Biorepository is a collection of human biological material, collected and stored throughout the execution of a specific research project, according to regulations or pre-defined technical, ethical and operational standards, under institutional responsibility and under the management of the researcher, without commercial purposes.
The storage of any biological material in a Biorepository or Biobank must be indicated on the Brazil Platform for Basic Project Information Form, in the field “Will samples be retained for storage in a bank?”.
2. Storage and use of biological material:
- A Biorepository can only be constituted in association with a specific research project, with a breakdown of the conditions and responsibility for safekeeping and storage of the material, including those involving confidentiality of the identity of the participant from which the material originates.
- The use of this material is restricted to research purposes in the specific project. The possible use in other(s) project(s) is conditioned to the fulfillment of requirements listed in (4).
- Except in cases of authorized use in other project(s), the biological material stored in the Biorepository must be destroyed and discarded after the end of the project, or even after the period authorized by the Research Ethics Committee (CEP)/UNICAMP , greater than the duration of the project (maximum total period of 10 (ten) years).
- Alternatively, at the end of the storage period provided for in 2(.3), the biological material may be formally transferred to another Biorepository or Biobank. For this, it is necessary that it is regularized and authorized by the CEP/CONEP system, and that the transfer is communicated to the participant and approved by the CEP.
3. Participant's rights (which should also be explained in the free and informed consent form (TCLE)):
- Stored biological material belongs to the participant from whom the material originated. This is not a donation or assignment of rights over the material, but an authorization for its use only in a specific research project.
- The participant or his legal representative may, at any time and without any burden or damages, withdraw the consent for the safekeeping and use of the biological material stored in the Biorepository. For this, he must present a written document signed by him or his legal representative, requesting the withdrawal of consent, and the existing samples must be returned or the material must be destroyed in his presence.
- All project participants from whom said biological material was obtained will be guaranteed the guarantee that results obtained that are of interest to them and/or may have an impact on their health and/or treatment will be communicated to them and/or to the physician responsible for your treatment, if applicable.
- The participant will be informed if there is loss/destruction of their biological material, as well as in case of closure of the Biorepository and/or transfer of the material to another Biorepository or Biobank.
- The use of the material in other projects requires the participant's authorization (see (4)).
- If so desired, the participant may indicate successor(s) to whom he will assign his rights over his biological material, in case of death or incapacity.
4. About the use of Biorepository samples in other projects:
- The stored samples may be used in other projects previously approved by the CEP/CONEP system.
- For this, the participant's free and informed consent must be obtained by signing a specific TCLE for the new project.
- When based on the impossibility of obtaining the consent of the participant to use the sample in the new project, CEP/UNICAMP must be requested to waive the TCLE for the use of this specific biological material, which will only be granted if the justification presented is considered relevant by CEP.
- Regarding the transfer of biological material to another Biorepository or Biobank, see (2(.4)).
5. If the Biorepository involves more than one institution, in Brazil or abroad:
- Include in the constitution of the Biorepository the name of all institutions and respective participating researchers, discriminating:
- where and under whose custody which materials will be stored;
- the conditions for sharing the use of the material;
- planning on the destination of the material at the end of the project/storage period, and in case of dissolution of the partnership between the institutions for the specific project to which the Biorepository is associated.
- Attach to the regulation of the Biorepository documentation agreement between collaborating institutions (Term of Transfer of Biological Material -TTMB), declaring the terms of the partnership and presenting the information contained in the paragraph above, such as conditions of storage, custody and use of the material, and ensuring ( if applicable) the commitment to use the material exclusively for research purposes, patenting and commercial use being prohibited.
- In this case, all decisions that depend on authorization from the CEP/CONEP system must be forwarded to the CEP of the institution to which the person responsible for the project is linked.
For more information, consult CONEP Resolution 441 of May 12, 2011 (https://conselho.saude.gov.br/resolucoes/2011/Reso441.pdf).