This section sets out the responsibilities of the College and its employees in relation to research.
If you are a College employee, or hold an honorary College contract, and you are involved in healthcare or non-healthcare research it is important for you to be aware of your obligations under relevant UK regulations, such as the Research Governance Framework and Good Clinical Practice. By healthcare research, we mean any research which involves humans, their tissue and/or data.
The responsibilities of each role are given below:
Imperial as an employer
Where employees of the College are involved in health and social care research, including Chief/Principal Investigators and Researchers, the College undertakes certain liabilities in respect of the work of those employees.
The College is responsible for:
- Developing and promoting a high quality research culture and holding employees to account for professional misconduct of research.
- Ensuring that Chief/Principal Investigators and researchers understand and discharge their obligations to the research and the clinical research process as set out in law and relevant guidance.
- Complying with all current employment and health and safety legislation.
- Demonstrating the existence of clear codes of practice for our staff and mechanisms to monitor and assess compliance.
- Discharging the agreed role of the management and monitoring of clinical research, as appropriate.
- Operating systems for continuous professional development of all staff involved in research.
- Having agreements and systems in place for the identification, protection and exploitation of intellectual property.
- Ensuring anyone harmed as a result of negligence on the part of College staff, students and others for whom the College is liable for, can be compensated. This may also extend to compensating participants for non-negligent harm arising from research for a particular study where this has been agreed.
- Operating systems to detect and address fraud, and other allegations of other scientific or professional misconduct by our staff.
- Having systems to address and learn lessons from any errors or complaints brought against our employees.
- Permitting and assisting any statutory audits or inspections by relevant authorities arising from errors or complaints associated with our employees.
Imperial as a legal sponsor
Where the College is a legal sponsor of a study it is responsible for ensuring appropriate arrangements are in place for:
- The collection of high quality and accurate data.
- The management and monitoring of research, to ensure it is carried out in accordance with the approved protocol (or proposal) and regulatory requirements.
- Recording and reporting of significant developments as research proceeds, either in relation to the safety of individuals or scientific direction. In particular, ensuring appropriate arrangements for the recording and reporting of serious adverse events/reactions of any kind.
- Approving modifications to the design of studies, obtaining any regulatory approvals and implementing them.
- The conclusion of a study, including plans for disseminating findings.
The College is also responsible for ensuring that:
- Research proposals respect the dignity, rights, safety and well-being of participants and for healthcare research the relationship with care professionals.
- Only research of high scientific quality and good value for money is undertaken.
- An appropriate Research Ethics Committee has approved all clinical research projects.
- For clinical trials of investigational medicinal products, the Chief Investigator obtains a clinical trial authorisation and all trial arrangements comply with the law.
- All clinical research being undertaken through or within Imperial, including research undertaken by students as part of their training, is formally registered.
- The Chief Investigator and other key researchers have the necessary expertise and experience to conduct research as proposed.
- Agreement has been reached about compensation in the event of harm to research participants. Further information about this can be found on the Insurance page.
- Auditing or inspection by relevant authorities is permitted and assisted.
Principal Investigator (PI)
The Principal Investigator (PI) takes ultimate responsibility for the design, conduct, analyses and reporting of a clinical study.
The PI is accountable to:
The College (as their employer) for the design, conduct and reporting of a study and through the College, to the sponsor of the research (which may be Imperial College, an NHS Trust or other organisation) and to the care organisation(s) if relevant within which the research is taking place.
Further details on responsibilities for healthcare research can be found on the PI for healthcare research tab.
The PI is responsible for ensuring:
- Suitable experience and expertise is in place, in the conduct of research so that the PI can either; undertake the design, conduct and reporting of a study to standards set out in regulations or lead and manage others with delegated responsibility for some of these aspects.
- The research team give priority to the dignity, rights, safety and well-being of participants and potential participants are fully informed befoe deciding whether or not to join a study.
- The study complies with all legal and ethical requirements.
- Students and new researchers have adequate supervision support and training.
