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Research

Research

Physical processing and storage of research data

The main rule is that personal data shall be stored in de-identified (see the list of definitions) form. There must never be a higher level of personal identification than that required for the research. You will rarely need to register research participants' names or personal ID numbers.

Sample size can be significant in relation to whether personal data is deemed adequately de-identified or anonymised (see the list of definitions). If the sample is small, more personally identifiable information must be removed from the personal data in the de-identification/anonymisation process than would be necessary for a bigger sample.

The documents shall be marked 'contains research data' or similar. The marking must be in a clearly visible place.

Research samples and other raw material that is not anonymised must be stored and processed with respect for the donor of the material, and in such a manner that confidentiality, integrity (accuracy) and accessibility are safeguarded.

Research samples

Research samples should be stored as de-identified samples, cf. Section 27 of the Health Research Act.

For storage in cupboards/freezers, the cupboard/freezer must be lockable with a lock to which access can be regulated. If the cupboard is in a room that is in general use, it is recommended that a safe or a cupboard with two doors is used to make it difficult to break into it. If the cupboard is stored in a room that is not in general use, an ordinary lockable cupboard may be sufficient. The objective is

  •  to ensure that research participants' privacy is protected if the samples are stored with personally identifiable information,
  •  to ensure that unauthorised persons do not use cupboards/freezers and put in/remove samples.

When processing research samples, you must ensure that no unauthorised persons are present in the room.

The cupboard/freezer must be fireproof and have smoke detectors and fire extinguishing equipment/a sprinkler system in the same room if the research samples are important in order to ensure verifiability.

Special rules for freezers:

  • Temperature monitoring is important to ensure the quality of the samples. The quality can be documented using temperature logs.
  • They must be placed in a room with sufficient ventilation, as they generate a lot of heat.
  • In the event of a power cut, it must be possible to use an emergency generator to ensure a sufficient electricity supply, so that the freezers maintain the right temperature (minus 80 degrees).

You must log when, who and for which purpose each time you handle the research samples.

You should use a barcode marking system to make it possible to efficiently handle large amounts of samples.

Paper-based research data that are not anonymised

When handling paper-based research data, the research data should be de-identified. The scrambling key for paper and personal data (in e.g. questionnaire surveys) should be stored separately.

Research data that are not anonymised should be kept in a locked archive or a cupboard to which access is controlled. If the cupboard is in a room that is in general use, it is recommended that a safe or a cupboard with two doors be used to make it difficult to break into it. If the cupboard is stored in a room that is not in general use, an ordinary lockable cupboard may be sufficient. See also the information security guidelines on storing, sending, sharing and deleting data (in Norwegian only). 

The cupboard must be fireproof and have smoke detectors and fire extinguishing equipment/a sprinkler system in the same room if the raw material is important in order to ensure verifiability.

If paper-based research data are stored in the office during working hours, you must lock the office when you leave it, see also the information security guidelines on physical securing of HiOA's premises (in Norwegian only).

There should be a procedure for storing keys/key cards for doors and cupboards.

You must log when, who and for which purpose each time you handle the research samples.

Resources

Definitions and abbreviations

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