Help - Preparing & submitting applications - ARSAC
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ARSAC

Preparing and submitting applications to the Administration of Radioactive Substances Advisory Committee (ARSAC)



This page provides the following information:

When do you need to obtain ARSAC research approval


If you are a study sponsor you must obtain ARSAC research approval for all your research projects where the protocol:
  • Requires the administration of radioactive substances
  • Specifies the frequency, activity or processing for an administration that would otherwise be considered standard care

You do not need to obtain ARSAC research approval for research projects where:
  • The protocol does not specify any administrations of radioactive substances
  • The only administration of a radioactive substance mentioned in the protocol is an inclusion criterion that would be received by all participants as part of standard care, for example a trial where all participants must have received a radioiodine therapy to be considered eligible


How to apply to ARSAC


Follow these steps to submit your application:
  1. Create a Preliminary Research Assessment (PRA) form in IRAS for new studies, which involve the administration of radioactive substances. Note this form is generated by your responses in the project filter page and that PRA form is listed in the Project Forms list in the Navigation Page view
  2. Check and electronically authorise all sections of the PRA form in IRAS
  3. Create a New Research Application on the ARSAC Online Portal. You will need to create an account if you do not have one already. You should do this at the same time as you submit your IRAS application to the Research Ethics Committee.
  4. Complete all required questions and attach the PRA form and a copy of the participant information sheet (PIS). If your study has gone through radiation assurance, please attach F1 of the research exposure form. Please note the research protocol is only required for studies involving therapeutic nuclear medicine procedures. Further guidance on how to use the ARSAC Online Portal is available here

Once ARSAC receives your application, details on how and when to pay the required fee will be provided depending on the type of study and your preferred payment method:
  • Multi-centre studies: £350
  • Single-centre studies: £300
  • Low dose studies (<1mSv total participant dose): £200
All communication will be made through the online portal but you will also receive email notifications. Once the study has been approved the approval document will be added to the portal for you to download and share. For further information on applying to ARSAC, please visit the ARSAC website. ARSAC contact details are available on the Contact Us page.


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Page last updated: 02 Septemer 2020


 
IRAS Integrated Research Application System, version 5.16, 01/09/2020, IRAS Dataset version 3.5.
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