Data stored locally on a computer should be backed-up. Electronic files containing personal data should be encrypted or password protected and access to them should limited to as few people as possible. Researchers in the Clinical School must follow the Clinical School Information Governance Policy which states that all identifiable research participant data must be stored in an approved Clinical School Safe Haven or on an NHS computer. It is of paramount importance that confidentiality, where required, is maintained.

Retention periods for research data will vary according to specific contractual requirements and the nature and sensitivity of the research. Most funders consider a minimum of ten years after the completion of a project to be an appropriate period. However, research based on clinical samples or relating to public health may require longer storage to allow for long-term follow-up to occur. Researchers should adhere to guidance provided by funding bodies, professional guidance, School or local policies, as well as University requirements as set out here, the Research Data Management website and in the guidance on records management.

Manual research records, as defined in the University of Cambridge Research Data Management Policy Framework, should be handled in line with funder policies and the University Statement of Records Management Practice and Master Records Retention Schedule. This means that researchers should – in line with funder policies and as appropriate for their disciplinary norm – destroy ephemeral manual research records as necessary and, as far as possible, digitise those required for longer-term retention periods, including to share with a wider research lab/group or to comprise their core underlying data to evidence any particular research output. Where manual research records cannot be digitised and remain necessary for compliance with funder policies, regulations and/or ethical requirements or need to be kept to evidence the integrity of the research, they should be retained in manual form for as long as required by funders, regulators or disciplinary norms. Some manual research records, like electronic ones, may be suitable for permanent preservation in the University Archives, where they may be used for future research.

7.3 Record keeping

Researchers should keep clear and accurate records of the procedures followed and the approvals granted during the research process, including records of the interim results obtained as well as of the final research outcomes. This is necessary not only as a means of demonstrating proper research practice, but also in case questions are subsequently asked about the conduct of the research, the results obtained, or inventorship on patentable inventions.

8. Dissemination and publication of results

The University encourages the publication of and dissemination of results of high quality research but believes that researchers must do this responsibly and with an awareness of the consequences of any such dissemination in the wider media. Dissemination will normally be a requirement of research council and charity funding.

The University tries to ensure that any funders who do not require dissemination understand that researchers must have academic freedom and funders should not discourage publication nor the dissemination of research or research findings. Funding agreements will normally require funders to be informed of any potential publication or dissemination of the research findings. This will enable the funder in question to have adequate time and accurate information to protect any arising intellectual property or to plan their own public relations, in conjunction with the University. Publicity may be important to industrial funders and to fundraising charities and is increasingly important to the University itself. Advice on press releases and publicity can be obtained from the University's Office of External Affairs and Communications.

Arrangements and responsibilities for the publication of results should be taken into account when planning a study and should ideally be agreed by all investigators at the outset. These should be revisited where role and contributions change over the life cycle of the study. Such discussions might include authorship, authorisation for the content of papers, and the intended place of publication.

Further guidance on authorship is available on the Research Integrity website.

Researchers should take into account the following guidance when publishing or disseminating their research or research findings including any plans they may have to publish or publicise research at conferences or on web sites.

Research should normally be peer reviewed prior to it being published, publicised or disseminated. If research is placed in the public domain before peer review has been undertaken, it is good practice to make this clear in any publicity.
Funding sources should normally be acknowledged in any publication or publicity.
Results of research should be published in an appropriate form.
Anyone listed as an author on a paper should accept responsibility for ensuring that he or she is familiar with the contents of the paper and can identify his or her contribution to it. Honorary authorship is not good practice.
The contributions of formal collaborators and all others who directly assist or indirectly support the research should be both specified and properly acknowledged.
Researchers should make every effort to ensure that research is disseminated in a responsible manner, in such a way that results are not overstated. The Research Communications team can provide advice on research dissemination.
Similarly, in accordance with the Concordat on Openness on Animal Research, where research has been conducted using animal models, this should be clearly stated in press materials and news stories.

Examples of good publication practice can be found in the Committee on Publication Ethics guidelines Code of Conduct, the International Committee of Medical Journal Editors Recommendations and on the Nature website.

9. Intellectual Property

The University’s Intellectual Property Policy can be found in Chapter XIII of the University’s Statutes and Ordinances. For guidance on the University’s Intellectual Property Policy, see the Cambridge Enterprise website.

Cambridge Enterprise Ltd., is a wholly owned subsidiary and exists to help University of Cambridge inventors, innovators and entrepreneurs make their ideas and concepts more commercially successful for the benefit of society, the UK economy, the inventors and the University. Further details of the University's approach to managing intellectual property are available on the Cambridge Enterprise website.

The University, which has charitable status, carries out research and the research councils and charities fund research for public benefit and not for direct commercial or private gain.

