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LTHT FAQ's for Integrated Research Application System (IRAS) Applications

dot How do I identify the Research Sponsor?

dot Who is the Research Governance Lead for LTHT?

dot How to save the NRES form as an xml file
dot How to save the NRES form as a pdf file

How do I get a LTHT R&D Reference Number?

If you need an R&D reference number, you should find this on any correspondence we have sent you. If you have not received any correspondence from us, please contact the R&D Department and we can issue you with a number.

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What are the Indemnity Arrangements for studies that are not commercially sponsored?

Question A76-1 Liability arising from the management of the research

Normally the Research Governance Sponsor will hold insurance or provide indemnity to cover their liabilities as Research Governance Sponsor.  Where the sponsor is the employer of the Chief Investigator this is likely to be covered through insurance or indemnity for employers liability. If the sponsor is the LTHT then normal NHS Indemnity arrangement will apply. You should check with the R&D Department to confirm that the LTHT is the Sponsor. The REC will not be able to accept your submission until Sponsorship in principle is confirmed.

 

Question A76-2 Liability arising from the design of the research

The design of the research is the responsibility of the author and any co-authors of the protocol. Employers are responsible for the actions of their staff who design research studies as part of their employment. If the author is employed by a university, or the design of the research has been undertaken in the course of an honorary arrangement with a university, tick the response to indicate that other insurance or indemnity arrangements will apply and give details. This situation applies to researchers employed by a university, regardless of whether or not they hold any honorary contract with an NHS organisation.

For commercially sponsored research, the protocol will have developed the protocol and therefore be responsible.

Question A76-3 Liability arising from the conduct of the research

Employers are normally responsible for the actions of their staff who conduct research procedures as part of their employment.

However, where the research involves NHS patients under the care of NHS organisations (including independent contractors), indemnity for harm to participants resulting from clinical negligence is provided either through NHS schemes or through professional indemnity. R&D approval must be obtained in writing before the start of the research. 

NHS indemnity covers NHS staff and academic staff with honorary contracts. NHS bodies cannot offer advanced indemnities nor take out commercial insurance for non-negligent harm as there is no legal liability where a person is harmed but no-one has acted negligently.

Question A77 Has the sponsor(s) made arrangements for payment of compensation in the event of harm to the research participants where no legal liability arises? (Also known as 'no-fault- compensation.)

For all Commercially Sponsored Research:

Arrangements for no fault compensation will normally be provided in accordance with the Association of British Pharmaceutical Industry (ABPI) or Association of British Healthcare Industry (ABHI) schemes.  A copy of the form of indemnity must be included with the Agreement/Contract.

For non-commercial sponsored research:

Arrangements for no fault compensation cannot be made in advance by the NHS or other public bodies (e.g. MRC). Such organisations, although not accepting liability, may consider making an ex gratia payment on a voluntary basis in the event of a claim.

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How do I identify the Research Sponsor?

Question A64-1 Lead Research Sponsor

The Research Governance Sponsor is the organisation which accepts and takes on the legal responsibility for the research project. This includes overseeing the management of the project in the Leeds Teaching Hospitals and any of the host participating sites.

In general, the Research Governance Sponsor is normally the organisation which substanively employes the Chief Investigator. The Chief Investigator has the delegated responsibility for managing the trial (writing the protocol, managing and running the study, enrolment of patients, reporting to regulatory authority as required and writing the study report).   Some of these main responsibilities can be formally delegated to other persons or institutions.

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What are the Sponsor Contact Details for the Trust and University?

Question A64-2 Sponsor's UK Contact Details

The Leeds Teaching Hospitals NHS Trust
The University of Leeds
Dr Derek Norfolk Ms Clare Skinner

Associate Director of R&D

 Research Manager
Department of Research & Development
Faculty of Medicine and Health

The Leeds Teaching Hospitals NHS Trust

 Level 10 Room 10.110
34 Hyde Terrace
 Worsley Building
Leeds
 University of Leeds
LS2 9LN Leeds LS2 9LN
   
   
Tel: 0113 392 2878 Tel: 0113 343 4897/34974
Fax: 0113 392 6397 Fax: 0113 343 4217
Email: r&d@leedsth.nhs.uk Email:c.e.skinner@leeds.ac.uk

Who is the Research Governance Lead for LTHT?

Question A68 - Give details of the lead NHS R&D contact for this research:

The Leeds Teaching Hospitals NHS Trust
Dr Derek Norfolk

Associate Director of R&D
Department of Research & Development

The Leeds Teaching Hospitals NHS Trust
34 Hyde Terrace
Leeds
Great George Street
LS2 9LN
 
Tel: 0113 392 2878
Fax: 0113 392 6397
Email:r&d@leedsth.nhs.uk

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