SLaM/IoPPN R&D Office Sponsorship Guidance – V15
This guidance is for researchers (including students) at the Institute of Psychiatry, Psychology & Neuroscience (IoPPN) or South London and Maudsley NHS Foundation Trust who require confirmation of sponsorship for health research applications that come within the remit of the Health Research Authority, this includes NHS Research Ethics, HRA approval (required for any study that involves the NHS), HRA CAG section 251.
Please note: As of 31 March all studies that take place within the NHS in England are required to apply for HRA approval. This this is in addition to the NHS ethics and other health research applications. Details of HRA approval can be found here: http://www.hra.nhs.uk/about-the-hra/our-plans-and-projects/assessment-approval/. General information about the Health Research Authority (HRA) and approvals for health research can be found here: http://www.hra.nhs.uk/
Sponsorship
The sponsor is the institution or organisation which takes on the legal responsibility for the initiation and management of a research study. The sponsor is required to review and sign off research applications before submission and maintain oversight during the life of the study. These functions are managed by the SLaM/IoPPN R&D office where the study involves South London and Maudsley NHS Foundation Trust (including where SLaM has been awarded external funding for the study).
Where a study has no SLaM involvement but involves King’s College Hospital and/or Guys and St Thomas NHS Foundation Trusts, the R&D offices at KCH or GSTT will be your point of contact and will assist you with sponsorship arrangements, including KCL lead sponsor sign off.
If you are a King’s College London researcher and your project doesn’t fall within the remit of the Health Research Authority it will be reviewed by the college ethics committee instead: http://www.kcl.ac.uk/innovation/research/support/ethics/index.aspx
If your study is using the NIHR/Wellcome Trust King's CRF at Denmark Hill, please note that from a research governance point of view the CRF is regarded as an NHS site; the governance for studies will come under either SLaM or KCH as follows:
- All studies overseen by IoPPN/SLaM PIs & recruiting SLaM patients or healthy volunteers will be processed for research governance approval by the SLaM R&D office.
- All studies overseen by KCH PIs and IoPPN clinical academics where their main research activity is in KCH who are recruiting KCH patients or healthy volunteers will be processed for research governance approval by the KCH R&D office.
Please be aware that the above arrangements include healthy volunteer studies with KCL college ethics approval. SLaM/IoPPN R&D office will undertake the sponsorship review and act as a co-sponsor for all KCL led studies where the governance comes under our R&D office. This means that if you are an IoPPN/SLaM PI and are conducting research on healthy volunteers and using the CRF, with KCL College ethics approval, you will also need to submit an application to the Health Research Authority for HRA approval in order to obtain SLaM approval to use the CRF. The sponsorship for this application will be managed through this office.
If your research project only involves recruitment of NHS staff as participants, it will be reviewed by the college ethics committee but will also need HRA approval and formal permission from the NHS Trust where the research will take place. Sponsorship for the HRA application will be undertaken by the SLaM/IoPPN R&D office where the research takes place within SLaM.
If your study is a service evaluation or audit rather than research, please contact the R&D office of the NHS Trust where the project will take place for guidance on how to obtain approval within that trust (for SLaM projects contact the SLaM/IoPPN R&D office)
Sponsorship review
The purpose of sponsorship review is to support you to ensure that your research project complies with national regulations pertaining to research, and with local organisational policies and procedures for IoPPN and SLaM.
The process for seeking sponsorship is as follows:
Please read the following sections first
· A. Appendices
· B. KCL insurance exclusions
· C. Institute of Psychiatry, Psychology & Neuroscience: requirement for college health and safety assessment
· D. Requirements for registration of clinical trials
Then go to:
· E. Sponsor sign off for IRAS research applications
A. APPENDICES
Please read any of the following appendices that apply to your study, if these haven’t been provided to you please request them from the R&D office.
