Procedure for archiving paper informed consent forms
What should you do with paper informed consent forms after completing a research project? How long should you keep them, and how can you store them securely during the required retention period?
To answer these questions, BMS has developed a procedure together with the UT archive specialist for the digitisation and long-term archiving of original paper informed consent forms. This procedure ensures that the digital version is legally valid. Simply scanning signed consent forms yourself is not sufficient for this purpose.
You can also use this procedure for research that falls under the WMO (Medical Research Involving Human Subjects Act).
The service is already available within the ET faculty and is now also available to researchers within BMS. You can use the service immediately. During the renovation period, priority is given to researchers and sections located in Cubicus who need to clear or relocate physical archives.
Procedure for archiving paper informed consent forms
Follow the steps below if you want to archive original paper informed consent forms in the UT archive after completing your research project.
1. Store the consent forms securely during and after your research
Keep the original signed consent forms in a secure location, such as a locked cabinet or locker. Only authorised staff should have access to them.
2. Complete the intake form after completing your research
Once you have completed your research and all required actions, complete the Intake form for archiving informed consent forms – Faculty BMS (below).
For example, if applicable, make sure that participants have received a copy of the consent form before you complete the intake form.
We recommend completing the form digitally to avoid errors caused by illegible handwriting.
3. Keep a digital copy of the intake form with your research documentation
Store the completed intake form together with your research data and supporting documentation, such as your ethics application and ethics approval or advice.
4. Prepare the documents for archiving
Print the completed intake form and attach it to the outside of a sealed envelope containing:
- the original paper informed consent forms;
- the participant information letter or brochure used for the study.
Before submitting the documents, check that the consent forms contain all required information.
You only need to include one copy of the participant information letter or brochure if you used the same version for all participants. Place it on top of the bundle so that it is archived first.
The standard retention period for digitised informed consent forms is 10 years. A different retention period may apply depending on the type of research, legal requirements or the purpose of the data processing. This includes, for example, WMO research.
Only original paper consent forms with a wet signature can be submitted for archiving. Copies cannot be archived through this procedure.
5. Hand in the sealed envelope
Preferably, give the sealed envelope to your section or department secretary.
The researcher or secretary then contacts LISA Archive record administrator Ronnie Harmelink at r.h.m.harmelink@utwente.nl to arrange collection.
Until LISA Archive collects the envelope, store it securely in a locked location.
6. LISA Archive collects the documents
LISA Archive collects the sealed envelope and starts the formal archiving process.
7. LISA Archive digitises and archives the documents in JOIN
LISA Archive scans the consent forms, participant information letter and intake form into JOIN in accordance with the UT replacement manual.
Consent forms fall under Process 72 (Research) of the selection list for Dutch universities and are therefore covered by the authorisation for replacement.
For more information, see the UT replacement manual (appendices 2 & 3).
8. The original paper documents are destroyed after 12 months
After digitisation, LISA Archive retains the original paper documents for 12 months. After this period, the documents are securely destroyed in accordance with the replacement manual (appendices 4 & 5).
9. Access remains possible during the retention period
If you need access to the archived consent forms, you can request access through LISA Archive during the applicable retention period.
The following people can request access:
- the researcher(s) or supervisor(s) listed on the intake form;
- the head of the research chair.