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Research Governance in Essential Healthcare: Roles & Procedures at University of Sheffield, Study notes of Ethics

University Research CommitteesHealthcare Research EthicsGovernance in Higher Education

An overview of research governance processes at the University of Sheffield, including the roles of key committees, sub-committees, and individuals. It covers ethical approval, HRA approval, sponsor authorization, and other relevant approvals required for healthcare research. The document also includes contact information for departmental healthcare governance contacts and additional resources for applicants.

What you will learn

  • What are the requirements for obtaining HRA approval for healthcare research?
  • What types of studies require NHS REC review and HRA approval?
  • What is the role of the Health and Human-Interventional Studies Research Governance Sub-Committee?
  • What is the process for obtaining ethics approval for university-sponsored studies?
  • What are the responsibilities of the Research Governance Sponsor in healthcare research?

Typology: Study notes

2021/2022

Uploaded on 09/12/2022

lilwayne
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Download Research Governance in Essential Healthcare: Roles & Procedures at University of Sheffield and more Study notes Ethics in PDF only on Docsity! Essential Healthcare Research Governance Processes Cindy Cooper, Lindsay Unwin and Judith Cohen, UoS Aims • Overview of governance processes including recent changes to remit • Reminder of HoD and PI responsibilities • Remit of the Health and Human- Interventional Studies Research Governance Sub-Committee Chair Cindy Cooper Secretary Anita Kenny School / Department Representatives Medicine Liz Williams ScHARR Judith Cohen Psychology Andrew Thompson Nursing and Midwifery & Human Communication Sciences & Clinical Dentistry Nicolas Martin University Research Ethics Committee Peter Bath RIS Lindsay Unwin Research governance • Standards to improve quality • Planning and resourcing • Securing of authorisations • Ethical and scientific quality • Safety of staff and participants • Exploitation and dissemination of results Research Governance Framework for Health and Social Care •Protect human participants in research •Strengthen scientific quality •Clarify accountabilities & responsibilities of individuals and organisations Overview 1. The Initial Decisions stage  Does the Research Governance Procedure apply?  Who should be the sponsor?  Is it a human-interventional study?  Do I need a Research Passport? 2. The Registration stage URMS 3. The Approvals stage  Scientific approval  Ethics approval  HRA approval  Insurance 4. Sponsor authorisation & post award responsibilities 1. INITIAL DECISIONS STAGE - Does the Research Governance Procedure apply to your project? (consult: http://www.sheffield.ac.uk/ris/other/gov-ethics/governance/definition) Only if the research requires NHS REC review (part of HRA approval): http://www.hra-decisiontools.org.uk/ethics/ (…or needs other aspects of HRA approval – as a sponsor will be needed to sign off IRAS form even if NHS REC approval not needed) To clarify… IF YOUR STUDY DOES NOT: • NEED NHS ETHICS APPROVAL; or • INVOLVE THE NHS IN ANY OTHER WAY You don’t need governance! (but you will still need ethics approval if involves human participants/tissue/personal data) 1. INITIAL DECISIONS STAGE - If University-sponsored, is it a human interventional study? (consult: https://www.sheffield.ac.uk/ris/other/gov-ethics/clinicaltrials) University definition (only if University-sponsored): • ‘research studies designed to answer specific questions about interventions in human participants, whose purpose is to investigate the effectiveness of the intervention(s) & to assess clinical or physiological outcomes’ • Previously referred to as clinical trials Some examples: • Surgery and other interventional procedures; • Diagnostic tests; • Screening; • Behavioural and/or educational interventions designed to affect health; • Devices; • Administration of a food product; • Physiotherapy and/ or psychotherapy; • Administration of a cosmetic product; • Complementary therapies; • Administration of human whole blood products. 2. REGISTRATION STAGE (nb. In terms of Research Governance Procedure) - Register the project on the University Research Management System (URMS) (consult: http://www.sheffield.ac.uk/ris/application/pricing- URMS helpline: 222 1450) *This includes Student Projects even if they are not funded. The supervisor, who is formally the Principal Investigator, enters the details on URMS as a ‘student governance project’. (See guidance tutorial: http://www.researchoffice.dept.shef.ac.uk/shef- only%20/Tutorials/Student%20Governance.swf) …..Registering on URMS (and stating that the DoH Research Governance Framework applies) will alert your department’s Healthcare Research Governance Contact, who will contact you to request the necessary documentation….. 3. APPROVALS STAGE Confirmation of ethics approval: Possible routes for approval: - NHS REC (IRAS) - (Now part of HRA approval!) Needed if participants are identified from, or because of, their past or present use of NHS services (or relatives/carers) + other specific cases e.g. human tissue, CTIMPs etc: http://www.hra- decisiontools.org.uk/ethics/index.html - University - needed for ALL research involving human participants/personal data UNLESS obtained from other approved body e.g. NHS = May still apply even if NHS ethics not needed (different definition of research)!! - Alternative - other university/research organisations’ ethics review procedure (needs to be UREC approved) IRAS – Declaration by the Sponsor • IRAS applications need authorisation from the sponsor • If the University is sponsor: enter email address of departmental signatory and they will be sent an automatic email • Other sponsors will have own arrangements – contact relevant research support office • Also need to include certificate of insurance: consult http://www.sheffield.ac.uk/ris/other/gov-ethics/governance/insurance Departmental healthcare governance contacts Academic department Designated contact ScHARR Miss Ellen Nicolson ([email protected] - 25446) Clinical Dentistry Mrs Sue Spriggs ([email protected] – 817954) Dr Lynne Bingle ([email protected] – 817953) Nursing & Midwifery Mrs Andrea Lowery ([email protected] – 