79C3C34C52B45572883A05D425EB0F82
Good Research Practice: Principles and Guidelines
https://mrc.ukri.org/publications/browse/good-research-practice-principles-and-guidelines/
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| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Political / political affiliation
Searching for indicator political:
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p.000018: I.3 While participating in peer review researchers are obliged to report appropriately, in confidence, any
p.000018: concerns they may have relating to research practice: such concerns may include plagiarism, fabrication, falsification,
p.000018: omission, ethical design or duplicate application.
p.000018:
p.000018:
p.000018: Related links
p.000018: (1) RCUK policy and code of conduct on the governance of good research conduct, Integrity, Clarity and Good Management
p.000018: (2013): http://www.rcuk.ac.uk/RCUK-prod/assets/documents/reviews/grc/
p.000018: RCUKPolicyandGuidelinesonGovernanceofGoodResearchPracticeFebruary2013.pdf
p.000018: (5) UK Research Integrity Office, Code of practice for research: Promoting good practice and preventing misconduct
p.000018: (2009) and Recommended Checklist for Researchers: http://www.ukrio.org/publications/code- of-practice-for-research/
p.000018: (43) Committee on Publication Ethics, Code of conduct and related guidelines and resources:
p.000018: publicationethics.org/resources/code-conduct
p.000018:
p.000018:
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p.000018: Section 2: Guidelines and standards
p.000019: 19
p.000019:
p.000019:
p.000019:
p.000019:
p.000019: (44) International Committee of Medical Journal Editors, guidance on ethical considerations and international
p.000019: standards: www.icmje.org/index.html
p.000019:
p.000019:
p.000019:
p.000019: J Conflicts of interest
p.000019: J.1 The MRC recognises that conflicts of interest may arise, or appear to exist, at different levels of research
p.000019: endeavour from planning the research to disseminating and exploiting the results and in the associated peer review– and
p.000019: in many forms. Apart from financial interests, conflicts might, for example, be personal, academic, political or arise
p.000019: from the acceptance of gifts or hospitality.
p.000019: J.2 The MRC expects procedures to be in place for identifying, declaring and addressing professional, private or
p.000019: commercial interests that might, or might be perceived to arise in relation to MRC-funded research. As much attention
p.000019: should be paid to perceived and potential conflicts of interest as to actual conflicts. All conflicts should be openly
p.000019: declared when reporting the outcomes of MRC-funded research at scientific meetings and conferences and in publications
p.000019: or when taking part in peer review.
p.000019: J.3 The MRC’s Code of Conduct for employees requires that any real, or perceived, conflicts must be discussed
p.000019: with the MRC unit director. Registers of declared interests and gifts and hospitality must be retained locally.
p.000019: Interests declared by members of the MRC’s Council and decision-making bodies are routinely published (50).
p.000019:
p.000019:
p.000019: Related links
p.000019: (8) MRC Code of Conduct for Employees: www.mrc.ac.uk
p.000019: (50) MRC Policy on Declarations of Interest: http://www.mrc.ac.uk/about/
p.000019:
p.000019:
p.000019:
p.000019:
p.000019: K Allegations of research misconduct
p.000019: K.1 The MRC takes allegations of misconduct in research very seriously and requires that allegations be
p.000019: investigated fully. Research misconduct is defined by the MRC and RCUK as follows:
p.000019: • Fabrication.
p.000019: • Falsification.
p.000019: • Plagiarism.
p.000019: • Misrepresentation.
p.000019: • Mismanagement or inadequate preservation of data and/or related materials.
p.000019: • Breach of duty of care.
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Health / Healthy People
Searching for indicator volunteers:
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p.000007: and reporting trials that involve the participation of human subjects, should be followed (13). Where practicable,
p.000007: consent that is freely given and informed should be sought from all competent participants. Guidance on writing
p.000007: participant information is available from
p.000007: the National Research Ethics Service (NRES)(14); this includes guidance for research that involves adults who lack
p.000007: capacity to give consent or children (15). Consent discussions should include how feedback on any health related
p.000007: finding will be handled, what withdrawal from a study will mean
p.000007: in practice and that this can occur at any time and for any reason up to the point of data analysis or up to the point
p.000007: of submission for publication. In line with the MRC’s policy on data and tissue
p.000007:
p.000007:
p.000007:
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p.000008: Good research practice: principles and guidelines
p.000008:
p.000008:
p.000008:
p.000008: sharing, participants should also be made aware of potential reuse in future research and the arrangements for consent.
p.000008:
p.000008: A.6 Responsibilities for overseeing the scientific and ethical conduct of the study must be identified, allocated
p.000008: and agreed as the scientific plans are put into practice. This is especially important in projects involving patients,
p.000008: volunteers or confidential or identifiable data, tissue, biological samples and animals and in other complex,
p.000008: collaborative programmes.
p.000008: A.7 Research organisations should have appropriate research governance systems, in which roles are allocated to
p.000008: meet corporate and individual project responsibilities, and are accepted and carried out within a sound research and
p.000008: project management framework. This may involve the identification of sponsors, appropriate and proportionate quality,
p.000008: risk management and monitoring systems, or the use of preferred project management processes or tools. When considering
p.000008: proportionate risks important aspects to consider include the impact on research delivery, supporting creativity, the
p.000008: credibility and robustness of results and the risks involved in methods used in studies involving human participants.
p.000008: A.8 The proper use and maintenance of equipment and systems is an important element of the research process.
p.000008: Appropriate procedures should be in place and responsibilities assigned to ensure training and support for use, regular
p.000008: servicing and calibration of equipment by trained staff, appropriate records of calibration, servicing, faults,
p.000008: breakdowns and misuse.
p.000008:
p.000008: A.9 Where possible, and most often for studies involving patients and volunteers, researchers should engage with
p.000008: service-users, carers, representative groups and other stakeholders and beneficiaries in the design, conduct, analysis
p.000008: and reporting of research. Advisory bodies which promote active public and patient involvement should be consulted as
p.000008: appropriate (20)(21).
p.000008:
p.000008:
p.000008: Related links
p.000008: (1) RCUK policy and code of conduct on the governance of good research conduct, Integrity, Clarity and Good Management
p.000008: (2013): http://www.rcuk.ac.uk/RCUK-prod/assets/documents/reviews/grc/
p.000008: RCUKPolicyandGuidelinesonGovernanceofGoodResearchPracticeFebruary2013.pdf
p.000008: (2) MRC policy on health department research governance frameworks: http://www.mrc.ac.uk/research/
p.000008: research-policy-ethics/clinical-research-governance/
p.000008: (4) Universities UK Concordat to Support Research Integrity: http://www.universitiesuk.ac.uk/
p.000008: highereducation/Documents/2012/TheConcordatToSupportResearchIntegrity.pdf
p.000008: (5) UK Research Integrity Office, Code of practice for research: Promoting good practice and preventing misconduct
p.000008: (2009) and Recommended Checklist for Researchers: http://www.ukrio.org/publications/code- of-practice-for-research/
p.000008: (11) RCUK and MRC terms and conditions for grants: http://www.rcuk.ac.uk/funding/grantstcs/
p.000008: (12) RCUK statement of expectation on economic and societal impact: http://www.rcuk.ac.uk/Publications/
p.000008: archive/StatementofExpectationon/
p.000008: (13) Good Clinical Practice principles: www.ichgcp.net
p.000008: (14) HRA guidance on consent: http://www.hra.nhs.uk/resources/before-you-apply/consent-and-
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Health / stem cells
Searching for indicator stem cells:
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p.000022: Good research practice: principles and guidelines
p.000022:
p.000022:
p.000022: Section 3
p.000022: New and emerging areas
p.000022: Research methods, technologies and tools move forward rapidly and the MRC recognises that additional guidance may be
p.000022: helpful to those working in new and emerging fields, and in areas which are developing quickly. This document will be
p.000022: reviewed regularly, but given the pace of change this guidance should be considered as a working document which will be
p.000022: updated as necessary. Please contact the MRC at corporate@ headoffice.mrc.ac.uk to suggest areas where new or revised
p.000022: guidance might be helpful.
p.000022:
p.000022:
p.000022:
p.000022: Section 4: Further advice and resources
p.000023: 23
p.000023:
p.000023: Section 4
p.000023: Further advice and resources
p.000023: In addition to specific research management expertise available within MRC research units, institutes and regional
p.000023: centres, other resources which aim to provide advice on specific aspects of good research practice are available to MRC
p.000023: researchers and the wider biomedical research community, including:
p.000023:
p.000023: The MRC Regulatory Support Centre
p.000023:
p.000023: The MRC Regulatory Support Centre (RSC) (16) provides support to MRC-funded researchers and to the wider scientific
p.000023: community on the legislative and good practice requirements specifically relating to research involving human
p.000023: participants, their tissues or data. The RSC works with MRC research units and institutes, regulators and the wider UK
p.000023: research community to share good practice and develop practical tools and e-learning in areas such as research use of
p.000023: personal data and tissue samples, experimental medicine and stem cells. The RSC provides advice to MRC-staff and
p.000023: provides training on regulation, ethics and governance.
p.000023:
p.000023: UK Research Integrity Office
p.000023:
p.000023: The UK Research Integrity Office (UKRIO) (5) provides expert advice and guidance to UK researchers, practice and
p.000023: improving research integrity in academic, scientific and medical research.
p.000023:
p.000023: EQUATOR Network
p.000023:
p.000023: The EQUATOR Network (52) provides guidance on resources for reporting of health research studies).
p.000023:
p.000023: Learning and Development for MRC research units and institutes
p.000023:
p.000023: The Learning and Development Group provides access to training and resources for MRC staff to support training and
p.000023: development.
p.000023:
p.000023: NC3Rs
p.000023:
p.000023: The National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs) (41) is an independent
p.000023: scientific organisation supporting the UK science base in the application of the 3Rs. It provides information, advice
p.000023: and funding in the field.
p.000023:
p.000023:
p.000023: Related links
p.000023: (5) UK Research Integrity Office, Code of practice for research: Promoting good practice and preventing misconduct
p.000023: (2009) and Recommended Checklist for Researchers: http://www.ukrio.org/publications/code- of-practice-for-research/
p.000023: (16) MRC Regulatory Support Centre resources and tool kits: http://www.mrc.ac.uk/research/facilities/
p.000023: regulatory-support-centre/
p.000023: (41) National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs):
p.000023: www.nc3rs.org.uk
p.000023: (52) EQUATOR Network guidance on reporting: www.equator-network.org
p.000023:
p.000023:
p.000023:
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Social / Access to Social Goods
Searching for indicator access:
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p.000017: 17
p.000017: I Integrity in peer review
p.000018: 18
p.000018: J Conflicts of interest
p.000019: 19
p.000019: K Allegations of research misconduct
p.000019: 19
p.000019: L Supporting training and skills
p.000020: 20
p.000020: 3. New and emerging areas
p.000022: 22
p.000022: 4. Further advice and resources
p.000023: 23
p.000023: 5. Related documents and references
p.000024: 24
p.000024: 6. Acknowledgments and history
p.000027: 27
p.000027:
p.000004: 4
p.000004: Good research practice: principles and guidelines
p.000004:
p.000004: Introduction
p.000004:
p.000004: Good research practice underpins high-quality science and supports the robust evidence base needed to drive
p.000004: improvements in health. It provides strong foundations for research careers, supporting high quality education and
p.000004: training, and delivers assurance to those whose work builds on the findings of others. Good research practice also
p.000004: helps to increase public confidence and trust in the research process and its outputs.
p.000004: The responsibility for promoting and delivering good research practice is shared by the whole research community.
p.000004: Researchers should strive for the highest achievable standards in the planning, conduct and reporting of their research
p.000004: and demonstrate integrity in their dealings with others. Research organisations should foster a culture which supports
p.000004: and embeds good research practice and aims to prevent research misconduct. Researchers and research organisations have
p.000004: a duty to ensure roles and responsibilities are clear, and that appropriate resources and skills are in place to
p.000004: deliver the research and maintain high standards of integrity, either by seeking access to training or developing
p.000004: collaborations with others with the necessary expertise.
p.000004: Achievement of the highest quality and ethical standards in research depends on the integrity, honesty and
p.000004: professionalism of all individuals involved in the research process. Research organisations’ staff recruitment
p.000004: practices at all levels should reflect the importance of these qualities.
p.000004: The MRC expects that all MRC-funded research is conducted to the highest levels of integrity, clarity and good
p.000004: management. Researchers supported by the MRC must adhere to the highest ethical standards, and conform to requirements
p.000004: and guidance set out in this document and by national and international regulatory bodies, professional bodies, and
p.000004: local research ethics and governance frameworks.
p.000004: This document aims to clarify these expectations and how they apply within the MRC’s own research units and institutes
p.000004: and to research supported by the MRC in university units, centres and grants, fellowships and studentships. It includes
p.000004: both high-level principles and more detailed guidance to ensure the standards can be achieved in practice. It builds on
p.000004: the joint research council policy and code of conduct on the governance of good research conduct issued by Research
p.000004: Councils UK, RCUK Integrity, Clarity and Good Management (1), the Health Departments’ Research Governance Frameworks
p.000004: (2), the Government Chief Scientific Advisor’s
p.000004: Universal Ethical Code for Scientists, Rigour, Respect and Responsibility (3), The Concordat to Support Research
p.000004: Integrity (4) and the UK Research Integrity Office, Code of practice for research: promoting good practice and
p.000004: preventing misconduct (5).
...
p.000005: The following principles outline the MRC’s expectations relating to the conduct of research. They should underpin all
p.000005: MRC-funded research within the MRC’s own research units and institutes and in other research organisations, whether
p.000005: they are supported either in whole, or in part, by the MRC. They apply to everyone involved in MRC-funded research,
p.000005: including researchers, research support staff, students, research managers and administrators and aim to reflect
p.000005: principles that apply more widely across public life such as those outlined by the Committee on Standards in Public
p.000005: Life (7). The principles also underpin the expectations the MRC has of its own staff which are outlined in the MRC Code
p.000005: of Conduct for Employees (8).
p.000005:
p.000005: Research excellence and integrity:
p.000005:
p.000005: The MRC is dedicated to excellence and high-ethical standards in the design, conduct, reporting and exploitation of
p.000005: publicly-funded research. The MRC expects all of those it supports to act with care and skill at all times in order to
p.000005: deliver high-quality science. Everyone involved in MRC-funded research must recognise and accept personal
p.000005: responsibility for the integrity of the research record, whether this is used as the basis for the further development
p.000005: of scientific knowledge, for improvements in healthcare, or the prevention of disease.
p.000005:
p.000005: Respect, ethics and professional standards:
p.000005:
p.000005: All research supported by the MRC must respect and maintain the dignity, rights, safety and wellbeing of all involved,
p.000005: or who could be affected by it.
p.000005: All researchers should be familiar with, and know how to access, the relevant legal and ethical requirements. They must
p.000005: take appropriate steps to work within these frameworks to manage data and records appropriately, maintain
p.000005: confidentiality and to minimise any adverse impact their work may have on people, animals and the natural environment;
p.000005: and to work with those with corporate responsibility within their organisations for meeting the requirements of the
p.000005: frameworks. Risks relating to the potential for research outcomes to be misused for harmful purposes must be recognised
p.000005: and managed.
p.000005:
p.000005: Honesty and transparency:
p.000005:
p.000005: All of those involved in MRC-funded research should be honest in respect of their own actions and their responses to
p.000005: the actions of others. The research community must foster and support a culture of transparency and honesty which
p.000005: promotes good practice, recognises relevant interests or conflicts and deals with these openly and explicitly. This
p.000005: applies across the whole range of research activity from study and experimental design, generating, analysing and
p.000005: recording (including archiving) data, sharing data and materials, applying for funding, publishing findings,
p.000005: acknowledging the contributions of others and engaging in the peer review process.
p.000005: Procedures for reporting and investigating allegations of research misconduct should be clear, thorough, fair,
p.000005: constructive, conclusive and timely. Any remedial action should be promptly implemented.
p.000005:
p.000005: Openness and accountability:
p.000005:
p.000005: MRC-funded researchers are expected to foster the exchange of ideas and to be as open as possible in discussing their
p.000005: work with other scientists and the public.
p.000005: The findings of MRC-funded research must be made available to the research community and the public, in a timely
p.000005: manner. A complete, balanced and accurate account of scientific evidence must be presented to support the appropriate
p.000005: and effective use of this knowledge.
