SAM and CURIOS@

Written by:Mark Holland, President to the Society for Acute Medicine

Endorsed by:Alistair Douglas, Immediate Past President to the Society for Acute Medicine

Nick Scriven, President Elect to the Society for Acute Medicine

Hannah Skene, Secretary to the Society for Acute Medicine

Sue Crossland, Treasurer to the Society for Acute Medicine

Distribution:Prabath Nanayakkara

Chris Subbe

Tim Cooksley

Mark Kramer

Louella Vaughan

Derek Bell

November 1st 2016.

Thank you to everyone for taking the time to write to me or speak to me about the Society for Acute Medicine’s (SAM) involvement with the CURIOS@ Study. As we all know, the issue raised relates to the study starting to recruit patients in the UK but prior to full ethics approval being received.

My understanding of the problem is as follows:

  1. Dr Chris Subbe was the UK lead for the study and very rightly sought ethical approval in November 2015
  2. A favourable ethical opinion was granted on 11/1/16 (Wales REC 5)
  3. R & D (Research and development) approval for all sites in Wales was granted on 1/6/16
  4. Health Research Authority (HRA)approval for England was granted on 11/8/16
  5. The study is questionnaire based. Most importantly there is clear agreement that no patients have come to any harm.
  6. Over the last 12-months the mechanism for obtaining multicentre ethics approval in the UK has changed. In essence, Dr Chris Subbe followed the right process in November 2015 and if the rules had not changed we would not face this current problem.
  7. However, the rules did change. To recruit patients in England, HRA approval was needed. Some sites in England started recruitment prior to the HRA approval in August 2016.
  8. There is agreement that recruitment in England should not have started when it did but this was appears to be a genuine mistake by the UK investigators.
  9. I was first made aware of this problem on Sunday 11th September 2016 at SAMEdinburgh / Past, Present and Future.
  10. My concern as SAM President was whether SAM had infringed the HRA’s rules.
  11. I am informed that CURIOS@ is related to collaborative working between colleagues in the Netherlands, who are leading the study, and acute medicine researchers in the UK. SAM has no material involvement with the study.
  12. Dr Louella Vaughan, the Chair for SAM’s Research Committee, sought permission from SAM Council to write to Dr Chris Subbe, in her role as Chair of the Research Committee, advising Dr Chris Subbe to directly inform the HRA. In response I declined the request as I wanted to know exactly what SAM’s role was in CURIOS@.
  13. Whilst conducting the investigation I have received a letter from the Dr Chris Subbe’s R&D stating that they are aware of the problem and are conducting an investigation.
  14. The site in England which prematurely started data collection was the University Hospital of South Manchester (UHSM), the local lead being Dr Tim Cooksley.
  15. I have spoken to the R&D Manager at UHSM, who is very experienced and previously worked with the HRA. I was reassured that this problem is not unique, and since the rules changed other studies have mistakenly started to recruit patients before full ethics approval has been granted.
  16. It was the opinion of UHSM’s R&D manager that this was not a GMC notifiable issue. However, I have been advised that the HRA must be made aware and that the responsibility for reporting lies withthe UK lead investigator site, namely Bangor.
  17. UHSM have contacted Bangor and Bangor is reporting this matter to the HRA. This is clearly the right thing to do.
  18. It appears that once audit checks have been completed at each recruiting site, any data collected prior to full ethics approval will still be valid for use in the study; approval will need to come from individual sites. The use of data collected prior to the full ethics approval is not a matter for SAM but for the sites collecting and submitting data and the study’s Principal Investigator.
  19. Inconclusion:

a)The CURIOS@ study started in the UK before full ethics approval was received.

b)SAM is not responsible for the study.

c)The premature start appears to be a genuine mistake.

d)Bangor will inform the HRA. There is still the possibility that a major investigation will be undertaken by the HRA/RECs. As Bangor are leading the study in the UK this a matter for Bangor to notify the HRA and recruiting sites.

