UNIVERSITY OF SHEFFIELD PROCEDURE FOR HEALTHCARE RESEARCH GOVERNANCE [nb.UoS sponsored Clinical Trials (ie. Any healthcare research study involving a human intervention) are administered by the team in R&IS. , please contact Catherine Wynn in the R&IS Quality and Governance Team, ext 21400, email@example.com]
Why Healthcare Governance? It’s where the Buck Stops. The process is controlled by the Health Research Authority’s Framework for Health and Social Care It ensures that a clearly designated organisation takes on the overall responsibility for the health care research project… The majority of Healthcare Research carried out within the University is sponsored by Sheffield Teaching Hospitals; other NHS trusts or private pharmaceutical companies. However, the University will sponsor research (but not Clinical Trials of Investigational Medicinal Products) where no other sponsor is appropriate (see Annex One of the Devolution Information).
What is covered by Healthcare Governance? Department of Health Definition of Healthcare Research: Research which is: - being concerned with the protection and promotion of public health - taking place in or by the Department of Health and the NHS - by Universities within the healthcare system which may have an impact on the quality of these services
Sponsors Responsibilities The Key Concerns of the Healthcare Research Governance Framework are: - to protect participants in Healthcare Research - To further strengthen scientific quality - to clarify accountabilities and responsibilities The Governance Sponsor must: Ensure that the healthcare research projects are adhering to any conditions set by research ethics committees (including procedures for informed consent) Have arrangements to monitor the health care research projects Have a system to record any adverse events, should they occur Have a system to inform service users and the public about the research Have arrangements to ensure that the research is appropriately disseminated Have a system for identifying, owning and exploiting research-based intellectual property
The University’s Approach The University has devolved the compliance with the RG Framework to the individual Investigators and their Heads of Department. This is set down in writing alongside the confirmation of the University’s sponsorship of the Research (see Devolution materials Annex 4) The work of the Devolved process is overseen by a sub committee of the Research and Innovation Committee: the Health and Human Interventional Studies Research Sub Committee. Clinical Trials (Human Interventional Studies) undergo an additional risk assessment to ascertain what level of process oversight is required. This contrasts with the approach of STH where the Clinical Research Office takes an active role in post award monitoring (for example, checking the content of the Project Site Files)
OVERVIEW OF THE TUOS PROCESS PRIOR TO INVOLVEMENT OF THE HEALTHCARE CONTACT (unless involved through an additional job role)
1. INITIAL DECISIONS STAGE (nb. This should already have been established prior to details being sent to the Healthcare Research Governance Contact) Decide if the project is a healthcare research project (consult: http://www.sheffield.ac.uk/ris/other/gov-ethics/governance/definition) Decide which organisation is the project’s research governance sponsor (consult: http://www.sheffield.ac.uk/polopoly_fs/1.121332!/file/sponsor.pdf) For work within the NHS it may be that an honorary research contract or letter of access is needed. If so, the Research Passport application form needs completing (consult the guidance: http://www.sheffield.ac.uk/ris/other/gov-ethics/governance/passport]
2. REGISTRATION STAGE: nb. In terms of Healthcare University: 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. There are guidance notes on how to do this at: http://www.researchoffice.dept.shef.ac.uk/shef-only%20/Tutorials/Student%20Governance.swf NHS: AND IF THE PROJECT INVOLVES THE NHS THEN ALSO Register the project with the NHS Trust(s) and/or Primary Care Trust(s) which are involved (the list of Trust R&D contacts is at: www.rdforum.nhs.uk/044.asp) Nb. RIS’s Pricing & Contracts team is automatically notified about all studies registered with the STH Trust 3. Healthcare Governance Sponsorship confirmation Confirmation of Sponsorship is the Responsibility of the Healthcare Research Governance Contact. The Devolved Process is outlined on the following slides
HEALTHCARE GOVERNANCE CONFIRMATION OF SPONSORSHIP CONTACT RESPONSIBILITIES: PROCESS OVERVIEW
Receive an email from the Pricing Team • Email received from the pricing team by the Governance Contact • The email includes: • - URMS number- Programme name/Project title • - Name and Department of Principal (Primary) Investigator (PI) • - Research governance sponsor(as on URMS) • If a funded project: confirmation that a letter confirming the award of funding has been received(which can be taken as scientific approval) • You should enter these details onto your Healthcare Research Governance Spreadsheet (found in the electronic Devolution Resources (see next slide)) • Project details should not be passed on to Research Finance by the departmental governance contact until the governance checks are complete (these checks are outlined in the following slides) • The details for non funded projects do not need to be returned to Research Finance, however, the project should not start until the Governance checks are complete and the Sponsorship confirmed
Record the stages of the Governance Check in the spreadsheet • (Blank Spreadsheet can be found in the electronic ‘Devolution’ resources) STEP 3 STEP 4 STEP 5 Included in Email from URMS Team Eg. progress/ people contacted/ description of evidence of sponsorship provided STEP 2 Complete if non UoS sponsor STEP 1 Enter these details if UoS is the sponsor (n/a if not) See note (under STEP 5, regarding conditional authorisation)
Research Governance Sponsorship Checks STEP 1: CONFIRM WHO IS THE RESEARCH GOVERNANCE SPONSOR Is it a funded project? If YES, move to STEP 2 If NO, contact PI to ask who the RG sponsor should be NB. The RG sponsor is not necessarily the same as the financial sponsor… see Annex 2 (of Devolution resources) (Slide 3) for guidanceon appropriate RG sponsors See Annex 3 (of Devolution resources) for template emails for seeking further information Nb. Prior to contacting the PI, it is worth looking through the future steps to determine what further information may be required so that the emails can be merged File and record the response. Then move to STEP 2
Research Governance Sponsorship Checks STEP 2: IF TUOS is not the Research Sponsor. Is the RG sponsor an organisation other than the University of Sheffield? - If YES, contact the PI to ask for a copy of a letter/email from the organisation that is the project's RG sponsor which confirms its agreement to be the RGsponsor (template emails are included at Annex 3 of the Devolution Documents) File and record the response. MOVE TO STEP 6 (Steps 3 – 5 are not required). - If NO, (i.e. if the University of Sheffield is the RG sponsor) move to STEPS 3 - 5
STEP 3: SCIENTIFIC APPROVAL (Uos Sponsored Projects): Has the project been independently scientifically approved? If YES, record date on spreadsheet and file a copy of the email from Pricing Team confirming this If NO, obtain written confirmation that the project has been independently scientifically approved (template emails are included at Annex 3) NB – Please read Step 4 before contacting the PI: it may be that evidence of both Scientific and Ethical review is required and therefore both can be requested in the same email.