p.000005:
p.000005:
p.000005:
p.000005:
p.000006: 6
p.000006: Good research practice: principles and guidelines
p.000006:
p.000006:
p.000006:
p.000006: To maximise public benefit, the MRC supports open access to the published outputs of research as well as initiatives
p.000006: that aim to extend access to the valuable, and often unique, data, materials and resources generated in the course of
p.000006: MRC-funded work. Extending access, through initiatives such as data sharing, promotes the efficient use of resources
p.000006: for new research, assures the quality of research outputs and helps to maximise the impact of outputs on health.
p.000006: All involved in research have a responsibility to ensure the efficient and proper use of resources provided from public
p.000006: and charitable funds. Those planning and delivering research must make efforts to maximise effectiveness and avoid
p.000006: waste, including reviewing project progress and appropriate business continuity planning.
p.000006: Researchers should proactively engage openly in communication with the public to discuss the issues their work raises
p.000006: for society, and to listen to the aspirations and concerns of patients, carers, study participants and others in
p.000006: relation to the research.
p.000006:
p.000006: Supporting training and skills:
p.000006:
p.000006: All of those engaged in MRC-funded research have a responsibility to develop and maintain the skills they need in their
p.000006: research and to assist others with their personal development. Research organisations, managers and research leaders
p.000006: are expected to provide the direction, resources, training and opportunities for development to support their teams in
p.000006: conducting their work to the highest standards. Research organisations, supervisors and research team leaders should
p.000006: recognise and deliver on their responsibilities for mentoring and staff development and ensure students, new
p.000006: researchers, support, technical and administrative staff are supported in understanding and adopting good practice at
p.000006: an early stage and throughout their career.
p.000006:
p.000006:
p.000006: Related links
p.000006: (1) RCUK policy and code of conduct on the governance of good research conduct, Integrity, Clarity and Good Management
...
p.000006: (7) Committee for Standards in Public Life: https://www.gov.uk/government/organisations/the-committee-
p.000006: on-standards-in-public-life
p.000006: (8) MRC Code of Conduct for Employees: www.mrc.ac.uk
p.000006: (9) MRC position statement on bioterrorism and biomedical research (2005): http://www.mrc.ac.uk/
p.000006: research/research-policy-ethics/bioterrorism/
p.000006: (10) The Concordat to support career development for researchers, an agreement between the funders and employers of
p.000006: research in the UK (2008): https://www.vitae.ac.uk/policy/concordat-to-support-the-career- development-of-researchers
p.000006:
p.000006:
p.000006:
p.000006: Section 2: Guidelines and standards
p.000007: 7
p.000007:
p.000007: Section 2
p.000007: Guidelines and standards
p.000007: These guidelines and standards outline how the principles above should be applied within MRC research units and
p.000007: institutes and clarify the MRC’s expectations for MRC-funded research within universities, medical schools, hospitals
p.000007: and other research organisations.
p.000007: They apply to everyone involved in MRC-funded research including researchers, research support staff, students,
p.000007: research managers and administrators.
p.000007:
p.000007:
p.000007: A Planning and conducting MRC-funded research
p.000007: A.1 Those planning and delivering MRC-funded research should have the necessary expertise, professional skills and
p.000007: experience to deliver the project proposed. This may include seeking specialist advice or securing access to expertise
p.000007: through collaboration. Plans should include an assessment of all resources needed (including staff, space, funding,
p.000007: facilities, biological resources and clinical support) to ensure the study is viable within the available means and the
p.000007: efficient and proper use of all resources. This position should be reviewed as the project progresses. Researchers
p.000007: supported by the MRC should consider at an early stage of the design of the project how they will adhere to the
p.000007: principles and standards of Good Research Practice over the course of their research and aim to anticipate any issues
p.000007: or challenges that might arise.
p.000007: A.2 The rationale for the study and any subsequent modifications must be clearly documented within a well
p.000007: maintained system, for example in project proposals, contracts, protocol documents, laboratory notebooks or as
p.000007: electronic records. All projects must be documented clearly, systematically and in a timely manner, including clear
p.000007: outcomes and end points, plans for statistical analysis, any ethical and regulatory approvals and any subsequent
p.000007: amendments. Key records or documents should be held in an accessible form. Any changes should be validated and recorded
p.000007: with appropriate version control by the researcher responsible, to establish the provenance of the study and protect
p.000007: intellectual property.
p.000007: A.3 MRC-funded research must adhere to current ethical standards, safety practices, relevant legal requirements,
p.000007: local organisational policies and other guidelines. Researchers should ensure they are aware of, and keep up to date
...
p.000010: • Studies which propose retention periods beyond 20 years must include valid justification, for example, research data
p.000010: relating to longitudinal studies will often be retained indefinitely and archived and managed accordingly.
p.000010: Where complete retention of all research data is not appropriate, the data must be validated using quality assurance
p.000010: procedures and the justification carefully assessed before any data are destroyed. Further guidance relating to
p.000010: retention periods can be found in the Clinical Trials and Data and Tissues tool kits.
p.000010: Research data relating to studies which directly inform national policymaking should be considered for permanent
p.000010: preservation or deposit in an archive or repository: discussions may need to involve staff across the MRC, including
p.000010: experts in data management and research governance. In some cases the potential
p.000010:
p.000010:
p.000010:
p.000010: Section 2: Guidelines and standards
p.000011: 11
p.000011:
p.000011:
p.000011:
p.000011:
p.000011: impact on policy may be a clear aim of the study, while in others the significance may only come to light later. It may
p.000011: therefore be necessary to consider the impact of the study at several stages during its life- cycle, particularly for
p.000011: studies which have long-term goals and which may be running for many years.
p.000011:
p.000011: Retention, storage and archiving
p.000011: • All primary/raw data and related materials retained, stored or archived should be recorded and held securely, in such
p.000011: a way as to allow them to be understood and used by others in future. This would include information about regulatory
p.000011: and ethical requirements relating to access and use.
p.000011: • Research data held electronically should be backed up regularly and duplicate copies held in a secure and accessible
p.000011: format where possible.
p.000011: • The digital continuity and future accessibility of electronic records and data should be considered.
p.000011:
p.000011:
p.000011:
p.000011: B.4 Research data (including images) should be recorded and retained. Retention periods should be informed by
p.000011: data management and quality assurance needs. Where primary/raw data are subsequently enhanced, original and enhanced
p.000011: data should be stored together. It is important to avoid the over-enhancement or over-interpretation of data and
p.000011: images.
p.000011: B.5 It is essential to manage confidential identifiable data appropriately, including data associated with tissue
p.000011: and biological samples. A number of tool kits have been developed to provide a guide to the regulatory environment
p.000011: including the MRC Data and Tissues tool kit (24) which outlines the requirements for use
p.000011: of confidential identifiable data and human tissue samples in healthcare research. The tool kit route maps are aimed at
p.000011: guiding researchers through the planning and approvals process and provide practical help on legislative and good
p.000011: practice requirements as well as a summary of MRC policies in this area.
p.000011: Publication of any research data, including in Masters/Doctoral theses or in an accessible data repository, does not
p.000011: negate the need to retain primary/raw data.
p.000011: B.6 Local procedures (for example, Standard Operating Procedures, protocols, etc) for all routine methods to be
p.000011: replicated across a study, together with associated risk assessments, should be documented systematically, in plain
p.000011: English and ideally in a standard format to ensure clarity, consistency and accuracy. Where there is more than one
p.000011: approved technique for any given procedure within the organisation, clear records should be kept on which were used.
p.000011: Where procedures change, they should be version controlled and the current version should be available and readily
p.000011: accessible to all staff, students and visiting workers.
p.000011: B.7 Protocols for the use, calibration and maintenance of equipment, together with associated risk assessments,
p.000011: must be clearly documented to ensure optimal performance and research data quality. Where protocols change they should
p.000011: be version controlled and the current version should be available and readily accessible. Instructions for the safe
p.000011: shutdown of equipment in case of emergency should be readily accessible. Such quality assurance measures as outlined in
p.000011: B.6 and B.7 help demonstrate the robustness and validity of research data.
p.000011: B.8 To maximise public benefit the MRC supports open access (27) to the published outputs of research in a timely
p.000011: manner as well as initiatives that aim to extend access to research data and resources generated in the course of
p.000011: MRC-funded work. These may include the preservation and sharing of datasets and other relevant materials in line with
p.000011: the MRC’s policy on research data sharing (17). Where it is possible to share data and materials, guidance must be
p.000011: provided to ensure they are used appropriately, with proper regard for issues relating to consent, confidentiality and
p.000011: in accordance with any relevant data security guidelines, including guidance on encryption and data management, and
p.000011: other relevant conditions.
p.000011: B.9 There should be clarity on the ownership and custodianship of research data, samples and related material
p.000011: used or created in the course of the research. Agreements should be used to clarify
p.000011:
p.000011:
p.000011:
p.000011:
p.000012: 12
p.000012: Good research practice: principles and guidelines
p.000012:
p.000012:
p.000012:
p.000012: responsibilities, arrangements for access to data and managing permissions, including sharing with collaborators or
p.000012: with researchers who move away from the original organisation. Agreements should be developed at an early stage and
p.000012: should take account of requirements imposed by the research funder in their terms and conditions. Agreements might
p.000012: outline the responsibilities of steering groups, research
p.000012: investigators and team leaders in relation to these issues. Where personal data and/or biological samples are involved,
p.000012: the terms of the consent must be taken into account. Model agreements, such as those developed by UKCRC working groups,
p.000012: should be considered where relevant (29).
p.000012: B.10 Where an MRC unit is due to close or where programmes end and programme leaders or principal investigators
p.000012: transfer or retire, arrangements must be made in advance to support the retention and management of samples and data.
p.000012: This may include the transfer of custodianship to another individual within the unit or to another organisation and
p.000012: arrangements should detail provisions for access and eventual destruction. Where relevant the Data Controller and/or
p.000012: the Designated Individual of the new organisation should be notified.
p.000012: Further guidance on MRC policy on research data sharing, preservation and management can be found on the MRC website.
p.000012:
p.000012:
p.000012: Related links
p.000012: (11) RCUK and MRC terms and conditions for grants: http://www.rcuk.ac.uk/funding/grantstcs/
p.000012: (16) MRC Regulatory Support Centre resources and tool kits: http://www.mrc.ac.uk/research/facilities/
p.000012: regulatory-support-centre/
p.000012: (17) MRC policy on research data sharing and preservation: http://www.mrc.ac.uk/research/research-policy-
p.000012: ethics/data-sharing/
p.000012: (23) MRC Guidance on data sharing requirements for population and patient studies http://www.mrc.ac.uk/
p.000012: research/research-policy-ethics/data-sharing/population-patient-studies/
p.000012: (24) MRC Data and Tissues tool kit: www.dt-toolkit.ac.uk
p.000012: (25) UK Clinical Trials tool kit: www.ct-toolkit.ac.uk
p.000012: (26) MRC Information Security Policy: www.mrc.ac.uk
p.000012: (27) MRC policy on open access publishing: http://www.mrc.ac.uk/research/research-policy-ethics/open- access-policy/
p.000012: (28) Europe PubMedCentral: http://europepmc.org/
p.000012: (29) UK Clinical Research Collaboration Model Agreements: http://www.ukcrc.org/regulation-governance/ model-agreements/
p.000012:
p.000012:
p.000012:
p.000012: C Collaborative working
p.000012: C.1 MRC-funded research often involves collaboration, which can range in scale from simple discussions through to
p.000012: significant long-term partnerships. In some cases collaborations can raise significant risks and challenges for
p.000012: research governance. Discussion, and where necessary written agreements, should be used to clarify and agree key
p.000012: aspects, including responsibilities, common approaches or standards and procedures. Differences in practice or
p.000012: expectations should be identified and if necessary resolved. This is especially important where the work involves
p.000012: researchers from different disciplines, organisations and/ or countries. Agreements must be drawn up and signed by
p.000012: properly authorised signatories within the research organisation and representatives of the collaborating organisation
p.000012: and finalised prior to the commencement of the work.
p.000012:
p.000012:
p.000012:
p.000012: Section 2: Guidelines and standards
p.000013: 13
p.000013:
p.000013:
p.000013:
p.000013: C.2 Most collaborations will usually require some of the following to be addressed during the course of the
p.000013: research. Formal collaboration agreements may include:
p.000013: • Scope, duration and aims of the proposed project.
p.000013: • Finance and in-kind resource commitments.
p.000013: • Key tasks and responsibilities of the partners (including sponsorship arrangements where appropriate).
p.000013: • Project management arrangements, including lines of accountability and communication.
p.000013: • Training requirements and responsibilities.
...
p.000016: Appropriate training must be provided on safety measures for research which involves potentially hazardous or harmful
p.000016: materials and processes, and for research in risky settings or locations. In highly collaborative environments clear
p.000016: communication of appropriate procedures is essential.
p.000016: F.2 The MRC Safety, Security and Resilience Team is responsible for central planning and policy development
p.000016: within MRC research units and institutes. They also support compliance assurance and provide advice and training to
p.000016: local teams and to MRC-staff. MRC policies, resources and training available within MRC research units and institutes
p.000016: can be found on the MRC’s website (42).
p.000016: F.3 Research organisations hosting MRC research are responsible for health and safety policy and procedures.
p.000016: Researchers undertaking activities within another research organisation must cooperate fully with the host on all
p.000016: health and safety matters.
p.000016: F.4 Research organisations should have robust business continuity plans in place to ensure any interruptions to
p.000016: the operations of a project or programme are handled appropriately and that any impact on the research outcomes is
p.000016: minimised.
p.000016:
p.000016:
p.000016: Related links
p.000016: (42) MRC guidance on safety, security and resilience: http://www.mrc.ac.uk/skills-careers/working-for-mrc/
p.000016: safety-security-resilience/
p.000016:
p.000016:
p.000016:
p.000016: G Reporting and disseminating research
p.000016: G.1 Arrangements and responsibilities for the publication of results relating to MRC-funded research, including
p.000016: outline plans for public engagement activities and payment of open access fees, should be taken into account when
p.000016: planning the study and agreed at the outset. Arrangements should be made at an early stage and involve all
p.000016: investigators and should be revisited where roles and contributions change over the life cycle of the study; this is
p.000016: particularly important for collaborative and multidisciplinary projects.
p.000016: G.2 Discussions may be needed to address authorship, including lead responsibility, authorisation for the content
p.000016: of papers and the intended place of publication and any pre-existing obligations. Arrangements should outline
p.000016: responsibilities for ensuring accuracy of methods, integrity of results, adequacy of internal peer review, appropriate
p.000016: protection of intellectual property, authorship and arrangements for the timely correction of any errors or retraction.
p.000016: For collaborative and multidisciplinary projects differences in publication practice across disciplines or institutions
p.000016: should be identified and addressed at an early stage.
p.000016: G.3 Authorship should include all individuals who have made a substantial intellectual contribution and all
p.000016: authors are expected to take public responsibility for their contribution to the work. The MRC endorses the guidance of
p.000016: the Committee on Publication Ethics (43) and the International Committee of Medical Journal Editors (ICMJE) (44). The
p.000016: MRC endorses the ICMJE guidelines on authorship and contributorship; the practice of ‘honorary authorship’ is not
p.000016: acceptable. All contributions to the research must be clearly acknowledged and appropriate permissions sought for the
...
p.000017: understand the factors that may have influenced the research team and would include any interests that might be
p.000017: considered by others, including the public, to be a conflict. Research findings that are likely
p.000017: to attract strong public or media interest should be drawn to the attention of the MRC and/or other research funders
p.000017: before publication.
p.000017: G.6 The final results of MRC-funded research must be collated, summarised and subjected to quality assurance and,
p.000017: where appropriate, peer review. A conclusion should be drawn and the outcome confirmed by the research team. The MRC
p.000017: encourages the publication of all research findings, including findings that do not support the initial hypotheses to
p.000017: allow others to benefit from the work and to avoid unnecessary repetition.
p.000017: G.7 The outcomes of MRC-funded research should normally be published as a coherent entity rather than as part of a
p.000017: series, unless there is a legitimate need to demonstrate first discovery by publishing preliminary data. Quality is
p.000017: paramount and the proliferation of papers to increase the quantity of publications is discouraged. Duplicate or
p.000017: redundant submission or publication is not acceptable as it may distort the evidence base upon which meta-analyses
p.000017: rely.