· Appendix A - Protocol template and required inclusions (everyone, unless you are a student using your course protocol template)
· Appendix B - Peer review (for studies that have not undergone peer review as part of a competitive funding process that resulted in secured funding)
· Appendix C - Risk assessment (for all studies that involve administering a drug or substance)
· Appendix D – If you are taking any tissue samples (including blood, saliva, urine)
· Appendix E – local services and initiatives (Denmark Hill CRF, SLaM Consent for Contact, Centre for Neuroimaging Sciences, IMANOVA, BRC Bioresource)
· Appendix F – Training and resources
· Appendix G – SLaM/KCL Secure Voice Recordings guidance - please use this guidance if you are doing any audio recording as part of your study.
B. King’s College London insurance exclusions (KCL sponsored studies):
KCL insurance has certain exclusions, although it may be possible to obtain cover through insurers. Full details of the college insurance cover and exclusions are found here: https://internal.kcl.ac.uk/about/ps/finance/treasry/insure.aspx, the exclusions are listed below.
1. Injury to any subject in a pregnancy trial.
2. Injury to any subject who is under the age of 5 years at the time of the trial.
3. Any claim arising from Hepatitis or any condition directly or indirectly caused by or associated with Human T-Cell Lymphotropic Virus Type iii (HTLV iii) or Lymphadenopathy Associated Virus (LAV) or the mutants derivatives or variations thereof or in any way related to Acquired Immune Deficiency Syndrome or any syndrome or condition of a similar kind howsoever it may be named.
4. Any claim arising from the condition directly or indirectly caused by or associated with Creutzfeldt-Jakob Disease (CJD) variant Creutzfeldt-Jakob Disease (vCJD) or new variant Creutzfeld-Jakob Disease (nvCJD).
5. Trials or research involving more than 5,000 subjects.
6. Any overseas trial.
If you think your trial comes under one of these exclusions please send the following information to |, Finance Department, Room 8.20, James Clerk Maxwell Building.
1. Copy of the trial protocol.
2. Copy of the informed consent form.
3. Confirmation of the country where the trial is taking place.
You should expect confirmation that your research is agreed with the insurers and this should come
from Herman Codner once he has received confirmation from the insurers that they are content to take on the College’s risk. Without this confirmation KCL insurance cover will not apply and you will therefore be personally liable for any claims that may arise from the trial.
Please advise the R&D office if any of the exclusions apply to your study and foward the communications with Herman Codner. This will need to be done before we can confirm sponsorship
C. Institute of Psychiatry, Psychology & Neuroscience: requirement for college health and safety assessment (IoPPN researchers)
All research projects conducted by IoPPN researchers are required by the college to have a written health and safety risk assessment. These is to ensure that the college complies with Health & Safety law. Details are on the KCL Health & Safety webpage https://internal.kcl.ac.uk/about/ps/safety/general/riskass.aspx
Please note that this is a separate requirement to the IoPPN/SLaM R&D requirement for a risk assessment for studies involving a drug or other substance (see Appendix C). The college health and safety risk assessment comes under the responsibility of individual KCL departments rather than the R&D office. There is no requirement to forward details of your college health and safety risk assessment to the R&D office.
D. Requirements for registration of Clinical Trials (all researchers)
From 30 September 2013 all clinical trial applications which receive a favourable opinion from an NHS ethics committee are required to be registered on a publicly accessible trial register. This is a condition of the ethical favourable opinion and failure to register will be regarded as a serious breach of good research practice by the National Research Ethics Service (NRES).
Registration applies to the following categories of research, which are defined as the first four categories of the IRAS project filter question 2:
· Clinical trial of an investigational medicinal project (CTIMP)
· Clinical investigation or other study of a medical device
· Combined trial of an investigational medicinal project and an investigational medical device
· Other clinical trial to study a novel intervention or randomised clinical trial to compare interventions in clinical practice
It is expected that studies are to be registered before the first participant is recruited, however research given a REC favourable opinion will not be considered in breach of the favourable opinion if the study is registered within 6 weeks of the first participant having been recruited.
Formal confirmation that a study has been registered will need to be provided to the REC and to the R&D office as sponsor.
If you are unsure whether your study is a clinical trial or not, please contact us to discuss
E. Sponsor sign off for IRAS applications
Applications for NHS research ethics, HRA approval and HRA CAG s251 are made via the online Integrated Research Application System (IRAS). https://www.myresearchproject.org.uk/ .
