1. NHS Research Ethics Committees (RECs) WHY? (are we here) WHO? (are we) WHAT? (is our purpose) WHEN? (Everything you wanted to know about RECs but were too afraid to ask!)

2. Why are we here? The Nuremburg Code 1947  The Protagonists of the practice of Human Experimentation justify their views on the basis that such experiments yield result for the good of society that are unprocurable by other methods or means of study….. Certain basic principles must be observed in order to satisfy moral, ethical & legal concepts

3. Why? (are we here) cont’d The Voluntary consent of the human subject is absolutely essential. This means that the person involved should have legal capacity to give consent – Free power of choice – no fears, deceit, duress, coercion etc and have full comprehension of the subject matter – To make an understanding and enlightened decision.

4. Essential reading for all researchers  The Treaty of Helsinki – World Medical Assembly 1964 amended 1975, 1983, 1996, 2013 Recommended Reading:  ‘Informed Consent in Medical Research’ Len Doyal, J S Tobias, BMJ books 2001

5. In case you think that it could not happen again:  In the last century the Tuskagee Alabama Syphilis study with 300 black patients ran from 1932 studying the long term effects of untreated disease until uncovered in 1972.  In the US it was 1962 before injecting seriously ill patients with live cancer cells was stopped.  In Psychology Milgram’s pain experiments are most controversial (worth reading on the web)  >5% of all research in the UK is fraudulent!

6. WHO ? (are we)  Around 70 committees (dropping to 60 eventually) in UK & NI (7 in Wales)  Composition – 18 members, 12 expert, 6 lay  Payment – None! All volunteers, expenses only  Receive ongoing training (commitment)  Attendance – Must attend minimum 2/3 of meetings  REC Manager the only professional, but not a Committee member.

7. Who? (are we) cont’d  Reports to………No-one! But governed by a strict set of Standard Operating Procedures (SOPs) and Governance Arrangements for RECs (GAfREC)  Standards reviewed by the Health Research Authority (England) and Health & Care Research (Wales)  Wales REC 6 meet once a month > 6 proposals per month  Strict timescale  Issues ‘opinion’ not ‘approval’  Co-operates with R&D and Joint Study Review Committee.

8. What? (is our purpose) “The purpose of the Research Ethics Committee in reviewing a proposed study is to protect the dignity, rights, safety and well-being of all actual or potential research participants. In their decision making RECs need to have independence from political, institutional, profession related or market influence”.

9. The Things We Look At  Is the research objective achievable?  Statistics  Resources  Time  Confidentiality  Risk  Participant Information (Informed Consent)  Coercion  Safety of researcher  Insurance  Scientific / Peer review

10. Informed Consent  Is the information in the Participant Information Sheet (PIS) comprehensible to the participant?  Comprehension The average reading age in the UK is that of a reasonably educated 9 year old!  Recommended tool for the researcher – the SMOG Index.

11. SMOG – Simplified Measure of Gobbledygook  SMOG – is a mathematical formula that gives a readability level for written material. Readability is an attempt to match the reading level of written material to the “reading with understanding” level of the reader. The SMOG calculator can be accessed at http://literacytrust.org.uk/campaign/SMOG.html http://literacytrust.org.uk/campaign/SMOG.html

12. SMOG scores 0 - 6Very low literacy 7 – 8 junior high schoolUK school years 5-9 9-11 some high schoolUK school years 10-13 12 high school graduateUK A levels 13 – 15 some further college education - 16 University degreeDegree 17 – 18 19+ Post-graduate studies Post-graduate degree

13. Advantages  Free  Easy to use – cut and paste text into the calculator and it will calculate the score within seconds  Can be used to evaluate a block of text or a single sentence  Does not involve other processes like spellchecking.

14. WHEN?  As soon as you have written a tight proposal that has been scientifically / peer reviewed and is able to be clearly understood and consented to by the participants.

15. BEWARE  ‘In the prevailing climate of research there is the danger that physicians will come to view their patients as interesting rather than suffering, as available rather than in need’  Williams B. Listener 15 June 1967; 795

16. FINALLY  Despite what you may have been led to believe, the REC is not “a cul-de-sac to which ideas are lured and then quietly strangled” (Bullen K, 2007, personal communication)