p.000017: G.8 Agreed standards for reporting the outcomes of research in specific areas have been developed and should be
p.000017: observed. Standards endorsed and supported by the MRC include the CONSORT Statement (CONsolidated Standards of
p.000017: Reporting Trials) (46) and the ARRIVE guidelines (Animal Research: Reporting in-vivo experiments) (47).
p.000017:
p.000017:
p.000017: Related links
p.000017: (27) MRC policy on open access publishing: http://www.mrc.ac.uk/research/research-policy-ethics/open- access-policy/
p.000017: (28) Europe PubMedCentral: http://europepmc.org/
p.000017: (43) Committee on Publication Ethics, Code of conduct and related guidelines and resources:
p.000017: publicationethics.org/resources/code-conduct
p.000017: (44) International Committee of Medical Journal Editors, guidance on ethical considerations and international
p.000017: standards: www.icmje.org/index.html
p.000017: (45) Researchfish: www.researchfish.com
p.000017: (46) CONSORT (CONsolidated Standards of Reporting Trials) Statement (2010): www.consort-statement.
p.000017: org/consort-statement
p.000017: (47) ARRIVE: Animal Research: Reporting in-vivo experiments (2010): www.nc3rs.org.uk/downloaddoc.
p.000017: asp?id=1206&page=1357&skin=0
p.000017:
p.000017:
p.000017:
p.000017: H Translation of research findings and management of intellectual property
p.000017: H.1 MRC-funded researchers have a responsibility to ensure that any findings which have a potential impact on
p.000017: clinical practice, public policy or the development of new treatments or preventive interventions are actively
p.000017: disseminated to the relevant user community. Plans for translation of such findings should be put in place in order to
p.000017: ensure that potential benefits for health or healthcare are realised as quickly as possible.
p.000017: H.2 The potential for MRC-funded research to generate intellectual property of value should be anticipated
p.000017: throughout the life cycle of the project. Researchers should ensure they are aware of the ownership and
p.000017:
p.000017:
p.000017:
p.000017:
p.000018: 18
p.000018: Good research practice: principles and guidelines
p.000018:
p.000018:
p.000018:
...
p.000023: 23
p.000023:
p.000023: Section 4
p.000023: Further advice and resources
p.000023: In addition to specific research management expertise available within MRC research units, institutes and regional
p.000023: centres, other resources which aim to provide advice on specific aspects of good research practice are available to MRC
p.000023: researchers and the wider biomedical research community, including:
p.000023:
p.000023: The MRC Regulatory Support Centre
p.000023:
p.000023: The MRC Regulatory Support Centre (RSC) (16) provides support to MRC-funded researchers and to the wider scientific
p.000023: community on the legislative and good practice requirements specifically relating to research involving human
p.000023: participants, their tissues or data. The RSC works with MRC research units and institutes, regulators and the wider UK
p.000023: research community to share good practice and develop practical tools and e-learning in areas such as research use of
p.000023: personal data and tissue samples, experimental medicine and stem cells. The RSC provides advice to MRC-staff and
p.000023: provides training on regulation, ethics and governance.
p.000023:
p.000023: UK Research Integrity Office
p.000023:
p.000023: The UK Research Integrity Office (UKRIO) (5) provides expert advice and guidance to UK researchers, practice and
p.000023: improving research integrity in academic, scientific and medical research.
p.000023:
p.000023: EQUATOR Network
p.000023:
p.000023: The EQUATOR Network (52) provides guidance on resources for reporting of health research studies).
p.000023:
p.000023: Learning and Development for MRC research units and institutes
p.000023:
p.000023: The Learning and Development Group provides access to training and resources for MRC staff to support training and
p.000023: development.
p.000023:
p.000023: NC3Rs
p.000023:
p.000023: The National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs) (41) is an independent
p.000023: scientific organisation supporting the UK science base in the application of the 3Rs. It provides information, advice
p.000023: and funding in the field.
p.000023:
p.000023:
p.000023: Related links
p.000023: (5) UK Research Integrity Office, Code of practice for research: Promoting good practice and preventing misconduct
p.000023: (2009) and Recommended Checklist for Researchers: http://www.ukrio.org/publications/code- of-practice-for-research/
p.000023: (16) MRC Regulatory Support Centre resources and tool kits: http://www.mrc.ac.uk/research/facilities/
p.000023: regulatory-support-centre/
p.000023: (41) National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs):
p.000023: www.nc3rs.org.uk
p.000023: (52) EQUATOR Network guidance on reporting: www.equator-network.org
p.000023:
p.000023:
p.000023:
p.000023:
p.000024: 24
p.000024: Good research practice: principles and guidelines
p.000024:
p.000024:
p.000024: Section 5
p.000024: Related documents and references
p.000024:
p.000024: (1) RCUK policy and code of conduct on the governance of good research conduct, Integrity, Clarity and Good Management
p.000024: (2013): http://www.rcuk.ac.uk/RCUK-prod/assets/documents/reviews/grc/
p.000024: RCUKPolicyandGuidelinesonGovernanceofGoodResearchPracticeFebruary2013.pdf
p.000024: (2) MRC policy on health department research governance frameworks: http://www.mrc.ac.uk/research/
p.000024: research-policy-ethics/clinical-research-governance/
...
p.000024: to consent, Medical research involving children: http://www.mrc.ac.uk/research/research-policy- ethics/
p.000024: (16) MRC Regulatory Support Centre resources and tool kits: http://www.mrc.ac.uk/research/facilities/
p.000024: regulatory-support-centre/
p.000024: (17) MRC policy on research data sharing and preservation: http://www.mrc.ac.uk/research/research-policy-
p.000024: ethics/data-sharing/
p.000024: (18) UK research funders vision for human tissue resources: http://www.ukcrc.org/research-infrastructure/
p.000024: experimental-medicine/funders-vision-for-human-tissue-resources/
p.000024:
p.000024:
p.000024:
p.000024: Section 5: Related documents and references
p.000025: 25
p.000025:
p.000025:
p.000025:
p.000025:
p.000025: (19) RCUK Concordat and guidance on engaging the public with research: http://www.rcuk.ac.uk/pe/ Concordat/
p.000025: (20) NIHR guidance on patient and public awareness: http://www.nihr.ac.uk/get-involved/
p.000025: (21) INVOLVE: Promoting public involvement in research: www.invo.org.uk/resource-centre
p.000025: (22) NIHR Clinical Research Network: http://www.crn.nihr.ac.uk/
p.000025: (23) MRC Guidance on data sharing requirements for population and patient studies http://www.mrc.ac.uk/
p.000025: research/research-policy-ethics/data-sharing/population-patient-studies/
p.000025: (24) MRC Data and Tissues tool kit: www.dt-toolkit.ac.uk
p.000025: (25) UK Clinical Trials tool kit: www.ct-toolkit.ac.uk
p.000025: (26) MRC Information Security Policy: www.mrc.ac.uk
p.000025: (27) MRC policy on open access publishing: http://www.mrc.ac.uk/research/research-policy-ethics/open- access-policy/
p.000025: (28) Europe PubMedCentral: http://europepmc.org/
p.000025: (29) UK Clinical Research Collaboration Model Agreements: http://www.ukcrc.org/regulation-governance/ model-agreements/
p.000025: (30) NIHR model Industrial Collaborative Research Agreement (mICRA): http://www.nihr.ac.uk/policy-and-
p.000025: standards/standard-research-agreements.htm
p.000025: (31) The European Science Foundation Code of Conduct for Research Integrity (2011): http://www.esf.org/
p.000025: coordinating-research/mo-fora/research-integrity.html
p.000025: (32) OECD Global Science Forum, Investigating Research Misconduct Allegations in International Collaborative Research
p.000025: Projects: A PRACTICAL GUIDE (2009): http://www.oecd.org/science/sci-tech/
p.000025: researchintegritypreventingmisconductanddealingwithallegations.htm
p.000025: (33) Singapore Statement on Research Integrity, developed following the 2nd World Conference on Research Integrity:
p.000025: www.singaporestatement.org
p.000025: (34) For example: General Medical Council, Guidance on Good Practice in Research and related guidance on consent and
p.000025: confidentiality: www.gmc-uk.org/guidance/ethical_guidance/5992.asp
p.000025: (35) For example: Department of Health Information Governance tool kit for research involving NHS patients and patient
p.000025: data: https://www.igt.hscic.gov.uk/
p.000025: (36) For example: WHO research review ethics committee guidance on Ethical standards and procedures forresearch with
p.000025: human beings: www.who.int/ethics/research/en
p.000025: (37) Clinical trials for medicines, UK legislation: www.mhra.gov.uk/Howweregulate/Medicines/
p.000025: Licensingofmedicines/Clinicaltrials/Legislation/index.htm
...
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p.000007: local organisational policies and other guidelines. Researchers should ensure they are aware of, and keep up to date
p.000007: with, all the regulatory, ethical and governance requirements that may apply to their area of research and are working
p.000007: with the teams and individuals within their organisations who have a corporate responsibility to ensure that these
p.000007: requirements are adhered to within the organisations. All appropriate licences and permissions must be in place before
p.000007: the research starts and updated as necessary if plans change. The expectations and requirements of professional codes
p.000007: of conduct and standards, including arrangements for managing consent and information governance should be addressed in
p.000007: the planning and conduct of the study (see section D below).
p.000007: A.4 For all research involving people as participants, their tissues or data, the relevant principles of Good
p.000007: Clinical Practice (GCP), an international ethical and scientific quality standard for designing, conducting, recording
p.000007: and reporting trials that involve the participation of human subjects, should be followed (13). Where practicable,
p.000007: consent that is freely given and informed should be sought from all competent participants. Guidance on writing
p.000007: participant information is available from
p.000007: the National Research Ethics Service (NRES)(14); this includes guidance for research that involves adults who lack
p.000007: capacity to give consent or children (15). Consent discussions should include how feedback on any health related
p.000007: finding will be handled, what withdrawal from a study will mean
p.000007: in practice and that this can occur at any time and for any reason up to the point of data analysis or up to the point
p.000007: of submission for publication. In line with the MRC’s policy on data and tissue
p.000007:
p.000007:
p.000007:
p.000007:
p.000008: 8
p.000008: Good research practice: principles and guidelines
p.000008:
p.000008:
p.000008:
p.000008: sharing, participants should also be made aware of potential reuse in future research and the arrangements for consent.
p.000008:
p.000008: A.6 Responsibilities for overseeing the scientific and ethical conduct of the study must be identified, allocated
p.000008: and agreed as the scientific plans are put into practice. This is especially important in projects involving patients,
p.000008: volunteers or confidential or identifiable data, tissue, biological samples and animals and in other complex,
p.000008: collaborative programmes.
p.000008: A.7 Research organisations should have appropriate research governance systems, in which roles are allocated to
p.000008: meet corporate and individual project responsibilities, and are accepted and carried out within a sound research and
p.000008: project management framework. This may involve the identification of sponsors, appropriate and proportionate quality,
p.000008: risk management and monitoring systems, or the use of preferred project management processes or tools. When considering
p.000008: proportionate risks important aspects to consider include the impact on research delivery, supporting creativity, the
...
p.000008: (2013): http://www.rcuk.ac.uk/RCUK-prod/assets/documents/reviews/grc/
p.000008: RCUKPolicyandGuidelinesonGovernanceofGoodResearchPracticeFebruary2013.pdf
p.000008: (2) MRC policy on health department research governance frameworks: http://www.mrc.ac.uk/research/
p.000008: research-policy-ethics/clinical-research-governance/
p.000008: (4) Universities UK Concordat to Support Research Integrity: http://www.universitiesuk.ac.uk/
p.000008: highereducation/Documents/2012/TheConcordatToSupportResearchIntegrity.pdf
p.000008: (5) UK Research Integrity Office, Code of practice for research: Promoting good practice and preventing misconduct
p.000008: (2009) and Recommended Checklist for Researchers: http://www.ukrio.org/publications/code- of-practice-for-research/
p.000008: (11) RCUK and MRC terms and conditions for grants: http://www.rcuk.ac.uk/funding/grantstcs/
p.000008: (12) RCUK statement of expectation on economic and societal impact: http://www.rcuk.ac.uk/Publications/
p.000008: archive/StatementofExpectationon/
p.000008: (13) Good Clinical Practice principles: www.ichgcp.net
p.000008: (14) HRA guidance on consent: http://www.hra.nhs.uk/resources/before-you-apply/consent-and-
p.000008: participation/consent-and-participant-information/
p.000008: (15) MRC ethics series; Personal information in medical research, Medical research involving adults who lack capacity
p.000008: to consent, Medical research involving children: http://www.mrc.ac.uk/research/research-policy- ethics/
p.000008: (16) MRC Regulatory Support Centre resources and tool kits: http://www.mrc.ac.uk/research/facilities/
p.000008: regulatory-support-centre/
p.000008:
p.000008:
p.000008:
p.000008: Section 2: Guidelines and standards
p.000009: 9
p.000009:
p.000009:
p.000009:
p.000009:
p.000009: (17) MRC policy on research data sharing and preservation: http://www.mrc.ac.uk/research/research-policy-
p.000009: ethics/data-sharing/
p.000009: (18) UK research funders vision for human tissue resources: http://www.ukcrc.org/research-infrastructure/
p.000009: experimental-medicine/funders-vision-for-human-tissue-resources/
p.000009: (19) RCUK Concordat and guidance on engaging the public with research: http://www.rcuk.ac.uk/pe/ Concordat/
p.000009: (20) NIHR guidance on patient and public awareness: http://www.nihr.ac.uk/get-involved/
p.000009: (21) INVOLVE: Promoting public involvement in research: www.invo.org.uk/resource-centre
p.000009: (22) NIHR Clinical Research Network: http://www.crn.nihr.ac.uk/
p.000009:
p.000009:
p.000009:
p.000009:
p.000009: B Data: management, integrity, retention and preservation
p.000009: B.1 MRC-funded research covers a broad spectrum, including fundamental lab-based science, population health
p.000009: science, patient-based studies and clinical trials. All research data generated through MRC-funded research must be
p.000009: managed and curated effectively throughout its lifecycle, including archiving, to ensure integrity, security and
p.000009: quality and where possible to support new research and research data sharing (17)
p.000009: (23) to maximise the benefit and impact of MRC research funding. Records should be kept to enable understanding of what
...
p.000015: research-policy-ethics/clinical-research-governance/
p.000015: (6) MRC ethics and research guidance: http://www.mrc.ac.uk/research/research-policy-ethics/
p.000015: (8) MRC Code of Conduct for Employees: www.mrc.ac.uk
p.000015: (24) MRC Data and Tissues tool kit: www.dt-toolkit.ac.uk
p.000015: (34) For example: General Medical Council, Guidance on Good Practice in Research and related guidance on consent and
p.000015: confidentiality: www.gmc-uk.org/guidance/ethical_guidance/5992.asp
p.000015: (35) For example: Department of Health Information Governance tool kit for research involving NHS patients and patient
p.000015: data: https://www.igt.hscic.gov.uk/
p.000015: (36) For example: WHO research review ethics committee guidance on Ethical standards and procedures for research with
p.000015: human beings: www.who.int/ethics/research/en
p.000015: (37) Clinical trials for medicines, UK legislation: www.mhra.gov.uk/Howweregulate/Medicines/
p.000015: Licensingofmedicines/Clinicaltrials /Legislation/index.htm
p.000015: (38) MRC policy on UK clinical trials regulations: http://www.mrc.ac.uk/research/research-policy-ethics/
p.000015: clinical-research-governance/clinical-trials-regulations/
p.000015: (39) MRC policy on consent to take part in research, including research involving children, adults who lack capacity
p.000015: to consent and the use of personal information in research: http://www.mrc.ac.uk/research/ research-policy-ethics/
p.000015: (40) MRC policy and guidance on the use of animals in research, including guidance on the responsibility and use of
p.000015: animal in research: http://www.mrc.ac.uk/research/research-policy-ethics/use-of-animals/
p.000015: (41) National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs):
p.000015: www.nc3rs.org.uk
p.000015:
p.000015:
p.000015:
p.000015: E Research misuse
p.000015: E.1 The risks of research outcomes being misused for harmful purposes, for example bioterrorism, must be
p.000015: considered throughout the whole life-cycle of an MRC-funded study. Mechanisms must be in place to ensure that a
p.000015: thorough risk assessment is undertaken, any risks of misuse are identified and actively
p.000015: managed, and that advice is available to research teams to take appropriate steps to minimise identified risks. The MRC
p.000015: position statement on bioterrorism and biomedical research provides advice on balancing benefit and risk in relation to
p.000015: potential misuse (9).