e)All sites who have participated in the UK should be informed that the HRA are involved. Dr Vaughan informs me North Bristol and Northumbria are among the participating sites. This is not SAM’s responsibility but that of the UK Principal Investigator. Such sites may be subject to a HRA investigation/audit. It would be only right and proper that all UK sites are aware of the ethical issues as soon as possible.

f)The use of data collected prior to approval being granted is a matter for the Principal Investigator and individual UK sites.

g)SAM will not escalate this matter further as we believe the HRA are now involved and this is not a SAM sponsored study.

h)Any individual who disagrees with point g) is free to make personal representation to the HRA or GMC.

i)I am unaware of any patient who has come to harm through early recruitment.

As SAM President, my primary concern is for the integrity of the Society. I am happy that SAM has now fulfilled its professional obligations. We learnt a lot about ourselves and we must move forward, having made positive changes. In this later respect I have two clear objectives:

  • To develop SAM’s Research Committee.
  • To maintain SAM’s excellent links with our friends and colleagues in the Netherlands.

SAM Research Committee

As a relatively small organisation, and still very much in its infancy, we need develop a Research Committee with clear aims and objectives. We are constrained by finances, human resources and a large body of expertise. In the UK we have one Professor of Acute Medicine and one genuine centre for research at Imperial College.

In my first year as SAM President the piece of work I have identified as needing to change is SAM’s governance and structural processes. Whilst we have a robust constitution, we have expanded very rapidly and some of our structures are no longer fit for purpose. Thus refocusing the vision and structure of the Research Committee is part of a larger reconfiguration within SAM.

On November 29th and 30th2016 we are holding an extraordinary SAM Council Meeting to discuss our ‘VGS – Vision, Structure and Governance’. We have set the date for an extraordinary AGM in Cardiff on May 4th 2017, to approve the proposed changes, including regional representation on Council.

We need to focus on the 5-year strategy for the Research Committee and this should include:

  • Developing young researchers
  • Educating our members, especially around the basic fundamentals of research, such as ethics approval, funding, responsibility, governance etc. Many people have excellentresearch questions but sadly they are often lacking in their understanding of the rigors academia. We need to walk before we run.
  • Developing SAMBA – with a SAMBA Lead who has a clear mandate, embedded within a robust governance structure.
  • Placing acute medicine on the national research agenda – building on excellent work already undertaken by Dr Louella Vaughan.
  • Working collaboratively with colleagueswithin the UK and abroad.
  • What SAM cannot do is run research, certainly not yet, as we need to get the basics right first.

To fulfil the aims and objectives we need to restructure the Research Committee. Instead of being an open forum I suggest we have a fixed group of people. We can draw on expertise of individuals to join the steering groups of projects with which collaborate. A new committee might look like this:

  • Chair
  • SAMBA Lead
  • Editor of Acute Medicine
  • Executive member of SAM Council, e.g. Immediate Past President
  • ‘Lay Person’ – A leading academic to at act in an advisory capacity. This person would have a background in any acute specialty and their expertise would be academic as opposed specifically to acute medicine.
  • Representatives from Netherlands and Ireland
  • Trainee
  • Nurse or AHP

The committee will report directly to SAM Council. We will allocate a budget to the Research Committee to develop young researchers and to educate our members. The ethos will to develop acute medicine research from bottom upwards, as opposed to the top down

SAM and DAM

Our relationship with friends and colleagues in the Netherlands is very important to SAM. In changing our structures I hope that we can cement our relationship and build on all the good things we have done so far:

  • Representative to join SAM Research Committee
  • DAM to identify a link to regularly contribute to the SAM’s newsletter
  • SAMsterDAM 2 – provisionally for May 2018.

Summing-Up

I hope these thoughts are of use. In terms of developing the Research Committee we will have more details following our Council meeting in late November 2016.

I think we should see this experience as a learning opportunity. As I often quote in my presentations, ‘Out of a muddy pond ten thousand flowers bloom’. I hope to see a beautiful bouquet of daffodils, tulips and roses, garnished with thistles and shamrocks.