And don’t forget… ethics and R&D Susan Shenkin Questions to: Alex Bailey, Scientific Officer, South East Scotland Research Ethics Service alex.bailey@nhslothian.scot.nhs.uk

Aim Why, when and how to apply for ethics approval Why, when and how to apply for R&D approval

Ethics: Why? Protect participants from poor quality, dangerous or inappropriate medical research Ensure ethical principles and relevant legislation are complied with Facilitate, and sometimes improve, worthwhile research

Ethics: When? Research (not audit) Research = acquiring new knowledge Audit/service evaluation = assessing implementation of known knowledge Audit and service evaluations should be registered with a NHS Quality Improvement Team annette.henderson@luht.scot.nhs.uk Unsure? See NRES guidance or send copy of protocol to ethics or R&D for advice.

Ethics: When? Patients or users of the NHS Relatives or carers of NHS patients/users Access to the personal data or bodily material of NHS patients Foetal material and IVF involving NHS patients The recently dead in NHS premises The use of, or potential access to, NHS premises/facilities NHS staff recruited as research participants by virtue of their professional role Research just on staff, about their job, will soon not require NHS ethical review

Ethics: How? National Research Ethics Service (NRES) A single ethical opinion given by a Research Ethics Committee (REC) within 60 days of a valid application Fill out an application using IRAS https://www.myresearchproject.org.uk/ Make a reservation and submit a paper copy to the REC If valid you will receive an acknowledgement and a time/date for the meeting. If not valid, the application will be withdrawn

Timeline Max. days 7 28 7 21 Book meeting Submit application Receive letter stating application invalid Receive validation letter Meeting details 28 Attend meeting 7 In reality, you are looking at about 3 months Final unfavourable opinion Provisional opinion Final favourable opinion 21 Correspondence between REC and researcher

What do ethics committees consider? What do you hope to learn? (aims) How do you intend to do it? (methods) Will you get an answer? (statistics) Is it feasible? (funding, time, personnel) Participants: Risks, side effects, distress, inconvenience Coercion, role conflicts, over-studying Information sheets, consent forms, letters etc

Changes… http://www.nres.npsa.nhs.uk/ There are no LRECs or MRECs CTIMP (Clinical Trials of Investigational Medical Products), Adults with Incapacity, (other flags). Approach via Central Application System: 0845 270 4400 Non-CTIMP, non-AWI studies. Single-site or student research to a local REC. Multi-site to any REC. Approach directly: 0131 536 9126 Cross-border AWI studies need multiple reviews http://www.nres.npsa.nhs.uk/

Adults with Incapacity (AWI(S) Act 2000) Have to be reviewed by Scotland A REC (based in Edinburgh) Get consent from guardian, welfare attorney, nearest relative. Unlike England, not from a medic (unless the study is a CTIMP) Four key requirements: 1) Research into the condition for the benefit of the patient, their family or others with the disorder 2) Unable to get a valid and reliable answer using patients who can consent 3) Minimal or no foreseeable risk 4) Minimal or no foreseeable discomfort If unsure, contact ethics

Advice http://www.nres.npsa.nhs.uk/ PLAN: a minimum of 2 months to get ethical approval ASK: prior applicants, supervisor (but note change in system), R&D, ethics SERVICE ATTEND the meeting http://www.nres.npsa.nhs.uk/ http://intranet.lothian.scot.nhs.uk/NHSLothian/Corporate/A-Z/RAndD/ApplyingForRAndDApproval/Pages/EthicalApproval.aspx

R&D (NHS Management Approval): Why? All Health Boards must comply with the Research Governance Framework for Health and Community Care Management approval process coordinated by R&D departments. Meet once a week

R&D: When? Research involving NHS patients NHS staff NHS resources Approval within 30 days of valid application

How? NHS Lothian R&D Apply via IRAS Parallel to ethics Documentation depends on research Mandatory (Sponsorship, ethics, funding, protocols, site-specific approvals) Project-dependent (honorary contracts, radiation approval, etc)

Advice PLAN: ask R&D at study design stage BOTTLENECKS beware: Departmental sign-offs (Contact R&D) Honorary contracts Lisa.wellfare@luht.scot.nhs.uk Karen.Maitland@luht.scot.nhs.uk

Further information Try IRAS at: https://www.myresearchproject.org.uk/ National Research Ethics Service http://www.nres.npsa.nhs.uk/ IRAS training courses are available from the WTCRF http://www.wtcrf.ed.ac.uk/education/courses.htm Research starter pack: http://intranet.lothian.scot.nhs.uk/NHSLothian/Corporate/A-Z/RAndD/Documents/RS%20Pack%20July%202008%20v5.PDF NHS Lothian R&D: http://www.research.luht.scot.nhs.uk/