R&D Approval Guidance V10 29/07/2015

R&D Approval Guidance – V10 – 29/07/2015

GUIDANCE NOTES

R&D Approval

Background

Under the Department of Health’s Research Governance Framework NHS Trusts are required to formally approve all research involving Trust patients and/or staff or their tissues, samples or data before the research may commence. Through the R&D approval process, Trusts must be satisfied that the research fulfils all of the requirements of the Research Governance Framework. This includes ensuring all research is of a high scientific and ethical standard, ensuring researchers have the appropriate honorary or substantive contracts with the Trust and ensuring financial probity. The Trust is also required to ensure compliance with other areas of relevant legislation including the Human Tissue Act, Mental Capacity Act and Medicines for Human Use (Clinical Trials Regulations) and assess the suitability of the site.

Please note that R&D and ethics are two separate processes, and that both are required for studies involving the NHS.

There are now three systems for gaining R&D Approval depending on the type of funding that you have achieved for your research:

NIHR CSP

Firstly if your funder is eligible to be part of the UKCRN portfolio (these include the Research Councils, most large national medical research charities, government departments and EU for full details see and your study involves SLaM patients then your approval will be organised via National Institute for Health Research Coordinated System for gaining NHS Permissions (NIHR CSP). It is essential that this route is used for all of these studies as this is the only mechanism for the Trust to receive the support funding for your research. Further details on the process for CSP are available from the R&D Office ( ext 0251). Applications for NHS Permission through NIHR CSP must be made via the Integrated Research Application System (IRAS) at the following link:

Researchers who have started to complete applications in IRAS but have not yet made applications to R&D offices should contact the NIHR CSP Unit at for guidance. If in error you bypass this route for eligible funders, the R&D Office will return your application to your for CSP submission which will delay the process.

Commercial Studies

If your study is sponsored by a commercial organisation you will need to contact the King’s Health Partners Clinical Trials Office (KHP CTO) who will undertake the administration and contract negotiations for these studies. Please contact the R&D Office ( ext 0251) and we will advise you who to make contact with at the KHP CTO.

All other Studies

If your study does not fall under either of the categories above then please follow the guidance below on how to obtain R&D approval within SLaM.

Detailed Guidance on Completion of R&D Cover Sheet

Please complete all questions on the form. If you are unable to answer a question please contact the R&D Office for help, contact details are given at the end of these notes.

Question 4: Project Type

Please indicate which of the categories the project falls into.

a) If your project is externally funded (non-commercial) we require details of the funder and the Grant Code (IoPPN staff/students only) to enable us to link our system with that of Research Grants

b) If your project is a commercial study (where the commercial company is the sponsor, is responsible for the protocol and retains Intellectual Property and Publication rights) you will need to discuss your study with King’s Health Partners Clinical Trials Office (KHP CTO) (contact details available from R&D Office) who will undertake contract negotiations etc on your behalf.

c) If your study involves the administration of a substance (whether or not it is a Clinical Trial of an Investigational Medicinal Product (CTIMP) the R&D office will undertake a risk assessment of the project before giving R&D Approval. This is undertaken electronically and we ask therefore for you to e-mail a copy of your protocol to Jenny Liebscher () who will undertake this process on your behalf.

Question 5: Clinical Academic Group (CAG) approval

It is essential that the relevant CAG directorate(s) accommodating the research project approve the project before R&D Approval can be granted. Please discuss your project with the relevant contact as stated below. Please ensure that copies of e-mail correspondence are included when you submit your SSI form and R&D Approval Cover Sheet.

As well as details of the study, the CAGs will need to be provided with the following in order to assess the impact the study may have on services and activity:

• How many patients will be required for the study
• How they will be accessed/invited.

It is also important that you involve directorate clinical staff in the study where possible either as collaborators or by discussing and feeding back outcomes or observations to local teams.

SLaM CAG

Application process

Question 6: Recruitment Information

SLaM is required to provide quarterly data reports to the Department of Health on performance in initiating research. The expectation is that studies recruit their first patient within 70 days of the R&D office receiving a valid R&D submission. At the stage of R&D review we ask for an estimated date of first patient recruited within SLaM in order to enable us to identify any potential recruitment issues at an early stage.

If your study is on the NIHR portfolio and processed through NIHR CSP, we will receive this information directly from the CLRN. For non portfolio studies that are processed outside of CSP we will contact you quarterly to see the date on which the first patient is recruited.

Where the 70 days is exceeded we need to understand and report the reasons to the Department of Health. Where this occurs we will contact you for the reasons why, in some cases there will be a good reason as set out in the protocol.

The definition of a valid R&D submission has been defined as:

• A complete research application that has been received by the NHS provider following its submission via IRAS that enables regulatory reviews by other agencies (including but not limited to Research Ethics Committee and MHRA approval) to be conducted in parallel with the work on NHS permission by the contractor.
• For CSP studies, this will correspond to the valid application package for local review (i.e. the Site-Specific Information Form and associated documents, as set out in the IRAS checklist2) and, for non-CSP studies, the valid application package for both study-wide and local reviews (again, as set out in the IRAS checklist).

