Principal Investigator's Responsibilities

Who is the 'Chief Investigator' (CI)?

This is the person designated as taking overall responsibility within the team of researchers for the design, conduct and reporting of the study.

Who is the 'Principal Investigator' (PI)?

This may be the chief investigator, or where the research involves more than one site, the principal investigator is the person at each site responsible for the day to day running of the research project.

The Chief/Principal Investigator is responsible for ensuring that:

• The dignity, rights, safety and well being of subjects are given priority at all times.
• The study has WAHT Research & Development (R&D) approval prior to commencement
• The study has appropriate Research Ethical Committee (REC) approval prior to commencement.
• The Data Protection Officer has been informed of the study.
• Where appropriate, permission to conduct the study has been granted by the Caldicott Guardian.
• R&D and necessary REC approval will be gained for all protocol amendments.
• In the event that REC and/or R&D approval be withdrawn, the study will be suspended until approval is re-instated.
• Care staff will be adequately informed of the subjects' participation in this study.
• The study will be conducted by the CI/PI personally and/or members of his/her research team.
• Each member of the research team, including CI/PI, who has direct involvement with research subjects and/or person-identifiable data, has a full, honorary or a letter of access with WAHT.
• Each member of the research team, including CI/PI, is suitably qualified by education, training and experience.
• Students and new researchers have adequate supervision, support and training.
• Procedures are in place to ensure collection of high quality, accurate data.
• Data will be processed and stored in accordance with the Data Protection Act 1998 and the Caldicott Principles.
• Arrangements have been made to comply with WAHT Health and Safety policy, in accordance with the Health and Safety Act 1974.
• Serious Adverse Events will be reported to the REC and Research & Development Dept.
• Arrangements are in place for the management of financial and other resources provided for the study, including the management of any intellectual property arising.
• Adequate and accurate records will be maintained and made available for audit as required.
• Reports on the progress and outcomes of the work required by the Research & Development Dept. will be produced on time and to an acceptable standard.
• The findings from the work will be open to critical review and disseminated appropriately.
• Suspected research misconduct and/or fraud will be reported through appropriate systems.
• All members of the research team are informed of their obligations in meeting the above commitments.

Responsibility for others

Chief and Principal Investigators have a responsibility to inform others involved in the research project about the requirements of Research Governance as it applies to them. The Principal or Lead Researcher must ensure that all researchers working on the project are aware of their responsibilities to:

• Make sure that any research undertaken adheres to the agreed protocol.
• Help care professionals to ensure that participants receive appropriate care while involved in research.
• Protect the integrity and confidentiality of clinical and other records and data generated by research.
• Report any failures in respect of drug reactions and other events or suspected misconduct through appropriate systems.

Useful links:

• Research Governance Framework
• Declaration of Helsinki
• Data Protection
• Health & Safety
• GCP & Reporting Adverse Events
• Research Design Service - for assistance with research design and statistics contact staff in the RDS.