Detailed guide: How and when to submit research applications to ARSAC

Administration Of Radioactive Substances Advisory Committee

February 2
16:00 2018

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

Submit your study assessment to ARSAC

  1. Create a preliminary research assessment (PRA) form on the Integrated Research Application System (IRAS) for new studies which involve the administration of radioactive substances.
  2. Check and electronically sign all sections of the PRA form in IRAS.
  3. Email the PRA form to the ARSAC Support Unit with a copy of the participant information sheet (PIS) at the same time as you submit the Research Ethics Committee (REC) application to the REC. You do not need to send the research protocol to ARSAC.

Once ARSAC receives your application, you will be sent a reference number and details on how and when to pay the required fee depending on the type of study:

  • multi-centre studies: 350
  • single-centre studies: 300
  • low-dose studies (<1mSv total participant dose): 200

Applications by individual medical radiological installations

Under the Ionising Radiation (Medical Exposure) Regulations (IR(ME)R):

  • study sponsors should notify the practitioner (the nuclear medicine physician, for example) and the employer about the research protocol during set up, before any administrations take place at each medical radiological installation

  • the practitioner and the employer need to check that their licences under the IR(ME)R allow the administrations within the protocol

Please read the application forms and guidance to find more information on how to apply for licence.

If you have a valid research certificate

You do not have to do anything because IR(ME)R allows you to continue to legally administer the specified radioactive substances until this certificate expires.

If you do not have a research certificate for this study

Check with the practitioner whether the administrations in your approved research study are additional to standard care because:

  • if the administrations are additional to standard care, the employer and practitioner must authorise these exposures under a valid licence

  • if they do not hold a licence covering the procedures in the study, they must apply for new licences

  • if the administrations in your approved research study are equivalent to standard care, then you do not need to do anything; you can authorise these exposures under any valid routine certificate at that installation

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 the age of participants)
  • changes to the radiation risk information in the PIS following changes to the protocol

These changes normally meet the criteria for notifying substantial amendments to the REC or Gene Therapy Advisory Committee (GTAC).

The sponsor should notify the ARSAC Support Unit by email with the following:

  • 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 (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 PIS

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 is assessing the amendment, you remain authorised to continue administrations in line with the original application.

Once you receive approval, 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.

ARSAC Support Unit

Questions about applications

ARSAC Support Unit
Centre for Radiation, Chemical and Environmental Hazards
Public Health England

OX11 0RQ

Published 30 October 2014
Last updated 2 February 2018 +show all updates
  1. Updated guidance to reflect new regulations and include details of fees.
  2. Added 'amendments to research studies'

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