If you are a University employee or student and are involved in research involving human subjects or tissue it is important you are aware of your obligations under all relevant UK and EU regulations.
Your specific responsibilities will depend on your role in the research. You may be involved in a number of different capacities for example as a Researcher, Chief Investigator or Principal Investigator (if the study involves more than one site).
Responsibilities as a Chief or Principal Investigator
For Clinical Trials a Chief Investigator (CI) is defined as the person with overall responsibility for the running of a study, which includes the development of the trial protocol. For Clinical Trials, a Principal Investigator (PI) is the person responsible for the running of the trial at an individual site (if there are multiple sites to the study).
For other studies involving humans a Principal Investigator (PI) is defined as the person with responsibility for the running of a study. As a Chief or Principal Investigator you are accountable to the trial sponsors.
The University requires all PI's and CI's to ensure that before a study starts:
- The Research Regulation and Compliance Office is aware of the planned research.
- The study complies with all ethical, legal and regulatory requirements. See Clinical Trials and Research Governance Framework sections for more information.
- The study has adequate finance and infrastructure in place in order to be conducted to standards.
During a study PIs and CIs must ensure:
- The research follows the version of the protocol approved by both the ethics committee and regulatory body (where appropriate). Any substantive changes to the protocol must be submitted to the original approving bodies including NHS R&D. If the University is acting as sponsor or co-sponsor, the Research Regulation and Compliance Officer should also be made aware of the amendment.
- The data collected is of high quality and accurate and the confidentiality of all participating subjects is protected at all times. Furthermore, Investigators must ensure the dignity, rights and well being of the research participants are upheld at all times.
- All research staff are given adequate support, training and supervision. All research team members, including those at collaborating sites, must be qualified by education, training and experience to discharge their role within the study. All qualifications should be documented and available for review by the sponsor/co-sponsor and any relevant regulatory body or ethics committee.
- All potential participants are provided with sufficient information to be able to give fully informed consent before being entered into a study and new information is provided during the study.
- All records are retained for the appropriate length of time.
**Please note the University requires records to be held for a minimum of ten years**
All relevant staff should have suitable experience and expertise in the conduct of research so that they can:
- Undertake the design, conduct and reporting of a study to standards set out in the Clinical Trial Regulations or the Research Governance Framework.
- Lead and manage others where appropriate.
Responsibilities of a Research Sponsor
The sponsor is responsible for implementing and maintaining quality assurance and quality control systems to ensure that studies are conducted and data are generated, documented and recorded in compliance with Good Clinical Practice.
Responsibilities of a Researcher
A Researcher should:
- Ensure that research follows the correct version of the approved protocol.
- Assist health care professionals to ensure patients receive appropriate care whilst involved in the research.
- Ensure that the integrity and confidentiality of all clinical and other information generated by the research is protected.
- Report adverse reactions or other events and suspected misconduct through the appropriate channels - internally or externally.
Responsibilities of an Employing Organisation
An Employing Organisation should ensure that:
- All Chief and Principal Investigators and Researchers understand and discharge their obligations to the clinical research process, as set out in current research legislation or guidelines.
- The research complies with all current employment and health and safety legislation.
- Clear codes of practice for staff, and mechanisms to monitor and assess compliance are in place.
- It discharges its agreed role in the management and monitoring of clinical research.
- Operating systems for continuous professional development of all staff involved in clinical research are in place.
- All agreements and systems for the identification, protection and exploitation of intellectual property are in place. Contact Alasdair Street for intellectual property issues.
- Anyone harmed as a result of negligence on the part of University staff or students, for whom it has a liability, can be compensated.
- Any statutory audits or inspections by regulatory authorities are conducted as and when required.
- Systems are in place to address and learn from any errors or complaints brought against its employees.