Research Governance Framework Responsibilities
A detailed account of the responsibilities of the various groups for which the Research Governance Framework applies can be located in pages 19- 38 of:
The research governance responsibilities of those involved in research under the Research Governance Framework are summarised below.
The Sponsor is the organisation that takes on responsibility for confirming there are appropriate arrangements to initiate, manage and monitor, and finance a study. For any research that takes place in the context of the NHS or Social Care services, it is necessary that a Sponsor is identified. The Sponsor is normally expected to be the lead employer of the research team, the lead health or social care organisation, or the main funder. For further information regarding sponsorship please contact the Research Governance team. Formal confirmation that Cardiff University will act as Sponsor can only be given by RACD on the University's behalf. A Sponsor Registration form can be found on the Forms, Procedures, SOPs and Guidelines page.
The Sponsor has the responsibility for ensuring that all the necessary arrangements are in place before the study can proceed, including:
- ensuring that the research study has obtained scientific quality approval from the necessary bodies
- ensuring that the study has obtained ethical approval
- ensuring arrangements are in place for the monitoring and reporting of research
- ensuring the research team have access to resources and support to deliver the research as proposed
A senior individual must be designated as the Chief Investigator for any research undertaken in or through the NHS or social services, which involves participants or their organs, tissue or data.
- The Chief Investigator is the individual who takes overall responsibility for the design, conduct and reporting of a study if it is at one site; or if the study involves researchers at more than one site, the Chief Investigator takes responsibility for the design, management and reporting of the study, co-ordinating the investigators who take the lead at each site
In respect to student projects (PhD, Mphil, MSc, BSc), the academic supervisor must act as the Chief Investigator. For the purposes of obtaining ethical approval, if the student has designed the project then the student should be named as the Chief Investigator on the ethics application form.
The Principal Investigator is the person responsible individually, or as the leader of researchers at a particular site, for the conduct of a study.
- submit proposals for ethical review
- obtain Sponsorship approval
- conduct research according to agreed protocol & in accordance with legal requirements
- ensure participant welfare
- record keeping
- adverse event reporting
- dissemination of results
Participants can be defined as patients, service users and carers, relatives of the deceased, professional carers or members of the public agreeing to take part in the study.
- Inform Chief/Principal Investigators if they do not understand information and explanations given in relation to the study
- Inform the Chief/Principal Investigators about any concerns or about participation/withdrawal from the study
This can be defined as the organisation(s) employing the Chief Investigator(s) and/or other researchers. The organisation employing the Chief Investigator will normally hold the contract(s) or grant agreement(s) with the funder(s) of the study. Organisations holding contracts with funders are responsible for the management of the funds provided.
- Promote quality research culture
- Ensure researchers understand & discharge their responsibilities
- Ensure independent scientific review
- Ensure research is properly managed & monitored
It is the responsibility of organisations (NHS Trusts, Primary Care) providing Health and Social Care to be aware of all research being undertaken in their organisation, or involving participants, organs, tissue or data obtained through the organisation. Care organisations are responsible for the quality of the care of their patients or service users and carers, whether or not individuals are involved in research and whoever conducts or funds that research.
Organisations providing care are responsible for satisfying themselves that they have adequate arrangements and resources for any research involving their patients, service users and carers, or staff to meet the standards set out in the Research Governance Framework.
- Authorises all research involving their patients, staff or facilities
- Ensure research meets standards of Research Governance Framework
- Ensure ethics committee approval obtained
- Duty of Care to participants