p.000015:
p.000015:
p.000015: Related links
p.000015: (9) MRC position statement on bioterrorism and biomedical research (2005): http://www.mrc.ac.uk/
p.000015: research/research-policy-ethics/bioterrorism/
p.000015:
p.000015:
p.000015:
p.000015:
p.000016: 16
p.000016: Good research practice: principles and guidelines
p.000016:
...
p.000024: (7) Committee for Standards in Public Life: https://www.gov.uk/government/organisations/the-committee-
p.000024: on-standards-in-public-life
p.000024: (8) MRC Code of Conduct for Employees: www.mrc.ac.uk
p.000024: (9) MRC position statement on bioterrorism and biomedical research (2005): http://www.mrc.ac.uk/
p.000024: research/research-policy-ethics/bioterrorism/
p.000024: (10) The Concordat to support career development for researchers, an agreement between the funders and employers of
p.000024: research in the UK (2008): https://www.vitae.ac.uk/policy/concordat-to-support-the-career- development-of-researchers
p.000024: (11) RCUK and MRC terms and conditions for grants: http://www.rcuk.ac.uk/funding/grantstcs/
p.000024: (12) RCUK statement of expectation on economic and societal impact: http://www.rcuk.ac.uk/Publications/
p.000024: archive/StatementofExpectationon/
p.000024: (13) Good Clinical Practice principles: www.ichgcp.net
p.000024: (14) HRA guidance on consent: http://www.hra.nhs.uk/resources/before-you-apply/consent-and-
p.000024: participation/consent-and-participant-information/
p.000024: (15) MRC ethics series; Personal information in medical research, Medical research involving adults who lack capacity
p.000024: to consent, Medical research involving children: http://www.mrc.ac.uk/research/research-policy- ethics/
p.000024: (16) MRC Regulatory Support Centre resources and tool kits: http://www.mrc.ac.uk/research/facilities/
p.000024: regulatory-support-centre/
p.000024: (17) MRC policy on research data sharing and preservation: http://www.mrc.ac.uk/research/research-policy-
p.000024: ethics/data-sharing/
p.000024: (18) UK research funders vision for human tissue resources: http://www.ukcrc.org/research-infrastructure/
p.000024: experimental-medicine/funders-vision-for-human-tissue-resources/
p.000024:
p.000024:
p.000024:
p.000024: Section 5: Related documents and references
p.000025: 25
p.000025:
p.000025:
p.000025:
p.000025:
p.000025: (19) RCUK Concordat and guidance on engaging the public with research: http://www.rcuk.ac.uk/pe/ Concordat/
p.000025: (20) NIHR guidance on patient and public awareness: http://www.nihr.ac.uk/get-involved/
p.000025: (21) INVOLVE: Promoting public involvement in research: www.invo.org.uk/resource-centre
p.000025: (22) NIHR Clinical Research Network: http://www.crn.nihr.ac.uk/
p.000025: (23) MRC Guidance on data sharing requirements for population and patient studies http://www.mrc.ac.uk/
p.000025: research/research-policy-ethics/data-sharing/population-patient-studies/
p.000025: (24) MRC Data and Tissues tool kit: www.dt-toolkit.ac.uk
p.000025: (25) UK Clinical Trials tool kit: www.ct-toolkit.ac.uk
p.000025: (26) MRC Information Security Policy: www.mrc.ac.uk
p.000025: (27) MRC policy on open access publishing: http://www.mrc.ac.uk/research/research-policy-ethics/open- access-policy/
...
p.000025: coordinating-research/mo-fora/research-integrity.html
p.000025: (32) OECD Global Science Forum, Investigating Research Misconduct Allegations in International Collaborative Research
p.000025: Projects: A PRACTICAL GUIDE (2009): http://www.oecd.org/science/sci-tech/
p.000025: researchintegritypreventingmisconductanddealingwithallegations.htm
p.000025: (33) Singapore Statement on Research Integrity, developed following the 2nd World Conference on Research Integrity:
p.000025: www.singaporestatement.org
p.000025: (34) For example: General Medical Council, Guidance on Good Practice in Research and related guidance on consent and
p.000025: confidentiality: www.gmc-uk.org/guidance/ethical_guidance/5992.asp
p.000025: (35) For example: Department of Health Information Governance tool kit for research involving NHS patients and patient
p.000025: data: https://www.igt.hscic.gov.uk/
p.000025: (36) For example: WHO research review ethics committee guidance on Ethical standards and procedures forresearch with
p.000025: human beings: www.who.int/ethics/research/en
p.000025: (37) Clinical trials for medicines, UK legislation: www.mhra.gov.uk/Howweregulate/Medicines/
p.000025: Licensingofmedicines/Clinicaltrials/Legislation/index.htm
p.000025: (38) MRC policy on UK clinical trials regulations: http://www.mrc.ac.uk/research/research-policy-ethics/
p.000025: clinical-research-governance/clinical-trials-regulations/
p.000025: (39) MRC policy on consent to take part in research, including research involving children, adults who lack capacity
p.000025: to consent and the use of personal information in research: http://www.mrc.ac.uk/research/ research-policy-ethics/
p.000025: (40) MRC policy and guidance on the use of animals in research, including guidance on the responsibility and use of
p.000025: animal in research: http://www.mrc.ac.uk/research/research-policy-ethics/use-of-animals/
p.000025: (41) National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs):
p.000025: www.nc3rs.org.uk
p.000025:
p.000025:
p.000025:
p.000025:
p.000026: 26
p.000026: Good research practice: principles and guidelines
p.000026:
p.000026:
p.000026:
p.000026:
p.000026: (42) MRC guidance on safety, security and resilience: http://www.mrc.ac.uk/skills-careers/working-for-mrc/
p.000026: safety-security-resilience/
p.000026: (43) Committee on Publication Ethics, Code of conduct and related guidelines and resources:
p.000026: publicationethics.org/resources/code-conduct
p.000026: (44) International Committee of Medical Journal Editors, guidance on ethical considerations and international
p.000026: standards: www.icmje.org/index.html
p.000026: (45) Researchfish: www.researchfish.com
p.000026: (46) CONSORT (CONsolidated Standards of Reporting Trials) Statement (2010): www.consort-statement.
p.000026: org/consort-statement
p.000026: (47) ARRIVE: Animal Research: Reporting in-vivo experiments (2010): www.nc3rs.org.uk/downloaddoc.
p.000026: asp?id=1206&page=1357&skin=0
p.000026: (48) RCUK knowledge exchange principles and position on intellectual property and asset management:
...
Social / Property Ownership
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p.000009: was done, how and why, and which allow the work to be assessed retrospectively and repeated if necessary.
p.000009: B.2 The principles, standards and technical processes for data management, retention and preservation will be
p.000009: determined by the area of science, for instance the needs of fundamental studies may differ from population-based and
p.000009: clinical studies. Processes should be supported by appropriate data standards addressing confidentiality and
p.000009: information security, monitoring and quality assurance, data recovery and data management reviews where suitable.
p.000009: B.3 Research data generated in the course of MRC-funded research must be retained in an appropriate format in
p.000009: line with agreed retention periods (see box 1 below). Related material should also be retained to ensure accessibility,
p.000009: integrity, the application of new analytical tools or statistical techniques, and to enable new research where possible
p.000009: (see box 1 below).
p.000009:
p.000009:
p.000009: Box 1: Retaining research data
p.000009:
p.000009: Types of research data
p.000009: Primary/raw data include any information, images, observations, questionnaires, products, devices, procedures and any
p.000009: other data sources that are generated, recorded or used during the project.
p.000009: Related material includes approvals, information on the consent process (including signed consent forms), meta-data,
p.000009: information relating to analysis and methodology, quality assurance records that demonstrate the validity of the data
p.000009: and/or adherence to experimental protocols, calibration data,
p.000009: collaborative agreements, intellectual property ownership, management and agreements and other relevant correspondence.
p.000009: Confidential identifiable data comprise any information that relates to an individual (either living or dead) from
p.000009: which that individual can be identified.
p.000009: The main record refers to the record where the research data are primarily recorded (for example, in electronic or hard
p.000009: copy laboratory notebooks, clinical trial master files).
p.000009:
p.000009:
p.000009:
p.000009:
p.000010: 10
p.000010: Good research practice: principles and guidelines
p.000010:
p.000010:
p.000010:
p.000010:
p.000010: Requirements
p.000010: • All research data must be recorded and retained securely (for example, in electronic or hard copy laboratory
p.000010: notebooks) in a form that is original, legible, attributable and contemporaneous.
p.000010: • Normally, specimens and samples should be retained within the research establishment that utilised them in line with
p.000010: relevant legislation, approvals and governance arrangements. Any transfer or disposal should be documented.
p.000010: • Questionnaires, digital/audiotapes, etc should be retained in their original form within the research establishment
p.000010: that generated them.
p.000010: • Where research data relating to a project are held in different formats (for example, completed questionnaires,
p.000010: machine readings, images and scans), these must be cross-referenced and recorded in the main record.
p.000010: • The main record should be updated as soon as possible after data are collected; where the dates of collection and
p.000010: recording are different, this should be recorded.
p.000010: • The main record should be approved by a supervisor to evidence that records are complete and accurate. Queries should
p.000010: be discussed as soon as possible and any changes resulting should be signed-off by the relevant parties.
...
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p.000002:
p.000002:
p.000002: MRC ethics series
p.000002: Good research practice: Principles and guidelines
p.000002:
p.000002: The Medical Research Council (MRC) is dedicated to improving human health through excellent medical research. The MRC
p.000002: expects that the research it supports is conducted according to the highest achievable standards of research practice
p.000002: in order to ensure the integrity of the research and outputs.
p.000002: This document is part of the MRC’s ethics series and sets out the MRC’s expectations for MRC research units and
p.000002: institutes, MRC university units, MRC centres and MRC grant holders in the form of principles, guidelines and standards
p.000002: to foster good research practice in all MRC-funded research. While it is primarily for those involved in research
p.000002: supported, in whole or in part, by the MRC, we hope it will also be useful to others.
p.000002:
p.000002:
p.000002:
p.000002: Contents
p.000003: 3
p.000003: Contents
p.000003:
p.000003:
p.000003: Introduction
p.000004: 4
p.000004: 1. Principles
p.000005: 5
p.000005: 2. Guidelines and standards
p.000007: 7
p.000007: A Planning and conducting MRC-funded research
p.000007: 7
p.000007: B Data: management, integrity, retention and preservation
p.000009: 9
p.000009: C Collaborative working
p.000012: 12
p.000012: D Codes of conduct, ethics and professional standards
p.000014: 14
p.000014: E Research misuse
p.000015: 15
p.000015: F Safety, security and resilience
p.000016: 16
p.000016: G Reporting and disseminating research
p.000016: 16
p.000016: H Translation of research findings and management of intellectual property
p.000017: 17
p.000017: I Integrity in peer review
p.000018: 18
p.000018: J Conflicts of interest
p.000019: 19
p.000019: K Allegations of research misconduct
p.000019: 19
p.000019: L Supporting training and skills
p.000020: 20
p.000020: 3. New and emerging areas
p.000022: 22
p.000022: 4. Further advice and resources
p.000023: 23
p.000023: 5. Related documents and references
p.000024: 24
p.000024: 6. Acknowledgments and history
p.000027: 27
p.000027:
p.000004: 4
p.000004: Good research practice: principles and guidelines
p.000004:
p.000004: Introduction
p.000004:
p.000004: Good research practice underpins high-quality science and supports the robust evidence base needed to drive
p.000004: improvements in health. It provides strong foundations for research careers, supporting high quality education and
p.000004: training, and delivers assurance to those whose work builds on the findings of others. Good research practice also
p.000004: helps to increase public confidence and trust in the research process and its outputs.
p.000004: The responsibility for promoting and delivering good research practice is shared by the whole research community.
p.000004: Researchers should strive for the highest achievable standards in the planning, conduct and reporting of their research
p.000004: and demonstrate integrity in their dealings with others. Research organisations should foster a culture which supports
p.000004: and embeds good research practice and aims to prevent research misconduct. Researchers and research organisations have
p.000004: a duty to ensure roles and responsibilities are clear, and that appropriate resources and skills are in place to
...
p.000007:
p.000007: A Planning and conducting MRC-funded research
p.000007: A.1 Those planning and delivering MRC-funded research should have the necessary expertise, professional skills and
p.000007: experience to deliver the project proposed. This may include seeking specialist advice or securing access to expertise
p.000007: through collaboration. Plans should include an assessment of all resources needed (including staff, space, funding,
p.000007: facilities, biological resources and clinical support) to ensure the study is viable within the available means and the
p.000007: efficient and proper use of all resources. This position should be reviewed as the project progresses. Researchers
p.000007: supported by the MRC should consider at an early stage of the design of the project how they will adhere to the
p.000007: principles and standards of Good Research Practice over the course of their research and aim to anticipate any issues
p.000007: or challenges that might arise.
p.000007: A.2 The rationale for the study and any subsequent modifications must be clearly documented within a well
p.000007: maintained system, for example in project proposals, contracts, protocol documents, laboratory notebooks or as
p.000007: electronic records. All projects must be documented clearly, systematically and in a timely manner, including clear
p.000007: outcomes and end points, plans for statistical analysis, any ethical and regulatory approvals and any subsequent
p.000007: amendments. Key records or documents should be held in an accessible form. Any changes should be validated and recorded
p.000007: with appropriate version control by the researcher responsible, to establish the provenance of the study and protect
p.000007: intellectual property.
p.000007: A.3 MRC-funded research must adhere to current ethical standards, safety practices, relevant legal requirements,
p.000007: local organisational policies and other guidelines. Researchers should ensure they are aware of, and keep up to date
p.000007: with, all the regulatory, ethical and governance requirements that may apply to their area of research and are working
p.000007: with the teams and individuals within their organisations who have a corporate responsibility to ensure that these
p.000007: requirements are adhered to within the organisations. All appropriate licences and permissions must be in place before
p.000007: the research starts and updated as necessary if plans change. The expectations and requirements of professional codes
p.000007: of conduct and standards, including arrangements for managing consent and information governance should be addressed in
p.000007: the planning and conduct of the study (see section D below).
p.000007: A.4 For all research involving people as participants, their tissues or data, the relevant principles of Good
p.000007: Clinical Practice (GCP), an international ethical and scientific quality standard for designing, conducting, recording
p.000007: and reporting trials that involve the participation of human subjects, should be followed (13). Where practicable,
p.000007: consent that is freely given and informed should be sought from all competent participants. Guidance on writing
p.000007: participant information is available from
p.000007: the National Research Ethics Service (NRES)(14); this includes guidance for research that involves adults who lack
...
p.000012: research governance. Discussion, and where necessary written agreements, should be used to clarify and agree key
p.000012: aspects, including responsibilities, common approaches or standards and procedures. Differences in practice or
p.000012: expectations should be identified and if necessary resolved. This is especially important where the work involves
p.000012: researchers from different disciplines, organisations and/ or countries. Agreements must be drawn up and signed by
p.000012: properly authorised signatories within the research organisation and representatives of the collaborating organisation
p.000012: and finalised prior to the commencement of the work.
p.000012:
p.000012:
p.000012:
p.000012: Section 2: Guidelines and standards
p.000013: 13
p.000013:
p.000013:
p.000013:
p.000013: C.2 Most collaborations will usually require some of the following to be addressed during the course of the
p.000013: research. Formal collaboration agreements may include:
p.000013: • Scope, duration and aims of the proposed project.
p.000013: • Finance and in-kind resource commitments.
p.000013: • Key tasks and responsibilities of the partners (including sponsorship arrangements where appropriate).
p.000013: • Project management arrangements, including lines of accountability and communication.
p.000013: • Training requirements and responsibilities.
p.000013: • Health and safety arrangements for shared or seconded staff.
p.000013: • Research governance standards and ethical and regulatory arrangements including approvals, confidentiality and use of
p.000013: animals.
p.000013: • Publication and authorship.
p.000013: • Ownership, custodianship, transfer and arrangement for the future use of research data and samples (including return
p.000013: or disposal).
p.000013: • Arrangements for handling intellectual property (see H.4).
