This section sets out the responsibilities of the College and employees in healthcare research.
If you are a College employee, or hold an honorary College contract, and are involved in healthcare research it is important you are aware of your obligations under relevant UK regulations, the Research Governance Framework and Good Clinical Practice. By healthcare research, we mean any research which involves humans, their tissue and/or data.
Your specific responsibilities will depend on how exactly you are involved in the research and as an individual you may be involved in a number of different capacities.
Imperial as an employer
To remain liable for the work of employees who are involved in health and social care research, including Chief Investigators and Researchers.
The College is responsible for:
- Developing and promoting a high quality research culture and holding employees to account for the professional conduct of research.
- Ensuring that Principal Investigators and Researchers understand and discharge their obligations to 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 our agreed role in the management and monitoring our clinical research, as appropriate.
- Operating systems for continuous professional development of all staff involved in clinical research.
- Having agreements and systems for the identification, protection and exploitation of intellectual property.
- Ensuring anyone harmed as a result of negligence on the part of our staff, students and others for whom we have a liability can be compensated. Also, where it has been agreed for a particular study, compensating participants for non-negligent harm arising from the research.
- Operating systems to detect and address fraud, and 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 sponsor
To be responsible for ensuring appropriate arrangements are in place for the initiation, management and financing of clinical research projects.
The College is responsible for ensuring appropriate arrangements are in place for:
- Research teams to access sufficient resources to deliver their research as proposed.
- 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 clinical 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 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. For further information about this, please see our section on insurance.
- Auditing or inspection by relevant authorities is permitted and assisted.
To take ultimate responsibility for the design, conduct, analyses and reporting of a clinical study.
Are accountable to:
The College (as your 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) within which the research is taking place.
Are responsible for ensuring:
- You have suitable experience and expertise in the conduct of research so that you can either; undertake the design, conduct and reporting of a study to standards set out in regulations and the RGF 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.
- The study complies with all legal and ethical requirements and the Research Governance Framework.
- 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.
- Each investigator involved in a clinical trial of a medicinal product is aware of his/her legal duties.
- Students and new researchers have adequate supervision support and training.
- The Joint Research Compliance Office and Faculty Research Services have been informed that the research is planned and appropriate approvals are sought. Please see our Standard Operating Procedures section for more information about seeking approvals and registering projects.
- 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.
- Potential participants are fully informed before deciding whether or not to join a study.
- 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.
- Potential participants are involved in the design and conduct of a study whenever possible.
- The study is submitted to a relevant Research Ethics Committee for ethical review and does not start without a favourable opinion.
- The particpants' Care Professionals are given any information directly relevant to their care that arises in the research (unless participants or the ethics opinion says otherwise).
- 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 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. If the College is the Sponsor, these changes should be sent to the Research Governance Manager responsible for the research site.
- Clinical trials of medicinal products follow any conditions imposed by the MHRA.
- 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.
- 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.
- You are involved in the prevention and detection of scientific misconduct by adopting the role of guarantor on published outputs.
- 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 JRCO, NHS Trusts and external inspection authorities (where applicable).
To be responsible for the day-to-day aspects of a clinical study.
Are responsible for:
- Ensuring research you 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.
To retain responsibility for the care of your 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, 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.