- The Research Governance and Integrity Team and Faculty Research Services have been informed that the research is planned and appropriate approvals are sought. Please see our SOP, Associated Documents & Templates section for more information about seeking approvals and registering projects.
- The study is submitted to a relevent Research Ethics Committee for ethical review and does not start without a favourable opinion.
- The research follows the protocol or proposal approved by the relevant ethics committee and sponsor.
- Procedures are in place to ensure collection of high quality and accurate data, and the integrity and confidentiality of data during processing and storage is maintained at all times.
- Arrangements are in place for the effective financial management of the study. For advice about financial management of research please contact a member of your Faculty Research Services Team.
- You are involved in the prevention and detection of scientific misconduct by adopting the role of guarantor on published outputs.
In order to obtain College sponsorship for a project please see the obtaining sponsorship page.
For sponsorship of non-NHS healthcare or non-healthcare research please see the Imperial Ethics Process.
Further responsibilities that you are advised to read are found below.
- Each member of the research team including those at collaborating sites is qualified by; education, training and experience to discharge his or her role in the study and their qualifications are documented.
- The research follows the protocol or proposal approved by the relevant ethics committee and sponsor. If you want the College to sponsor the research, you will need to contact a Research Governance Manager who will review the application for sponsorship. Please see our Obtaining sponsorship section for more information about this process.
- Substantive changes to the protocol or proposal are submitted for ethical review and to the sponsor for agreement.
- Reports on progress and research outcomes are supplied to the sponsor, research funders or others with a legitimate interest, in a timely manner and to an acceptable standard .
- Findings are disseminated promptly and fed back as appropriate to participants.
- Arrangements are made for the appropriate archiving of data when research has finished.
- All data and documentation associated with the study are available at the request of the RGIT, NHS Trusts and external inspection authorities (where applicable).
Researchers are responsible for the day-to-day aspects of a clinical study, which includes:
- Familiarising themselves with the protocol and only carrying out responsibilities delegated to them by the PI.
- Ensuring research they undertake follows the current version of the agreed protocol (or proposal).
- Helping care professionals to ensure their patients receive appropriate care whilst involved in research.
- Protecting the integrity and confidentiality of clinical and other information generated by the research.
- Reporting any failures in these respects, any adverse reactions and other events and suspected misconduct through the appropriate systems.
- Researchers must be GCP trained if conducting healthcare research.
Care professionals retain responsibility for the care of their patients or service users, when they participate in research.
Are responsible for:
- Checking that the Principal Investigator has obtained the appropriate approvals from the College, relevant NHS Trust, HRA approval, an appropriate research ethics committee and/or the MHRA (as appropriate) before any of your patients can be approached to take part in a study.
- Contacting the Chief Investigator and/or the appropriate Research Governance Manager at the College immediately, if you are unsure whether a project has received approval, are concerned about informed consent or the way in which the research is being conducted.
- Ensure a contract agreement is in place before any trial activity is carried out. If you are unsure, please check with the PI who will follow this up with the contracts team.
PI for Healthcare research
The PI for a healthcare research study is responsible for:
Each investigator involved in a clinical trial of a medicinal product is aware of his/her legal duties.
The relevant NHS Trust is informed that the study is planned and their permission is sought before the research starts. Please see our section on NHS Trust contacts to identify who you need to contact.
When a study involves patients under the care of a doctor, nurse or social worker for the condition to which the study relates, those care professionals are informed that their patients are being invited to participate and agree to retain overall responsibility for their care.
The participants' care professionals are given any information directly relevant to their care that arises from the research (unless participants or the ethics opinion state otherwise).
If you want the College to sponsor the research, you will need to contact a Research Governance Manager who will review the application for sponsorship. Please see the Obtaining sponsorship page for more information about this process.
Clinical trials of medicinal products follow any conditions imposed by the MHRA.
All data and documentation associated with the study are available at the request of the RGIT, NHS Trusts and external inspection authorities (where applicable).