p.000013: • Specific requirements for information governance and information security, including record keeping, data management,
p.000013: handling or transfer.
p.000013: • Financial/resource contributions and liabilities/indemnity.
p.000013: • Arrangements for reporting and handling allegations of research misconduct.
p.000013: C.3 Agreements to support clinical research collaborations which involve the pharmaceutical and biotechnology
p.000013: industries, academia and NHS organisations across the UK should address issues relating to allocation of
p.000013: responsibilities, rights and liabilities. Examples of template agreements which may
p.000013: be used to support bespoke agreements include the NIHR model Industry Collaborative Research Agreement (30) and the
p.000013: UKCRC Academic Sponsor/NHS trust agreement.
p.000013: C.4 Agreements involving international partners, or where work will be undertaken outside the UK and where
p.000013: different legislative or ethical requirements apply, require particularly careful negotiation. The guidance produced by
p.000013: international organisations, such as the European Science Foundation (31) and the OECD Global Science Forum(32), and
p.000013: statements developed by the research community, such as the Singapore Statement on Research Integrity (33) identify
p.000013: some of the key issues to consider.
p.000013:
p.000013: Related links
p.000013: (1) RCUK policy and code of conduct on the governance of good research conduct, Integrity, Clarity and Good Management
p.000013: (2013): http://www.rcuk.ac.uk/RCUK-prod/assets/documents/reviews/grc/
p.000013: RCUKPolicyandGuidelinesonGovernanceofGoodResearchPracticeFebruary2013.pdf
p.000013: (4) Universities UK Concordat to Support Research Integrity: http://www.universitiesuk.ac.uk/
p.000013: highereducation/Documents/2012/TheConcordatToSupportResearchIntegrity.pdf
...
p.000016: Researchers undertaking activities within another research organisation must cooperate fully with the host on all
p.000016: health and safety matters.
p.000016: F.4 Research organisations should have robust business continuity plans in place to ensure any interruptions to
p.000016: the operations of a project or programme are handled appropriately and that any impact on the research outcomes is
p.000016: minimised.
p.000016:
p.000016:
p.000016: Related links
p.000016: (42) MRC guidance on safety, security and resilience: http://www.mrc.ac.uk/skills-careers/working-for-mrc/
p.000016: safety-security-resilience/
p.000016:
p.000016:
p.000016:
p.000016: G Reporting and disseminating research
p.000016: G.1 Arrangements and responsibilities for the publication of results relating to MRC-funded research, including
p.000016: outline plans for public engagement activities and payment of open access fees, should be taken into account when
p.000016: planning the study and agreed at the outset. Arrangements should be made at an early stage and involve all
p.000016: investigators and should be revisited where roles and contributions change over the life cycle of the study; this is
p.000016: particularly important for collaborative and multidisciplinary projects.
p.000016: G.2 Discussions may be needed to address authorship, including lead responsibility, authorisation for the content
p.000016: of papers and the intended place of publication and any pre-existing obligations. Arrangements should outline
p.000016: responsibilities for ensuring accuracy of methods, integrity of results, adequacy of internal peer review, appropriate
p.000016: protection of intellectual property, authorship and arrangements for the timely correction of any errors or retraction.
p.000016: For collaborative and multidisciplinary projects differences in publication practice across disciplines or institutions
p.000016: should be identified and addressed at an early stage.
p.000016: G.3 Authorship should include all individuals who have made a substantial intellectual contribution and all
p.000016: authors are expected to take public responsibility for their contribution to the work. The MRC endorses the guidance of
p.000016: the Committee on Publication Ethics (43) and the International Committee of Medical Journal Editors (ICMJE) (44). The
p.000016: MRC endorses the ICMJE guidelines on authorship and contributorship; the practice of ‘honorary authorship’ is not
p.000016: acceptable. All contributions to the research must be clearly acknowledged and appropriate permissions sought for the
p.000016: use of the work of others. No person who fulfils the criteria for authorship should be excluded.
p.000016: G.4 The contributions of funders should be clearly acknowledged and managed appropriately, particularly when using
p.000016: tools such as UK PubMedCentral (UKPMC)(28) and Researchfish (45).
p.000016:
p.000016:
p.000016:
p.000016: Section 2: Guidelines and standards
p.000017: 17
p.000017:
p.000017:
p.000017:
p.000017: G.5 When reporting research findings in publications, presenting at scientific meetings and engaging in debates in
p.000017: the media or in public, any relevant interests must be declared. This is to help others
p.000017: understand the factors that may have influenced the research team and would include any interests that might be
p.000017: considered by others, including the public, to be a conflict. Research findings that are likely
...
p.000017: paramount and the proliferation of papers to increase the quantity of publications is discouraged. Duplicate or
p.000017: redundant submission or publication is not acceptable as it may distort the evidence base upon which meta-analyses
p.000017: rely.
p.000017: G.8 Agreed standards for reporting the outcomes of research in specific areas have been developed and should be
p.000017: observed. Standards endorsed and supported by the MRC include the CONSORT Statement (CONsolidated Standards of
p.000017: Reporting Trials) (46) and the ARRIVE guidelines (Animal Research: Reporting in-vivo experiments) (47).
p.000017:
p.000017:
p.000017: Related links
p.000017: (27) MRC policy on open access publishing: http://www.mrc.ac.uk/research/research-policy-ethics/open- access-policy/
p.000017: (28) Europe PubMedCentral: http://europepmc.org/
p.000017: (43) Committee on Publication Ethics, Code of conduct and related guidelines and resources:
p.000017: publicationethics.org/resources/code-conduct
p.000017: (44) International Committee of Medical Journal Editors, guidance on ethical considerations and international
p.000017: standards: www.icmje.org/index.html
p.000017: (45) Researchfish: www.researchfish.com
p.000017: (46) CONSORT (CONsolidated Standards of Reporting Trials) Statement (2010): www.consort-statement.
p.000017: org/consort-statement
p.000017: (47) ARRIVE: Animal Research: Reporting in-vivo experiments (2010): www.nc3rs.org.uk/downloaddoc.
p.000017: asp?id=1206&page=1357&skin=0
p.000017:
p.000017:
p.000017:
p.000017: H Translation of research findings and management of intellectual property
p.000017: H.1 MRC-funded researchers have a responsibility to ensure that any findings which have a potential impact on
p.000017: clinical practice, public policy or the development of new treatments or preventive interventions are actively
p.000017: disseminated to the relevant user community. Plans for translation of such findings should be put in place in order to
p.000017: ensure that potential benefits for health or healthcare are realised as quickly as possible.
p.000017: H.2 The potential for MRC-funded research to generate intellectual property of value should be anticipated
p.000017: throughout the life cycle of the project. Researchers should ensure they are aware of the ownership and
p.000017:
p.000017:
p.000017:
p.000017:
p.000018: 18
p.000018: Good research practice: principles and guidelines
p.000018:
p.000018:
p.000018:
p.000018: arrangements for the management of intellectual property within their establishment. Steps should be taken to ensure
p.000018: that any results are effectively protected and any intellectual property generated is exploited.
p.000018: H.3 All intellectual property, intellectual property rights, know-how, data, devices, reagents, or materials
p.000018: generated by MRC employees are normally the property of the MRC. This is usually also the case for visiting workers and
p.000018: students. Intellectual property generated within MRC units and institutes is managed by the MRC, in partnership with
p.000018: MRC Technology (49).
p.000018: H.4 Arrangements for managing and handling intellectual property generated during a collaborative project,
p.000018: including additional conditions or requirements relating to the conduct of the project, should be clarified and agreed
p.000018: before any work commences. Transfer agreements and confidentiality agreements are important for protecting resources
p.000018: that may potentially have great value and should be considered. However, expert advice should be sought before entering
p.000018: into any such agreement; it is a requirement for MRC Technology to advise on all commercial contracts involving MRC
p.000018: units and institutes.
p.000018:
p.000018:
p.000018: Related links
p.000018: (11) RCUK and MRC terms and conditions for grants: http://www.rcuk.ac.uk/funding/grantstcs/
p.000018: (48) RCUK knowledge exchange principles and position on intellectual property and asset management:
p.000018: http://www.rcuk.ac.uk/ke/policies/
p.000018: (49) Medical Research Council Technology: www.mrctechnology.org
p.000018:
p.000018:
p.000018:
p.000018:
p.000018: I Integrity in peer review
p.000018: I.1 All researchers supported by the MRC are expected to participate in peer review, acting as reviewers for
p.000018: meetings, journals, grant applications and the ethical review of research proposals at a level appropriate to their
p.000018: experience and training. Peer review should be conducted to the highest standards and in line with the guidelines
p.000018: provided by the organisation seeking a review, including any obligation relating to confidentiality. Objectivity must
p.000018: be observed and any relevant conflicts of interest declared.
p.000018: I.2 Those involved in peer review must not retain or copy any material under review or share it with others
p.000018: without express permission from the author and the organisation which requested the review. They must not make use of
p.000018: research designs or research findings from a proposal or paper under review without the express permission of the
p.000018: author(s) and should not allow others to do so.
p.000018: I.3 While participating in peer review researchers are obliged to report appropriately, in confidence, any
p.000018: concerns they may have relating to research practice: such concerns may include plagiarism, fabrication, falsification,
p.000018: omission, ethical design or duplicate application.
p.000018:
p.000018:
p.000018: Related links
p.000018: (1) RCUK policy and code of conduct on the governance of good research conduct, Integrity, Clarity and Good Management
p.000018: (2013): http://www.rcuk.ac.uk/RCUK-prod/assets/documents/reviews/grc/
p.000018: RCUKPolicyandGuidelinesonGovernanceofGoodResearchPracticeFebruary2013.pdf
...
p.000025: to consent and the use of personal information in research: http://www.mrc.ac.uk/research/ research-policy-ethics/
p.000025: (40) MRC policy and guidance on the use of animals in research, including guidance on the responsibility and use of
p.000025: animal in research: http://www.mrc.ac.uk/research/research-policy-ethics/use-of-animals/
p.000025: (41) National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs):
p.000025: www.nc3rs.org.uk
p.000025:
p.000025:
p.000025:
p.000025:
p.000026: 26
p.000026: Good research practice: principles and guidelines
p.000026:
p.000026:
p.000026:
p.000026:
p.000026: (42) MRC guidance on safety, security and resilience: http://www.mrc.ac.uk/skills-careers/working-for-mrc/
p.000026: safety-security-resilience/
p.000026: (43) Committee on Publication Ethics, Code of conduct and related guidelines and resources:
p.000026: publicationethics.org/resources/code-conduct
p.000026: (44) International Committee of Medical Journal Editors, guidance on ethical considerations and international
p.000026: standards: www.icmje.org/index.html
p.000026: (45) Researchfish: www.researchfish.com
p.000026: (46) CONSORT (CONsolidated Standards of Reporting Trials) Statement (2010): www.consort-statement.
p.000026: org/consort-statement
p.000026: (47) ARRIVE: Animal Research: Reporting in-vivo experiments (2010): www.nc3rs.org.uk/downloaddoc.
p.000026: asp?id=1206&page=1357&skin=0
p.000026: (48) RCUK knowledge exchange principles and position on intellectual property and asset management:
p.000026: http://www.rcuk.ac.uk/ke/policies/
p.000026: (49) Medical Research Council Technology: www.mrctechnology.org
p.000026: (50) MRC Policy on Declarations of Interest: http://www.mrc.ac.uk/about/
p.000026: (51) MRC Procedure for investigating allegations of misconduct in research: http://www.mrc.ac.uk/research/
p.000026: research-policy-ethics/allegations-of-research-misconduct/
p.000026: (52) EQUATOR Network guidance on reporting: www.equator-network.org
p.000026:
p.000026:
p.000026:
p.000026: Section 6: Acknowledgements and history
p.000027: 27
p.000027:
p.000027: Section 6
p.000027: Acknowledgments and history
p.000027:
p.000027: Acknowledgements
p.000027:
p.000027: These principles and guidelines were developed in 2010/11 by an MRC working group.
p.000027:
p.000027: We are very grateful to all members of the group, and to all those who contributed at the consultation phase. The
p.000027: principles and guidelines reflect the RCUK policy and code of conduct on the governance of good research conduct,
p.000027: Integrity, Clarity and Good Management (2009). In addition to the RCUK code, the working group would like to
p.000027: acknowledge work of the UK Research Integrity Office, specifically the Code of practice for research: promoting good
p.000027: practice and preventing misconduct (2009), which is referred to extensively and
...
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p.000019: These terms are defined in detail in the RCUK Policy and Code of Conduct and the process for investigating allegations
p.000019: in the MRC Procedure for investigating allegations of misconduct in research (51).
p.000019: K.2 The MRC requires organisations receiving MRC funding to have appropriate processes for addressing allegations
p.000019: of misconduct. The process for reporting concerns and making formal allegations must be clear and accessible. Processes
p.000019: for investigating allegations must be thorough, fair, constructive, conclusive and timely.
p.000019:
p.000019:
p.000019:
p.000019:
p.000020: 20
p.000020: Good research practice: principles and guidelines
p.000020:
p.000020:
p.000020:
p.000020:
p.000020: The MRC procedure for investigating allegations of misconduct in research outlines the process which applies within MRC
p.000020: research units and institutes.
p.000020: The MRC procedure also acts as a guide to the MRC’s expectations as they relate to the requirements outlined by RCUK.
p.000020:
p.000020:
p.000020:
p.000020: K.3 The MRC expects that wherever possible allegations of misconduct will be raised with the researcher’s
p.000020: employer directly. However, where allegations relating to MRC-funded researchers, or to applications for funding, are
p.000020: reported to the MRC, the matter will be raised with the relevant research organisation(s),
p.000020: in confidence, at the earliest opportunity. The MRC reserves the right to take appropriate action after consultation
p.000020: with the research organisation.
p.000020: K.4 As a research funder the MRC should be informed, in confidence, of any formal investigations of research
p.000020: misconduct relating to any individual funded by, or engaged with, the MRC, including those acting as a supervisor for
p.000020: an MRC postgraduate student or engaged with peer review activities, even where the work to which the allegation relates
p.000020: is not connected with an MRC-funded project. The MRC reserves the right to take appropriate action, after consultation
p.000020: with the research organisation, about any duties being performed for the MRC.
p.000020: K.5 Where any investigation finds a distortion or inaccuracy in the published research record the institution
p.000020: should take all necessary steps to correct the public record.
p.000020: K.6 Arrangements for handling allegations relating to research misconduct should be addressed explicitly in
p.000020: collaborative research agreements, particularly those involving international partners.
p.000020: K.7 The MRC expects research organisations to be aware of the potential for fraud in relation to the conduct of
p.000020: research (for example duplicate applications for research funds for a project already funded) and have arrangements in
p.000020: place to address any such allegations.
p.000020:
p.000020:
p.000020: Related links
p.000020: (1) RCUK policy and code of conduct on the governance of good research conduct, Integrity, Clarity and Good Management
p.000020: (2013): http://www.rcuk.ac.uk/RCUK-prod/assets/documents/reviews/grc/
p.000020: RCUKPolicyandGuidelinesonGovernanceofGoodResearchPracticeFebruary2013.pdf
p.000020: (51) MRC Procedure for investigating allegations of misconduct in research: http://www.mrc.ac.uk/research/
p.000020: research-policy-ethics/allegations-of-research-misconduct/
p.000020:
p.000020:
p.000020:
p.000020: L Supporting training and skills
p.000020: L.1 All research organisations in receipt of MRC funding are expected to foster an environment and culture where
...