STEP 4: EVIDENCE OF ETHICAL APPROVAL (UoS Sponsored): Obtain written evidence that the project has been independently ethically approved Contact the PI if necessary (template emails are included at Annex 3) [NB. ethics approval should not be sought until the project has been scientifically approved] Record and file the evidence Move to STEP 5 See next Slide (Step 4a) in the cases where Ethics approval needs to be sought via the NHS).
STEP 4A - ETHICS APPROVAL VIA THE NHS (UoS Sponsored Projects) IRAS application needs to be signed electronically by an authorised signatory from the applicants department (after a physical copy is signed and filed) IRAS authorisation should not be granted until a project is registered on URMS and the Research Governance contact has received confirmation of Scientific Approval. If the department wishes to do so, it can arrange for the departmental governance contact to automatically receive such emails and to have access to the relevant signatory’s password for the IRAS system, so they can electronically authorise the form on the signatory’s behalf (ensuring that a hard copy if signed first by an authorised signatory). A detailed guidance document about the electronic approval process is available in Annex 7 of the devolved materials [NB. Where a researcher is applying for NRES (i.e. NHS) ethics approval and needs to enclose the University’s certificate of insurance s/he should send an email to firstname.lastname@example.org requesting a copy of the certificate.]
FINAL CHECK: YOU SHOULD NOW HAVE... • Confirmation of who the RG Sponsor is • PLUS.... • IF THE RGSPONSOR IS NOT THE UNIVERSITY OF SHEFFIELD... • Evidence confirming that the RGsponsor agrees to take on this responsibility • OR • IF THE RGSPONSOR ISTHE UNIVERSITY OF SHEFFIELD... • - Confirmation of independent scientific approval • - Confirmation of independent ethics approval
STEP 5: ONLY REQUIRED IF THE RGSPONSOR IS THE UNIVERSITY OF SHEFFIELD Send RG Sponsorship Letter to the PI/ student This officially authorises the project to start on behalf of the University as Rgsponsor. Send the letter to the PI, cc. the Head of Department (if a student project, send to the student cc. the Head of Department and supervisor) (template letters are provided at Annex 4). The letter should be signed by one of the department’s authorised signatories. Record the date the letter was sent and file a copy. ADDITIONAL NOTE REGARDING CONDITIONAL AUTHORISATION In some cases, projects may need to commence BEFORE independent ethics approval has been sought (i.e. if the aspect of the project requiring ethics approval will not take place until a later stage in the project, but the funding needs to be released immediately by Research Finance). In such cases, a CONDITIONAL letter authorising the project to start can be sent, and STEP 6 followed; however, evidence of ethics approval must be provided by the PI as soon as possible, and a standard authorisation letter should then be sent to the PI and a copy emailed to the Pricing Team.
STEP 6:FOR FUNDED PROJECTS ONLY Email the Pricing Team in Research & Innovation Services to confirm that governance checks on the project are complete Attach EITHERthe evidence confirming that the RGsponsor agrees to take on this responsibility ORa copy of the letter authorising the project to start (or conditional authorisation letter if applicable) (a template email is included at Annex 3 of the Devolution materials) STEP 7:FOR ALL PROJECTS Ensure all relevant documents are filed and record keeping is up to date (for guidance, refer to the record keeping factsheet at Annex 5).
Supporting guidance and documentation for the administration of the procedure are provided on the following pages, as follows: Summary Devolved Governance Procedure supported by: Annex 1: Flow diagram showing the full research governance procedure for researchers Annex 2: Guidance on establishing who the Research Governance Sponsor should be Annex 3: Template emails for key stages in the process Annex 4: Template sponsor authorisation letters Annex 5: Record keeping factsheet and example spreadsheet Annex 6: Template email responses to common queries Annex 7: IRAS electronic authorisation – guide for authorisers
GOVERNANCE PROCESS University wide oversight is provided by the Health and Human Interventional Studies Research Sub Committee Meetings 4 times per year: Representatives: Medicine ScHARR Psychology Dentistry (on behalf of Dentistry, Nursing and HCS) University Ethics Committee Reports to University Research and Innovation Committee The team in R&IS also fulfil an ‘Intelligence’ function: looking for changes; responding on behalf of the University to consultations; attending workshop etc
AUDIT PROCESS (Under review by the Health and Human-Interventional Studies Research Sub Committee) Annual Review in Feb/ March 1. Submit Spreadsheet of recorded applications to RIS team 2. R&IS select up to 5 cases and request copies of the necessary documentation. 3. Results are reported to the HHISRSC and guidance/ assistance provided where identified Departmental visits by member of HHISRSC To be conducted throughout the 2014/2014 Academic Year. - primarily to assess the Departmental Monitoring of Low Risk Clinical Trials (Human Interventional Studies) - also review applications processed and feedback on the processes for Healthcare Governance