Question 7: Pharmacy Arrangements

If you project involves the dispensing of medicines it is essential that the manager of the pharmacy(ies) involved in the research project agree to the project before R&D Approval can be granted. Please discuss your project with the relevant pharmacy department. Please ensure that copies of e-mail correspondence are included when you submit your SSI form and R&D Approval Cover Sheet.

Question 8: Human Tissue (IoPPN Staff/Students Only)

Following the implementation of the Human Tissue Act 2004 there is a requirement for all holdings of Human Tissue to be licensed. The Institute of Psychiatry has a license from the Human Tissue Authority to retain such tissue associated with research. It is however mandatory that a log of retained tissue is maintained, we therefore require confirmation from the relevant contact that they are aware of your holdings prior to giving R&D approval. If your samples are going to be stored at the Institute of Psychiatry you should contact Claire Troakes. Please ensure that copies of email correspondence are included when you submit your documentation.

Question 9: ICT Requirements

Please include the names of all staff involved in the project that will need access to the selected SLaM IT system. You will then be sent the relevant request forms which should be returned to the R&D Office for processing.

Please note that access to medical records will only be granted within the terms of your ethics approval

Question 10. Clinical trials / interventions studies –requirements for recording research involvement in the SLaM patient health record:

Where the study is a clinical trial/interventional study and as such affects a patient’s clinical care, it is a Trust requirement to ensure that the patient’s participation in the study is noted in the patient’s health record, and include a copy of the patient’s consent form in the record. This is to ensure that information about patients’ involvement in clinical trials can be accessed at a later date, for example in the event of a serious incident investigation.

This can either be done by the research team or by the patients care co-ordinator or clinical team, but please take this requirement into account when organising your study within SLaM.

Documents to be submitted

Please see the final page of the R&D Cover form for details

Human Resources (HR) Arrangements for Researchers

If your research involves SLaM patients, data or facilities and you are not already employed by the Trust, in addition to requiring R&D permission for your project, you may need to be covered by an appropriate HR agreement before your research can begin.

The type of HR agreement you need will be assessed by the R&D office in accordance with the principles of the Research in the NHS: HR Good Practice Resource Pack (the Resource Pack) as part of the R&D governance approval process at SLaM. The Resource Pack describes streamlined arrangements, including the Research Passport System, for those wishing to conduct their research in the NHS. Researchers should familiarise themselves with the process flowcharts and guidance documents available on the NIHR website.

Depending on the nature of your research, it may be necessary for you to undergo specific pre-engagement checks, such as a Criminal Records Bureau (CRB) check and/or occupational health screening. The Resource Pack sets out procedures to enable researchers to demonstrate that the pre-engagement checks undertaken on them have been carried out in line with NHS Employment Check Standards. It is your employer’s responsibility to ensure that checks meet the requirements of relevant safeguarding and health and safety legislation. The algorithm of research activity and pre-engagement checks provides guidance on the requirements in particular research situations. NHS host organisations need to ensure that checks are commensurate with your research role, the type of research and their duty of care.

Where required, any new or additional pre-engagement checks should be arranged through your substantive employer. On occasion, however, it may be necessary for SLaM to repeat specific checks and/or request that additional pre-engagement checks are undertaken. It is advisable therefore to contact our HR Good Practice/Research Passport Lead (see below) early in the study set up phase to discuss the pre-engagement checks required for your research activity and ensure that these are undertaken in good time.

Please note the R&D office can only process your request once confirmation of the necessary pre-engagement checks has been provided through either the Research Passport form for university staff or through the NHS to NHS proforma confirmation of pre-engagement checks for NHS-employed staff.

Key Documents:

• Research Passport form v3
• Research Passport form Appendix v2
• Research Passport Algorithm of Research Activity and pre-engagement Checks
• NHS to NHS confirmation of pre-engagement checks

For all questions/queries in relation to the procedure for obtaining a research passport/honorary contract or general queries in relation to pre-engagement checks please contact: Jenny Liebscher, SLaM R&D Governance and Delivery Manager ()

For staff employed by SLaM who wish to conduct their research at another NHS site and require an NHS to NHS proforma confirmation of pre-engagement checks, this will be done by SLaM HR, not the R&D office. Contact: SLaM Human Resources at the Maudsley Hospital

Timelines for common pre-engagement checks (should be used as a guide only)

The CRB aims to process 90% of Standard checks in 10 days and 90% of Enhanced checks in four weeks http://www.crb.homeoffice.gov.uk/faqs/applicants.aspx#howlong. You also need to allow time for your employer to work with you to complete and submit your CRB application form.

You will need to allow sufficient time to complete an occupational health assessment form, and depending on your research activity, this may result in you requiring additional checks and immunisations. Please note some immunisations can take up to six months to complete. Please refer to Part 2 of the Department of Health's "Green Book" (http://www.dh.gov.uk/en/Publichealth/Healthprotection/Immunisation/Greenbook/DH_4097254) for further details

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