1. And don’t forget… ethics and R&D
Susan Shenkin
Questions to:
Alex Bailey, Scientific Officer,
South East Scotland Research Ethics Service

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

3. 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

4. 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
Unsure? See NRES guidance or send copy of protocol to ethics or R&D for advice.

5. 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

6. 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
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If not valid, the application will be withdrawn

7. 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

8. 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

9. 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:
Non-CTIMP, non-AWI studies.
Single-site or student research to a local REC.
Multi-site to any REC.
Approach directly:
Cross-border AWI studies need multiple reviews

10. 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

11. 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

12. 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

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

14. 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)

15. Advice PLAN: ask R&D at study design stage BOTTLENECKS beware:
Departmental sign-offs (Contact R&D)
Honorary contracts

16. Further information Try IRAS at: https://www.myresearchproject.org.uk/
National Research Ethics Service
IRAS training courses are available from the WTCRF
Research starter pack:
NHS Lothian R&D: