A proposal for a model of informed consent for the collection, storage and use of biological materials for research purposes.

OBJECTIVE

To suggest a model of informed consent for the collection, storage and use of biological materials in local biobanks for health research purposes.

METHODS

Review of the major ethical issues related to collection, storage and use of human biological materials for research purposes.

RESULTS

An informed consent form for the collection and use of biological materials in a specific research project, and an informed consent form for the collection, storage and use of biological materials in a biobank were separately developed. Two main rules govern the proposed model, as follows: the informed consent for the use of biological materials shall (i) give donors sufficient information to take informed decisions about possible present and future uses of their biological materials and (ii) consider the specific biological and genetic aims of the research being performed.

CONCLUSION

Even if informed consent for the collection, storage and use of biological materials is a hard process, donors can actually be provided with sufficient information and choices to give a 'really informed consent'.

PRACTICE IMPLICATIONS

The proposed model can be a useful guideline for the development of specific informed consent forms to be used by researchers. It can also be a good tool to let the donors know which information and guarantees they can request from researchers.