Which changes to a protocol should be reported as an amendment? See a list here (in Danish) 

Amendments are submitted when they are ready; they do not have to await the submission deadlines for new protocols. 

Remember the following:  

• Update documents’ version number (in top text and filename) and date (in filename) 
• Only documents affected by the change(s) are to be submitted (and never the protocol summary) 
• Always use the "track-changes" function when updating documents for re-submission or amendments

The principal investigator and sponsor are to notify the Committee about the closing of the protocol within 90 days after termination of the project. The project is considered terminated when the last subject has been completed.

Reporting the closing takes place by submitting a form together with the final report or publication to the regional ethics committee by means of digital employee signature.

If the project is closed before the scheduled time, the Committee must be informed about this within 15 days from the time when the decision of closing the project is made. A reason for the termination must be given.

Download the form for closing a protocol here.

A protocol consists of the following sections: 

• The protocol (in either English or Danish) 
• The protocol summary (in Danish) 
• Information for participants (in Danish + English in case of English-speaking subjects) 
• Form for Declaration of Consent (in Danish + English in case of English-speaking subjects) 
• Advertisement for recruiting of subjects (in Danish + English in case of English-speaking subjects)) - may be omitted if subjects are recruited through, e.g. healthcare workers at a hospital 
• Additional material in the form of questionnaires etc. to be handed out to the participants during the experiment (in Danish + English in case of English-speaking subjects)) - may be omitted if nothing is handed out to the subjects 

• If you do not have a digital e-mail signature, please start by contacting AAU IT Support to have one. Please ensure that you have the signature well in advance of the date of submission 
  • Register the protocol electronically on the web-page of the Ethics Committee (in Danish) 
• Print out the form from the electronic registration - it must be signed by the principal investigator of the experiment and the sponsor (if any) 
   
• Send the following files together with a requisition number to Lone S. Andersen. An email with the documents will then be composed and returned to the principle investigator for submission to the Ethics Committee with his/her digital signature: 
  • The form from the electronic registration duly signed (File name “Elektronisk anmeldelse”) 
  • The protocol (File name "Protokol_v1_DDMMYYYY.doc") 
  • The protocol summary (File name "Protokolresume_v1_DDMMYYYY.doc) 
  • Information for participants (File name "Deltagerinformation_v1_DDMMYYYY.doc) 
  • Declaration of Consent (File name "Informeret samtykke_v1_DDMMYYYY.doc) 
  • Advertisement/letter/e-mail for recruiting of subjects, if any (File name "Opslag_v1_MMDDYYYY.doc") 
  • Other relevant material (e.g. questionnaires), if any (File name "Bilag_v1_MMDDYYYY.doc") 
  • Documentation for Principal Investigator: 
    • copy of health insurance card or driver's license 
    • copy of diploma 
    • short cv 
  • Documentation for Clinically Responsible Doctor and Sponsor (if any) 
    • short cv 
    • authorization number 

Overall guidelines for protocols to be approved by the Ethics Committee can be found here: 

Ansøgerguide (in Danish)

When your protocol (or an amendment protocol) has been approved by the Ethics Committee, please send a copy of the  

• electronic registration form 
• the approval letter  
• the approved version of the protocol/amendment protocol 

to Lone S. Andersen  

Each year the Ethics Committee is obliged to conduct a number of site inspections of ongoing protocols. As HST is a substantial contributor to the Committee in The North Denmark Region, we may very well expect that some of our protocols are selected for inspection. 

An inspection consists of two parts: 

• An interview with the principal investigator (PI) by 2-3 of the committee members about the procedures of the protocol especially with focus on the selection and enrolment of subjects. If requested by the committee, the interview ends with an inspection of the lab where the experiment has been performed. 
   
• A check of all project-related documents made by the secretariat of the committee. 

After the inspection, the Committee sends an inspection report to the PI. The PI can then give his/her comments and the Committee will deal with the inspection report on a Committee meeting. 

Therefore, it is important to emphasize the following for all HST researchers doing experiments on human subjects: 

It is mandatory that you always fulfill all ethic committee rules when doing experiments. Any negative evaluations from a site inspection may cause severe legal issues (fine or prison to the PI) and in addition significantly impair our chances of doing human experiments in the future. This would not only affect the individual PI, but the entire HST.

Based on previous inspections, it is of the utmost importance that: 

• consent forms are signed by the PI (unless the PI has given power of attorney to another person - the power of attorney must be present in the project folder; duly dated and signed) and that the consent forms have not been changed in any way compared to the approved version 
   
• protocol documents with the approved version number are present in the project folder 

Please also note that single methods from the approved protocols cannot be selected and used for stand-alone experiments unless this has been specifically approved by a protocol amendment. 

Further, please also note that if you add more researchers or students to the project group of the protocol, this must be notified by e-mail to the Committee (see also Amendments and Updated Documents). 

Projects handling personal data must be reported to the  AAU internal notification scheme with the Danish Data Protection Agency.  

The registration takes place online here.

Further information about personal data can be found here (in Danish). 

Registration of a student project depends on the purpose of the project: 

• If the purpose of the project is education/teaching, the project should not be registered with the Ethics Committee. 
• If the purpose of the project is research (obtaining new knowledge), the project must be registered with the Ethics Committee. A protocol is drawn up with the supervisor as the principal investigator. The protocol is subject to check with the Research Ethics Officer at HST before submission. 

Supervisors are to pay strict attention to the informed consent and participant information when students conduct protocols. The consent form and the participant information are to follow the approved documents exactly - it is not allowed to make any changes, including in the title of the project. 

HST has templates for each of the protocol documents; except the additional material. These templates should always be used. Download the templates below to ensure that you always use the most recent and updated templates. The templates are always updated with the latest requirements from the Ethics Committee. 

The templates contain all the mandatory headlines together with a number of standard texts or proposals for texts which are to be used in the application. Further, the templates include a mixture of explanations/translations (written in grey/orange italic) which are to be deleted after filling in the template. 

TEMPLATES  

When preparing your protocol, please note that the Ethics Committee has very strict rules for approval; i.e. all numbers, statements etc. in the material must be consistent, and none of the required sections can be omitted.