Social / education
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p.000002: supported, in whole or in part, by the MRC, we hope it will also be useful to others.
p.000002:
p.000002:
p.000002:
p.000002: Contents
p.000003: 3
p.000003: Contents
p.000003:
p.000003:
p.000003: Introduction
p.000004: 4
p.000004: 1. Principles
p.000005: 5
p.000005: 2. Guidelines and standards
p.000007: 7
p.000007: A Planning and conducting MRC-funded research
p.000007: 7
p.000007: B Data: management, integrity, retention and preservation
p.000009: 9
p.000009: C Collaborative working
p.000012: 12
p.000012: D Codes of conduct, ethics and professional standards
p.000014: 14
p.000014: E Research misuse
p.000015: 15
p.000015: F Safety, security and resilience
p.000016: 16
p.000016: G Reporting and disseminating research
p.000016: 16
p.000016: H Translation of research findings and management of intellectual property
p.000017: 17
p.000017: I Integrity in peer review
p.000018: 18
p.000018: J Conflicts of interest
p.000019: 19
p.000019: K Allegations of research misconduct
p.000019: 19
p.000019: L Supporting training and skills
p.000020: 20
p.000020: 3. New and emerging areas
p.000022: 22
p.000022: 4. Further advice and resources
p.000023: 23
p.000023: 5. Related documents and references
p.000024: 24
p.000024: 6. Acknowledgments and history
p.000027: 27
p.000027:
p.000004: 4
p.000004: Good research practice: principles and guidelines
p.000004:
p.000004: Introduction
p.000004:
p.000004: Good research practice underpins high-quality science and supports the robust evidence base needed to drive
p.000004: improvements in health. It provides strong foundations for research careers, supporting high quality education and
p.000004: training, and delivers assurance to those whose work builds on the findings of others. Good research practice also
p.000004: helps to increase public confidence and trust in the research process and its outputs.
p.000004: The responsibility for promoting and delivering good research practice is shared by the whole research community.
p.000004: Researchers should strive for the highest achievable standards in the planning, conduct and reporting of their research
p.000004: and demonstrate integrity in their dealings with others. Research organisations should foster a culture which supports
p.000004: and embeds good research practice and aims to prevent research misconduct. Researchers and research organisations have
p.000004: a duty to ensure roles and responsibilities are clear, and that appropriate resources and skills are in place to
p.000004: deliver the research and maintain high standards of integrity, either by seeking access to training or developing
p.000004: collaborations with others with the necessary expertise.
p.000004: Achievement of the highest quality and ethical standards in research depends on the integrity, honesty and
p.000004: professionalism of all individuals involved in the research process. Research organisations’ staff recruitment
p.000004: practices at all levels should reflect the importance of these qualities.
p.000004: The MRC expects that all MRC-funded research is conducted to the highest levels of integrity, clarity and good
p.000004: management. Researchers supported by the MRC must adhere to the highest ethical standards, and conform to requirements
p.000004: and guidance set out in this document and by national and international regulatory bodies, professional bodies, and
...
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p.000004: (2), the Government Chief Scientific Advisor’s
p.000004: Universal Ethical Code for Scientists, Rigour, Respect and Responsibility (3), The Concordat to Support Research
p.000004: Integrity (4) and the UK Research Integrity Office, Code of practice for research: promoting good practice and
p.000004: preventing misconduct (5).
p.000004: The principles and guidelines outlined in this document are intended to complement not replace statutory or regulatory
p.000004: requirements and codes of conduct and ethical standards relating to specific professions, research areas or research
p.000004: environments and settings or the guidelines of other research funders. They also recognise local organisational
p.000004: policies and procedures and relevant MRC policies and position statements, including those within the MRC’s ethics
p.000004: series (6).
p.000004:
p.000004:
p.000004:
p.000004: Section 1: Principles
p.000005: 5
p.000005:
p.000005: Section 1 Principles
p.000005: The following principles outline the MRC’s expectations relating to the conduct of research. They should underpin all
p.000005: MRC-funded research within the MRC’s own research units and institutes and in other research organisations, whether
p.000005: they are supported either in whole, or in part, by the MRC. They apply to everyone involved in MRC-funded research,
p.000005: including researchers, research support staff, students, research managers and administrators and aim to reflect
p.000005: principles that apply more widely across public life such as those outlined by the Committee on Standards in Public
p.000005: Life (7). The principles also underpin the expectations the MRC has of its own staff which are outlined in the MRC Code
p.000005: of Conduct for Employees (8).
p.000005:
p.000005: Research excellence and integrity:
p.000005:
p.000005: The MRC is dedicated to excellence and high-ethical standards in the design, conduct, reporting and exploitation of
p.000005: publicly-funded research. The MRC expects all of those it supports to act with care and skill at all times in order to
p.000005: deliver high-quality science. Everyone involved in MRC-funded research must recognise and accept personal
p.000005: responsibility for the integrity of the research record, whether this is used as the basis for the further development
p.000005: of scientific knowledge, for improvements in healthcare, or the prevention of disease.
p.000005:
p.000005: Respect, ethics and professional standards:
p.000005:
p.000005: All research supported by the MRC must respect and maintain the dignity, rights, safety and wellbeing of all involved,
p.000005: or who could be affected by it.
p.000005: All researchers should be familiar with, and know how to access, the relevant legal and ethical requirements. They must
p.000005: take appropriate steps to work within these frameworks to manage data and records appropriately, maintain
p.000005: confidentiality and to minimise any adverse impact their work may have on people, animals and the natural environment;
p.000005: and to work with those with corporate responsibility within their organisations for meeting the requirements of the
p.000005: frameworks. Risks relating to the potential for research outcomes to be misused for harmful purposes must be recognised
p.000005: and managed.
p.000005:
p.000005: Honesty and transparency:
p.000005:
p.000005: All of those involved in MRC-funded research should be honest in respect of their own actions and their responses to
...
p.000006: researchers, support, technical and administrative staff are supported in understanding and adopting good practice at
p.000006: an early stage and throughout their career.
p.000006:
p.000006:
p.000006: Related links
p.000006: (1) RCUK policy and code of conduct on the governance of good research conduct, Integrity, Clarity and Good Management
p.000006: (2013): http://www.rcuk.ac.uk/RCUK-prod/assets/documents/reviews/grc/
p.000006: RCUKPolicyandGuidelinesonGovernanceofGoodResearchPracticeFebruary2013.pdf
p.000006: (2) MRC policy on health department research governance frameworks: http://www.mrc.ac.uk/research/
p.000006: research-policy-ethics/clinical-research-governance/
p.000006: (3) Government Office for Science, Rigour, Respect and Responsibility: A universal ethical code for scientists (2007):
p.000006: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/283157/universal- ethical-code-scientists.pdf
p.000006: (4) Universities UK Concordat to Support Research Integrity: http://www.universitiesuk.ac.uk/
p.000006: highereducation/Documents/2012/TheConcordatToSupportResearchIntegrity.pdf
p.000006: (5) UK Research Integrity Office, Code of practice for research: Promoting good practice and preventing misconduct
p.000006: (2009) and Recommended Checklist for Researchers: http://www.ukrio.org/publications/code- of-practice-for-research/
p.000006: (6) MRC ethics and research guidance: http://www.mrc.ac.uk/research/research-policy-ethics/
p.000006: (7) Committee for Standards in Public Life: https://www.gov.uk/government/organisations/the-committee-
p.000006: on-standards-in-public-life
p.000006: (8) MRC Code of Conduct for Employees: www.mrc.ac.uk
p.000006: (9) MRC position statement on bioterrorism and biomedical research (2005): http://www.mrc.ac.uk/
p.000006: research/research-policy-ethics/bioterrorism/
p.000006: (10) The Concordat to support career development for researchers, an agreement between the funders and employers of
p.000006: research in the UK (2008): https://www.vitae.ac.uk/policy/concordat-to-support-the-career- development-of-researchers
p.000006:
p.000006:
p.000006:
p.000006: Section 2: Guidelines and standards
p.000007: 7
p.000007:
p.000007: Section 2
p.000007: Guidelines and standards
p.000007: These guidelines and standards outline how the principles above should be applied within MRC research units and
p.000007: institutes and clarify the MRC’s expectations for MRC-funded research within universities, medical schools, hospitals
p.000007: and other research organisations.
p.000007: They apply to everyone involved in MRC-funded research including researchers, research support staff, students,
p.000007: research managers and administrators.
p.000007:
p.000007:
p.000007: A Planning and conducting MRC-funded research
p.000007: A.1 Those planning and delivering MRC-funded research should have the necessary expertise, professional skills and
p.000007: experience to deliver the project proposed. This may include seeking specialist advice or securing access to expertise
p.000007: through collaboration. Plans should include an assessment of all resources needed (including staff, space, funding,
p.000007: facilities, biological resources and clinical support) to ensure the study is viable within the available means and the
p.000007: efficient and proper use of all resources. This position should be reviewed as the project progresses. Researchers
...
p.000013: coordinating-research/mo-fora/research-integrity.html
p.000013: (32) OECD Global Science Forum, Investigating Research Misconduct Allegations in International Collaborative Research
p.000013: Projects: A PRACTICAL GUIDE (2009): http://www.oecd.org/science/sci-tech/
p.000013: researchintegritypreventingmisconductanddealingwithallegations.htm
p.000013: (33) Singapore Statement on Research Integrity, developed following the 2nd World Conference on Research Integrity:
p.000013: www.singaporestatement.org
p.000013:
p.000013:
p.000013:
p.000013:
p.000014: 14
p.000014: Good research practice: principles and guidelines
p.000014:
p.000014:
p.000014: D Codes of conduct, ethics and professional standards
p.000014:
p.000014: D.1 MRC-funded researchers must be aware of, and adhere to, all legal requirements and relevant codes of conduct
p.000014: required by their employer, place of work and any professional bodies to which they, or members of their research teams
p.000014: belong (34). In some areas of research, for example, for research involving human participants, corporate
p.000014: responsibility is assigned by the research organisation as employers, and in some cases sponsors, to specific
p.000014: individuals to act as health and safety officers, research governance leads, designated individuals on Human Tissue
p.000014: Authority licences, etc. These individuals will work closely with research teams within the organisation and have a
p.000014: responsibility to develop systems that provide accountability that the requirements placed on the employer are being
p.000014: met and to demonstrate that the organisation meets the highest legal and ethical standards.
p.000014:
p.000014: The MRC’s code of conduct for employees is available on the RCUK SSC Knowledgebase alongside other policies which apply
p.000014: when working within an MRC unit or institute.
p.000014:
p.000014:
p.000014: D.2 All MRC-funded research involving human participants, human material, confidential identifiable information or
p.000014: the use of animals or regulated materials must address and comply with all necessary legal and ethical requirements and
p.000014: standards, including governance arrangements outlined in MRC policies and other relevant guidelines (34)(35)(36). The
p.000014: expectations and requirements of professional codes
p.000014: of conduct, standards and organisational policies should be addressed in the planning, resourcing and conduct of the
p.000014: study and all appropriate ethical, regulatory and NHS approvals must be in place before any research commences.
p.000014:
p.000014: The MRC ethics series outlines relevant policies and requirements for specific areas, activities and research settings.
p.000014: MRC research units/institutes are required to nominate a Research Governance representative to lead on the
p.000014: implementation of appropriate systems within the unit.
p.000014:
p.000014:
p.000014: D.3 MRC-funded research involving international partners, or work undertaken outside the UK, must comply with all
p.000014: applicable legal and regulatory requirements. Research involving human participants should have ethical approval both
p.000014: in the UK and the country (or countries) where the work is being undertaken. Further information on ethical reviews in
p.000014: the UK can be found in the MRC Data and Tissues tool kit.
p.000014: D.4 Specific requirements have been developed to support MRC-funded research under the Research Governance
...
p.000014: Regulations 2004. The requirements cover all clinical trials of investigational medicinal products supported by the MRC
p.000014: (38).
p.000014:
p.000014: Further information and advice on meeting regulatory, ethical and governance requirements in research that involves
p.000014: human participants, their tissues or data is available from the MRC Regulatory Support Centre.
p.000014: www.mrc.ac.uk/regulatorysupportcentre
p.000014:
p.000014:
p.000014: D.6. The MRC has high expectations for the design, conduct and reporting of medical research involving animals.
p.000014: Implementation of the 3Rs (replacement, refinement and reduction) is essential to meet ethical
p.000014:
p.000014:
p.000014:
p.000014: Section 2: Guidelines and standards
p.000015: 15
p.000015:
p.000015:
p.000015:
p.000015: standards and to obtain the best possible scientific results. The publication Responsibility in the use of animals in
p.000015: bioscience research (40) was coordinated by the NC3Rs (41) and outlines the expectations of the MRC and other UK
p.000015: research councils and charitable bodies which provide funding for research involving animals. Additional codes of
p.000015: practice and guidelines which relate to the use of animals in research issued by the MRC must also be adhered to.
p.000015:
p.000015: Related links
p.000015: (2) MRC policy on health department research governance frameworks: http://www.mrc.ac.uk/research/
p.000015: research-policy-ethics/clinical-research-governance/
p.000015: (6) MRC ethics and research guidance: http://www.mrc.ac.uk/research/research-policy-ethics/
p.000015: (8) MRC Code of Conduct for Employees: www.mrc.ac.uk
p.000015: (24) MRC Data and Tissues tool kit: www.dt-toolkit.ac.uk
p.000015: (34) For example: General Medical Council, Guidance on Good Practice in Research and related guidance on consent and
p.000015: confidentiality: www.gmc-uk.org/guidance/ethical_guidance/5992.asp
p.000015: (35) For example: Department of Health Information Governance tool kit for research involving NHS patients and patient
p.000015: data: https://www.igt.hscic.gov.uk/
p.000015: (36) For example: WHO research review ethics committee guidance on Ethical standards and procedures for research with
p.000015: human beings: www.who.int/ethics/research/en
p.000015: (37) Clinical trials for medicines, UK legislation: www.mhra.gov.uk/Howweregulate/Medicines/
p.000015: Licensingofmedicines/Clinicaltrials /Legislation/index.htm
p.000015: (38) MRC policy on UK clinical trials regulations: http://www.mrc.ac.uk/research/research-policy-ethics/
p.000015: clinical-research-governance/clinical-trials-regulations/
p.000015: (39) MRC policy on consent to take part in research, including research involving children, adults who lack capacity
p.000015: to consent and the use of personal information in research: http://www.mrc.ac.uk/research/ research-policy-ethics/
p.000015: (40) MRC policy and guidance on the use of animals in research, including guidance on the responsibility and use of
...
p.000017: (47) ARRIVE: Animal Research: Reporting in-vivo experiments (2010): www.nc3rs.org.uk/downloaddoc.
p.000017: asp?id=1206&page=1357&skin=0
p.000017:
p.000017:
p.000017:
p.000017: H Translation of research findings and management of intellectual property
p.000017: H.1 MRC-funded researchers have a responsibility to ensure that any findings which have a potential impact on
p.000017: clinical practice, public policy or the development of new treatments or preventive interventions are actively
p.000017: disseminated to the relevant user community. Plans for translation of such findings should be put in place in order to
p.000017: ensure that potential benefits for health or healthcare are realised as quickly as possible.
p.000017: H.2 The potential for MRC-funded research to generate intellectual property of value should be anticipated
p.000017: throughout the life cycle of the project. Researchers should ensure they are aware of the ownership and
p.000017:
p.000017:
p.000017:
p.000017:
p.000018: 18
p.000018: Good research practice: principles and guidelines
p.000018:
p.000018:
p.000018:
p.000018: arrangements for the management of intellectual property within their establishment. Steps should be taken to ensure
p.000018: that any results are effectively protected and any intellectual property generated is exploited.
p.000018: H.3 All intellectual property, intellectual property rights, know-how, data, devices, reagents, or materials
p.000018: generated by MRC employees are normally the property of the MRC. This is usually also the case for visiting workers and
p.000018: students. Intellectual property generated within MRC units and institutes is managed by the MRC, in partnership with
p.000018: MRC Technology (49).
p.000018: H.4 Arrangements for managing and handling intellectual property generated during a collaborative project,
p.000018: including additional conditions or requirements relating to the conduct of the project, should be clarified and agreed
p.000018: before any work commences. Transfer agreements and confidentiality agreements are important for protecting resources
p.000018: that may potentially have great value and should be considered. However, expert advice should be sought before entering
p.000018: into any such agreement; it is a requirement for MRC Technology to advise on all commercial contracts involving MRC
p.000018: units and institutes.
p.000018:
p.000018:
p.000018: Related links
p.000018: (11) RCUK and MRC terms and conditions for grants: http://www.rcuk.ac.uk/funding/grantstcs/
p.000018: (48) RCUK knowledge exchange principles and position on intellectual property and asset management:
p.000018: http://www.rcuk.ac.uk/ke/policies/
p.000018: (49) Medical Research Council Technology: www.mrctechnology.org
p.000018:
p.000018:
p.000018:
p.000018:
p.000018: I Integrity in peer review
p.000018: I.1 All researchers supported by the MRC are expected to participate in peer review, acting as reviewers for
p.000018: meetings, journals, grant applications and the ethical review of research proposals at a level appropriate to their
...