Public benefit may arise from education, i.e. the gain of knowledge that is placed in the public domain, or in the case of biomedical research improvement in the treatment or care of patients or in the prevention or cure of diseases. Although the University cannot carry out research solely for the purpose of commercial gain, commercial benefit from the exploitation of the results of research may, subject to expectations of funders, accrue to their inventor(s), the University and, by agreement, to the funder of the research. Commercialisation may also be the most effective means of disseminating research results and accruing public benefit.

10. Ethical practice

All research carried out at the University must comply with relevant legal, regulatory, professional and ethical requirements and standards. Researchers should be familiar with, and know how to access such requirements including University ethical guidance and policies. Researchers who are unsure whether such requirements apply to their projects should seek advice.

Researchers should work to ensure that, throughout the lifecycle of their investigations, ethical issues relating to their research projects are identified and managed. Ethical issues should be interpreted broadly and may encompass areas where regulation and approval processes exist as well as areas where they do not. All appropriate licences, permissions and approvals must be in place before research starts and be updated as necessary if plans change.

10.1 Ethical practice in research involving human participants, human tissue and personal data

All research involving human participants or personal data carried out by University employees or on University premises must abide by departmental and faculty research ethics policies and the University’s Policy on the Ethics of Research Involving Human Participants and Personal Data.

Researchers are required to consider the ethical risk of any procedure within a research project which involves human participation or personal data, consulting the relevant Faculty, Department, School and University policies and personnel before any work is undertaken. Advice must be sought in case of doubt. Where the need for formal review is identified, reasonable and proportionate independent ethical review must be carried out prior to research work commencing. Guidance for those applying for ethical approval is available on the Research Integrity website.

Details of the University’s research ethics review system, including contact details for research ethics committees, are available on the Research Integrity website.

The ethical issues that researchers encounter in their work may vary according to the type of research they undertake. As such, researchers should familiarise themselves with the ethical guidance relevant to their subject area or issued by their department or funder. The University’s research integrity website provides information on many of the key guidance documents.

There are some particular considerations that will apply to certain types of research involving human participants, human tissue or personal data:

Those undertaking social research involving human participants may find it particularly useful to consult the ESRC’s Framework for Research Ethics, compliance with which is compulsory for ESRC-funded research.
Most research involving NHS patients, staff or facilities will come under the Research
Governance Framework for Health and Social Care and will require review by a National Research Ethics Service (NRES) Committee. Some other research will also require NRES review for legal and policy reasons. Details of when NRES review is needed are provided on the Health Research Authority website. In some cases it may be also appropriate to seek the views of relevant patient groups.
Those undertaking research at the Clinical School should be familiar with and comply with the research governance information provided by the School
Researchers must also comply with the Human Tissue Act. This regulates the removal, storage and use of human tissue – defined as material that has come from a human body and consists of, or includes, human cells. Access guidance on the Human Tissue Act and links to further information.
Researchers should ensure the confidentiality of personal information relating to the participants in research, and that the research fulfils any legal requirements such as those of data protection legislation (see Sections 4 and 8.2 above).

The University reminds researchers of the importance of obtaining necessary regulatory approval from bodies such as:

Human Fertilisation and Embryology Authority
Gene Therapy Advisory Committee.
Medicine Healthcare Regulatory Authority

10.2 Research involving animals

The University and its funders require that research involving animals should have been subject to the following (through the appropriate bodies):

Ethical Review Process
Home Office licence application

Researchers are required by law to consider the opportunities for Reduction, Replacement and Refinement of animal involvement in research – the principle of "The Three Rs". The University recommends that researchers refer to the relevant national guidelines on the appropriate and ethical use of animals in research. Publications using data acquired from animal research must follow the principles of the ARRIVE Guidelines (Animal Research: Reporting In Vivo Experiments.) All animal research is overseen by the University Biomedical Support Service (UBSS) and in compliance with University Animal Welfare Policy, Codes of Practice and Procedures. In accordance with the Concordat on the Declaration of Openness in Animal Research, there is a requirement to support the University’s goal of appropriate openness and transparency with respect to our use of animals.

10.3 Research misuse, non-proliferation and dual-use research

Researchers must consider any risks that their research will generate outcomes that could be misused for harmful purposes. See section 12 for further details.

11. Patient and consumer involvement

Researchers should consider and be aware of the active involvement of patients and consumer groups in research and in the dissemination of research findings. Where possible, and most often for studies involving patients and volunteers, researchers should engage with service-users, carers, representative groups and other stakeholders and beneficiaries in the design, conduct, analysis and reporting of research. It is important that researchers in the biomedical areas consider the impact any publication of research findings may have on patients with the condition under investigation, those involved in their care, those involved in the research and on consumer groups.

Further details about user involvement may be found in the MRC's Good Research Practice guidelines.

12. Regulatory and Compliance matters

All research carried out at the University must comply with relevant legal and regulatory, requirements and standards. Researchers who are unsure whether such requirements apply to their projects should seek advice.

