Types of informed consent | Definition | Advantages | Disadvantages |
---|---|---|---|
Specific, or fully restricted, informed consent | This is the classic type of consent, in conformity with bioethics declarations, recommendations and codes | Biological samples and data can only be used for immediate research. This model guarantees the maximum protection of the donor’s autonomy. | Prohibits research not authorized in the original consent. High costs of research. Possible loss of unused biological material. |
Partially narrow consent | A less rigid version of specific informed consent | Allows use of the biological samples and data for the immediate research and also for future studies directly or indirectly connected to it. | Narrowness –not too rigid- limited to the research goals stated |
Multi-layered consent | The typical type used in studies presented in the scientific literature. | Includes different options stating the knowledge goals to be reached through distinct but not yet specified studies. The donor can be asked to approve the use of samples for: 1)future studies of the same phase; 2) studies in research areas that are similar in terms of the pathology type (for example, diabetes, cancer, etc.); 3) future studies in independent research areas but on the same pathology (ex. pharmacokinetics studies, population studies, etc.) |
When the biological material is stored in a network of biobanks that manage studies with totally different goals [38], it may happen that the consent given is for a kind of research that is totally different from kind of study that researchers wish to do [38] |
Broad consent | The consent is not actually informed. Rather, it is a generic transposition of news, in consideration of the uncertainty of future research. | Permits the use of biological samples and their data for the research in question and also for the future study of any kind. | The rights of the subject are sacrificed to the interests of the study, contrary to the national and international legislation on the self-determination of subjects. |
Blanket consent | The biological sample obtained for clinical tests is stored in the biobank and remains there for an indefinite time. | Goals and research are not specified. The donor can refuse permission for the sample and data to be kept in the biobank. | |
Open consent | This type is used for the collection of biological material in populations | No limitations to the type of research allowed. | At the moment of donation, the donors give up their rights to the protection of their personal data and are aware that their privacy cannot be guaranteed. |