Hertfordshire Hospitals R&D Consortium Incorporating West Herts Hospitals NHS Trust and East & North Herts NHS Trust STANDARD OPERATING PROCEDURE FOR RESEARCH THE START UP PROCEDURE FOR RESEARCH STUDIES Author s Name Author s Job Title Division Department F Smith Research & Development (R&D) Manager Medical Executive R&D Version number 2 Ratifying Committee Clinical Governance Ratified Date October 2009 Review Date October 2011 Manager responsible for review F Smith Job title of manager responsible for review R&D Manager E-mail address for this Manager Fiona.smith@whht.nhs.uk Source of Evidence (If applicable) MHRA, NRES Level of Evidence indicated National Referenced (Yes/No) Yes Key words (to aid searching) Research, study, procedure, start User Group Research Staff Previous version v1, Sept 2008 Location of archived copy R&D Office The Trust is committed to promoting an environment that values diversity. All staff are responsible for ensuring that all patients and their carers are treated equally and fairly and not discriminated against on the grounds of race, sex, disability, religion, age, sexual orientation or any other unjustifiable reason in the application of this policy, and recognising the need to work in partnership with and seek guidance from other agencies and services to ensure that special needs are met. 1
BACKGROUND Before commencing a research study it is essential to ensure that it complies with all legal and ethical requirements. The Research Governance Framework 2001 states that the Department of Health requires that research involving patients, service users, care professionals or volunteers, or their organs, tissue or data, is reviewed independently to ensure it meets ethical standards. The National Research Ethics Service (NRES) works with colleagues in the UK to maintain a UK-wide system of ethical review that protects the safety, dignity and well-being or research participants, whilst facilitating nd promoting ethical research within the NHS. Paragraph 3.10.4 of the Research Governance Framework summarises the main responsibilities of organisations providing care. These include that: they be aware and maintain a record of all research they ensure that: all research involving participants for whom they are responsible has ethical approval and a person authorised to do so has given written permission on behalf of the organisation providing care. INTRODUCTION Local Management approval is therefore required for all studies undertaken in the NHS. The s review research studies in the Trust to decide whether or not they should be allowed to proceed. The R&D department advises and assists researchers to get studies started and obtain the necessary approval. PURPOSE The purpose of this SOP is to describe the procedures for obtaining Ethics, Regulatory body and R&D approval prior to starting a research study. PROCESS WHO? It is the responsibility of the local investigator to liaise with the R&D department to ensure that the correct procedure is followed. It is the responsibility of the Director of R&D to sign off the study when ethics and R&D approval have been obtained. WHEN? The study documents should be sent to R&D at the same time as the project is submitted to NRES. 2
HOW? Initially it is important to establish the type of research study that is proposed. The type of Ethics application depends on many factors such as whether the study is single site or multi-site and whether there is to be a local researcher or not. A study should be identified as one of the following so that the correct approval procedure can be followed: Type of Study Single Site study with a Chief Investigator Multiple site study with a Trust site as the primary site and Chief Investigator Multiple site study with MREC approval and a local Principal Investigator MREC approved study previously specified as no local investigator (NLI) or SSA Exempt Required Approval Full Ethics and R&D approval Full Ethics and R&D approval R&D approval R&D approval Make sure that you have applied for any necessary approval and certificates from appropriate statutory regulatory authorities via IRAS (www.myresearchproject.org.uk). for research involving medicinal products see the website www.mhra.gov.uk, www.emea.eu.int or http://eudract.emea.eu.int). for research into uses of medical devices see the website for the Medicines and Healthcare products Regulatory Agency (www.mhra.gov.uk How we regulate Devices Clinical Trials. Please refer to the Research Governance Policy for additional information. Ethics Applications Guidance is available at www.nres.npsa.nhs.uk R&D Approval Please submit the following documents to wherts-tr.rdapplications@nhs.net Protocol Completed SSIF form (see ethics page for full instructions on the completion of this form) Copy of Ethics form parts A and B (pdf file) Copy of Ethics from parts A and B as XML file Patient Information Sheet Upon receipt of the above, the review of the project will commence. When available, please forward, electronically if at all possible, the following additional documents, to the Email address above SSIF signature pages Ethics approval letter MHRA Clinical Trial Authorisation (if applicable) Clinical Trial Agreement 3
Local versions of all approved patient documents (on hospital headed paper) Copies of any approved adverts or posters to be used Sponsors letter Costing pro-forma Hard copies of any documents not available electronically should be sent to R&D Department The Clock tower Mount Vernon Hospital Rickmansworth Road Northwood Middlesex HA6 2RN For researchers using CSP (Coordinated System for gaining NHS Permissions) please follow the guidance from the lead CLRN. RESPONSIBILITIES Chief investigator, investigators, other researchers: Developing proposals that are scientifically sound and ethical Submitting the design for independent expert review Submitting the study (or proposal) for independent ethical review Conducting a study to the agreed protocol (or proposal) in accordance with legal requirements, guidance and accepted standards in good practice Preparing and providing information for participants Ensuring participants welfare while in the study Arranging to make findings and data accessible following expert review Feeding back the results of research to participants Sponsor: Confirming that everything is ready for the research to begin: o taking on responsibility for putting and keeping in place arrangements to initiate, manage and fund the study o satisfying itself that the research protocol, team and environment have passed appropriate scientific quality assurance o satisfying itself that the study has ethical approval before it begins o for clinical trials involving medicines, seeking a clinical trial authorisation and making arrangements for investigational medicinal products Satisfying itself that arrangements are kept in place for good practice in conducting the study and for monitoring and reporting, including prompt reporting of suspected unexpected serious adverse events or reactions. Employing organisation: promoting a quality research culture 4
ensuring researchers understand and discharge their responsibilities ensuring studies are properly designed and submitted for independent review ensuring studies are managed, monitored and reported as agreed, according to the protocol providing written procedures, training and supervision taking action if misconduct or fraud is suspected Organisation providing care: Arranging for an appropriate person to give permission for research involving their patients, service users, carers or staff, before the research starts Ensuring any such research is conducted to the standards set out in the research governance framework Requiring evidence of ethical review before recruitment to any research that affects their duty of care Before recruitment to trials with medicines, requiring evidence of a positive ethical opinion and a clinical trials authorisation Retaining responsibility for the care of participants to whom they have a duty. 5