Guidance

How and when to submit research applications to ARSAC

Guide to submitting research applications to the Administration of Radioactive Substances Advisory Committee (ARSAC).

If you are a study sponsor you must obtain Administration of Radioactive Substances Advisory Committee (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

Submit your study assessment to ARSAC

Follow these steps to submit your application:

  1. Create a preliminary research assessment (PRA) form on the Integrated Research Application System (IRAS) for new studies that involve the administration of radioactive substances.
  2. Check and electronically sign all sections of the PRA form in IRAS.
  3. Create a New Research Application on the ARSAC online portal at the same time as you submit the Research Ethics Committee (REC) application to the REC. You will need to create an account if you do not have one already.
  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 online portal is available.

Once ARSAC receives your application, details on how and when to pay the 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.

Individual research sites

Study sponsors should notify the practitioner (for example, the nuclear medicine physician) and the employer under the Ionising Radiation (Medical Exposure) Regulations (IR(ME)R) about the research protocol during set-up, before any administrations take place at each medical radiological installation. Sponsors will be sent an approval document indicating which procedures have been approved. The Sponsor should provide the approval document to the practitioner and employer.

Amendments to research studies

You should notify ARSAC of any changes to a study involving the administration of radioactive substances because this may affect the approval granted. Changes include, but are not limited to:

  • changes to the number of administrations of radioactive substances from Section A1 of the original PRA
  • addition or removal of a procedure involving the administration of a radioactive substance
  • addition of a new study population with a different clinical condition (including changing of the age of participants)
  • changes to the radiation risk information in the PIS following changes to the protocol

Such changes normally meet the criteria for notifying substantial amendments to the Research Ethics Committee (or GTAC). Notification should be made to the ARSAC Support Unit, by email to ARSAC@phe.gov.uk. At this time, the online portal should not be used to submit amendments. Please include the following in your email:

  • short summary of the changes
  • notice of Substantial Amendment when this is submitted to the REC
  • updated PRA form if there are changes to the number of administrations or procedures involving radioactive substances (note: you will need to revise the integrated dataset Part A or B3, or both and then create an up-to-date PDF of the PRA form via the submission tab)
  • any other relevant enclosures, for example, a participant information sheet

Once you have submitted your amendment request, ARSAC will send you a reference number and details on how and when to pay the £250 fee.

While ARSAC assesses the amendment, you remain authorised within the limits of the initial submission and administrations may continue in line with the original application.

Once approval has been granted to you, individual installations can proceed with the amended study for all procedures on their licence. It is not necessary for each installation to notify ARSAC of amendments.

Research notifications

You should notify ARSAC of minor changes to research trials to ensure the approval remains valid. Changes include but are not limited to the following:

  • change to the research trial title
  • change to IRAS ID
  • closure of a trial

Notifications should be made to the ARSAC Support Unit by email to ARSAC@phe.gov.uk and are not subject to a fee.

ARSAC Support Unit

Email: arsac@phe.gov.uk

Telephone: 01235 825006

Published 30 October 2014
Last updated 1 September 2020 + show all updates
  1. Updated how to submit your study assessment to ARSAC, individual research sites and notifications.

  2. Updated guidance to reflect new regulations and include details of fees.

  3. Added 'amendments to research studies' section.

  4. Updated guidance on individual site applications - to be submitted by the ARSAC certificate holder.

  5. First published.