Researchers should work to ensure that, throughout the lifecycle of their investigations, regulatory and compliance issues relating to their research projects are identified and managed. All appropriate licences, permissions and approvals must be in place before research starts.

12.1 Research misuse and dual-use research

A range of regulatory requirements apply to research that are designed to minimise the risk that research will be misused for harmful purposes, support national security, and control the export of dual-use or military technology.

Researchers should ensure that they are aware of the compliance requirements that apply to their work and seek advice when unsure. Support is available from the research governance team via researchgovernance@admin.cam.ac.uk.

Export Control

An export is the transfer of goods or technology or software from the UK to a destination outside the UK. Export control regulations apply to the exports of tangible goods, such as equipment and samples, and intangibles, such as technology, software and/or knowledge, that may be used for military purposes (either directly or civilian items that can be used for military purposes [dual-use]) or for Weapons of Mass Destruction (WMD) purposes. Researchers undertaking research activities in controlled areas must comply with applicable export control legislation and are advised to search the UK Strategic Export Control Lists to identify whether their research is controlled. The University has webpages providing information and guidance on how to proceed and, if necessary, apply for an export control licence. Support is available from the research governance team via researchgovernance@admin.cam.ac.uk.

Sanction, WMD and Military End Use Controls

Exports which are not specifically listed in the UK Strategic Export Control Lists, but are intended, either in their entirety or in part, for Weapons of Mass Destruction (WMD) purposes may also require a licence. WMD controls only apply if you have been informed of, are aware or suspect WMD end use.

Items or technology or software to be exported to a specific country which is subject to an embargo or sanctions (note that sanctions may include items that are not included on the Control Lists) may also be controlled and require a licence. End use controls apply to sanctioned activities; i.e. an export cannot occur if the exporter knows that the items would be used in relation to a sanctioned activity. Military end use controls may apply in countries under an arms embargo and if the exporter knows or has been informed that the export would be used for military end use purposes.

National Security & Investment Act

The National Security and Investment Act (NSI Act) allows the government to scrutinise and intervene in certain acquisitions made by anyone that could harm the UK’s national security. The new rules empower the government to impose conditions on qualifying acquisitions of entities and assets, or, if necessary, to block or unwind the offending transactions.

Intellectual Property can be a qualifying asset under the Act, if it falls into / is close to the 17 sensitive areas the UK government considers likely to give rise to national security risks. As with export control, the responsibility for national security due diligence rests ultimately with the Principal Investigator. For more information, please see the University’s guidance on the NSI Act on the Research Operations website.

Academic Technology Approval Scheme (ATAS)

Academic Technology Approval Scheme (ATAS) clearance may be required, particularly when teaching postgraduate students in certain science or technology subject areas. Further information is available on the postgraduate student website.

12.2 Trusted Research

When establishing new research collaborations, particularly international collaborations, researchers should consider whether their collaboration will expose them, their research, data or intellectual property to risk. This is particularly relevant for those working in STEM subjects, dual-use technologies, emerging technologies, social sciences and commercially sensitive areas. The University Trusted Research webpages provide guidance and support to help researchers understand their responsibilities and protect their research (and their research reputation) from potential risks.

12.3 Access-Benefiting Sharing (ABS) & the Nagoya Protocol

The Nagoya Protocol is an international Access-Benefiting Sharing (ABS) agreement that facilitates the international exchange of non-human genetic resources to support the fair and equitable sharing of benefits that arise from the use of genetic resources. Researchers that use non-human genetic resources that originate from overseas must meet certain compliance and due diligence obligations under the UK (ABS) Regulation that implements the Nagoya Protocol in the UK. As relevant, ABS permissions and approvals must be in place before research starts. For more information, please see the Nagoya Protocol and ABS webpages.

13. Collaboration

Research is increasingly collaborative, involving individuals from different disciplines and from institutions within and beyond the UK. In establishing research collaborations researchers should be mindful of the University’s policies and guidelines, as well as funder, legal and regulatory requirements, and ensure that research partners and their employing institutions are able to meet the required standards of research conduct. There needs to be clear agreement on and articulation of the standards and frameworks that will apply to collaborative work.

This is particularly important in relation to the provenance of intellectual ideas and ownership of research outcomes as well as the specific conditions under which these may be shared. All parties should be clear about their respective roles and responsibilities within the collaboration, which should be set out in any formal collaboration agreement. The Research Operations Office can advise and has various model agreements for use in such collaborations.

Guidance on research integrity in collaborative research is provided by the Montreal Statement on Research Integrity in Cross-Boundary Research Collaborations.

Researchers collaborating with an international partner should be aware of the risks posed by international collaborations and comply with all legal requirements relating to Trusted Research, non-proliferation of WMD and dual-use items and technology, particularly export controls (see section 12.1)