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 a new application to ARSAC

Follow these steps to submit your application on the ARSAC online portal:

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 ARSAC 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.

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 can download the approval document from the online portal, this lists the approved procedures. 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 radioactive substances
• addition of a new study population with a different clinical condition (including changing of the age of participants)
• addition of healthy volunteers receiving administrations of radioactive substances
• changes to the radiation risk information in the PIS following changes to the protocol for the administration of radioactive substances

Such changes normally meet the criteria for notifying substantial amendments to the Research Ethics Committee. If you are not sure if your amendment requires ARSAC approval you can contact the Support Unit for guidance by email or telephone prior to submitting your application.

Follow these steps to submit an amendment application on the ARSAC online portal:

1. Create an Amendment to Research Application on the ARSAC online portal at the same time as you submit the notice of substantial amendment to the Research Ethics Committee. You will need to create an account if you do not have one already.

2. Complete all required questions and attach the following:

• notice of Substantial Amendment
• updated PRA form if there are changes to the number of administrations, to the procedures involving radioactive substances or to the study population (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 in IRAS)
• any other relevant documents, for example a participant information sheet or updated protocol for therapeutic studies

Further guidance on how to use the ARSAC online portal is available.

Once you have submitted your amendment application, ARSAC will send you details on how and when to pay the fee.

While ARSAC assesses the amendment, the previous approval is unaffected and administrations may continue as stated in the previously approved application form.

Once the study has been approved, an approval document will be added to the portal for you to download and share with participating sites. Individual installations can then proceed with the amended study for all procedures on their licence and the approval document. It is not necessary for each installation to notify ARSAC of amendments.

Research notifications

You should notify ARSAC through the online portal of changes to research trial titles to ensure the approval remains valid.

Notifications should be made to the ARSAC by following these steps:

1. Create a Research notification application on the ARSAC online portal. You will need to create an account if you do not have one already.
2. Complete all required questions on the online form and attach the supporting documentation requested.
3. Further guidance on how to use the ARSAC online portal is available.

Research approval fees

Once ARSAC receives your application, details on how and when to pay the fee will be provided through the portal depending on the type of study and your preferred payment method, that is:

• new multi-centre studies – £410
• new single-centre studies – £360
• new low dose studies (<1mSv total participant dose) – £260
• amendments to low-dose studies (<1mSv total participant dose) – £260
• amendments to multi-centre and single-centre studies with >1mSv dose – £310

There is no fee for research notifications.

ARSAC support unit

Email: arsac@ukhsa.gov.uk

Telephone: 01235 825006