3. Recording, documentation, storage, custody, and sharing of data and biological or chemical materials arising from research

PRBB 0093.1. Data collection and storage
All research plans must include a system for collection of data, registries, and biological or chemical material arising from the research, along with a plan relating to their custody and storage.

3.2. Recording of data and alterations
Without exception, all data arising from experiments or research observations must be recorded. That information must remain permanently recorded in databases, registered notebooks, or other appropriate format, in a condition that facilitates external review. The records must also include changes, errors and negative, unexpected, or conflicting results, as well as an indication of the person who performed the experiment or made the observation.

3.3. Storage of data
The necessary means and infrastructure must be provided for correct storage and safekeeping of all documentation and biological or chemical material resulting from a research project. In the case of data recorded on electronic media, a specific plan will be included for the preparation and physical storage of backup copies.

3.4. Custody and access to collected data
All individuals who belong to the research group must be able to access information on the data obtained and their interpretation. The individual responsible for the research will have a single record accessible to third parties, of the locations of all samples and data-collection instruments (registered notebooks, databases, etc).

3.5. Ownership of data and samples
All primary documentation (registered data-collection notebooks, databases, etc.) and biological or chemical material obtained in the course of a research project is the property of the centre to which the person responsible for the research is affiliated[12]. Recording, storage, and safekeeping of that material are the responsibility of the individual responsible for the project. Should a researcher change institutions, the individual responsible for the project may make available a photocopy of part or all of the records, a copy of the existing electronic information, a photocopy of the data-collection notebooks, or aliquots of available biological or chemical materials, provided such sharing is necessary. A Material Transfer Agreement must be signed for all human biological samples (blood, serum, DNA, tissues etc). When the change involves the person responsible for the research, the director of the Centre will take responsibility for supervising this process.

3.6. Sharing of data and samples with outside parties
Data and materials arising from a research project must be publicly available and in a condition to be shared with outside parties, except in cases where restrictions have been established on the basis of possible future commercial use. Provision of data or materials will require that information be provided on the intended use by the person who has requested them, that the research group is aware of the request, that there is a material or data transfer agreement with the approval of the individual responsible for the research, and that the person making the request is willing to pay all possible costs of production and shipping. Sharing may be restricted for reasons of availability, competition, or confidentiality. Material or data obtained from human subjects must be shared in such a way that the subjects cannot be identified; if identification of individual subjects is possible, those individuals must first consent.

3.7. Length of storage of data and samples
All original primary information and biological and chemical material arising from a research project must be stored for a minimum of 5 years from the date of the first publication of the results, except in those cases in which the law allows shorter storage periods or requires longer periods to be applied. If the centre allows, the primary information and material may remain stored for longer periods, provided their final destination meets the approval of the person responsible for the research.

3.8. Falsification and fabrication
Falsification and fabrication of data are research misconduct and serious offences. Falsification is the modification, incomplete or inaccurate reporting of findings in order to deceive. Fabrication is the intentional misrepresentation of research results by invention of data, findings or procedures that were not conducted.

[12] This includes human tissue samples donated for research purposes. Although the tissue donor maintains the right to instruct if or when the tissue be destroyed, the material is the property of the research institute.


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