The following documents are required for confirmation of sponsorship.
· Sponsorship request form
· CV for Chief Investigator
· IRAS form (for REC and HRA applications), HRA CAG IRAS s251 form (s251 applications) – these can be produced by going to your project on IRAS, selecting the relevant form from the left hand side of the screen, go to the ‘Save/Print’ tab, and then ‘Print this form for review’. Wait for the file to download (click ‘HERE’ if this doesn’t happen straight away). The pdf file of the application form will appear, save this file to your computer and you can then email the file as an attachment or save on disk.
· Protocol
· Confirmation of secured funding.
o Where there is external funding please forward the funding award letter along with details of which organisation has received the funding (for example, KCL or SLaM).
o Studentships - If you have been awarded funding from KCL for the purposes of your studentship, please forward the award letter from KCL.
o For non-student studies, where a study has not been awarded full funding, please contact the R&D office for an internal costings form. Unfunded studies will also require confirmation from the department or CAG involved that they are happy to support the study and this confirmation should be included with the documents for sponsorship review.
o If your study is funded by the BRC / BDU we do not need a formal award letter, but please advise us which BRC theme is funding the study, whether the BRC / BDU funding covers the cost of the entire study and forward any confirmation that you do have (an email is fine).
· Students: confirmation that your protocol has been reviewed and approved by your course supervisor, and for PhD students confirmation that your study is formally registered as a PhD project with the Institute of Psychiatry, Psychology & Neuroscience (IoPPN).
· Consent documents – please use the Health Research Authority guidance and templates: http://www.hra.nhs.uk/resources/before-you-apply/consent-and-participation/consent-and-participant-information/
· Protocol, participant information sheet and consent form: please read through the relevant sections of the HRA assessment criteria and standards document for details of what the HRA will expect to see in these documents (one example is that the information sheet and consent document and all other participant facing document should have the study title and IRAS project ID on them). The HRA assessment and standards document is on the HRA website here: http://www.hra.nhs.uk/resources/hra-approval-applicant-guidance/hra-assessment-criteria-and-standards/
· Confirmation of scientific review (either 2 x external reviews, or confirmation from R&D office, or competitively awarded external funding for single project)
· Confirmation completion of SLaM/IoPPN risk assessment (if your study involves a drug)
HRA Statement of Activities and Schedule of Events forms
Under the new HRA assessment process SSI forms are no longer required, instead the HRA require completion of Statement of Activities and Schedule of Events forms, details of these are here: http://www.hra.nhs.uk/resources/hra-approval-applicant-guidance/statement-activities-hra-approval/. The need for these documents is waived if the study is sponsored or co-sponsored by SLaM and SLaM is the only NHS site involved. If you do need to complete these forms you will be given assistance in doing this, for the moment please just forward the other study documents to the R&D office and we will contact you about the Statement of Activities and Schedule of Events forms once we have undertaken the initial sponsorship review.
Sponsor & administrative entries on IRAS
§ A6-1 IRAS
This section requires a lay summary. This will be published publicly by the National Research Ethics Service (NRES) along with a summary of ethical issues to fulfil requirements under the freedom of information act and also to come in line with requirements of the Clinical Trials Regulations.
§ IRAS A72
If any research activities with participants are taking place at the Institute of Psychiatry, Psychology & Neuroscience (IoPPN) please tick ‘educational establishment’. You do not need to tick this option if the activities at the IoP are limited to storing and analysing data.
§ IRAS A76 1 &2
If KCL will be taking on the role of sponsor or co-sponsor the “other” box will need to be ticked and quote details of the KCL insurance policy. A copy of the KCL indemnity documents should be included with the submission to ethics. These will be emailed to you by the R&D office when sponsorship is agreed.
If SLaM is taking the role of sponsor then you would need to tick the NHS indemnity answer.
§ IRAS A76 3
If the research is NHS based (whether or not it is SLaM or another NHS organisation) then you would need to tick the NHS indemnity answer. If you are not using the NHS then you would need to tick other again quote details of the KCL insurance policy.