Honorary Research Honorary Research Contracts and the Research Contracts and the Research

PassportPassportJulia Miller Assistant Director of Julia Miller Assistant Director of

Research and DevelopmentResearch and Development

NW SHANW SHA

Aims of workshopAims of workshop

• Understanding of honorary research contracts

• Understanding of the research passport system

HistoryHistory

• Research governance process had no standard implementation plan

• Problems emerging frequently for Trust R&D managers and researchers

• HR concerns needed to be addressed

• Cheshire, Greater Manchester & Cumbria and Lancashire, National

Why do researchers need HRCs in Why do researchers need HRCs in the NHS?the NHS?

• Duty of care

• Legal obligations

• Clear relationship with NHS organisation

• Part of the research governance framework

• By issuing a contract the organisation becomes responsible for a individual for the period of the contract

Type of contract Type of contract

• Substantive– Legal contract with

defined roles and responsibilities

– Employers vicariously (on behalf of another) liable for negligent acts of employees

– Malpractice handled by CNST (Trust) or employing organisation

• Honorary– Working without

remuneration for benefit of organisation

– Clarifying and confirming accountability to the NHS

– H Employer vicariously liable for actions while working for the honorary employer

Clinical academicsClinical academics

• Clinical duties (accountable by NHS)

• Academic duties (accountable by NHS)

• Accountabilities clear

• Research covered in contractual arrangements

When is an HRC needed?When is an HRC needed?

• When research has direct bearing on quality of care

• Where the employing organisation does not have accountability for NHS activities

• Inappropriate use of honorary contracts can transfer liability from the substantive employer to the honorary employer which poses a potential risk

HRC or no HRC? What other bodies also regulate. HRC or no HRC? What other bodies also regulate. What questions do you need to ask?What questions do you need to ask?

• University researcher wanting to send questionnaires to 400 patients

• NHS employee wanting to interview patients in an other NHS Trust

• NHS employee wanting to interview colleagues in other Trusts

• University researcher wanting to recruit patients to a clinical trial

Other regulatorsOther regulators

• Ethics (university and NHS)

• Research Governance (Trust approval)

• Agreements between organisations

• MHRA

• Professional bodies

• Legislation (e.g. Data Protection Act, MH Act and Human Tissues Act)

Duty of careDuty of care

• NHS has a duty where researcher has a foreseeable impact on type quality or extent of prevention, diagnosis or treatment of illness, injury or loss (HRC)

• NHS not liable for anything which unforeseeably influences type or quality etc.– Eg. An interview where the need for

intervention in a patients care may be revealed

ConfidentialityConfidentiality

• Anonymised data is not confidential• Patients must consent to information being

shared outside the NHS and how this will be done

• HRC does not give the right to access information for research purposes without patients consent

• Researchers responsibility for data confidentiality and should be aware of issues.

Pre employment checksPre employment checks

• Must be commensurate with the role in the organisation (e.g. the type of research, role of researcher and duty of care)

• Occupational Health interaction with patients (not always a new one)

• Standard Criminal Records Bureau (patients)• Enhanced CRB (vulnerable adults, children)• Amount of times a CRB is done varies

DebateDebate

• Discussion of table one.

• Think of an e.g. for each of these

• Where might there be grey areas?

PrinciplesPrinciples

• Application for an honorary research contract• Onus on researchers employer to complete

checks on suitability• Ensures accountability• Increases efficiency• System auditable and can be shared• Appropriate assurances• Enhances reputation of the NHS• Streamlines bureaucracy• Standardises procedures

Processes for issueProcesses for issue

• R&D office advises on the need for an HRC• Standard application form given with guidance and

advice• Other approvals sought e.g. ethics• Researcher returns signed form to the Trust with original

documents• Project limited (>5 years) or 5 years • RP signed by R&D/HR, photocopied and originals

returned to the individual• HRC issued when permission agreed for research to

take place

Fitting with existing systemsFitting with existing systems

• R&D issuing contracts• Good co-ordination• Links to R&D database• Alerts when contracts ending• Good records system including audits• Swift processing (>2 weeks) preferably in

partnership with the Trust approval process (to ensure research teams processed together)

• Researcher & R&D Office ensures kept up to date

Multi-CentreMulti-Centre

• Host organisation needs to check passport has ensured the relevant checks and is valid

• Any amendments e.g. additional checks should be recorded on the RP

• Letter confirming acceptance may be sent to individuals which constitutes an HRC

Multiple research projectsMultiple research projects

• Additional projects can be added to RP

• Additional checks may be required

• Advise researcher

• For those involved with may studies it may be best to get the highest level of checks

• Ask researcher about future projects

ResponsibilitiesResponsibilities

• Principle Investigators• Study sponsor• NHS research hosting departments• NHS HR (delegated either within or

outside organisation)• NHS R&D Office• Researchers employers• HEIs

Responsibility of researcherResponsibility of researcher

• Respect organisations policies and procedures eg– Incident reporting– Research governance– Misconduct and Fraud– Management of IP– Data storage and handling– Health and safety

Addressing difficultiesAddressing difficulties

• Communication established with substantive employer

• HRCs lay out a clear way of working

• Agreements support the way of working and may consider in more detail how information is exchanged etc

• Complaints from researchers in NHS dealt with by the NHS

Other issuesOther issues

• CRB may reveal convictions (NHS org must satisfy that there is low risk)

• Foreign nationals• Timescales need to be accounted for by the

researcher• Monitoring and sharing• Students• Records• ID badges

Making the system workMaking the system work

• Acceptable and implementable

• Not catering for one organisation

• Regular review

• Point to feedback comments

What next for the research What next for the research passport?passport?

• Adopted by the UKCRC– Small working group/endorsement by NHS

employers

• Formal evaluation of a number of health economies

• Better presentation of the document.• Encouragement of Trusts to start adopting

the principles of the passport and work together on these issues.