INORMS 2018 and NHS regulatory changes

[Alison Lloyd]

Dear All,

I hope this email finds you well, and looking forward to the Easter break.

I have received some useful information recently, and I wanted to share this with you in case you would also find this useful.

INORMS 2018
The draft INORMS programme has now been announced – http://www.inorms2018.org/programme/2018/. There is a fantastic selection of research ethics and integrity themed talks detailing work that has been going on locally and globally. There are also plenty of opportunities to network and to learn more about other areas related to research administration. I hope you are able to attend the conference, and I look forward to meeting you there.

NHS regulatory news
• Capability and capacity decisions where no formal confirmation is required
Sponsors are now responsible for passing on capacity and capability decisions to associated organisations where no formal confirmation is required. In order to do this, organisations are advised to continue to keep accurate details on the R&D forum directory in order to ensure they receive all relevant information about studies the HRA judge as not requiring formal confirmation of capability and capacity. More information about this process can be found in the attached document.

• Health and Care Research Wales has aligned their processes and paperwork with that currently used in England
From the 16th April 2018 all researchers starting new applications in IRAS with sites in Wales will be required to complete a Statement of Activities (SoA)/Schedule of Events (SoE) rather than a Site Specific Information (SSI) form.

For submitted applications which have an SSI application in progress the process will not change. All applications will be accepted in Wales until the 10th June 2018, but after this date SoE/SoA will be accepted.

For more information, please visit the Health and Care Research Wales website.

• Radiation assurance process will launch on the 16th April 2018
The new Radiation Assurance process will launch on the 16th April 2018. The first phase will be available to all oncology studies involving ionising radiation taking place in the NHS. As this is a phased roll out, other study types will follow later in the year.

• Updates versions of the model agreements for commercially sponsored research in the NHS (mCTA and CRO-mCTA)
Updated versions of the model agreements for commercially sponsored research in the NHS (mCTA and CRO-MCTA) were launched on IRAS on the 1st March 2018.

I hope you find the above useful. I will be getting in touch in the next few weeks with a few ideas about how we can develop the SIG, and for ideas around future events/information sharing sessions, so if you have any thoughts in the meantime, please let me know.

With warm regards,

Alison

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