It is the entity responsible for research that must decide whether an amendment is “substantial”. The decisive factor is whether the change may affect the research participants’ safety or could otherwise affect the risk-benefit assessment made during the previous review of the initial application.
Substantial amendments to an ongoing and previously approved study normally require ethical review and approval before they can be implemented.
It is the entity responsible for research that must decide whether an amendment is “substantial”. The decisive factor is whether the change may affect the research participants’ safety or could otherwise affect the risk-benefit assessment made during the previous review of the initial application. For example, new research may have revealed risks that were previously unknown, or new findings that could affect the scientific value of the study may have emerged.
Other examples of substantial amendments may include
- a change of entity responsible for research or of the principal investigator (PI)
- inclusion of more research participants
- addition of new units or study sites
- use of new methods or analyses of material already collected (under the same main scientific question).
Amendment or new application?
The Swedish Ethical Review Authority neither can nor may issue an advance notice of whether an application for amendment is necessary or not.
If a change to an original project is deemed too extensive, a new application must be submitted. This applies, for example, to a new study plan or research hypothesis, or to studying new groups of research participants with characteristics differing from those of the original subjects.
Applying for an amendment
It is the PI or the authorised representative of the entity responsible for research who applies for an amendment. The reference number and the project title of the application to which the change relates must be stated. The amendment application must contain a brief description of the change concerned and the reasons for it; an assessment of the balance between the risks and benefits of the project modifications; and, where applicable, an account of the changes to be made to information provided, including information given to the research participants.
Relevant documents regarding the amendment (the amended research plan and protocol, information to the research participants and more) must be attached to the amendment application. It must be submitted in the Ethix portal. Besides submission, the portal is also where notifications, decisions and other matters related to the application are posted.
In connection with amendments, the applicant certify that they have provided information about the amendment to all the operations concerned, the activities in which the research is to take place. The applicant also ensure that resources are available to guarantee the research participant’s safety. How the PI has ensured that resources are available at other sites than its own, is left to the PI to decide.
Annexes other than application form
Revised annexes from previously approved applications must be submitted with all changes marked, preferably by means of a tracked changes function. Any new radiation doses or biological sampling must be described in the application form. Other annexes that are associated with new modifications of the initial application must also, of course, be submitted. When a PI is replaced, the new PI’s CV must be submitted.
Normally, the Swedish Ethical Review Authority should reach its decision within 35 days after receiving a complete amendment application and the fee. If the application concerns a clinical trial of a medicinal product, a decision must be made within the said time limit.
The Swedish Ethical Review Authority’s ruling
Your application for amendment can be approved, approved subject to conditions, refused or rejected. For the application to be approved, the established requirements for approval under the Ethical Review Act must be met. In the event of rejection, the application is not examined on its merits.
An approval expires if the research has not commenced within two years after the decision has gained legal effect.
If a decision is not in favour of the applicant, the applicant may appeal the decision to the Ethics Review Appeals Board. The appeal must be filed with the Swedish Ethical Review Authority within three weeks of the appellant receiving the decision. See the Ethics Review Appeals Board website.
Amendment application form
For guiding purpose we provide an English translation of the application form. Note that this PDF cannot be used to apply for ethical review. The application has to be submitted in Ethix and be written in Swedish.