Regulations, Policies and Guidelines
Regulations and Policies
The University’s current Regulations and Policies are:
- Regulations for Research Involving Human Participants (pdf)
- QUB Policy on the Ethical Approval of Research (pdf)
- Code of Conduct and Integrity in Research (pdf)
- QUB Regulations Governing the Allegation and Investigation of Misconduct in Research (pdf)
- QUB Regulations Governing Research Involving Animals (pdf)
- QUB Guidance for Research in the Digital Space (pdf)
- QUB Policy and Procedure for the Duty of Care of staff and Students travelling for research purposes to high-risk locations*
*Please note that the previous Policy on Fieldwork in Conflict Zones has been absorbed into the QUB Policy and Procedure for the Duty of Care of staff and Students travelling for research purposes to high-risk locations.
STANDARD OPERATING PROCEDURES
The Research SOPS are undergoing review and revision. The SOPs on this page
have been approved for use by the Research Governance Ethics and Integrity
Committee. The remaining SOPS are still being revised and will be uploaded once
relevant approvals are in place. If you require anything urgently, please
contact researchgovernance@qub.ac.uk
• Creation, Control, Amendment and Storage of SOPs
• Development and Review of Research Plan/Study Protocol
• The Ethical Approval of Research
• Informed Consent for Research
• Delegation of Responsibilities
• Reporting and Managing Research Related Adverse Events
• Preparation, Completion, Signing and Correcting Case Report Forms
• Setting Up, Maintaining and Archiving Research Files
• Education, Training and Experience
• Amendment to Study Documentation
• End of Study Declaration, Early Termination and Final Report
• Production of Progress Reports
• Indemnity and Sponsorship of Research Studies
• Data Management, Collection, Validation and Storage
• Research Governance Audit
• Matters of Non-Compliance with Study Protocol
• Risk Assessment of Research Studies
• Monitoring of Research Studies
• Complaints from Research Participants
• Maintaining Laboratory Books
• Breach of Participant Confidentiality
• Clinical Trial Sample Analysis in University Laboratories
• Sponsor Green Light
• Registration of Clinical Trials
• Convening of Trial Steering Committees and Data Monitoring Committees
for Clinical Trials
• Contracting for CTIMPs
Useful Guidelines
Please click each section below for guidance relating to each topic:
-
Authorship and Publication
Authorship is an important aspect of responsible research. Practices around authorship are discipline specific, as are the outputs generated. However, the principles of research integrity: Honesty, Rigour, Transparency and Open Communication, Care and Respect and Accountability should be at the core of developing and disseminating the out-workings of research.
The University’s Guidelines on Authorship and Publication provide advice as to the approach and areas to consider when authoring an output. The document contains links to enable further reading on specific issues, inter-alia, predatory journals, reporting on animal research, open science and assigning authorship.
- Research in Conflict Zones
In order to protect the integrity of the research process and to facilitate staff and students in completing projects that support our research strategies, the University has an obligation to provide insurance for staff and students who need to travel to conflict zones, so long as the travel has been approved through an appropriately robust risk assessment process. Schools have already established procedures for managing risk through research approval processes that are used for projects conducted by students and staff.
In order to deal specifically with the issue of undertaking travel to countries that the Foreign & Commonwealth Office (FCO) has deemed to be unsafe, it is recommended that these additional procedures should be introduced.
- Research File Guidelines
A Research File is a standardised filing system which allows for the logical and effective storage of documentation relating to a research project.
Guidelines on the content (and rationale for inclusion), storage, archive and audit of Research Files can be found here:Documents required will vary according to the type of research. A contents checklist which can be adapted to suit specific projects can be found here:
- Guidance on the Appropriate Use of PPI
Guidance on the appropriate Use of PPI can be found here. Further information and resources in relation to PPI can be found on the QUB Personal & Public Involvement Network (https://www.ppihub.org/) and PPI Resource Hub (https://www.ppihub.org/resource-hub)
- Community-University Research
These guidelines have been produced by a special Project Group of the Senator George J. Mitchell Institute for Global Peace, Security and Justice in order to ensure that strong and meaningful partnerships are formed in every community/university project that is undertaken.