p.000018: (2009) and Recommended Checklist for Researchers: http://www.ukrio.org/publications/code- of-practice-for-research/
p.000018: (43) Committee on Publication Ethics, Code of conduct and related guidelines and resources:
p.000018: publicationethics.org/resources/code-conduct
p.000018:
p.000018:
p.000018:
p.000018: Section 2: Guidelines and standards
p.000019: 19
p.000019:
p.000019:
p.000019:
p.000019:
p.000019: (44) International Committee of Medical Journal Editors, guidance on ethical considerations and international
p.000019: standards: www.icmje.org/index.html
p.000019:
p.000019:
p.000019:
p.000019: J Conflicts of interest
p.000019: J.1 The MRC recognises that conflicts of interest may arise, or appear to exist, at different levels of research
p.000019: endeavour from planning the research to disseminating and exploiting the results and in the associated peer review– and
p.000019: in many forms. Apart from financial interests, conflicts might, for example, be personal, academic, political or arise
p.000019: from the acceptance of gifts or hospitality.
p.000019: J.2 The MRC expects procedures to be in place for identifying, declaring and addressing professional, private or
p.000019: commercial interests that might, or might be perceived to arise in relation to MRC-funded research. As much attention
p.000019: should be paid to perceived and potential conflicts of interest as to actual conflicts. All conflicts should be openly
p.000019: declared when reporting the outcomes of MRC-funded research at scientific meetings and conferences and in publications
p.000019: or when taking part in peer review.
p.000019: J.3 The MRC’s Code of Conduct for employees requires that any real, or perceived, conflicts must be discussed
p.000019: with the MRC unit director. Registers of declared interests and gifts and hospitality must be retained locally.
p.000019: Interests declared by members of the MRC’s Council and decision-making bodies are routinely published (50).
p.000019:
p.000019:
p.000019: Related links
p.000019: (8) MRC Code of Conduct for Employees: www.mrc.ac.uk
p.000019: (50) MRC Policy on Declarations of Interest: http://www.mrc.ac.uk/about/
p.000019:
p.000019:
p.000019:
p.000019:
p.000019: K Allegations of research misconduct
p.000019: K.1 The MRC takes allegations of misconduct in research very seriously and requires that allegations be
p.000019: investigated fully. Research misconduct is defined by the MRC and RCUK as follows:
p.000019: • Fabrication.
p.000019: • Falsification.
p.000019: • Plagiarism.
p.000019: • Misrepresentation.
p.000019: • Mismanagement or inadequate preservation of data and/or related materials.
p.000019: • Breach of duty of care.
p.000019: These terms are defined in detail in the RCUK Policy and Code of Conduct and the process for investigating allegations
p.000019: in the MRC Procedure for investigating allegations of misconduct in research (51).
p.000019: K.2 The MRC requires organisations receiving MRC funding to have appropriate processes for addressing allegations
p.000019: of misconduct. The process for reporting concerns and making formal allegations must be clear and accessible. Processes
p.000019: for investigating allegations must be thorough, fair, constructive, conclusive and timely.
p.000019:
p.000019:
p.000019:
p.000019:
p.000020: 20
p.000020: Good research practice: principles and guidelines
p.000020:
p.000020:
p.000020:
p.000020:
p.000020: The MRC procedure for investigating allegations of misconduct in research outlines the process which applies within MRC
p.000020: research units and institutes.
p.000020: The MRC procedure also acts as a guide to the MRC’s expectations as they relate to the requirements outlined by RCUK.
p.000020:
p.000020:
p.000020:
p.000020: K.3 The MRC expects that wherever possible allegations of misconduct will be raised with the researcher’s
...
p.000023:
p.000023:
p.000023:
p.000023:
p.000024: 24
p.000024: Good research practice: principles and guidelines
p.000024:
p.000024:
p.000024: Section 5
p.000024: Related documents and references
p.000024:
p.000024: (1) RCUK policy and code of conduct on the governance of good research conduct, Integrity, Clarity and Good Management
p.000024: (2013): http://www.rcuk.ac.uk/RCUK-prod/assets/documents/reviews/grc/
p.000024: RCUKPolicyandGuidelinesonGovernanceofGoodResearchPracticeFebruary2013.pdf
p.000024: (2) MRC policy on health department research governance frameworks: http://www.mrc.ac.uk/research/
p.000024: research-policy-ethics/clinical-research-governance/
p.000024: (3) Government Office for Science, Rigour, Respect and Responsibility: A universal ethical code for scientists (2007):
p.000024: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/283157/universal- ethical-code-scientists.pdf
p.000024: (4) Universities UK Concordat to Support Research Integrity: http://www.universitiesuk.ac.uk/
p.000024: highereducation/Documents/2012/TheConcordatToSupportResearchIntegrity.pdf
p.000024: (5) UK Research Integrity Office, Code of practice for research: Promoting good practice and preventing misconduct
p.000024: (2009) and Recommended Checklist for Researchers: http://www.ukrio.org/publications/code- of-practice-for-research/
p.000024: (6) MRC ethics and research guidance: http://www.mrc.ac.uk/research/research-policy-ethics/
p.000024: (7) Committee for Standards in Public Life: https://www.gov.uk/government/organisations/the-committee-
p.000024: on-standards-in-public-life
p.000024: (8) MRC Code of Conduct for Employees: www.mrc.ac.uk
p.000024: (9) MRC position statement on bioterrorism and biomedical research (2005): http://www.mrc.ac.uk/
p.000024: research/research-policy-ethics/bioterrorism/
p.000024: (10) The Concordat to support career development for researchers, an agreement between the funders and employers of
p.000024: research in the UK (2008): https://www.vitae.ac.uk/policy/concordat-to-support-the-career- development-of-researchers
p.000024: (11) RCUK and MRC terms and conditions for grants: http://www.rcuk.ac.uk/funding/grantstcs/
p.000024: (12) RCUK statement of expectation on economic and societal impact: http://www.rcuk.ac.uk/Publications/
p.000024: archive/StatementofExpectationon/
p.000024: (13) Good Clinical Practice principles: www.ichgcp.net
p.000024: (14) HRA guidance on consent: http://www.hra.nhs.uk/resources/before-you-apply/consent-and-
p.000024: participation/consent-and-participant-information/
p.000024: (15) MRC ethics series; Personal information in medical research, Medical research involving adults who lack capacity
p.000024: to consent, Medical research involving children: http://www.mrc.ac.uk/research/research-policy- ethics/
p.000024: (16) MRC Regulatory Support Centre resources and tool kits: http://www.mrc.ac.uk/research/facilities/
p.000024: regulatory-support-centre/
p.000024: (17) MRC policy on research data sharing and preservation: http://www.mrc.ac.uk/research/research-policy-
...
General/Other / Public Emergency
Searching for indicator emergency:
(return to top)
p.000011: including the MRC Data and Tissues tool kit (24) which outlines the requirements for use
p.000011: of confidential identifiable data and human tissue samples in healthcare research. The tool kit route maps are aimed at
p.000011: guiding researchers through the planning and approvals process and provide practical help on legislative and good
p.000011: practice requirements as well as a summary of MRC policies in this area.
p.000011: Publication of any research data, including in Masters/Doctoral theses or in an accessible data repository, does not
p.000011: negate the need to retain primary/raw data.
p.000011: B.6 Local procedures (for example, Standard Operating Procedures, protocols, etc) for all routine methods to be
p.000011: replicated across a study, together with associated risk assessments, should be documented systematically, in plain
p.000011: English and ideally in a standard format to ensure clarity, consistency and accuracy. Where there is more than one
p.000011: approved technique for any given procedure within the organisation, clear records should be kept on which were used.
p.000011: Where procedures change, they should be version controlled and the current version should be available and readily
p.000011: accessible to all staff, students and visiting workers.
p.000011: B.7 Protocols for the use, calibration and maintenance of equipment, together with associated risk assessments,
p.000011: must be clearly documented to ensure optimal performance and research data quality. Where protocols change they should
p.000011: be version controlled and the current version should be available and readily accessible. Instructions for the safe
p.000011: shutdown of equipment in case of emergency should be readily accessible. Such quality assurance measures as outlined in
p.000011: B.6 and B.7 help demonstrate the robustness and validity of research data.
p.000011: B.8 To maximise public benefit the MRC supports open access (27) to the published outputs of research in a timely
p.000011: manner as well as initiatives that aim to extend access to research data and resources generated in the course of
p.000011: MRC-funded work. These may include the preservation and sharing of datasets and other relevant materials in line with
p.000011: the MRC’s policy on research data sharing (17). Where it is possible to share data and materials, guidance must be
p.000011: provided to ensure they are used appropriately, with proper regard for issues relating to consent, confidentiality and
p.000011: in accordance with any relevant data security guidelines, including guidance on encryption and data management, and
p.000011: other relevant conditions.
p.000011: B.9 There should be clarity on the ownership and custodianship of research data, samples and related material
p.000011: used or created in the course of the research. Agreements should be used to clarify
p.000011:
p.000011:
p.000011:
p.000011:
p.000012: 12
p.000012: Good research practice: principles and guidelines
p.000012:
p.000012:
p.000012:
p.000012: responsibilities, arrangements for access to data and managing permissions, including sharing with collaborators or
p.000012: with researchers who move away from the original organisation. Agreements should be developed at an early stage and
p.000012: should take account of requirements imposed by the research funder in their terms and conditions. Agreements might
...
General/Other / Relationship to Authority
Searching for indicator authority:
(return to top)
p.000013: (2009) and Recommended Checklist for Researchers: http://www.ukrio.org/publications/code- of-practice-for-research/
p.000013: (30) NIHR model Industrial Collaborative Research Agreement (mICRA): http://www.nihr.ac.uk/policy-and-
p.000013: standards/standard-research-agreements.htm
p.000013: (31) The European Science Foundation Code of Conduct for Research Integrity (2011): http://www.esf.org/
p.000013: coordinating-research/mo-fora/research-integrity.html
p.000013: (32) OECD Global Science Forum, Investigating Research Misconduct Allegations in International Collaborative Research
p.000013: Projects: A PRACTICAL GUIDE (2009): http://www.oecd.org/science/sci-tech/
p.000013: researchintegritypreventingmisconductanddealingwithallegations.htm
p.000013: (33) Singapore Statement on Research Integrity, developed following the 2nd World Conference on Research Integrity:
p.000013: www.singaporestatement.org
p.000013:
p.000013:
p.000013:
p.000013:
p.000014: 14
p.000014: Good research practice: principles and guidelines
p.000014:
p.000014:
p.000014: D Codes of conduct, ethics and professional standards
p.000014:
p.000014: D.1 MRC-funded researchers must be aware of, and adhere to, all legal requirements and relevant codes of conduct
p.000014: required by their employer, place of work and any professional bodies to which they, or members of their research teams
p.000014: belong (34). In some areas of research, for example, for research involving human participants, corporate
p.000014: responsibility is assigned by the research organisation as employers, and in some cases sponsors, to specific
p.000014: individuals to act as health and safety officers, research governance leads, designated individuals on Human Tissue
p.000014: Authority licences, etc. These individuals will work closely with research teams within the organisation and have a
p.000014: responsibility to develop systems that provide accountability that the requirements placed on the employer are being
p.000014: met and to demonstrate that the organisation meets the highest legal and ethical standards.
p.000014:
p.000014: The MRC’s code of conduct for employees is available on the RCUK SSC Knowledgebase alongside other policies which apply
p.000014: when working within an MRC unit or institute.
p.000014:
p.000014:
p.000014: D.2 All MRC-funded research involving human participants, human material, confidential identifiable information or
p.000014: the use of animals or regulated materials must address and comply with all necessary legal and ethical requirements and
p.000014: standards, including governance arrangements outlined in MRC policies and other relevant guidelines (34)(35)(36). The
p.000014: expectations and requirements of professional codes
p.000014: of conduct, standards and organisational policies should be addressed in the planning, resourcing and conduct of the
p.000014: study and all appropriate ethical, regulatory and NHS approvals must be in place before any research commences.
p.000014:
p.000014: The MRC ethics series outlines relevant policies and requirements for specific areas, activities and research settings.
p.000014: MRC research units/institutes are required to nominate a Research Governance representative to lead on the
p.000014: implementation of appropriate systems within the unit.
p.000014:
p.000014:
p.000014: D.3 MRC-funded research involving international partners, or work undertaken outside the UK, must comply with all
...
Orphaned Trigger Words
p.000014: 14
p.000014: E Research misuse
p.000015: 15
p.000015: F Safety, security and resilience
p.000016: 16
p.000016: G Reporting and disseminating research
p.000016: 16
p.000016: H Translation of research findings and management of intellectual property
p.000017: 17
p.000017: I Integrity in peer review
p.000018: 18
p.000018: J Conflicts of interest
p.000019: 19
p.000019: K Allegations of research misconduct
p.000019: 19
p.000019: L Supporting training and skills
p.000020: 20
p.000020: 3. New and emerging areas
p.000022: 22
p.000022: 4. Further advice and resources
p.000023: 23
p.000023: 5. Related documents and references
p.000024: 24
p.000024: 6. Acknowledgments and history
p.000027: 27
p.000027:
p.000004: 4
p.000004: Good research practice: principles and guidelines
p.000004:
p.000004: Introduction
p.000004:
p.000004: Good research practice underpins high-quality science and supports the robust evidence base needed to drive
p.000004: improvements in health. It provides strong foundations for research careers, supporting high quality education and
p.000004: training, and delivers assurance to those whose work builds on the findings of others. Good research practice also
p.000004: helps to increase public confidence and trust in the research process and its outputs.
p.000004: The responsibility for promoting and delivering good research practice is shared by the whole research community.
p.000004: Researchers should strive for the highest achievable standards in the planning, conduct and reporting of their research
p.000004: and demonstrate integrity in their dealings with others. Research organisations should foster a culture which supports
p.000004: and embeds good research practice and aims to prevent research misconduct. Researchers and research organisations have
p.000004: a duty to ensure roles and responsibilities are clear, and that appropriate resources and skills are in place to
p.000004: deliver the research and maintain high standards of integrity, either by seeking access to training or developing
p.000004: collaborations with others with the necessary expertise.
p.000004: Achievement of the highest quality and ethical standards in research depends on the integrity, honesty and
p.000004: professionalism of all individuals involved in the research process. Research organisations’ staff recruitment
p.000004: practices at all levels should reflect the importance of these qualities.
p.000004: The MRC expects that all MRC-funded research is conducted to the highest levels of integrity, clarity and good
p.000004: management. Researchers supported by the MRC must adhere to the highest ethical standards, and conform to requirements
p.000004: and guidance set out in this document and by national and international regulatory bodies, professional bodies, and
p.000004: local research ethics and governance frameworks.
p.000004: This document aims to clarify these expectations and how they apply within the MRC’s own research units and institutes
p.000004: and to research supported by the MRC in university units, centres and grants, fellowships and studentships. It includes
p.000004: both high-level principles and more detailed guidance to ensure the standards can be achieved in practice. It builds on
p.000004: the joint research council policy and code of conduct on the governance of good research conduct issued by Research
p.000004: Councils UK, RCUK Integrity, Clarity and Good Management (1), the Health Departments’ Research Governance Frameworks
p.000004: (2), the Government Chief Scientific Advisor’s
p.000004: Universal Ethical Code for Scientists, Rigour, Respect and Responsibility (3), The Concordat to Support Research
p.000004: Integrity (4) and the UK Research Integrity Office, Code of practice for research: promoting good practice and
p.000004: preventing misconduct (5).
p.000004: The principles and guidelines outlined in this document are intended to complement not replace statutory or regulatory
p.000004: requirements and codes of conduct and ethical standards relating to specific professions, research areas or research
p.000004: environments and settings or the guidelines of other research funders. They also recognise local organisational
p.000004: policies and procedures and relevant MRC policies and position statements, including those within the MRC’s ethics
p.000004: series (6).
p.000004:
p.000004:
p.000004:
p.000004: Section 1: Principles
p.000005: 5
p.000005:
p.000005: Section 1 Principles
p.000005: The following principles outline the MRC’s expectations relating to the conduct of research. They should underpin all
p.000005: MRC-funded research within the MRC’s own research units and institutes and in other research organisations, whether
p.000005: they are supported either in whole, or in part, by the MRC. They apply to everyone involved in MRC-funded research,
p.000005: including researchers, research support staff, students, research managers and administrators and aim to reflect
p.000005: principles that apply more widely across public life such as those outlined by the Committee on Standards in Public
p.000005: Life (7). The principles also underpin the expectations the MRC has of its own staff which are outlined in the MRC Code
p.000005: of Conduct for Employees (8).
