Procedure Archiving Paper Informed Consent Forms

A question we often get from researchers is: 1) What should I do with the informed consent forms, 2) How long should I keep them, and 3) How do I store the consent for a longer time after the research is completed? As scientific integrity and the GDPR (deleting personal data as soon as possible) conflicted in these cases, it was difficult to find a good solution to these questions. Therefore, in consultation with the UT archival specialist, we have come up with a specific procedure to make paper consent forms digital and legally binding as scanning informed consent forms by yourself is not legally sufficient. In addition, this procedure is also suitable for research subject to the WMO (medical research). The ET faculty already facilitates this service, and we are happy to announce that this service is now available within BMS as well. 

BMS has set up a procedure for archiving paper informed consent forms collected during research projects involving human participants. We can facilitate this service immediately, however, we prioritize the researchers and sections in Cubicus given the need to clean up due to the renovation. 

PROCEDURE ARCHIVING PAPER INFORMED CONSENT FORMS

The following steps should be performed if you are planning to archive paper informed consent forms (after the completion of a research project) at the UT archive: 

1. During and after the research, the informed consent forms are stored at a secure location (e.g., the researcher/secretariat's locker). 
2. When the research is finished, and all necessary actions, like providing a copy to the participant, have been undertaken, the researcher fills (preferably digitally, to avoid handwriting reading errors) in the information form below (‘Intake form for archiving informed consent forms faculty BMS’).  
3. Store the information form in a folder with your research data and supporting materials (e.g., ethics form).  
4. Print a paper version of the information form, and put this on the outside of a sealed envelope that contains the research participant information letter and the informed consent forms of the participants.  
   1. Please check that the consent forms have all the necessary information 
   2. Include the research information letter/brochure that was handed out to the participants that informs on the details of your research for which the participants gave consent. It is enough to add this information letter once, and (if possible) not accompanied with every consent form, as this may result in an unnecessary workload for the archive procedure. Put the information letter on top of the bundle of forms, so that it is archived at first. 
   3. Please note that the default retention period is 10 years for archiving the digitalized informed consent forms but may vary based on your type of research (e.g., WMO research) and data processing goals. Note that only the original paper consent forms with a wet signature can be archived (no copies of consent forms). 
5. This sealed envelope can be handed in preferably to your secretary’s office. You or the secretary contact LISA-Archive record administrator Ronnie Harmelink (r.h.m.harmelink@utwente.nl) to pick up the envelope and store the envelope in a locker until they are picked up by LISA-Archive. 
6. LISA-Archive picks up the envelope and proceeds with archiving the informed consent forms. 
7. The consent forms, the information brochure, and the intake form are scanned into JOIN by LISA-Archive according to the guidelines of the replacement manual (see appendices 2 and 3 in the manual). Consent forms are part of Process 72 (research) of the selection list of Dutch universities and therefore fall under the authorization for replacement. 
8. After scanning, the paper forms are kept for 12 months and then destroyed following the replacement manual (see appendices 4 and 5). 
9. If needed, the researcher(s) or supervisor(s) as mentioned on the intake form on the outside of the sealed envelope, or the head of the research chair, can get access to the consent forms for the retention period mentioned on the intake form below, after contacting LISA-Archive.