The Chief Investigator (CI) is the person designated overall responsibility for the design, conduct and reporting of a study. The Chief Investigator must ensure that the ‘proposed’ sponsor is made aware of their research proposal as early as is possible in study development / funding application stages so that steps can be taken by the sponsor to assess whether to accept the sponsor responsibilities.
The Chief Investigator is required to declare any potential conflicts of interest including those of self, immediate family, spouses, partners and children at the sponsorship request stage. So for example, declaring where there is an existing relationship with a company or organisation that will be involved in the research that could lead them to benefit financially or commercially from the outcome of the research (i.e this may compromise or bias professional judgment and objectivity).
- Chief Investigator requirements
The sponsor is responsible for ensuring that an appropriate individual is designated as the Chief Investigator for any research undertaken in or through the NHS. In considering a sponsorship request Noclor will review how the proposed research will be managed and assess the Chief Investigator’s suitability, experience, expertise and capacity (from the information provided in the on-line application and accompanying Curriculum Vitae) to ensure that they are commensurate with the roles and responsibilities that they will be delegated by sponsor.
For Clinical Trials of Investigational Medicinal Products (CTIMPs), the Chief Investigator must be a health professional as defined in the Medicines for Human Use (Clinical Trials) Regulations 2004 (SI 2004/1031). This means a person registered in the UK as a doctor, dentist, nurse or pharmacist.
The Chief Investigator must have a contract (either substantive or honorary clinical contract) with the Trust s/he is proposing acts as sponsor.
For funded research the Chief Investigator would normally be expected to be the grant-holder (i.e lead applicant on the funding application).
For a single-site study the Chief Investigator must also be the Principal Investigator (PI). If the study involves more than one site, the Chief Investigator takes primary responsibility for the design, conduct and reporting of the entire study whether or not that person is an Investigator at any particular site (and for research sponsored by a Noclor partner, s/he would still be expected to be the Principal Investigator where there is research site within the sponsor organisation).
- Chief Investigator responsibilities
Although the sponsor takes primary responsibility for ensuring that the design of the study meets appropriate standards and that arrangements are in place to ensure appropriate conduct and reporting, the Chief Investigator is the person designated overall responsibility (as delegated by the sponsor).
For clinical trials where a Noclor partner has agreed to act as sponsor, the responsibilities delegated to the Chief Investigator are clearly defined in the Delegation of Responsibilities Agreement (CTIMP or non-CTIMP) signed by both parties (Chief Investigator and sponsor) prior to the sponsor declaring final sponsorship /study activation.
In line with Noclor’s risk-proportionate approach to managing sponsored research (where a Noclor partner is to act as sponsor); for research that is not defined as a clinical trial, the Chief Investigator will not be required to sign an additional declaration of responsibilities agreement with the sponsor (unless specified at time of sponsorship review/a condition of sponsorship declaration) as by signing the IRAS Declaration (Part D of the IRAS application forms) the Chief Investigator is legally agreeing to its contents and will be personally liable for any deviation from the agreement.
- Changes to Chief Investigator
Any change to the Chief Investigator’s circumstances that are likely to significantly impact on the management of the research study (for example planned change of Chief Investigator employer or absence due to ill health/sabbatical etc) and should be notified to the Noclor Sponsor Representative immediately so that an assessment of the situation can be made and the appropriate decisive action can be taken.
Changes to the Chief Investigator’s circumstances may result in one of the following (with the ultimate decision being made by the sponsor):
- Replacing Chief Investigator (this would require a risk assessment and documented action plan which would include: notice of substantial amendment, possible amendment to contracts and a documented handover between outgoing and incoming Chief Investigator for the Study/Trial Master File (S/TMF), for CTIMPs possible revision of label of IMP etc)
- Temporary halt/suspension
- Early termination (in the event of no suitable replacement being found)
- Transfer or withdrawal of sponsorship