p.000005:
p.000005: Research excellence and integrity:
p.000005:
p.000005: The MRC is dedicated to excellence and high-ethical standards in the design, conduct, reporting and exploitation of
p.000005: publicly-funded research. The MRC expects all of those it supports to act with care and skill at all times in order to
p.000005: deliver high-quality science. Everyone involved in MRC-funded research must recognise and accept personal
p.000005: responsibility for the integrity of the research record, whether this is used as the basis for the further development
p.000005: of scientific knowledge, for improvements in healthcare, or the prevention of disease.
p.000005:
p.000005: Respect, ethics and professional standards:
p.000005:
p.000005: All research supported by the MRC must respect and maintain the dignity, rights, safety and wellbeing of all involved,
p.000005: or who could be affected by it.
p.000005: All researchers should be familiar with, and know how to access, the relevant legal and ethical requirements. They must
p.000005: take appropriate steps to work within these frameworks to manage data and records appropriately, maintain
p.000005: confidentiality and to minimise any adverse impact their work may have on people, animals and the natural environment;
p.000005: and to work with those with corporate responsibility within their organisations for meeting the requirements of the
p.000005: frameworks. Risks relating to the potential for research outcomes to be misused for harmful purposes must be recognised
p.000005: and managed.
p.000005:
p.000005: Honesty and transparency:
p.000005:
p.000005: All of those involved in MRC-funded research should be honest in respect of their own actions and their responses to
p.000005: the actions of others. The research community must foster and support a culture of transparency and honesty which
p.000005: promotes good practice, recognises relevant interests or conflicts and deals with these openly and explicitly. This
p.000005: applies across the whole range of research activity from study and experimental design, generating, analysing and
p.000005: recording (including archiving) data, sharing data and materials, applying for funding, publishing findings,
p.000005: acknowledging the contributions of others and engaging in the peer review process.
p.000005: Procedures for reporting and investigating allegations of research misconduct should be clear, thorough, fair,
p.000005: constructive, conclusive and timely. Any remedial action should be promptly implemented.
p.000005:
p.000005: Openness and accountability:
p.000005:
p.000005: MRC-funded researchers are expected to foster the exchange of ideas and to be as open as possible in discussing their
p.000005: work with other scientists and the public.
p.000005: The findings of MRC-funded research must be made available to the research community and the public, in a timely
p.000005: manner. A complete, balanced and accurate account of scientific evidence must be presented to support the appropriate
p.000005: and effective use of this knowledge.
p.000005:
p.000005:
p.000005:
p.000005:
p.000006: 6
p.000006: Good research practice: principles and guidelines
p.000006:
p.000006:
p.000006:
p.000006: To maximise public benefit, the MRC supports open access to the published outputs of research as well as initiatives
p.000006: that aim to extend access to the valuable, and often unique, data, materials and resources generated in the course of
p.000006: MRC-funded work. Extending access, through initiatives such as data sharing, promotes the efficient use of resources
p.000006: for new research, assures the quality of research outputs and helps to maximise the impact of outputs on health.
p.000006: All involved in research have a responsibility to ensure the efficient and proper use of resources provided from public
p.000006: and charitable funds. Those planning and delivering research must make efforts to maximise effectiveness and avoid
p.000006: waste, including reviewing project progress and appropriate business continuity planning.
p.000006: Researchers should proactively engage openly in communication with the public to discuss the issues their work raises
p.000006: for society, and to listen to the aspirations and concerns of patients, carers, study participants and others in
p.000006: relation to the research.
p.000006:
p.000006: Supporting training and skills:
p.000006:
p.000006: All of those engaged in MRC-funded research have a responsibility to develop and maintain the skills they need in their
p.000006: research and to assist others with their personal development. Research organisations, managers and research leaders
p.000006: are expected to provide the direction, resources, training and opportunities for development to support their teams in
p.000006: conducting their work to the highest standards. Research organisations, supervisors and research team leaders should
p.000006: recognise and deliver on their responsibilities for mentoring and staff development and ensure students, new
p.000006: researchers, support, technical and administrative staff are supported in understanding and adopting good practice at
p.000006: an early stage and throughout their career.
p.000006:
p.000006:
p.000006: Related links
p.000006: (1) RCUK policy and code of conduct on the governance of good research conduct, Integrity, Clarity and Good Management
p.000006: (2013): http://www.rcuk.ac.uk/RCUK-prod/assets/documents/reviews/grc/
p.000006: RCUKPolicyandGuidelinesonGovernanceofGoodResearchPracticeFebruary2013.pdf
p.000006: (2) MRC policy on health department research governance frameworks: http://www.mrc.ac.uk/research/
p.000006: research-policy-ethics/clinical-research-governance/
p.000006: (3) Government Office for Science, Rigour, Respect and Responsibility: A universal ethical code for scientists (2007):
p.000006: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/283157/universal- ethical-code-scientists.pdf
p.000006: (4) Universities UK Concordat to Support Research Integrity: http://www.universitiesuk.ac.uk/
p.000006: highereducation/Documents/2012/TheConcordatToSupportResearchIntegrity.pdf
p.000006: (5) UK Research Integrity Office, Code of practice for research: Promoting good practice and preventing misconduct
p.000006: (2009) and Recommended Checklist for Researchers: http://www.ukrio.org/publications/code- of-practice-for-research/
p.000006: (6) MRC ethics and research guidance: http://www.mrc.ac.uk/research/research-policy-ethics/
p.000006: (7) Committee for Standards in Public Life: https://www.gov.uk/government/organisations/the-committee-
p.000006: on-standards-in-public-life
p.000006: (8) MRC Code of Conduct for Employees: www.mrc.ac.uk
p.000006: (9) MRC position statement on bioterrorism and biomedical research (2005): http://www.mrc.ac.uk/
p.000006: research/research-policy-ethics/bioterrorism/
p.000006: (10) The Concordat to support career development for researchers, an agreement between the funders and employers of
p.000006: research in the UK (2008): https://www.vitae.ac.uk/policy/concordat-to-support-the-career- development-of-researchers
p.000006:
p.000006:
p.000006:
p.000006: Section 2: Guidelines and standards
p.000007: 7
p.000007:
p.000007: Section 2
p.000007: Guidelines and standards
p.000007: These guidelines and standards outline how the principles above should be applied within MRC research units and
p.000007: institutes and clarify the MRC’s expectations for MRC-funded research within universities, medical schools, hospitals
p.000007: and other research organisations.
p.000007: They apply to everyone involved in MRC-funded research including researchers, research support staff, students,
p.000007: research managers and administrators.
p.000007:
p.000007:
p.000007: A Planning and conducting MRC-funded research
p.000007: A.1 Those planning and delivering MRC-funded research should have the necessary expertise, professional skills and
p.000007: experience to deliver the project proposed. This may include seeking specialist advice or securing access to expertise
p.000007: through collaboration. Plans should include an assessment of all resources needed (including staff, space, funding,
p.000007: facilities, biological resources and clinical support) to ensure the study is viable within the available means and the
p.000007: efficient and proper use of all resources. This position should be reviewed as the project progresses. Researchers
p.000007: supported by the MRC should consider at an early stage of the design of the project how they will adhere to the
p.000007: principles and standards of Good Research Practice over the course of their research and aim to anticipate any issues
p.000007: or challenges that might arise.
p.000007: A.2 The rationale for the study and any subsequent modifications must be clearly documented within a well
p.000007: maintained system, for example in project proposals, contracts, protocol documents, laboratory notebooks or as
p.000007: electronic records. All projects must be documented clearly, systematically and in a timely manner, including clear
p.000007: outcomes and end points, plans for statistical analysis, any ethical and regulatory approvals and any subsequent
p.000007: amendments. Key records or documents should be held in an accessible form. Any changes should be validated and recorded
p.000007: with appropriate version control by the researcher responsible, to establish the provenance of the study and protect
p.000007: intellectual property.
p.000007: A.3 MRC-funded research must adhere to current ethical standards, safety practices, relevant legal requirements,
p.000007: local organisational policies and other guidelines. Researchers should ensure they are aware of, and keep up to date
p.000007: with, all the regulatory, ethical and governance requirements that may apply to their area of research and are working
p.000007: with the teams and individuals within their organisations who have a corporate responsibility to ensure that these
p.000007: requirements are adhered to within the organisations. All appropriate licences and permissions must be in place before
p.000007: the research starts and updated as necessary if plans change. The expectations and requirements of professional codes
p.000007: of conduct and standards, including arrangements for managing consent and information governance should be addressed in
p.000007: the planning and conduct of the study (see section D below).
p.000007: A.4 For all research involving people as participants, their tissues or data, the relevant principles of Good
p.000007: Clinical Practice (GCP), an international ethical and scientific quality standard for designing, conducting, recording
p.000007: and reporting trials that involve the participation of human subjects, should be followed (13). Where practicable,
p.000007: consent that is freely given and informed should be sought from all competent participants. Guidance on writing
p.000007: participant information is available from
p.000007: the National Research Ethics Service (NRES)(14); this includes guidance for research that involves adults who lack
p.000007: capacity to give consent or children (15). Consent discussions should include how feedback on any health related
p.000007: finding will be handled, what withdrawal from a study will mean
p.000007: in practice and that this can occur at any time and for any reason up to the point of data analysis or up to the point
p.000007: of submission for publication. In line with the MRC’s policy on data and tissue
p.000007:
p.000007:
p.000007:
p.000007:
p.000008: 8
p.000008: Good research practice: principles and guidelines
p.000008:
p.000008:
p.000008:
p.000008: sharing, participants should also be made aware of potential reuse in future research and the arrangements for consent.
p.000008:
p.000008: A.6 Responsibilities for overseeing the scientific and ethical conduct of the study must be identified, allocated
p.000008: and agreed as the scientific plans are put into practice. This is especially important in projects involving patients,
p.000008: volunteers or confidential or identifiable data, tissue, biological samples and animals and in other complex,
p.000008: collaborative programmes.
p.000008: A.7 Research organisations should have appropriate research governance systems, in which roles are allocated to
p.000008: meet corporate and individual project responsibilities, and are accepted and carried out within a sound research and
p.000008: project management framework. This may involve the identification of sponsors, appropriate and proportionate quality,
p.000008: risk management and monitoring systems, or the use of preferred project management processes or tools. When considering
p.000008: proportionate risks important aspects to consider include the impact on research delivery, supporting creativity, the
p.000008: credibility and robustness of results and the risks involved in methods used in studies involving human participants.
p.000008: A.8 The proper use and maintenance of equipment and systems is an important element of the research process.
p.000008: Appropriate procedures should be in place and responsibilities assigned to ensure training and support for use, regular
p.000008: servicing and calibration of equipment by trained staff, appropriate records of calibration, servicing, faults,
p.000008: breakdowns and misuse.
p.000008:
p.000008: A.9 Where possible, and most often for studies involving patients and volunteers, researchers should engage with
p.000008: service-users, carers, representative groups and other stakeholders and beneficiaries in the design, conduct, analysis
p.000008: and reporting of research. Advisory bodies which promote active public and patient involvement should be consulted as
p.000008: appropriate (20)(21).
p.000008:
p.000008:
p.000008: Related links
p.000008: (1) RCUK policy and code of conduct on the governance of good research conduct, Integrity, Clarity and Good Management
p.000008: (2013): http://www.rcuk.ac.uk/RCUK-prod/assets/documents/reviews/grc/
p.000008: RCUKPolicyandGuidelinesonGovernanceofGoodResearchPracticeFebruary2013.pdf
p.000008: (2) MRC policy on health department research governance frameworks: http://www.mrc.ac.uk/research/
p.000008: research-policy-ethics/clinical-research-governance/
p.000008: (4) Universities UK Concordat to Support Research Integrity: http://www.universitiesuk.ac.uk/
p.000008: highereducation/Documents/2012/TheConcordatToSupportResearchIntegrity.pdf
p.000008: (5) UK Research Integrity Office, Code of practice for research: Promoting good practice and preventing misconduct
p.000008: (2009) and Recommended Checklist for Researchers: http://www.ukrio.org/publications/code- of-practice-for-research/
p.000008: (11) RCUK and MRC terms and conditions for grants: http://www.rcuk.ac.uk/funding/grantstcs/
p.000008: (12) RCUK statement of expectation on economic and societal impact: http://www.rcuk.ac.uk/Publications/
p.000008: archive/StatementofExpectationon/
p.000008: (13) Good Clinical Practice principles: www.ichgcp.net
p.000008: (14) HRA guidance on consent: http://www.hra.nhs.uk/resources/before-you-apply/consent-and-
p.000008: participation/consent-and-participant-information/
p.000008: (15) MRC ethics series; Personal information in medical research, Medical research involving adults who lack capacity
p.000008: to consent, Medical research involving children: http://www.mrc.ac.uk/research/research-policy- ethics/
p.000008: (16) MRC Regulatory Support Centre resources and tool kits: http://www.mrc.ac.uk/research/facilities/
p.000008: regulatory-support-centre/
p.000008:
p.000008:
p.000008:
p.000008: Section 2: Guidelines and standards
p.000009: 9
p.000009:
p.000009:
p.000009:
p.000009:
p.000009: (17) MRC policy on research data sharing and preservation: http://www.mrc.ac.uk/research/research-policy-
p.000009: ethics/data-sharing/
p.000009: (18) UK research funders vision for human tissue resources: http://www.ukcrc.org/research-infrastructure/
p.000009: experimental-medicine/funders-vision-for-human-tissue-resources/
p.000009: (19) RCUK Concordat and guidance on engaging the public with research: http://www.rcuk.ac.uk/pe/ Concordat/
p.000009: (20) NIHR guidance on patient and public awareness: http://www.nihr.ac.uk/get-involved/
p.000009: (21) INVOLVE: Promoting public involvement in research: www.invo.org.uk/resource-centre
p.000009: (22) NIHR Clinical Research Network: http://www.crn.nihr.ac.uk/
p.000009:
p.000009:
p.000009:
p.000009:
p.000009: B Data: management, integrity, retention and preservation
p.000009: B.1 MRC-funded research covers a broad spectrum, including fundamental lab-based science, population health
p.000009: science, patient-based studies and clinical trials. All research data generated through MRC-funded research must be
p.000009: managed and curated effectively throughout its lifecycle, including archiving, to ensure integrity, security and
p.000009: quality and where possible to support new research and research data sharing (17)
p.000009: (23) to maximise the benefit and impact of MRC research funding. Records should be kept to enable understanding of what
p.000009: was done, how and why, and which allow the work to be assessed retrospectively and repeated if necessary.
p.000009: B.2 The principles, standards and technical processes for data management, retention and preservation will be
p.000009: determined by the area of science, for instance the needs of fundamental studies may differ from population-based and
p.000009: clinical studies. Processes should be supported by appropriate data standards addressing confidentiality and
p.000009: information security, monitoring and quality assurance, data recovery and data management reviews where suitable.
p.000009: B.3 Research data generated in the course of MRC-funded research must be retained in an appropriate format in
p.000009: line with agreed retention periods (see box 1 below). Related material should also be retained to ensure accessibility,
p.000009: integrity, the application of new analytical tools or statistical techniques, and to enable new research where possible
p.000009: (see box 1 below).
p.000009:
p.000009:
p.000009: Box 1: Retaining research data
p.000009:
p.000009: Types of research data
p.000009: Primary/raw data include any information, images, observations, questionnaires, products, devices, procedures and any
p.000009: other data sources that are generated, recorded or used during the project.
p.000009: Related material includes approvals, information on the consent process (including signed consent forms), meta-data,
p.000009: information relating to analysis and methodology, quality assurance records that demonstrate the validity of the data
p.000009: and/or adherence to experimental protocols, calibration data,
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| access | Access to Social Goods |
| authority | Relationship to Authority |
| children | Child |
| education | education |
| emergency | Public Emergency |
| employees | employees |
| political | political affiliation |
| property | Property Ownership |
| property ownership | Property Ownership |
| stem cells | stem cells |
| student | Student |
| volunteers | Healthy People |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| property | ['propertyXownership'] |
| property ownership | ['property'] |
Trigger Words
capacity
consent
developing
ethics
protect
protection
risk
Applicable Type / Vulnerability / Indicator Overlay for this Input