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're 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 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 all participants would receive as part of standard care, for example a trial where all participants must have received a radioiodine therapy to be eligible


How to apply to ARSAC


Follow these steps to submit your application on the ARSAC online portal:
  1. Create a new project in the Integrated Research Application System (IRAS) for your new study. You should then complete the project filter page and identify in it that the study will involve exposure to radioactive materials. After completing the filter page the Preliminary Research Assessment (PRA) form should be listed in the Project Forms list in the Navigation Page view.

  2. Complete the full set of data for your project in IRAS. Once complete you should check and electronically authorise all sections of the PRA form in IRAS.

  3. Create a New Research Application on the ARSAC Online Portal. You'll need to create an account in the ARSAC Online Portal 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) and any other relevant participant information materials. If your study has gone through radiation assurance, you should attach F1 of the research exposure form. You should also note that the research protocol is only required for studies involving therapeutic nuclear medicine procedures.  

Once ARSAC receives your application, details on how and when to pay the required fee will be provided. The fee will depend on the type of study and your preferred payment method. For:
  • new multi-centre studies the fee is £410
  • new single-centre studies the fee is £360
  • new low dose studies (<1mSv total participant dose) the fee is £260
  • research notifications there is no fee
All communication will be made through the online portal, but you’ll also receive email notifications. Once approval for your study is in place you can download the approval document from the online portal so you can then share it. For further information on applying to ARSAC you should visit the ARSAC website. ARSAC contact details are available on the Contact Us page.


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Page last updated: 23 October 2024


 
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