22053) Psychology For DClinPsy students: Mr Amrit Sinha ([email protected] - 26650); Others: Dr Tom Webb - 26516 Medicine Miss Anita Kenny ([email protected] – 21400) Human Communication Sciences Dr Traci Walker ([email protected] – 22420) Other academic departments Miss Anita Kenny ([email protected] – 21400) 4. SPONSOR AUTHORISATION STAGE Once all approvals obtained: - University will issue an authorisation letter confirming the research can go ahead Monitoring responsibilities of the PI: *Establish a site file, progress reporting (to HoD and funder), adverse event reporting, arrangements for recording, reporting and reviewing significant developments, arrangements to record, handle and, as appropriate, store all information collected Monitoring responsibilities of the HoD: * Review progress reports, review adverse events, ensure compliance with conditions of ethics approval, regular correspondence with PI (as appropriate for risk) Additional quality assurance process for human interventional studies only • Sponsorship letter sent to PI by R&IS after standard requirements of research governance procedure are met (Head of Dept. cc’d); – Low risk projects: PI completes self- certification statement, signed by HoD; – Medium/high risk projects: After the project goes live, Committee meets with PI to discuss management of project. Monitoring and audit • Departmental healthcare research governance contacts keep relevant records • Annual report of healthcare research projects & audit of some • Reviewed by Health and Human Interventional Studies Research Governance Sub- Committee Thanks to all involved!! • Regulations only apply to trials of medicinal products in human subjects • Medicinal products are substances which:  Prevent/treat disease  Are administered for diagnostic purposes  Restore, correct or modify physiological function • A clinical trial is an investigation intended to:  Discover or verify the clinical, pharmacological, and/or pharmacodynamic effects of one or more medicinal products  Identify adverse reactions  Study the absorption, distribution, metabolism or excretion • Clinical studies involving only medical devices, food supplements or other non-medicinal therapies are not covered by the directive When is a CTA required? Is your trial within the scope of the UK regulations? Examples of projects planned in UoS Probiotic supplement to relieve symptoms of Irritable Bowel Syndrome. • Clinical trial to investigate the putative beneficial effect of a probiotic supplement to relieve symptoms of Irritable Bowel Syndrome. • Commercially available product, LAB4, presented as a food supplement. • Patients recruited from outpatient gastroenterology clinics and asked to consume the supplement for 8 weeks. • Patients complete a questionnaire about their bowel health at intervals during the intervention. Medical Devices Trials • Although medical device trials are not covered by the clinical trials directive, other regulations apply • Medical Devices Regulations 2002 (and 2008 Amendment) require manufacturers of medical devices to submit details of planned clinical investigations to the MHRA and to report SAEs • Notification is not required if the device used is CE-marked for the purpose under investigation • Note that Apps and software can be classed as devices • Fees of £2 - £5k for MHRA approval Medical Devices Trials Medical Devices Directive, Article 1: ‘medical device’ means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of: ◄ — diagnosis, prevention, monitoring, treatment or alleviation of disease, — diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap, — investigation, replacement or modification of the anatomy or of a physiological process, — control of conception, and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means; (b) ‘accessory’ means an article which whilst not being a device is intended specifically by its manufacturer to be used together with a device to enable it to be used in accordance with the use of the device intended by the manufacturer of the device; Medical Devices Trials Software apps • Mobile devices can store personal information, are always switched on, have a light source and a camera that can take high quality images. They can also provide information such as orientation through built-in sensors. The use of this type of software for medical purposes has increased. • If these software applications meet the definition of a medical device, it will be regulated by MHRA as a medical device • There are a number of words likely to contribute to MHRA determining if an app is a medical device. These include: Amplify, analysis, interpret, alarms, calculates, controls, converts, detects, diagnose, measures, monitors The Clinical Trials Toolkit - Routemap iar National Institute for Health Research Funding Safety Secured Reporting Progress Reporting . Ongoing RaD Peer Trial is Management & ‘in the Consultation Review CTA Submission Abandoned Monitoring scope of the Reg} Gu > Funding ulations? PI ! roposal Permissions & Clinical Triat ‘Approvals MHRA End of Trial ‘Summary Obtained Inspection Declaration Report Archiving o= ? Sponsorship v - --O-- Trial Risk Confirm Final Trial Informed Audit Statistical Dissemination of Planning & Assessment\ Sponsor Management Consent Data Analysis Results Design Documentation Substantial Amendments Feasibility & R&D Submission Addition of Investigator 7 New Sites & Selection Cichecklist Investigators Protocol Before Seeking ‘ Development Approval t sodQbose, Key to Symbols Contracts & Agreements @ Urgent Satety Demonstrates processes that can Trial t Measures bbe done in pareltel Management & Trial i ‘ Demonstrates that not all Monitoving | [Documentation processes will apply to all rials GCA & Setious Temporary Halt or Trial does not a ee reac Early Termination Recommence = = Reporting ‘oi it Pharmacovigilance Sede for tals Trial win 9 ° ° Supplies = . Ret gg OQ O "Version 1.1 — August 2013. Please visit www.ct-toolkit.ac.uk to ensure you to all trials have the latest version of the routemap. CTIMPs at UoS • UoS cannot be the research governance sponsor for CTIMPs • Another sponsor would need to be agreed if projects are deemed CTIMPs • Students should not be the CI on CTIMPs • Always check with the MHRA if uncertain if the study would be a CTIMP • You may need to alter the project design if it is a student project Any questions for the committee?