Only employers can be accountable for the suitability of an individual applying to do research in terms of training, experience and conduct. Substantive employers therefore retain the primary accountability and liability for the actions of their researchers. Once NHS organisations have given permission for research that affects their legal duty of quality and common law duty of care, they then accept vicarious liability for harm due to clinical negligence.
Defining "a direct bearing on the quality of care"
Activities that could have a direct bearing on the quality of care are those that could foreseeably directly affect the type, quality or extent of prevention, diagnosis or treatment of illness or foreseeably cause injury or loss to an individual to whom the NHS organisation has a duty of care.
Staff with substantive NHS contracts
Honorary research contracts are not required for these staff. When NHS employees wish to conduct research in other NHS organisations, this should be covered by an agreement between the NHS organisation who is the substantive employer of the individual and the NHS organisation in which it is proposed to undertake research. At present, a Letter of Access needs to be issued by or to CPFT for researchers who fall into this category.
Staff employed by Higher Education Institutions (HEIs)
Researchers with no contractual relationship with the NHS:
The NHS organisation where the research will be undertaken will determine whether an honorary research contract is required and which pre-engagement checks may be necessary. Pre-engagement checks should be documented in the Research Passport.
- where a researcher is conducting activities that will have a direct bearing on the quality of care, the individual will be accountable to the NHS organisation that gave permission for these activities. An honorary research contract should be issued by the NHS organisation to clarify and confirm this accountability.
- when researchers conduct activities with no direct bearing on the quality of care, the vicarious liability for the actions of the individual rests with the substantive employer; an honorary research contract should NOT be issued by the NHS organisation. Instead, a letter of access (for researchers who do not require an honorary research contract) outlining the researcher's responsibilities to the NHS organisation should be issued and copied to the researcher's employer.
In both cases the Research Passport scheme should be used to ensure that appropriate pre-engagement checks have been completed.
Researchers with a substantive HEI contract and an honorary NHS contract, e.g. clinical academics:
- Clinical academics do not need an honorary research contract in order to undertake research in the partner NHS organisation where they undertake their clinical duties: this will be covered by their honorary clinical contract.
- when clinical academics wish to conduct research in other NHS organisations, this should be covered by an agreement between the NHS organisations where the clinical academic undertakes clinical duties, and the NHS organisation in which it is proposed to undertake research. At present, a Letter of Access will need to be issued by or to CPFT to cover researchers who fall into this category.
In both instances, the Research Passport scheme should be used to ensure that the appropriate pre-engagement checks are in place.
Students (undergraduate and postgraduate)
Students on a healthcare placement:
Undergraduate and postgraduate students may conduct research as part of their healthcare placements. A memorandum of understanding between the HEI and the NHS organisation should be in place for healthcare placements, which should confirm the accountability arrangements between the organisations. Therefore students conducting research as part of a healthcare placement should not be issued with honorary research contracts by the NHS organisation.
Postgraduate students:
- Postgraduate students may conduct research within the NHS other than through healthcare placements. When the student is not appropriately clinically qualified to undertake research activities that may have a direct bearing on the quality of care, the student should be supervised by a clinical supervisor who is an NHS employee or an HEI employee with an honorary clinical or research contract. Students supervised in this way should not be issued with honorary research contracts by the NHS organisation.
- Where a postgraduate student is appropriately clinically qualified and experienced, direct supervision may be inappropriate. The student must be issued with an honorary research contract by the NHS organisation if the research will have a direct bearing on the quality of care.
Pre-engagement checks should be arranged by the HEI and, in all cases, the Research Passport system should be used to ensure that the appropriate checks are in place.
Research where the participants are NHS staff
Where research involves NHS employees as participants, the duty of care of the NHS organisation to its employees is non-delegable and the NHS organisation will always be liable, regardless of who employs the researcher. Where the individual conducting the research is not substantively employed by the NHS organisation, an honorary research contract will not affect accountability or liability and should not be issued by the NHS organisation.